Case 1 :03-cv-11445-WGY Document 45 Filed 02/21/08 Page 1 ot `30 __ % UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS . UNITED STATES OF AMERICA; THE ) STATES OF CALIFORNIA, DELAWARE, ) FLORIDA. GEORGIA, HAWAII, ILLINOIS, ) ? ~ : INDIANA, LOUISIANA, MASSACHUSETTS, ) ` MICHIGAN, MONTANA, NEW ) . V _ HAMPSHIRE. NEW JERSEY. NEW ) . MEXICO, NEW YORK, NEVADA, ) ' OKLAHOMA. RHODE ISLAND, ) , i TENNESSEE, TEXAS, and VIRGINIA; COOK ) . COUNTY, ILLINOIS; THE CITIES OF ) 4 . _ , CHICAGO AND NEW YORK; and THE ) FILED IN CAMERA ' DISTRICT OF COLUMBIA ex rel. ANGELA ) AND UNDER SEAL MAHER and ANASTASIA SAVKA- ) KLOVSKI and ANGELA MAHER and ) ANASTASIA SAVKA-KLOVSKI, ) Case No. 03-I 1445--WGY individually. ) ChiefJustice William G. Young ) Plaintiffs. ) ) v. ) ) ORTHO-McNEIL PHARI\/IACEUTICAL, a ) New Jersey corporation, ) ) Defendant. ) SIXTH AMENDED COMPLAINT FOR VIOLATION OF FALSE CLAIMS ACT TRIAL BY JURY REQ QUESTED Pursuant to 3] U.S,C, ? 3730(b)(1) and the False Claims Acts ofthe States, County, Cities and District, as defined and more specifically listed below, Angela Maher and Anastasia Savka-- Klovski, for themselves and on behalf of the United States of America; the States of Califomia. Delaware, Florida, Georgia, Hawaii. Illinois, Indiana, Louisiana, Massachusetts. Michigan, Montana. New Hampshire, New Jersey, New Mexico, New York, Nevada, Oklahoma., Rhode Island, Tennessee, Texas, and Virginia; the County of Cook, Illinois; the cities of Chicago and New York; Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 2 ot 30 and the District of Columbia, by their attomeys. Frank, Haron. Weiner and Navarro, bring this civil action under the False Claims Act, 3l U.S.C. ? 3729 ?g,. the False Claims Acts of the above- listed States, County, Cities and District, and under common law theories of payment by mistake, unjust enrichment, and allege as follows; JURISDICTION AND VENUE 1. This action arises under 31 U.S.C. ? 3729 etgjg also knovm as the False Claim Act, (the "Act") and the common law to recover treble damages and civil penalties on behalf of the United States of America arising out of the Defendant's violation ofthe Act. 2. Under ? 3732 of the Act, this Court has exclusive jurisdiction over actions brought under the Act and concurrent jurisdiction over state claims arising from the transactions giving rise to the claims under the Act. F urthennore, jurisdiction over this action is conferred on this Court by 28 U.S.C. ?l33l because this civil action arises under the laws of the United States. 3. This Court has supplemental jurisdiction over all other claims set forth in this Complaint because these claims are so related to the claims arising under the Federal False Claims Act that they form part ofthe same case or controversy. 28 U.S.C.? l 367, 4. Venue is proper in this district pursuant to ? 3732 (a) ofthe Act, which provides that "`any action under ? 3730 may be brought in any judicial district in which the Defendant or, in the case ofmultiple Defendants, any one Defendant can be found, resides, transacts business, or in which any act proscribed by ? 3729 occurred." The acts, which are the subject of this action, occurred in the State of Massachusetts, among other states, within this judicial district. At all tirnes material hereto, Defendant regularly conducted substantial business within the State of Massachusetts, maintained permanent employees and ottices in the State ofMassachusetts, amd made and is making -2- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 3 of 30 significant sales within the State of Massachusetts, within this judicial district. Additionally, venue is proper in this district pursua.nt to 28 U.S.C. ? l39l(b)(l)-(2). FILING UNDER SEAL 5. Under the Act, this complaint is to be filed in camera and remain under seal for a period of at least sixty (60) days and shall not be served on Defendant until the Court so orders. The Govemment may elect to intervene and proceed with the action within sixty (60) days after it receives the Complaint 6. As required by the False Claims Act, Relators voluntarily submitted prior to the filing of this complaint a confidential written disclosure statement (subject to the attomey-client privilege) to the United States Govemment containing material evidence and infomiation in their possession pertaining to the allegations contained in this complaint. PARTIES 7. Relator Angela Maher is a resident of the State of Michigan and a former sales representative of Defendant Ortho-McNeil Pharmaceutical ("OMP" or Defendant). 8. Relator Anastasia Savka-Klovski is a resident ofthe State of Michigan and a former sales representative of OMP. 9. Relators are individually and respectively original sources ofthe facts and information hereinafter set forth conceming the activities of OMP. The facts averred herein are based entirely upon their personal observation and documents in their possession. I0. OMP is aNew Jersey corporation with its principal place of business in Raritan, New Jersey. OMP is principally engaged in the manufacture and sale of pharmaceuticals, including -3- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 4 of 30 prescription pharmaceuticals falling under thejurisdiction and regulation of the U.S. Food and Drug Administration. OMP is a wholly-owned subsidiary of Johnson & Johnson. GENERAL ALLEGATIONS OMP`s Sales Force 1 1 . OMP specializes in pharmaceutical products in the areas o1`women's health. central nervous system, infectious diseases. and wound healing. 12. OMP's "ground" sales force consists of 149 sales representatives, each of whom has a "territory" and reports to a District Manager. During the times in question, Relator Maher`s District Manager were Kevin Gueno and Julie Graves and Relator Savka-1> label uses of Topamax for brief periods of time and in which physicians and their families or other guests were wined and dined by OMP to induce off-label prescriptions: a. November 18. 2001: "Fiddler on the Roof" event at the Fisher Theater and dining at the nearby gourmet Cuisine Restaurant. The speaker for that event was frequently used by Relator Maher because he freely spoke of Topamax off-label uses for OMP. Price Tag for the night's event: $5,000. b. April 19, 2001 : OMP event featuring dinner and at show produced by Jeff Daniels at the Gem Theatre in Detroit. The presenter was a headache specialist. The primary subject of discussion was Topamax off-label use for migraine. Price Tag for the night (twelve physicians in attendance), including speakers' honorarium: $5 ,5 00 ($4,000 dinner and show and $1,500 speaker fee). Relator Maher's manager was present during this event. c. November 18, 2001: OMP event at Venus Day Spa. The Speaker made a short presentation about Topamax off-label use for weight loss for a $1,500 fee. Price tag for the night`s event: $5,000. Relator Maher's manager was present during this event. d. January 12, 2002: OMP event at Duet, another gourmet restaurant in Detroit, featuring the Broadway show "Mama Mia." The speaker made a short presentation about Topamax off-label use in monotherapy for a $1,500 fee. Price tag for the night's event: $5,000. e. January 30, 2002: OMP event at the \Nhitney, featuring the Broadway show "S outh Pacific." The speaker made a 20 minute presentation of Topamax off-label uses on headache and weight loss for a $1,500 fee. Price tag for the night`s event: $5,000. -14- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 15 of 30 f. October 8, 2002: OMP dinner event at "posh" Opus One in Detroit. The speaker, an anesthesiologist, made a short presentation on Topamax oi'f--label use for the treatment ofpain for a $1.500 fee. Price tag for the night's event: $5,000. Out-of-Town "Entertainment" were Kickbacks 46. oi/1P also made its sales--reps available to entertain providers anytime they were out- oiltown for conventions. There were no presentations nor expense limitations whatsoever attached to these entertainment outings. Educational "Grarits'" were Kickbacks 47. During Relator Maher`s employment with OMP. the latter also had a no-questions/no- restrictions "Grant" program which allowed Relator Maher to offer and hand-out money to any providers of her choosing. 