Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 1 of 51 1 2 3 4 5 6 7 8 9 10 11 12 Dena C. Sharp (State Bar No. 245869) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD SHARP LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dsharp@girardsharp.com jelias@girardsharp.com apolk@girardsharp.com Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com Amy M. Zeman (State Bar No. 273100) GIBBS LAW GROUP LLP 505 14th Street, Suite 1110 Oakland, CA 94162 Tel: (510) 350-9700 amz@classlawgroup.com 18 Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com 19 Counsel for Plaintiffs and Interim Class Counsel 20 [Additional Counsel on Signature Page] 13 14 15 16 17 21 22 23 24 25 26 27 28 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION IN RE PACIFIC FERTILITY CENTER LITIGATION ) ) ) ) ) ) ) ) ) Case No. 3:18-cv-01586-JSC FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT DEMAND FOR JURY TRIAL REDACTED FILED UNDER SEAL FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 2 of 51 1 TABLE OF CONTENTS 2 NATURE OF THE ACTION ................................................................................................................... 1  3 JURISDICTION AND VENUE ............................................................................................................... 3  4 INTRADISTRICT ASSIGNMENT.......................................................................................................... 4  5 PARTIES .................................................................................................................................................. 4  6 7 A.  Plaintiffs ................................................................................................................ 4  B.  Defendants ............................................................................................................ 4  8 9 10 11 12 13 1.  Prelude and Pacific MSO ........................................................................... 4  2.  PFC ............................................................................................................ 5  3.  Chart........................................................................................................... 6  FACTUAL ALLEGATIONS ................................................................................................................... 6  I.  for the Safe Storage of Plaintiffs’ Eggs and Embryos at the Time of the Incident. ......................................................................................................... 6  14 A.  Background on Cryopreservation and Freezer Storage. ....................................... 7  15 B.  PFC markets cryopreservation and freezer storage services as an insurance policy..................................................................................................................... 8  C.  PFC represented on its website, and in sales and marketing materials, that it would keep Plaintiffs’ eggs and embryos safe in a state-of-the-art facility..........9  D.  PFC to Prelude in September 2017 Without Advising Plaintiffs. ............................................................................... 11  16 17 18 19 20 II.  21 Precision and Care Are Required in the Retrieval, Cryopreservation and Storage of Eggs and Embryos. ......................................................................................................... 12  22 A.  The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. ................................................................................. 12  B.  The loss of eggs and embryos results in emotional distress, pain, and suffering. ............................................................................................................. 14  C.  Successful cryopreservation and storage depend on strict adherence to protocols. ............................................................................................................. 14  23 24 25 26 27 III.  Prelude Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. ......................................................................................................................... 16  28 i FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 3 of 51 A.  Prelude should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. ............................................... 16  B.  Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident................................................................................................................ 17  4 C.  Multiple investigations were opened after the Tank 4 incident. ......................... 18  5 D.  Prelude’s failure to keep Plaintiffs’ eggs and embryos safe and secure has resulted in harm................................................................................................... 18  E.  PFC’s communications regarding the incident have compounded the harm. ..... 20  1 2 3 6 7 8 PLAINTIFF-SPECIFIC ALLEGATIONS ............................................................................................. 22  9 CLASS ACTION ALLEGATIONS ....................................................................................................... 28  10 CLAIMS FOR RELIEF .......................................................................................................................... 30  11 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against Prelude and Pacific MSO) ............................................................................................ 30  12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 SECOND CAUSE OF ACTION Negligent Failure to Recall (Against Chart) ..........................33  THIRD CAUSE OF ACTION Bailment (Against Prelude and Pacific MSO) .......................... 33  FOURTH CAUSE OF ACTION Premises Liability (Against Prelude and Pacific MSO) ........ 34  FIFTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against Prelude, Pacific MSO, Chart, and PFC) ....... 35  SIXTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against PFC, Prelude, and Pacific MSO) ................................................. 39  SEVENTH CAUSE OF ACTION Fraudulent Concealment (Against PFC, Prelude, and Pacific MSO) ............................................................................................................................ 42  EIGHTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart)... 44  NINTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) ......................................................................................................................... 45  TENTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Consumer Expectations Test (Against Chart) .............................................................................................. 45  ELEVENTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) .................................................................................................................... 46  PRAYER FOR RELIEF ......................................................................................................................... 46  DEMAND FOR JURY TRIAL .............................................................................................................. 47  ii FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 4 of 51 1 Plaintiffs A.B., C.D., E.F., G.H., I.J., K.L., M.N., and O.P. (“Plaintiffs”), individually and on 2 behalf of all others similarly situated, file this First Amended Consolidated Class Action Complaint 3 against Defendants Prelude Fertility, Inc. (“Prelude”), Pacific MSO, LLC (“Pacific MSO”), Chart, Inc. 4 (“Chart”), and San Francisco Fertility Centers, d/b/a Pacific Fertility Center (“PFC”), and allege as 5 follows: 6 NATURE OF THE ACTION 1. 7 PFC markets and sells fertility services, including fertility treatment, egg and embryo 8 cryopreservation, and long-term freezer storage services. On its website and in sales and marketing 9 materials, PFC likens cryopreservation to an insurance policy for women and families, claiming the 10 services provide peace of mind to those who wish to defer having children and relief to those seeking to 11 overcome a diagnosis of infertility. 2. 12 Cryopreservation involves preservation of tissue—here, human eggs and embryos— 13 using cooling techniques. In the 1980s, facilities began using a cryopreservation technique known as 14 “slow freezing” to preserve human reproductive tissue. Cryopreservation became more prevalent after 15 the advent in the early 2000s of vitrification, a process by which tissue is cooled more quickly, leading 16 to higher egg and embryo survival rates. Eggs and embryos frozen through cryopreservation are stored 17 in specially designed metal tanks. 3. 18 The use of appropriate technologies and maintenance protocols is necessary to ensure 19 the safekeeping of cryopreserved eggs and embryos. Safe long-term storage requires backup 20 redundancies to guard against catastrophic failure, regular inspections of the tanks, and automated 21 temperature and fill-level gauges linked to alarm systems to notify staff immediately of a potential 22 failure. 23 24 25 26 27 4. Between 2010 and 2016 Plaintiffs decided to undergo fertility treatment at PFC and to procure long-term freezer storage services for their eggs and embryos at its San Francisco facility. 5. Unbeknownst to Plaintiffs, , which operates a national network of egg and embryo long-term freezer storage facilities, , Prelude, an unlicensed, non-medical corporation, 28 1 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC . Under Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 5 of 51 1 2 Prelude has no doctors on staff and provides only non-clinical services. Despite multiple 3 opportunities to do so, neither PFC nor Prelude notified Plaintiffs of the Prelude-PFC transaction or that 4 because of it, 5 (and the doctors it employs) . Instead, on its website and in other sales and marketing materials, 6 7 . 6. On March 4, 2018, Prelude discovered that the liquid nitrogen levels in a tank known as 8 “Tank 4” had dropped to an unsafe level for an undetermined period of time, destroying or jeopardizing 9 the eggs and embryos stored in the tank, including Plaintiffs’ stored tissue. Chart manufactured Tank 4. 10 7. Plaintiffs were first notified of the Tank 4 failure via an email sent at approximately 4:00 11 a.m. Pacific time on Sunday, March 11, 2018. The email described the failure as “a very unfortunate 12 incident” in which the storage tank containing Plaintiffs’ cryopreserved eggs and embryos “lost liquid 13 nitrogen for a brief period of time,” and stated that a “preliminary analysis” suggested some of the eggs 14 and embryos in the tank may have been destroyed. It has now been confirmed that a substantial portion 15 of the eggs and embryos contained in Tank 4 were destroyed in the incident. 16 8. Over a month later, on April 19, 2018, Plaintiffs and others whose eggs and embryos 17 had been stored in Tank 4 received another email—this time notifying them that an investigation had 18 revealed that the incident “likely involved a failure of the tank’s vacuum seal.” Four days later, on April 19 23, 2018, Chart recalled several of its cryopreservation tanks, citing “reports of a vacuum leak or failure 20 that could compromise the product.” 21 9. As of March 4, 2018, for operating Tank 4, monitoring Tank 22 4’s performance for fluctuations in temperature or liquid nitrogen levels, and maintaining safety and 23 backup systems to mitigate any harm that a tank failure might cause. But Prelude failed to safely 24 preserve the eggs and embryos under its care, including the eggs and embryos belonging to Plaintiffs. 25 10. As a result of the incident, Plaintiffs have suffered harm. For many, the tissue in Tank 4 26 represented their last and only chance for a biological child. PFC and Prelude have informed Plaintiffs 27 that it is not possible to know whether their eggs or embryos are viable until they are thawed and (for 28 eggs) fertilized and that, even then, the survival cannot be determined without attempting a pregnancy. 2 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 6 of 51 1 PFC has also warned the proposed class that attempted pregnancies with Tank 4 embryos may involve 2 “additional risks [that are] unknown at this time.” The resulting uncertainty has caused Plaintiffs—who 3 are now unable to generate eggs of the same quality as when their eggs were extracted—to experience 4 pain and suffering. 5 11. As to Prelude, Plaintiffs bring claims for negligence, premises liability, bailment, and 6 violations of California’s Unfair Competition Law (“UCL”) arising out of Prelude’s failure to 7 adequately store and maintain Plaintiffs’ eggs and embryos. Plaintiffs also assert omissions-based fraud 8 claims against Prelude for failing to disclose 9 , that it lacks a medical or tissue bank license, and that the processes it had in place to protect 10 Plaintiffs’ tissue were inadequate. As to Chart, Plaintiffs assert claims for strict products liability, for 11 negligent failure to recall, and under the UCL based on Chart’s defective design and manufacture of 12 Tank 4 and failure to warn of its defective nature. As to PFC, Plaintiffs assert omissions-based fraud 13 claims arising out of PFC’s failure to disclose 14 15 and that Prelude’s prevailing systems and processes in place for safe storage were inadequate. 16 17 JURISDICTION AND VENUE 12. This Court has subject matter jurisdiction over this action under the Class Action 18 Fairness Act of 2005, 28 U.S.C. § 1332(d), because (a) Plaintiffs are citizens of states different from 19 Defendants; (b) the amount in controversy exceeds $5,000,000, excluding interest and costs; (c) the 20 proposed class consists of more than 100 individuals; and (d) none of the exceptions under the 21 subsection applies to this action. 22 13. This Court has personal jurisdiction over Defendants. They conduct substantial business 23 in California and intentionally availed themselves of the laws and markets of this state. A significant 24 portion of the acts and omissions at issue occurred in California, and Plaintiffs and many class 25 members suffered harm in California. Plaintiffs’ claims against Defendants are meaningfully connected 26 to California in that: (1) each Plaintiff had eggs or embryos stored at PFC, which is located in 27 California and within the Prelude network; and (2) each Plaintiff had eggs or embryos stored in Chart’s 28 3 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 7 of 51 1 tank, which was physically located at PFC’s San Francisco facility, and which failed, resulting in 2 damage to Plaintiffs. 3 4 14. Venue is proper in this District under 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in this District. 5 6 INTRADISTRICT ASSIGNMENT 15. Assignment to the San Francisco Division is proper under Local Rules 3-2(c) and (d) 7 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in San 8 Francisco. PARTIES 9 10 A. Plaintiffs 11 16. Plaintiff A.B. is a citizen and resident of Wyandot County, Ohio. 12 17. Plaintiff C.D. is a citizen and resident of Wyandot County, Ohio. 13 18. Plaintiff E.F. is a citizen and resident of San Francisco County, California. 14 19. Plaintiff G.H. is a citizen and resident of San Francisco County, California. 15 20. Plaintiff I.J. is a citizen and resident of Contra Costa County, California. 16 21. Plaintiff K.L. is a citizen and resident of San Francisco County, California. 17 22. Plaintiff M.N. is a citizen and resident of San Francisco County, California. 18 23. Plaintiff O.P. is a citizen and resident of San Mateo County, California. 19 24. Given the sensitive nature of their claims and the services they purchased from PFC and 20 Prelude, Plaintiffs are using initials in this litigation to protect their privacy. If so directed by the Court, 21 Plaintiffs will seek permission to proceed under these pseudonyms. 22 B. 1. 23 24 Defendants 25. Prelude and Pacific MSO At all relevant times, Defendant Prelude Fertility, Inc. was a Delaware corporation 25 headquartered in Florida. Prelude operates the largest frozen donor egg bank in North America, in 26 addition to a network of egg and embryo storage facilities—including PFC—across the country. 27 28 26. Prelude was founded in 2016 by startup entrepreneur Martin Varsavsky with a $200 million investment by New York-based Lee Equity Partners. Prelude’s stated business plan is to create 4 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 8 of 51 1 a national network of egg and embryo storage centers. According to Varsavsky, “What Prelude does is 2 bridge the gap, it makes people’s biology meet their psychology” through “The Prelude Method”: “You 3 freeze your gametes when fertile, thaw them and create embryos when ready, genetically sequence the 4 embryos, and then transfer one embryo at a time. And you continue to do this until you achieve your 5 desired number of children.” 6 27. 7 September 2017. 8 28. 9 Prelude added PFC to its national network of fertility clinics and storage facilities in In conjunction with its transaction with PFC, on September 15, 2017, Prelude formed Pacific MSO, LLC, a wholly owned subsidiary, . Pacific MSO is a Delaware corporation with its principal executive 10 11 12 13 office located at 55 Francisco Street, Suite 500—the same location as PFC’s office. 29. Prelude describes “egg freezing, in vitro fertilization (IVF), genetic screening of embryos, and donor egg matching” as part of “Prelude’s comprehensive services.” Prelude, independently or through its qualified subsidiary Defendant Pacific MSO, 14 . At 15 16 the time of the incident, . 17 18 19 31. Pacific MSO provide only non-clinical (i.e., non-medical) services and do not employ any physicians. 2. 20 21 22 23 Neither Prelude nor Pacific MSO is licensed to provide medical services. Prelude and 32. PFC PFC is a private unincorporated entity located at 55 Francisco Street, Suite 500, San Francisco, California 94133. 33. PFC was founded in 1999 and advertises a full range of fertility services, including egg 24 cryopreservation, IVF, genetic testing, “cutting-edge laboratory techniques and technology such as . . . 25 vitrification,” and storage of cryopreserved eggs and embryos. 26 27 34. At all relevant times, Plaintiffs’ eggs and embryos were stored at a laboratory located at PFC’s San Francisco facility. 28 5 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 9 of 51 1 35. At the time of the incident on March 4, 2018, Tank 4 was located at PFC’s San 2 Francisco facility. 3. 3 Chart 4 36. Defendant Chart, Inc. is a Delaware corporation headquartered in Georgia. 5 37. Founded in 1992, Chart is a publicly traded global manufacturer of equipment used in 6 the production, storage, and application of industrial gases. Chart produces a variety of cryogenic 7 equipment. On its website, Chart states that its “focus is cryogenics.” Chart claims that its products 8 “utilize our proprietary vacuum and insulation technologies, including storage equipment,” and that 9 “[o]ur industry-proven core-competency provides the highest insulation thermal performance in 10 cryogenics[.]” Chart holds itself out as “a recognized global brand for the design and manufacture of 11 highly engineered cryogenic equipment” and a “leading global manufacturer of vacuum insulated 12 products and cryogenic systems.” 38. 13 Chart, through its MVE brand, sells a line of cryogenic equipment that includes freezers 14 and metal storage tanks. Chart claims that its MVE brand “is the benchmark for biological storage 15 systems, used for the cryogenic preservation of human . . . tissues.” 39. 16 Chart states that its “cryobiological storage products include vacuum insulated 17 containment vessels for the storage of biological materials.” Chart describes the competition for 18 cryobiological storage products as “significant” and notes that “competition in this field is focused on 19 design, reliability, and price.” 40. 20 21 Chart designed and manufactured Tank 4, the storage tank in which Plaintiffs’ eggs and embryos were stored on the date of the incident at issue in this lawsuit. FACTUAL ALLEGATIONS 22 23 I. for the Safe Storage of Plaintiffs’ Eggs and Embryos at the 24 Time of the Incident. 25 41. Prelude claims that it is “on a mission” to provide “the best options, science, and care so 26 everyone can have the opportunity to be a mom or dad when they are ready.” According to Martin 27 Varsavsky, Prelude’s Founder and Executive Chairman, and self-described “serial tech entrepreneur”: 28 6 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 10 of 51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The Prelude method is for anyone who would like to have healthy babies when they are ready. To increase the chances of having healthy babies when they are ready. . . . . Right now we live in a society in which we leave to chance one of the most important aspects of our life which is to have children. We leave it to chance and frequently we face adverse outcomes. . . . What we want is . . . for people to have healthy babies in a reliable way. . . . To work on your career when you want to work on your career, to do your maternity when you want to do your maternity . . . . 42. As alleged below, as of September 2017 for the safe storage of Plaintiffs’ eggs and embryos. Safe storage requires maintaining functional alarm, monitoring, liquid nitrogen autofilling, and backup systems—all safety measures PFC represented on its website that it had in place to ensure the safe storage of Plaintiffs’ eggs and embryos. A. Background on Cryopreservation and Freezer Storage. 43. Cryopreservation is the process of vitrifying (freezing) eggs and embryos and is conducted by personnel after a doctor has retrieved the necessary biologic material from a patient. Freezer storage is the service that provides for the storage of the vitrified eggs or embryos and is overseen by non-clinical personnel. Freezer storage facilities are often in different locations from the clinics where doctors retrieve the biologic material, and sometimes are even in different locations from the facilities where the cryopreservation was performed. 44. Successful storage of eggs and embryos requires stocking the storage facility with the necessary and appropriate equipment (such as tanks, controllers, liquid nitrogen autofillers, and alarms), properly maintaining that equipment, logging the results of regular inspections, and adhering strictly to the systems and protocols in place to protect against harm to eggs and embryos that may result from tank failure, changes in temperature, or declining liquid nitrogen levels. 45. Stocking a storage facility with the proper equipment and strictly following the designated protocols is of critical importance given the value of human eggs and embryos to the individuals and families who deposit them for safekeeping. 46. Human eggs, also known as oocytes, are a limited resource. According to PFC, a woman has about one million eggs at birth, and this supply diminishes at the rate of about 1,000 per month, beginning at her birth. This decline is part of the natural aging process and is commonly referred to as a woman’s biological clock. The loss of oocytes from the ovaries continues in the absence of menstrual cycles, and even when women are pregnant, nursing, or taking oral contraceptives. In addition, as PFC 7 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 11 of 51 1 acknowledges on its website, egg quality diminishes with time, with miscarriages and chromosomal 2 abnormalities occurring more frequently for women who are older at the time of pregnancy. By their 3 early-to-mid 40s, it becomes very difficult for women to conceive a child naturally. 4 47. The purpose of egg and embryo cryopreservation and storage is to allow women and 5 their reproductive partners to preserve their reproductive material so that they may be fertilized (for 6 eggs) and implanted (for embryos) at a later time. Prelude highlights egg freezing on its website as a 7 means of preserving options, and allowing women to “[f]ind that right person. Focus on your career. 8 9 10 11 12 13 Finish your education. . . . Freeze your eggs to preserve your option to build a family when you're ready. . . Set it and forget it until you’re ready.” 48. PFC emphasizes on its website and in sales and marketing materials that egg and embryo cryopreservation and storage allows for flexibility in family planning. That, in turn, PFC notes, gives women freedom, including the freedom to wait for the right child-rearing partner or to focus on their careers during their most fertile years. 14 15 16 B. PFC markets cryopreservation and freezer storage services as an insurance policy. 49. According to its website, PFC provides egg and embryo cryopreservation services (up 17 until the point of storage) as a means of preserving “a precious resource, limited to just a few years of 18 your life[,]” and further states that cryopreserving eggs and embryos “can increase your chances of 19 conception by 5 to 10 times.” 20 21 50. and insurance in family planning by purchasing its services: 22 6 Reasons to Preserve Your Fertility Today! (1) For a future family . . . (2) To allow for educational pursuits . . . (3) To have time to develop a business or career . . . (4) To give your relationship time to mature . . . (5) To reduce the risk of medical treatments that might impact fertility . . . (6) To achieve control over your future. 23 24 25 26 PFC—through its website—emphasizes that people like Plaintiffs can achieve flexibility 51. PFC also promotes—on its website and in sales and marketing materials—its egg and 27 embryo cryopreservation services to people diagnosed with infertility, which it describes as a 28 “workable challenge.” 8 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 12 of 51 1 2 3 52. Infertility is defined as the inability to conceive after one year of unprotected intercourse if a woman is under the age of 35, or after six months if a woman is 35 or older. 53. For many individuals and couples experiencing infertility, PFC’s embryo 4 cryopreservation services represented their only hope of having a biological child or of having 5 children who are biological siblings. 6 C. PFC represented on its website, and in sales and marketing materials, that it would keep Plaintiffs’ eggs and embryos safe in a state-of-the-art facility. 54. Before Plaintiffs’ purchases of cryopreservation and storage services, PFC—on its 7 8 9 website and in its sales and marketing materials—emphasized (and it continues to emphasize today) 10 that eggs and embryos will be safely stored, indefinitely, for future family planning. The below 11 representations can all be found on PFC’s website and existed there prior to Plaintiffs’ purchases of 12 frozen storage services. 13 14 15 16 17 18 19 55. PFC states that its customers’ “[e]ggs remain frozen until you need them” and that “there is no limit to how long cells remain viable in the frozen state.” 56. Regarding embryos, PFC similarly explains that some customers “have come back after 10-15 years and the embryos have been thawed successfully and created healthy babies.” 57. PFC claims that its facility is state of the art, meeting a “gold standard,” and that it has a large and experienced staff dedicated to the “care and well-being of eggs, embryos and sperm.” 58. The main techniques to cryopreserve eggs and embryos have been slow freezing and 20 vitrification. With slow freezing—first used in 1986—it takes about two hours for eggs to reach final 21 storing temperature. Starting in the mid-2000s, eggs and embryos began to be preserved through a rapid 22 cryopreservation process called vitrification. 23 59. Vitrification is a more advanced and reliable technology that PFC describes as being 24 “used in the embryo and egg freezing process so that they can be stored for later use.” PFC states the 25 newer vitrification process is safer than earlier slow-freezing technologies, which could lead to 26 crystallization threatening the viability of cryopreserved tissue. “Avoiding ice formation in this way,” 27 PFC represents, “successfully protects the embryos from damage and allows them to be warmed later 28 9 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 13 of 51 1 giving survival rates consistently above 90%.” “Over 90% of frozen eggs, on average, survive the 2 freeze-thaw process” according to PFC. 3 60. PFC further states that all eggs and embryos are stored in vacuum-lined liquid nitrogen 4 tanks—“like a large thermos flask”—that “are computer controlled and monitored 7 days a week with a 5 dedicated alarm system.” 6 61. PFC claims that liquid nitrogen “is very stable and easy to work with” and that each tank 7 is equipped with numerous sensors to monitor temperature increases above ‒196°C or a drop in the 8 level of liquid nitrogen. PFC also represents that the sensors “are connected to a telephone alarm 9 system that will alert staff to an alarm condition outside of normal working hours. . . . The alarm 10 system is tested weekly and continues to run on battery power in the event of a power failure. The 11 alarm system can also be checked remotely.” When a tank alarm goes off, the on-call embryologist is 12 supposed to arrive within 30 minutes regardless of time of day and must conduct a physical inspection 13 of the tank before the alarm can be turned off. 14 62. PFC further claims that, in addition to constant electronic monitoring, each tank “gets a 15 physical inspection daily, looking for problems or signs of problems,” and that the amount of nitrogen 16 in the tank “is assessed as a means of monitoring for a possible slow leak or an impending tank failure.” 17 18 63. are needed because the nitrogen in the tanks continuously evaporates at a slow rate: 19 Embryos and sperm in freezers don’t actually need power at all, provided that we physically fill the cryo tanks with liquid nitrogen once or twice a week. The computers that usually monitor and automatically fill these tanks do need power of course, but they are not essential to maintain refrigeration. 20 21 22 23 24 25 26 27 On its website, PFC emphasizes its use of liquid nitrogen autofillers, which it represents 64. PFC also emphasized on its website that a functional monitoring, alarm, and autofilling system mitigated any risk presented to Plaintiffs’ eggs and embryos, explaining that computerized controllers were constantly monitoring and addressing any issues: “the computer is monitoring and maintaining the liquid nitrogen levels most of the time in the same way that the autopilot on an airplane does most of the flying.” 65. PFC likewise advertises the durability of its tanks and storage facility on its website: 28 10 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 14 of 51 The storage tanks require no power and would not be impacted by a power failure or blackout. They are made of metal and would probably survive a small or moderate fire. If the tanks were not physically damaged or knocked over in a disaster, they should survive intact. Even if no one was able to physically check the tanks, or if we were unable to obtain liquid nitrogen, the tanks should still maintain their temperature for several days. 1 2 3 4 5 D. PFC Advising Plaintiffs. 66. Plaintiffs and class members engaged PFC to provide egg retrieval, embryo creation, 6 7 8 9 10 in September 2017 Without and cryopreservation services. Many also paid PFC for long-term storage of their eggs and embryos after the cryopreservation services were complete. 67. In September 2017, without advising Plaintiffs, 11 12 13 14 15 16 17 18 19 20 21 22 23 24 69. 25 26 27 28 11 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 15 of 51 1 70. Prelude is a non-medical entity, has no license to perform medical services, and has no 2 doctors on staff. Concurrently with the Prelude-PFC transaction—months before the Tank 4 incident— 3 Prelude’s subsidiary, Pacific MSO, amended its articles of incorporation to reflect that “[t]he 4 Corporation is no longer engaging in the profession of medicine . . . .” 5 71. 6 . Prelude also did not disclose 7 8 9 that it was unlicensed, or that its employees were wholly nonmedical. II. 10 Precision and Care Are Required in the Retrieval, Cryopreservation and Storage of Eggs and Embryos. 11 A. The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. 72. People who engage in fertility services and cryopreservation make large monetary and 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 emotional investments. They endure painful and invasive procedures, financial stress, and the strain the process puts on their mental health and relationships with others, all in the hopes that one day they will be able to have a child. 73. Women take drug and hormone cocktails and injections over several weeks to stabilize the uterine lining, stimulate ovaries into producing follicles, and stop these ovary follicles from releasing eggs. Then, after an ovulation trigger injection, eggs are collected under sedation or a general anesthetic. A woman may be subjected to multiple injections each day, resulting in bruising, swelling, and discomfort. The drug and hormone therapy may also trigger other side effects, such as tiredness, nausea, headaches, and blood clots, as well as negative emotions. The process can limit travel and other activities, and often requires time off from work. The retrieval procedure itself requires insertion of a thick needle through the vaginal wall to drain the ovary follicles of their fluid. After the procedure, a woman often experiences residual pain for about a week and may need bed rest for several days. Some women suffer significant side effects, such as ovarian hyperstimulation syndrome, requiring hospitalization. 28 12 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 16 of 51 1 74. PFC acknowledges on its website that undergoing egg retrieval is “emotionally trying” 2 and physically demanding. PFC recognizes that “the time and energy that is needed, both physically 3 and emotionally can drain even the staunchest crusader.” 4 75. Infertility is associated with anger, depression, anxiety, marital problems, and loss of 5 self-esteem among prospective parents. PFC warns customers online that they may experience intense 6 anger, despair, and guilt, and that it is “is very common to experience symptoms of anxiety and 7 depression as a result of this experience.” 8 76. The egg retrieval process compounds these emotions and stresses. For many, this 9 process represents their last hope for having children. Each cycle can produce anxiety and fear that not 10 enough eggs will be retrieved, or that the eggs retrieved will not be of a high enough quality. Multiple 11 cycles are often required. Many women experience and express strong feelings of anxiety, failure, 12 hopelessness, and disappointment during this process. 13 14 15 77. Prelude is also aware of the vulnerability experienced by individuals going through the egg retrieval and embryo creation process. 78. Egg retrieval, embryo creation, and cryopreservation services are costly. Customers pay 16 more than $8,000 for a single cycle of egg retrieval, which includes clinical monitoring, 17 cryopreservation, and one year of storage. Additional cycles cost $6,995 each. On its website, PFC 18 recommends storing more eggs than a woman typically produces in a single cycle. It is not uncommon 19 for women to undergo three or more egg retrieval cycles. 20 79. Embryo creation services are even costlier: PFC charges $11,595 for basic IVF, 21 including clinical monitoring, egg retrieval, lab processing, and embryo transfer. If a customer chooses 22 to use Comprehensive Chromosome Screening to select the healthiest embryo to transfer, PFC’s basic 23 IVF cost rises to $16,085. 24 25 26 80. After freezing, Plaintiffs and other customers paid approximately $600 per year for Prelude’s storage of their eggs or embryos. 81. The above amounts do not include the costs of in-person consultations ($375 each 27 consultation), pre-cycle lab work, egg cryopreservation medications ($2,000‒$6,000), embryo 28 transferring ($2,845‒$4,460), and embryo transfer medications ($300‒$600). Customers typically also 13 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 17 of 51 1 pay thousands of dollars for fertility drugs leading up to egg retrieval, and often spend hundreds of 2 dollars on acupuncture and other services recommended to improve outcomes. The entire process often 3 costs tens of thousands of dollars. 4 B. The loss of eggs and embryos results in emotional distress, pain, and suffering. 5 82. Prelude and PFC are aware of the lengths to which people go to obtain eggs and 6 embryos, how much these eggs and embryos mean to their customers, the customers’ emotional (and 7 financial) investment in the survival of the eggs and embryos, and the customers’ expectations that 8 great care will be taken to preserve and protect the eggs and embryos to avoid irreparable harm. 9 83. As women age, the quantity and quality of their eggs diminish. The most determinative 10 factor in IVF success is the woman’s age when her eggs were extracted. At some point, usually around 11 her mid-40s, a woman can no longer produce viable eggs. Even if additional eggs can be retrieved, one 12 cannot replace 35-year-old eggs with 40-year-old eggs and expect the same result. When eggs and 13 embryos are damaged or compromised, it may be impossible for customers to have their own biological 14 children. There is no possibility of creating substitute embryos for cancer survivors or those whose 15 spouses have died. Likewise, those who used donor eggs or sperm to create embryos may find it 16 impossible to retrieve additional material from the same donors. Thus, donor-users who already have 17 children may be prevented from having additional children who are biologically related to their 18 siblings. 19 84. The success or failure of egg and embryo cryopreservation and storage services has 20 substantial emotional and psychological ramifications for those seeking to become parents. Losing eggs 21 or embryos results in severe emotional distress for the owner. 22 C. Successful cryopreservation and storage depend on strict adherence to protocols. 23 85. Eggs and embryos are fragile. They must be handled and stored carefully. Cooling, 24 storing, warming, and removing cryoprotectants must follow precise, controlled protocols. Failure to 25 adhere to these protocols can render the egg or embryo nonviable, impair implantation and viability, 26 and introduce chromosomal abnormalities. 27 28 86. A key goal of cryopreservation is to reduce cellular damage caused by the formation of ice crystals and the expansion of water as cryopreserved material cools to subzero temperatures. PFC 14 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 18 of 51 1 states on its website that “[t]he key to successful egg freezing is determining a technique that will not 2 damage the fragile chromosomes of the egg”; this is because “the chromosomes of the egg are 3 vulnerable to damage, including damage from the exertion of the freezing and thawing process.” 4 87. As noted above, two primary cryopreservation technologies have emerged. Both rely 5 upon cryoprotectants, which are solutions added to the cells that reduce cell damage by displacing 6 water in a manner similar to antifreeze. The first technology, slow freezing (also known as slow 7 programmable freezing), utilizes specialized equipment that lowers the temperature of embryos 8 conditioned with cryoprotectants in a slow, controlled manner to ‒190°C. The second and newer 9 technology, vitrification, refers to any process resulting in “glass formation”—that is, transformation 10 from a liquid to a hardened liquid with minimal crystallization (ice crystals). According to PFC’s 11 website, vitrification “cools the cells in the embryo at rates close to 5,000 degrees per minute[,]” and 12 “embryos that are vitrified are exposed to 5-10 times more cryoprotectant than slow frozen embryos.” 13 The ultra-rapid nature of this process minimizes (1) the formation of ice crystals and (2) toxicity 14 damage to the cells that cryoprotectants can cause during longer exposure to warmer temperatures. 15 88. The process of warming eggs and embryos that have been preserved through 16 cryopreservation is similarly precise and dependent on specialized techniques and chemical solutions. 17 PFC describes the embryo warming process as follows on its website: “embryos coming out of the 18 freezer (at -196°C) are warmed to room temperature in a maximum of three seconds. This rapid 19 warming method minimizes damage to the embryo from ice crystals that can form during warming.” A 20 key part of the warming procedure is the precise dilution and eventual replacement of the toxic 21 cryoprotectant fluid with a solvent compatible with cytoplasmic fluid. PFC also states on its website 22 that it “incubat[es] the embryo in decreasing concentrations of the antifreeze, and increasing 23 concentrations of water. Over a period of 15 minutes, the embryo is stepped through 3 different 24 solutions, until finally the antifreeze is gone and all the water has been replaced.” 25 89. For slow-frozen tissue, the failure to thaw slowly can result in cells over-expanding, 26 rupturing, and dying. For vitrification, it is important to warm quickly to avoid ice formation. Thus, it is 27 critical that eggs or embryos cryopreserved through slow freezing be thawed slowly, and that tissue 28 cryopreserved through vitrification be warmed quickly in a carefully controlled manner. An 15 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 19 of 51 1 uncontrolled rise in temperature in a storage tank, like the one at issue here, can have catastrophic 2 consequences for eggs and embryos. 3 III. 4 Prelude Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. 5 90. On March 4, 2018, Prelude discovered a loss of a substantial amount of liquid nitrogen 6 in one of the cryogenic storage tanks located at PFC, Tank 4, manufactured by Chart. This incident 7 affected thousands of cryopreserved eggs and embryos belonging to more than 400 individuals and 8 families. 9 A. Prelude should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. 91. Liquid nitrogen in cryopreservation tanks evaporates at a slow rate. Absent extreme 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 circumstances, even when a leak occurs it should take days for a tank to warm enough to cause damage to the enclosed eggs and embryos. 92. Egg and embryo storage facilities have developed and implemented a variety of systems and processes to protect against liquid nitrogen levels dropping to levels low enough to endanger customers’ eggs and embryos. These systems and processes include maintaining a functional controller that constantly monitors temperature and liquid nitrogen levels, conducting regular inspections of the tank and controller to verify controller functionality and accuracy, deploying multiple alarm systems (both local and remote) that detect and send alerts of low liquid nitrogen levels, and installing autofillers that detect and automatically replenish low liquid nitrogen levels. 93. On its website and in sales and marketing materials, PFC told its customers that the storage facility located at its San Francisco headquarters was state of the art, containing tanks equipped with around-the-clock monitoring, alarm systems, and response protocols, with further protection from daily walk-throughs. But no alarms or phone alerts notified Prelude of the March 4 malfunction. Instead, an unidentified Prelude employee discovered the problem while working in the lab. Staff then transferred the eggs and embryos from Tank 4 to another tank. 94. Prelude lacked monitoring, alarm, and response systems and processes sufficient to detect and prevent harm from a dangerous temperature rise in Tank 4. Prelude has not explained why 16 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 20 of 51 1 Tank 4 was not equipped with a controller that detected problems with the tank’s temperature and 2 liquid nitrogen level and consumption, why staff did not detect problems with Tank 4 during walk- 3 throughs prior to March 4, or why Prelude did not have a functional autofilling mechanism on Tank 4 4 to replenish low liquid nitrogen levels. 5 95. Prelude (and in the first instance, PFC) further failed to mitigate the risk of loss of stored 6 reproductive material by failing to store multiple eggs and embryos belonging to a single customer in 7 separate vials and tanks. 8 9 96. just that: 10 “It’s really quite sad the samples weren’t split up,” says Nahid Turan, who directs laboratory operations at the Coriell Institute for Medical Research, one of the oldest and largest biobanks in the US. “They were literally putting all the eggs in one basket.” In addition to having samples in multiple tanks at their New Jersey facility, Coriell also has back-up sites in multiple locations around the country. And its software engineers built real-time monitoring systems to flag any tanks trending in a troubling direction before they fail. 11 12 13 14 15 Wired interviewed one laboratory director who opined that Prelude should have done 97. Cryopreserved eggs and embryos belonging to many hundreds of other people were 16 stored in the same tank as Plaintiffs’ tissue. Tank 4 housed up to 15% of the total cryopreserved tissue 17 located at PFC’s San Francisco facility, consisting of thousands of eggs and embryos. 18 19 98. Most people with eggs and embryos stored in Tank 4 had all of their eggs and embryos stored in that single tank. 20 B. Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident. 21 99. On April 23, 2018, Chart, the manufacturer of Tank 4, recalled certain cryostorage 22 tanks, stating in its recall notice: “Chart is presently investigating the possible cause of the VACUUM 23 LEAK AND/OR FAILURE which may be due to inadequate adhesion of the composite neck to the 24 aluminum unit” (emphasis in original). Chart added that the “issue appears to be an isolated occurrence 25 involving the machine and binding agent used during the manufacturing process.” 26 100. Chart announced the recall four days after PFC’s April 19 email to its customers 27 revealed the conclusion of “independent experts” that the March 4 incident “likely involved a failure of 28 the tank’s vacuum seal.” 17 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 21 of 51 1 C. Multiple investigations were opened after the Tank 4 incident. 2 101. Various government entities and trade groups have responded to the March 4, 2018 3 incident. The College of American Pathologists (CAP) is conducting a formal investigation into the 4 incident, as is the California Department of Public Health. The American Society for Reproductive 5 Medicine also is studying the incident and has stated that it intends to make recommendations to its 6 members based on its findings. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 D. Prelude’s failure to keep Plaintiffs’ eggs and embryos safe and secure has resulted in harm. 102. As a result of Prelude’s deficient performance of their storage duties, Plaintiffs have suffered serious, lifelong harm and lost the family planning flexibility that caused them to cryopreserve their eggs and embryos in the first place. 103. Prelude has refused to share publicly the data it has collected regarding the number of Tank 4 eggs and embryos that have been thawed or the resulting outcomes. The survival rate for these eggs and embryos is far lower than it would have been had the incident not occurred. 104. PFC has taken the position that the embryos in Tank 4 must be fully thawed to determine whether they remain viable after the incident. PFC also asserts that the eggs in Tank 4 must be fully thawed and fertilized to determine whether they remain viable after the incident. Because of the risks associated with re-freezing embryos, a family must be prepared before thawing to transfer the embryo into a woman’s uterus and attempt a pregnancy if the embryo is deemed viable. 105. Many of those affected by the Tank 4 incident have attempted to thaw their eggs or embryos, only to confirm that their eggs or embryos are no longer viable. Many families and individuals have lost their best or only chance of having a child. Those who can undergo additional retrievals face a greater risk that those eggs or embryos will not lead to a successful pregnancy, as the age at which a woman’s eggs are retrieved is the dominant factor for rates of success or failure. 106. Neither PFC nor Prelude has provided a comprehensive analysis of the risks of attempting a pregnancy with any of the tissue from Tank 4, including the risks that the drop in liquid nitrogen levels may have caused chromosomal or other defects undetectable from a thaw. In fact, after 28 18 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 22 of 51 1 the Tank 4 incident, PFC has told its customers that pregnancies derived from material stored in Tank 4 2 may face “unknown” risks. 3 107. Nevertheless, PFC has advised Plaintiffs with affected eggs and embryos to attempt 4 pregnancies with Tank 4 tissue. Before undergoing an embryo or egg thaw, embryo transfer, or egg 5 fertilization, PFC requires customers to sign a consent statement acknowledging that the risks are 6 uncertain and waiving any liability on the part of PFC arising out of the thaw, transfer, or fertilization 7 procedure. 