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1 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 1 of 30 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF ILLINOIS EAST ST. LOUIS DIVISION DONNA MYLER, individually And on behalf of all others similarly situated, v. Plaintiffs, PFIZER, INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) ) CLASS ACTION COMPLAINT CASE NO. 3:08-cv-568-MJR JURY TRIAL DEMANDED Plaintiff, Donna Myler, on behalf of herself and all others similarly situated, by counsel, hereby alleges the following facts and states the following claims against Defendant, Pfizer, Inc. I. NATURE OF THE CASE 1. Plaintiff, individually, and on behalf of all others similarly situated brings this class action against Pfizer who conspired to conceal facts and evidence regarding the dangerous side effects of the prescription drug Chantix (hereinafter referred to as CHANTIX ) by deliberately constructing clinical studies which would conceal a Courthouse News Service multitude of side effects, including but not limited to depression, aggression, suicide and suicidal ideation, and suicidal tendencies, in order to realize billions of dollars in profits from the sale of CHANTIX. Through a series of fraudulent schemes Pfizer s implemented its calculated and deceitful marketing campaign that began prior to U.S. Food and Drug Administration (hereinafter FDA ) approval of CHANTIX. Pfizer s

2 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 2 of 30 scheme was implemented so it could tap into the enormous market demand for a drug to aid in smoking cessation. Pfizer unlawfully marketed and promoted CHANTIX through its conspiracies, and deliberately mislead physicians and consumers into believing that CHANTIX was safe and effective. Plaintiff and members of the Plaintiff Class suffered injuries resulting from Pfizer s illegal and fraudulent activities. Plaintiff and the members of the Plaintiff Class seek to recover damages suffered as a result of these schemes under sections 1962(c) and 1962(d) of the Racketeer Influenced and Corrupt Organizations Act ( RICO ). 2. Plaintiffs bring this action on behalf of all persons residing in the United States who purchased, were prescribed and ingested CHANTIX manufactured by Pfizer, Inc. Plaintiffs bring this action pursuant to Rule 23 of the Federal Rules of Civil Procedure to recover compensatory, equitable, and actual damages and attorney s fees suffered by Plaintiff and the members of the Plaintiff Class as a direct and proximate result of the Pfizer s illegal activity in connection with the packaging, advertising, promoting, marketing, distribution, labeling, and/or sale of its drug CHANTIX. II. STATEMENT OF JURISDICTION AND VENUE 3. This Court has subject matter jurisdiction over federal law claims under 28 U.S.C and 18 U.S.C. 1965(a). 4. Federal jurisdiction is proper under the Class Action Fairness Act, 28 U.S.C. 1332(d), as the amount exceeds $5,000, and diversity of citizenship exists between the representative Plaintiff and the Defendant. 2

3 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 3 of Venue is proper in the Southern District of Illinois pursuant to 28 U.S.C and 18 U.S.C because the Defendant resides in, is found in, has an agent in and/or transacts its affairs in, the Southern District of Illinois. III. PARTIES 6. Plaintiff, Donna Myler, at all times relevant herein is a citizen of the State of Illinois, purchased and ingested CHANTIX pursuant to a physician s prescription and suffered damages and loss as a result. 7. Plaintiff seeks to represent the following class: CHANTIX Class: All citizens, residents, or domiciliaries of the United States who purchased, ingested or were prescribed CHANTIX manufactured by Pfizer, Inc., and such citizens, residents and domiciliaries estates, representatives, administrators, spouses, relatives, and significant others as their heirs or survivors. 8. Defendant Pfizer, Inc. (hereinafter Pfizer) is a Delaware corporation with its principal place of business at 235 East 42 nd Street, New York, New York, and regularly conducts business throughout the United States and specifically in, Illinois, including but not limited to the selling, marketing, labeling, packaging, dosing, advertising, promotion, and/or distribution of CHANTIX. Pfizer regularly conducts business in the State of Illinois and throughout the United States, and has and is engaged in racketeering activity by promulgating illegal, fraudulent, misleading, inaccurate and false materials relating to the sale, marketing, advertising and promotion of CHANTIX through and by use of the mail and/or wires, which are being used by Plaintiff, members of the Plaintiff Class, medical experts and physicians, and other members of the medical community. 3

4 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 4 of At material times hereto, Pfizer: a. Was and is, engaged in the business of selling, marketing, labeling, packaging, advertising and promoting of CHANTIX in the United States and Illinois either directly or indirectly through third-parties or related entities; b. Was and is, in the business of profiting from the sale, marketing, labeling, packaging, advertising and promotion of CHANTIX; c. Conducted continuous and substantial business in the State of Illinois and, d. Published illegal and fraudulent information targeted to Plaintiff and members of the Plaintiff class and their physicians through the mail or over the wires. Plaintiff and members of the Plaintiff Class and their physicians have relied on the fraudulent information disseminated by the RICO defendant, Pfizer. e. Purposefully deceived and confused Plaintiff and members of the Plaintiff Class, their physicians and the medical community so it could illegally profit from the sale of CHANTIX. f. Purposefully misrepresented and suppressed the truth made with the intention either to obtain an unjust advantage, or to cause a loss, or inconvenience to the Plaintiff and members of the Plaintiff Class. g. Acted and gained knowledge itself by and through its various agents, servants, employees, and/or ostensible agents. IV. FACTUAL ALLEGATIONS AS TO ALL COUNTS 10. CHANTIX is the brand-name of varenicline, and is indicated for use as an aid to smoking cessation treatment. 11. CHANTIX is a registered trademark of Defendant, Pfizer, Inc. 12. Pfizer, Inc., requested and received an accelerated review and/or priority review of CHANTIX by the U.S. Food and Drug Administration. 4