48. OMP did not ibllow up with physicians to ensure that OMP`s cash gifts went to bona- tide research or educational activities. OMP's policy was a "n0 questions asked" policy. 49. The following is a non-exhaustive list of cash that was handed out by Maher for OMP without any restrictions nor ibllow-up of its ultimate use: a. On June 25, 2001, OMP made an unrestricted gift of $400 to Henry Ford Systems. b. On November 12. 2001, OMP made an unrestricted gift of $3.000 to the Detroit Medical Center/Wayne State University Department of Neurology,. which was intended to influence and reward two faculty members for prescribing Topamax for off--label use at the Veterans Administration Hospital in Detroit. -] 5- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 16 of 30 c. On January l, 2002, OMP made an unrestricted gift 0f$250 to a doctor in Garden City, Michigan, to reward him for his off-label sales of Toparnax. d. On January l, 2002, OMF made an unrestricted gilt of $250 to a frequent OMF diner and speaker doctor in Garden City, Michigan to reward him for his off-label prescriptions of ' fopamax. Sponsorships of "Educational" Programs were Kickba$ 50. OMP also sponsored "educational" programs, which relied heavily on presentations by OMF frequent-diners and speakers and, thus, had received kickbacks from OMP. 5 l. The following is a non-exhaustive list of such programs: a. March 23, 2002: OMP "sp0nsored" an "`educational" program called "Update on Epilepsy" presented by Henry Ford. OMP paid $5,000 to support this program, which included as speakers two doctors who frequently received "grant" and inflated "Speaker" honoraria hom OMF. Their topic of presentation was monotherapy, an off-label use of Topamax. b. October 27. 2001: OMF "sponsored" an "educational" program called "Neurology for the Non-Neurologist" presented by Wayne State University. As with the Henry Ford presentation, OMP paid $5,000 to support this program, which, once again, included as speakers two doctors who were heavy prescribers of Topamax for off-label use in treating headaches and monotherapy and who were all frequent Toparnax "speakers." Relator Savka--Klovski 52. Relator Savka-Klovski joined OMF in January of 1999, after spending years with other Johnson and Johnson companies, as a pharmaceutical specialty representative in the -] 6- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 17 of 30 Neuroscience! Metabolic Division. She was hired to promote Topamax and Ultram, amoderate pain reliever. to neurologists in Ann Arbor and Toledo. 53. From 1999 through January 2001, Relator Savka-Klovski was a "star" at OMP. She received numerous sales awards, numerous raises, and was consistently at the top of her district`s sales. 54. Beginning in January 1, 2001, after Julie Graves became her District Manager and Sebastian Borriello was appointed National Sales Director, Relator Savka-Klovski began to experience substantial pressure to promote Topamax off-label to psychiatrists, among other specialties, from OMP's management, including Julie Graves and Brian Nappi, the Region's Sales Manager, and to use misleading information about Topamax? safety and efficacy, as well as economic and/or entertainment incentives to encourage off--1abe1 prescriptions of Topamax. Training on Offllsabel - Misrepresentations - Relator Savka Q 55. Beginning in January of 2001, Relator Savka-Klovksi was repeatedly instructed by OMP supervisors to focus her marketing efforts on the off-label promotion of Topamax and to use incomplete and misleading statements regarding the existence of scientific studies on the efficacy and safety of Topamax for off?labe1 use. 56r Relator Savka--Klovski, like other sales reps for OMP, received "Ca11 Plans" which described the physicians on whom she was required to call to market Topamax. One-half of the physicians on Relator Savka--K1ovski Call Plans were psychiatrists. a specialty that only has a demand for off-label uses of Topamax. -]7- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 18 of 30 57. The following is a non-exhaustive list of occasions in which Relator Savka--Klovski was instructed to push off label sales and to "call on" off--label specialties; and to misrepresent the efficacy and safety of Topamax off-label uses: a. On October 200l. at a 3'd Cycle Meeting in Detroit, OMP representatives instructed sales reps, including Relator Savka-Klovski. on how to "'bait" physicians into asking about the oH`-label uses of Topamax. b. On June 17, 2002, OMP representatives instructed Relator Savka-Klovski on how to push off--labe1 sales of Topamax for binge-eating and pain at a Training Session at the Detroit Marriot. c. On September 19, 2002, Brian Nappi, OPM's Region Business Director, instructed Relator Savka--Klovski in writing (and copied Kevin Gueno, Relator`s District Sales Director) to push off-label sales to psychiatry d. On numerous occasions, all of the foregoing individuals instructed Relator Savka-Klovksi to make misleading statements and misrepresentations to physicians in her territory, to which she obliged, regarding the existence of scientific studies and medical intormation which demonstrated the safety and efficacy of Topamax for the off-label uses which she was required to promote, even though OMP knew that said scientific studies and medical information were not scientifically sound. e. On numerous occasions, all of the foregoing individuals instructed Relator Savka-Klovski, and she obliged, to withhold from physicians infonnation about adverse side effects of Topamax, including liver damage and secondary myopic glaucoma, which called into question the safety and efficacy of Topamax for the off--label uses she was forced to promote. -18- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 19 of 30 The "Free Lunch" Program were Kickbacks 58. Like Relator Maher. Relator Savka-Klovski pandered physicians for oilllabel prescriptions of Topamax on beha1fofOl\/IP by providing entertainment, food, and money under a number of programs that were designed to influence physicians' prescription habits. 59. Among those programs was the *'Free Lunch" Program. 60. The "Free Lunch" program worked as lbllows: a. Relator Savka-Klovski was given an annual "b1ank check" for entertainment of target providers gd their families/guests. b. In order to make the program look "educational," Relator Savka-Klovski was required to schedule a guest speaker, who was paid an honorarium of $1,000 for a 20-30 minute presentation, or make some kind of product presentation. c. lmportantly, the subject of the presentations always revolved heavily, if not exclusively, around Topamax off-label uses. d. The remaining time of the program was spent entertaining the guests. e. In order to avoid the appearance of impropriety due to the high tag of these events, OMP paid the speakers honorarium and other program expenses through a marketing firm by the name of Ilacqua, Dibona & Associates (ID&A). 61. Free lunches were typically provided to providers on a weekly basis at a cost which often exceeded $500 per lunch for a handful of physicians. 