8 108. Thus, as a result of the Tank 4 incident, Plaintiffs are being asked to make consequential 9 reproductive decisions immediately—depriving them of the freedom and flexibility they sought when 10 they decided to store their frozen eggs and embryos. To determine whether their tissue remains viable, 11 PFC has counseled those affected by the incident to thaw and immediately fertilize eggs, and to transfer 12 embryos to a woman’s uterus. Yet the purpose of cryopreservation was to allow these customers to 13 make reproductive choices on their own timelines. Many customers do not yet have a partner with 14 whom they wish to fertilize their eggs, or are not ready to move forward with a sperm donor, much less 15 try to get pregnant now or arrange for a surrogate. Others were busy with their careers and other 16 commitments when the incident occurred, making it inconvenient or impossible to attempt a pregnancy 17 right away. 18 109. People affected by the March 4 incident have described being thrust into a state of 19 limbo, as the “insurance policy” they paid for has vanished. To restore their future fertility options, 20 some are attempting additional retrieval cycles at an older age, with lower-quality eggs, and at 21 considerable cost, burden, and disruption to their lives. These additional retrieval cycles also involve 22 medical risks and potential complications. Many class members completed these cycles only to learn 23 they were incapable of producing sufficient, or any, viable eggs or embryos. Other class members, for 24 whom additional retrievals are not possible or recommended, fear that they will remain childless. 25 110. The National Infertility Association recognized the negative impact of the March 4 26 incident on women and families, stating that it was “shocked” to hear of this “unprecedented traged[y]” 27 for “the entire family building community. Our hearts break for each person impacted. We know first- 28 19 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 23 of 51 1 hand what someone goes through to have eggs or embryos to freeze, and to have this outcome is 2 devastating for everyone.” 3 4 5 111. The Tank 4 incident has exacted an enormous emotional toll on Plaintiffs, who are distraught. 112. Given the sensitive nature of the eggs and embryos entrusted to their care, as well as 6 their familiarity with the deeply emotional aspects of their services, PFC and Prelude were aware of the 7 substantial adverse consequences for PFC’s customers that would result from a failure to keep their 8 eggs and embryos safe and secure. 9 10 11 12 13 E. PFC’s communications regarding the incident have compounded the harm. 113. PFC first attempted to notify its customers of the March 4 incident a week after it occurred. 114. email stating: 14 Earlier this week, a single piece of equipment lost liquid nitrogen for a brief period of time. The remainder of the equipment and cryo-storage facility was not affected. As soon as the issue was discovered, our most senior embryologists took immediate action to secure all tissue in that single cryostorage tank. The tank was immediately retired, and the facility is operating securely. 15 16 17 18 We have hired independent experts and launched an in-depth investigation of the matter. We felt it was imperative to advise you that your tissue was stored in the affected tank and may have been impacted. Based on our preliminary analysis, the good news is that we do expect that some of the tissue from that tank remains viable. We are continuing to gather information but wanted to share these developments with you directly. 19 20 21 22 23 At approximately 4:00 a.m. Pacific time on March 11, 2018, PFC sent its customers an 115. The email further stated, “[w]e are incredibly sorry that this happened and for the 24 anxiety that this will surely cause. We are heartbroken by this situation and our thoughts are with each 25 of you who may have been touched by this event.” 26 27 116. The email invited Plaintiffs and other families with eggs and embryos stored in Tank 4 to call to discuss the incident with their fertility specialists. The call center was overwhelmed for 28 20 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 24 of 51 1 weeks, and the information provided over the phone and in person has been vague and often 2 inconsistent. Different PFC staff members have provided customers with conflicting information. 3 117. PFC did not provide further written information until over a month later, on April 19, 4 2018, when it wrote to its customers with “several updates following the tank failure that occurred in 5 the embryology lab on March 4, 2018.” 6 7 8 9 118. PFC wrote that “independent experts have been investigating the incident” and preliminarily determined that it “likely involved a failure of the tank’s vacuum seal.” 119. PFC did not—in either its initial March 11 communication or its April 19 follow up— disclose to Plaintiffs, or to anyone else with tissue stored at its facility, 10 11 120. PFC’s public messages have exacerbated Plaintiffs’ pain and confusion. On March 11, 12 2018, a PFC employee told ABC News that a large number of families with eggs and embryos stored at 13 the facility were “people who won’t use them anyway.” Other customers with eggs and embryos in 14 Tank 4 were billed for storage fees after the incident occurred and before it was disclosed to them. 15 121. While PFC has offered some of its customers a free additional cycle for egg retrieval, 16 such a remedy is not adequate to compensate for the incident. Older women are generally not able to 17 produce eggs of as high a quality as when they were younger, and in many cases go through the entire 18 process only to learn they are unable to produce any viable eggs. Even where some eggs can be 19 retrieved, women confront a greater risk that those eggs will not lead to a successful transfer and 20 pregnancy. Moreover, additional retrievals are time consuming, expensive, physically painful, and 21 emotionally exhausting, and typically require time away from work. Even two or three cycles may not 22 fully replenish the number of viable eggs that were lost. 23 122. PFC’s April 19, 2018 email blaming the incident on a failure of Tank 4’s vacuum seal 24 left Plaintiffs with more questions than answers. PFC did not say why it failed to detect the incident 25 until it was too late to prevent harm to Plaintiffs’ eggs and embryos. Plaintiffs were not told why no 26 alarm alerted storage staff, why a backup system (e.g., an autofill function or additional generator) did 27 not engage, or why the problem went undiscovered until March 4. 28 21 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 25 of 51 1 123. PFC states on its website that tanks can go without power or liquid nitrogen for “several 2 days” without compromising the enclosed reproductive tissue. It is unclear why Prelude failed to detect 3 the problem with Tank 4 until it was too late. 4 124. PFC’s April 19 email also stated that it “can report several early pregnancies” from 5 thawed and transferred embryos, and that it had “successfully thawed a limited number of eggs[,] 6 confirm[ing] that there is viable tissue from the tank.” PFC did not disclose to its customers, however, 7 that much of the tissue in the tank is unviable. Nor did PFC provide a comparison of the survival rate of 8 affected tissue to the survival rate of eggs and embryos under normal circumstances. PFC still has not 9 publicly provided this information. Instead, PFC notified all people with tissue in Tank 4, including 10 Plaintiffs, that their eggs and embryos might be “viable” despite knowing this was not true for many or 11 most of these people. 12 13 125. PFC’s failure to communicate clearly and consistently with victims of the Tank 4 incident has compounded the harm caused by the incident. 14 PLAINTIFF-SPECIFIC ALLEGATIONS 15 Plaintiffs A.B. and C.D. 16 17 18 19 20 126. Plaintiffs A.B. and C.D. first contacted PFC in or around May 2013 about the possibility of creating embryos and having their embryos frozen. 127. In July 2013 Plaintiffs A.B. and C.D. hired PFC to create and preserve their embryos for future use. 128. Before freezing their embryos at PFC, Plaintiffs A.B. and C.D. conducted extensive 21 research concerning IVF and fertility centers and chose PFC based on the belief that it provided high- 22 quality services that were state of the art. Before having their embryos cryopreserved with PFC, 23 Plaintiffs A.B. and C.D. saw representations about PFC’s services on its website, including PFC’s 24 claims that it provided high-quality services. Plaintiffs A.B. and C.D. also had both phone and in- 25 person consultation sessions with Dr. Eldon Shriock in May and June 2013. During these sessions, Dr. 26 Shriock told Plaintiffs A.B. and C.D. about PFC’s care, professionalism, and state-of-the-art facilities. 27 28 129. Over the course of the summer of 2013, Plaintiffs A.B. and C.D. underwent procedures to prepare for embryo creation and cryopreservation. 22 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 26 of 51 1 130. Before the egg retrieval procedure in August 2013, Plaintiff A.B. went through a month 2 of treatment and injections. PFC ultimately retrieved approximately twenty-two of her eggs, which 3 were then fertilized with Plaintiff C.D.’s sperm. 4 5 6 131. At the time of the March 4, 2018 incident, Plaintiffs A.B. and C.D. had four healthy, viable cryopreserved embryos. 132. At the time of the Tank 4 incident, Plaintiffs A.B. and C.D.’s embryos were under 7 8 9 . 133. Prelude kept Plaintiffs A.B. and C.D.’s embryos within a metal storage tank—Tank 4— at PFC’s San Francisco facility. Rather than mitigating the risk of tank failure by spreading Plaintiffs 10 A.B. and C.D.’s embryos among several tanks, Prelude stored all of Plaintiffs A.B. and C.D.’s embryos 11 in the same tank. 12 134. Plaintiffs A.B. and C.D. paid approximately $32,242.30 for the creation of their embryos 13 in 2013, of which $25,200 was paid directly to PFC. They have since paid $600 annually for their 14 embryos’ storage. 15 135. 16 Plaintiffs A.B. and C.D. experienced severe emotional distress when they learned of the March 4, 2018 incident and in the months that have followed. 17 18 19 20 21 22 Plaintiff E.F. 136. Plaintiff E.F. first contacted PFC in or around May 2016 about the possibility of having her eggs frozen. 137. In or around June 2016, Plaintiff E.F. hired PFC to retrieve and preserve her eggs for future use. 138. Before having her eggs frozen with PFC, Plaintiff E.F. saw representations about PFC’s 23 services on its website, including claims regarding the qualifications of PFC’s staff and the science 24 behind the clinic’s procedures. Plaintiff E.F. also met with Dr. Carolyn Givens, who told her about 25 PFC’s use of cutting-edge technology and assured her that her eggs would be there for as long as she 26 needed them. 27 28 23 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 27 of 51 1 139. In the summer of 2016, Plaintiff E.F. underwent procedures to prepare for egg 2 cryopreservation. Before the retrieval procedure, she went through two months of treatment and 3 injections. PFC ultimately retrieved and cryopreserved approximately nine of her eggs. 4 140. At the time of the Tank 4 incident, Plaintiff E.F.’s eggs were under 141. Prelude kept Plaintiff E.F.’s eggs within a metal storage tank—Tank 4—at PFC’s San 5 6 7 Francisco facility. Rather than mitigating the risk of tank failure by spreading Plaintiff E.F.’s eggs 8 among several tanks, Prelude stored all of her eggs in the same tank. 9 142. Plaintiff E.F. has paid approximately $11,000 for the retrieval and storage of her eggs. 10 She experienced severe emotional distress when she learned of the March 4, 2018 incident and in the 11 months that have followed. 12 13 14 15 16 17 Plaintiff G.H. 143. Plaintiff G.H. first contacted PFC in or around February 2016 about the possibility of having her eggs frozen. 144. In or around April 2016, Plaintiff G.H. hired PFC to retrieve and preserve her eggs for future use. 145. Before having her eggs frozen with PFC, Plaintiff G.H. saw representations about PFC’s 18 services on its website, including claims about the quality of its services. Plaintiff G.H. also met with 19 Dr. Carolyn Givens, who provided information regarding PFC’s services. 20 146. In the spring of 2016, Plaintiff G.H. underwent procedures to prepare for egg retrieval 21 and cryopreservation. Before the retrieval procedure, she went through two months of treatment and 22 injections. PFC ultimately retrieved and cryopreserved approximately two of her eggs. 23 147. At the time of the Tank 4 incident, Plaintiff G.H.’s eggs were under 148. Prelude kept Plaintiff G.H.’s eggs within a metal storage tank—Tank 4—at PFC’s San 24 25 26 Francisco facility. Rather than mitigating the risk of tank failure by spreading Plaintiff G.H.’s eggs 27 among several tanks, Prelude stored all of her eggs in the same tank. 28 24 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 28 of 51 1 149. Plaintiff G.H. has paid approximately $14,500 for the retrieval and storage of her eggs. 2 She experienced severe emotional distress when she learned of the March 4, 2018 incident and in the 3 months that have followed. 4 5 6 7 8 9 Plaintiff I.J. 150. Plaintiff I.J. first contacted PFC in or around November 2012 about the possibility of having her eggs frozen. 151. In or around December 2012, Plaintiff I.J hired PFC to retrieve and preserve her eggs for future use. 152. Before freezing her eggs with PFC, Plaintiff I.J. saw representations about PFC’s 10 services in PFC’s brochure, including claims that PFC “had a very strong embryo freezing program” 11 and that its customers “can avoid high order multiple pregnancies by transferring fewer fresh embryos 12 and successfully freezing the remaining embryos.” Plaintiff I.J. also saw representations that PFC 13 “devoted considerable time and effort into assembling one of the most highly trained teams in the 14 country.” Plaintiff I.J. met with staff at PFC who assured her that her eggs would be there for as long as 15 she needed them. 16 153. In February 2013, Plaintiff I.J. underwent procedures to prepare for egg retrieval and 17 cryopreservation. Before the retrieval procedure, she went through two months of treatment and 18 injections. PFC ultimately retrieved and cryopreserved approximately 17 of her eggs. 19 154. At the time of the Tank 4 incident, Plaintiff I.J.’s 155. Prelude kept Plaintiff I.J.’s eggs within a metal storage tank—Tank 4—at PFC’s San 20 21 22 Francisco facility. Rather than mitigating the risk of tank failure by spreading Plaintiff I.J.’s eggs 23 among several tanks, Prelude stored all of her eggs in the same tank. 24 156. Plaintiff I.J. has paid approximately $17,000 to PFC and Prelude for procedures, 25 medications, and storage of her eggs. She experienced severe emotional distress when she learned of 26 the March 4, 2018 incident and in the months that have followed. 27 28 25 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 29 of 51 1 Plaintiff K.L. 2 3 157. having her eggs cryopreserved. 4 5 Plaintiff K.L. first contacted PFC on or around June 3, 2010, about the possibility of 158. In or around December 2015, Plaintiff K.L. hired PFC to retrieve and preserve her eggs for future use. 6 159. Before having her eggs frozen with PFC, Plaintiff K.L. saw representations about PFC’s 7 services on its website, including PFC’s claims that the clinic and its services were safe and reliable, 8 and that eggs could be stored until the right time for the customer. Plaintiff K.L. also saw PFC’s 9 representations that the process was quick and easy for customers and had a very high likelihood of 10 success. In addition, Plaintiff K.L. met with Dr. Eldon Schriock, who told her that storage at PFC was 11 safe. 12 160. In February 2016, Plaintiff K.L. underwent procedures to prepare for egg retrieval and 13 freezing. Before the retrieval procedure, she went through months of treatment and injections. She also 14 had to take several days off from work and could not travel for work for two weeks. PFC ultimately 15 retrieved and froze five of her eggs. 16 161. At the time of the Tank 4 incident, Plaintiff K.L.’s eggs were under 162. Prelude kept Plaintiff K.L.’s eggs from her first cycle within a metal storage tank—Tank 17 18 19 4—at PFC’s San Francisco facility. Rather than mitigating the risk of tank failure by spreading Plaintiff 20 K.L.’s eggs from that cycle among several tanks, Prelude stored all of her eggs in the same tank. 21 163. Plaintiff K.L. has paid approximately $12,000 to PFC and Prelude for procedures, 22 medications, and storage of her eggs. She experienced severe emotional distress when she learned of 23 the March 4, 2018 incident and in the months that have followed. 24 25 26 27 28 Plaintiffs M.N. and O.P. 164. Plaintiff M.N. first contacted PFC in or around September 2011 about the possibility of having her eggs frozen. 165. In or around late 2011, Plaintiff M.N hired PFC to retrieve and preserve her eggs for future use. 26 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 30 of 51 1 166. Before having her eggs frozen with PFC, Plaintiff M.N. saw representations about 2 PFC’s services on its website, including claims regarding its success rates and ability to help people 3 have a family and plan for the future. Plaintiff M.N. also met with Dr. Eldon Schriock, who told her 4 about PFC’s statistics and success rates. 5 167. In January 2012, Plaintiff M.N. underwent procedures to prepare for egg freezing. She 6 went through months of invasive and time-consuming treatments, including injections, blood tests, and 7 ultrasounds. She underwent approximately three retrieval cycles, yielding approximately 37 eggs. 8 9 10 168. In 2016, Plaintiff M.N. hired PFC to fertilize half of her eggs with a sperm donor, resulting in three embryos. Her remaining 15 eggs were stored in Tank 4. 169. At the time of the Tank 4 incident, Plaintiff M.N.’s remaining eggs were under 170. Prelude kept M.N.’s eggs within a metal storage tank—Tank 4—at PFC’s San Francisco 11 12 13 facility. Rather than mitigating the risk of tank failure by spreading Plaintiff M.N.’s eggs among several 14 tanks, Prelude stored all of her eggs in the same tank. 15 171. In December 2017, after Plaintiff M.N. met her reproductive partner, O.P., M.N. and 16 O.P. hired PFC to fertilize M.N.’s remaining eggs with O.P.’s sperm to create embryos. In consultation 17 with PFC specialists, M.N. and O.P. decided to proceed with the fertilization by mid-2018. 18 172. Plaintiff M.N. has paid more than $25,000 to PFC and Prelude for procedures, 19 medications, and storage of her eggs. Plaintiffs M.N. and O.P. experienced severe emotional distress 20 when they learned of the March 4, 2018 incident and in the months that have followed. 21 22 23 24 * * * 173. PFC had multiple opportunities—on its website, in written correspondence, over the phone and in person—to inform Plaintiffs and that Prelude’s protocols and equipment were inadequate to protect against damage to their 25 eggs and embryos. Prelude had similar opportunities, including through its personnel’s communications 26 with class members, to 27 safeguards that were in place. Nevertheless, despite knowing (1) that PFC had 28 and the nature of the , and (2) that Prelude’s standards, systems, and processes were inadequate to 27 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 31 of 51 1 protect Plaintiffs’ eggs and embryos, PFC and Prelude did not accurately disclose the nature and details 2 of their tissue storage operation to Plaintiffs. 3 174. Had either or both PFC and Prelude disclosed 4 or that the Prelude’s storage monitoring and alarm systems and other 5 processes were deficient, nonfunctional, or incapable of protecting their eggs and embryos in the event 6 of a tank failure, Plaintiffs would not have purchased or continued using the egg and embryo storage 7 services. 8 9 10 CLASS ACTION ALLEGATIONS 175. and (b)(3) of the Federal Rules of Civil Procedure: 11 All individuals, and their reproductive partners, who had eggs, embryos, or other material in Tank 4 at Pacific Fertility Center in San Francisco, California on March 4, 2018. 12 13 14 15 16 17 18 19 20 21 22 23 24 Excluded from this class are Defendants, their affiliates and subsidiaries, and their officers, directors, partners, employees, and agents; class counsel, employees of class counsel’s firms, and class counsel’s immediate family members; defense counsel, their employees, and their immediate family members; and any judicial officer who considers or renders a decision or ruling in this case, their staff, and their immediate family members. 176. 27 28 Numerosity. The members of the class are so numerous that their individual joinder is impracticable. There are more than 400 class members, whose names and addresses are readily available from PFC’s records. 177. Existence and Predominance of Common Questions of Fact and Law. Class certification is appropriate under Rule 23(b)(3) because this action involves common questions of law and fact that predominate over any questions affecting individual class members, including, without limitation: 25 26 Plaintiffs propose certification of the following class, pursuant to Rules 23(a), (b)(2), a. Whether Tank 4 was defective, including due to Chart’s manufacturing or design b. Whether Prelude owed a duty to Plaintiffs and class members to protect the eggs of the tank; and embryos under its care; 28 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 32 of 51 1 2 c. Prelude’s negligence or other wrongful conduct; 3 4 d. e. 9 10 11 f. g. 16 Whether PFC and Prelude fraudulently concealed material information regarding egg and embryo storage, practices, and procedures; h. The type(s) and measure(s) of compensable and other redressable injury incurred by Plaintiffs and class members as a result of Defendants’ conduct alleged herein; and i. 14 15 Whether Prelude breached its duties to protect the eggs and embryos that Plaintiffs and class members entrusted to its care; 12 13 Whether Prelude failed to take available steps to ensure that liquid nitrogen levels in its storage tanks would remain sufficient; 7 8 Whether Prelude failed to take adequate and reasonable measures to ensure that its systems were protected; 5 6 Whether the March 4, 2018 loss of liquid nitrogen in Tank 4 resulted from What measures are necessary to ensure that eggs and embryos stored at PFC are properly safeguarded in the future. 178. Typicality. Plaintiffs’ claims are typical of the other class members’ claims because 17 Plaintiffs and class members were subjected to the same wrongful conduct and damaged in the same 18 way by having their eggs and embryos compromised. 19 179. Adequacy of Representation. Plaintiffs are adequate class representatives. Their interests 20 do not conflict with the interests of the other class members they seek to represent. Plaintiffs have 21 retained counsel competent and experienced in complex class action litigation, as well as in matters 22 concerning egg and embryo loss, who will prosecute this action vigorously. Plaintiffs and their counsel 23 will fairly and adequately pursue and protect the interests of the class. 24 180. Superiority. A class action is superior to all other available means for the fair and 25 efficient adjudication of this controversy. The sensitive, private nature of the facts involved here, as 26 well as the fear that bringing an individual suit could affect future treatment at PFC, favors providing a 27 class vehicle to adjudicate these claims. The damages or other financial detriment suffered by Plaintiffs 28 and the other class members are relatively small compared to the burden and expense that would be 29 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 33 of 51 1 required to individually litigate these claims. As a result, it would be impracticable for class members 2 to seek redress individually. Individualized litigation would also create a potential for inconsistent or 3 contradictory judgments and increase the delay and expense to all parties and the court system. By 4 contrast, a class action presents far fewer management difficulties and provides the benefits of single 5 adjudication, economy of scale, and comprehensive supervision by a single court. 6 181. Class certification is also appropriate under Rule 23(b)(2) because Defendants acted or 7 refused to act on grounds generally applicable to the class, thereby making appropriate final injunctive 8 relief with respect to the members of the class as a whole. 9 182. The claims of class members include common issues whose efficient adjudication in a 10 class proceeding would materially advance the litigation and aid in achieving judicial economy and 11 efficiency. Hence, in the alternative, class certification under Rule 23(c)(4) may be appropriate as to 12 certain issues. 13 CLAIMS FOR RELIEF 14 183. Plaintiffs bring each of the following claims under California law. 15 184. None of Plaintiffs’ claims involves any allegation of medical malpractice. 16 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against Prelude and Pacific MSO)1 17 18 19 20 21 22 23 24 25 26 185. Plaintiffs incorporate the above and below allegations by reference. 186. This is not a claim for professional negligence. Neither Prelude nor Pacific MSO is a health care provider. At no relevant time has Prelude been licensed or certified to provide medical services. In September 2017, concurrently with the PFC transaction, Pacific MSO amended its articles of incorporation to make clear that it was not engaged in the practice of medicine; thus, like Prelude, Pacific MSO has at no relevant time been licensed or certified to provide medical services. 187. Given the special relationship arising from the sensitive services they undertook to perform—storage of human egg and embryos—Prelude and Pacific MSO owed Plaintiffs a duty to 27 28 1 For the sake of clarity, Prelude and Pacific MSO are referred to separately hereinafter. 30 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 34 of 51 1 exercise reasonable care in all aspects of the storage of Plaintiffs’ eggs and embryos so as to avoid 2 destroying them, damaging them, or jeopardizing their viability given that doing so would inevitably 3 lead to emotional distress. Egg and embryo storage services are intertwined with Plaintiffs’ most vital 4 concerns, such as comfort, happiness, and personal welfare. 5 188. Prelude and Pacific MSO also owed a duty to Plaintiffs because 6 . Such services were of a kind that 7 Prelude and Pacific MSO should have recognized and did recognize as needing to be performed with 8 reasonable care for the protection of Plaintiffs’ emotional tranquility and peace of mind. 9 189. Plaintiffs’ harms occurred in the course of specified categories of activities, 10 undertakings, or relationships in which negligent actions and negligent failures to act were especially 11 likely to cause serious harm. 12 13 14 190. It was reasonably foreseeable to Prelude and Pacific MSO that Plaintiffs would experience severe emotional distress as a result of any breach of their duty of reasonable care. 191. Recognition that Prelude and Pacific MSO have a duty to avoid causing emotional 15 distress and other harm will promote the policy of preventing future harm, by motivating Prelude and 16 Pacific MSO to implement processes and systems reasonably likely to safeguard the eggs and embryos 17 entrusted to them going forward. This duty also furthers the community’s interest in ensuring that 18 reliable long-term egg and embryo freezer storage services are available to those who wish to become 19 parents one day in the future. 20 192. The burden on Prelude and Pacific MSO from a duty to avoid causing emotional distress 21 is fair and appropriate, in light of the importance of the eggs and embryos they voluntarily agreed to 22 store and protect, at considerable cost to Plaintiffs. 23 193. As detailed above, Prelude and Pacific MSO took actions that a reasonably careful 24 person would not have taken in the same situation and also failed to take actions that a reasonably 25 careful person would have taken in the same situation. Prelude and Pacific MSO therefore breached 26 their duty to exercise reasonable care in the storage of Plaintiffs’ eggs and embryos. 27 28 31 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 35 of 51 1 194. Prelude and Pacific MSO’s acts and omissions constitute gross negligence, because they 2 constitute a total lack of care and an extreme departure from what a reasonably careful person would do 3 in the same situation to prevent foreseeable loss of eggs and embryos. 4 195. Prelude and Pacific MSO’s carelessness and negligence directly and foreseeably 5 damaged Plaintiffs. Prelude and Pacific MSO’s mishandling of Plaintiffs’ eggs and embryos naturally 6 and foreseeably caused mental anguish and serious emotional distress, among other injuries, to 7 Plaintiffs. 8 9 10 11 196. There is a very close connection between Prelude and Pacific MSO’s conduct and Plaintiffs’ injuries. Plaintiffs’ emotional distress and other harms occurred because of Prelude and Pacific MSO’s failure to act reasonably in all aspects of the storage of Plaintiffs’ eggs and embryos. 197. Plaintiffs trusted that those responsible for storing their eggs and embryos would use 12 reasonable care to safeguard them. Prelude and Pacific MSO’s carelessness with this precious material, 13 and ultimately, with Plaintiffs’ careful plans for parenthood, amounts to despicable conduct. 14 198. Prelude and Pacific MSO acted, and failed to act, willfully and with conscious and 15 reckless disregard for the rights and interests of Plaintiffs. Prelude and Pacific MSO’s acts and 16 omissions had a great probability of causing significant harm and in fact caused such harm. 17 18 19 199. Prelude and Pacific MSO’s failure to use reasonable care in handling and safeguarding Plaintiffs’ eggs and embryos was a substantial factor in causing Plaintiffs’ harm. 200. Prelude and Pacific MSO’s negligence was a substantial factor in causing Plaintiffs 20 severe emotional distress, regardless of whether it is ever determined conclusively that the eggs and 21 embryos in Tank 4 are no longer viable. Prelude and Pacific MSO’s misconduct has irreparably 22 breached trust and caused uncertainty, anxiety, and fear among Plaintiffs and other affected families 23 over how to proceed without being informed as to the long-term effects from an egg or embryo’s 24 presence in Tank 4 during the incident. 25 201. As a direct and proximate result of Prelude and Pacific MSO’s negligence, Plaintiffs 26 suffered harm in an amount to be determined at trial, including serious emotional distress consisting of 27 worry, shock, fright, horror, anguish, suffering, grief, anxiety, nervousness, embarrassment, 28 32 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 36 of 51 1 humiliation, and shame. A reasonable person would be unable to cope with the losses suffered by 2 Plaintiffs. 3 SECOND CAUSE OF ACTION Negligent Failure to Recall (Against Chart) 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 202. Plaintiffs incorporate the above and below allegations by reference. 203. Chart acted negligently by failing to recall, prior to the incident of March 4, 2018, the line of tanks that included Tank 4. 204. Chart designed, manufactured, assembled, produced, distributed, and/or sold this line of 205. Chart knew or reasonably should have known that, when used as intended, Tank 4 tanks. presented or was likely to present a danger to eggs and embryos. Chart knew or reasonably should have known that the vacuum seal on Tank 4 was vulnerable to breach, and that upon such breach liquid nitrogen levels would drop, causing the eggs and embryos stored inside the tank to reach dangerously elevated temperatures. 206. should have known that the tank’s vacuum seal was susceptible to breaking. Nevertheless, at no point during this time period did Chart recall, repair, or warn of the danger posed by the tank. 207. A reasonable designer, manufacturer, distributor, or seller facing the same or similar circumstances as Chart, in the exercise of reasonable care, would have recalled Tank 4 to ensure eggs and embryos were not endangered. 208. Chart’s failure to timely recall Tank 4 was a substantial factor in causing harm to Plaintiffs. Had Chart recalled Tank 4 before the incident, the other Defendants would not have used it, and it would not have failed while Plaintiffs’ eggs were stored within it. THIRD CAUSE OF ACTION Bailment (Against Prelude and Pacific MSO) 25 26 27 After Chart sold Tank 4 to PFC and before March 4, 2018, Chart knew or reasonably 209. Plaintiffs incorporate the above and below allegations by reference. 28 33 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 37 of 51 1 210. A bailment arises where possession, but not ownership, of property is transferred from 2 one party, a bailor, to another, a bailee. Where the personal property of a bailor is delivered to a bailee, 3 a duty of care is owed. 4 211. Prelude and Pacific MSO received for safekeeping Plaintiffs’ irreplaceable personal 5 property to be safely and securely kept for the benefit of Plaintiffs, and to be redelivered to them upon 6 demand. 7 8 9 212. Plaintiffs agreed to pay, and did pay, substantial sums in exchange for the safekeeping of their eggs and embryos. 213. Prelude and Pacific MSO had a duty to exercise care in maintaining, preserving, and 10 protecting Plaintiffs’ eggs and embryos. Further, Prelude and Pacific MSO had a duty to return the eggs 11 and embryos, undamaged, to Plaintiffs. 12 13 14 15 16 214. Because of Prelude and Pacific MSO’s wrongful conduct, as set forth herein, the irreplaceable property of Plaintiffs was irreparably damaged, precluding its redelivery to them. 215. Prelude and Pacific MSO breached their duties to exercise care in the safekeeping of Plaintiffs’ eggs and embryos and to return the eggs and embryos, undamaged, to Plaintiffs. 216. As a direct and proximate result of Prelude and Pacific MSO’s breach of the foregoing 17 duties, Plaintiffs have been deprived of the opportunity to use their eggs and embryos, and have 18 suffered damages in an amount to be determined at trial. 19 FOURTH CAUSE OF ACTION Premises Liability (Against Prelude and Pacific MSO) 20 21 217. Plaintiffs incorporate the above and below allegations by reference. 22 218. At all relevant times, Prelude and Pacific MSO owned, leased, and/or occupied the 23 property, premises, machinery, and equipment, including Tank 4, on the premises at 55 Francisco 24 Street, Suite 500, San Francisco, California 94133. 25 26 219. At all relevant times, Prelude and Pacific MSO had a duty to exercise reasonable care to keep Plaintiffs’ eggs and embryos in a reasonably safe condition and free from injury or harm. 27 28 34 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 38 of 51 1 220. At all relevant times, Prelude and Pacific MSO knew, or by reasonable inspection and 2 monitoring should have known, of the defective condition of the premises, and specifically of Tank 4 3 and its accompanying equipment. 4 221. At all relevant times, Prelude and Pacific MSO were careless and negligent in the 5 ownership, management, control, and maintenance of the aforementioned real property, such that 6 Plaintiffs, whose cryopreserved eggs were under Prelude and Pacific MSO’s care, were harmed. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 222. By reason of the foregoing, and as a direct and legal cause thereof, Plaintiffs have suffered injury, loss, harm, and damages. FIFTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against Prelude, Pacific MSO, Chart, and PFC) 223. Plaintiffs incorporate the above and below allegations by reference. 224. The UCL prohibits acts of “unfair competition,” including any “unlawful, unfair or fraudulent business act or practice.” Unlawful 225. This claim is asserted against PFC, Prelude, and Pacific MSO. PFC, Prelude, and Pacific MSO’s conduct is unlawful in violation of the UCL, because—as set forth below in the Sixth Cause of Action—it violates the California Consumers Legal Remedies Act. Unfair 226. This claim is asserted against Defendants Prelude, Pacific MSO, and Chart. 227. Prelude, Pacific MSO, and Chart’s conduct is unfair because it is immoral, unethical, unscrupulous, oppressive, and substantially injurious. 228. Prelude and Pacific MSO voluntarily took responsibility for safeguarding Plaintiffs’ eggs and embryos through long-term freezer storage in order to preserve Plaintiffs’ options for procreation, parenting, or assisting others experiencing infertility. Prelude and Pacific MSO breached that trust and acted in an unethical, unscrupulous, outrageous, oppressive, and substantially injurious manner by, among other things: 28 35 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 39 of 51 1 a. failing to adequately maintain, inspect, monitor, and test the liquid nitrogen 2 freezer tanks, including through a functional electronic tank monitoring system capable of detecting a 3 rise in temperature or a drop in liquid nitrogen levels and promptly alerting staff to the immediate 4 problem; 5 6 b. permitting a leakage or tank failure to occur with respect to one of their liquid nitrogen storage tanks—Tank 4—containing human eggs and embryos; 7 c. failing to adequately inspect Tank 4 on a regular basis; 8 d. failing to establish, maintain, and properly activate alarms; 9 e. failing to establish, maintain, and properly activate backup redundancies; 10 f. failing to establish, maintain, and properly activate the controller and/or autofill g. failing to properly safeguard the eggs and embryos in their care, including by 11 devices; and 12 13 implementing and abiding by appropriate protocols and procedures. 14 15 229. substantially injurious manner, by, among other things: 16 17 a. failing to adequately design Tank 4 to avoid catastrophic failure resulting in damage to or destruction of frozen reproductive materials, including eggs or embryos; 18 19 Chart acted unfairly, in an unethical, unscrupulous, outrageous, oppressive, and b. failing to adequately manufacture Tank 4 to avoid catastrophic failure resulting in damage to or destruction of frozen reproductive materials, including eggs or embryos; 20 c. failing to adequately warn users concerning the risks presented by Tank 4; and 21 d. failing to recall, prior to the Tank 4 incident, the line of tanks that included Tank 22 23 4. 230. As a direct and proximate result of Prelude, Pacific MSO, and Chart’s unfair conduct 24 violative of the UCL, Plaintiffs have suffered injuries in fact and lost money or property, and they seek 25 appropriate relief under the UCL, including injunctive relief and restitution. 26 231. The gravity of the harm resulting from Prelude, Pacific MSO, and Chart’s conduct far 27 outweighs any conceivable utility of this conduct. There are reasonably available alternatives that 28 would further Prelude, Pacific MSO, and Chart’s legitimate business interests, such as implementing 36 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 40 of 51 1 adequate design, testing, manufacturing, warning, and recall protocols, and implementing reasonable 2 protocols and procedures to prevent catastrophic failure. 3 232. Plaintiffs could not have reasonably avoided injury from Prelude, Pacific MSO, and 4 Chart’s unfair conduct. Plaintiffs did not know, and had no reasonable means of learning, that Prelude 5 and Pacific MSO , let alone that they were not properly 6 safeguarding the eggs and embryos . Nor did Plaintiffs have occasion to 7 know that Chart had supplied and failed to recall a defective storage tank. 8 9 Fraudulent 233. This claim is asserted against PFC, Prelude, and Pacific MSO. PFC, Prelude, and Pacific 10 MSO’s conduct is fraudulent in violation of the UCL because it was likely to mislead a reasonable 11 consumer, in at least the following respects: 12 a. When offering to provide long-term freezer storage services to Plaintiffs and 13 class members, PFC knowingly and intentionally failed to disclose and actively concealed that it did 14 not have reasonable processes and systems in place to safeguard Plaintiffs’ and class members’ eggs 15 and embryos; 16 17 b. PFC also knowingly and intentionally failed to disclose and actively concealed that it had 18 ; and 19 20 c. actively concealed: (1) that they 21 22 23 Prelude and Pacific MSO knowingly and intentionally failed to disclose and had no license, and had no medical personnel on staff; and (2) that their systems and processes in place to safeguard the eggs and embryos were inadequate. 234. PFC had ample means and opportunities to alert Plaintiffs and class members at the 24 outset to the fact that it was not employing reasonable processes and systems to safeguard Plaintiffs’ 25 eggs and embryos. Later, PFC also had the means and opportunity to alert Plaintiffs and class members 26 to the fact that 27 28 235. . Prelude and Pacific MSO also had opportunities to disclose these facts to Plaintiffs, including through their employees, who consulted with customers concerning their tissue. 37 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 41 of 51 1 236. Despite these opportunities, PFC, Prelude, and Pacific MSO all independently failed to 2 disclose the above information to Plaintiffs and the other members of the class. Had Defendants made 3 those disclosures, Plaintiffs would not have purchased, or continued purchasing, the long-term freezer 4 storage services at issue. 5 237. PFC had a duty to accurately disclose who was responsible for tissue storage, and to 6 warn of the inadequacies in its tissue storage systems and processes, because it made partial 7 representations concerning the egg and embryo storage operation in place at its facility. PFC 8 volunteered specific information to Plaintiffs through advertising, on its website, and in documents that 9 its storage services were high quality and reliable, including representations that a tank could go 10 without power or liquid nitrogen for “several days” without damaging the tissue it contained. PFC also 11 had exclusive and superior knowledge of the relevant facts, compared to Plaintiffs and class members, 12 yet actively concealed the information rather than disclosing it. 13 238. Prelude and Pacific MSO were under a duty to disclose both 14 , and that their storage systems and processes were inadequate, given their exclusive 15 knowledge of these matters. Yet they actively concealed the information rather than disclosing it. 16 239. As a direct and proximate result of PFC, Prelude, and Pacific MSO’s fraudulent conduct 17 violative of the UCL, Plaintiffs have suffered injuries in fact and lost money or property, and they seek 18 appropriate relief under the UCL, including injunctive relief and restitution. 19 240. Had PFC, Prelude, and Pacific MSO not made misleading statements and omissions 20 regarding the control over, and the adequacy of, the relevant equipment, systems, and processes, 21 Plaintiffs would not have purchased and continued purchasing the storage services. In the meantime, 22 PFC, Prelude, and Pacific MSO generated more revenue than they otherwise would have, unjustly 23 enriching themselves. 24 25 26 27 241. Plaintiffs were harmed, and PFC, Prelude, and Pacific MSO’s misleading statements and omissions were a substantial factor in causing Plaintiffs’ harm. 242. The requested injunction under the UCL will primarily benefit the interests of the general public. It will have the primary purpose and effect of prohibiting unlawful action and inaction 28 38 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 42 of 51 1 that threatens injury to members of the public who have placed, or who in the future place, reproductive 2 tissue under Prelude or Pacific MSO’s care or in one of Chart’s tanks. 3 4 5 6 7 8 9 10 11 12 13 SIXTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against PFC, Prelude, and Pacific MSO) 243. Plaintiffs incorporate the above and below allegations by reference. 244. PFC, Prelude, and Pacific MSO is each a “person” as defined by Civil Code §§ 1761(c) and 1770 and have provided “services” as defined by Civil Code §§ 1761(b) and 1770. 245. engaged in “transaction[s]” as defined by Civil Code §§ 1761(e) and 1770. 246. including by: 15 16 18 19 20 23 24 25 26 27 28 a. passing off services as those of another; b. misrepresenting the source of goods or services; c. misrepresenting the affiliation, connection, or association with another; d. representing that their services had characteristics, uses, and benefits that they e. representing that their services were of a particular standard, quality, or grade, did not have; when they were not; 21 22 PFC, Prelude, and Pacific MSO’s acts and practices were intended to and did result in the continued sale of services to Plaintiffs, and those acts and practices violated Civil Code § 1770, 14 17 Plaintiffs are “consumers” as defined by Civil Code §§ 1761(d) and 1770 and have f. advertising services with intent not to sell them as advertised; and g. representing that the subject of a transaction had been supplied in accordance with a previous representation when it had not. 247. PFC, Prelude, and Pacific MSO’s acts and practices violated the Consumers Legal Remedies Act because each of these Defendants failed to disclose information that was material to Plaintiffs’ relevant transactions. For example: a. When offering to provide long-term freezer storage services to Plaintiffs and class members, PFC knowingly and intentionally failed to disclose and actively concealed that it did 39 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 43 of 51 1 not have reasonable processes and systems in place to safeguard Plaintiffs’ and class members’ eggs 2 and embryos; 3 4 b. PFC also knowingly and intentionally failed to disclose and actively concealed that it had 5 ; and 6 7 c. actively concealed: (1) that 8 9 10 Prelude and Pacific MSO knowingly and intentionally failed to disclose and had no license, and had no medical personnel on staff; and (2) that their systems and processes in place to safeguard the eggs and embryos were inadequate. 248. PFC had ample means and opportunities to alert Plaintiffs and class members at the 11 outset to the fact that it was not employing reasonable processes and systems to safeguard Plaintiffs’ 12 eggs and embryos. Later, PFC also had the means and opportunity to alert Plaintiffs and class members 13 to the fact that 14 15 16 249. . Prelude and Pacific MSO also had opportunities to disclose these facts to Plaintiffs, including through their employees, who consulted with customers concerning their tissue. 250. Despite these opportunities, PFC, Prelude, and Pacific MSO all independently failed to 17 disclose the above information to Plaintiffs and the other members of the class. Had Defendants made 18 those disclosures, Plaintiffs would not have purchased, or continued purchasing, the long-term freezer 19 storage services at issue. 20 251. PFC had a duty to accurately disclose who was responsible for tissue storage, and to 21 warn of the inadequacies in its tissue storage systems and processes, because it made partial 22 representations concerning the egg and embryo storage operation in place at its facility. PFC 23 volunteered specific information to Plaintiffs through advertising, on its website, and in documents that 24 its storage services were high quality and reliable, including representations that a tank could go 25 without power or liquid nitrogen for “several days” without damaging the tissue it contained. PFC also 26 had exclusive and superior knowledge of the relevant facts, compared to Plaintiffs and class members, 27 yet actively concealed the information rather than disclosing it. 28 40 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 44 of 51 1 252. Prelude and Pacific MSO were under a duty to disclose both 2 and that their storage systems and processes were inadequate, given their exclusive 3 knowledge of these matters. Yet they actively concealed the information rather than disclosing it. 4 253. As a direct and proximate result of PFC, Prelude, and Pacific MSO’s deceptive acts and 5 practices in violation of the Consumers Legal Remedies Act, Plaintiffs have suffered actual damages. 6 Had PFC, Prelude, and Pacific MSO not made misleading statements and omissions regarding the 7 control over, and the adequacy of, the relevant equipment, systems, and processes, Plaintiffs would not 8 have purchased and continued purchasing the storage services. In the meantime, PFC, Prelude, and 9 Pacific MSO generated more revenue than they otherwise would have, unjustly enriching themselves. 10 11 12 254. Plaintiffs were harmed, and PFC, Prelude, and Pacific MSO’s misleading statements and omissions were a substantial factor in causing Plaintiffs’ harm. 255. Plaintiffs accordingly are entitled to equitable relief, reasonable attorneys’ fees and 13 costs, declaratory relief, and a permanent injunction enjoining PFC, Prelude, and Pacific MSO from 14 their unlawful, fraudulent, and deceitful activity. 15 256. Moreover, the conduct of PFC, Prelude, and Pacific MSO set forth herein was 16 reprehensible and subjected Plaintiffs to cruel and unjust hardship in conscious disregard of their rights, 17 constituting oppression, for which PFC, Prelude, and Pacific MSO should be punished by punitive and 18 exemplary damages in an amount according to proof. PFC, Prelude, and Pacific MSO’s behavior 19 evidences a conscious disregard for the safety of the eggs and embryos entrusted to them, and by 20 extension, those who placed the eggs and embryos in their care, including Plaintiffs. PFC, Prelude, and 21 Pacific MSO’s conduct was and is despicable conduct and constitutes malice under Section 3294 of the 22 California Civil Code. An officer, director, or managing agent of PFC, Prelude, and Pacific MSO 23 personally committed, authorized, and/or ratified the reprehensible conduct set forth herein. Plaintiffs 24 thus seek an award of punitive damages sufficient to penalize PFC, Prelude, and Pacific MSO. 25 257. Pursuant to Civil Code § 1782(a), on June 21, 2018, Plaintiffs—on their own behalf and 26 on behalf of the class—sent letters to Prelude and PFC notifying them of their CLRA violations and 27 affording them the opportunity to correct their business practices and rectify the harm they caused. 