Filing fl 441(13931 E-Filed AM IN THE CIRCUIT CCURT CF THE 11TH JUDICIAL CIRCUIT IN AND FUR COUNTY, FLCRIDA Bans, Plaintiff, CIRCUIT ansIon CASE CA 30 y. snsassn oassnnaun, M.D., EYE: Defendants. AMENDED FDR DAMAGES AND DEMAND FDR. JURY TRIAL The Plaintiff Patsy Bade sues the Defendants Shareen Dreenhaum, M.D., and Hollywood Institute, as, and alleges as follows: 1. This ease arises out of negligent preoperative elearanee of the Plaintiff by the Defendant Dr. Greenhaum and the subsequent provision of stern cell therapy to Plaintiff. As alleged in detail below, Dr. Greenbauln negligently allowed the Plaintiff partieipate in and he suhjeeted to a so- ealled elinieal trial wherein a ?stem cell? rnedieal product was injeeted direetly into Plaintiff?s eyes, eausing her to suffer permanent hlindness. JURISDICTIIDNAL STATEMENT AND IDENTIFICATIDN DF THE PARTIES 2. This is an action for damages in exeess of this Court?s minimum jurisdietional limits, exclusive of interest and eosts. 3. Venue is proper in Eroward County, Florida, where one or more of the Defendants reside and the events giving rise to this lawsuit oeeurred. 4. Plaintiff Patsy Bade resides in Sarasota County, Florida. 5. Defendant Shareen Dreenbaum, MD. is a medical dnctar, specializing in aphthalmalagy. She lives in Westc-n, Flarida, and practices medicine in I?Iallywac-d and Sunrise, Flarida. 6. Defendant Institute, RA. Eye?] is the Flarida praiessianal assaciatian thmugh which Dr. Greenbaum operates her medical practice. WITH CDHDITIUNE PRECEDENT AND FLORIDA STATUTE BECTIDN 766. Netice bf lntentian ta Initiate Litigatian against the Defendants named in this was given and acknc-wledged in accardance with the requirements sf Fla. Stat. The Plaintiff has camplied with all hi the requirements nf the Department cf Health, Agency far Health Care Administratic-n. capy af the Camplaint will be sent ta that entity at the time the Camplaint is filed. This acticm is praperly braught within tw-a years [if when the alleged negligent incident accurred pr within twa years fram the date the alleged negligent incident cauld have been discavered with the exercise cf due diligence. Any and all canditicns precedent tn the filing cf this lawsuit have been camplied with. CERTIFICATE DF CDUHSEL S. Thmugh caunsel?s signature below, it is hereby certified, pursuant ta Flarida Statute section that caunsel far the Plaintiff, hefpre filing this actic-n, made a reasanable investigaticn as permitted by the circumstances tn determine that there are graunds far a gaad faith belief that there was negligence in the care and treatment cf Patsy Bade. Such reascnahle investigatiun has given rise tc a faith belief that grcunds esist fer an acticn against the named Defendant. FACTS GIVING RISE TO THE ACTIDNB A. Stem Cell Claims tn Provide Effective SteLn Cell Thera?. 9. Pi Flc-rida called LLB. Stem Cell, lne., formerly knuwn as ?Biuhart,? uperates a ?stem cell? therapy business, which it advertises including research and clinical trials. 1-3. LLB. Stem Cell, lne. claims te- harvest stern cells by using lipcsucticn tc ccilect adipcse tissue ircni patients and by precessing that tissue tc isulate stem cells. LLB. Stem Cell, Inc. thrcugh its agents, e?icers and then injects the stem cells via needle intc varicus parts cf patients? bodies. 11. U.B. Stem Cell, lne. claims that this stern cell therapy is cutting edge therapy and can he used in treat a myriad cf ailments and diseases, including niacular degeneraticn. 12. Despite these representaticns cf fact, nu scientific evidence cr peer?reviewed literature that LLB. Stem Cell, lne.?s stem cell therapies previde any medical benefit macular degeneratien. 13. LLB. Stem Cell, Inc. administers its services at a clinic called Btem Cell Clinic,? [seated at the Bawgrass Mall in Bunrise, Flerida. 