62. The following is a non-exhaustive list of free lunches provided by Relator Savka- Klovski on behalf of OMP to physicians for the purpose of inducing prescriptions of Topamax; -]9- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 20 of 30 a. On February 26, 1999, OMP sponsored the first of its "free lunch" Friday series catered by Zingerman Deli for the Stroke group at the University of Michigan, The "free lunch" Friday series was continued weekly during Relator Savka-Klovski`s tenure with OMP. b. ln early 1999, OMP sponsored its regular "free lunch" Tuesday series tor the Michigan Drug Trial at the University of Michigan. The "free lunch" Tuesday series was continued every six weeks during Relator Savka-Klovski`s tenure with OMP. The "Speaker" Series were Kickbacks 63. Just like Relator Maher, Relator Savka-Klovski had wine--and--dine events for her doctors on behalf of OMP, which OMP benevolently labeled as "'Speaker" programs - even though presentations were a very minor part of the event (20-25 minutes maxim um) -- in order to package them as educational. In reality, these events were nothing more than a way for OMP to pay for access to physicians and influence their Topamax prescription habits. 64. OMP never set a budget or a spending limit by Relator Savka--Klovski for entertainment of her providers (or, if it ever set one, it never enforced it). 65. All night events and speaker fees paid through lD&A. 66. The following is a non-exhaustive list of '"Speaker" events sponsored by Relator Savka Klovski on behalf of OMP: a. On April 25 and 26, 1999, OMP hosted a lavish dinner and auction for physicians at the Ann Arbor Art Association Fund Raising Dinner and Auction. The event had a price tag of $2,500 for 12 people, not including the speaker's fee of $1,000. b. On October 10, 1999, Relator Savka-Klovski (along with 2 other sales reps) rented out the entire Lark Restaurant, one ofthe highest-rated and most expensive restaurants in the -20- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 21 of 30 Detroit area, The price tag for the evening was substantially in excess 0f$ I 2,000, not including the $1.000 speaker`s fee for Dr. Rosenfeld. c. On November 19, 1999, Relator Savka--Klovski sponsored a Wine Tasting Program. including an evening of wine, hors d'oeuvres. and music, at the Ritz Carlton Hotel in Dearborn. Michigan. The tag for the night was well over $1,000 for 8 guests, 110t including the speaker`s fee of $1 ,000. di On September l , 2000, Relator Savka-Klovski once again rented out the entire Lark Restaurant for 12 physicians and 1 nurse practitioner. The price tag for the night was in the thousands. e. On October 21, 2000, Relator Savka-Klovski sponsored a "lecture" on Topamax, which "featured" a dinner and performance at the Detroit Opera House, to which a handful of physicians attended accompanied by spouses and parents. The price tag for the night was in the thousands. f On April 1, 2002, OMP hosted a "'program" at the Fran Coy Salon and Day Spa--C ari, featuring a brief presentation on off-label uses from a frequent diner and speaker physician. g. On May 18, 2002, OMP hosted a "Cooking C lass" featuring, once again, a short presentation of Topamax off-label uses by another frequent diner and speaker. h. On May 30, 2002, OMP hosted a dinner at the West End Grille, featuring a short presentation by a physician on migraine, head pain, and neuralgia. all ofiilabel uses of Topamax. i. On May 16, 2002, Relator Savka sponsored a day--event featuring lunch and dinner at Fifi's Restaurant in the company of an OMP speaker whose entire presentation consisted -2]- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 22 of 30 V of Neuroprotection uses (ofiilabel) of Topamax. The price tag for this event was also in the thousands. The speaker fee was $2,000. The "Grant" Program were kickbacks: 67. As with Relator Maher. OMP had a no--questions/no-restrictions "'Grant" program which allowed Relator Savka-Klovski to offer and hand--out money to any providers of her choosing. 68. OMP frequently used the "Grant" program as a method for compensating physicians for speaking tavorably of Topamax (i.e., as speaker`s honoraria). 69. The following is a non--exhaustive list of the foregoing: a. On January 8, 2001, OMP paid a University of Michigan physician $1,000 tor speaking about Topamax for 25 minutes during an OMP outing. b. On April 20. 2001, OMP paid a "frequent" OMP speaker $3,000 to do one day of physician "rounds" with Relator Savka-Klovski and speaking about treatment of pain (off- label) with Topamax. Relatcrs' off-label sales of Topamax "spiked" following Relators office-gg; to physicians and were best amongst those physicians who recc@:_> Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 26 of 30 86. Upon infomation and belief} Topamax was prescribed and reimbursed through state- administered MCOs. 87. The Medicaid statute allows states to cover outpatient prescription drugs through their respective Medicaid programs. 42 U.S.C. ? 1396a(a)(l0)(a). 88. Likewise. the Department of Veterans' Affairs ("VA") provides numerous prescription drugs in connection with VA programs. 89. Medicaid and the VA programs are funded by federal funds. 90. With the exception of CHAMPUS, the federal reimbursement scheme provides that prescription drugs are only reimbursable if they are FDA-approved or otherwise medically accepted to treat the particular diagnosis for which the drug is prescribed (even if that renders the use off- label), as evidenced by the drug's inclusion in a number of recognized conipendia. 91. Under CHAMPUS (i.e., the Civilian Health and Medical Program hir the Uniformed Services). benefits may not be extended for drugs not approved by the FDA. ?ge 32 C.F.R. ? l99.4. 92. The efficacy of Topamax for off-label uses is not supported by scientifically-based peer review or approved compendia. 93. Accordingly, Topamax for off-label use is not reimbursable by Medicare (MCO), Medicaid. VA, or CHAMPUS. 94. All such federal pro grams have reimbursed Topamax for off-label use throughout the country as a direct result of ()MP`s unlawful and false national marketing scheme and kickbacks. Therapeutic Eguivalency Denigration 95. Even if scientifically-based peer review were to support some off-label use of Topamax, OMP's aggressive and false marketing scheme of off-label uses has denigrated the -26- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 27 of 30 integrity of these federal programs, as it has enabled OMP to avoid price controls deriving out of therapeutic equivalency rules. 96. 42 U.S.C. ? l396r-8 lays out numerous requirements that must be met for federal coverage of prescription drugs under federally funded programs, such as Medicare and Medicaid. 42 U.S.C. ? 1396r-8 is equally applicable to benefits to Cl-IAMPUS and Veter.an`s affairs drug coverage programs. 97. Among other things, federally funded programs are required to enter into agreements with drug manufacturers which set price controls and formulary inclusion for the covered drugs based on therapeutic equivalencies. gg generally 42 U.S.C. ? 1396r-8. 98. OMP's off-label promotion and avoidance of proper FDA procedures for approval of a new drug has resulted in the lack of any classification of Topamax for therape utic equivalency as to its off-label uses. 99. As a result, Topamax has not been subjected to federal price limits based on therapeutic equivalency. lOO. The federal govemment has been harmed by this avoidance of a rating of Topamax off-label uses because other less expensive drugs are capable of conferring the same benefit as Topamax. lf Topamax were properly rated fer therapeutic equivalency. the federally funded programs would be able to achieve the same benefits for less money. Formulary Violations lOl. Moreover, under 42 U.S.C. ? 1396r-8, the agencies in charge of administering federally funded drug prescription programs are required to establish formularies for the purpose of defining those prescription drugs and uses for which reimbursement may be had. -27- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 28 of 30 102. The underlying purpose of formularies is to direct prescribers (i.e., physicians) and patients to lower-cost, but similarly safe and effective drugs and to help in price negotiations to obtain such lower-cost drugs. 