28 Plaintiffs sent the CLRA notice via certified mail, return receipt requested, to PFC and Prelude’s 41 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 45 of 51 1 principal places of business. These notices are attached to this Complaint as Exhibits 1 and 2. PFC, 2 Prelude, and Pacific MSO failed to correct their business practices or provide the relief requested 3 within 30 days. Therefore, Plaintiffs seek money damages under the CLRA. 4 5 258. In accordance with Civil Code § 1780(d), Plaintiffs’ CLRA venue declarations are attached to this Complaint as Exhibits 3-9. 6 SEVENTH CAUSE OF ACTION Fraudulent Concealment (Against PFC, Prelude, and Pacific MSO) 7 8 9 10 11 12 13 14 15 16 17 18 259. Plaintiffs incorporate the above and below allegations by reference. 260. PFC, Prelude, and Pacific MSO’s acts and practices constitute fraudulent concealment because each of these Defendants failed to disclose information that was material to Plaintiffs’ relevant transactions. For example: a. class members, PFC knowingly and intentionally failed to disclose and actively concealed that it did not have reasonable processes and systems in place to safeguard Plaintiffs’ and class members’ eggs and embryos; b. 21 22 23 24 25 26 27 PFC also knowingly and intentionally failed to disclose and actively concealed that it had ; and 19 20 When offering to provide long-term freezer storage services to Plaintiffs and c. Prelude and Pacific MSO knowingly and intentionally failed to disclose and actively concealed: (1) that they had no license, and had no medical personnel on staff; and (2) that their systems and processes in place to safeguard the eggs and embryos were inadequate. 261. PFC had ample means and opportunities to alert Plaintiffs and class members at the outset to the fact that it was not employing reasonable processes and systems to safeguard Plaintiffs’ eggs and embryos. Later, PFC also had the means and opportunity to alert Plaintiffs and class members to the fact that 28 42 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 46 of 51 1 2 3 262. Prelude and Pacific MSO also had opportunities to disclose these facts to Plaintiffs, including through their employees, who consulted with customers concerning their tissue. 263. Despite these opportunities, PFC, Prelude, and Pacific MSO all independently failed to 4 disclose the above information to Plaintiffs and the other members of the class. Had Defendants made 5 those disclosures, Plaintiffs would not have purchased, or continued purchasing, the long-term freezer 6 storage services at issue. 7 264. PFC had a duty to accurately disclose who was responsible for tissue storage, and to 8 warn of the inadequacies in its tissue storage systems and processes, because it made partial 9 representations concerning the egg and embryo storage operation in place at its facility. PFC 10 volunteered specific information to Plaintiffs through advertising, on its website, and in documents that 11 its storage services were high quality and reliable, including representations that a tank could go 12 without power or liquid nitrogen for “several days” without damaging the tissue it contained. PFC also 13 had exclusive and superior knowledge of the relevant facts, compared to Plaintiffs and class members, 14 yet actively concealed the information rather than disclosing it. 15 265. Prelude and Pacific MSO were under a duty to disclose both the 16 , and that their storage systems and processes were inadequate, given their exclusive 17 knowledge of these matters. Yet they actively concealed the information rather than disclosing it. 18 266. As a direct and proximate result of PFC, Prelude, and Pacific MSO’s misleading 19 statements and omissions, Plaintiffs have suffered actual damages. Had PFC, Prelude, and Pacific MSO 20 not made misleading statements and omissions regarding the control over, and the adequacy of, the 21 relevant equipment, systems, and processes, Plaintiffs would not have purchased and continued 22 purchasing the storage services. In the meantime, PFC, Prelude, and Pacific MSO generated more 23 revenue than they otherwise would have, unjustly enriching themselves. 24 25 26 267. Plaintiffs were harmed, and PFC, Prelude, and Pacific MSO’s misleading statements and omissions were a substantial factor in causing Plaintiffs’ harm. 268. The foregoing acts and omissions of PFC, Prelude, and Pacific MSO were committed 27 maliciously, oppressively, deliberately, with intent to defraud, and in reckless disregard of Plaintiffs’ 28 rights, interests, and well-being to enrich PFC, Prelude, and Pacific MSO. PFC, Prelude, and Pacific 43 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 47 of 51 1 MSO’s conduct warrants an assessment of punitive damages in an amount sufficient to deter such 2 conduct in the future, which amount is to be determined according to proof. 3 EIGHTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart) 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 269. Plaintiffs incorporate the above and below allegations by reference. 270. Chart manufactured, distributed, and/or sold cryogenic equipment used at PFC, including Tank 4. 271. The cryogenic storage tank at issue had potential risks that were known or knowable in light of the scientific and medical knowledge that was generally accepted in the scientific and medical community at the time of the manufacture, distribution, or sale of the cryogenic storage Tank 4. 272. The cryogenic storage Tank 4 was defective and unreasonably dangerous when it left Chart’s possession because it did not contain adequate warnings, including warnings concerning the risk of defective seals that may result in catastrophic nitrogen loss, the risk of nitrogen loss and prevalence of this occurrence, the risk of a rise in temperature that can damage and/or cause destruction of eggs or embryos, the rate of failure of the cryogenic storage tanks in the preservation of eggs or embryos or other human tissue, and the need for maintenance, inspection, and/or replacement of the cryogenic storage tanks. 273. The potential risks presented a substantial danger when the cryogenic storage tank at issue was used or misused in an intended or reasonably foreseeable way. The ordinary consumer would not have recognized the potential for risks. 274. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable care should have known, that the cryogenic storage Tank 4 was dangerous, had risks, and was defective in manufacture or design, including because it could cause nitrogen loss resulting in damage to or destruction of frozen reproductive materials, including eggs or embryos. 275. Chart failed to adequately warn or instruct concerning the potential risks of the cryogenic storage tank. 28 44 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 48 of 51 1 276. It was foreseeable to Chart that failure to adequately warn about the risks of its 2 cryogenic storage tank would cause irreparable harm, including the type of emotional distress suffered 3 by Plaintiffs, whose eggs and embryos were stored therein. 4 277. As a result of Chart’s failures to adequately warn, Plaintiffs were harmed as described 5 herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 6 are not viable. The lack of sufficient instructions and warnings was a substantial factor in causing 7 Plaintiffs’ harm. NINTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) 8 9 10 278. Plaintiffs incorporate the above and below allegations by reference. 11 279. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 12 280. The cryogenic storage tank contained a manufacturing defect when it left Chart’s 13 possession. 14 281. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 15 care should have known, that the cryogenic storage tank was dangerous, had risks, and was defective in 16 manufacture, including because it could cause nitrogen loss resulting in damage to or destruction of 17 frozen reproductive materials, including eggs or embryos. 18 282. As a result of the manufacturing defect in Tank 4, Plaintiffs were harmed as described 19 herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 20 are not viable. 21 22 283. The defective nature of the cryogenic storage tank was a substantial factor in causing Plaintiffs’ harm. TENTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Consumer Expectations Test (Against Chart) 23 24 25 284. Plaintiffs incorporate the above and below allegations by reference. 26 285. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 27 286. The cryogenic storage tank did not perform as safely as an ordinary consumer would 28 have expected it to perform when used or misused in an intended or reasonably foreseeable way. 45 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 49 of 51 1 287. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 2 care should have known, that the cryogenic storage tank was dangerous, had risks, and was defective in 3 design, including because it could cause nitrogen loss resulting in damage to or destruction of stored 4 frozen reproductive materials, including eggs or embryos. 5 288. As a result of the design defect in Tank 4, Plaintiffs were harmed as described herein, 6 regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 are not 7 viable. 8 9 289. The cryogenic storage tank’s failure to perform safely was a substantial factor in causing Plaintiffs’ harm. ELEVENTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) 10 11 12 290. Plaintiffs incorporate the above and below allegations by reference. 13 291. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 14 292. The benefits of this tank’s design are not outweighed by its risks, considering the gravity 15 of the potential harm resulting from the use of the tank, the likelihood that the harm would occur, the 16 feasibility of an alternative safer design at the time of manufacture, and the disadvantages of an 17 alternative design. 18 293. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 19 care should have known, that the cryogenic storage tank was dangerous, had risks, and was defective in 20 design, including because it could cause nitrogen loss resulting in damage to or destruction of frozen 21 reproductive materials, including eggs or embryos. 22 294. Plaintiffs were harmed because Tank 4 lost liquid nitrogen. 23 295. Chart’s design of the tank was a substantial factor in causing Plaintiffs’ harm. PRAYER FOR RELIEF 24 25 26 WHEREFORE, Plaintiffs, individually and on behalf of the class defined above, respectfully request that the Court: 27 28 46 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 50 of 51 1 A. Certify the class under Federal Rules of Civil Procedure 23(a), (b)(2), (b)(3), 2 and/or (c)(4), as appropriate; appoint Plaintiffs as representatives of the class; and appoint the 3 undersigned counsel as class counsel; 4 5 B. Award Plaintiffs compensatory, restitutionary, rescissory, general, consequential, punitive and exemplary damages in an amount to be determined at trial; 6 C. Award prejudgment interest as permitted by law; 7 D. Enter an appropriate injunction against Defendants and their officers, agents, 8 9 10 successors, employees, representatives, and assigns; E. Appoint a monitor and retain jurisdiction to ensure that Defendants comply with the injunctive provisions of any decree of this Court; 11 F. Enter other appropriate equitable relief; 12 G. Award reasonable attorneys’ fees and costs, as provided for by law; and 13 H. Grant such other and further relief as the Court deems just and proper. 14 15 DEMAND FOR JURY TRIAL Plaintiffs demand a trial by jury on all issues so triable. 16 17 18 19 20 21 22 23 24 25 26 27 28 Dated: November 30, 2018 Respectfully submitted, By: /s/ Adam E. Polk Dena C. Sharp (State Bar No. 245869) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD SHARP LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dsharp@girardsharp.com jelias@girardsharp.com apolk@girardsharp.com Eric H. Gibbs (State Bar No. 178658) Dylan Hughes (State Bar No. 209113) Steven M. Tindall (State Bar No. 187862) Amy M. Zeman (State Bar No. 273100) GIBBS LAW GROUP LLP 47 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143 Filed 11/30/18 Page 51 of 51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 505 14th Street, Suite 1110 Oakland, CA 94162 Tel: (510) 350-9700 Fax: (510) 350-9701 ehg@classlawgroup.com dsh@classlawgroup.com smt@classlawgroup.com amz@classlawgroup.com Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com 22 Interim Class Counsel 23 Joseph G. Sauder (pro hac vice) SAUDER SCHELKOPF LLC 555 Lancaster Avenue Berwyn, Pennsylvania 19312 Tel: (610) 200-0580 jgs@sstriallawyers.com 24 25 26 27 Plaintiffs’ Counsel 28 48 FIRST AMENDED CONSOLIDATED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Document 143-1 Filed 11/30/18 Page 1 of 62 EXHIBIT 1 Case 3:18-cv-01586-JSC Document 143-1 Filed 11/30/18 Page 2 of 62   June 21, 2018 VIA FEDERAL EXPRESS AND CERTIFIED MAIL RETURN RECEIPT REQUESTED Prelude Fertility, Inc. c/o April P. Eckardt 1100 Johnson Ferry Rd #200 Atlanta, GA 30342 Re: Notice of Violation of California’s Consumers Legal Remedies Act and Demand for Relief, Pursuant to Cal. Civ. Code § 1782 To Whom It May Concern: Girard Gibbs LLP, Lieff Cabraser Heimann & Bernstein, LLP, and Peiffer Wolf Carr & Kane, A.P.L.C. represent A.B., C.D., E.F., G.H., I.J., K.L., M.N., and O.P. (“Plaintiffs”). As reflected in further detail in the attached complaint, filed in In re Pacific Fertility Center Litigation, Case No. 3:18-cv-01586-JSC (N.D. Cal.), Plaintiffs allege that Pacific Fertility and Prelude engaged in deceptive acts and practices, including by failing to disclose that their storage tank, electronic monitoring, alarm, and response systems and processes were inadequate to safely store Plaintiffs’ eggs and embryos. As a result, on March 4, 2018, Pacific Fertility discovered that the nitrogen levels in a storage tank known as “Tank 4” had dropped to an unsafe level for an undetermined period of time, destroying or jeopardizing the eggs and embryos stored in the tank, including those belonging to Plaintiffs. Defendants’ conduct violates California consumer protection law, including California’s Consumers Legal Remedies Act, Cal. Civ. Code § 1750, et seq., because Pacific Fertility and Prelude: 1. Represented that their services had characteristics, uses, and benefits that they did not have (Cal. Civ. Code § 1770(5)); 2. Represented that their services were of a particular standard, quality, or grade when they were not (Cal. Civ. Code § 1770(7)); 3. Advertised services with intent not to sell them as advertised (Cal. Civ. Code § 1770(9)); and 4. Represented that the subject of a transaction had been supplied in accordance with a previous representation when it had not (Cal. Civ. Code § 1770(16)). With this letter, our firms, on behalf of Plaintiffs and a proposed class of all individuals and their reproductive partners who had eggs, embryos, or other material in Tank 4 at Pacific Fertility Center in San Francisco, California on March 4, 2018, demand that you correct your business practices and take prompt action.   Case 3:18-cv-01586-JSC Document 143-1 Filed 11/30/18 Page 3 of 62 To: Re: Date: Page: Prelude Fertility, Inc. Notice of Violation of CLRA and Demand for Relief June 21, 2018 2 of 3   Please direct all communications or responses regarding this notice to the following counsel: Daniel C. Girard Steven M. Tindall Jordan Elias Adam E. Polk GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com REQUESTED REMEDIES Plaintiffs DEMAND THAT WITHIN THIRTY DAYS you remedy your violations by doing the following:   I. Disseminate a notice reasonably intended to reach all proposed class members, setting forth: a. The existence and description of the Pacific Fertility Center litigation, including a summary of the subject matter and the claims asserted; b. The name, address, and telephone number of Plaintiffs’ counsel, identified above; and c. The right of proposed class members to obtain the remedies described below. II. Subject to monitoring and confirmation by Plaintiffs’ counsel, compensate proposed class members for all injuries caused by Pacific Fertility and Prelude’s failure to disclose that their systems and processes were inadequate to safely store human reproductive tissue, including for class members’ resulting emotional distress, mitigation expenses, and the costs of Defendants’ services. III. Immediately cease selling services while maintaining systems and processes that are inadequate to safely store human reproductive tissue, until you: a. Allow Plaintiffs’ counsel to inspect Pacific Fertility and Prelude’s current systems and processes; and Case 3:18-cv-01586-JSC Document 143-1 Filed 11/30/18 Page 4 of 62 To: Re: Date: Page: Prelude Fertility, Inc. Notice of Violation of CLRA and Demand for Relief June 21, 2018 3 of 3   b. IV. Implement all system and process improvements demanded by Plaintiffs’ counsel following inspections. Pay into a court-approved escrow account an amount of money sufficient to pay Plaintiffs’ reasonable attorneys’ fees and costs. Please contact us within thirty days to discuss Pacific Fertility and Prelude’s implementation of these remedies. Very truly yours, GIRARD GIBBS LLP Adam E. Polk Enclosure cc:   Erin M. Bosman William F. Tarantino Julie Y. Park MORRISON & FOERSTER LLP 425 Market Street San Francisco, CA 94105 Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1 5ofof5862 1 2 3 4 5 6 7 8 9 Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com Daniel C. Girard (State Bar No. 114826) Steven M. Tindall (State Bar No. 187862) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com 15 Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com 16 Counsel for Plaintiffs and Interim Class Counsel 10 11 12 13 14 17 [Additional Counsel on Signature Page] 18 19 UNITED STATES DISTRICT COURT 20 NORTHERN DISTRICT OF CALIFORNIA 21 SAN FRANCISCO DIVISION 22 23 24 25 26 27 IN RE PACIFIC FERTILITY CENTER LITIGATION ) ) ) ) ) ) ) ) ) Case No. 3:18-cv-01586-JSC CONSOLIDATED AMENDED CLASS ACTION COMPLAINT DEMAND FOR JURY TRIAL 28 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2 6ofof5862 1 TABLE OF CONTENTS 2 NATURE OF THE ACTION ................................................................................................................... 1  3 JURISDICTION AND VENUE ............................................................................................................... 2  4 INTRADISTRICT ASSIGNMENT.......................................................................................................... 3  5 PARTIES .................................................................................................................................................. 3  6 7 A.  Plaintiffs ................................................................................................................ 3  B.  Defendants ............................................................................................................ 4  8 9 10 11 12 13 Prelude ...................................................................................................... 4  2.  Pacific Fertility.......................................................................................... 5  3.  Chart .......................................................................................................... 6  FACTUAL ALLEGATIONS ................................................................................................................... 7  I.  14 Plaintiffs Entrusted Prelude and Pacific Fertility with Keeping their Eggs and Embryos Safe and Secure. ................................................................................................ 7  A.  Defendants market their cryopreservation services as an insurance policy that unwinds the biological clock, preserving the opportunity to have children when the time is right. ........................................................................................... 7  B.  Defendants market their cryopreservation and storage services to people struggling with infertility. ..................................................................................... 9  C.  Defendants promised to keep Plaintiffs’ eggs and embryos safe in a state-ofthe-art facility. ..................................................................................................... 10  15 16 17 18 19 20 1.  II.  21 Precision and Care Are Required in the Cryopreservation and Storage of Eggs and Embryos. ......................................................................................................................... 13  22 A.  The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. ................................................................................. 13  B.  The loss of eggs and embryos results in emotional trauma. ............................... 18  C.  Successful cryopreservation depends on strict adherence to protocols. ............. 19  23 24 25 26 27 28 III.  Defendants Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. ..................................................................................................................21  A.  Prelude and Pacific Fertility should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. ......................... 21  i CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3 7ofof5862 B.  Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident. ............................................................................................................... 22  C.  Multiple investigations were opened after the Tank 4 incident. ......................... 22  D.  Defendants’ failure to keep Plaintiffs’ eggs and embryos safe and secure has caused irreparable harm. ..................................................................................... 23  E.  6 Pacific Fertility and Prelude’s communications regarding the incident have compounded the harm. ........................................................................................ 26  7 PLAINTIFF-SPECIFIC ALLEGATIONS .............................................................................................29  8 CLASS ACTION ALLEGATIONS ....................................................................................................... 34  9 CLAIMS FOR RELIEF .......................................................................................................................... 37  10 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against All Defendants) ................................................ 37  1 2 3 4 5 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 SECOND CAUSE OF ACTION Breach of Contract (Against Pacific Fertility and Prelude) ........................................................ 40  THIRD CAUSE OF ACTION Bailment (Against Pacific Fertility and Prelude) ........................................................................ 40  FOURTH CAUSE OF ACTION Premises Liability (Against Pacific Fertility and Prelude) ......................................................... 41  FIFTH CAUSE OF ACTION Breach of Fiduciary Duty ‒ Failure to Use Reasonable Care (Against Pacific Fertility and Prelude) .......................................................................................42  SIXTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against All Defendants) ............................................................................................................ 43  SEVENTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against Pacific Fertility and Prelude) .......................................................................................45  EIGHTH CAUSE OF ACTION Deceit and Fraudulent Concealment (Against Pacific Fertility and Prelude) ............................. 47  NINTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart) ....................................................... 49  TENTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) ............................................. 50  ii CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4 8ofof5862 1 2 3 4 5 6 7 ELEVENTH CAUSE OF ACTION Strict Products Liability — Design Defect — Consumer Expectations Test (Against Chart) ...50  TWELFTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) .......................... 51  THIRTEENTH CAUSE OF ACTION Negligent Failure to Recall (Against Chart) ............................................................................... 51  PRAYER FOR RELIEF ......................................................................................................................... 52  DEMAND FOR JURY TRIAL .............................................................................................................. 53  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iii CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5 9ofof5862 1 Plaintiffs A.B., C.D., E.F., G.H., I.J., K.L., M.N., and O.P. (“Plaintiffs”), individually and on 2 behalf of all others similarly situated, file this Consolidated Class Action Complaint against 3 Defendants Pacific Fertility Center (“Pacific Fertility” or “PFC”), Prelude Fertility, Inc. (“Prelude”), 4 and Chart Industries (“Chart”) (collectively, “Defendants”) and allege as follows: 5 6 NATURE OF THE ACTION 1. Prelude and Pacific Fertility market and sell egg and embryo cryopreservation services. 7 They liken these services to an insurance policy for women and families, claiming the services provide 8 peace of mind to those who wish to defer having children and relief to those seeking to overcome a 9 diagnosis of infertility. Cryopreservation involves preservation of tissue—here, human eggs and 10 embryos—using cooling techniques. In the 1980s, facilities began using a cryopreservation technique 11 known as “slow freezing” to preserve human reproductive tissue. Cryopreservation became more 12 prevalent after the advent in the early 2000s of vitrification, a process by which tissue is cooled more 13 quickly, resulting in higher egg and embryo survival rates. Eggs or embryos frozen through 14 cryopreservation are stored in specially designed metal tanks. 15 2. Recognizing that the eggs and embryos entrusted to their care are irreplaceable, Prelude 16 and Pacific Fertility promise their clients, including Plaintiffs, that they will use state-of-the-art 17 laboratory equipment and protocols to ensure the safekeeping of the eggs and embryos. Safe storage 18 requires backup redundancies to guard against a catastrophic failure, daily inspections of the tanks, and 19 alarm systems to immediately notify staff of a potential failure. 20 3. On March 4, 2018, Pacific Fertility discovered that the liquid nitrogen levels in a tank 21 known as “Tank 4” had dropped to an unsafe level for an undetermined period of time, destroying or 22 jeopardizing the eggs and embryos stored in the tank, including those belonging to Plaintiffs. Chart 23 manufactured Tank 4. 24 4. Pacific Fertility’s first notification of the failure of Tank 4 was via an email sent at four 25 in the morning Pacific time on Sunday, March 11, 2018. Pacific Fertility described the failure as “a 26 very unfortunate incident” in which the storage tank containing Plaintiffs’ cryopreserved eggs and 27 embryos “lost liquid nitrogen for a brief period of time,” and stated that a “preliminary analysis” 28 suggested some of the eggs and embryos in the tank may have been destroyed. 1 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-1 44 Filed Filed05/30/18 11/30/18 Page Page610 of of 5862 1 5. Over a month later, on April 19, 2018, Pacific Fertility again wrote to Plaintiffs, 2 notifying them that an investigation had shown the incident resulted from “a failure of the tank’s 3 vacuum seal.” Four days later, Chart recalled several of its cryopreservation tanks, citing “reports of a 4 vacuum leak or failure that could compromise the product.” 5 6. Pacific Fertility and Prelude were responsible for monitoring Tank 4’s performance for 6 fluctuations in temperature or liquid nitrogen levels, which could endanger the enclosed eggs and 7 embryos, and to maintain safety systems to mitigate a tank failure. Pacific Fertility and Prelude failed 8 in that responsibility, committed gross negligence, and breached their agreement by failing to safely 9 preserve the eggs and embryos under their care. 10 11 7. To Plaintiffs’ shock and dismay, Pacific Fertility and Prelude did not separate their eggs or embryos into different tanks to ensure that at least some tissue would be safe if one tank failed. 12 8. As a result of Defendants’ failures, Plaintiffs and the proposed class have suffered harm. 13 Learning that their reproductive tissue was compromised has caused them devastation, panic, and 14 distress. For many, the tissue in Tank 4 represented their last and only chance for a biological child. 15 Pacific Fertility and Prelude have informed Plaintiffs that it is not possible to know whether their eggs 16 or embryos are viable until they are warmed, and even then, the full extent of the damage cannot be 17 known without attempting a pregnancy. These messages have cast a cloud of uncertainty over women 18 and families, causing anguish and despair. 19 20 9. Plaintiffs, individually and on behalf of the class, seek appropriate relief through this action. 21 22 JURISDICTION AND VENUE 10. This Court has subject matter jurisdiction over this action under the Class Action 23 Fairness Act of 2005, 28 U.S.C. § 1332(d), because (a) Plaintiffs are citizens of states different from 24 Prelude and Chart, (b) the amount in controversy exceeds $5,000,000, excluding interest and costs, (c) 25 the proposed class consists of more than 100 individuals, and (d) none of the exceptions under the 26 subsection applies to this action. 27 28 11. This Court has personal jurisdiction over Defendants. They conduct substantial business in California and intentionally availed themselves of the laws and markets of this state. A significant 2 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-1 44 Filed Filed05/30/18 11/30/18 Page Page711 of of 5862 1 portion of the acts and omissions at issue occurred in California, and Plaintiffs and many class 2 members suffered harm in California. Plaintiffs’ claims against Defendants are meaningfully 3 connected to California in that: (1) each Plaintiff had eggs and embryos stored at Pacific Fertility, 4 which is located in California and within the Prelude network; and (2) each Plaintiff had eggs and 5 embryos stored in Chart’s tank, which was physically located at Pacific Fertility’s San Francisco 6 facility, and which failed, resulting in damage to Plaintiffs. 7 8 12. Venue is proper in this District under 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in this District. 9 10 INTRADISTRICT ASSIGNMENT 13. Assignment to the San Francisco Division is proper under Local Rules 3-2(c) and (d) 11 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in San 12 Francisco. 13 PARTIES 14 A. Plaintiffs 15 14. Plaintiff A.B. is a citizen and resident of Sacramento County, California. 16 15. Plaintiff C.D. is a citizen and resident of Sacramento County, California. 17 16. Plaintiff E.F. is a citizen and resident of San Francisco County, California. 18 17. Plaintiff G.H. is a citizen and resident of San Francisco County, California. 19 18. Plaintiff I.J. is a citizen and resident of San Francisco County, California. 20 19. Plaintiff K.L. is a citizen and resident of San Francisco County, California. 21 20. Plaintiff M.N. is a citizen and resident of San Francisco County, California. 22 21. Plaintiff O.P. is a citizen and resident of San Mateo County, California. 23 22. Given the sensitive nature of their claims and the services they purchased from Pacific 24 Fertility and Prelude, Plaintiffs are using initials in this litigation to protect their privacy. If required by 25 the Court, Plaintiffs will seek permission to proceed under these pseudonyms. 26 27 28 3 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-1 44 Filed Filed05/30/18 11/30/18 Page Page812 of of 5862 1 B. 2 Defendants 1. 3 23. Prelude At all relevant times, Defendant Prelude Fertility, Inc. was a Delaware corporation 4 headquartered in Florida. Prelude owns and runs a network of fertility clinics and egg and embryo 5 storage facilities—including Pacific Fertility Center—across the country. 6 24. Prelude was founded in 2016 by startup entrepreneur Martin Varsavsky with a $200 7 million investment by New York-based Lee Equity Partners. Prelude’s stated business plan is to create 8 a national network of fertility clinics, as well as egg and embryo cryopreservation and storage centers 9 “all delivered with the highest level of personalized care by the nation’s leading reproductive 10 endocrinologists and practitioners.”1 According to Varsavsky, “What Prelude does is bridge the gap, it 11 makes people’s biology meet their psychology” through “The Prelude Method”: “You freeze your 12 gametes when fertile, thaw them and create embryos when ready, genetically sequence the embryos, 13 and then transfer one embryo at a time. And you continue to do this until you achieve your desired 14 number of children.”2 15 25. Included within the Prelude network is MyEggBank, which Prelude claims has the 16 largest and most diverse selection of egg donors in the country. Prelude also claims that its embryo 17 survival rates are greater than 90% and that women who use eggs from MyEggBank have a 90% 18 pregnancy success rate within three cycles.3 19 26. Prelude acquired Pacific Fertility in September 2017 as part of Prelude’s business plan 20 to build its national network. Prelude directs potential clients to Pacific Fertility via its website and its 21 network of fertility clinics. Prelude also provides financing plans for services at Pacific Fertility. 22 23 24 25 26 27 1 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 18, 2018). 2 Martin Varsavsky, Why I founded Prelude Fertility: Background on vision and bringing on the team to make it thrive (Mar. 7, 2017), http://vator.tv/news/2017-03-07-why-i-founded-prelude-fertility (last visited May 30, 2018). 3 28 Have Questions?, Prelude Fertility, https://preludefertility.com/faq (last visited May 18, 2018). 4 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-1 44 Filed Filed05/30/18 11/30/18 Page Page913 of of 5862 1 2 27. Prelude represents that Pacific Fertility is one of “Our Clinics.”4 It represents that Pacific Fertility’s clients are “Our” clients.5 3 28. In its press release announcing the addition of Pacific Fertility to its network of fertility 4 clinics, Prelude described “egg freezing, in vitro fertilization (IVF), genetic screening of embryos, and 5 donor egg matching” as part of “Prelude’s comprehensive services.”6 6 7 29. Tank 4 at the time of the March 4, 2018, incident. 8 9 30. The employees responsible for performing daily monitoring and maintenance of the tanks, including Tank 4, are employees of Prelude. 10 2. 11 12 Prelude owns the laboratory, storage facility, and tanks at Pacific Fertility. It owned 31. Pacific Fertility Defendant Pacific Fertility Center is a private unincorporated entity located at 55 Francisco Street, Suite 500, San Francisco, California 94133. 13 32. Pacific Fertility was founded in 1999 and provides a full range of fertility services, 14 including egg cryopreservation, IVF, genetic testing, “cutting-edge laboratory techniques and 15 technology such as . . . vitrification,” and storage of cryopreserved eggs and embryos.7 16 17 33. cryopreserved and stored eggs and embryos, including those belonging to Plaintiffs.8 18 19 At all relevant times, Pacific Fertility’s on-site San Francisco laboratory has 34. At the time of the March 4, 2018, incident, Tank 4 was located at Pacific Fertility Center’s laboratory in San Francisco. 20 21 22 23 24 25 26 27 28 4 Options Preserved, Our Clinics, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). 5 Pacific Fertility Center: San Francisco, Prelude Fertility, https://www.preludefertility.com/clinic/pacificfertility-center (last visited May 18, 2018). 6 Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude Fertility, https://www.prnewswire.com/news-releases/prelude-fertility-expands-network-with-pacific-fertility-center-insan-francisco-300524534.html (last visited May 18, 2018). 7 Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude Fertility, https://www.preludefertility.com/press-release/prelude-fertility-expands-network-pacific-fertility-center-sanfrancisco (last visited May 20, 2018). 8 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited May 18, 2018). 5 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1014ofof5862 1 3. Chart 2 35. Defendant Chart Industries, Inc. is a Delaware corporation headquartered in Georgia.9 3 36. Founded in 1992, Chart is a publicly traded global manufacturer of equipment used in 4 the production, storage, and application of industrial gases. Chart produces a variety of cryogenic 5 equipment. On its website, Chart states that its “focus is cryogenics.”10 Chart claims that its products 6 “utilize our proprietary vacuum and insulation technologies, including storage equipment,” and that 7 “[o]ur industry-proven core-competency provides the highest insulation thermal performance in 8 cryogenics[.]”11 Chart touts itself as “a recognized global brand for the design and manufacture of 9 highly engineered cryogenic equipment” and a “leading global manufacturer of vacuum insulated 10 products and cryogenic systems.”12 11 37. In its annual report for 2017, Chart described itself as a “leading diversified global 12 manufacturer of highly engineered equipment, packaged solutions, and value-add services used 13 throughout the gas to liquid cycle in all industries that require gases as cryogenic liquids or alternative 14 equipment for gas generation, generally for the industrial gas, energy, and biomedical industries.”13 15 38. Through its MVE brand, Chart sells a line of cryogenic equipment that includes freezers 16 and metal storage tanks. Chart claims that its cryogenic products “are engineered for reliability and 17 durability”14 and that its MVE brand “is the benchmark for biological storage systems, used for the 18 cryogenic preservation of human . . . tissues.”15 19 20 21 22 23 24 25 26 27 28 9 Plaintiffs only recently discovered the identity of the manufacturer—Defendant Chart—of the cryostorage tank in which Plaintiffs’ and class members’ eggs and embryos were stored at Pacific Fertility. Chart is being served concurrently with the filing of this Consolidated Amended Complaint. 10 About Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May 20, 2018). 11 Cryogenics, Chart Industries, http://www.chartindustries.com/Industry/Markets-Served/Cryogenics (last visited May 20, 2018). 12 MVE Cryopreservation for Life Science, Chart Industries, http://files.chartindustries.com/Cryopres%20Catalog%20ML-CRYO0009%20K%203b.pdf (last visited May 20, 2018). 13 SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934.pdf (last visited May 20, 2018). 14 Life Sciences, Chart Industries, http://www.chartindustries.com/Life-Sciences (last visited May 20, 2018). 15 About Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May 20, 2018). 6 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1115ofof5862 1 39. Chart’s BioMedical segment accounted for around 20% of its total sales. Its 2 “cryobiological storage products include vacuum insulated containment vessels for the storage of 3 biological materials.”16 Chart describes the competition for cryobiological storage products as 4 “significant” and notes that “competition in this field is focused on design, reliability, and price.”17 5 6 40. were stored on the date of the subject incident. 7 8 FACTUAL ALLEGATIONS I. Plaintiffs Entrusted Prelude and Pacific Fertility with Keeping their Eggs and Embryos Safe and Secure. 9 41. 10 11 Defendants Prelude and Pacific Fertility have partnered to offer cryopreservation and storage of eggs and embryos, among other fertility services. 42. 12 13 Chart designed and manufactured the storage tank in which Plaintiffs’ eggs and embryos Prelude claims that it is “on a mission” to provide “the best options, science, and care so everyone can have the opportunity to be a mom or dad when they are ready.”18 14 43. Pacific Fertility states that it has one goal: to help clients build a healthy family.19 15 A. Defendants market their cryopreservation services as an insurance policy that unwinds the biological clock, preserving the opportunity to have children when the time is right. 44. Human eggs, also known as oocytes, are a limited resource. According to Pacific 16 17 18 Fertility, a woman has about 600,000 eggs at birth, and this supply diminishes at the rate of about 1,000 19 per month, beginning at her birth.20 This decline is part of the natural aging process and is commonly 20 referred to as a woman’s biological clock. The loss of oocytes from the ovaries is relentless and 21 22 23 24 25 26 27 28 16 SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934.pdf (last visited May 20, 2018). 17 Id. 18 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 18, 2018). 19 Pacific Fertility Center, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertilitycenter (last visited May 28, 2018). 20 Egg Freezing in Northern California, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/fertility-preservation-egg-freezing (last visited May 27, 2018). 7 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1216ofof5862 1 continues even in the absence of menstrual cycles, and even when women are pregnant, nursing, or 2 taking oral contraceptives. In addition, as Pacific Fertility acknowledges, egg quality diminishes with 3 time, with miscarriages and chromosomal abnormalities occurring more frequently the older a woman 4 is at the time of pregnancy. By their early-to-mid 40s, women typically can no longer conceive a child 5 naturally.21 6 45. The purpose of egg cryopreservation is to allow women and their reproductive partners 7 to preserve eggs so that they may be fertilized and implanted at a later time. Both Pacific Fertility 8 Center and Prelude emphasize that their cryopreservation and storage services allow for flexibility in 9 their clients’ family planning, freeing women, for example, to wait for the right person and to focus on 10 their careers during their most fertile years. 11 46. Prelude advertises its cryopreservation and storage services as providing women with 12 “peace of mind” and more control over their childbearing choices.22 In marketing its cryopreservation 13 and storage services, Prelude specifically appeals to women’s declining fertility and limited eggs: “Age 14 Matters . . . We’re born with all the eggs we’ll ever have—and their quantity and quality decrease as we 15 age. If you think you might want a baby someday, but aren’t ready right now, freezing your eggs keeps 16 your options open.”23 Prelude likewise states that young women cryopreserve eggs “to have the 17 option—an insurance policy that unwinds the biological clock and lets women pursue career 18 advancement as freely as men without having to compromise in their choice of partner.”24 19 20 47. In large type, Prelude states on its website, “Options Preserved,” and proceeds to advertise multiple benefits from cryopreservation and storage: 21 22 23 24 25 26 27 28 21 Id. 22 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 23 Options Preserved, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). 24 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 8 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1317ofof5862 Find that right person. Focus on your career. Finish your education. The age of your eggs (not you) is the number one cause of infertility. Freeze your eggs to preserve your option to build a family when you’re ready.25 1 2 3 Prelude goes on to describe the storage process as hassle free: “Set it and forget it until you’re ready.”26 4 48. Pacific Fertility offers egg cryopreservation services as a means of preserving “a 5 precious resource, limited to just a few years of your life[,]” and states that cryopreserving eggs and 6 embryos “can increase your chances of conception by 5 to 10 times.”27 7 49. 8 6 Reasons to Preserve Your Fertility Today! (1) For a future family . . . (2) To allow for educational pursuits . . . (3) To have time to develop a business or career . . . (4) To give your relationship time to mature . . . (5) To reduce the risk of medical treatments that might impact fertility . . . (6) To achieve control over your future.28 9 10 11 12 13 14 15 B. Defendants market their cryopreservation and storage services to people struggling with infertility. 50. Defendants also promote their egg and embryo cryopreservation and storage services to people diagnosed with infertility. 51. 16 17 Pacific Fertility touts similar benefits from its fertility preservation services: Infertility is defined as the inability to conceive after one year of unprotected intercourse if a woman is under the age of 35, or after six months if a woman is 35 or older. 18 52. Pacific Fertility states that it sees infertility as a “workable challenge.” 29 19 53. Similarly, Prelude states: “we’re here to help you become a parent. We’ll use all of 20 our training, science, technology, lab skills, and most importantly, human-kindness skills, to fully 21 support you through every step of the process.”30 22 25 23 26 24 27 25 28 26 27 28 Options Preserved, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). Id. Should I freeze my eggs?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/my-eggs (last visited May 18, 2018). 6 Reasons to Preserve Your Fertility Today!, Pacific Fertility Center (June 30, 2017), https://www.pacificfertilitycenter.com/fertility-preservation/blog/6-reasons-to-preserve-your-fertility-today. 29 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 30 Let’s Make a Baby, Prelude Fertility, https://www.preludefertility.com/ivf (last visited May 27, 2018). 9 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1418ofof5862 1 54. For many individuals and couples experiencing infertility, Defendants’ embryo 2 cryopreservation services represented their best and only hope of having a biological child or of 3 having children who are biological siblings. 4 5 6 7 C. Defendants promised to keep Plaintiffs’ eggs and embryos safe in a state-of-theart facility. 55. Defendants emphasize that eggs and embryos will be safely stored, indefinitely, for future family planning. 56. 8 Prelude’s marketing messages recognize the importance of proper egg storage for those 9 who use its services. A Prelude spokesperson, Allison Johnson, said: “If you know that your eggs are 10 safe and sound, what decisions would you make about your life? . . . Go pursue that graduate degree. 11 Wait for your soul mate. Go travel the world. Your eggs are waiting for you. For me that’s as 12 liberating for women as the pill was in the 60s.”31 57. 13 14 that “there is no limit to how long cells remain viable in the frozen state.”33 58. 15 16 Pacific Fertility states that its clients’ “[e]ggs remain frozen until you need them”32 and Regarding embryos, Pacific Fertility similarly reassures its clients that some “have come back after 10-15 years and the embryos have been thawed successfully and created healthy babies.”34 59. 17 Pacific Fertility claims that its laboratory is state of the art, meeting a “gold standard,”35 18 and that it has a large and experienced laboratory staff dedicated to the “care and well being of eggs, 19 embryos and sperm.”36 20 21 22 23 24 25 26 27 28 31 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 32 What is the process?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertility-preservation/myeggs#treatment (last visited May 18, 2018). 33 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited May 18, 2018). 34 Id. 35 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 36 IVF Laboratory Team, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertility-specialists/ivflaboratory-team (last visited May 20, 2018). 10 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1519ofof5862 1 60. Since the advent of cryopreservation, the main techniques to cryopreserve eggs and 2 embryos have been slow freezing and vitrification. With slow freezing—first used in 1986—it takes 3 about two hours for eggs to reach final storing temperature. Starting in the mid-2000s, eggs and 4 embryos began to be preserved through a rapid cryopreservation process called vitrification. 61. 