14. A wcinan named Kristin Ccmella, an aerchics instructs-r at the YMCA in Westnn, Flcrida, serves as LLB. Stem Cell, Inc?s chief scientific 1.35:: Less-h. .. "rle?m?l? - of?cer. Ms. Cornella is not. a physician, and, at. all times relevant to this lawsuit, she did not have an}.r degree in medicine or cell biology. Nonetheless, Ms. Cornelia touted herself as an expert in adipose stem cell research and actively participated in LLS. Stem Cell, Inc.?s stem cell procedures. 15. Also working for LLB. Stem Cell Clinic during the times relevant to this lawsuit, was a registered nurse practitioner, Alejandro Peres. Mr. Perez was permitted to conduct procedures at the clinic that. should have been performed by a medical doctor. Mr. Peres, who was supposedlyF trained as a doctor in Cuba, was routinely introduced as a physician to prospective LLS. Stem Cell Clinic patients. B. Defendant Dr. Agrees to Lead a Clinical Trial, Without lastsr Experience of Formal Training1 15. Dr. Greenhaurn first became aware of LLS. Stem Cell, Inc. through Ms. Comella. Dr. Greenhaurn routiner exercises at the local YMCA, where she met Ms. Contella and the two developed a close friendship. Because of their friendship, Ms. Cornella asked Dr. Greenhaun'i if she would be interested in being the principal investigator in a clinical trial of a treatment for Age Related Macular Degeneration a progressive condition for which there is no known medical treatment. 18. Dr. Creenhaum had little or no experience in conducting medical research or clinical trials and had no experience with stem cells. Ms. Cornelia knew this, but advised that experience was not necessary. Dr. rxl?irI-?- Elite-amen 1352:.- .. ?i-le-L?Ei" C-reenhaum initiallj,F refu sed the effer, but later agreed te participate in the clinical trial. 19. In preparatien te oversee the AME) clinical trial, in Cleteber 2013, Dr. tank a ceurse taught by Ms. Cemella en hew to harvest and use adipese derived stem cells. Ms. Cemella agreed te defer the nnrmal cast hi the enurse in exchange for Dr. Greenbaum?s werlr en the AMI) clinical trial. 20. Ev December 2U13. LLB. Stem Cell, Inc. was representing that. Dr. Creenbaum was the principal investigater fer the AMD clinical trial. 21. Dr. Greenbaum believed that the U.S. Stem Cell, Inc. clinical trial an weuld be legitimate that weuld be gathered and shared, there weuld he feller up exams at the patients, and with the gas] of identifying a quality treatment tn help patients af?icted with AMD. 22. The AMT) clinical trial was listed as an angering clinical trial en the United States Natienal Institute ef I?lealth?s clinical trial website, which is the central reppsiterrgs,r fer engeing clinical trials threugheut the world. Defendant Dr. Greenhann: Begins Performing Stem Cell Therapy Surgeries and Realises the Clinical Trial to be a Beans. 23. Cver the next year, Dr. Greenbanm participated in approximately [3 separate stem cell treatments en different patients. 24. LLS. Stem Cell, lne. charged the clinical trial participants theusands ef dellars te receive the treatment and paid Dr. Greenbaum fees ll} perferm her functicns. 25. On each at the patients, Dr. Greenbaum eendueted a pre? precedure exam in her office ts determine whether the patient had the appropriate diagnssis. If the patient was an eligible candidate and met inclusicn criteria, Dr. Greenhaum wculd then the "stem cell? treatment, which entailed a mini lippsucticn pracedure tc- extract the patient?s adipcse tissue cr fat and is then ancther precedure tc inject adipcse derived stem cells directlv intc- the glshe cf the patient?s eye. 26. Ms. Ccmella was present and participated in the cperaticns. Cince the adipcse tissue cr fat was remcved fram the patient, lvls. Camella cr cversaw the ?stem cell? eatracticn and isclaticn pracess. She then returned t0 the aperating tc mcnitcr and direct the injecticn cf the material intc the patient. Thus, Dr. Greenhaum and Ms. Ccmella hath had direct patient ccntact and ccmmunicaticn during the clinical trial prpcedures. 