103. Thus, federal law requires that these fomularies include only medically- accepted uses of prescription drugs by reference to the publications set forth therein (i.e.. American Hospital Formulary Service Drug lnfomation, the United States Pharmacopeia-Drug Infomation, the American Medical Association Drug Evaluations, or by peer-reviewed medical literature). Other criteria besides medical efficacy include drug utilization review, generic substitution. and therapeutic interchange (as previously explained). 104. The management of fomularies is very complex. l05. Topamax's inclusion or exclusion in formularies for which federal reimbursement is available is not susceptible to generalization, as the content offormularies nationwide differs by program, state agency, and region. a. MCOs, for example, have different fomiularies, prior approval, and co- payment provisions for different clients, such as employers, individuals, Medicare, and Medicaid programs. b. The VA has a national fomulary, together with region and specialty-specific fomularies which often differ from the national fomulary insofar as coverage of a drug is ? conccmed. 106. The lack of formulary standardization has led to the systematic reimbursement of otherwise non--reimbursable off-label uses of Topamax by the federal govemment because, as a general rule, the agencies/entities administering federal funds in this area lack the ability to monitor -23- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 29 of 30 precisely whether the medical diagnosis coincides with the formulary use in the case of individual prescriptions. as well as the technical ability to reject reimbursement for off-label uses of` prescription drugs which otherwise show up in their formularies. 107. OMP has taken advantage of`this lack of technical ability ? an unfortunate loop-hole in the scheme of formulary-based health programs, such as Medicaid. Medicare (MCO's). CHAMPUS, and the VA Health-system - by aggressively marketing Topamax to physicians, such as VA physicians, which OMP knew primarily (if not only) use the drug for non-reimbursable off- label purposes. States False Claims Acts 108. In addition to being funded by federal funds, the Medicaid program is iiinded by state funds in each pertinent state. 109. OMP's conduct is actionable in the States of Califomia (Cal Gov't Code ? 12650 et seq.), Delaware (Delaware False Claims and False Reporting Act, 6 Del C. ? 1201 et seq.), Florida (Florida False Claims Act, Fla. Stat. Ann. ? 68.081 er seq.), Georgia (Georgia State False Medicaid Claims Act. Code of` Georgia, Chpt. 4 of Title 49), Hawaii (Haw. Rev. Stat. ? 661-21 ei seq.), Illinois (lllinois Whistleblower Reward and Protection Act, 740 Ill. Comp. Stat. ? 175/1 er seq.), Indiana (Indiana False Claims and Whistleblower Protection Act, IC 5-1 1-5.1 ul seq.), Louisiana (La. Rev. Stat. Ann. ? 46:439.1 et seq.), Massachusetts (Massachusetts False Claims Law, Mass. Gen. Laws Ch. 12 ? 5 er seq.), Michigan (Michigan Medicaid False Claims Act, 400.601 @@1,), Montana (2005 Mont. Code, CH. 465, HB 146 (2005)), New Hampshire (New Hampshire False Claims Act, NH. 167: 61-b ei seq.), New Jersey (New Jersey False Claims Act, S.B. 232, 213'*' Leg. (2008)), New Mexico (New Mexico Medicaid False Claims Act. N.M.S.A. 1978, 27-14-1), New York (New -29- Case 1:03-cv-11445-WGY Document 45 Filed 02/21/08 Page 30 ot 30 York False Claims Act, N.Y,S. 2108C er seq.), Nevada (Nevada False Claims Act, Nev. Rev. Stat. Ann. ? 357.010 el seq.), Oklahoma (Oklahoma Medicaid False Claims Act. 63 Okl. St. Ann. ? 5053 el seq.), Rhode lsland (Rhode lsland State False Claims Act, Title 9 ? 9-1.1-1 et seq.), Tennessee (Tennessee Medicaid False Claims Act, Tenn. Code Ann. ? 71-5-181 el seq.), Texas (Texas Medicaid Fraud Prevention Law. Tex. Hum. Res. Code Ann. ? 36.001 e/ seq.), Virginia (Virginia Fraud Against Taxpayers Act. Va. Code Ann. ? 8.01-216.1 er seq.), Cook County. lllinois (Cook County False Claims Act, Resolution No. 03-R--394). the City of Chicago (City ot Chicago False Claims Act, 1-21-010 el seq.), the City of New York (New York City False Claims Act Local Law 53 ol 2005), and the District ol`Co1umbia (District of Columbia Procurement Reform Amendment Act, D.C. Code Ann. ? 1-1 188.13 er seq.) (collectively. the "States") pursuant to the respective False Claims Acts in those states. Conclusion 1 10. ln sum, through the pervasive practices described herein, OMF has systematically violated FDA rules, has systematically relied on kickbacks to induce providers to prescribe and endorse the use of Topamax, and has systematically misrepresented the efficacy and safety of Topamax`s off-label uses, knowing that all such conduct would cause false claims to be presented and paid by the United States Govemment and the States. 1 1 1. OMP's practices have and continue to denigrate the integrity of all lederal programs which provide drug-benefits, including Medicare, Medicaid, the Veterans' Administration. and CHAMPU S and has caused millions of dollars in damages to the United States Government and the States. -30- Case 1 :03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 1 of 24 COUNT [ Federal False Claims Act - Presentation of False (@;n? I I2. Relators reallege and incorporate paragraphs I-I I I of this complaint as if fully set forth herein. I 13. In performing the acts described above. OMP. through the acts of its officers. knowingly presented or caused to be presented to an agency, officer, or employee of the United States false or fraudulent claims for payment in violation of 31 U.S.C. ? 3729(a)( I). 114. The United States, unaware of the foregoing circumstances and conduct of the Defendant, made lull payments, which resulted in its being damaged in an amount to be determined. COUNT Il Federal False Claims Act - False Statements 115. Relators reallege and incorporate paragraphs I-l 1 1 of this complaint as if fully set forth herein. I I6. In performing the acts described above, OMP through the acts of its officers. knowingly made, used, or caused to be made or used, false records or statements to get a false or fraudulent claim paid or approved by the Government in violation of 31 U.S.C. ? 3729(a)(2). I17, The United States, unaware of the foregoing circumstances and conduct of the Defendant, made full payments which resulted in its being damaged in an amount to be determined. COUNT III F edgral False Claims Ac; - Concealing of an Obligatgi l 18. Relators reallege and incorporates paragraphs 1-1 1 1 of this complaint as if fully set forth herein, -3 1 - Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 2 of 24 119. ln performing the acts described above, OMP through the acts of its ofhcers. knowingly made, used, or caused to be made or used, false records or statements to conceal. avoid, or decrease an obligation to pay or transmit money to the Government in violation of 31 U.S.C. ? 3729(a)(7). 120. The United States. unaware of the foregoing circumstances and conduct of the Defendant. made full payments, which resulted in its being damaged in an amount to be determined. COUNT IV Payment Under Mistake of Fact 121. Relators reallege and incorporates paragraph l--l l 1 of the complaint as if fully set forth herein, 122. This is an action to recover monies paid by the United States under a mistake in fact that was caused by OMP through the activities described in this complaint. 123. The United States made payments for Topamax prescriptions throughout the country under the erroneous belief that the records, statements, and proposed amounts upon which reimbursement was based were true, correct and proper. l24. The United States' erroneous beliefs were material to the payments made by the Govemment. 125. Because of these mistakes of fact, the United States paid moneys for prescriptions of Topamax that were not reimbursable and to which the United States is entitled. 