5 Vitrification is a more advanced and reliable technology that Pacific Fertility describes 6 as being “used in the embryo and egg freezing process so that they can be stored for later use.”37 7 Pacific Fertility states the newer vitrification process is safer than earlier slow-freezing technologies, 8 which could lead to crystallization threatening the viability of cryopreserved tissue. “Avoiding ice 9 formation in this way,” Pacific Fertility represents, “successfully protects the embryos from damage 10 and allows them to be warmed later giving survival rates consistently above 90%.”38 11 62. Pacific Fertility further states that all eggs and embryos would be stored in vacuum-lined 12 liquid nitrogen tanks—“like a large thermos flask”—that “are computer controlled and monitored 7 13 days a week with a dedicated alarm system.”39 14 63. Pacific Fertility claims that liquid nitrogen “is very stable and easy to work with” and 15 that each tank is equipped with numerous sensors to monitor temperature increases above ‒196°C or a 16 drop in the level of liquid nitrogen.40 Pacific Fertility also claims that the sensors “are connected to a 17 telephone alarm system that will alert staff to an alarm condition outside of normal working hours. . . . 18 The alarm system is tested weekly and continues to run on battery power in the event of a power 19 failure. The alarm system can also be checked remotely.” When a tank alarm goes off, the on-call 20 embryologist is supposed to arrive within 30 minutes regardless of time of day and must conduct a 21 physical inspection of the tank before the alarm can be turned off.41 22 23 24 25 26 27 37 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 38 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited Mar. 23, 2018). 40 41 28 Id. 39 Id. Id 11 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1620ofof5862 1 64. Pacific Fertility further claims that, in addition to being constantly monitored, each tank 2 “gets a physical inspection daily, looking for problems or signs of problems,” and that the amount of 3 nitrogen in the tank “is assessed as a means of monitoring for a possible slow leak or an impending 4 tank failure.”42 5 65. Each tank is also supposed to receive a daily refill of nitrogen because the nitrogen in 6 the tanks continuously evaporates at a slow rate.43 It is standard in the egg and embryo storage industry 7 for facilities to equip their tanks with autofilling mechanisms to refill the liquid nitrogen when the 8 system detects that levels are low. 9 10 66. Pacific Fertility advertises the durability of its tanks and storage facility on its website, stating: 11 The storage tanks require no power and would not be impacted by a power failure or blackout. They are made of metal and would probably survive a small or moderate fire. If the tanks were not physically damaged or knocked over in a disaster, they should survive intact. Even if no one was able to physically check the tanks, or if we were unable to obtain liquid nitrogen, the tanks should still maintain their temperature for several days.44 12 13 14 15 67. 16 17 18 Pacific Fertility represents that its egg and embryo cryopreservation and freezing services are highly successful, with egg survival rates of 83%45 and embryos survival rates consistently above 90%.46 68. 19 Prelude also touts “greater than 90%” egg and embryo survival rates.47 20 21 22 23 24 25 26 27 28 42 43 44 Id. Id Lab FAQs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/lab-faq (May 20, 2018). 45 What are your success rates?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/my-eggs#success (last visited May 20, 2018). 46 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 47 Have Questions?, What are the chances of pregnancy with frozen embryos?, Prelude Fertility, https://www.preludefertility.com/faq (last visited May 27, 2018). 12 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1721ofof5862 1 II. 2 Precision and Care Are Required in the Cryopreservation and Storage of Eggs and Embryos. 3 A. The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. 69. People who use Defendants’ cryopreservation services typically make an enormous 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 emotional investment. They endure painful and invasive procedures, financial stress, and the strain the process puts on their mental health and relationships with others, all in the hopes that one day they will be able to have a child. 70. Women take drug and hormone cocktails and injections over several weeks to stabilize the uterine lining, stimulate ovaries into producing follicles, and stop these ovary follicles from releasing eggs. Then, after an ovulation trigger injection, eggs are collected under sedation or a general anesthetic. A woman may be subjected to multiple painful injections each day, resulting in bruising, swelling, and overall discomfort. The drug and hormone therapy may also trigger other side effects, such as tiredness, nausea, headaches, and blood clots, as well as negative emotions. Many women also undergo acupuncture sessions, recommended by Pacific Fertility, to improve IVF outcomes. The process can limit travel and other activities, and often requires time off from work. The harvesting procedure itself can be painful and hard to endure, requiring insertion of a thick needle through the vaginal wall to drain the ovary follicles of their fluid. After the procedure, a woman often experiences residual pain for about a week and may need bed rest for several days. Some women suffer significant side effects, such as ovarian hyperstimulation syndrome, requiring hospitalization. 71. Undergoing egg retrieval is “emotionally trying” as well as physically demanding.48 Pacific Fertility acknowledges that feelings of anxiousness, depression, isolation, and helplessness are common among clients undergoing IVF services, and that strained and stressful relations with spouses, partners, and other loved ones are also common. IVF typically causes those undergoing treatment to 25 26 27 28 48 Patient Support, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/patient-support (last visited May 27, 2018). 13 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1822ofof5862 1 rely heavily on friends and significant others for support, including, for example, with coping with 2 stress and providing rides to and from appointments.49 3 4 72. According to Pacific Fertility’s website, “the time and energy that is needed, both physically and emotionally can drain even the staunchest crusader.”50 5 73. According to one research study, half of women seeking IVF services described 6 infertility as the most upsetting experience of their lives.51 Other studies show that infertility causes 7 anguish similar to that accompanying a cancer diagnosis or the loss of a loved one.52 Infertility is 8 associated with anger, depression, anxiety, marital problems, and loss of self-esteem among prospective 9 parents experiencing infertility.53 Pacific Fertility warns clients that they may experience intense anger, 10 despair, and guilt, and that it is “is very common to experience symptoms of anxiety and depression as 11 a result of this experience.”54 12 74. The cryopreservation process compounds these emotions and stresses. For many, this 13 process represents their last hope for having children. Each cycle can produce anxiety and fear that 14 there won’t be enough eggs retrieved, or that the eggs retrieved won’t be of a high enough quality. 15 Multiple cycles are often required. Many women experience and express strong feelings of anxiety, 16 failure, hopelessness, and disappointment during this process. 17 18 75. Prelude acknowledges its clients’ vulnerability during the cryopreservation process and trains its staff on how to empathize with clients: 19 20 49 21 50 22 51 23 52 24 25 26 27 28 Resources at Your Fingertips, Pacific Fertility Center (Nov. 22, 2004), https://www.pacificfertilitycenter.com/blog/fertility-resources-your-fingertips. Id. The psychological impact of infertility and its treatment, Harvard Medical School (May 2009), https://www.health.harvard.edu/newsletter_article/The-psychological-impact-of-infertility-and-its-treatment. A.D. Domar et al., The psychological impact of infertility: a comparison with patients with other medical conditions, Journal of Psychosomatic Obstetrics & Gynecology (1993), https://www.massgeneral.org/bhi/assets/pdfs/publications/Domar%201993%20J%20Psychosom%20Obstet%20 Gynaecol.pdf; C. A. Bryson, Post IVF syndrome? Psychological implications of failed IVF, The Obstetrician & Gynaecologist (2002), https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201. 53 P.K. Dekar et al., Psychological aspects of infertility, British Journal of Medical Practitioners (2010), http://www.bjmp.org/content/psychological-aspects-infertility. 54 Coping Strategies, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/copingstrategies (last visited May 20, 2018). 14 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page1923ofof5862 1 Fertility is such an incredibly personal and vulnerable subject. The World Health Organization has designated infertility as the ‘third biggest global epidemic,’ and yet as a society, we hardly even talk about it . . . until it gets personal. As more people delay childbirth past their peak fertility years to pursue careers, advanced degrees, or the right life partner, the chances of having a baby the old fashioned way start to decline.55 2 3 4 5 * * * 6 As women, mothers, sisters, and daughters we make it a priority to educate and support all of our staff on how it feels to go through these journeys and how much it means.56 7 8 76. 9 10 said. She further noted that a number of Prelude’s own employees have been touched by infertility.57 77. 11 12 “Emotional health” and “well being” are central to Pacific Fertility’s stated mission: We are dedicated to a whole patient approach. We recognize that fertility treatment may impact all corners of our patient’s lives, including work, personal relationships and financial concerns. When designing their treatment course, our physicians, nurses and counselors work with them to accommodate all of these considerations. 13 14 15 Our support is integrated. Emotional health and well being are central to our patient’s care. Our clinic’s services include acupuncture and an array of Mind/Body and stress reduction workshops, seminars and support groups. Our in-house family therapist is available to any patient and will also gladly provide referrals to other qualified professionals.58 16 17 18 19 20 “The emotional part is driving what we are trying to do,” Prelude’s chief revenue officer 78. Pacific Fertility recognizes the need to address clients’ “emotional and even spiritual needs” during the “emotional ups and downs” of infertility: 21 At PFC, we know that the physical demands and emotional ups and downs of 22 23 24 25 26 27 28 55 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 20, 2018). 56 Id. 57 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 58 Fertility Treatment and Care, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/fertility-treatment-and-care (last visited May 27, 2018). 15 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2024ofof5862 infertility experience can impact life at home, at work and with family. This is a path that one likely did not anticipate and, while there is much reason for hope, the treatment process can also be emotionally trying. The well being of our patients is a crucial aspect of fertility treatment, and we encourage our patients to take advantage of the many resources we have developed to address the emotional and even spiritual needs they may have as a part of their journey. 1 2 3 4 5 PFC’s extensive support system includes a devoted patient care team, experienced clinical coordinators and educators and an in-house marriage and family therapist who has long specialized in fertility and third party parenting issues.59 6 7 8 9 10 79. Acknowledging the stress and challenges those contending with infertility face, Pacific Fertility promises its clients that it will be “by their side every step of the way”: A diagnosis of infertility can feel overwhelming and stressful for individuals and couples who always assumed that pregnancy would come easily. At Pacific Fertility Center, we see infertility as a workable challenge. . . . 11 12 13 We feel strongly that the physical well being is tied to emotional well being, and we take into account all of the challenges[,] . . . [including d]iagnosis, treatment and the inevitable ‘waiting game’ as well as financial stress . . . . We are by their side every step of the way to help address each and all of these needs.60 14 15 16 17 80. Pacific Fertility and Prelude’s services are costly. Clients pay more than $8,000 for a 18 single cycle of egg cryopreservation, which includes clinical monitoring, egg retrieval, 19 cryopreservation, and one year of egg storage. Additional cycles cost $6,995 each. Pacific Fertility 20 recommends storing more eggs than a woman typically produces in a single cycle.61 It is not 21 uncommon for women to undergo three or more egg cryopreservation cycles. 22 23 24 25 26 27 28 59 Patient Support, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/patient-support (last visited May 27, 2018). 60 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 61 How many eggs do I need to freeze?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/ask-us#how-many (last visited May 21, 2018); How Many Eggs Should I Freeze?, Southern California Reproductive Center, https://blog.scrcivf.com/how-many-eggs-should-i-freeze (last visited May 21, 2018). 16 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2125ofof5862 1 81. The costs incurred to cryopreserve embryos are even higher. Pacific Fertility charges 2 $11,595 for basic IVF, including clinical monitoring, egg retrieval, lab processing, and embryo 3 transfer.62 If a client chooses to use Comprehensive Chromosome Screening to select the healthiest 4 embryo to transfer, Pacific Fertility’s basic IVF costs rise to $16,085.63 5 82. The above amounts do not include the costs of in-person consultations ($375), pre-cycle 6 lab work, egg cryopreservation medications ($2,000‒6,000), embryo transferring ($2,845‒4,460), 7 embryo transfer medications ($300‒600), and continuing charges for egg and embryo storage ($600 per 8 year).64 Clients typically also pay thousands of dollars for fertility drugs leading up to egg retrieval, 9 and often spend hundreds of dollars on acupuncture and other recommended services to improve 10 outcomes. The entire process often costs many tens of thousands of dollars. 11 83. Most insurance plans do not cover egg cryopreservation and other fertility services.65 A 12 2017 study by Mercer found that only 26% of companies with over 500 employees cover IVF.66 As a 13 result, people seeking fertility services have taken out home equity loans, borrowed from their 401(k) 14 accounts, tapped their lines of credit, and moved in with their parents.67 15 84. In part because of these challenging processes, costs, and experiences, many clients 16 form strong emotional attachments to their eggs and embryos. It is not unusual for women and their 17 reproductive partners to think about their eggs or embryos every day. 18 19 20 21 22 23 24 25 26 27 28 62 In-Vitro Fertilization (IVF) Costs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/financingfees/vitro-fertilization-ivf-costs (last visited May 21, 2018). 63 64 Id. Id. 65 Fertility treatments are becoming a financial and physical risk for many Americans, CNBC (Nov. 20, 2017), https://www.cnbc.com/2017/11/17/most-patients-getting-ivf-arent-covered-by-insurance.html; M. Inhorn et al., Medical egg freezing: How cost and lack of insurance cover impact women and their families, Reproductive Biomedicine & Society Online (Jan. 21, 2018), https://www.sciencedirect.com/science/article/pii/S2405661818300017. 66 Fertility treatments are becoming a financial and physical risk for many Americans, CNBC (Nov. 20, 2017), https://www.cnbc.com/2017/11/17/most-patients-getting-ivf-arent-covered-by-insurance.html. 67 Id.; Infertility Treatment Grants and Scholarships, RESOLVE, https://resolve.org/what-are-myoptions/making-infertility-affordable/infertility-treatment-grants-scholarships/ (last visited May 21, 2018). 17 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2226ofof5862 1 B. The loss of eggs and embryos results in emotional trauma. 2 85. Prelude and Pacific Fertility are well aware of the lengths to which people go to obtain 3 eggs and embryos, how much these eggs and embryos mean to their clients, the clients’ emotional 4 investment in the survival of the eggs and embryos, and the clients’ expectations that great care will be 5 taken to preserve and protect the eggs and embryos to avoid irreparable, devastating harm. 6 86. Eggs and embryos are precious. They offer the opportunity to fulfill one of the most 7 fundamental human urges: to become a parent and create one’s own family when the time is right. 8 Even for those who have already met their family planning goals, their remaining eggs and embryos 9 retain emotional value. Many opt to continue storing their eggs and embryos for years after they have 10 successfully had children. Some hold funeral ceremonies for embryos.68 Others who no longer plan to 11 use their eggs and embryos hope to donate them to a family member or other couple struggling with 12 infertility, or toward beneficial research. 13 87. Eggs and embryos are irreplaceable. As women age, their egg quantity and quality 14 diminish. The most determinative factor in IVF success is the woman’s age at the time her eggs were 15 extracted. At some point, usually around her mid-40s, a woman can no longer produce viable eggs. 16 Even if additional eggs can be retrieved, one cannot replace 35-year-old eggs with 42-year-old eggs and 17 expect the same result. When eggs and embryos are damaged or compromised, it may be impossible 18 for clients to have their own biological children. There is no possibility of creating substitute embryos 19 for cancer survivors or those whose spouses have died. Likewise, those who used donor eggs or sperm 20 to create embryos may find it impossible to retrieve additional material from the same donors. Thus, 21 donor-users who already have children may be prevented from having additional children who are 22 biologically related to their siblings. 88. 23 24 At the time of their freezing, most of the eggs and embryos that Pacific Fertility stored were viable rather than being compromised or incapable of successful fertilization or implantation. 25 26 27 28 68 J. Fraga, After IVF, Some Struggle With What To Do With Leftover Embryos, NPR (Aug. 20, 2016), https://www.npr.org/sections/health-shots/2016/08/20/489232868/after-ivf-some-struggle-with-what-to-do-withleftover-embryos. 18 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2327ofof5862 1 Most of the embryos that Pacific Fertility stored had been tested and found free of chromosomal 2 abnormalities. 3 89. The success or failure of egg and embryo cryopreservation and storage services has 4 emotional and psychological ramifications for those seeking to become parents. Losing an egg or 5 embryo provokes the fear that having a child is no longer possible, causing feelings of devastation and 6 despair. Many experience grief and anguish when fertility treatment does not result in pregnancy or 7 when they lose fertility choices.69 Pacific Fertility’s website itself provides coping strategies and 8 techniques for reducing stress.70 9 C. Successful cryopreservation depends on strict adherence to protocols. 10 90. Eggs and embryos are fragile. It is critical that they be handled and stored 11 carefully. Cooling, warming, and the removal of cryoprotectants must follow precise, controlled 12 protocols. Failure to adhere to these protocols can kill the egg or embryo, impair implantation and 13 viability, and introduce chromosomal abnormalities. 14 91. Egg and embryo cryopreservation entails preserving the reproductive material at subzero 15 temperatures. A key goal of cryopreservation is to reduce cell damage caused by the formation of ice 16 crystals and the expansion of water as cryopreserved material cools to subzero temperatures. 17 According to Pacific Fertility, “[t]he key to successful egg freezing is determining a technique that will 18 not damage the fragile chromosomes of the egg”; this is because “the chromosomes of the egg are 19 vulnerable to damage, including damage from the exertion of the freezing and thawing process.”71 20 92. As noted above, two primary cryopreservation technologies have emerged. Both rely 21 upon cryoprotectants, which are solutions added to the cells that reduce cell damage by displacing 22 water in a manner similar to antifreeze. The first technology, slow freezing (also known as slow 23 programmable freezing), utilizes specialized laboratory equipment that lowers the temperature of 24 25 26 27 28 69 C. A. Bryson, Post IVF syndrome? Psychological implications of failed IVF, The Obstetrician & Gynaecologist (2002), https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201. 70 When to See a Therapist, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/whento-see-a-therapist (last viewed May 20, 2018). 71 New Clinical Study: New Technique for Egg Freezing, Pacific Fertility Center (Feb. 25, 2006), https://www.pacificfertilitycenter.com/blog/new-clinical-study-new-technique-egg-freezing. 19 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2428ofof5862 1 embryos conditioned with cryoprotectants in a slow, controlled manner to ‒190°C. The second and 2 newer technology, vitrification, refers to any process resulting in “glass formation”—that is, the 3 transformation from a liquid to a hardened liquid with minimal crystallization (ice crystals). According 4 to Pacific Fertility, vitrification “cools the cells in the embryo at rates close to 5,000 degrees per 5 minute[,]” and “embryos that are vitrified are exposed to 5-10 times more cryoprotectant than slow 6 frozen embryos.”72 The ultra-rapid nature of this process minimizes (1) the formation of ice crystals 7 and (2) toxicity damage to the cells that cryoprotectants can cause during longer exposure to warmer 8 temperatures. 93. 9 The process of warming eggs and embryos that have been preserved through 10 cryopreservation is also precise and dependent on specialized techniques and chemical 11 solutions. Pacific Fertility states that “embryos coming out of the freezer (at –196°C) are warmed to 12 room temperature in a maximum of three seconds. This rapid warming method minimizes damage to 13 the embryo from ice crystals that can form during warming.”73 A key part of the warming procedure is 14 the careful dilution and eventual replacement of the toxic cryoprotectant fluid with a solvent compatible 15 with cytoplasmic fluid. Pacific Fertility states that it “incubat[es] the embryo in decreasing 16 concentrations of the antifreeze, and increasing concentrations of water. Over a period of 15 minutes, 17 the embryo is stepped through 3 different solutions, until finally the antifreeze is gone and all the water 18 has been replaced.”74 19 94. For slow-frozen tissue, the failure to thaw slowly can result in cells over-expanding, 20 rupturing, and dying. For vitrification, it is important to warm quickly to avoid ice formation. Thus, it 21 is critical that tissue cryopreserved through slow freezing be thawed slowly, and that tissue 22 cryopreserved through vitrification be warmed quickly.75 An uncontrolled rise in temperature, like the 23 one at issue here, can have catastrophic consequences for eggs and embryos. 24 25 26 27 28 72 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 73 74 Lab FAQs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/lab-faq (May 20, 2018). Id. 75 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 20 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2529ofof5862 1 III. 2 Defendants Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. 3 95. On March 4, 2018, Pacific Fertility discovered a loss of a substantial amount of liquid 4 nitrogen in one of its cryogenic storage tanks, Tank 4, manufactured by Chart. This incident affected 5 thousands of cryopreserved eggs and embryos and more than 400 individuals and families. 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A. Prelude and Pacific Fertility should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. 96. Liquid nitrogen in cryopreservation tanks evaporates at a slow rate. Absent extreme circumstances, even when a leak occurs it should take days for a tank to warm enough to cause damage to the enclosed eggs and embryos. 97. Egg and embryo storage facilities have developed and implemented a variety of systems and processes to protect against liquid nitrogen levels dropping to levels low enough to endanger clients’ eggs and embryos. These systems and processes include daily tank inspections, multiple alarm systems that detect and send alerts regarding low liquid nitrogen levels, and autofillers that detect and automatically replenish low liquid nitrogen levels. 98. Pacific Fertility promised its clients that its laboratory was state of the art, including that its tanks were equipped with around-the-clock monitoring, alarm systems, and response protocols as well as daily walk-throughs. But no alarms or phone alerts notified Pacific Fertility or Prelude of the March 4 malfunction. Instead, an embryologist discovered the problem during a routine walk-through. Staff then had to manually replenish liquid nitrogen levels in the tank. 99. Pacific Fertility and Prelude have not explained why they did not detect the problem during prior walk-throughs or why they did not have a functional autofilling mechanism to replenish the low liquid nitrogen levels. Pacific Fertility and Prelude also lacked monitoring, alarm, and response systems and processes sufficient to detect and prevent harm from a dangerous temperature rise in Tank 4. Pacific Fertility and Prelude further failed to mitigate risk by failing to implement a policy and practice of storing multiple eggs and embryos belonging to a given client in separate vials and tanks. 100. Wired interviewed one laboratory director who noted preventive measures Pacific Fertility and Prelude should have taken: 21 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2630ofof5862 “It’s really quite sad the samples weren’t split up,” says Nahid Turan, who directs laboratory operations at the Coriell Institute for Medical Research, one of the oldest and largest biobanks in the US. “They were literally putting all the eggs in one basket.” In addition to having samples in multiple tanks at their New Jersey facility, Coriell also has back-up sites in multiple locations around the country. And its software engineers built real-time monitoring systems to flag any tanks trending in a troubling direction before they fail.76 1 2 3 4 5 6 7 8 9 10 11 101. stored in the same tank as Plaintiffs’. Tank 4 housed up to 15% of Pacific Fertility’s total cryopreserved tissue, consisting of thousands of eggs and embryos. 102. 14 15 16 17 18 19 incident for not mitigating the risk by spreading their eggs and embryos across multiple tanks. 24 25 26 27 28 Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident. 103. On April 23, 2018, Chart, the manufacturer of Tank 4, recalled certain cryostorage LEAK AND/OR FAILURE which may be due to inadequate adhesion of the composite neck to the aluminum unit” (emphasis in original). Chart added that the “issue appears to be an isolated occurrence involving the machine and binding agent used during the manufacturing process.” 104. Chart announced the recall four days after Pacific Fertility revealed the conclusion of “independent experts” that the March 4 incident “likely involved a failure of the tank’s vacuum seal.” 21 23 B. tanks, stating in its recall notice: “Chart is presently investigating the possible cause of the VACUUM 20 22 Most people with eggs and embryos stored in Tank 4 had all of their eggs and embryos stored in that single tank. Pacific Fertility has expressed regret to clients affected by the March 4 12 13 Cryopreserved eggs and embryos belonging to many hundreds of other people were C. Multiple investigations were opened after the Tank 4 incident. 105. Various government entities and trade groups have responded to the March 4, 2018, incident. The College of American Pathologists (CAP) opened and is conducting a formal investigation into the incident, as is the State of California. The American Society for Reproductive Medicine also is studying the incident and intends to make recommendations to its members based on its findings.77 76 M. Molteni, What Keeps Egg-Freezing Operations From Failing?, Wired (Mar. 13, 2018), https://www.wired.com/story/what-keeps-egg-freezing-operations-from-failing/. 77 A. E. Cha, FAQ: Are my frozen embryos safe? Everything you need to know about the freezer malfunctions, The Washington Post (Mar. 14, 2018), https://www.washingtonpost.com/news/to-your- 22 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2731ofof5862 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 D. Defendants’ failure to keep Plaintiffs’ eggs and embryos safe and secure has caused irreparable harm. 106. As a result of Defendants’ conduct, Plaintiffs have suffered emotional trauma, including anxiety, hopelessness, fear, depression, devastation, and grief. Plaintiffs lost the very peace of mind they sought when availing themselves of Pacific Fertility’s services, and the time, energy, and cost associated with storing their eggs and embryos have been lost as well. 107. Pacific Fertility asserts that the embryos in Tank 4 must be fully thawed to determine whether they remain viable after the incident. But, because of the risks associated with re-freezing embryos, a family must be prepared before thawing to transfer the affected embryo into a woman’s uterus and attempt a pregnancy if the embryo is deemed viable. Pacific Fertility also asserts that the eggs in Tank 4 must be fully thawed and fertilized to determine whether they remain viable after the incident. 108. Pacific Fertility has agreed in some instances to thaw eggs or embryos from Tank 4, check their viability, and then refreeze the eggs or embryos. In those instances, however, Pacific Fertility has made clear that the added cycle of thawing and refreezing—resulting from its own mishandling of the eggs and embryos—creates further risks to their ultimate viability. Although this procedure would not be needed absent Defendants’ failures, Pacific Fertility requires clients to sign forms purporting to waive their legal rights merely to check the viability of their tissue. 109. Some of Defendants’ affected clients have decided to thaw tissue in Tank 4, and this process confirmed that their eggs or embryos are no longer viable. Many families and individuals have lost their best or only chance of having a child. They have suffered despair, depression, and heartbreak. Those who can undergo additional retrievals face a greater risk that those eggs or embryos will not lead to a successful pregnancy, as the age at which a woman’s eggs are retrieved is the dominant factor for rates of success or failure. 25 26 27 28 health/wp/2018/03/14/faq-are-my-frozen-embryos-safe-everything-you-need-to-know-given-two-fertilityclinics-recent-problems/?utm_term=.86e4c34f31f3. 23 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2832ofof5862 1 110. While Pacific Fertility has not shared the data it has collected regarding the number of 2 Tank 4 eggs and embryos that have been thawed and resulting outcomes, the survival rates for these 3 eggs and embryos is lower than it would have been had the incident not occurred. 4 111. Pacific Fertility has not provided a comprehensive analysis of the risks of attempting a 5 pregnancy with any of the tissue from Tank 4, including the risks that the drop in nitrogen levels may 6 have caused chromosomal or other defects that would not be detected from a thaw alone. 7 112. Nevertheless, Pacific Fertility has advised Plaintiffs A.B., C.D., and others with affected 8 eggs and embryos to attempt pregnancies with Tank 4 tissue. Before undergoing an embryo or egg 9 thaw, embryo transfer, or egg fertilization, Pacific Fertility requires clients to sign a consent statement 10 acknowledging that the risks are uncertain and waiving any liability on the part of Pacific Fertility 11 arising out of the thaw, transfer, or fertilization procedure. 12 113. As a result of the Tank 4 incident, Plaintiffs are being asked to make significant 13 reproductive decisions now—depriving them of the very freedom and flexibility they sought when 14 placing their eggs or embryos in Defendants’ care. Pacific Fertility has counseled affected clients to 15 thaw and immediately fertilize eggs, and to transfer embryos to a woman’s uterus, to determine 16 whether their tissue remains viable. Yet the purpose of cryopreservation was to allow these clients to 17 make reproductive choices on their own timelines. Many clients do not yet have a partner with whom 18 they wish to fertilize their eggs, or are not ready to move forward with a sperm donor, much less try to 19 get pregnant now or arrange for a surrogate. Others were busy with their lives when the incident 20 occurred—finishing graduate school, planning for international travel, or even preparing to welcome a 21 new baby—making it impossible or highly inconvenient to attempt a pregnancy now, especially one 22 fraught with more risk and potential heartache than normal. 23 114. People affected by the March 4 incident have described being thrust into a state of 24 limbo, as the “insurance policy” they paid for has vanished. To restore their future fertility options, 25 some are attempting additional retrieval cycles at an older age, with lower-quality eggs, and at 26 considerable cost, burden, and disruption to their lives, subjecting them to substantial physical and 27 emotional strain. These additional retrieval cycles also involve medical risks and potential 28 complications. Many class members completed these cycles only to learn they were incapable of 24 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page2933ofof5862 1 producing sufficient or any viable eggs or embryos. Other class members, for whom additional 2 retrievals are not possible or recommended, have been left to fear the worst—that they will be childless. 3 115. The National Infertility Association recognized the negative impact of the March 4 4 incident on women and families, stating that it was “shocked” to hear of this “unprecedented traged[y]” 5 for “the entire family building community. Our hearts break for each person impacted. We know first- 6 hand what someone goes through to have eggs or embryos to freeze, and to have this outcome is 7 devastating for everyone.”78 8 9 10 116. In response to a similar incident in Ohio, clinical psychologists advised that the loss of eggs and embryos should be acknowledged like any other death, and suggested grief counseling and organization of a memorial in response.79 11 117. In sum, those with eggs and embryos in Tank 4 are devastated, and have compared the 12 resulting feeling of powerlessness to that caused by a natural disaster. Many of those who had saved 13 eggs and embryos report having lost their only chance to have biologically related children. In some 14 cases, those affected have avoided telling family, knowing their loved ones would be “heartbroken” not 15 to have siblings or grandchildren.80 One couple, who had gone through the process after a cancer 16 diagnosis, described their emotions: 17 My heart just sank and I felt physically ill. I felt just sick to my stomach. The world of infertility is a very isolating world, it’s very lonely[,] it’s a complete loss of control. 18 19 * * * 20 21 22 23 24 25 26 27 28 78 Statement on Storage Tank Malfunction Impacting Hundreds of Patients, RESOLVE (Mar. 12, 2018), https://resolve.org/about-us/news-and-press-releases/statement-on-storage-tank-malfunction-at-universityhospitals-fertility-center-in-cleveland-oh/. 79 J. Washington, Experts recommend counseling & support for UH patients who lost eggs, embryos, The Plain Dealer (Mar. 21, 2018), http://www.cleveland.com/healthfit/index.ssf/2018/03/uh_patient_who_lost_eggs_embry.html. 80 D. Kapp, What It’s Like to Be a Victim of a ‘Fertility Disaster’, The Cut (Mar. 15, 2018), https://www.thecut.com/2018/03/pacific-fertility-center-clinic-disaster-cleveland-university-hospital.html; S. Steimle, Patients at Troubled San Francisco Fertility Clinic Mull Legal Action, CBS SF Bay Area (Mar. 14, 2018), http://sanfrancisco.cbslocal.com/2018/03/14/patients-san-francisco-fertility-clinic-mull-legal-action/. 25 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3034ofof5862 For some this is their last hope, I mean they physically, financially, mentally can’t put themselves through that again. I’ve gone from anger, I’ve gone through just feeling a sense of loss, grief, I think right now I’m angry to be honest.81 1 2 3 118. 4 5 6 7 their familiarity with the deeply emotional aspects of their services, Pacific Fertility and Prelude were aware of the devastating consequences for their clients that would result from a failure to keep their eggs and embryos safe and secure. 8 9 10 11 12 13 Given the sensitive nature of the eggs and embryos entrusted to their care, as well as E. Pacific Fertility and Prelude’s communications regarding the incident have compounded the harm. 119. Pacific Fertility first attempted to notify its clients of the March 4 incident a week after it occurred. 120. At approximately 4 a.m. Pacific time on March 11, 2018, Pacific Fertility sent its clients an email stating: Earlier this week, a single piece of equipment lost liquid nitrogen for a brief period of time. The remainder of the equipment and cryo-storage facility was not affected. As soon as the issue was discovered, our most senior embryologists took immediate action to secure all tissue in that single cryostorage tank. The tank was immediately retired, and the facility is operating securely. 14 15 16 17 18 We have hired independent experts and launched an in-depth investigation of the matter. We felt it was imperative to advise you that your tissue was stored in the affected tank and may have been impacted. Based on our preliminary analysis, the good news is that we do expect that some of the tissue from that tank remains viable. We are continuing to gather information but wanted to share these developments with you directly. 19 20 21 22 121. The email further stated, “[w]e are incredibly sorry that this happened and for the 23 anxiety that this will surely cause. We are heartbroken by this situation and our thoughts are with each 24 of you who may have been touched by this event.” 25 26 27 28 81 Mother felt “physically ill” after hearing embryos possibly destroyed at fertility center, CBS Evening News (Mar. 9, 2018), https://www.cbsnews.com/news/mother-felt-physically-ill-after-hearing-embryos-possiblydestroyed-at-fertility-center/. 26 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3135ofof5862 1 122. The email invited Plaintiffs and other families with eggs and embryos stored in Tank 4 2 to call to discuss the incident with their fertility specialists. But the call center has been overwhelmed, 3 and the information provided over the phone and in person has been vague and often inconsistent. 4 Different Pacific Fertility staff members have provided clients with conflicting information. 5 123. Pacific Fertility did not provide further written information until over a month later, on 6 April 19, 2018, when Pacific Fertility wrote to its clients with “several updates following the tank 7 failure that occurred in the embryology lab on March 4, 2018.” 8 9 10 124. Pacific Fertility stated that “independent experts have been investigating the incident” and preliminarily determined that it “likely involved a failure of the tank’s vacuum seal.” 125. Pacific Fertility also stated that it had implemented new protocols—“re-inspection of 11 onsite storage tanks, the purchase of several emergency tanks beyond our standard back-up tanks, and 12 an extra layer of redundancy in our warning systems”—to avoid future loss of eggs and embryos, steps 13 it should have taken before the incident. 14 126. Pacific Fertility initially told some clients definitively that their tissue was destroyed in 15 the incident. It told other clients it could not determine whether their tissue survived unless they 16 thawed and fertilized their eggs, or thawed and transferred their embryos. Pacific Fertility also refused 17 to tell many other people whether their tissue was even stored in Tank 4, instead stating simply that an 18 incident had occurred at its facility that may have impacted certain clients’ tissue. In post-incident 19 calls, Pacific Fertility stated that it assumed that many were not going to use the tissue stored in Tank 20 4—so clients “should just let it go.” Similarly, on March 11, 2018, a Pacific Fertility employee told 21 ABC News that a large number of families with eggs and embryos stored at the facility were “people 22 who won’t use them anyway.” Other clients with eggs and embryos in Tank 4 were billed for storage 23 fees after the incident occurred and before it was disclosed to them. 24 127. Pacific Fertility has offered some of its clients a free additional cycle for egg retrieval. 25 Pacific Fertility’s proposed remedy is inadequate. The mishandling of client eggs and embryos is 26 devastating and irreparable. Many can no longer undergo additional retrievals. Older women are 27 generally not able to produce as many eggs of as high a quality as when they were younger, and in 28 many cases go through the entire process only to learn they were unable to produce any viable eggs. 27 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3236ofof5862 1 Even where some eggs can be retrieved, women confront a greater risk that those eggs will not lead to a 2 successful transfer and pregnancy. Moreover, additional retrievals are time consuming, expensive, and 3 physically and emotionally exhausting and burdensome, and typically require time away from work. 4 Even two or three cycles may not fully replenish the number of viable eggs or embryos lost. 5 128. Pacific Fertility’s April 19, 2018, email blaming the tank failure on Chart left clients 6 with more questions than answers. Pacific Fertility did not say why the remedial steps mentioned in the 7 email, like adding redundancies, were not in place before the incident. Clients were not told why an 8 alarm did not alert Pacific Fertility staff, why a backup system (e.g., an autofill function or additional 9 generator) did not engage, or why the problem went undiscovered until someone walked through the 10 11 lab during a routine check. 129. Pacific Fertility states that tanks can go without power or liquid nitrogen for “several 12 days” without compromising the enclosed reproductive tissue. It is unclear why Pacific Fertility failed 13 to detect the problem with Tank 4 until it was too late. 14 130. Pacific Fertility’s April 19 email also raised false hopes, stating that Pacific Fertility 15 “can report several early pregnancies” from thawed and transferred embryos, and had “successfully 16 thawed a limited number of eggs[,] confirm[ing] that there is viable tissue from the tank.” Pacific 17 Fertility failed to mention that there is also unviable tissue from the tank. Pacific Fertility 18 indiscriminately notified all people with tissue in Tank 4 that their eggs and embryos might be “viable” 19 despite knowing this was not true for many of these people. 20 131. Clients who were devastated upon learning, in the days and weeks after Pacific 21 Fertility’s first mass email, that their tissue was not viable have been doubly devastated by the 22 insensitivity of Pacific Fertility’s second mass email. 23 132. Pacific Fertility executives and employees were well aware that the March 4 incident 24 would cause significant distress. Nevertheless, even though Pacific Fertility has a counselor on staff, it 25 offered no additional support services or counseling to those affected by the incident. 26 133. Pacific Fertility’s failure to offer compassionate support services and to communicate 27 clearly and consistently with victims of the incident has caused them further confusion, pain, and 28 distrust. 28 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3337ofof5862 1 PLAINTIFF-SPECIFIC ALLEGATIONS 2 Plaintiffs A.B. and C.D. 3 4 5 6 7 134. Plaintiffs A.B. and C.D. first contacted Pacific Fertility in or around January 2015 about the possibility of creating embryos and having their embryos frozen. 135. In January 2015, Plaintiffs A.B. and C.D. contracted with Pacific Fertility to create and have their embryos preserved for future use. 136. Plaintiffs A.B. and C.D. conducted extensive research concerning IVF and fertility 8 centers and chose Pacific Fertility based on the belief that it provided high-quality services that were 9 state of the art. Before having their embryos cryopreserved with Pacific Fertility, Plaintiffs A.B. and 10 C.D. saw representations about Pacific Fertility’s services on Pacific Fertility’s website, including 11 Pacific Fertility’s claims that it provided high-quality services. Plaintiffs A.B. and C.D. also had a 12 consultation session with Dr. Carl M. Herbert, who told them about Pacific Fertility’s care, 13 professionalism, and state-of-the-art facilities. 14 137. In early 2015, Plaintiffs A.B. and C.D. underwent procedures to prepare for embryo 15 creation and cryopreservation. Before the egg retrieval procedure in March 2015, Plaintiff A.B. 16 underwent a month of treatment and injections. Pacific Fertility ultimately retrieved approximately 21 17 of her eggs, which were then fertilized with Plaintiff C.D.’s sperm. After the fertility treatment ended, 18 the embryos Pacific Fertility created were cryopreserved for storage. At the time of the March 4, 2018, 19 incident, Plaintiffs A.B. and C.D. had eight viable cryopreserved embryos. 20 21 22 138. At all relevant times, Plaintiffs A.B. and C.D.’s embryos were under Pacific Fertility’s protection, custody, and control. 139. Defendants kept Plaintiffs A.B. and C.D.’s embryos within a metal storage tank—Tank 23 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of 24 tank failure by spreading Plaintiffs A.B. and C.D.’s embryos among several tanks, Defendants stored 25 all of Plaintiffs A.B. and C.D.’s embryos in the same tank. 26 140. Plaintiffs A.B. and C.D. have paid approximately $21,105.78 for the creation and 27 storage of their embryos. They experienced severe emotional distress when they learned of the March 28 4, 2018, incident and in the weeks that followed. 29 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3438ofof5862 1 2 3 4 5 6 Plaintiff E.F. 141. Plaintiff E.F. first contacted Pacific Fertility in or around May 2016 about the possibility of having her eggs frozen. 142. In or around June 2016, Plaintiff E.F. contracted with Pacific Fertility to have her eggs retrieved and preserved for potential future use. 143. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff E.F. saw 7 representations about Pacific Fertility’s services on Pacific Fertility’s website, including claims 8 regarding the qualifications of Pacific Fertility’s staff and the science behind the clinic’s procedures. 9 Plaintiff E.F. also met with Dr. Carolyn Givens, who told her about Pacific Fertility’s use of cutting- 10 11 edge technology and assured her that her eggs would be there for as long as she needed them. 144. In the summer of 2016, Plaintiff E.F. underwent procedures to prepare for egg 12 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 13 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately nine of her eggs. 14 15 16 145. At all relevant times thereafter, Plaintiff E.F.’s eggs were under Pacific Fertility’s protection, custody, and control. 146. Defendants kept Plaintiff E.F.’s eggs within a metal storage tank—Tank 4—at their San 17 Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 18 spreading Plaintiff E.F.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 19 147. Plaintiff E.F. has paid approximately $11,000 for the retrieval and storage of her eggs. 20 She experienced severe emotional distress when she learned of the March 4, 2018, incident and in the 21 weeks that followed. 22 23 24 25 26 27 28 Plaintiff G.H. 148. Plaintiff G.H. first contacted Pacific Fertility in or around February 2016 about the possibility of having her eggs frozen. 149. In or around April 2016, Plaintiff G.H. contracted with Pacific Fertility to have her eggs retrieved and preserved for potential future use. 150. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff G.H. saw representations about Pacific Fertility’s services on Pacific Fertility’s website, including claims about 30 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3539ofof5862 1 the reputable quality of their services. Plaintiff G.H. also met with Dr. Carolyn Givens, who provided 2 information regarding Pacific Fertility’s services. 3 151. In the spring of 2016, Plaintiff G.H. underwent procedures to prepare for egg 4 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 5 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately two of her eggs. 6 7 8 9 10 11 152. At all relevant times thereafter, Plaintiff G.H.’s eggs were under Pacific Fertility’s protection, custody, and control. 153. Defendants kept Plaintiff G.H.’s eggs within a metal storage tank—Tank 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by spreading Plaintiff G.H.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 154. Plaintiff G.H. has paid approximately $14,500 for the retrieval and storage of her eggs. 12 She experienced severe emotional distress when she learned of the March 4, 2018, incident and in the 13 weeks that followed. 14 15 16 17 18 19 Plaintiff I.J. 155. Plaintiff I.J. first contacted Pacific Fertility in or around November 2012 about the possibility of having her eggs frozen. 