28. Over the ccurse cf the year, Dr. Greenhaum witnessed the manner in which LLB. Stem Cell, Inc. was conducting the trial. She saw or cverheard LLS. Stem Cell, Inc. and representatives lie c-r make misrepresentatic-ns tn patients ahcut the trial. Additicunallv, Dr. Greenhaum knew that nc up an the patients was tc determine whether the treatment was effective or even harmful. And, she alsc determined that there was nc gathering cr sharing cf regarding the treatment. In U.S. Stem Cell, Inc. was cperating a business fer prciit, under the guise sf a clinical research trial. 29. P-Ictwithstanding the failures regarding the clinical trial, Dr. Greenbaum did nothing until the spring of 2015, when she ?nally advised her good friend, Ms. Cornelia, that she would no longer participate. 30. Ms. Comeiia became extremely upset and ultimately convinced Dr. Greenbaum to at least perform the pre procedure exams for the already scheduled procedures. Dr. Greenbaum agreed to continue working for LLB. Stern Cell, Inc. on these terms, notwithstanding that she knew the aforementioned information and the clinical trial to be a scam. D. Dr. Greenhaum Clears Ma. Earle to Participate in the Clinical Trial. 31. Ms. Bade discovered LLB. Stem Cell, lnc.?s AMI) clinical trial one day while browsing the US. Health clinical trials website. 32. Ms. Bade had been diagnosed with AMD years before and had experienced some progression. at this point, she could not read small print. without the help of a magnifying glass and was having trouble driving at night. But, even with these limitations, Ms. Bade was living entirely independently. 33. Ms. Bade phoned US. Stem Cell, inc., spoke several times to Kristin Con'iella, and made plans to travel to Sunrise, Florida to undergo the procedure. 34. A short time later, lvis. Bade inquired of 1.1.8. Stem Cell, inc. whether the steroid medication she used to relieve knee pain would complicate her scheduled stem cell therapy surgery. The US. Stem Cell, Inc. representative told her that it would not, but that for an additional fee a us. Stem Cell, inc. physician could also inject stem cells into 1.35:: Cost-h. .. "rle?m?l? - her knee to treat. her pain. Ms. Bade was persuaded to page the extra amount and undergo this knee procedure as well. 35. [in June 15, 21315, Dr. Greenhaurn saw Ms. Bade for the pre procedure errant in her of?ce. 36. During this visit, Dr. Greenhaurn examined Ms. Bade and cleared her for the clinical trial, which Dr. lGreenhaun'i knew would he conducted the following day at LLS. Stem Cell Clinic in Sunrise, Florida. Dr. Greenhaunt assured Ms. Bade that she was a candidate for the procedure and that it was safe for her to proceed. 38. At no point did Dr. Greenhaum warn Ms. Bade that the AMD clinical trial was not operating as represented or of her concerns about the trial which caused her to stop acting as the chief investigator. In short, Dr. Greenhaun'i did nothing to communicate her concerns about the clinical trial, nor did she do anything to dissuade Ms. Bade from going forward with this procedure. 39. Pursuant to Dr. Greenhauin?s orders, the following day, on June 2015, Ms. Bade arrived at 1.1.3. Stem Dell?s clinic at Sawgrass Mills. There, Ms. Bade was introduced to Mr. Alejandro Perez and told that he was the who would he performing the stern cell therapy,r surgeries on her and knee. 40. Mr. Peres, a nurse, then proceeded with the surgeryr on Ms. Elade, with Ms. Contella participating as well. Specifically, Ms. Comella isolated the stem cells front Ms. Bade?s adipose tissue and then directed the injection of these cells into Ms. Bade's eyes and knees. 41. Following the surgeer Ms. Elade?s vision worsened drastically and she is now legallyr blind. 