126. By reason of these payments, the United States has suffered damages in an amount to be determined. -32- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 3 of 24 COUN T V Un |`ust Enrichment 127. Relators reallege and incorporates paragraphs 1-1 1 1 ofthe complaint as if fully set forth herein. 128. This an action to recover monies by which OMP has been unjustly enriched. Due to the Def endant`s improper practice. the United States paid monies by which OMP has been unjustly enriched. 129. By reason of its payments, the United States is entitled to damages in an amount to be determined. COUNT V1 California False Claims Act -- Cal. Govt. Qoge ? 12651 (an] [ and {a)j2[ 130. Relators reallege and incorporates paragraphs 1-1 1 1 of the complaint as if fully set forth herein. l3 1. In performing the acts described above. OMP, through the acts of its officers. knowingly presented or caused to be presented to the California State Government fraudulent claim s for payment in violation of Cal. Govt. Code ? l265l(a)(l). 132. In performing the acts described above, OMP, through the acts of its officers. knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the California State Government in violation of Cal. Govt. Code ? 1265 l(a)(2). 133. The State of California, unaware of the foregoing circumstances and conduct ofthe Defendant, made full payments, which resulted in its being damaged in an amount to be determined. -33- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 4 of 24 134. The State of California is entitled to the maximum penalty o1`$1?0,000 for each and every false or fraudulent claim. record or statement made, used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT VII Delaware False Claims and Reporting Act- 6 Del. C. ? 120 L(g)_(l)_ar;1_Q) 135. Relators reallege and incorporates paragraphs 1-1 1 1 ofthe complaint as if fully set forth herein. 136. ln performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the Delaware State Government fraudulent claims for payment in violation of 6 Del. C. ? 1201 (a)(l ). l37. In performing the acts described above, OMP, through the acts of its ofiicers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Delaware State Government in violation of 6 Del. C. ?l20l(a)(2). 138. The State of Delaware, unaware ofthe foregoing circumstances and conduct ofthe Defendant. made full payments, which resulted in its being damaged in an amount to be determined. 139. The State of Delaware is entitled to the maximum penalty of $11,000 {br each and every false or fraudulent claim, record or statement made, used. presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNI VIII Florida False Qlaims Act - Fla. Stat. Ann. ? 68.08242)ga);_(g] 140. Relators reallege and incorporates paragraphs 1-1 1 1 ofthe complaint as if fully set forth herein. -34- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 5 of 24 141 , ln performing the acts described above, OM P, through the acts of its ofhcers, knowingly presented or caused to be presented to the Florida State Govemment fraudulent claims for payment in violation of Fla, Stat. Ann. ? 68.082(2)(a). 142, ln performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Florida State Government in violation of Fla. Stat. Antn. ? 68.082(2)(b). 143. The State of Florida, unaware of the foregoing circumstances and conduct of the Florida, made full payments, which resulted in its being damaged in an amount to be determined 144. The State of F lorida is entitled to the maximtun penalty of $ 1 0,000 for each and every false or fraudulent claim, record or statement made. used, presented. or caused to be made. used or presented by the Defendant, as well as treble damages and penalties. COUNT IX Georgia State F alsg Medicaid Claims Act, Code of Georgia, C1; '@_j2 145. Relators reallege and reincorporate paragraphs 1-1 1 1 of this Complaint as if fullyset forth herein. 146. ln performing the acts described above, Defendant, throught the acts of its officers, agents. employees and sales representatives knowingly presented or caused to be presented to the State of Georgia fraudulent claims for payment in violation of Georgia's State False Medicaid Claims Act. HB. 551, 49-4-168 Q gi. 147. ln performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives, knowingly made or caused to be made or used a false -35- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 6 of 24 record or statement to get a false claim paid or approved by the State of Georgia in violation of Ge0rgia`s State False Medicaid Claims Act, H.B. 55l, 49-4-168 g gg. 148. The State of Georgia, unaware of the foregoing circumstances and conduct of the Defendant, made full payments which resulted in its being damaged in an amount to be determined. l49. The State of Georgia is entitled to treble damages and civil recoveries for each any every false or fraudulent claim, record or statement made, used, presented or caused to be made, used or presented by the Defendant. COUNT X Hawaii False Claims Act- Haw. Rev. Stat. ? 661-21{a)_(l_);(_l) 150. Relators reallege and incorporates paragraphs l-l ll ofthe complaint as if fully set forth herein. 151. ln perfbnning the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the Hawaii State Government fraudulent claims fbr payment in violation of Haw. Rev, Stat. ? 651-21(a)(l). 152. ln performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Hawaii State Government in violation of Haw. Rev. St. ? 651-2l(a)(2). 153. The State of Hawaii, unaware of the foregoing circumstances and conduct of the Defendant. made full payments, which resulted in its being damaged in an amount to be determined. 154. The State of Hawaii is entitled to the maximum penalty of $ l 0.000 for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. -36- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 7 of 24 COUNT XI lllinois Whistleblower Reward And Protection Act - 740 Ill. C0mp=_&zg? 175/3?a|gl)-(Z; 155. Relators reallege and incorporates paragraphs 1-1 1 1 ofthe complaint as if fully set forth herein. 156. ln perlorming the acts described above. OMP. through the acts of its officers. knowingly presented or caused to be presented to the Illinois State Government fraudulent claims for payment in violation of 740 lll. Comp. Stat. ?l75/3(a)(1). 157. In performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get :1 false claim paid or approved by the Illinois State Government in violation of 740 lll. Comp. Stat,. ? 175/3(a)(2). 158. The State of Illinois, unaware of the foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 159. The State of Illinois is entitled to the maximum penalty of$10.000lbr each and every false or fraudulent claim, record or statement made. used. presented. or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XII Indiana F alse Claims and Whistleblower Protectign Act - IC ?-;?;?;Lg;g_q. 160. Relator re-alleges and incorporates paragraphs 1-1 1 1 of the Complaint as if fully set forth herein. 161. ln performing the acts described above, Defendant, through the acts of its officers, agents. employees and sales representatives knowingly presented or caused to be presented to the -37- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 8 of 24 Govemment of Indiana fraudulent claims for payment in violation ofthe Indiana False Claims and Whistleblower Protection Act, IC 5-I I-5.5-I el seq. 162. In performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the State of Indiana in violation ofthe Indiana False Claims and Whistleblower Protection Act, IC 5-I I-5.5-l el seq. 163. The State of Indiana, unaware ofthe foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. I64. The State of Indiana is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made. used, presented, or caused to be made, used or presented by the Defendant. COUNT XIII Louisiana False Claims Act, Act 1373 ? 