156. In or around December 2012, Plaintiff I.J. contracted with Pacific Fertility to have her eggs preserved for potential future use. 157. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff I.J. saw 20 representations about Pacific Fertility’s services in Pacific Fertility’s brochure, including claims that 21 Pacific Fertility “had a very strong embryo freezing program” and that its clients “can avoid high order 22 multiple pregnancies by transferring fewer fresh embryos and successfully freezing the remaining 23 embryos.” Plaintiff I.J. also saw representations that Pacific Fertility “devoted considerable time and 24 effort into assembling one of the most highly trained teams in the country.” Plaintiff I.J. met with staff 25 at Pacific Fertility who assured that her eggs would be there for as long as she needed them. 26 158. In February 2013, Plaintiff I.J. underwent procedures to prepare for egg 27 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 28 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately 17 of her eggs. 31 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3640ofof5862 1 2 3 159. At all relevant times thereafter, Plaintiff I.J.’s eggs were under Pacific Fertility’s protection, custody, and control. 160. Defendants kept Plaintiff I.J.’s eggs within a metal storage tank—Tank 4—at their San 4 Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 5 spreading Plaintiff I.J.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 6 161. Plaintiff I.J. has paid approximately $17,000 to Defendants for procedures, medications, 7 and storage of her eggs. She experienced severe emotional distress when she learned of the March 4, 8 2018, incident and in the weeks that followed. 9 10 11 12 13 14 Plaintiff K.L. 162. Plaintiff K.L. first contacted Pacific Fertility on or around June 3, 2010, about the possibility of having her eggs cryopreserved. 163. In or around December 2015, Plaintiff K.L. contracted with Pacific Fertility to have her eggs preserved for potential future use. 164. Before having her eggs frozen with Pacific Fertility, Plaintiff K.L. saw representations 15 about Pacific Fertility’s services on Pacific Fertility’s website, including Pacific Fertility’s claims that 16 the clinic and its services were safe and reliable, and that eggs could be stored until the right time for 17 the client. Plaintiff K.L. also saw Pacific Fertility’s representations that the process was quick and easy 18 for clients and had a very high likelihood of success. In addition, Plaintiff K.L. met with Dr. Eldon 19 Schriock, who told her that storage at Pacific Fertility was safe. 20 165. In February 2016, Plaintiff K.L. underwent procedures to prepare for egg freezing. 21 Before the retrieval procedure, she underwent months of treatment and injections. She also had to take 22 several days off from work and could not travel for work for two weeks. Pacific Fertility ultimately 23 retrieved and froze five of her eggs. 24 25 26 27 166. At all relevant times thereafter, Plaintiff K.L.’s eggs were under Pacific Fertility’s protection, custody, and control. 167. Defendants kept Plaintiff K.L.’s eggs from her first cycle within a metal storage tank— Tank 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk 28 32 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3741ofof5862 1 of tank failure by spreading Plaintiff K.L.’s eggs from that cycle among several tanks, Defendants 2 stored all of her eggs in the same tank. 3 168. Plaintiff K.L. has paid approximately $12,000 to Defendants for procedures 4 (approximately $9,300), medications (approximately $1,200), and storage (approximately $600 per 5 year) of her eggs. She experienced severe emotional distress when she learned of the March 4, 2018, 6 incident and in the weeks that followed. 7 Plaintiffs M.N. and O.P. 8 9 169. possibility of having her eggs frozen. 10 11 Plaintiff M.N. first contacted Pacific Fertility in or around September 2011 about the 170. In or around late 2011, Plaintiff M.N. contracted with Pacific Fertility to have her eggs preserved for potential future use. 12 171. Before having her eggs frozen with Pacific Fertility, Plaintiff M.N. saw representations 13 about Pacific Fertility’s services on its website, including claims regarding its success rates and ability 14 to help couples and single people have a family and plan for the future. Plaintiff M.N. also met with 15 Dr. Eldon Schriock, who told her about Pacific Fertility’s statistics and success rates. 16 172. In January 2012, Plaintiff M.N. underwent procedures to prepare for egg freezing. She 17 went through months of invasive and time-consuming treatments, including injections, blood tests, and 18 ultrasounds. She underwent approximately three retrieval cycles, resulting in approximately 37 eggs. 19 20 173. sperm donor, resulting in three high-quality embryos. Her remaining 15 eggs were stored in Tank 4. 21 22 In 2016, Plaintiff M.N. contracted with Defendants to fertilize half of her eggs with a 174. At all relevant times thereafter, Plaintiff M.N.’s remaining eggs were under Pacific Fertility’s protection, custody, and control. 23 175. Defendants kept Plaintiff M.N.’s eggs within a metal storage tank—Tank 4—at their 24 San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 25 spreading Plaintiff M.N.’s eggs among several tanks, Defendants stored all of her eggs in the same 26 tank. 27 28 176. After Plaintiff M.N. finally met the right partner, O.P., they decided to move ahead with fertilizing the rest of her eggs. Plaintiffs M.N. and O.P. are in a committed relationship and plan to 33 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3842ofof5862 1 raise children together. O.P. also became a client of Pacific Fertility in December 2017, when he and 2 M.N. consulted with Pacific Fertility to begin the process of fertilizing M.N.’s remaining eggs with 3 O.P.’s sperm. In consultation with Pacific Fertility specialists, M.N. and O.P. decided to proceed with 4 the fertilization by mid-2018. 5 177. Plaintiff M.N. has paid more than $25,000 to Defendants for procedures, medications, 6 and storage of her eggs. The process was mentally and physically draining: Plaintiff M.N. had 7 approximately 70 blood tests, 30 ultrasounds, and numerous injections and prescriptions. The process 8 was also time consuming and required her to take time off from work. Plaintiffs M.N. and O.P. 9 experienced severe emotional distress when they learned of the March 4, 2018, incident and in the 10 weeks that followed. 11 12 * 178. * * As described above, each Plaintiff encountered specific representations by Pacific 13 Fertility and/or Prelude regarding their egg and embryo storage services. All Plaintiffs encountered 14 materially similar pre-treatment materials provided by Pacific Fertility. 15 179. At all relevant times before the incident, the oral representations and promotional and 16 contractual materials regarding egg and embryo cryopreservation services that Plaintiffs and, 17 inferentially, the class members received, were standardized, common, and essentially uniform. 18 180. Despite (1) knowledge that their electronic monitoring and alarms, and accompanying 19 response systems and/or processes, were inadequate to protect against damage to Plaintiffs’ eggs and 20 embryos, and (2) multiple opportunities to inform Plaintiffs of the true condition of such systems and 21 processes before Plaintiffs purchased and used their storage services, Pacific Fertility and Prelude 22 uniformly failed to disclose to any Plaintiff that their systems were inadequate. 23 181. Had Defendants disclosed that their storage monitoring and alarm systems were 24 deficient, nonfunctional, and/or incapable of protecting eggs and embryos during a tank failure, 25 Plaintiffs would not have purchased and used Defendants’ egg and embryo storage services. 26 27 28 CLASS ACTION ALLEGATIONS 182. Plaintiffs propose that the Court streamline the determination of common claims or issues in this case, as Defendants’ misconduct leading to a single incident—the failure in Tank 4—has 34 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page3943ofof5862 1 affected hundreds of people at once. To facilitate such efforts through the joint trial of common 2 questions, Plaintiffs propose certification of the following class, pursuant to Rule 23 of the Federal 3 Rules of Civil Procedure: 4 All individuals, and their reproductive partners, who had eggs, embryos, or other material in Tank 4 at Pacific Fertility Center in San Francisco, California on March 4, 2018. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Excluded from this class are Defendants, their affiliates and subsidiaries, and their officers, directors, partners, employees, and agents; class counsel, employees of class counsel’s firms, and class counsel’s immediate family members; defense counsel, their employees, and their immediate family members; and any judicial officer who considers or renders a decision or ruling in this case, their staff, and their immediate family members. 183. Numerosity. The members of the class are so numerous that their individual joinder is impracticable. There are at least 400 class members, whose names and addresses are readily available from Defendants’ records. 184. Existence and Predominance of Common Questions of Fact and Law. This action involves common questions of law and fact that predominate over any questions affecting individual class members, including, without limitation: a. Whether Tank 4 was defective; b. Whether Defendants owed a duty to Plaintiffs and class members to protect the eggs and embryos they entrusted to Defendants’ care; 21 c. Whether that duty was non-delegable; 22 d. Whether Defendants breached their duties to protect the eggs and embryos that 23 24 25 26 27 Plaintiffs and class members entrusted to their care; e. Whether the March 4, 2018, loss of liquid nitrogen in a tank at Defendants’ San Francisco facility resulted from Defendants’ negligence or other wrongful conduct; f. Whether Defendants failed to take adequate and reasonable measures to ensure that their systems were protected; 28 35 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4044ofof5862 1 2 g. Whether Defendants failed to take available steps to ensure that liquid nitrogen levels in their storage tanks would remain sufficient; 3 h. Whether Defendants breached their contracts with Plaintiffs and class members; 4 i. Whether Defendants fraudulently concealed material information regarding their 5 laboratory practices and procedures; 6 7 j. by Plaintiffs and class members as a result of Defendants’ conduct alleged herein; and 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 The type(s) and measure(s) of compensable and other redressable injury incurred k. What measures are necessary to ensure that eggs and embryos stored at Pacific Fertility are properly safeguarded in the future. 185. Typicality. Plaintiffs’ claims are typical of the other class members’ claims because Plaintiffs and class members were subjected to the same wrongful conduct and damaged in the same way by having their eggs and embryos destroyed, damaged, or jeopardized. 186. Adequacy of Representation. Plaintiffs are adequate class representatives. Their interests do not conflict with the interests of the other class members they seek to represent. Plaintiffs have retained counsel competent and experienced in complex class action litigation, as well as in matters concerning egg and embryo loss, and they intend to prosecute this action vigorously. Plaintiffs and their counsel will fairly and adequately pursue and protect the interests of the class. 187. Superiority. A class action is superior to all other available means for the fair and efficient adjudication of this controversy. The highly sensitive and private nature of the facts involved here, as well as the fear that bringing an individual suit could affect future treatment at Pacific Fertility, counsels toward providing a class vehicle to adjudicate these claims. The damages or other financial detriment suffered by Plaintiffs and the other class members are relatively small compared to the burden and expense that would be required to individually litigate these claims. As a result, it would be impracticable for class members to seek redress individually. Individualized litigation would also create a potential for inconsistent or contradictory judgments and increase the delay and expense to all parties and the court system. By contrast, the class action device presents far fewer management 28 36 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4145ofof5862 1 difficulties and provides the benefits of single adjudication, economy of scale, and comprehensive 2 supervision by a single court. 3 CLAIMS FOR RELIEF 4 188. Plaintiffs bring each of the following claims under California law. 5 189. None of Plaintiffs’ claims involves any allegation of medical malpractice. 6 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against All Defendants) 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 190. Plaintiffs incorporate the above and below allegations by reference. 191. Defendants owed Plaintiffs a duty to exercise the highest degree of care when maintaining, inspecting, monitoring, and testing the liquid nitrogen storage tanks used for the preservation of eggs and embryos at Defendants’ San Francisco laboratory. 192. Defendants owed a duty of care to Plaintiffs to act reasonably in all aspects of the storage of Plaintiffs’ eggs and embryos so as to avoid destroying them, damaging them, or jeopardizing their viability given that doing so would inevitably lead to emotional distress. 193. Defendants assumed that duty of care through communications with actual and prospective clients and by reason of Defendants’ special relationship with Plaintiffs arising from the sensitive services Defendants undertook to perform: human egg and embryo cryopreservation and storage. 194. Plaintiffs’ harms occurred in the course of specified categories of activities, undertakings, or relationships in which negligent conduct is especially likely to cause serious harm. As Pacific Fertility states in its marketing, fertility services, including those relating to cryopreserved egg and embryo storage, can be stressful and overwhelming for those who use them. 195. It was reasonably foreseeable to Defendants that Plaintiffs would experience severe emotional distress as a result of Defendants’ breach of their duty of care. 196. Defendants’ carelessness and negligence directly and foreseeably damaged Plaintiffs. Plaintiffs entrusted Defendants with preserving and storing their eggs and embryos, and Defendants’ mishandling of those eggs and embryos, and their subsequent mishandling of communications, 37 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4246ofof5862 1 naturally and foreseeably caused mental anguish and emotional distress, among other injuries, to 2 Plaintiffs. 3 197. There was a close connection between Defendants’ conduct and Plaintiffs’ injuries. 4 Plaintiffs’ emotional distress and other harms occurred because of Defendants’ failure to act reasonably 5 in all aspects of the storage of Plaintiffs’ eggs and embryos. 6 198. Plaintiffs entrusted Defendants to use reasonable care to safeguard their eggs and 7 embryos to preserve their reproductive options. Defendants’ carelessness with this precious material, 8 and ultimately, with the affected families’ careful plans for parenthood, is reprehensible. 9 199. Imposing a duty on Defendants to avoid causing emotional distress would promote the 10 policy of preventing future harm, insofar as they will be motivated to: (1) in the case of Prelude and 11 Pacific Fertility, implement more effective processes and systems to ensure that eggs and embryos are 12 safeguarded and properly stored going forward; and (2) in the case of Chart, take steps to ensure that 13 tanks it designs to hold eggs and embryos are free from defects capable of destroying, damaging, or 14 jeopardizing their contents. Imposing a duty on Defendants to avoid causing emotional distress also 15 furthers the community’s interest in ensuring that reliable fertility services are available to those who 16 wish to become parents. 17 200. The burden on Defendants from a duty to avoid causing emotional distress is fair and 18 appropriate, in light of the importance of the eggs and embryos they voluntarily agreed to protect, at 19 considerable cost to Plaintiffs. 20 21 22 23 24 201. Defendants owed Plaintiffs a non-delegable duty of care with respect to the maintenance and protection of the eggs and embryos entrusted to their care. 202. Defendants breached these duties and acted with negligence and gross negligence in at least the following respects: a. failing to adequately design, manufacture, maintain, inspect, monitor, and/or test 25 their liquid nitrogen storage tanks, including through a functional electronic tank monitoring system 26 capable of detecting a rise in temperature or a drop in liquid nitrogen levels and promptly alerting staff 27 to the immediate problem; 28 38 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4347ofof5862 1 2 b. permitting a leakage or tank failure to occur with respect to one of their liquid nitrogen storage tanks—Tank 4—containing human eggs and embryos; 3 c. failing to inspect and/or adequately inspect Tank 4 on a daily basis; 4 d. failing to establish, maintain, and properly activate alarms; 5 e. failing to establish, maintain, and properly activate autofill devices and/or 6 generator systems; 7 8 f. failing to disclose that it did not have appropriate processes and systems in place to protect clients’ eggs and embryos; 9 g. failing to properly safeguard the eggs and embryos in its care; and 10 h. failing to follow reasonable scientific and laboratory procedures for safeguarding 11 12 the eggs and embryos in their care. 203. Defendants’ acts and omissions constitute gross negligence, because they constitute an 13 extreme departure from what a reasonably careful person would do in the same situation to prevent 14 foreseeable loss of eggs and embryos. 15 204. Defendants acted willfully, wantonly, and with conscious and reckless disregard for the 16 rights and interests of Plaintiffs. Defendants’ acts and omissions had a great probability of causing 17 significant harm and in fact did. 18 205. Defendants’ failure to appropriately handle and safeguard Plaintiffs’ eggs and embryos 19 has caused severe emotional distress, regardless of whether it is ever determined conclusively that the 20 eggs and embryos in Tank 4 are not viable. Defendants’ misconduct has irreparably breached trust and 21 caused uncertainty, anxiety, and fear among Plaintiffs and other affected families over how to proceed 22 without being informed as to the long-term effects from an egg or embryo’s presence in Tank 4 during 23 the incident. 24 206. As a proximate result of Defendants’ negligence and/or gross negligence, Plaintiffs 25 suffered harm in an amount to be determined at trial, including severe emotional distress consisting of 26 shock, fright, horror, anguish, suffering, grief, anxiety, nervousness, embarrassment, humiliation, and 27 shame. A reasonable person would be unable to cope with the losses suffered by Plaintiffs. 28 39 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4448ofof5862 SECOND CAUSE OF ACTION Breach of Contract (Against Pacific Fertility and Prelude) 1 2 3 207. Plaintiffs incorporate the above allegations by reference. 4 208. Defendants entered into contracts with Plaintiffs, under which Defendants agreed to 5 store and preserve their eggs and embryos or those obtained on their behalf, and under which 6 Defendants assumed a non-delegable duty of care to ensure such safekeeping and preservation. 7 209. A contract involving egg and embryo storage and preservation is highly personal and 8 implicates vital concerns regarding parenthood, procreation, and assisting others in achieving their 9 family plans. 10 210. In consideration of Defendants’ promises, including to keep the eggs and embryos safe 11 and secure by following practices and protocols, including as outlined on their websites and in other 12 marketing materials, Plaintiffs agreed to pay, and did pay, substantial sums for the services rendered. 13 14 15 211. Plaintiffs performed all of the terms and conditions required of them under their contracts with Defendants. 212. Based on the conduct described herein, Defendants breached their contracts with 16 Plaintiffs, including the incorporated contractual covenant of good faith and fair dealing. Defendants’ 17 failure to safely store and preserve Plaintiffs’ eggs and embryos violated commercial norms, deprived 18 Plaintiffs of the fruits of the contracts, and contravened their objectively reasonable expectations under 19 the contracts. 20 213. A contract whereby a fertility clinic undertakes to store human eggs and embryos is one 21 as to which it is reasonably foreseeable that breach thereof will cause mental anguish to the person or 22 persons who entrusted the clinic with such material. 23 24 214. harm, including mental anguish, in an amount to be determined at trial. 25 THIRD CAUSE OF ACTION Bailment (Against Pacific Fertility and Prelude) 26 27 As a direct and proximate result of Defendants’ breach of contract, Plaintiffs suffered 215. Plaintiffs incorporate the above allegations by reference. 28 40 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4549ofof5862 1 2 216. Plaintiffs delivered to Defendants for safekeeping irreplaceable personal property to be safely and securely kept for the benefit of Plaintiffs, and to be redelivered to them upon demand. 3 217. Defendants received eggs and embryos from Plaintiffs on this condition. 4 218. Plaintiffs agreed to pay, and did pay, substantial sums in exchange for Defendants’ 5 6 promise to safeguard their eggs and embryos for the benefit of Plaintiffs. 219. Defendants had a duty to exercise care in maintaining, preserving, and protecting 7 Plaintiffs’ eggs and embryos that were delivered to Defendants. Further, Defendants had a duty to 8 return the eggs and embryos, undamaged, to Plaintiffs, to whom the eggs and embryos belonged. 9 220. Defendants invited the general public, including Plaintiffs, to entrust eggs and embryos 10 to Defendants’ care by holding out Pacific Fertility as a competent, capable, and established 11 reproductive and storage facility able to handle and care for eggs and embryos in a safe and satisfactory 12 manner, and in a manner specified on their websites. 13 221. Because of Defendants’ wrongful conduct, as set forth herein, the irreplaceable property 14 of Plaintiffs was irreplaceably damaged, precluding its redelivery to them as provided for under the 15 bailment contract. 16 222. 17 18 Defendants breached their duty to exercise care in the safekeeping of Plaintiffs’ eggs and embryos delivered to Defendants and to return the eggs and embryos, undamaged, to Plaintiffs. 223. As a direct and proximate result of Defendants’ breach of bailment contract, Plaintiffs 19 have been deprived of the opportunity to use the eggs and embryos they entrusted to Defendants, and 20 have suffered damages in an amount to be determined at trial. 21 FOURTH CAUSE OF ACTION Premises Liability (Against Pacific Fertility and Prelude) 22 23 224. Plaintiffs incorporate the above allegations by reference. 24 225. At all relevant times, Pacific Fertility and Prelude owned, leased, and/or occupied the 25 property, premises, machinery, and equipment, including Tank 4, on the premises at 55 Francisco 26 Street, Suite 500, San Francisco, California 94133. 27 28 41 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4650ofof5862 1 226. At all relevant times, Pacific Fertility and Prelude had a duty to use reasonable care to 2 keep Plaintiffs’ irreplaceable personal property in a reasonably safe condition and free from defects that 3 would cause injury or harm to Plaintiffs’ stored eggs and embryos. 4 5 6 227. At all relevant times, Pacific Fertility and Prelude knew, or by reasonable inspection and monitoring should have known, of the defective condition of the premises, and specifically of Tank 4. 228. At all relevant times, Pacific Fertility and Prelude were careless and negligent in the 7 ownership, management, control and maintenance of the aforementioned real property, such that 8 Plaintiffs, whose cryopreserved eggs and embryos were entrusted to Pacific Fertility and Prelude’s 9 care, were harmed. 10 229. 11 suffered injury, loss, harm, and damages. 12 FIFTH CAUSE OF ACTION Breach of Fiduciary Duty ‒ Failure to Use Reasonable Care (Against Pacific Fertility and Prelude) 13 14 15 16 17 18 19 20 21 22 23 24 25 26 By reason of the foregoing, and as a direct and legal cause thereof, Plaintiffs have 230. Plaintiffs incorporate the above allegations by reference. 231. At all times herein mentioned, Pacific Fertility and Prelude were the fiduciaries of Plaintiffs because they agreed to store, safeguard, secure, maintain, and account for Plaintiffs’ eggs and embryos and because they represented that they were experts in the field of maintenance and protection of eggs and embryos. 232. Pacific Fertility and Prelude acted on Plaintiffs’ behalf for purposes of the maintenance and protection of Plaintiffs’ eggs and embryos. 233. Pacific Fertility and Prelude failed to act as a reasonably careful fiduciary would have acted under the same or similar circumstances with respect to the maintenance and protection of the eggs and embryos entrusted to their care. 234. Pacific Fertility and Prelude’s breach of fiduciary duty was a substantial factor in causing harm to Plaintiffs. 27 28 42 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4751ofof5862 1 2 SIXTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against All Defendants) 3 235. Plaintiffs incorporate the above allegations by reference. 4 236. The UCL prohibits acts of “unfair competition,” including any “unlawful, unfair or 5 6 7 8 9 fraudulent business act or practice.” 237. Defendants’ conduct set forth herein is unlawful because it constitutes negligence, gross negligence, breach of contract, bailment, breach of fiduciary duty, deceit, and strict products liability. 238. Defendants’ conduct is unfair because it is immoral, unethical, unscrupulous, oppressive, and substantially injurious. Plaintiffs entrusted Defendants with their eggs and embryos to 10 preserve their options for procreation, parenting, or assisting others experiencing infertility. 11 Defendants breached that trust by, among other things: 12 a. failing to adequately design, manufacture, maintain, inspect, monitor, and/or test 13 their liquid nitrogen storage tanks, including through a functional electronic tank monitoring system 14 capable of detecting a rise in temperature or a drop in liquid nitrogen levels and promptly alerting staff 15 to the immediate problem; 16 17 b. permitting a leakage or tank failure to occur with respect to one of their liquid nitrogen storage tanks—Tank 4—containing human eggs and embryos; 18 c. failing to inspect and/or adequately inspect Tank 4 on a daily basis; 19 d. failing to establish, maintain, and properly activate alarms; e. failing to establish, maintain, and properly activate autofill devices and/or 20 21 22 23 24 25 26 27 generator systems; f. failing to disclose that it did not have appropriate processes and systems in place to protect clients’ eggs and embryos; g. failing to properly safeguard the eggs and embryos in its care; and h. failing to follow reasonable scientific and laboratory procedures for safeguarding the eggs and embryos in their care. 28 43 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4852ofof5862 1 239. The gravity of the harm resulting from Defendants’ conduct far outweighs any 2 conceivable utility of this conduct. There are reasonably available alternatives that would further 3 Defendants’ legitimate business interests, such as implementing reasonable protocols and procedures, 4 as promised, to prevent a catastrophic failure. 5 240. Plaintiffs could not have reasonably avoided injury from Defendants’ unfair conduct. 6 Plaintiffs did not know, and had no reasonable means of learning, that Defendants were not adequately 7 safeguarding the eggs and embryos in their custody and control. 8 9 10 241. Defendants’ conduct also is fraudulent in violation of the UCL because it is likely to deceive a reasonable consumer. 242. Defendants knowingly and intentionally concealed from Plaintiffs that their electronic 11 monitoring and alarm and response systems and processes, and other equipment, including the storage 12 tank, were inadequate to protect against damage to Plaintiffs’ eggs and embryos. 13 14 15 16 17 18 19 20 21 243. Defendants volunteered specific information to Plaintiffs through advertising, on websites, and in documents that their storage services were high quality, including representing that a tank could go without power or liquid nitrogen for “several days” without damaging the tissue it contained. Plaintiffs viewed and relied upon Defendants’ representations that their storage services were high quality, safe, and reliable. 244. Defendants made these specific representations despite knowing their systems were inadequate to protect against damage to Plaintiffs’ eggs and embryos. 245. Defendants had ample means and opportunities to alert Plaintiffs to the fact that their 22 electronic monitoring and alarm and response systems and processes were inadequate to protect against 23 damage to Plaintiffs’ eggs and embryos. Defendants failed to disclose such inadequacies to Plaintiffs. 24 Had Defendants disclosed such inadequacies to Plaintiffs, Plaintiffs would not have purchased 25 Defendants’ egg and embryo storage services. 26 246. Defendants were under a duty to disclose that their storage systems and processes were 27 inadequate given their exclusive knowledge of the inadequacies and because they made partial 28 representations about their storage services without disclosing the inadequacies. 44 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page4953ofof5862 1 247. As a direct and proximate result of Defendants’ unlawful and unfair conduct, Plaintiffs 2 have suffered injuries in fact and seek appropriate relief under the UCL, including injunctive relief and 3 restitution. 4 248. The requested injunction under the UCL will primarily benefit the interests of the 5 general public. It will have the primary purpose and effect of prohibiting unlawful acts that threaten 6 injury to members of the public who have placed, or who in the future will place, reproductive tissue 7 under Defendants’ care. 8 9 10 11 12 13 14 15 16 17 18 19 20 21 SEVENTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against Pacific Fertility and Prelude) 249. Plaintiffs incorporate the above allegations by reference. 250. Pacific Fertility and Prelude are “persons” as defined by Civil Code §§ 1761(c) and 1770 and have provided “services” as defined by Civil Code §§ 1761(b) and 1770. 251. engaged in “transaction[s]” as defined by Civil Code §§ 1761(e) and 1770. 252. 24 25 26 Pacific Fertility and Prelude’s acts and practices were intended to and did result in the sale of services to Plaintiffs, and those acts and practices violated Civil Code § 1770, including by: a. representing that their services had characteristics, uses, and benefits that they b. representing that their services were of a particular standard, quality, or grade, did not have; when they were not; 22 23 Plaintiffs are “consumers” as defined by Civil Code §§ 1761(d) and 1770 and have c. advertising services with intent not to sell them as advertised; and d. representing that the subject of a transaction had been supplied in accordance with a previous representation when it had not. 253. Pacific Fertility and Prelude’s acts and practices violated the Consumers Legal Remedies Act by failing to disclose information in the context of transactions. 27 28 45 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5054ofof5862 1 254. Pacific Fertility and Prelude knew that their equipment, systems, and processes, 2 including Defendants’ storage tank, electronic monitoring, alarm, and response systems and processes, 3 were inadequate to safely store Plaintiffs’ eggs and embryos. 4 255. Pacific Fertility and Prelude were under a duty to disclose that their equipment, systems, 5 and processes were inadequate because they actively concealed this information and because they had 6 exclusive knowledge, not known or reasonably accessible to Plaintiffs, of the inadequacy of their 7 equipment, systems, and processes. They were also subject to a duty to disclose because the 8 information they failed to disclose was contrary to partial representations they made concerning the 9 adequacy of their equipment, systems, and processes. 10 256. Pacific Fertility and Prelude had ample means and opportunities to alert Plaintiffs to the 11 fact that their equipment, systems, and processes were inadequate, including in person when meeting 12 with Plaintiffs before egg and embryo storage. Despite their opportunities to do so, Pacific Fertility and 13 Prelude failed to disclose to Plaintiffs, and actively concealed, that Defendants’ equipment, systems, 14 and processes were inadequate to safely store human reproductive tissue. 15 257. Pacific Fertility and Prelude’s omissions were material because reasonable consumers 16 would consider important, and would want to be told, information about the inadequacy of Defendants’ 17 equipment, systems, or processes connected to their ability to safely store Plaintiffs eggs and embryos 18 258. As a direct and proximate result of this conduct, Plaintiffs have suffered damage. Had 19 Defendants not misrepresented the adequacy of, and concealed the inadequacy of, their equipment, 20 systems, and processes, Plaintiffs would not have purchased Defendants’ services and would not have 21 gone through the time and emotional investment to store their reproductive tissue with Defendants. In 22 the meantime, Pacific Fertility and Prelude generated more revenue than they otherwise would have, 23 unjustly enriching themselves. 24 259. Plaintiffs are entitled to equitable relief, reasonable attorneys’ fees and costs, declaratory 25 relief, and a permanent injunction enjoining Pacific Fertility and Prelude from their unlawful, 26 fraudulent, and deceitful activity. 27 28 260. Pursuant to Cal. Civ. Code § 1782(a), Plaintiffs will send letters to Defendants notifying them of their CLRA violations and providing them with the opportunity to correct their business 46 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5155ofof5862 1 practices. If Pacific Fertility and Prelude do not correct their business practices, Plaintiffs will amend 2 (or seek leave to amend) the complaint to add claims for monetary relief, including for actual, 3 restitutionary, emotional distress, and punitive damages under the CLRA. 4 261. The conduct of Pacific Fertility and Prelude set forth herein was reprehensible and 5 subjected Plaintiffs to cruel and unjust hardship in conscious disregard of their rights, constituting 6 oppression, for which Pacific Fertility and Prelude must be punished by punitive and exemplary 7 damages in an amount according to proof. Pacific Fertility and Prelude’s behavior evidences a 8 conscious disregard for the safety of the eggs and embryos entrusted to them, and by extension, those 9 who placed the eggs and embryos in their care, including Plaintiffs. Pacific Fertility and Prelude’s 10 conduct was and is despicable conduct and constitutes malice under Section 3294 of the California 11 Civil Code. An officer, director, or managing agent of Pacific Fertility and Prelude personally 12 committed, authorized, and/or ratified the reprehensible conduct set forth herein. Plaintiffs are entitled 13 to an award of punitive damages sufficient to punish and make an example of these Defendants. 14 EIGHTH CAUSE OF ACTION Deceit and Fraudulent Concealment (Against Pacific Fertility and Prelude) 15 16 17 18 19 20 21 22 23 24 25 26 27 262. Plaintiffs incorporate the above allegations by reference. 263. Defendants marketed and promoted their services and made representations to the public and to Plaintiffs that they were experts in cryopreservation, had state-of-the-art facilities, and would safely preserve and store Plaintiffs’ eggs and embryos in liquid nitrogen according to certain protocols and standards until they were ready to use them. 264. Defendants’ representations were false, and Defendants either knew the truth or made the representations without regard for the truth. 265. Defendants intended for Plaintiffs to rely on their representations and engage Defendants to perform services to preserve Plaintiffs’ eggs and embryos, and Plaintiffs reasonably relied on Defendants’ representations when availing themselves of Defendants’ services for egg and embryo storage. 28 47 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5256ofof5862 1 266. Defendants intentionally suppressed and concealed material facts concerning the 2 adequacy of its storage systems and processes. Defendants knew or reasonably should have known 3 their electronic monitoring and alarm storage systems and processes were inadequate to protect against 4 damage to Plaintiffs’ eggs and embryos. Though it is standard in the industry to do so, Defendants did 5 not equip Tank 4 with a liquid nitrogen autofilling system sufficient to replenish declining liquid 6 nitrogen levels. Defendants willfully omitted to disclose the inadequate nature of its storage systems 7 and processes to Plaintiffs. 8 9 267. Plaintiffs had no reasonable means of knowing Defendants’ storage systems and processes were inadequate, or that Defendants’ representations about such systems were incomplete, 10 false, or misleading in that they failed to disclose such inadequacies. Plaintiffs did not and reasonably 11 could not have discovered Defendants’ deception prior to purchasing their storage services. 12 268. Defendants had ample means and opportunities to alert Plaintiffs to the fact that their 13 electronic monitoring and alarm and response systems and processes were inadequate to protect against 14 damage to Plaintiffs’ eggs and embryos. Defendants willfully failed to disclose such inadequacies to 15 Plaintiffs. Had Defendants disclosed the inadequacies to Plaintiffs, they would not have purchased 16 Defendants’ egg and embryo storage services. 17 269. Defendants were under a duty to disclose that their storage systems and processes were 18 inadequate given their exclusive knowledge of the inadequacies and because they made partial 19 representations about their storage services without disclosing the inadequacies. 20 270. Plaintiffs reasonably relied to their detriment upon Defendants’ material omissions 21 regarding the adequacy of their storage systems and processes. Plaintiffs were unaware of the omitted 22 material facts and would not have acted as they did had these facts been disclosed. Had Plaintiffs 23 known that Defendants’ storage systems and processes were inadequate to protect against damage to 24 their eggs and/or embryos, they would not have purchased such services. 25 26 27 28 271. Plaintiffs sustained damage as a direct and proximate result of Defendants’ deceit and fraudulent concealment. 272. The foregoing acts and omissions of Defendants were committed maliciously, oppressively, deliberately, with intent to defraud, and in reckless disregard of Plaintiffs’ rights, 48 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5357ofof5862 1 interests, and well-being to enrich Defendants. Defendants’ conduct warrants an assessment of 2 punitive damages in an amount sufficient to deter such conduct in the future, which amount is to be 3 determined according to proof. 4 NINTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart) 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 273. Plaintiffs incorporate the above allegations by reference. 274. Chart manufactured, distributed, and/or sold the cryogenic equipment used at Pacific Fertility, including Tank 4. 275. The cryogenic storage tank at issue had potential risks that were known or knowable in light of the scientific and medical knowledge that was generally accepted in the scientific and medical community at the time of the manufacture, distribution, or sale of the cryogenic storage Tank 4. 276. The cryogenic storage Tank 4 was defective and unreasonably dangerous when it left Chart’s possession because it did not contain adequate warnings, including warnings concerning certain risks, including the risk of defective seals that may result in catastrophic nitrogen loss, the risk of nitrogen loss and prevalence of this occurrence, the risk of a rise in temperature and the fact that the tanks are not equipped with sufficient alarms to notify users of catastrophic nitrogen loss or a rise in temperature that can damage and/or cause destruction of eggs or embryos, the rate of failure of the cryogenic storage tanks in the preservation of eggs or embryos or other human tissue, and the need for maintenance, inspection, and/or replacement of the cryogenic storage tanks. 277. The potential risks presented a substantial danger when the cryogenic storage tank at issue was used or misused in an intended or reasonably foreseeable way. 278. The ordinary consumer would not have recognized the potential for risks. 279. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable care, should have known that the cryogenic storage Tank 4 was dangerous, had risks, and/or was defective in manufacture and/or design, including that it could cause nitrogen loss and would damage and/or cause the destruction of cryopreserved materials, including eggs or embryos. 28 49 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5458ofof5862 1 2 3 280. Chart failed to adequately warn or instruct concerning the potential risks of the cryogenic storage tank. 281. It was foreseeable to Chart that failure to adequately warn about the risks of its 4 cryogenic storage tank would cause irreparable harm to those whose eggs and embryos were 5 cryopreserved therein, including the types of emotional distress suffered by Plaintiffs. 6 282. As a result of Chart’s failures to adequately warn, Plaintiffs were harmed as described 7 herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 8 are not viable. The lack of sufficient instructions and warnings was a substantial factor in causing 9 Plaintiffs’ harm. 10 TENTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) 11 12 13 14 15 16 17 18 19 20 21 22 23 24 283. Plaintiffs incorporate the above allegations by reference. 284. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 285. The cryogenic storage tank contained a manufacturing defect when it left Chart’s possession. 286. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were defective in manufacture, including that they could cause nitrogen loss and would damage and/or cause the destruction of cryopreserved materials, including eggs or embryos. 287. As a result of Chart’s conduct, Plaintiffs were harmed as described herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 are not viable. 288. The defective nature of the cryogenic storage tank was a substantial factor in causing Plaintiffs’ harm. ELEVENTH CAUSE OF ACTION Strict Products Liability — Design Defect — Consumer Expectations Test (Against Chart) 25 26 289. Plaintiffs incorporate the above allegations by reference. 27 290. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 28 50 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5559ofof5862 1 2 3 291. The cryogenic storage tank did not perform as safely as an ordinary consumer would have expected it to perform when used in an intended or reasonably foreseeable way. 292. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 4 care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were 5 defective, including in design, including that they could result in nitrogen loss and would damage 6 and/or cause the destruction of cryopreserved materials, including eggs or embryos. 7 8 9 10 293. As a result of Chart’s conduct, Plaintiffs were harmed as described herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 are not viable. 294. The cryogenic storage tank’s failure to perform safely was a substantial factor in causing Plaintiffs’ harm. TWELFTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) 11 12 13 295. Plaintiffs incorporate the above allegations by reference. 14 296. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 15 297. The benefits of this tank’s design are not outweighed by its risks, considering the gravity 16 of the potential harm resulting from the use of the tank, the likelihood that the harm would occur, the 17 feasibility of an alternative safer design at the time of manufacture, and the disadvantages of an 18 alternative design. 19 298. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 20 care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were 21 defective in design, including that they could result in nitrogen loss and would damage and/or cause the 22 destruction of cryopreserved materials, including eggs or embryos. 23 299. Plaintiffs were harmed because the tank lost liquid nitrogen. 24 300. Chart’s design of the tank was a substantial factor in causing Plaintiffs’ harm. 25 THIRTEENTH CAUSE OF ACTION Negligent Failure to Recall (Against Chart) 26 27 301. Plaintiffs incorporate the above allegations by reference. 28 51 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5660ofof5862 1 2 302. Chart acted negligently by failing to recall, prior to the incident of March 4, 2018, the line of tanks that included Tank 4. 3 303. Chart manufactured, distributed, and/or sold this line of tanks. 4 304. Chart knew or reasonably should have known that, when used as intended, Tank 4 5 presented or was likely to present a danger to eggs and embryos. Chart knew or reasonably should 6 have known that the vacuum seal on Tank 4 was vulnerable to breach, and that upon such breach liquid 7 nitrogen levels would drop, causing the eggs and embryos stored inside the tank to reach dangerously 8 elevated temperatures. 9 305. After Chart sold Tank 4 to Pacific Fertility and before March 4, 2018, Chart knew or 10 reasonably should have known that the tank was susceptible to its vacuum seal breaking. Nevertheless, 11 at no point during this time period did Chart recall, repair, or warn of the danger posed by the tank. 12 13 14 306. A reasonable manufacturer, distributor, or seller facing the same or similar circumstances as Chart would have recalled Tank 4 to ensure eggs and embryos were not endangered. 307. Chart’s failure to timely recall Tank 4 was a substantial factor in causing harm to 15 Plaintiffs. Had Chart recalled Tank 4 before the incident, the other Defendants would not have used it, 16 and it would not have failed while Plaintiffs’ eggs and embryos were stored within it. 17 18 19 PRAYER FOR RELIEF WHEREFORE, Plaintiffs, individually and on behalf of the class defined above, respectfully request that the Court: 20 A. Certify the class under Fed. R. Civ. P. 23(a), (b)(1), (b)(2), (b)(3), and/or (c)(4), 21 as appropriate; appoint Plaintiffs as representatives of the class; and appoint the undersigned counsel as 22 class counsel; 23 24 B. Award Plaintiffs compensatory, restitutionary, rescissory, general, consequential, punitive and/or exemplary damages in an amount to be determined at trial; 25 C. Award prejudgment interest as permitted by law; 26 D. Enter an injunction against Defendants and their officers, agents, successors, 27 employees, representatives, assigns, and any and all persons acting in concert with them, to ensure 28 Defendants’ compliance with California Business and Professions Code section 17200 et seq.; 52 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5761ofof5862 1 E. Enter an injunction against Defendants and their officers, agents, successors, 2 employees, representatives, assigns, and any and all persons acting in concert with them, mandating 3 that Defendants cease engaging in unfair competition as set forth above; 4 5 F. Appoint a monitor to ensure Defendants comply with the injunctive provisions of any decree of this Court; 6 G. Retain jurisdiction over this action to ensure Defendants comply with such a 8 H. Enter other appropriate equitable relief; 9 I. Award reasonable attorneys’ fees and costs, as provided for by law; and 10 J. Grant such other and further relief as the Court deems just and proper. 7 decree; 11 12 DEMAND FOR JURY TRIAL Plaintiffs demand a trial by jury on all issues so triable. 13 14 Dated: May 30, 2018 Respectfully submitted, 15 16 17 18 19 20 21 22 23 24 25 26 27 28 By: /s/ Adam E. Polk Daniel C. Girard (State Bar No. 114826) Steven M. Tindall (State Bar No. 187862) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com By: /s/ Adam B. Wolf Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 53 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-1 44 Filed Filed05/30/18 11/30/18 Page Page5862ofof5862 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com 1 2 3 12 By: /s/ Sarah R. London Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com 13 Interim Class Counsel 4 5 6 7 8 9 10 11 14 Joseph G. Sauder (pro hac vice) SAUDER SCHELKOPF LLC 555 Lancaster Avenue Berwyn, Pennsylvania 19312 Tel: (610) 200-0580 jgs@sstriallawyers.com 15 16 17 18 Plaintiffs’ Counsel 19 20 ATTESTATION 21 22 23 24 I, Adam E. Polk, am the ECF User whose identification and password are being used to file this Consolidated Amended Class Action Complaint. Pursuant to Civil L.R. 5-1(i)(3), I attest under penalty of perjury that concurrence in this filing has been obtained by all counsel listed above. 