42. As a direct and proximate cause of Dr. Greenbaum?s negligence, Ms. Bade suffered permanent damage, as alleged in more detail below. COUNT I lCLAIllilI AGAINST DEFENDANT SHAREEN GREENBAUM, MJJ. PRUFE-SSIDNAL NEGLIGENCE 43. The Plaintiff adopts and realleges paragraphs 1 through 42 and further alleges: 44. The Defendant Sharcen Grecnbaum, held herself out to the public in general and Ms. Bade in particular as a healthcare provider capable of and who undertook the corresponding dutyr to Ms. Fiade of providing healthcare services to Ms. Bade in accordance with that level of care and skill that is recognised as acceptable and appropriate by reasonably,F prudent similar healtheare providers under the same or similar circumstances. 45. Notwithstanding the duties undertaken, Defendant Dr. Greenbaum breached her duties by a. Negligentlv clearing Ms. Bade to undergo the LLB. Stem Cell, Inc.?s stern cell therapjg.F procedure to treat her macular degeneration; h. Negligentlv advising Ms. Bade on a stem cell procedure, about which Dr. Greenbaum lacked expertise and experience; e. Negligently representing tn Ms. Bade that. US. Stein ICell, Ine.?s stern eell therapy was capable ef treating the pregressinn sf maeular degeneration; d. lilegligerutlg,r failing to warn Ms. Bade ed the seridus and danger-tins side effects and risk at injury at" the LLB. Stem Cell, Ine.?s stem eel] therapy; e. Negligently alldwing Ms. Bade ta undergn the stem cell therapy when Dr. Greenbaum knew er sheuld have known that US. Stem Cell, Inc. was net eperating a legitimate elinieal trial and that the stern eell therapj,F it was selling tn Ms. Bade wnulel prewide any bene?t fer her maeular degeneratinn; Negligently allnwing Ms. Earle tn undergn a stem cell therapyr that Dr. Greenhaum knew shduld have wnuld net he a qualified medieal prefessie-nal; and g. allewing Ms. Elade ta g0 fer-ward with the stem cell therapy,r when she did ne-t meet the criteria fer inclusion in the elinieai trial. 46. As a direct and presimate eause er the negligence dl' Defendant Dr. Greenhaurn, Ms. Elaele underwent the LLS. Stem Dell, Inc. stem eell therapy,r and sustained seridus permanent damages as alleged in detail belnw. CDUNT II AGAINST EYE INSTITUTE, P.A. VICARIDUS LIABILITY FDR. THE NEGLIGENCE DF BHAREEN GREEHBAUM, MIL The Plaintiff adapts and realleges paragraphs 1 thrnugh 42, and further alleges: 45. At all times material ta this eause ef aetidn, Dr. Greenhaum was the principal, agent, servant, er at" Hallwedd Institute, Pane, her prafessinnal assnciatinn, and was acting within the course and scape cf her er agency and under its central. 46. Therefere, Defendant Hellyweed Institute, PA, is vicarinusly liable far the negligence uf Dr. Greenhaum, as set forth in Ccunt I. DAME-EB CLAIMED BY BABE The Plaintiff Patsy Bade, as a direct and proximate result cf the Defendants alleged aheve, has in the past and will in the future ccntinue tc suffer the fellewing damages: a. Eedtly injury; h. Pain and suffering; c. Disability; d. Disfigurement; e. Less cf the capacity fer the cf life; . aggravaticn cf prc-caisting ccnditicns; g. Medical and hespital care and expenses; h. Less nf earnings; i. Less nf earning capacity in the future; j. Rehabilitaticn expenses; and 1c Mental distress; WHEREFDRE, Plaintiff Patsy Bade demands judgment against Defendants damages in an aineunt in eacess Df the jurisdictional limits cf .. a. "rle?m?l? - this Court exclusive of interest and costs, and all sueh other relief as the Court deems just and proper. DEMAND FDR JURY TRIAL The Plaintiff demands trial by jar},r of all issues triahle as of right. CERTIFICATE CF SERVICE I HEREBY CERTIFY that the foregoing document 1aras electronicallyr ?led with the IClerk of Court on this 191" day of July. EDIE: and electronicallyr served on all eounsel on the attached Service List GROSSMAN RUTH CDHEN, RA. Counsaifor Plaintiffs 2525 Ponee de Leon Blvd, #11513 lCoral "Sablesr Florida 33134 Telephone: {305] 442-3556 Facsimile: 285-1558 Primary: abvfagrossmanrotheom 133?: sfi?indrew B. Ya?a ANDREW E. YAFFA Fla. Bar No.: 391310 NEHL A. RUTH Fla. Bar No; EEGSTEI ru. avian-:5 Hie-5541331 . - ?ler-l.? SERVICE L1 51? Marc P. Gang. Esq. Noaich :35 Gan: T5 Valencia, Suite 1 Caz-1'31 Gables. FL 33134 Email: {manum?u?ggatmrneyaxam; Cnurmelf?r Dr. Greenbaum {aha-95 ., - Hie-a": Ft'fl?d?. I. --