437.1 et seq, l65. Relator re-alleges and incorporates pmagraphs l-l l I ofthe Complaint as if fully set forth herein. I66. In perfomiin g the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives, knowingly presented or caused to be presented to the Louisiana State Government fraudulent claims for payment in violation of Louisiana False Claims Act. Act l373 ?437.l et seq, I67. In performing the acts described above, Defendant, through the acts of its officers. agents, employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or Louisiana False Claims Act, Act I373 ?437. I , et seq. -38- . Case 1:03-cv--11445--WGY Document 45-2 Filed 02/21/08 Page 9 of 24 168. The State of`Louisiana, unaware of the foregoing circumstances and conduct of the Defendant. made full payments. which resulted in its being damaged in an amount; to be detemiined. 169. The State of Louisiana is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used. presented, or caused to be made. uscd or presented by the Defendant COUNT XIV Massachusetts False Claims Law - Mass. Gen, Laws Ch. l1L?_Q_Q_);(_Q) 170. Relators reallege and incorporates paragraphs 1?11 1 of the complaint as if fully set forth herein. 171. ln performing the acts described above. OMP, through the acts of its officers, knowingly presented or caused to be presented to the Massachusetts State Government fraudulent claims for payment in violation of Mass Gen. Laws Ch. 12 ? 5B(1). 172. ln performing the acts described above, OMP. through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Massachusetts State Govemment in violation of Mass. Gen. Laws Ch. 12. ? 5B(2). 173. The State of Massachusetts, unaware of the foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 174. The State of Massachusetts is entitled to the maximum penalty of $10,000 for each and every false or fraudulent claim, record or statement made. used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. -3 9- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 10 of 24 COUNT XV Michigan Medicaid False Claims Act, MCLA ? 400.6(L@q; 175. Relator re-alleges and incorporates paragraphs 1 -1 1 1 ot the Complaint as if fully set forth herein. 176. In performing the acts described above, Defendant, through the acts of its officers. agents. employees and sales representatives knowingly presented or caused to be presented to the Michigan State Government fraudulent claims tor payment in violation of MCLA ? 400.604 et seq. 177. ln performing the acts described above, Defendant, through the acts of its officers, agents. employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Michigan State Government in violation of MCLA ? 400.604. 178. The State of Michigan, unaware ofthe foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 1 79. The State of Michigan is entitled to treble damages and civi.l recoveries for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made. used or presented by the Defendant. COUNT XVI Montana False Claims Agt - Mon. Stat. 17-8-401 et @4; I 80. Relator re-alleges and incorporates paragraphs 1-1 1 1 of the Complaint as if fully set forth herein. -40- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 11 of 24 l8l. In performing the acts described above. Defendant. through the acts of its officers, agents, employees and sales representatives knowingly presented or caused to be presented to the Montana State Govemment fraudulent claims for payment in violation ot Mon. Stat. l 7-8-40] el seq. 182. ln performing the acts described above, Defendant. through the acts ot its officers, agents. employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Montana State Government in violation ofMon. Stat. l7-8-40] el seq. l83. The State of Montana, unaware ot the foregoing circumstances and conduct of the Defendant. made full payments, which resulted in its being damaged in an amount to be determined. l 84. The State of Montana is entitled to treble damages and civil recoveries for each and every talse or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. COUNT XVII Nevada False Claims Act - Nev. Rev. Stat. Ann. ?357.04QQ_)_(Q;(h) 185. Relators reallege and incorporates paragraphs l--l l l ofthe complaint as if fully set forth herein. 186. ln performing the acts described above, OMP, through the acts of its officers. knowingly presented or caused to be presented to the Nevada State Government iiaudulent claims for payment in violation ofNev. Rev. Stat. Ann. ? 357.()4()(l )(a), l87, ln performing the acts described above. OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Nevada State Government in violation of Nev. Rev. Stat. Ann. ? 357.()40(l )(b). -4] - Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 12 of 24 188. The State of Nevada, unaware of the foregoing circumstances and conduct of the Defendant, made full payments. which resulted in its being damaged in an amount to be determined. 189. The State of Nevada is entitled to the maximum penalty of $1 0,000 for each and every false or fraudulent claim, record or statement made, used, presented. or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XVIII New Hampshire False Claims Act- NH. 167: 61-b e_?_gq; 190. Relator re-alleges and incorporates paragraphs 1-1 1 1 of the Complaint as if fully set forth herein. 191. ln performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly presented or caused to be presented to the New Hampshire State Govemment fraudulent claims for payment in violation of NH. 167: 61 -b et seq. 192. ln performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the New Hampshire State Government in violation ofNl--1.167: 61-b el seq. 193. The State of New Hampshire, unaware of the foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. -42- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 13 of 24 194. The State of New Hampshire is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made. used or presented by the Defendant. COUNT XIX New Mexico Medicaid False Claims Act- N.M.S.A. ? Qggil 195. Relators reallege and incorporates paragraphs 1-111 ofthe complaint as if fully set forth herein. 196. ln performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the State of New Mexico claims for payment in violation under the Medicaid program, with knowledge that the claim was false and/or fraudulent, in violation of the New Mexico Medicaid False Claims Act, N.M.S.A. ? 27-14-4. 197. The State of New Mexico, unaware of the foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be detemiined. 198. The State of New Mexico is entitled to treble damages and civil recoveries for each and every ialse or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. COUNT XX New York False Claims Act- N.Y. S. 2108C Manuag 31_,A)@]; 199. Relator re-alleges and incorporates paragraphs 1-78 of the Complaint as if fully set forth herein. -43- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 14 of 24 200. ln performing the acts described above. Defendant. through the acts o1` its officers, agents, employees and sales representatives knowingly presented or caused to be presented to the New York state govemment fraudulent claims for payment in violation of N.Y.S. 2l 08C. 20l. ln performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the New York state government in violation ofN.Y.S. 2l08C. 202. The State of New York, unaware ofthe foregoing circumstances and conduct ofthe Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 203. The State of New York is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. COUNT XXI Oklahoma Medicaid False Qlaims Act, S.B. N0. 889 gEffective_@;L,@)j_} 204. Relators reallege and incorporate paragraphs l- ll l of the complaint as if fully set forth herein. 205. ln performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented tothe Oklahoma State Government fraudulent claims for payment in violation of Oklahoma Statute Section 5053.l(B)(l) of Title 63. 