25 26 27 Dated: May 30, 2018 /s/ Adam E. Polk Adam E. Polk 28 54 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Document 143-2 Filed 11/30/18 Page 1 of 62 EXHIBIT 2 Case 3:18-cv-01586-JSC Document 143-2 Filed 11/30/18 Page 2 of 62   June 21, 2018 VIA FEDERAL EXPRESS AND CERTIFIED MAIL RETURN RECEIPT REQUESTED Pacific Fertility Center 55 Francisco Street, Suite 500 San Francisco, CA 94133 Re: Notice of Violation of California’s Consumers Legal Remedies Act and Demand for Relief, Pursuant to Cal. Civ. Code § 1782 To Whom It May Concern: Girard Gibbs LLP, Lieff Cabraser Heimann & Bernstein, LLP, and Peiffer Wolf Carr & Kane, A.P.L.C. represent A.B., C.D., E.F., G.H., I.J., K.L., M.N., and O.P. (“Plaintiffs”). As reflected in further detail in the attached complaint, filed in In re Pacific Fertility Center Litigation, Case No. 3:18-cv-01586-JSC (N.D. Cal.), Plaintiffs allege that Pacific Fertility and Prelude engaged in deceptive acts and practices, including by failing to disclose that their storage tank, electronic monitoring, alarm, and response systems and processes were inadequate to safely store Plaintiffs’ eggs and embryos. As a result, on March 4, 2018, Pacific Fertility discovered that the nitrogen levels in a storage tank known as “Tank 4” had dropped to an unsafe level for an undetermined period of time, destroying or jeopardizing the eggs and embryos stored in the tank, including those belonging to Plaintiffs. Defendants’ conduct violates California consumer protection law, including California’s Consumers Legal Remedies Act, Cal. Civ. Code § 1750, et seq., because Pacific Fertility and Prelude: 1. Represented that their services had characteristics, uses, and benefits that they did not have (Cal. Civ. Code § 1770(5)); 2. Represented that their services were of a particular standard, quality, or grade when they were not (Cal. Civ. Code § 1770(7)); 3. Advertised services with intent not to sell them as advertised (Cal. Civ. Code § 1770(9)); and 4. Represented that the subject of a transaction had been supplied in accordance with a previous representation when it had not (Cal. Civ. Code § 1770(16)). With this letter, our firms, on behalf of Plaintiffs and a proposed class of all individuals and their reproductive partners who had eggs, embryos, or other material in Tank 4 at Pacific Fertility Center in San Francisco, California on March 4, 2018, demand that you correct your business practices and take prompt action.   Case 3:18-cv-01586-JSC Document 143-2 Filed 11/30/18 Page 3 of 62 To: Re: Date: Page:   Pacific Fertility Center Notice of Violation of CLRA and Demand for Relief June 21, 2018 2 of 3 Please direct all communications or responses regarding this notice to the following counsel: Daniel C. Girard Steven M. Tindall Jordan Elias Adam E. Polk GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com REQUESTED REMEDIES Plaintiffs DEMAND THAT WITHIN THIRTY DAYS you remedy your violations by doing the following:   I. Disseminate a notice reasonably intended to reach all proposed class members, setting forth: a. The existence and description of the Pacific Fertility Center litigation, including a summary of the subject matter and the claims asserted; b. The name, address, and telephone number of Plaintiffs’ counsel, identified above; and c. The right of proposed class members to obtain the remedies described below. II. Subject to monitoring and confirmation by Plaintiffs’ counsel, compensate proposed class members for all injuries caused by Pacific Fertility and Prelude’s failure to disclose that their systems and processes were inadequate to safely store human reproductive tissue, including for class members’ resulting emotional distress, mitigation expenses, and the costs of Defendants’ services. III. Immediately cease selling services while maintaining systems and processes that are inadequate to safely store human reproductive tissue, until you: a. Allow Plaintiffs’ counsel to inspect Pacific Fertility and Prelude’s current systems and processes; and Case 3:18-cv-01586-JSC Document 143-2 Filed 11/30/18 Page 4 of 62 To: Re: Date: Page:   Pacific Fertility Center Notice of Violation of CLRA and Demand for Relief June 21, 2018 3 of 3 b. IV. Implement all system and process improvements demanded by Plaintiffs’ counsel following inspections. Pay into a court-approved escrow account an amount of money sufficient to pay Plaintiffs’ reasonable attorneys’ fees and costs. Please contact us within thirty days to discuss Pacific Fertility and Prelude’s implementation of these remedies. Very truly yours, GIRARD GIBBS LLP Adam E. Polk Enclosure cc:   Joseph S. Picchi Aaron T. Schultz GALLOWAY, LUCCHESE, EVERSON & PICCHI 2300 Contra Costa Blvd., Suite 350 Pleasant Hill, CA 94523 Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1 5ofof5862 1 2 3 4 5 6 7 8 9 Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com Daniel C. Girard (State Bar No. 114826) Steven M. Tindall (State Bar No. 187862) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com 15 Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com 16 Counsel for Plaintiffs and Interim Class Counsel 10 11 12 13 14 17 [Additional Counsel on Signature Page] 18 19 UNITED STATES DISTRICT COURT 20 NORTHERN DISTRICT OF CALIFORNIA 21 SAN FRANCISCO DIVISION 22 23 24 25 26 27 IN RE PACIFIC FERTILITY CENTER LITIGATION ) ) ) ) ) ) ) ) ) Case No. 3:18-cv-01586-JSC CONSOLIDATED AMENDED CLASS ACTION COMPLAINT DEMAND FOR JURY TRIAL 28 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2 6ofof5862 1 TABLE OF CONTENTS 2 NATURE OF THE ACTION ................................................................................................................... 1  3 JURISDICTION AND VENUE ............................................................................................................... 2  4 INTRADISTRICT ASSIGNMENT.......................................................................................................... 3  5 PARTIES .................................................................................................................................................. 3  6 7 A.  Plaintiffs ................................................................................................................ 3  B.  Defendants ............................................................................................................ 4  8 9 10 11 12 13 Prelude ...................................................................................................... 4  2.  Pacific Fertility.......................................................................................... 5  3.  Chart .......................................................................................................... 6  FACTUAL ALLEGATIONS ................................................................................................................... 7  I.  14 Plaintiffs Entrusted Prelude and Pacific Fertility with Keeping their Eggs and Embryos Safe and Secure. ................................................................................................ 7  A.  Defendants market their cryopreservation services as an insurance policy that unwinds the biological clock, preserving the opportunity to have children when the time is right. ........................................................................................... 7  B.  Defendants market their cryopreservation and storage services to people struggling with infertility. ..................................................................................... 9  C.  Defendants promised to keep Plaintiffs’ eggs and embryos safe in a state-ofthe-art facility. ..................................................................................................... 10  15 16 17 18 19 20 1.  II.  21 Precision and Care Are Required in the Cryopreservation and Storage of Eggs and Embryos. ......................................................................................................................... 13  22 A.  The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. ................................................................................. 13  B.  The loss of eggs and embryos results in emotional trauma. ............................... 18  C.  Successful cryopreservation depends on strict adherence to protocols. ............. 19  23 24 25 26 27 28 III.  Defendants Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. ..................................................................................................................21  A.  Prelude and Pacific Fertility should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. ......................... 21  i CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3 7ofof5862 B.  Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident. ............................................................................................................... 22  C.  Multiple investigations were opened after the Tank 4 incident. ......................... 22  D.  Defendants’ failure to keep Plaintiffs’ eggs and embryos safe and secure has caused irreparable harm. ..................................................................................... 23  E.  6 Pacific Fertility and Prelude’s communications regarding the incident have compounded the harm. ........................................................................................ 26  7 PLAINTIFF-SPECIFIC ALLEGATIONS .............................................................................................29  8 CLASS ACTION ALLEGATIONS ....................................................................................................... 34  9 CLAIMS FOR RELIEF .......................................................................................................................... 37  10 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against All Defendants) ................................................ 37  1 2 3 4 5 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 SECOND CAUSE OF ACTION Breach of Contract (Against Pacific Fertility and Prelude) ........................................................ 40  THIRD CAUSE OF ACTION Bailment (Against Pacific Fertility and Prelude) ........................................................................ 40  FOURTH CAUSE OF ACTION Premises Liability (Against Pacific Fertility and Prelude) ......................................................... 41  FIFTH CAUSE OF ACTION Breach of Fiduciary Duty ‒ Failure to Use Reasonable Care (Against Pacific Fertility and Prelude) .......................................................................................42  SIXTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against All Defendants) ............................................................................................................ 43  SEVENTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against Pacific Fertility and Prelude) .......................................................................................45  EIGHTH CAUSE OF ACTION Deceit and Fraudulent Concealment (Against Pacific Fertility and Prelude) ............................. 47  NINTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart) ....................................................... 49  TENTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) ............................................. 50  ii CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4 8ofof5862 1 2 3 4 5 6 7 ELEVENTH CAUSE OF ACTION Strict Products Liability — Design Defect — Consumer Expectations Test (Against Chart) ...50  TWELFTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) .......................... 51  THIRTEENTH CAUSE OF ACTION Negligent Failure to Recall (Against Chart) ............................................................................... 51  PRAYER FOR RELIEF ......................................................................................................................... 52  DEMAND FOR JURY TRIAL .............................................................................................................. 53  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iii CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5 9ofof5862 1 Plaintiffs A.B., C.D., E.F., G.H., I.J., K.L., M.N., and O.P. (“Plaintiffs”), individually and on 2 behalf of all others similarly situated, file this Consolidated Class Action Complaint against 3 Defendants Pacific Fertility Center (“Pacific Fertility” or “PFC”), Prelude Fertility, Inc. (“Prelude”), 4 and Chart Industries (“Chart”) (collectively, “Defendants”) and allege as follows: 5 6 NATURE OF THE ACTION 1. Prelude and Pacific Fertility market and sell egg and embryo cryopreservation services. 7 They liken these services to an insurance policy for women and families, claiming the services provide 8 peace of mind to those who wish to defer having children and relief to those seeking to overcome a 9 diagnosis of infertility. Cryopreservation involves preservation of tissue—here, human eggs and 10 embryos—using cooling techniques. In the 1980s, facilities began using a cryopreservation technique 11 known as “slow freezing” to preserve human reproductive tissue. Cryopreservation became more 12 prevalent after the advent in the early 2000s of vitrification, a process by which tissue is cooled more 13 quickly, resulting in higher egg and embryo survival rates. Eggs or embryos frozen through 14 cryopreservation are stored in specially designed metal tanks. 15 2. Recognizing that the eggs and embryos entrusted to their care are irreplaceable, Prelude 16 and Pacific Fertility promise their clients, including Plaintiffs, that they will use state-of-the-art 17 laboratory equipment and protocols to ensure the safekeeping of the eggs and embryos. Safe storage 18 requires backup redundancies to guard against a catastrophic failure, daily inspections of the tanks, and 19 alarm systems to immediately notify staff of a potential failure. 20 3. On March 4, 2018, Pacific Fertility discovered that the liquid nitrogen levels in a tank 21 known as “Tank 4” had dropped to an unsafe level for an undetermined period of time, destroying or 22 jeopardizing the eggs and embryos stored in the tank, including those belonging to Plaintiffs. Chart 23 manufactured Tank 4. 24 4. Pacific Fertility’s first notification of the failure of Tank 4 was via an email sent at four 25 in the morning Pacific time on Sunday, March 11, 2018. Pacific Fertility described the failure as “a 26 very unfortunate incident” in which the storage tank containing Plaintiffs’ cryopreserved eggs and 27 embryos “lost liquid nitrogen for a brief period of time,” and stated that a “preliminary analysis” 28 suggested some of the eggs and embryos in the tank may have been destroyed. 1 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-2 44 Filed Filed05/30/18 11/30/18 Page Page610 of of 5862 1 5. Over a month later, on April 19, 2018, Pacific Fertility again wrote to Plaintiffs, 2 notifying them that an investigation had shown the incident resulted from “a failure of the tank’s 3 vacuum seal.” Four days later, Chart recalled several of its cryopreservation tanks, citing “reports of a 4 vacuum leak or failure that could compromise the product.” 5 6. Pacific Fertility and Prelude were responsible for monitoring Tank 4’s performance for 6 fluctuations in temperature or liquid nitrogen levels, which could endanger the enclosed eggs and 7 embryos, and to maintain safety systems to mitigate a tank failure. Pacific Fertility and Prelude failed 8 in that responsibility, committed gross negligence, and breached their agreement by failing to safely 9 preserve the eggs and embryos under their care. 10 11 7. To Plaintiffs’ shock and dismay, Pacific Fertility and Prelude did not separate their eggs or embryos into different tanks to ensure that at least some tissue would be safe if one tank failed. 12 8. As a result of Defendants’ failures, Plaintiffs and the proposed class have suffered harm. 13 Learning that their reproductive tissue was compromised has caused them devastation, panic, and 14 distress. For many, the tissue in Tank 4 represented their last and only chance for a biological child. 15 Pacific Fertility and Prelude have informed Plaintiffs that it is not possible to know whether their eggs 16 or embryos are viable until they are warmed, and even then, the full extent of the damage cannot be 17 known without attempting a pregnancy. These messages have cast a cloud of uncertainty over women 18 and families, causing anguish and despair. 19 20 9. Plaintiffs, individually and on behalf of the class, seek appropriate relief through this action. 21 22 JURISDICTION AND VENUE 10. This Court has subject matter jurisdiction over this action under the Class Action 23 Fairness Act of 2005, 28 U.S.C. § 1332(d), because (a) Plaintiffs are citizens of states different from 24 Prelude and Chart, (b) the amount in controversy exceeds $5,000,000, excluding interest and costs, (c) 25 the proposed class consists of more than 100 individuals, and (d) none of the exceptions under the 26 subsection applies to this action. 27 28 11. This Court has personal jurisdiction over Defendants. They conduct substantial business in California and intentionally availed themselves of the laws and markets of this state. A significant 2 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-2 44 Filed Filed05/30/18 11/30/18 Page Page711 of of 5862 1 portion of the acts and omissions at issue occurred in California, and Plaintiffs and many class 2 members suffered harm in California. Plaintiffs’ claims against Defendants are meaningfully 3 connected to California in that: (1) each Plaintiff had eggs and embryos stored at Pacific Fertility, 4 which is located in California and within the Prelude network; and (2) each Plaintiff had eggs and 5 embryos stored in Chart’s tank, which was physically located at Pacific Fertility’s San Francisco 6 facility, and which failed, resulting in damage to Plaintiffs. 7 8 12. Venue is proper in this District under 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in this District. 9 10 INTRADISTRICT ASSIGNMENT 13. Assignment to the San Francisco Division is proper under Local Rules 3-2(c) and (d) 11 because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in San 12 Francisco. 13 PARTIES 14 A. Plaintiffs 15 14. Plaintiff A.B. is a citizen and resident of Sacramento County, California. 16 15. Plaintiff C.D. is a citizen and resident of Sacramento County, California. 17 16. Plaintiff E.F. is a citizen and resident of San Francisco County, California. 18 17. Plaintiff G.H. is a citizen and resident of San Francisco County, California. 19 18. Plaintiff I.J. is a citizen and resident of San Francisco County, California. 20 19. Plaintiff K.L. is a citizen and resident of San Francisco County, California. 21 20. Plaintiff M.N. is a citizen and resident of San Francisco County, California. 22 21. Plaintiff O.P. is a citizen and resident of San Mateo County, California. 23 22. Given the sensitive nature of their claims and the services they purchased from Pacific 24 Fertility and Prelude, Plaintiffs are using initials in this litigation to protect their privacy. If required by 25 the Court, Plaintiffs will seek permission to proceed under these pseudonyms. 26 27 28 3 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-2 44 Filed Filed05/30/18 11/30/18 Page Page812 of of 5862 1 B. 2 Defendants 1. 3 23. Prelude At all relevant times, Defendant Prelude Fertility, Inc. was a Delaware corporation 4 headquartered in Florida. Prelude owns and runs a network of fertility clinics and egg and embryo 5 storage facilities—including Pacific Fertility Center—across the country. 6 24. Prelude was founded in 2016 by startup entrepreneur Martin Varsavsky with a $200 7 million investment by New York-based Lee Equity Partners. Prelude’s stated business plan is to create 8 a national network of fertility clinics, as well as egg and embryo cryopreservation and storage centers 9 “all delivered with the highest level of personalized care by the nation’s leading reproductive 10 endocrinologists and practitioners.”1 According to Varsavsky, “What Prelude does is bridge the gap, it 11 makes people’s biology meet their psychology” through “The Prelude Method”: “You freeze your 12 gametes when fertile, thaw them and create embryos when ready, genetically sequence the embryos, 13 and then transfer one embryo at a time. And you continue to do this until you achieve your desired 14 number of children.”2 15 25. Included within the Prelude network is MyEggBank, which Prelude claims has the 16 largest and most diverse selection of egg donors in the country. Prelude also claims that its embryo 17 survival rates are greater than 90% and that women who use eggs from MyEggBank have a 90% 18 pregnancy success rate within three cycles.3 19 26. Prelude acquired Pacific Fertility in September 2017 as part of Prelude’s business plan 20 to build its national network. Prelude directs potential clients to Pacific Fertility via its website and its 21 network of fertility clinics. Prelude also provides financing plans for services at Pacific Fertility. 22 23 24 25 26 27 1 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 18, 2018). 2 Martin Varsavsky, Why I founded Prelude Fertility: Background on vision and bringing on the team to make it thrive (Mar. 7, 2017), http://vator.tv/news/2017-03-07-why-i-founded-prelude-fertility (last visited May 30, 2018). 3 28 Have Questions?, Prelude Fertility, https://preludefertility.com/faq (last visited May 18, 2018). 4 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case 3:18-cv-01586-JSC 3:18-cv-01586-JSCDocument Document 143-2 44 Filed Filed05/30/18 11/30/18 Page Page913 of of 5862 1 2 27. Prelude represents that Pacific Fertility is one of “Our Clinics.”4 It represents that Pacific Fertility’s clients are “Our” clients.5 3 28. In its press release announcing the addition of Pacific Fertility to its network of fertility 4 clinics, Prelude described “egg freezing, in vitro fertilization (IVF), genetic screening of embryos, and 5 donor egg matching” as part of “Prelude’s comprehensive services.”6 6 7 29. Tank 4 at the time of the March 4, 2018, incident. 8 9 30. The employees responsible for performing daily monitoring and maintenance of the tanks, including Tank 4, are employees of Prelude. 10 2. 11 12 Prelude owns the laboratory, storage facility, and tanks at Pacific Fertility. It owned 31. Pacific Fertility Defendant Pacific Fertility Center is a private unincorporated entity located at 55 Francisco Street, Suite 500, San Francisco, California 94133. 13 32. Pacific Fertility was founded in 1999 and provides a full range of fertility services, 14 including egg cryopreservation, IVF, genetic testing, “cutting-edge laboratory techniques and 15 technology such as . . . vitrification,” and storage of cryopreserved eggs and embryos.7 16 17 33. cryopreserved and stored eggs and embryos, including those belonging to Plaintiffs.8 18 19 At all relevant times, Pacific Fertility’s on-site San Francisco laboratory has 34. At the time of the March 4, 2018, incident, Tank 4 was located at Pacific Fertility Center’s laboratory in San Francisco. 20 21 22 23 24 25 26 27 28 4 Options Preserved, Our Clinics, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). 5 Pacific Fertility Center: San Francisco, Prelude Fertility, https://www.preludefertility.com/clinic/pacificfertility-center (last visited May 18, 2018). 6 Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude Fertility, https://www.prnewswire.com/news-releases/prelude-fertility-expands-network-with-pacific-fertility-center-insan-francisco-300524534.html (last visited May 18, 2018). 7 Prelude Fertility Expands Network with Pacific Fertility Center in San Francisco, Prelude Fertility, https://www.preludefertility.com/press-release/prelude-fertility-expands-network-pacific-fertility-center-sanfrancisco (last visited May 20, 2018). 8 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited May 18, 2018). 5 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1014ofof5862 1 3. Chart 2 35. Defendant Chart Industries, Inc. is a Delaware corporation headquartered in Georgia.9 3 36. Founded in 1992, Chart is a publicly traded global manufacturer of equipment used in 4 the production, storage, and application of industrial gases. Chart produces a variety of cryogenic 5 equipment. On its website, Chart states that its “focus is cryogenics.”10 Chart claims that its products 6 “utilize our proprietary vacuum and insulation technologies, including storage equipment,” and that 7 “[o]ur industry-proven core-competency provides the highest insulation thermal performance in 8 cryogenics[.]”11 Chart touts itself as “a recognized global brand for the design and manufacture of 9 highly engineered cryogenic equipment” and a “leading global manufacturer of vacuum insulated 10 products and cryogenic systems.”12 11 37. In its annual report for 2017, Chart described itself as a “leading diversified global 12 manufacturer of highly engineered equipment, packaged solutions, and value-add services used 13 throughout the gas to liquid cycle in all industries that require gases as cryogenic liquids or alternative 14 equipment for gas generation, generally for the industrial gas, energy, and biomedical industries.”13 15 38. Through its MVE brand, Chart sells a line of cryogenic equipment that includes freezers 16 and metal storage tanks. Chart claims that its cryogenic products “are engineered for reliability and 17 durability”14 and that its MVE brand “is the benchmark for biological storage systems, used for the 18 cryogenic preservation of human . . . tissues.”15 19 20 21 22 23 24 25 26 27 28 9 Plaintiffs only recently discovered the identity of the manufacturer—Defendant Chart—of the cryostorage tank in which Plaintiffs’ and class members’ eggs and embryos were stored at Pacific Fertility. Chart is being served concurrently with the filing of this Consolidated Amended Complaint. 10 About Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May 20, 2018). 11 Cryogenics, Chart Industries, http://www.chartindustries.com/Industry/Markets-Served/Cryogenics (last visited May 20, 2018). 12 MVE Cryopreservation for Life Science, Chart Industries, http://files.chartindustries.com/Cryopres%20Catalog%20ML-CRYO0009%20K%203b.pdf (last visited May 20, 2018). 13 SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934.pdf (last visited May 20, 2018). 14 Life Sciences, Chart Industries, http://www.chartindustries.com/Life-Sciences (last visited May 20, 2018). 15 About Chart, Chart Industries, http://www.chartindustries.com/About-Chart (last visited May 20, 2018). 6 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1115ofof5862 1 39. Chart’s BioMedical segment accounted for around 20% of its total sales. Its 2 “cryobiological storage products include vacuum insulated containment vessels for the storage of 3 biological materials.”16 Chart describes the competition for cryobiological storage products as 4 “significant” and notes that “competition in this field is focused on design, reliability, and price.”17 5 6 40. were stored on the date of the subject incident. 7 8 FACTUAL ALLEGATIONS I. Plaintiffs Entrusted Prelude and Pacific Fertility with Keeping their Eggs and Embryos Safe and Secure. 9 41. 10 11 Defendants Prelude and Pacific Fertility have partnered to offer cryopreservation and storage of eggs and embryos, among other fertility services. 42. 12 13 Chart designed and manufactured the storage tank in which Plaintiffs’ eggs and embryos Prelude claims that it is “on a mission” to provide “the best options, science, and care so everyone can have the opportunity to be a mom or dad when they are ready.”18 14 43. Pacific Fertility states that it has one goal: to help clients build a healthy family.19 15 A. Defendants market their cryopreservation services as an insurance policy that unwinds the biological clock, preserving the opportunity to have children when the time is right. 44. Human eggs, also known as oocytes, are a limited resource. According to Pacific 16 17 18 Fertility, a woman has about 600,000 eggs at birth, and this supply diminishes at the rate of about 1,000 19 per month, beginning at her birth.20 This decline is part of the natural aging process and is commonly 20 referred to as a woman’s biological clock. The loss of oocytes from the ovaries is relentless and 21 22 23 24 25 26 27 28 16 SEC Form 10-K, Chart Industries, http://ir.chartindustries.com/Cache/392303934.pdf (last visited May 20, 2018). 17 Id. 18 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 18, 2018). 19 Pacific Fertility Center, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertilitycenter (last visited May 28, 2018). 20 Egg Freezing in Northern California, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/fertility-preservation-egg-freezing (last visited May 27, 2018). 7 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1216ofof5862 1 continues even in the absence of menstrual cycles, and even when women are pregnant, nursing, or 2 taking oral contraceptives. In addition, as Pacific Fertility acknowledges, egg quality diminishes with 3 time, with miscarriages and chromosomal abnormalities occurring more frequently the older a woman 4 is at the time of pregnancy. By their early-to-mid 40s, women typically can no longer conceive a child 5 naturally.21 6 45. The purpose of egg cryopreservation is to allow women and their reproductive partners 7 to preserve eggs so that they may be fertilized and implanted at a later time. Both Pacific Fertility 8 Center and Prelude emphasize that their cryopreservation and storage services allow for flexibility in 9 their clients’ family planning, freeing women, for example, to wait for the right person and to focus on 10 their careers during their most fertile years. 11 46. Prelude advertises its cryopreservation and storage services as providing women with 12 “peace of mind” and more control over their childbearing choices.22 In marketing its cryopreservation 13 and storage services, Prelude specifically appeals to women’s declining fertility and limited eggs: “Age 14 Matters . . . We’re born with all the eggs we’ll ever have—and their quantity and quality decrease as we 15 age. If you think you might want a baby someday, but aren’t ready right now, freezing your eggs keeps 16 your options open.”23 Prelude likewise states that young women cryopreserve eggs “to have the 17 option—an insurance policy that unwinds the biological clock and lets women pursue career 18 advancement as freely as men without having to compromise in their choice of partner.”24 19 20 47. In large type, Prelude states on its website, “Options Preserved,” and proceeds to advertise multiple benefits from cryopreservation and storage: 21 22 23 24 25 26 27 28 21 Id. 22 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 23 Options Preserved, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). 24 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 8 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1317ofof5862 Find that right person. Focus on your career. Finish your education. The age of your eggs (not you) is the number one cause of infertility. Freeze your eggs to preserve your option to build a family when you’re ready.25 1 2 3 Prelude goes on to describe the storage process as hassle free: “Set it and forget it until you’re ready.”26 4 48. Pacific Fertility offers egg cryopreservation services as a means of preserving “a 5 precious resource, limited to just a few years of your life[,]” and states that cryopreserving eggs and 6 embryos “can increase your chances of conception by 5 to 10 times.”27 7 49. 8 6 Reasons to Preserve Your Fertility Today! (1) For a future family . . . (2) To allow for educational pursuits . . . (3) To have time to develop a business or career . . . (4) To give your relationship time to mature . . . (5) To reduce the risk of medical treatments that might impact fertility . . . (6) To achieve control over your future.28 9 10 11 12 13 14 15 B. Defendants market their cryopreservation and storage services to people struggling with infertility. 50. Defendants also promote their egg and embryo cryopreservation and storage services to people diagnosed with infertility. 51. 16 17 Pacific Fertility touts similar benefits from its fertility preservation services: Infertility is defined as the inability to conceive after one year of unprotected intercourse if a woman is under the age of 35, or after six months if a woman is 35 or older. 18 52. Pacific Fertility states that it sees infertility as a “workable challenge.” 29 19 53. Similarly, Prelude states: “we’re here to help you become a parent. We’ll use all of 20 our training, science, technology, lab skills, and most importantly, human-kindness skills, to fully 21 support you through every step of the process.”30 22 25 23 26 24 27 25 28 26 27 28 Options Preserved, Prelude Fertility, https://www.preludefertility.com/freeze-eggs (last visited May 18, 2018). Id. Should I freeze my eggs?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/my-eggs (last visited May 18, 2018). 6 Reasons to Preserve Your Fertility Today!, Pacific Fertility Center (June 30, 2017), https://www.pacificfertilitycenter.com/fertility-preservation/blog/6-reasons-to-preserve-your-fertility-today. 29 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 30 Let’s Make a Baby, Prelude Fertility, https://www.preludefertility.com/ivf (last visited May 27, 2018). 9 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1418ofof5862 1 54. For many individuals and couples experiencing infertility, Defendants’ embryo 2 cryopreservation services represented their best and only hope of having a biological child or of 3 having children who are biological siblings. 4 5 6 7 C. Defendants promised to keep Plaintiffs’ eggs and embryos safe in a state-of-theart facility. 55. Defendants emphasize that eggs and embryos will be safely stored, indefinitely, for future family planning. 56. 8 Prelude’s marketing messages recognize the importance of proper egg storage for those 9 who use its services. A Prelude spokesperson, Allison Johnson, said: “If you know that your eggs are 10 safe and sound, what decisions would you make about your life? . . . Go pursue that graduate degree. 11 Wait for your soul mate. Go travel the world. Your eggs are waiting for you. For me that’s as 12 liberating for women as the pill was in the 60s.”31 57. 13 14 that “there is no limit to how long cells remain viable in the frozen state.”33 58. 15 16 Pacific Fertility states that its clients’ “[e]ggs remain frozen until you need them”32 and Regarding embryos, Pacific Fertility similarly reassures its clients that some “have come back after 10-15 years and the embryos have been thawed successfully and created healthy babies.”34 59. 17 Pacific Fertility claims that its laboratory is state of the art, meeting a “gold standard,”35 18 and that it has a large and experienced laboratory staff dedicated to the “care and well being of eggs, 19 embryos and sperm.”36 20 21 22 23 24 25 26 27 28 31 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 32 What is the process?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertility-preservation/myeggs#treatment (last visited May 18, 2018). 33 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited May 18, 2018). 34 Id. 35 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 36 IVF Laboratory Team, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertility-specialists/ivflaboratory-team (last visited May 20, 2018). 10 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1519ofof5862 1 60. Since the advent of cryopreservation, the main techniques to cryopreserve eggs and 2 embryos have been slow freezing and vitrification. With slow freezing—first used in 1986—it takes 3 about two hours for eggs to reach final storing temperature. Starting in the mid-2000s, eggs and 4 embryos began to be preserved through a rapid cryopreservation process called vitrification. 61. 5 Vitrification is a more advanced and reliable technology that Pacific Fertility describes 6 as being “used in the embryo and egg freezing process so that they can be stored for later use.”37 7 Pacific Fertility states the newer vitrification process is safer than earlier slow-freezing technologies, 8 which could lead to crystallization threatening the viability of cryopreserved tissue. “Avoiding ice 9 formation in this way,” Pacific Fertility represents, “successfully protects the embryos from damage 10 and allows them to be warmed later giving survival rates consistently above 90%.”38 11 62. Pacific Fertility further states that all eggs and embryos would be stored in vacuum-lined 12 liquid nitrogen tanks—“like a large thermos flask”—that “are computer controlled and monitored 7 13 days a week with a dedicated alarm system.”39 14 63. Pacific Fertility claims that liquid nitrogen “is very stable and easy to work with” and 15 that each tank is equipped with numerous sensors to monitor temperature increases above ‒196°C or a 16 drop in the level of liquid nitrogen.40 Pacific Fertility also claims that the sensors “are connected to a 17 telephone alarm system that will alert staff to an alarm condition outside of normal working hours. . . . 18 The alarm system is tested weekly and continues to run on battery power in the event of a power 19 failure. The alarm system can also be checked remotely.” When a tank alarm goes off, the on-call 20 embryologist is supposed to arrive within 30 minutes regardless of time of day and must conduct a 21 physical inspection of the tank before the alarm can be turned off.41 22 23 24 25 26 27 37 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 38 Sperm and Embryo Freezing, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/sperm-and-embryo-freezing (last visited Mar. 23, 2018). 40 41 28 Id. 39 Id. Id 11 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1620ofof5862 1 64. Pacific Fertility further claims that, in addition to being constantly monitored, each tank 2 “gets a physical inspection daily, looking for problems or signs of problems,” and that the amount of 3 nitrogen in the tank “is assessed as a means of monitoring for a possible slow leak or an impending 4 tank failure.”42 5 65. Each tank is also supposed to receive a daily refill of nitrogen because the nitrogen in 6 the tanks continuously evaporates at a slow rate.43 It is standard in the egg and embryo storage industry 7 for facilities to equip their tanks with autofilling mechanisms to refill the liquid nitrogen when the 8 system detects that levels are low. 9 10 66. Pacific Fertility advertises the durability of its tanks and storage facility on its website, stating: 11 The storage tanks require no power and would not be impacted by a power failure or blackout. They are made of metal and would probably survive a small or moderate fire. If the tanks were not physically damaged or knocked over in a disaster, they should survive intact. Even if no one was able to physically check the tanks, or if we were unable to obtain liquid nitrogen, the tanks should still maintain their temperature for several days.44 12 13 14 15 67. 16 17 18 Pacific Fertility represents that its egg and embryo cryopreservation and freezing services are highly successful, with egg survival rates of 83%45 and embryos survival rates consistently above 90%.46 68. 19 Prelude also touts “greater than 90%” egg and embryo survival rates.47 20 21 22 23 24 25 26 27 28 42 43 44 Id. Id Lab FAQs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/lab-faq (May 20, 2018). 45 What are your success rates?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/my-eggs#success (last visited May 20, 2018). 46 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 47 Have Questions?, What are the chances of pregnancy with frozen embryos?, Prelude Fertility, https://www.preludefertility.com/faq (last visited May 27, 2018). 12 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1721ofof5862 1 II. 2 Precision and Care Are Required in the Cryopreservation and Storage of Eggs and Embryos. 3 A. The process of retrieving and storing eggs and embryos is demanding, time consuming, and expensive. 69. People who use Defendants’ cryopreservation services typically make an enormous 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 emotional investment. They endure painful and invasive procedures, financial stress, and the strain the process puts on their mental health and relationships with others, all in the hopes that one day they will be able to have a child. 70. Women take drug and hormone cocktails and injections over several weeks to stabilize the uterine lining, stimulate ovaries into producing follicles, and stop these ovary follicles from releasing eggs. Then, after an ovulation trigger injection, eggs are collected under sedation or a general anesthetic. A woman may be subjected to multiple painful injections each day, resulting in bruising, swelling, and overall discomfort. The drug and hormone therapy may also trigger other side effects, such as tiredness, nausea, headaches, and blood clots, as well as negative emotions. Many women also undergo acupuncture sessions, recommended by Pacific Fertility, to improve IVF outcomes. The process can limit travel and other activities, and often requires time off from work. The harvesting procedure itself can be painful and hard to endure, requiring insertion of a thick needle through the vaginal wall to drain the ovary follicles of their fluid. After the procedure, a woman often experiences residual pain for about a week and may need bed rest for several days. Some women suffer significant side effects, such as ovarian hyperstimulation syndrome, requiring hospitalization. 71. Undergoing egg retrieval is “emotionally trying” as well as physically demanding.48 Pacific Fertility acknowledges that feelings of anxiousness, depression, isolation, and helplessness are common among clients undergoing IVF services, and that strained and stressful relations with spouses, partners, and other loved ones are also common. IVF typically causes those undergoing treatment to 25 26 27 28 48 Patient Support, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/patient-support (last visited May 27, 2018). 13 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1822ofof5862 1 rely heavily on friends and significant others for support, including, for example, with coping with 2 stress and providing rides to and from appointments.49 3 4 72. According to Pacific Fertility’s website, “the time and energy that is needed, both physically and emotionally can drain even the staunchest crusader.”50 5 73. According to one research study, half of women seeking IVF services described 6 infertility as the most upsetting experience of their lives.51 Other studies show that infertility causes 7 anguish similar to that accompanying a cancer diagnosis or the loss of a loved one.52 Infertility is 8 associated with anger, depression, anxiety, marital problems, and loss of self-esteem among prospective 9 parents experiencing infertility.53 Pacific Fertility warns clients that they may experience intense anger, 10 despair, and guilt, and that it is “is very common to experience symptoms of anxiety and depression as 11 a result of this experience.”54 12 74. The cryopreservation process compounds these emotions and stresses. For many, this 13 process represents their last hope for having children. Each cycle can produce anxiety and fear that 14 there won’t be enough eggs retrieved, or that the eggs retrieved won’t be of a high enough quality. 15 Multiple cycles are often required. Many women experience and express strong feelings of anxiety, 16 failure, hopelessness, and disappointment during this process. 17 18 75. Prelude acknowledges its clients’ vulnerability during the cryopreservation process and trains its staff on how to empathize with clients: 19 20 49 21 50 22 51 23 52 24 25 26 27 28 Resources at Your Fingertips, Pacific Fertility Center (Nov. 22, 2004), https://www.pacificfertilitycenter.com/blog/fertility-resources-your-fingertips. Id. The psychological impact of infertility and its treatment, Harvard Medical School (May 2009), https://www.health.harvard.edu/newsletter_article/The-psychological-impact-of-infertility-and-its-treatment. A.D. Domar et al., The psychological impact of infertility: a comparison with patients with other medical conditions, Journal of Psychosomatic Obstetrics & Gynecology (1993), https://www.massgeneral.org/bhi/assets/pdfs/publications/Domar%201993%20J%20Psychosom%20Obstet%20 Gynaecol.pdf; C. A. Bryson, Post IVF syndrome? Psychological implications of failed IVF, The Obstetrician & Gynaecologist (2002), https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201. 53 P.K. Dekar et al., Psychological aspects of infertility, British Journal of Medical Practitioners (2010), http://www.bjmp.org/content/psychological-aspects-infertility. 54 Coping Strategies, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/copingstrategies (last visited May 20, 2018). 14 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page1923ofof5862 1 Fertility is such an incredibly personal and vulnerable subject. The World Health Organization has designated infertility as the ‘third biggest global epidemic,’ and yet as a society, we hardly even talk about it . . . until it gets personal. As more people delay childbirth past their peak fertility years to pursue careers, advanced degrees, or the right life partner, the chances of having a baby the old fashioned way start to decline.55 2 3 4 5 * * * 6 As women, mothers, sisters, and daughters we make it a priority to educate and support all of our staff on how it feels to go through these journeys and how much it means.56 7 8 76. 9 10 said. She further noted that a number of Prelude’s own employees have been touched by infertility.57 77. 11 12 “Emotional health” and “well being” are central to Pacific Fertility’s stated mission: We are dedicated to a whole patient approach. We recognize that fertility treatment may impact all corners of our patient’s lives, including work, personal relationships and financial concerns. When designing their treatment course, our physicians, nurses and counselors work with them to accommodate all of these considerations. 13 14 15 Our support is integrated. Emotional health and well being are central to our patient’s care. Our clinic’s services include acupuncture and an array of Mind/Body and stress reduction workshops, seminars and support groups. Our in-house family therapist is available to any patient and will also gladly provide referrals to other qualified professionals.58 16 17 18 19 20 “The emotional part is driving what we are trying to do,” Prelude’s chief revenue officer 78. Pacific Fertility recognizes the need to address clients’ “emotional and even spiritual needs” during the “emotional ups and downs” of infertility: 21 At PFC, we know that the physical demands and emotional ups and downs of 22 23 24 25 26 27 28 55 A Modern Approach to Family, Prelude Fertility, https://www.preludefertility.com/about (last visited May 20, 2018). 56 Id. 57 Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock, Forbes (Oct. 17, 2016), https://www.forbes.com/sites/miguelhelft/2016/10/17/prelude-fertility-200-million-startup-stopbiological-clock/#d05688c7260f. 58 Fertility Treatment and Care, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatmentcare/fertility-treatment-and-care (last visited May 27, 2018). 15 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2024ofof5862 infertility experience can impact life at home, at work and with family. This is a path that one likely did not anticipate and, while there is much reason for hope, the treatment process can also be emotionally trying. The well being of our patients is a crucial aspect of fertility treatment, and we encourage our patients to take advantage of the many resources we have developed to address the emotional and even spiritual needs they may have as a part of their journey. 1 2 3 4 5 PFC’s extensive support system includes a devoted patient care team, experienced clinical coordinators and educators and an in-house marriage and family therapist who has long specialized in fertility and third party parenting issues.59 6 7 8 9 10 79. Acknowledging the stress and challenges those contending with infertility face, Pacific Fertility promises its clients that it will be “by their side every step of the way”: A diagnosis of infertility can feel overwhelming and stressful for individuals and couples who always assumed that pregnancy would come easily. At Pacific Fertility Center, we see infertility as a workable challenge. . . . 11 12 13 We feel strongly that the physical well being is tied to emotional well being, and we take into account all of the challenges[,] . . . [including d]iagnosis, treatment and the inevitable ‘waiting game’ as well as financial stress . . . . We are by their side every step of the way to help address each and all of these needs.60 14 15 16 17 80. Pacific Fertility and Prelude’s services are costly. Clients pay more than $8,000 for a 18 single cycle of egg cryopreservation, which includes clinical monitoring, egg retrieval, 19 cryopreservation, and one year of egg storage. Additional cycles cost $6,995 each. Pacific Fertility 20 recommends storing more eggs than a woman typically produces in a single cycle.61 It is not 21 uncommon for women to undergo three or more egg cryopreservation cycles. 22 23 24 25 26 27 28 59 Patient Support, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/patient-support (last visited May 27, 2018). 60 Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/infertility-center (last visited May 20, 2018). 61 How many eggs do I need to freeze?, Pacific Fertility Center, https://www.pacificfertilitycenter.com/fertilitypreservation/ask-us#how-many (last visited May 21, 2018); How Many Eggs Should I Freeze?, Southern California Reproductive Center, https://blog.scrcivf.com/how-many-eggs-should-i-freeze (last visited May 21, 2018). 16 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2125ofof5862 1 81. The costs incurred to cryopreserve embryos are even higher. Pacific Fertility charges 2 $11,595 for basic IVF, including clinical monitoring, egg retrieval, lab processing, and embryo 3 transfer.62 If a client chooses to use Comprehensive Chromosome Screening to select the healthiest 4 embryo to transfer, Pacific Fertility’s basic IVF costs rise to $16,085.63 5 82. The above amounts do not include the costs of in-person consultations ($375), pre-cycle 6 lab work, egg cryopreservation medications ($2,000‒6,000), embryo transferring ($2,845‒4,460), 7 embryo transfer medications ($300‒600), and continuing charges for egg and embryo storage ($600 per 8 year).64 Clients typically also pay thousands of dollars for fertility drugs leading up to egg retrieval, 9 and often spend hundreds of dollars on acupuncture and other recommended services to improve 10 outcomes. The entire process often costs many tens of thousands of dollars. 11 83. Most insurance plans do not cover egg cryopreservation and other fertility services.65 A 12 2017 study by Mercer found that only 26% of companies with over 500 employees cover IVF.66 As a 13 result, people seeking fertility services have taken out home equity loans, borrowed from their 401(k) 14 accounts, tapped their lines of credit, and moved in with their parents.67 15 84. In part because of these challenging processes, costs, and experiences, many clients 16 form strong emotional attachments to their eggs and embryos. It is not unusual for women and their 17 reproductive partners to think about their eggs or embryos every day. 18 19 20 21 22 23 24 25 26 27 28 62 In-Vitro Fertilization (IVF) Costs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/financingfees/vitro-fertilization-ivf-costs (last visited May 21, 2018). 63 64 Id. Id. 65 Fertility treatments are becoming a financial and physical risk for many Americans, CNBC (Nov. 20, 2017), https://www.cnbc.com/2017/11/17/most-patients-getting-ivf-arent-covered-by-insurance.html; M. Inhorn et al., Medical egg freezing: How cost and lack of insurance cover impact women and their families, Reproductive Biomedicine & Society Online (Jan. 21, 2018), https://www.sciencedirect.com/science/article/pii/S2405661818300017. 66 Fertility treatments are becoming a financial and physical risk for many Americans, CNBC (Nov. 20, 2017), https://www.cnbc.com/2017/11/17/most-patients-getting-ivf-arent-covered-by-insurance.html. 67 Id.; Infertility Treatment Grants and Scholarships, RESOLVE, https://resolve.org/what-are-myoptions/making-infertility-affordable/infertility-treatment-grants-scholarships/ (last visited May 21, 2018). 17 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2226ofof5862 1 B. The loss of eggs and embryos results in emotional trauma. 2 85. Prelude and Pacific Fertility are well aware of the lengths to which people go to obtain 3 eggs and embryos, how much these eggs and embryos mean to their clients, the clients’ emotional 4 investment in the survival of the eggs and embryos, and the clients’ expectations that great care will be 5 taken to preserve and protect the eggs and embryos to avoid irreparable, devastating harm. 6 86. Eggs and embryos are precious. They offer the opportunity to fulfill one of the most 7 fundamental human urges: to become a parent and create one’s own family when the time is right. 8 Even for those who have already met their family planning goals, their remaining eggs and embryos 9 retain emotional value. Many opt to continue storing their eggs and embryos for years after they have 10 successfully had children. Some hold funeral ceremonies for embryos.68 Others who no longer plan to 11 use their eggs and embryos hope to donate them to a family member or other couple struggling with 12 infertility, or toward beneficial research. 13 87. Eggs and embryos are irreplaceable. As women age, their egg quantity and quality 14 diminish. The most determinative factor in IVF success is the woman’s age at the time her eggs were 15 extracted. At some point, usually around her mid-40s, a woman can no longer produce viable eggs. 16 Even if additional eggs can be retrieved, one cannot replace 35-year-old eggs with 42-year-old eggs and 17 expect the same result. When eggs and embryos are damaged or compromised, it may be impossible 18 for clients to have their own biological children. There is no possibility of creating substitute embryos 19 for cancer survivors or those whose spouses have died. Likewise, those who used donor eggs or sperm 20 to create embryos may find it impossible to retrieve additional material from the same donors. Thus, 21 donor-users who already have children may be prevented from having additional children who are 22 biologically related to their siblings. 88. 23 24 At the time of their freezing, most of the eggs and embryos that Pacific Fertility stored were viable rather than being compromised or incapable of successful fertilization or implantation. 25 26 27 28 68 J. Fraga, After IVF, Some Struggle With What To Do With Leftover Embryos, NPR (Aug. 20, 2016), https://www.npr.org/sections/health-shots/2016/08/20/489232868/after-ivf-some-struggle-with-what-to-do-withleftover-embryos. 18 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2327ofof5862 1 Most of the embryos that Pacific Fertility stored had been tested and found free of chromosomal 2 abnormalities. 3 89. The success or failure of egg and embryo cryopreservation and storage services has 4 emotional and psychological ramifications for those seeking to become parents. Losing an egg or 5 embryo provokes the fear that having a child is no longer possible, causing feelings of devastation and 6 despair. Many experience grief and anguish when fertility treatment does not result in pregnancy or 7 when they lose fertility choices.69 Pacific Fertility’s website itself provides coping strategies and 8 techniques for reducing stress.70 9 C. Successful cryopreservation depends on strict adherence to protocols. 10 90. Eggs and embryos are fragile. It is critical that they be handled and stored 11 carefully. Cooling, warming, and the removal of cryoprotectants must follow precise, controlled 12 protocols. Failure to adhere to these protocols can kill the egg or embryo, impair implantation and 13 viability, and introduce chromosomal abnormalities. 14 91. Egg and embryo cryopreservation entails preserving the reproductive material at subzero 15 temperatures. A key goal of cryopreservation is to reduce cell damage caused by the formation of ice 16 crystals and the expansion of water as cryopreserved material cools to subzero temperatures. 17 According to Pacific Fertility, “[t]he key to successful egg freezing is determining a technique that will 18 not damage the fragile chromosomes of the egg”; this is because “the chromosomes of the egg are 19 vulnerable to damage, including damage from the exertion of the freezing and thawing process.”71 20 92. As noted above, two primary cryopreservation technologies have emerged. Both rely 21 upon cryoprotectants, which are solutions added to the cells that reduce cell damage by displacing 22 water in a manner similar to antifreeze. The first technology, slow freezing (also known as slow 23 programmable freezing), utilizes specialized laboratory equipment that lowers the temperature of 24 25 26 27 28 69 C. A. Bryson, Post IVF syndrome? Psychological implications of failed IVF, The Obstetrician & Gynaecologist (2002), https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1576/toag.2002.4.4.201. 70 When to See a Therapist, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/whento-see-a-therapist (last viewed May 20, 2018). 71 New Clinical Study: New Technique for Egg Freezing, Pacific Fertility Center (Feb. 25, 2006), https://www.pacificfertilitycenter.com/blog/new-clinical-study-new-technique-egg-freezing. 19 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2428ofof5862 1 embryos conditioned with cryoprotectants in a slow, controlled manner to ‒190°C. The second and 2 newer technology, vitrification, refers to any process resulting in “glass formation”—that is, the 3 transformation from a liquid to a hardened liquid with minimal crystallization (ice crystals). According 4 to Pacific Fertility, vitrification “cools the cells in the embryo at rates close to 5,000 degrees per 5 minute[,]” and “embryos that are vitrified are exposed to 5-10 times more cryoprotectant than slow 6 frozen embryos.”72 The ultra-rapid nature of this process minimizes (1) the formation of ice crystals 7 and (2) toxicity damage to the cells that cryoprotectants can cause during longer exposure to warmer 8 temperatures. 93. 9 The process of warming eggs and embryos that have been preserved through 10 cryopreservation is also precise and dependent on specialized techniques and chemical 11 solutions. Pacific Fertility states that “embryos coming out of the freezer (at –196°C) are warmed to 12 room temperature in a maximum of three seconds. This rapid warming method minimizes damage to 13 the embryo from ice crystals that can form during warming.”73 A key part of the warming procedure is 14 the careful dilution and eventual replacement of the toxic cryoprotectant fluid with a solvent compatible 15 with cytoplasmic fluid. Pacific Fertility states that it “incubat[es] the embryo in decreasing 16 concentrations of the antifreeze, and increasing concentrations of water. Over a period of 15 minutes, 17 the embryo is stepped through 3 different solutions, until finally the antifreeze is gone and all the water 18 has been replaced.”74 19 94. For slow-frozen tissue, the failure to thaw slowly can result in cells over-expanding, 20 rupturing, and dying. For vitrification, it is important to warm quickly to avoid ice formation. Thus, it 21 is critical that tissue cryopreserved through slow freezing be thawed slowly, and that tissue 22 cryopreserved through vitrification be warmed quickly.75 An uncontrolled rise in temperature, like the 23 one at issue here, can have catastrophic consequences for eggs and embryos. 24 25 26 27 28 72 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 73 74 Lab FAQs, Pacific Fertility Center, https://www.pacificfertilitycenter.com/the-center/lab-faq (May 20, 2018). Id. 75 Vitrification, Oocyte and Embryo Vitrification, Pacific Fertility Center, https://www.pacificfertilitycenter.com/treatment-care/vitrification (May 18, 2018). 20 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2529ofof5862 1 III. 2 Defendants Caused Irreparable Harm to Plaintiffs by Failing to Protect Their Eggs and Embryos. 3 95. On March 4, 2018, Pacific Fertility discovered a loss of a substantial amount of liquid 4 nitrogen in one of its cryogenic storage tanks, Tank 4, manufactured by Chart. This incident affected 5 thousands of cryopreserved eggs and embryos and more than 400 individuals and families. 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A. Prelude and Pacific Fertility should have had systems and processes in place to ensure that Plaintiffs’ eggs and embryos were not damaged. 96. Liquid nitrogen in cryopreservation tanks evaporates at a slow rate. Absent extreme circumstances, even when a leak occurs it should take days for a tank to warm enough to cause damage to the enclosed eggs and embryos. 97. Egg and embryo storage facilities have developed and implemented a variety of systems and processes to protect against liquid nitrogen levels dropping to levels low enough to endanger clients’ eggs and embryos. These systems and processes include daily tank inspections, multiple alarm systems that detect and send alerts regarding low liquid nitrogen levels, and autofillers that detect and automatically replenish low liquid nitrogen levels. 98. Pacific Fertility promised its clients that its laboratory was state of the art, including that its tanks were equipped with around-the-clock monitoring, alarm systems, and response protocols as well as daily walk-throughs. But no alarms or phone alerts notified Pacific Fertility or Prelude of the March 4 malfunction. Instead, an embryologist discovered the problem during a routine walk-through. Staff then had to manually replenish liquid nitrogen levels in the tank. 99. Pacific Fertility and Prelude have not explained why they did not detect the problem during prior walk-throughs or why they did not have a functional autofilling mechanism to replenish the low liquid nitrogen levels. Pacific Fertility and Prelude also lacked monitoring, alarm, and response systems and processes sufficient to detect and prevent harm from a dangerous temperature rise in Tank 4. Pacific Fertility and Prelude further failed to mitigate risk by failing to implement a policy and practice of storing multiple eggs and embryos belonging to a given client in separate vials and tanks. 100. Wired interviewed one laboratory director who noted preventive measures Pacific Fertility and Prelude should have taken: 21 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2630ofof5862 “It’s really quite sad the samples weren’t split up,” says Nahid Turan, who directs laboratory operations at the Coriell Institute for Medical Research, one of the oldest and largest biobanks in the US. “They were literally putting all the eggs in one basket.” In addition to having samples in multiple tanks at their New Jersey facility, Coriell also has back-up sites in multiple locations around the country. And its software engineers built real-time monitoring systems to flag any tanks trending in a troubling direction before they fail.76 1 2 3 4 5 6 7 8 9 10 11 101. stored in the same tank as Plaintiffs’. Tank 4 housed up to 15% of Pacific Fertility’s total cryopreserved tissue, consisting of thousands of eggs and embryos. 102. 14 15 16 17 18 19 incident for not mitigating the risk by spreading their eggs and embryos across multiple tanks. 24 25 26 27 28 Chart recalled cryostorage tanks for vacuum seal defects after the Tank 4 incident. 103. On April 23, 2018, Chart, the manufacturer of Tank 4, recalled certain cryostorage LEAK AND/OR FAILURE which may be due to inadequate adhesion of the composite neck to the aluminum unit” (emphasis in original). Chart added that the “issue appears to be an isolated occurrence involving the machine and binding agent used during the manufacturing process.” 104. Chart announced the recall four days after Pacific Fertility revealed the conclusion of “independent experts” that the March 4 incident “likely involved a failure of the tank’s vacuum seal.” 21 23 B. tanks, stating in its recall notice: “Chart is presently investigating the possible cause of the VACUUM 20 22 Most people with eggs and embryos stored in Tank 4 had all of their eggs and embryos stored in that single tank. Pacific Fertility has expressed regret to clients affected by the March 4 12 13 Cryopreserved eggs and embryos belonging to many hundreds of other people were C. Multiple investigations were opened after the Tank 4 incident. 105. Various government entities and trade groups have responded to the March 4, 2018, incident. The College of American Pathologists (CAP) opened and is conducting a formal investigation into the incident, as is the State of California. The American Society for Reproductive Medicine also is studying the incident and intends to make recommendations to its members based on its findings.77 76 M. Molteni, What Keeps Egg-Freezing Operations From Failing?, Wired (Mar. 13, 2018), https://www.wired.com/story/what-keeps-egg-freezing-operations-from-failing/. 77 A. E. Cha, FAQ: Are my frozen embryos safe? Everything you need to know about the freezer malfunctions, The Washington Post (Mar. 14, 2018), https://www.washingtonpost.com/news/to-your- 22 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2731ofof5862 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 D. Defendants’ failure to keep Plaintiffs’ eggs and embryos safe and secure has caused irreparable harm. 106. As a result of Defendants’ conduct, Plaintiffs have suffered emotional trauma, including anxiety, hopelessness, fear, depression, devastation, and grief. Plaintiffs lost the very peace of mind they sought when availing themselves of Pacific Fertility’s services, and the time, energy, and cost associated with storing their eggs and embryos have been lost as well. 107. Pacific Fertility asserts that the embryos in Tank 4 must be fully thawed to determine whether they remain viable after the incident. But, because of the risks associated with re-freezing embryos, a family must be prepared before thawing to transfer the affected embryo into a woman’s uterus and attempt a pregnancy if the embryo is deemed viable. Pacific Fertility also asserts that the eggs in Tank 4 must be fully thawed and fertilized to determine whether they remain viable after the incident. 108. Pacific Fertility has agreed in some instances to thaw eggs or embryos from Tank 4, check their viability, and then refreeze the eggs or embryos. In those instances, however, Pacific Fertility has made clear that the added cycle of thawing and refreezing—resulting from its own mishandling of the eggs and embryos—creates further risks to their ultimate viability. Although this procedure would not be needed absent Defendants’ failures, Pacific Fertility requires clients to sign forms purporting to waive their legal rights merely to check the viability of their tissue. 109. Some of Defendants’ affected clients have decided to thaw tissue in Tank 4, and this process confirmed that their eggs or embryos are no longer viable. Many families and individuals have lost their best or only chance of having a child. They have suffered despair, depression, and heartbreak. Those who can undergo additional retrievals face a greater risk that those eggs or embryos will not lead to a successful pregnancy, as the age at which a woman’s eggs are retrieved is the dominant factor for rates of success or failure. 25 26 27 28 health/wp/2018/03/14/faq-are-my-frozen-embryos-safe-everything-you-need-to-know-given-two-fertilityclinics-recent-problems/?utm_term=.86e4c34f31f3. 23 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2832ofof5862 1 110. While Pacific Fertility has not shared the data it has collected regarding the number of 2 Tank 4 eggs and embryos that have been thawed and resulting outcomes, the survival rates for these 3 eggs and embryos is lower than it would have been had the incident not occurred. 4 111. Pacific Fertility has not provided a comprehensive analysis of the risks of attempting a 5 pregnancy with any of the tissue from Tank 4, including the risks that the drop in nitrogen levels may 6 have caused chromosomal or other defects that would not be detected from a thaw alone. 7 112. Nevertheless, Pacific Fertility has advised Plaintiffs A.B., C.D., and others with affected 8 eggs and embryos to attempt pregnancies with Tank 4 tissue. Before undergoing an embryo or egg 9 thaw, embryo transfer, or egg fertilization, Pacific Fertility requires clients to sign a consent statement 10 acknowledging that the risks are uncertain and waiving any liability on the part of Pacific Fertility 11 arising out of the thaw, transfer, or fertilization procedure. 12 113. As a result of the Tank 4 incident, Plaintiffs are being asked to make significant 13 reproductive decisions now—depriving them of the very freedom and flexibility they sought when 14 placing their eggs or embryos in Defendants’ care. Pacific Fertility has counseled affected clients to 15 thaw and immediately fertilize eggs, and to transfer embryos to a woman’s uterus, to determine 16 whether their tissue remains viable. Yet the purpose of cryopreservation was to allow these clients to 17 make reproductive choices on their own timelines. Many clients do not yet have a partner with whom 18 they wish to fertilize their eggs, or are not ready to move forward with a sperm donor, much less try to 19 get pregnant now or arrange for a surrogate. Others were busy with their lives when the incident 20 occurred—finishing graduate school, planning for international travel, or even preparing to welcome a 21 new baby—making it impossible or highly inconvenient to attempt a pregnancy now, especially one 22 fraught with more risk and potential heartache than normal. 23 114. People affected by the March 4 incident have described being thrust into a state of 24 limbo, as the “insurance policy” they paid for has vanished. To restore their future fertility options, 25 some are attempting additional retrieval cycles at an older age, with lower-quality eggs, and at 26 considerable cost, burden, and disruption to their lives, subjecting them to substantial physical and 27 emotional strain. These additional retrieval cycles also involve medical risks and potential 28 complications. Many class members completed these cycles only to learn they were incapable of 24 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page2933ofof5862 1 producing sufficient or any viable eggs or embryos. Other class members, for whom additional 2 retrievals are not possible or recommended, have been left to fear the worst—that they will be childless. 3 115. The National Infertility Association recognized the negative impact of the March 4 4 incident on women and families, stating that it was “shocked” to hear of this “unprecedented traged[y]” 5 for “the entire family building community. Our hearts break for each person impacted. We know first- 6 hand what someone goes through to have eggs or embryos to freeze, and to have this outcome is 7 devastating for everyone.”78 8 9 10 116. In response to a similar incident in Ohio, clinical psychologists advised that the loss of eggs and embryos should be acknowledged like any other death, and suggested grief counseling and organization of a memorial in response.79 11 117. In sum, those with eggs and embryos in Tank 4 are devastated, and have compared the 12 resulting feeling of powerlessness to that caused by a natural disaster. Many of those who had saved 13 eggs and embryos report having lost their only chance to have biologically related children. In some 14 cases, those affected have avoided telling family, knowing their loved ones would be “heartbroken” not 15 to have siblings or grandchildren.80 One couple, who had gone through the process after a cancer 16 diagnosis, described their emotions: 17 My heart just sank and I felt physically ill. I felt just sick to my stomach. The world of infertility is a very isolating world, it’s very lonely[,] it’s a complete loss of control. 18 19 * * * 20 21 22 23 24 25 26 27 28 78 Statement on Storage Tank Malfunction Impacting Hundreds of Patients, RESOLVE (Mar. 12, 2018), https://resolve.org/about-us/news-and-press-releases/statement-on-storage-tank-malfunction-at-universityhospitals-fertility-center-in-cleveland-oh/. 79 J. Washington, Experts recommend counseling & support for UH patients who lost eggs, embryos, The Plain Dealer (Mar. 21, 2018), http://www.cleveland.com/healthfit/index.ssf/2018/03/uh_patient_who_lost_eggs_embry.html. 80 D. Kapp, What It’s Like to Be a Victim of a ‘Fertility Disaster’, The Cut (Mar. 15, 2018), https://www.thecut.com/2018/03/pacific-fertility-center-clinic-disaster-cleveland-university-hospital.html; S. Steimle, Patients at Troubled San Francisco Fertility Clinic Mull Legal Action, CBS SF Bay Area (Mar. 14, 2018), http://sanfrancisco.cbslocal.com/2018/03/14/patients-san-francisco-fertility-clinic-mull-legal-action/. 25 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3034ofof5862 For some this is their last hope, I mean they physically, financially, mentally can’t put themselves through that again. I’ve gone from anger, I’ve gone through just feeling a sense of loss, grief, I think right now I’m angry to be honest.81 1 2 3 118. 4 5 6 7 their familiarity with the deeply emotional aspects of their services, Pacific Fertility and Prelude were aware of the devastating consequences for their clients that would result from a failure to keep their eggs and embryos safe and secure. 8 9 10 11 12 13 Given the sensitive nature of the eggs and embryos entrusted to their care, as well as E. Pacific Fertility and Prelude’s communications regarding the incident have compounded the harm. 119. Pacific Fertility first attempted to notify its clients of the March 4 incident a week after it occurred. 120. At approximately 4 a.m. Pacific time on March 11, 2018, Pacific Fertility sent its clients an email stating: Earlier this week, a single piece of equipment lost liquid nitrogen for a brief period of time. The remainder of the equipment and cryo-storage facility was not affected. As soon as the issue was discovered, our most senior embryologists took immediate action to secure all tissue in that single cryostorage tank. The tank was immediately retired, and the facility is operating securely. 14 15 16 17 18 We have hired independent experts and launched an in-depth investigation of the matter. We felt it was imperative to advise you that your tissue was stored in the affected tank and may have been impacted. Based on our preliminary analysis, the good news is that we do expect that some of the tissue from that tank remains viable. We are continuing to gather information but wanted to share these developments with you directly. 19 20 21 22 121. The email further stated, “[w]e are incredibly sorry that this happened and for the 23 anxiety that this will surely cause. We are heartbroken by this situation and our thoughts are with each 24 of you who may have been touched by this event.” 25 26 27 28 81 Mother felt “physically ill” after hearing embryos possibly destroyed at fertility center, CBS Evening News (Mar. 9, 2018), https://www.cbsnews.com/news/mother-felt-physically-ill-after-hearing-embryos-possiblydestroyed-at-fertility-center/. 26 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3135ofof5862 1 122. The email invited Plaintiffs and other families with eggs and embryos stored in Tank 4 2 to call to discuss the incident with their fertility specialists. But the call center has been overwhelmed, 3 and the information provided over the phone and in person has been vague and often inconsistent. 4 Different Pacific Fertility staff members have provided clients with conflicting information. 5 123. Pacific Fertility did not provide further written information until over a month later, on 6 April 19, 2018, when Pacific Fertility wrote to its clients with “several updates following the tank 7 failure that occurred in the embryology lab on March 4, 2018.” 8 9 10 124. Pacific Fertility stated that “independent experts have been investigating the incident” and preliminarily determined that it “likely involved a failure of the tank’s vacuum seal.” 125. Pacific Fertility also stated that it had implemented new protocols—“re-inspection of 11 onsite storage tanks, the purchase of several emergency tanks beyond our standard back-up tanks, and 12 an extra layer of redundancy in our warning systems”—to avoid future loss of eggs and embryos, steps 13 it should have taken before the incident. 14 126. Pacific Fertility initially told some clients definitively that their tissue was destroyed in 15 the incident. It told other clients it could not determine whether their tissue survived unless they 16 thawed and fertilized their eggs, or thawed and transferred their embryos. Pacific Fertility also refused 17 to tell many other people whether their tissue was even stored in Tank 4, instead stating simply that an 18 incident had occurred at its facility that may have impacted certain clients’ tissue. In post-incident 19 calls, Pacific Fertility stated that it assumed that many were not going to use the tissue stored in Tank 20 4—so clients “should just let it go.” Similarly, on March 11, 2018, a Pacific Fertility employee told 21 ABC News that a large number of families with eggs and embryos stored at the facility were “people 22 who won’t use them anyway.” Other clients with eggs and embryos in Tank 4 were billed for storage 23 fees after the incident occurred and before it was disclosed to them. 24 127. Pacific Fertility has offered some of its clients a free additional cycle for egg retrieval. 25 Pacific Fertility’s proposed remedy is inadequate. The mishandling of client eggs and embryos is 26 devastating and irreparable. Many can no longer undergo additional retrievals. Older women are 27 generally not able to produce as many eggs of as high a quality as when they were younger, and in 28 many cases go through the entire process only to learn they were unable to produce any viable eggs. 27 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3236ofof5862 1 Even where some eggs can be retrieved, women confront a greater risk that those eggs will not lead to a 2 successful transfer and pregnancy. Moreover, additional retrievals are time consuming, expensive, and 3 physically and emotionally exhausting and burdensome, and typically require time away from work. 4 Even two or three cycles may not fully replenish the number of viable eggs or embryos lost. 5 128. Pacific Fertility’s April 19, 2018, email blaming the tank failure on Chart left clients 6 with more questions than answers. Pacific Fertility did not say why the remedial steps mentioned in the 7 email, like adding redundancies, were not in place before the incident. Clients were not told why an 8 alarm did not alert Pacific Fertility staff, why a backup system (e.g., an autofill function or additional 9 generator) did not engage, or why the problem went undiscovered until someone walked through the 10 11 lab during a routine check. 129. Pacific Fertility states that tanks can go without power or liquid nitrogen for “several 12 days” without compromising the enclosed reproductive tissue. It is unclear why Pacific Fertility failed 13 to detect the problem with Tank 4 until it was too late. 14 130. Pacific Fertility’s April 19 email also raised false hopes, stating that Pacific Fertility 15 “can report several early pregnancies” from thawed and transferred embryos, and had “successfully 16 thawed a limited number of eggs[,] confirm[ing] that there is viable tissue from the tank.” Pacific 17 Fertility failed to mention that there is also unviable tissue from the tank. Pacific Fertility 18 indiscriminately notified all people with tissue in Tank 4 that their eggs and embryos might be “viable” 19 despite knowing this was not true for many of these people. 20 131. Clients who were devastated upon learning, in the days and weeks after Pacific 21 Fertility’s first mass email, that their tissue was not viable have been doubly devastated by the 22 insensitivity of Pacific Fertility’s second mass email. 23 132. Pacific Fertility executives and employees were well aware that the March 4 incident 24 would cause significant distress. Nevertheless, even though Pacific Fertility has a counselor on staff, it 25 offered no additional support services or counseling to those affected by the incident. 26 133. Pacific Fertility’s failure to offer compassionate support services and to communicate 27 clearly and consistently with victims of the incident has caused them further confusion, pain, and 28 distrust. 28 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3337ofof5862 1 PLAINTIFF-SPECIFIC ALLEGATIONS 2 Plaintiffs A.B. and C.D. 3 4 5 6 7 134. Plaintiffs A.B. and C.D. first contacted Pacific Fertility in or around January 2015 about the possibility of creating embryos and having their embryos frozen. 135. In January 2015, Plaintiffs A.B. and C.D. contracted with Pacific Fertility to create and have their embryos preserved for future use. 136. Plaintiffs A.B. and C.D. conducted extensive research concerning IVF and fertility 8 centers and chose Pacific Fertility based on the belief that it provided high-quality services that were 9 state of the art. Before having their embryos cryopreserved with Pacific Fertility, Plaintiffs A.B. and 10 C.D. saw representations about Pacific Fertility’s services on Pacific Fertility’s website, including 11 Pacific Fertility’s claims that it provided high-quality services. Plaintiffs A.B. and C.D. also had a 12 consultation session with Dr. Carl M. Herbert, who told them about Pacific Fertility’s care, 13 professionalism, and state-of-the-art facilities. 14 137. In early 2015, Plaintiffs A.B. and C.D. underwent procedures to prepare for embryo 15 creation and cryopreservation. Before the egg retrieval procedure in March 2015, Plaintiff A.B. 16 underwent a month of treatment and injections. Pacific Fertility ultimately retrieved approximately 21 17 of her eggs, which were then fertilized with Plaintiff C.D.’s sperm. After the fertility treatment ended, 18 the embryos Pacific Fertility created were cryopreserved for storage. At the time of the March 4, 2018, 19 incident, Plaintiffs A.B. and C.D. had eight viable cryopreserved embryos. 20 21 22 138. At all relevant times, Plaintiffs A.B. and C.D.’s embryos were under Pacific Fertility’s protection, custody, and control. 139. Defendants kept Plaintiffs A.B. and C.D.’s embryos within a metal storage tank—Tank 23 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of 24 tank failure by spreading Plaintiffs A.B. and C.D.’s embryos among several tanks, Defendants stored 25 all of Plaintiffs A.B. and C.D.’s embryos in the same tank. 26 140. Plaintiffs A.B. and C.D. have paid approximately $21,105.78 for the creation and 27 storage of their embryos. They experienced severe emotional distress when they learned of the March 28 4, 2018, incident and in the weeks that followed. 29 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3438ofof5862 1 2 3 4 5 6 Plaintiff E.F. 141. Plaintiff E.F. first contacted Pacific Fertility in or around May 2016 about the possibility of having her eggs frozen. 142. In or around June 2016, Plaintiff E.F. contracted with Pacific Fertility to have her eggs retrieved and preserved for potential future use. 143. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff E.F. saw 7 representations about Pacific Fertility’s services on Pacific Fertility’s website, including claims 8 regarding the qualifications of Pacific Fertility’s staff and the science behind the clinic’s procedures. 9 Plaintiff E.F. also met with Dr. Carolyn Givens, who told her about Pacific Fertility’s use of cutting- 10 11 edge technology and assured her that her eggs would be there for as long as she needed them. 144. In the summer of 2016, Plaintiff E.F. underwent procedures to prepare for egg 12 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 13 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately nine of her eggs. 14 15 16 145. At all relevant times thereafter, Plaintiff E.F.’s eggs were under Pacific Fertility’s protection, custody, and control. 146. Defendants kept Plaintiff E.F.’s eggs within a metal storage tank—Tank 4—at their San 17 Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 18 spreading Plaintiff E.F.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 19 147. Plaintiff E.F. has paid approximately $11,000 for the retrieval and storage of her eggs. 20 She experienced severe emotional distress when she learned of the March 4, 2018, incident and in the 21 weeks that followed. 22 23 24 25 26 27 28 Plaintiff G.H. 148. Plaintiff G.H. first contacted Pacific Fertility in or around February 2016 about the possibility of having her eggs frozen. 149. In or around April 2016, Plaintiff G.H. contracted with Pacific Fertility to have her eggs retrieved and preserved for potential future use. 150. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff G.H. saw representations about Pacific Fertility’s services on Pacific Fertility’s website, including claims about 30 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3539ofof5862 1 the reputable quality of their services. Plaintiff G.H. also met with Dr. Carolyn Givens, who provided 2 information regarding Pacific Fertility’s services. 3 151. In the spring of 2016, Plaintiff G.H. underwent procedures to prepare for egg 4 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 5 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately two of her eggs. 6 7 8 9 10 11 152. At all relevant times thereafter, Plaintiff G.H.’s eggs were under Pacific Fertility’s protection, custody, and control. 153. Defendants kept Plaintiff G.H.’s eggs within a metal storage tank—Tank 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by spreading Plaintiff G.H.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 154. Plaintiff G.H. has paid approximately $14,500 for the retrieval and storage of her eggs. 12 She experienced severe emotional distress when she learned of the March 4, 2018, incident and in the 13 weeks that followed. 14 15 16 17 18 19 Plaintiff I.J. 155. Plaintiff I.J. first contacted Pacific Fertility in or around November 2012 about the possibility of having her eggs frozen. 156. In or around December 2012, Plaintiff I.J. contracted with Pacific Fertility to have her eggs preserved for potential future use. 157. Before having her eggs cryopreserved with Pacific Fertility, Plaintiff I.J. saw 20 representations about Pacific Fertility’s services in Pacific Fertility’s brochure, including claims that 21 Pacific Fertility “had a very strong embryo freezing program” and that its clients “can avoid high order 22 multiple pregnancies by transferring fewer fresh embryos and successfully freezing the remaining 23 embryos.” Plaintiff I.J. also saw representations that Pacific Fertility “devoted considerable time and 24 effort into assembling one of the most highly trained teams in the country.” Plaintiff I.J. met with staff 25 at Pacific Fertility who assured that her eggs would be there for as long as she needed them. 26 158. In February 2013, Plaintiff I.J. underwent procedures to prepare for egg 27 cryopreservation. Before the retrieval procedure, she underwent two months of treatment and 28 injections. Pacific Fertility ultimately retrieved and cryopreserved approximately 17 of her eggs. 31 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3640ofof5862 1 2 3 159. At all relevant times thereafter, Plaintiff I.J.’s eggs were under Pacific Fertility’s protection, custody, and control. 160. Defendants kept Plaintiff I.J.’s eggs within a metal storage tank—Tank 4—at their San 4 Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 5 spreading Plaintiff I.J.’s eggs among several tanks, Defendants stored all of her eggs in the same tank. 6 161. Plaintiff I.J. has paid approximately $17,000 to Defendants for procedures, medications, 7 and storage of her eggs. She experienced severe emotional distress when she learned of the March 4, 8 2018, incident and in the weeks that followed. 9 10 11 12 13 14 Plaintiff K.L. 162. Plaintiff K.L. first contacted Pacific Fertility on or around June 3, 2010, about the possibility of having her eggs cryopreserved. 163. In or around December 2015, Plaintiff K.L. contracted with Pacific Fertility to have her eggs preserved for potential future use. 164. Before having her eggs frozen with Pacific Fertility, Plaintiff K.L. saw representations 15 about Pacific Fertility’s services on Pacific Fertility’s website, including Pacific Fertility’s claims that 16 the clinic and its services were safe and reliable, and that eggs could be stored until the right time for 17 the client. Plaintiff K.L. also saw Pacific Fertility’s representations that the process was quick and easy 18 for clients and had a very high likelihood of success. In addition, Plaintiff K.L. met with Dr. Eldon 19 Schriock, who told her that storage at Pacific Fertility was safe. 20 165. In February 2016, Plaintiff K.L. underwent procedures to prepare for egg freezing. 21 Before the retrieval procedure, she underwent months of treatment and injections. She also had to take 22 several days off from work and could not travel for work for two weeks. Pacific Fertility ultimately 23 retrieved and froze five of her eggs. 24 25 26 27 166. At all relevant times thereafter, Plaintiff K.L.’s eggs were under Pacific Fertility’s protection, custody, and control. 167. Defendants kept Plaintiff K.L.’s eggs from her first cycle within a metal storage tank— Tank 4—at their San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk 28 32 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3741ofof5862 1 of tank failure by spreading Plaintiff K.L.’s eggs from that cycle among several tanks, Defendants 2 stored all of her eggs in the same tank. 3 168. Plaintiff K.L. has paid approximately $12,000 to Defendants for procedures 4 (approximately $9,300), medications (approximately $1,200), and storage (approximately $600 per 5 year) of her eggs. She experienced severe emotional distress when she learned of the March 4, 2018, 6 incident and in the weeks that followed. 7 Plaintiffs M.N. and O.P. 8 9 169. possibility of having her eggs frozen. 10 11 Plaintiff M.N. first contacted Pacific Fertility in or around September 2011 about the 170. In or around late 2011, Plaintiff M.N. contracted with Pacific Fertility to have her eggs preserved for potential future use. 12 171. Before having her eggs frozen with Pacific Fertility, Plaintiff M.N. saw representations 13 about Pacific Fertility’s services on its website, including claims regarding its success rates and ability 14 to help couples and single people have a family and plan for the future. Plaintiff M.N. also met with 15 Dr. Eldon Schriock, who told her about Pacific Fertility’s statistics and success rates. 16 172. In January 2012, Plaintiff M.N. underwent procedures to prepare for egg freezing. She 17 went through months of invasive and time-consuming treatments, including injections, blood tests, and 18 ultrasounds. She underwent approximately three retrieval cycles, resulting in approximately 37 eggs. 19 20 173. sperm donor, resulting in three high-quality embryos. Her remaining 15 eggs were stored in Tank 4. 21 22 In 2016, Plaintiff M.N. contracted with Defendants to fertilize half of her eggs with a 174. At all relevant times thereafter, Plaintiff M.N.’s remaining eggs were under Pacific Fertility’s protection, custody, and control. 23 175. Defendants kept Plaintiff M.N.’s eggs within a metal storage tank—Tank 4—at their 24 San Francisco laboratory facility on Francisco Street. Rather than mitigating the risk of tank failure by 25 spreading Plaintiff M.N.’s eggs among several tanks, Defendants stored all of her eggs in the same 26 tank. 27 28 176. After Plaintiff M.N. finally met the right partner, O.P., they decided to move ahead with fertilizing the rest of her eggs. Plaintiffs M.N. and O.P. are in a committed relationship and plan to 33 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3842ofof5862 1 raise children together. O.P. also became a client of Pacific Fertility in December 2017, when he and 2 M.N. consulted with Pacific Fertility to begin the process of fertilizing M.N.’s remaining eggs with 3 O.P.’s sperm. In consultation with Pacific Fertility specialists, M.N. and O.P. decided to proceed with 4 the fertilization by mid-2018. 5 177. Plaintiff M.N. has paid more than $25,000 to Defendants for procedures, medications, 6 and storage of her eggs. The process was mentally and physically draining: Plaintiff M.N. had 7 approximately 70 blood tests, 30 ultrasounds, and numerous injections and prescriptions. The process 8 was also time consuming and required her to take time off from work. Plaintiffs M.N. and O.P. 9 experienced severe emotional distress when they learned of the March 4, 2018, incident and in the 10 weeks that followed. 11 12 * 178. * * As described above, each Plaintiff encountered specific representations by Pacific 13 Fertility and/or Prelude regarding their egg and embryo storage services. All Plaintiffs encountered 14 materially similar pre-treatment materials provided by Pacific Fertility. 15 179. At all relevant times before the incident, the oral representations and promotional and 16 contractual materials regarding egg and embryo cryopreservation services that Plaintiffs and, 17 inferentially, the class members received, were standardized, common, and essentially uniform. 18 180. Despite (1) knowledge that their electronic monitoring and alarms, and accompanying 19 response systems and/or processes, were inadequate to protect against damage to Plaintiffs’ eggs and 20 embryos, and (2) multiple opportunities to inform Plaintiffs of the true condition of such systems and 21 processes before Plaintiffs purchased and used their storage services, Pacific Fertility and Prelude 22 uniformly failed to disclose to any Plaintiff that their systems were inadequate. 23 181. Had Defendants disclosed that their storage monitoring and alarm systems were 24 deficient, nonfunctional, and/or incapable of protecting eggs and embryos during a tank failure, 25 Plaintiffs would not have purchased and used Defendants’ egg and embryo storage services. 26 27 28 CLASS ACTION ALLEGATIONS 182. Plaintiffs propose that the Court streamline the determination of common claims or issues in this case, as Defendants’ misconduct leading to a single incident—the failure in Tank 4—has 34 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page3943ofof5862 1 affected hundreds of people at once. To facilitate such efforts through the joint trial of common 2 questions, Plaintiffs propose certification of the following class, pursuant to Rule 23 of the Federal 3 Rules of Civil Procedure: 4 All individuals, and their reproductive partners, who had eggs, embryos, or other material in Tank 4 at Pacific Fertility Center in San Francisco, California on March 4, 2018. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Excluded from this class are Defendants, their affiliates and subsidiaries, and their officers, directors, partners, employees, and agents; class counsel, employees of class counsel’s firms, and class counsel’s immediate family members; defense counsel, their employees, and their immediate family members; and any judicial officer who considers or renders a decision or ruling in this case, their staff, and their immediate family members. 183. Numerosity. The members of the class are so numerous that their individual joinder is impracticable. There are at least 400 class members, whose names and addresses are readily available from Defendants’ records. 184. Existence and Predominance of Common Questions of Fact and Law. This action involves common questions of law and fact that predominate over any questions affecting individual class members, including, without limitation: a. Whether Tank 4 was defective; b. Whether Defendants owed a duty to Plaintiffs and class members to protect the eggs and embryos they entrusted to Defendants’ care; 21 c. Whether that duty was non-delegable; 22 d. Whether Defendants breached their duties to protect the eggs and embryos that 23 24 25 26 27 Plaintiffs and class members entrusted to their care; e. Whether the March 4, 2018, loss of liquid nitrogen in a tank at Defendants’ San Francisco facility resulted from Defendants’ negligence or other wrongful conduct; f. Whether Defendants failed to take adequate and reasonable measures to ensure that their systems were protected; 28 35 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4044ofof5862 1 2 g. Whether Defendants failed to take available steps to ensure that liquid nitrogen levels in their storage tanks would remain sufficient; 3 h. Whether Defendants breached their contracts with Plaintiffs and class members; 4 i. Whether Defendants fraudulently concealed material information regarding their 5 laboratory practices and procedures; 6 7 j. by Plaintiffs and class members as a result of Defendants’ conduct alleged herein; and 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 The type(s) and measure(s) of compensable and other redressable injury incurred k. What measures are necessary to ensure that eggs and embryos stored at Pacific Fertility are properly safeguarded in the future. 185. Typicality. Plaintiffs’ claims are typical of the other class members’ claims because Plaintiffs and class members were subjected to the same wrongful conduct and damaged in the same way by having their eggs and embryos destroyed, damaged, or jeopardized. 186. Adequacy of Representation. Plaintiffs are adequate class representatives. Their interests do not conflict with the interests of the other class members they seek to represent. Plaintiffs have retained counsel competent and experienced in complex class action litigation, as well as in matters concerning egg and embryo loss, and they intend to prosecute this action vigorously. Plaintiffs and their counsel will fairly and adequately pursue and protect the interests of the class. 187. Superiority. A class action is superior to all other available means for the fair and efficient adjudication of this controversy. The highly sensitive and private nature of the facts involved here, as well as the fear that bringing an individual suit could affect future treatment at Pacific Fertility, counsels toward providing a class vehicle to adjudicate these claims. The damages or other financial detriment suffered by Plaintiffs and the other class members are relatively small compared to the burden and expense that would be required to individually litigate these claims. As a result, it would be impracticable for class members to seek redress individually. Individualized litigation would also create a potential for inconsistent or contradictory judgments and increase the delay and expense to all parties and the court system. By contrast, the class action device presents far fewer management 28 36 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4145ofof5862 1 difficulties and provides the benefits of single adjudication, economy of scale, and comprehensive 2 supervision by a single court. 