206. ln performing the acts described above, OMP, through the acts of its officers. knowingly made or caused to be made or used a false record or statement to get a false claim paid -44- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 15 ot 24 or approved by the Oklahoma State Government in violation of Oklahoma Statute Section 5053.l(B)(2) ofTitle 63. 207. The State of Oklahoma, unaware ofthe foregoing circumstances and conduct of the Defendant, made iirll payments, which resulted in its being damaged in an amount to be determined. 208. The State of Oklahoma is entitled to the maximum penalty of$l 0,000 for each and every ialse or liaudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XXII Tennessee Medicaid False Claims Act - Tenn. Code. Ann. ? 71-?@2_[gi|jl NA)-{B) g 209. Relators reallege and incorporates paragraphs l-ll l of the complaint as if fully set forth hereinr 210. ln performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the Tennessee State Government fraudulent claims for payment in violation of Temi. Code. Ami. ? 7l -5-l 82(a)(l)(A). 21 1. ln performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Tennessee State Government in violation of Temr. Code Ann. ? 7 l--5--l82 (M0 XB). 2l2. The State of Temiessee, unaware of the foregoing circumstances and conduct of the Defendant. made full payments, which resulted in its being damaged in an airnount to be determined. -45- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 16 ot 24 213. The State of Tennessee is entitled to the maximum penalty of $10,000 for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XXIII Texas Medicaid Fraud Prevention Law - Tex. Hum. Res. Codgigg ? 36.002 214. Relators reallege and incorporates paragraphs 1-1 1 1 ofthe complaint as iftully set forth herein. 215. ln perlorming the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the Texas State Government fraudulent claims for payment in violation ofTex. Hum. Res.,Code Ann. ? 36.002. 216. ln performing the acts described above. OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Texas State Government in violation of Tex. Hum. Res. Code Ann. ? 36.002. 217. The State of Texas, unaware of the foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 218. The State of Texas is entitled to the maximum penalty of $ 1 0,000 for each and every false or fraudulent claim, record or statement made, used. presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XXIV Virginia Fraud Against Taxpayers Act - Va. Code Ann. ? 8.01--_?>>_(a_)_(l);(2) 219. Relators reallege and incorporates paragraphs 1-111 of the complaint as if fully set torth herein. -46- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 17 of 24 220. In performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the Virginia State Government fraudulent claims for payment in violation ot`Va. Code Ann. ? 8.01-2l6.3(a)(l). 22l. ln performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get at false claim paid or approved by the Virginia State Government in violation of Va. Code Ann. ? 8.0l -2 l 6.3(a)(2). 222. The State of Virginia, unaware ofthe foregoing circumstances and conduct of the Defendant, made full payments, which resulted in its being damaged in an amount to be determined. 223. The State of Virginia is entitled to the maximum penalty of $10,000 for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant, as well as treble damages and penalties. COUNT XXV District of Columbia Procurement Reform Amendment Act - D.C. A_ng;?k?8.l44a[]1[--{2[ 224. Relators reallege and incorporates paragraphs l-l ll ofthe complaint as if fully set forth herein. 225. ln performing the acts described above, OMP, through the acts of its officers, knowingly presented or caused to be presented to the District of Columbia Govemment fraudulent claims for payment in violation ofD.C, Ann. ? 2-38. l4(a)(l ). 226. ln performing the acts described above, OMP, through the acts of its officers, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the District of Columbia Government in violation of D.C. Ann, ? 2--38. l4(a)(2) -47- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 18 of 24 22 7. The District of Columbia, unaware ofthe foregoing circumstances and conduct ofthe Defendant. made full payments, which resulted in its being damaged in an amount to be determined. 228. The District of Columbia is entitled to the maximum penalty of $1 0.000 for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. as well as treble damages and penalties. COUNT XXVI Cook County False Claims Act, Resolution No. 03-R_@;?_ 229. Relator re-alleges and incorporates paragraphs l--l l l ofthe Complaint as if fully set forth herein. 230. ln. performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly presented or caused to be presented to the Cook County, Illinois fraudulent claims for payment in violation of Cook County False Claims Act, as set out in County Resolution No. O3 -R-3 94. 231. ln performing the acts described above, Defendant, through the acts its officers, agents, employees and sales representatives, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the Cook County in violation of the Cook County False Claims Act, as set out in County Resolution No. 03 -R-394. 232. Cook County, unaware of the foregoing circumstances and conduct ofthe Defendant, made full payments which resulted in its being damaged in an amount to be detemiined. 233. Cook County is therefore entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. -43- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 19 of 24 COUNT XXVII City of Chicago False Claims AEM-010 et seg. 234. Relator re-alleges and incorporates paragraphs l-l l lof the Comp.laint as if fully set forth herein. 235. ln perfomiing the acts described above. Defendant. through the acts of its officers. agents. employees and sales representatives knowingly presented or caused to be presented to the City of Chicago fraudulent claims for payment in violation ofthe City of Chicago False Claims Act l-2l-010 cr seq. 236. In performing the acts described above, Defendant, through the acts its otlicers, agents, employees and sales representatives, knowingly made or caused to be macle or used a false record or statement to get a false claim paid or approved by the City of Chicago in violation of City of Chicago False Claims Act l-2l-010 er seq. 237. The City of Chicago, unaware ofthe foregoing circumstances ancl conduct of the Defendant, made full payments which resulted in its being damaged in an amount to be determined. 238. The City of Chicago is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used, presented, or caused to be made, used or presented by the Defendant. COUNT XXVIII New York City False Claims Act Local Law 53 of 2005 239. Relator re-alleges and incorporates paragraphs l-l l l ofthe Complaint as if fully set forth herein. -49- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 20 of 24 240. ln performing the acts described above, Defendant, through the acts of its officers, agents, employees and sales representatives knowingly presented or caused to be presented to the City ofNew York fraudulent claims for payment in violation ofCity of New York False Claims Act Local Law 53 of 2005. 24l. ln performing the acts described above. Defendant. through the acts of its officers. agents. employees and sales representatives, knowingly made or caused to be made or used a false record or statement to get a false claim paid or approved by the City of New York in violation of City of New York False Claims Act Local Law 53 of 2005. 242. The City of New York, unaware of the foregoing circumstances and conduct of the Delendant, made full payments which resulted in its being damaged in an amount to be determined. 