3 CLAIMS FOR RELIEF 4 188. Plaintiffs bring each of the following claims under California law. 5 189. None of Plaintiffs’ claims involves any allegation of medical malpractice. 6 FIRST CAUSE OF ACTION Negligence and/or Gross Negligence (Against All Defendants) 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 190. Plaintiffs incorporate the above and below allegations by reference. 191. Defendants owed Plaintiffs a duty to exercise the highest degree of care when maintaining, inspecting, monitoring, and testing the liquid nitrogen storage tanks used for the preservation of eggs and embryos at Defendants’ San Francisco laboratory. 192. Defendants owed a duty of care to Plaintiffs to act reasonably in all aspects of the storage of Plaintiffs’ eggs and embryos so as to avoid destroying them, damaging them, or jeopardizing their viability given that doing so would inevitably lead to emotional distress. 193. Defendants assumed that duty of care through communications with actual and prospective clients and by reason of Defendants’ special relationship with Plaintiffs arising from the sensitive services Defendants undertook to perform: human egg and embryo cryopreservation and storage. 194. Plaintiffs’ harms occurred in the course of specified categories of activities, undertakings, or relationships in which negligent conduct is especially likely to cause serious harm. As Pacific Fertility states in its marketing, fertility services, including those relating to cryopreserved egg and embryo storage, can be stressful and overwhelming for those who use them. 195. It was reasonably foreseeable to Defendants that Plaintiffs would experience severe emotional distress as a result of Defendants’ breach of their duty of care. 196. Defendants’ carelessness and negligence directly and foreseeably damaged Plaintiffs. Plaintiffs entrusted Defendants with preserving and storing their eggs and embryos, and Defendants’ mishandling of those eggs and embryos, and their subsequent mishandling of communications, 37 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4246ofof5862 1 naturally and foreseeably caused mental anguish and emotional distress, among other injuries, to 2 Plaintiffs. 3 197. There was a close connection between Defendants’ conduct and Plaintiffs’ injuries. 4 Plaintiffs’ emotional distress and other harms occurred because of Defendants’ failure to act reasonably 5 in all aspects of the storage of Plaintiffs’ eggs and embryos. 6 198. Plaintiffs entrusted Defendants to use reasonable care to safeguard their eggs and 7 embryos to preserve their reproductive options. Defendants’ carelessness with this precious material, 8 and ultimately, with the affected families’ careful plans for parenthood, is reprehensible. 9 199. Imposing a duty on Defendants to avoid causing emotional distress would promote the 10 policy of preventing future harm, insofar as they will be motivated to: (1) in the case of Prelude and 11 Pacific Fertility, implement more effective processes and systems to ensure that eggs and embryos are 12 safeguarded and properly stored going forward; and (2) in the case of Chart, take steps to ensure that 13 tanks it designs to hold eggs and embryos are free from defects capable of destroying, damaging, or 14 jeopardizing their contents. Imposing a duty on Defendants to avoid causing emotional distress also 15 furthers the community’s interest in ensuring that reliable fertility services are available to those who 16 wish to become parents. 17 200. The burden on Defendants from a duty to avoid causing emotional distress is fair and 18 appropriate, in light of the importance of the eggs and embryos they voluntarily agreed to protect, at 19 considerable cost to Plaintiffs. 20 21 22 23 24 201. Defendants owed Plaintiffs a non-delegable duty of care with respect to the maintenance and protection of the eggs and embryos entrusted to their care. 202. Defendants breached these duties and acted with negligence and gross negligence in at least the following respects: a. failing to adequately design, manufacture, maintain, inspect, monitor, and/or test 25 their liquid nitrogen storage tanks, including through a functional electronic tank monitoring system 26 capable of detecting a rise in temperature or a drop in liquid nitrogen levels and promptly alerting staff 27 to the immediate problem; 28 38 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4347ofof5862 1 2 b. permitting a leakage or tank failure to occur with respect to one of their liquid nitrogen storage tanks—Tank 4—containing human eggs and embryos; 3 c. failing to inspect and/or adequately inspect Tank 4 on a daily basis; 4 d. failing to establish, maintain, and properly activate alarms; 5 e. failing to establish, maintain, and properly activate autofill devices and/or 6 generator systems; 7 8 f. failing to disclose that it did not have appropriate processes and systems in place to protect clients’ eggs and embryos; 9 g. failing to properly safeguard the eggs and embryos in its care; and 10 h. failing to follow reasonable scientific and laboratory procedures for safeguarding 11 12 the eggs and embryos in their care. 203. Defendants’ acts and omissions constitute gross negligence, because they constitute an 13 extreme departure from what a reasonably careful person would do in the same situation to prevent 14 foreseeable loss of eggs and embryos. 15 204. Defendants acted willfully, wantonly, and with conscious and reckless disregard for the 16 rights and interests of Plaintiffs. Defendants’ acts and omissions had a great probability of causing 17 significant harm and in fact did. 18 205. Defendants’ failure to appropriately handle and safeguard Plaintiffs’ eggs and embryos 19 has caused severe emotional distress, regardless of whether it is ever determined conclusively that the 20 eggs and embryos in Tank 4 are not viable. Defendants’ misconduct has irreparably breached trust and 21 caused uncertainty, anxiety, and fear among Plaintiffs and other affected families over how to proceed 22 without being informed as to the long-term effects from an egg or embryo’s presence in Tank 4 during 23 the incident. 24 206. As a proximate result of Defendants’ negligence and/or gross negligence, Plaintiffs 25 suffered harm in an amount to be determined at trial, including severe emotional distress consisting of 26 shock, fright, horror, anguish, suffering, grief, anxiety, nervousness, embarrassment, humiliation, and 27 shame. A reasonable person would be unable to cope with the losses suffered by Plaintiffs. 28 39 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4448ofof5862 SECOND CAUSE OF ACTION Breach of Contract (Against Pacific Fertility and Prelude) 1 2 3 207. Plaintiffs incorporate the above allegations by reference. 4 208. Defendants entered into contracts with Plaintiffs, under which Defendants agreed to 5 store and preserve their eggs and embryos or those obtained on their behalf, and under which 6 Defendants assumed a non-delegable duty of care to ensure such safekeeping and preservation. 7 209. A contract involving egg and embryo storage and preservation is highly personal and 8 implicates vital concerns regarding parenthood, procreation, and assisting others in achieving their 9 family plans. 10 210. In consideration of Defendants’ promises, including to keep the eggs and embryos safe 11 and secure by following practices and protocols, including as outlined on their websites and in other 12 marketing materials, Plaintiffs agreed to pay, and did pay, substantial sums for the services rendered. 13 14 15 211. Plaintiffs performed all of the terms and conditions required of them under their contracts with Defendants. 212. Based on the conduct described herein, Defendants breached their contracts with 16 Plaintiffs, including the incorporated contractual covenant of good faith and fair dealing. Defendants’ 17 failure to safely store and preserve Plaintiffs’ eggs and embryos violated commercial norms, deprived 18 Plaintiffs of the fruits of the contracts, and contravened their objectively reasonable expectations under 19 the contracts. 20 213. A contract whereby a fertility clinic undertakes to store human eggs and embryos is one 21 as to which it is reasonably foreseeable that breach thereof will cause mental anguish to the person or 22 persons who entrusted the clinic with such material. 23 24 214. harm, including mental anguish, in an amount to be determined at trial. 25 THIRD CAUSE OF ACTION Bailment (Against Pacific Fertility and Prelude) 26 27 As a direct and proximate result of Defendants’ breach of contract, Plaintiffs suffered 215. Plaintiffs incorporate the above allegations by reference. 28 40 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4549ofof5862 1 2 216. Plaintiffs delivered to Defendants for safekeeping irreplaceable personal property to be safely and securely kept for the benefit of Plaintiffs, and to be redelivered to them upon demand. 3 217. Defendants received eggs and embryos from Plaintiffs on this condition. 4 218. Plaintiffs agreed to pay, and did pay, substantial sums in exchange for Defendants’ 5 6 promise to safeguard their eggs and embryos for the benefit of Plaintiffs. 219. Defendants had a duty to exercise care in maintaining, preserving, and protecting 7 Plaintiffs’ eggs and embryos that were delivered to Defendants. Further, Defendants had a duty to 8 return the eggs and embryos, undamaged, to Plaintiffs, to whom the eggs and embryos belonged. 9 220. Defendants invited the general public, including Plaintiffs, to entrust eggs and embryos 10 to Defendants’ care by holding out Pacific Fertility as a competent, capable, and established 11 reproductive and storage facility able to handle and care for eggs and embryos in a safe and satisfactory 12 manner, and in a manner specified on their websites. 13 221. Because of Defendants’ wrongful conduct, as set forth herein, the irreplaceable property 14 of Plaintiffs was irreplaceably damaged, precluding its redelivery to them as provided for under the 15 bailment contract. 16 222. 17 18 Defendants breached their duty to exercise care in the safekeeping of Plaintiffs’ eggs and embryos delivered to Defendants and to return the eggs and embryos, undamaged, to Plaintiffs. 223. As a direct and proximate result of Defendants’ breach of bailment contract, Plaintiffs 19 have been deprived of the opportunity to use the eggs and embryos they entrusted to Defendants, and 20 have suffered damages in an amount to be determined at trial. 21 FOURTH CAUSE OF ACTION Premises Liability (Against Pacific Fertility and Prelude) 22 23 224. Plaintiffs incorporate the above allegations by reference. 24 225. At all relevant times, Pacific Fertility and Prelude owned, leased, and/or occupied the 25 property, premises, machinery, and equipment, including Tank 4, on the premises at 55 Francisco 26 Street, Suite 500, San Francisco, California 94133. 27 28 41 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4650ofof5862 1 226. At all relevant times, Pacific Fertility and Prelude had a duty to use reasonable care to 2 keep Plaintiffs’ irreplaceable personal property in a reasonably safe condition and free from defects that 3 would cause injury or harm to Plaintiffs’ stored eggs and embryos. 4 5 6 227. At all relevant times, Pacific Fertility and Prelude knew, or by reasonable inspection and monitoring should have known, of the defective condition of the premises, and specifically of Tank 4. 228. At all relevant times, Pacific Fertility and Prelude were careless and negligent in the 7 ownership, management, control and maintenance of the aforementioned real property, such that 8 Plaintiffs, whose cryopreserved eggs and embryos were entrusted to Pacific Fertility and Prelude’s 9 care, were harmed. 10 229. 11 suffered injury, loss, harm, and damages. 12 FIFTH CAUSE OF ACTION Breach of Fiduciary Duty ‒ Failure to Use Reasonable Care (Against Pacific Fertility and Prelude) 13 14 15 16 17 18 19 20 21 22 23 24 25 26 By reason of the foregoing, and as a direct and legal cause thereof, Plaintiffs have 230. Plaintiffs incorporate the above allegations by reference. 231. At all times herein mentioned, Pacific Fertility and Prelude were the fiduciaries of Plaintiffs because they agreed to store, safeguard, secure, maintain, and account for Plaintiffs’ eggs and embryos and because they represented that they were experts in the field of maintenance and protection of eggs and embryos. 232. Pacific Fertility and Prelude acted on Plaintiffs’ behalf for purposes of the maintenance and protection of Plaintiffs’ eggs and embryos. 233. Pacific Fertility and Prelude failed to act as a reasonably careful fiduciary would have acted under the same or similar circumstances with respect to the maintenance and protection of the eggs and embryos entrusted to their care. 234. Pacific Fertility and Prelude’s breach of fiduciary duty was a substantial factor in causing harm to Plaintiffs. 27 28 42 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4751ofof5862 1 2 SIXTH CAUSE OF ACTION Violations of the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq. (Against All Defendants) 3 235. Plaintiffs incorporate the above allegations by reference. 4 236. The UCL prohibits acts of “unfair competition,” including any “unlawful, unfair or 5 6 7 8 9 fraudulent business act or practice.” 237. Defendants’ conduct set forth herein is unlawful because it constitutes negligence, gross negligence, breach of contract, bailment, breach of fiduciary duty, deceit, and strict products liability. 238. Defendants’ conduct is unfair because it is immoral, unethical, unscrupulous, oppressive, and substantially injurious. Plaintiffs entrusted Defendants with their eggs and embryos to 10 preserve their options for procreation, parenting, or assisting others experiencing infertility. 11 Defendants breached that trust by, among other things: 12 a. failing to adequately design, manufacture, maintain, inspect, monitor, and/or test 13 their liquid nitrogen storage tanks, including through a functional electronic tank monitoring system 14 capable of detecting a rise in temperature or a drop in liquid nitrogen levels and promptly alerting staff 15 to the immediate problem; 16 17 b. permitting a leakage or tank failure to occur with respect to one of their liquid nitrogen storage tanks—Tank 4—containing human eggs and embryos; 18 c. failing to inspect and/or adequately inspect Tank 4 on a daily basis; 19 d. failing to establish, maintain, and properly activate alarms; e. failing to establish, maintain, and properly activate autofill devices and/or 20 21 22 23 24 25 26 27 generator systems; f. failing to disclose that it did not have appropriate processes and systems in place to protect clients’ eggs and embryos; g. failing to properly safeguard the eggs and embryos in its care; and h. failing to follow reasonable scientific and laboratory procedures for safeguarding the eggs and embryos in their care. 28 43 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4852ofof5862 1 239. The gravity of the harm resulting from Defendants’ conduct far outweighs any 2 conceivable utility of this conduct. There are reasonably available alternatives that would further 3 Defendants’ legitimate business interests, such as implementing reasonable protocols and procedures, 4 as promised, to prevent a catastrophic failure. 5 240. Plaintiffs could not have reasonably avoided injury from Defendants’ unfair conduct. 6 Plaintiffs did not know, and had no reasonable means of learning, that Defendants were not adequately 7 safeguarding the eggs and embryos in their custody and control. 8 9 10 241. Defendants’ conduct also is fraudulent in violation of the UCL because it is likely to deceive a reasonable consumer. 242. Defendants knowingly and intentionally concealed from Plaintiffs that their electronic 11 monitoring and alarm and response systems and processes, and other equipment, including the storage 12 tank, were inadequate to protect against damage to Plaintiffs’ eggs and embryos. 13 14 15 16 17 18 19 20 21 243. Defendants volunteered specific information to Plaintiffs through advertising, on websites, and in documents that their storage services were high quality, including representing that a tank could go without power or liquid nitrogen for “several days” without damaging the tissue it contained. Plaintiffs viewed and relied upon Defendants’ representations that their storage services were high quality, safe, and reliable. 244. Defendants made these specific representations despite knowing their systems were inadequate to protect against damage to Plaintiffs’ eggs and embryos. 245. Defendants had ample means and opportunities to alert Plaintiffs to the fact that their 22 electronic monitoring and alarm and response systems and processes were inadequate to protect against 23 damage to Plaintiffs’ eggs and embryos. Defendants failed to disclose such inadequacies to Plaintiffs. 24 Had Defendants disclosed such inadequacies to Plaintiffs, Plaintiffs would not have purchased 25 Defendants’ egg and embryo storage services. 26 246. Defendants were under a duty to disclose that their storage systems and processes were 27 inadequate given their exclusive knowledge of the inadequacies and because they made partial 28 representations about their storage services without disclosing the inadequacies. 44 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page4953ofof5862 1 247. As a direct and proximate result of Defendants’ unlawful and unfair conduct, Plaintiffs 2 have suffered injuries in fact and seek appropriate relief under the UCL, including injunctive relief and 3 restitution. 4 248. The requested injunction under the UCL will primarily benefit the interests of the 5 general public. It will have the primary purpose and effect of prohibiting unlawful acts that threaten 6 injury to members of the public who have placed, or who in the future will place, reproductive tissue 7 under Defendants’ care. 8 9 10 11 12 13 14 15 16 17 18 19 20 21 SEVENTH CAUSE OF ACTION Violations of the Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (Against Pacific Fertility and Prelude) 249. Plaintiffs incorporate the above allegations by reference. 250. Pacific Fertility and Prelude are “persons” as defined by Civil Code §§ 1761(c) and 1770 and have provided “services” as defined by Civil Code §§ 1761(b) and 1770. 251. engaged in “transaction[s]” as defined by Civil Code §§ 1761(e) and 1770. 252. 24 25 26 Pacific Fertility and Prelude’s acts and practices were intended to and did result in the sale of services to Plaintiffs, and those acts and practices violated Civil Code § 1770, including by: a. representing that their services had characteristics, uses, and benefits that they b. representing that their services were of a particular standard, quality, or grade, did not have; when they were not; 22 23 Plaintiffs are “consumers” as defined by Civil Code §§ 1761(d) and 1770 and have c. advertising services with intent not to sell them as advertised; and d. representing that the subject of a transaction had been supplied in accordance with a previous representation when it had not. 253. Pacific Fertility and Prelude’s acts and practices violated the Consumers Legal Remedies Act by failing to disclose information in the context of transactions. 27 28 45 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5054ofof5862 1 254. Pacific Fertility and Prelude knew that their equipment, systems, and processes, 2 including Defendants’ storage tank, electronic monitoring, alarm, and response systems and processes, 3 were inadequate to safely store Plaintiffs’ eggs and embryos. 4 255. Pacific Fertility and Prelude were under a duty to disclose that their equipment, systems, 5 and processes were inadequate because they actively concealed this information and because they had 6 exclusive knowledge, not known or reasonably accessible to Plaintiffs, of the inadequacy of their 7 equipment, systems, and processes. They were also subject to a duty to disclose because the 8 information they failed to disclose was contrary to partial representations they made concerning the 9 adequacy of their equipment, systems, and processes. 10 256. Pacific Fertility and Prelude had ample means and opportunities to alert Plaintiffs to the 11 fact that their equipment, systems, and processes were inadequate, including in person when meeting 12 with Plaintiffs before egg and embryo storage. Despite their opportunities to do so, Pacific Fertility and 13 Prelude failed to disclose to Plaintiffs, and actively concealed, that Defendants’ equipment, systems, 14 and processes were inadequate to safely store human reproductive tissue. 15 257. Pacific Fertility and Prelude’s omissions were material because reasonable consumers 16 would consider important, and would want to be told, information about the inadequacy of Defendants’ 17 equipment, systems, or processes connected to their ability to safely store Plaintiffs eggs and embryos 18 258. As a direct and proximate result of this conduct, Plaintiffs have suffered damage. Had 19 Defendants not misrepresented the adequacy of, and concealed the inadequacy of, their equipment, 20 systems, and processes, Plaintiffs would not have purchased Defendants’ services and would not have 21 gone through the time and emotional investment to store their reproductive tissue with Defendants. In 22 the meantime, Pacific Fertility and Prelude generated more revenue than they otherwise would have, 23 unjustly enriching themselves. 24 259. Plaintiffs are entitled to equitable relief, reasonable attorneys’ fees and costs, declaratory 25 relief, and a permanent injunction enjoining Pacific Fertility and Prelude from their unlawful, 26 fraudulent, and deceitful activity. 27 28 260. Pursuant to Cal. Civ. Code § 1782(a), Plaintiffs will send letters to Defendants notifying them of their CLRA violations and providing them with the opportunity to correct their business 46 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5155ofof5862 1 practices. If Pacific Fertility and Prelude do not correct their business practices, Plaintiffs will amend 2 (or seek leave to amend) the complaint to add claims for monetary relief, including for actual, 3 restitutionary, emotional distress, and punitive damages under the CLRA. 4 261. The conduct of Pacific Fertility and Prelude set forth herein was reprehensible and 5 subjected Plaintiffs to cruel and unjust hardship in conscious disregard of their rights, constituting 6 oppression, for which Pacific Fertility and Prelude must be punished by punitive and exemplary 7 damages in an amount according to proof. Pacific Fertility and Prelude’s behavior evidences a 8 conscious disregard for the safety of the eggs and embryos entrusted to them, and by extension, those 9 who placed the eggs and embryos in their care, including Plaintiffs. Pacific Fertility and Prelude’s 10 conduct was and is despicable conduct and constitutes malice under Section 3294 of the California 11 Civil Code. An officer, director, or managing agent of Pacific Fertility and Prelude personally 12 committed, authorized, and/or ratified the reprehensible conduct set forth herein. Plaintiffs are entitled 13 to an award of punitive damages sufficient to punish and make an example of these Defendants. 14 EIGHTH CAUSE OF ACTION Deceit and Fraudulent Concealment (Against Pacific Fertility and Prelude) 15 16 17 18 19 20 21 22 23 24 25 26 27 262. Plaintiffs incorporate the above allegations by reference. 263. Defendants marketed and promoted their services and made representations to the public and to Plaintiffs that they were experts in cryopreservation, had state-of-the-art facilities, and would safely preserve and store Plaintiffs’ eggs and embryos in liquid nitrogen according to certain protocols and standards until they were ready to use them. 264. Defendants’ representations were false, and Defendants either knew the truth or made the representations without regard for the truth. 265. Defendants intended for Plaintiffs to rely on their representations and engage Defendants to perform services to preserve Plaintiffs’ eggs and embryos, and Plaintiffs reasonably relied on Defendants’ representations when availing themselves of Defendants’ services for egg and embryo storage. 28 47 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5256ofof5862 1 266. Defendants intentionally suppressed and concealed material facts concerning the 2 adequacy of its storage systems and processes. Defendants knew or reasonably should have known 3 their electronic monitoring and alarm storage systems and processes were inadequate to protect against 4 damage to Plaintiffs’ eggs and embryos. Though it is standard in the industry to do so, Defendants did 5 not equip Tank 4 with a liquid nitrogen autofilling system sufficient to replenish declining liquid 6 nitrogen levels. Defendants willfully omitted to disclose the inadequate nature of its storage systems 7 and processes to Plaintiffs. 8 9 267. Plaintiffs had no reasonable means of knowing Defendants’ storage systems and processes were inadequate, or that Defendants’ representations about such systems were incomplete, 10 false, or misleading in that they failed to disclose such inadequacies. Plaintiffs did not and reasonably 11 could not have discovered Defendants’ deception prior to purchasing their storage services. 12 268. Defendants had ample means and opportunities to alert Plaintiffs to the fact that their 13 electronic monitoring and alarm and response systems and processes were inadequate to protect against 14 damage to Plaintiffs’ eggs and embryos. Defendants willfully failed to disclose such inadequacies to 15 Plaintiffs. Had Defendants disclosed the inadequacies to Plaintiffs, they would not have purchased 16 Defendants’ egg and embryo storage services. 17 269. Defendants were under a duty to disclose that their storage systems and processes were 18 inadequate given their exclusive knowledge of the inadequacies and because they made partial 19 representations about their storage services without disclosing the inadequacies. 20 270. Plaintiffs reasonably relied to their detriment upon Defendants’ material omissions 21 regarding the adequacy of their storage systems and processes. Plaintiffs were unaware of the omitted 22 material facts and would not have acted as they did had these facts been disclosed. Had Plaintiffs 23 known that Defendants’ storage systems and processes were inadequate to protect against damage to 24 their eggs and/or embryos, they would not have purchased such services. 25 26 27 28 271. Plaintiffs sustained damage as a direct and proximate result of Defendants’ deceit and fraudulent concealment. 272. The foregoing acts and omissions of Defendants were committed maliciously, oppressively, deliberately, with intent to defraud, and in reckless disregard of Plaintiffs’ rights, 48 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5357ofof5862 1 interests, and well-being to enrich Defendants. Defendants’ conduct warrants an assessment of 2 punitive damages in an amount sufficient to deter such conduct in the future, which amount is to be 3 determined according to proof. 4 NINTH CAUSE OF ACTION Strict Products Liability ‒ Failure to Warn (Against Chart) 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 273. Plaintiffs incorporate the above allegations by reference. 274. Chart manufactured, distributed, and/or sold the cryogenic equipment used at Pacific Fertility, including Tank 4. 275. The cryogenic storage tank at issue had potential risks that were known or knowable in light of the scientific and medical knowledge that was generally accepted in the scientific and medical community at the time of the manufacture, distribution, or sale of the cryogenic storage Tank 4. 276. The cryogenic storage Tank 4 was defective and unreasonably dangerous when it left Chart’s possession because it did not contain adequate warnings, including warnings concerning certain risks, including the risk of defective seals that may result in catastrophic nitrogen loss, the risk of nitrogen loss and prevalence of this occurrence, the risk of a rise in temperature and the fact that the tanks are not equipped with sufficient alarms to notify users of catastrophic nitrogen loss or a rise in temperature that can damage and/or cause destruction of eggs or embryos, the rate of failure of the cryogenic storage tanks in the preservation of eggs or embryos or other human tissue, and the need for maintenance, inspection, and/or replacement of the cryogenic storage tanks. 277. The potential risks presented a substantial danger when the cryogenic storage tank at issue was used or misused in an intended or reasonably foreseeable way. 278. The ordinary consumer would not have recognized the potential for risks. 279. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable care, should have known that the cryogenic storage Tank 4 was dangerous, had risks, and/or was defective in manufacture and/or design, including that it could cause nitrogen loss and would damage and/or cause the destruction of cryopreserved materials, including eggs or embryos. 28 49 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5458ofof5862 1 2 3 280. Chart failed to adequately warn or instruct concerning the potential risks of the cryogenic storage tank. 281. It was foreseeable to Chart that failure to adequately warn about the risks of its 4 cryogenic storage tank would cause irreparable harm to those whose eggs and embryos were 5 cryopreserved therein, including the types of emotional distress suffered by Plaintiffs. 6 282. As a result of Chart’s failures to adequately warn, Plaintiffs were harmed as described 7 herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 8 are not viable. The lack of sufficient instructions and warnings was a substantial factor in causing 9 Plaintiffs’ harm. 10 TENTH CAUSE OF ACTION Strict Products Liability ‒ Manufacturing Defect (Against Chart) 11 12 13 14 15 16 17 18 19 20 21 22 23 24 283. Plaintiffs incorporate the above allegations by reference. 284. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 285. The cryogenic storage tank contained a manufacturing defect when it left Chart’s possession. 286. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were defective in manufacture, including that they could cause nitrogen loss and would damage and/or cause the destruction of cryopreserved materials, including eggs or embryos. 287. As a result of Chart’s conduct, Plaintiffs were harmed as described herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 are not viable. 288. The defective nature of the cryogenic storage tank was a substantial factor in causing Plaintiffs’ harm. ELEVENTH CAUSE OF ACTION Strict Products Liability — Design Defect — Consumer Expectations Test (Against Chart) 25 26 289. Plaintiffs incorporate the above allegations by reference. 27 290. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 28 50 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5559ofof5862 1 2 3 291. The cryogenic storage tank did not perform as safely as an ordinary consumer would have expected it to perform when used in an intended or reasonably foreseeable way. 292. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 4 care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were 5 defective, including in design, including that they could result in nitrogen loss and would damage 6 and/or cause the destruction of cryopreserved materials, including eggs or embryos. 7 8 9 10 293. As a result of Chart’s conduct, Plaintiffs were harmed as described herein, regardless of whether it is ever determined conclusively that certain eggs and embryos in Tank 4 are not viable. 294. The cryogenic storage tank’s failure to perform safely was a substantial factor in causing Plaintiffs’ harm. TWELFTH CAUSE OF ACTION Strict Products Liability ‒ Design Defect ‒ Risk-Utility Test (Against Chart) 11 12 13 295. Plaintiffs incorporate the above allegations by reference. 14 296. Chart manufactured, distributed, and/or sold the cryogenic storage Tank 4. 15 297. The benefits of this tank’s design are not outweighed by its risks, considering the gravity 16 of the potential harm resulting from the use of the tank, the likelihood that the harm would occur, the 17 feasibility of an alternative safer design at the time of manufacture, and the disadvantages of an 18 alternative design. 19 298. Chart had constructive notice or knowledge and knew, or in the exercise of reasonable 20 care, should have known that the cryogenic storage tanks were dangerous, had risks, and/or were 21 defective in design, including that they could result in nitrogen loss and would damage and/or cause the 22 destruction of cryopreserved materials, including eggs or embryos. 23 299. Plaintiffs were harmed because the tank lost liquid nitrogen. 24 300. Chart’s design of the tank was a substantial factor in causing Plaintiffs’ harm. 25 THIRTEENTH CAUSE OF ACTION Negligent Failure to Recall (Against Chart) 26 27 301. Plaintiffs incorporate the above allegations by reference. 28 51 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5660ofof5862 1 2 302. Chart acted negligently by failing to recall, prior to the incident of March 4, 2018, the line of tanks that included Tank 4. 3 303. Chart manufactured, distributed, and/or sold this line of tanks. 4 304. Chart knew or reasonably should have known that, when used as intended, Tank 4 5 presented or was likely to present a danger to eggs and embryos. Chart knew or reasonably should 6 have known that the vacuum seal on Tank 4 was vulnerable to breach, and that upon such breach liquid 7 nitrogen levels would drop, causing the eggs and embryos stored inside the tank to reach dangerously 8 elevated temperatures. 9 305. After Chart sold Tank 4 to Pacific Fertility and before March 4, 2018, Chart knew or 10 reasonably should have known that the tank was susceptible to its vacuum seal breaking. Nevertheless, 11 at no point during this time period did Chart recall, repair, or warn of the danger posed by the tank. 12 13 14 306. A reasonable manufacturer, distributor, or seller facing the same or similar circumstances as Chart would have recalled Tank 4 to ensure eggs and embryos were not endangered. 307. Chart’s failure to timely recall Tank 4 was a substantial factor in causing harm to 15 Plaintiffs. Had Chart recalled Tank 4 before the incident, the other Defendants would not have used it, 16 and it would not have failed while Plaintiffs’ eggs and embryos were stored within it. 17 18 19 PRAYER FOR RELIEF WHEREFORE, Plaintiffs, individually and on behalf of the class defined above, respectfully request that the Court: 20 A. Certify the class under Fed. R. Civ. P. 23(a), (b)(1), (b)(2), (b)(3), and/or (c)(4), 21 as appropriate; appoint Plaintiffs as representatives of the class; and appoint the undersigned counsel as 22 class counsel; 23 24 B. Award Plaintiffs compensatory, restitutionary, rescissory, general, consequential, punitive and/or exemplary damages in an amount to be determined at trial; 25 C. Award prejudgment interest as permitted by law; 26 D. Enter an injunction against Defendants and their officers, agents, successors, 27 employees, representatives, assigns, and any and all persons acting in concert with them, to ensure 28 Defendants’ compliance with California Business and Professions Code section 17200 et seq.; 52 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5761ofof5862 1 E. Enter an injunction against Defendants and their officers, agents, successors, 2 employees, representatives, assigns, and any and all persons acting in concert with them, mandating 3 that Defendants cease engaging in unfair competition as set forth above; 4 5 F. Appoint a monitor to ensure Defendants comply with the injunctive provisions of any decree of this Court; 6 G. Retain jurisdiction over this action to ensure Defendants comply with such a 8 H. Enter other appropriate equitable relief; 9 I. Award reasonable attorneys’ fees and costs, as provided for by law; and 10 J. Grant such other and further relief as the Court deems just and proper. 7 decree; 11 12 DEMAND FOR JURY TRIAL Plaintiffs demand a trial by jury on all issues so triable. 13 14 Dated: May 30, 2018 Respectfully submitted, 15 16 17 18 19 20 21 22 23 24 25 26 27 28 By: /s/ Adam E. Polk Daniel C. Girard (State Bar No. 114826) Steven M. Tindall (State Bar No. 187862) Jordan Elias (State Bar No. 228731) Adam E. Polk (State Bar No. 273000) GIRARD GIBBS LLP 601 California Street, 14th Floor San Francisco, CA 94108 Tel: (415) 981-4800 Fax: (415) 981-4846 dcg@girardgibbs.com smt@classlawgroup.com je@girardgibbs.com aep@girardgibbs.com By: /s/ Adam B. Wolf Adam B. Wolf (State Bar No. 215914) Tracey B. Cowan (State Bar No. 250053) PEIFFER WOLF CARR & KANE, A PROFESSIONAL LAW CORPORATION 4 Embarcadero Center, Suite 1400 San Francisco, CA 94111 53 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case Case3:18-cv-01586-JSC 3:18-cv-01586-JSC Document Document143-2 44 Filed Filed05/30/18 11/30/18 Page Page5862ofof5862 Tel: (415) 766-3545 Fax: (415) 402-0058 awolf@pwcklegal.com tcowan@pwcklegal.com 1 2 3 12 By: /s/ Sarah R. London Elizabeth J. Cabraser (State Bar No. 083151) Lexi J. Hazam (State Bar No. 224457) Sarah R. London (State Bar No. 267083) Tiseme G. Zegeye (State Bar No. 319927) LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 275 Battery Street, 29th Floor San Francisco, CA 94111 Tel: (415) 956-1000 Fax: (415) 956-1008 ecabraser@lchb.com lhazam@lchb.com slondon@lchb.com tzegeye@lchb.com 13 Interim Class Counsel 4 5 6 7 8 9 10 11 14 Joseph G. Sauder (pro hac vice) SAUDER SCHELKOPF LLC 555 Lancaster Avenue Berwyn, Pennsylvania 19312 Tel: (610) 200-0580 jgs@sstriallawyers.com 15 16 17 18 Plaintiffs’ Counsel 19 20 ATTESTATION 21 22 23 24 I, Adam E. Polk, am the ECF User whose identification and password are being used to file this Consolidated Amended Class Action Complaint. Pursuant to Civil L.R. 5-1(i)(3), I attest under penalty of perjury that concurrence in this filing has been obtained by all counsel listed above. 25 26 27 Dated: May 30, 2018 /s/ Adam E. Polk Adam E. Polk 28 54 CONSOLIDATED AMENDED CLASS ACTION COMPLAINT CASE NO. 3:18-cv-01586-JSC Case 3:18-cv-01586-JSC Document 143-3 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 3 Case Document 143-3 Filed 11/30/18 Page 2 Of 3 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION Case NO. 3:18-cv-01586-J SC IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3: 1 8-CV-01586-JSC QWQONMAMM Case Document 143-3 Filed 11/30/18 Page 3 of 3 I, declare as follows: 1. I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 2. I am a Plaintiff in the above-captioned action. 3. I submit this declaration in support of the First Amended Consolidated Class Action Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil Code section 1750 et seq. 4. The First Amended Consolidated Class Action Complaint has been filed in the proper place for trial of this action. 5. Defendant San Francisco Fertility Centers, d/b/a Paci?c Fertility Center has its principal place of business in San Francisco, California, which is within San Francisco County. PFC conducts substantial business, including the acts and practices at issue in this action, within San Francisco County. 6. I purchased long-term freezer storage for my embryos in California from PFC. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on November Q3, 2018 in fg'zr'? ?97, ()hio. CLRA VENUE DECLARATION OF PLAINTIFF - - PURSUANT To CALIFORNIA CIVIL CODE SECTION 1780(d) CASE No. Case 3:18-cv-01586-JSC Document 143-4 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 4 p?A Case Document 143-4 Filed 11/30/18 Page 2 Of 3 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION Case No. 3:18-cv-01 586-J SC IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CLRA VENUE DECLARATION OF PLAINTIFF - - PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. _l Case Document 143-4 Filed 11/30/18 Page 3 of 3 l- -, declare as follows: 1. I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 2. I am a Plaintiff in the above-captioned action. 3. I submit this declaration in support of the First Amended Consolidated Class Action Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil Code section 1750 et seq. 4. The First Amended Consolidated Class Action Complaint has been ?led in the proper place for trial of this action. 5. Defendant San Francisco Fertility Centers, d/b/a Paci?c Fertility Center has its principal place of business in San Francisco, California, which is within San Francisco County. PFC conducts substantial business, including the acts and practices at issue in this action, within San Francisco County. 6. I purchased long-term freezer storage for my embryos in California from PFC. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on November 2018 in Ohio. CLRA VENUE DECLARATION OF PLAINTIFF - - PURSUANT To CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. Case 3:18-cv-01586-JSC Document 143-5 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 5 Case 3:18-cv-01586-JSC Document 143-5 Filed 11/30/18 Page 2 of 3 1 2 3 4 5 6 7 8 9 10 11 12 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION 13 14 15 16 Case No. 3:18-cv-01586-JSC IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) 17 18 19 20 21 22 23 24 25 26 27 28 CLRA VENUE DECLARATION OF PLAINTIFF CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3:18-CV-01586-JSC PURSUANT TO Case 3:18-cv-01586-JSC Document 143-5 Filed 11/30/18 Page 3 of 3 1 I, 2 1. 3 , declare as follows: I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 4 2. I am a Plaintiff in the above-captioned action. 5 3. I am a resident of San Francisco County, California. 6 4. I submit this declaration in support of the First Amended Consolidated Class Action 7 Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil 8 Code section 1750 et seq. 9 10 5. The First Amended Consolidated Class Action Complaint has been filed in the proper place for trial of this action. 11 6. Defendant San Francisco Fertility Centers, d/b/a Pacific Fertility Center (“PFC”), has its 12 principal place of business in San Francisco, California, which is within San Francisco County. PFC 13 conducts substantial business, including the acts and practices at issue in this action, within San 14 Francisco County. 15 7. I purchased long-term freezer storage for my eggs in California from PFC. 16 17 18 19 I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on November 20 , 2018 in London, England . 20 21 By: 22 23 24 25 26 27 28 CLRA VENUE DECLARATION OF PLAINTIFF CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3:18-CV-01586-JSC PURSUANT TO , Case 3:18-cv-01586-JSC Document 143-6 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 6 Case Document 143-6 Filed 11/30/18 Page 2 of 3 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION Case No. IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CLRA VENUE DECLARATION OF PLAINTIFF TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. {huh-Case Document 143-6 Filed 11/30/18 Page 3 of 3 I, declare as follows: 1. I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 2. I am a Plaintiff in the above-captioned action. 3. I am a resident of San Francisco County, California. 4. I submit this declaration in support of the First Amended Consolidated Class Action Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil Code section 1750 et seq. 5. The First Amended Consolidated Class Action Complaint has been ?led in the proper place for trial of this action. 6. Defendant San Francisco Fertility Centers, d/b/a Paci?c Fertility Center has its principal place of business in San Francisco, California, which is within San Francisco County. PFC conducts substantial business, including the acts and practices at issue in this action, within San Francisco County. 7. I purchased long-term freezer storage for my eggs in California from PFC. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on Novemberzi, 2018 in ?/Ah?i 660 CLRA VENUE DECLARATION OF PLAINTIFF TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. Case 3:18-cv-01586-JSC Document 143-7 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 7 Case 3:18-cv-01586-JSC Document 143-7 Filed 11/30/18 Page 2 of 3 1 2 3 4 5 6 7 8 9 10 11 12 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION 13 14 15 16 Case No. 3:18-cv-01586-JSC IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) 17 18 19 20 21 22 23 24 25 26 27 28 CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3:18-CV-01586-JSC Case 3:18-cv-01586-JSC Document 143-7 Filed 11/30/18 Page 3 of 3 1 I, 2 1. 3 , declare as follows: I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 4 2. I am a Plaintiff in the above-captioned action. 5 3. I am a resident of Contra Costa County, California. 6 4. I submit this declaration in support of the First Amended Consolidated Class Action 7 Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil 8 Code section 1750 et seq. 9 10 11 5. The First Amended Consolidated Class Action Complaint has been filed in the proper place for trial of this action. 6. Defendant San Francisco Fertility Centers, d/b/a Pacific Fertility Center (“PFC”), has its 12 principal place of business in San Francisco, California, which is within San Francisco County. PFC 13 conducts substantial business, including the acts and practices at issue in this action, within San 14 Francisco County. 15 7. I purchased long-term freezer storage for my eggs in California from PFC. 16 17 I declare under penalty of perjury under the laws of the United States that the foregoing is true 18 and correct to the best of my knowledge. Executed on November ___, 2018 in __________________, 19 _____________________. 20 21 22 23 24 25 26 27 28 CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3:18-CV-01586-JSC Case 3:18-cv-01586-JSC Document 143-8 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 8 Case 3:18-cv-01586-JSC Document 143-8 Filed 11/30/18 Page 2 of 3 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION Case No. 3:18-cv-01586-JSC IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3:18-CV-01586-JSC 1666982.1 Wcument 143-8 Filed 11/30/18 Page 3 Of 3 declare as follows: 1. I have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 2. I am a Plaintiff in the above-captioned action. 3. I am a resident of San Francisco ormty, California. 4. I submit this declaration in support of the First Amended Consolidated Class Action Complaint, which is based in part on Violations of the Consumers Legal Remedies Act, California Civil Code section 1750 et seq. 5. The First Amended Consolidated Class Action Complaint has been ?led in the proper place for trial of this action. 6. Defendant San Francisco Fertility Centers, d/b/a Paci?c Fertility Center has its principal place of business in San Francisco, California, which is within San Francisco County. PFC conducts substantial business, including the acts and practices at issue in this action, within San Francisco ormty. 7. I purchased long-term freezer storage for my eggs in California from PFC. I declare rmder penalty of perjury rurder the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on November 29, 2018 in San Francisco. CA. CLRA VENUE DECLARATION OF PLAINTIFF PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 3: 16669821 Case 3:18-cv-01586-JSC Document 143-9 Filed 11/30/18 Page 1 of 3 REDACTED FILED UNDER SEAL EXHIBIT 9 Case Document 143-9 Filed 11/30/18 Page 2 Of 3 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN RANCISCO DIVISION IN RE PACIFIC FERTILITY CENTER LITIGATION CLRA VENUE DECLARATION OF PLAINTIFFS TO Case NO. CALIFORNIA CIVIL CODE SECTION 1780(d) 1666987. I CLRA VENUE DECLARATION OF PLAINTIFF TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. Case Document 143-9 Filed 11/30/18 Page 3 of 3 We: declare as follows: 1. We have personal knowledge of the facts stated herein and, if called upon to do so, could competently testify thereto. 2. We are Plaintiffs in the above-captioned action. 3. We are residents of San Mateo County, California. 4. We submit this declaration in support of the First Amended Consolidated Class Action Complaint, which is based in part on violations of the Consumers Legal Remedies Act, California Civil Code section 1750 et seq. 5. The First Amended Consolidated Class Action Complaint has been ?led in the proper place for trial of this action. 6. Defendant San Francisco Fertility Centers, d/b/a Paci?c Fertility Center has its principal place of business in San Francisco, California, which is within San Francisco County. PFC conducts substantial business, including the acts and practices at issue in this action, within San Francisco County. 7. We purchased long-term freezer storage for _eggs in California from PFC. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct to the best of my knowledge. Executed on November 2,2018 in Menlo Park, Calilomia. By: 4! I declare under penalty of perjury under the laws oi the United States that the foregoing lS true and correct to the best of my knowledge. Executed on November 2018 in Menlo Park, Calilornia. CLRA VENUE DECLARATION OF PLAINTIFFS - PURSUANT TO CALIFORNIA CIVIL CODE SECTION 1780(d) CASE NO. 1666987.]