243. The City of New York is entitled to treble damages and civil recoveries for each and every false or fraudulent claim, record or statement made, used. presented, or caused to be made, used or presented by the Defendant. PRAYER FOR RE@ WHEREF ORE, Relators respectfully request this Court to enter judgment against OMP as follows: a. That the United States be awarded damages in the amount of three times the damages sustained by the United States because ofthe false claims and fraud alleged within this Complaint, as the Civil False Claims Act, 31 U.S.C. ? 3729 gggq, provides; b. That civil penalties of $5,500 to $1 1,500 be imposed mr each and every false claim that Defendant caused to be presented to the United States; c. That the State of California be awarded damages in the amount of three times the damages sustained by the State of California because ofthe false claims -5()- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 21 of 24 and fraud alleged within this Complaint, plus a civil penalty of$10.000 for each violation of Cal. Govt. Code ? 12651(a); d. That the State of Delaware be awarded damages in the amount ofthree times the damages sustained by the State of Delaware because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $1 1.000 for each violation of6 Del. C. ? 1201 (a); e. That the State of Florida be awarded damages in the amount of three times the damages sustained by the State of Florida because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty o1`$ l 0,000 for each violation ofFla. Stat. Ann. ? 68.082(2); f. That the State of Georgia be awarded damages in the amount of three times the damages sustained by the State of Georgia because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation of Georgia"s State False Medicaid Claims Act, H.B. 551, 49-4-168 et seqr; g. That the State of Hawaii be awarded damages in the amount of three times the damages sustained by the State of Hawaii because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation of Haw. Rev. Stat. ? 661 -21 (a); h. That the State of Illinois be awarded damages in the amount of three times the damages sustained by the State of Illinois because ofthe false claims and fraud alleged within this Complaint. plus a civil penalty of $1 0,000 for each violation of 740. Ill. Comp. Stat. ? 175/3(a); i. That the State of Indiana be awarded damages in the amount of three times the damages sustained by the State of Indiana because ofthe false claims and fraud alleged within this Complaint, plus the maximum amount of civil penalties allowed under the law for each violation ofthe Indiana False Claims and Whistleblower Protection Act, IC 5-11-5.5-2; j. That the State of Louisiana be awarded damages in the amount of three times the damages sustained by the State of Louisiana because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty allowed for each violation of the Louisiana False Claims Act, Act 1373 ? 437.1 et seq.; k. That the State of Massachusetts be awarded damages in the amount of three times the damages sustained by the State of Massachusetts because ofthe -5]- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 22 of 24 false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation of Mass. Gen. L. Ch. l2 ? 5B; l. That the State of Michigan be awarded damages in the amount ofthree times the damages sustained by the State of Michigan because of the false claims and fraud alleged within this Complaint, plus the maximum amount of civil penalties allowed under the law for each violation ofthe Michigan Medicaid, MCL ? 400.607(l ); m. That the State of Montana be awarded damages in the amount ofthree times the damages sustained by the State of Montana because ofthe false claims and fraud alleged within this Complaint, plus civil penalty for each violation of Mon.l7~8-401 et seq.: n. That the State of New Hampshire be awarded damages in the amount of three times the damages sustained by the State of New Hampshire because of the false claims and fraud alleged within this Complaint, plus civil penalty for each violation of NH. 167: 6] -b ct seq.; o. That the State of New Mexico be awarded damages in the amount of three times the damages sustained by the State of New Mexico because ofthe false claims and fraud alleged within this Complaint, plus civil penalty for each violation of New Mexico House Bill No. 468, 46* Legislature, Second Regular Session; p. That the State of New York be awarded damages in the amount of three times the damages sustained by the State of New York because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation ofN.Y.S. 2108C.; q. That the State of Nevada be awarded damages in the amount of three times the damages sustained by the State of Nevada because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $ l 0,000 for each violation of Nev. Rev. Stat. Ann. ? 357.040( l)(a)-(b); r. That the State of Oklahoma be awarded damages in the amount of three times the damages sustained bythe State of Tennessee because of the false claims and fraud alleged within this Complaint, plus a civil penalty of $l0.000 for each violation of the Oklahoma Medicaid False Claims Act, S.B. No. S.B. No. 889; s. That the State of Tennessee be awarded damages in the amount of three times the damages sustained by the State of Tennessee because of the false claims -52- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 23 ot 24 and fraud alleged within this Complaint, plus civil penalty for each violation of"1`enn. Code Ann. ? 71-5-182 (a)(l)(B); t. That the State of Texas be awarded damages in the amount of three times the damages sustained by the State of Texas because of the false claims and fraud alleged within this Complaint, plus a civil penalty of $10.000 for each violation of Tex. Hum. Res. Code Ann. ? 36.002; u. That the State of Virginia be awarded damages in the amount of three times the damages sustained by the State of Virginia because of the false claims and fraud alleged within this Complaint, plus a civil penalty of$ 1 0.000 for each violation ofVa.. Code Ann. ? 8.01-2l6.3(a); v. That the District of Columbia be awarded damages in the amount of three times the damages sustained by the District of Columbia because ofthe false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation of D.C. Code Ann. ? 1.1l88.14(ia); w. That the County of Cook, Illinois be awarded damages inthe amount of three times the damages sustained by the County of Cook, Illinois because of the false claims and fraud alleged within this Complaint. plus a civil penalty of $10,000 for each violation of Cook County False Claims Act, as set out in County Resolution No. 03-R-394.; x. That the City of Chicago be awarded damages in the amount of three times the damages sustained by the City of Chicago because ofthe false claims and fraud alleged within this Complaint, plus civil penalty for each violation of the City of Chicago False Claims Act 1-22-101 et seq.; y. That the City of New York be awarded damages in the amount of three times the damages sustained by the City of New York because of the false claims and fraud alleged within this Complaint, plus a civil penalty of $10,000 for each violation ofthe City of New York False Claims Act Local Law 53 of 2005; 2. That pre- and post-judgment interest be awarded, along with reasonable attorneys' fees, costs, and expenses which Relators necessarily incurred in bringing and pressing this case; aa. That Relators be awarded the maximum amounts allowed pursuant to the False Claims Act and the equivalent provisions of the state statutes as set forth herein; -53- Case 1:03-cv-11445-WGY Document 45-2 Filed 02/21/08 Page 24 of 24 bb. That this Court award such other and further relief as it deems proper. DEMAND FOR A IURY TRIAL Relators demand ajury trial on all claims alleged herein. Dated: ?? 2* (IQ FRANK, HARON. WEINER AND NAVARRO l I -4. X W V X / p __ 2,/ ii By gf cd 1 [QL M 2 _ David L. Haron (Pl4655) (dHaron@H1wnlaw.com) Monica P. Navarro (P52985) (mnavarro@th wnlaw.c0m) Attorneys f or Rclators 5435 Corporate Drive, Suite 225 Troy, Michigan 48098 (248) 952-0400 (248) 952-0890 Facsimile -54-