5 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 5 of In May 2006, CHANTIX was approved for use and launched onto the market for sale in the United States. 14. CHANTIX is designed to work by specifically inhibiting nicotine receptors in the human brain. 15. CHANTIX uses a unique or novel mechanism of action that is intended to operate as both an agonist and antagonist to decrease nicotine craving and psychological rewards associated with smokers As an agonist CHANTIX is supposed to reduce nicotine craving and withdrawal symptoms. 17. As an antagonist CHANTIX is supposed to reduce the psychological reward associated with smoking. 18. The receptors in the human brain affected by CHANTIX are controlled by dopamine. 19. Dopamine is produced in several areas of the brain and operates as a neurotransmitter. 20. Smokers receive bursts of nicotine when they inhale which, coincidentally, triggers an immediate increase of dopamine; thus, creating the craving and perceived pleasure from smoking. 21. In theory, CHANTIX is supposed to work, by blocking dopamine, and thus the cravings for nicotine are diminished and psychological pleasure derived from smoking is reduced Essentially, CHANTIX regulates/restricts dopamine and blocks pleasure sensors to depress the normal flux of emotion experienced by humans in daily life. 1 Bailey, William C., Pharmacologic Therapy: Novel Approaches for Chronic Obstructive Pulmonary Disease Proc. Am. Thora. Soc. Vol 4, pp , CHANTIX activates release of 35 to 60% of the dopamine that nicotine would have caused to flow if sitting on the exact acetylcholine receptors. J.Med. Chem., 2005 May 19:48(10):

6 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 6 of Defendant negligently and/or intentionally failed to properly, fully and/or thoroughly study, evaluate and/or examine the mechanism of action and the effects thereof associated with CHANTIX 24. Defendant failed to adequately study CHANTIX to determine the risk of serious injury and/or death associated with its uses. 25. Defendant s failure to conduct adequate studies of CHANTIX include: a. Intentionally excluding certain patients from clinical trials. For example, the Defendant excluded patients from clinical trials if they had previous history and/or diagnosis of mental psychological disorders. 3 b. Intentionally ignoring any proper evaluation of depression, aggression, suicide, suicide ideation, suicidal thoughts, suicidal tendencies, etc. c. Failure to determine what other effect CHANTIX has on other receptors in the human brain and body. 26. Defendant admitted that [p]atients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the controlled clinical trial program Defendant knew or should have known that CHANTIX increased the risk of causing serious injuries and death including suicide and attempted suicide. 3 Varenicline Study Group, Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation, Arch. Intern. Med. August 2006, Vol. 166, p ; Melinda Beck, The Puff Power: Drug Warnings Speak to Nicotine s Sad Grip. Wall Street Journal, February 19, 2008, sec. D, p. 1; Deveraux, A., Mostafa, K. Laqueille, X. Efficacy of Varenicline for Smoking Cessation, JAMA 296 (December 6, 2006) Pfizer Press Release, January 18, See also When they tested the drug, the sample they chose simply isn t representative of the people they re targeting. By excluding drinkers, you re artificially inflating your results, potentially. I run a clinic and two out of three [smokers] I see have a psychiatric or mood problem. None of these people would have been part of the original trials. Derek de Koff, This my Brain on CHANTIX, New York Magazine, February 10, 2008, available at accessed March

7 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 7 of The active ingredient in CHANTIX is varenicline tartrate which was derived from cytosine Cytosine has been around for decades as a smoking cessation drug in Eastern European Countries Defendant knew or should have known that reports have documented as early as 1972 a link of cytosine (the derivative of the active ingredient in CHANTIX) to causes of suicide and attempted suicide According to a 2006 report by the European Medical Agency (EMEA), CHANTIX had six times the number of serious adverse reactions as the smoking cessation drug Zyban (bupropion). 32. In the fourth quarter of 2007 varenicline accounted for 988 serious injuries in the United States reported to the U.S. Food and Drug Administration, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury for 769 different drugs in the fourth quarter of the same period. 33. From May 2006 through December 2007, the FDA received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories were not mutually exclusive. 5 Etter, Jean-Francois, Cytisine for Smoking Cessation Arch Int. Med., Vol. 166, Aug. 14/28, Id. 7 Stoyanov, S. Yanachkova, M. Tabex-therapeutic efficacy and tolerance. Savr. Med. XXIII (6). 7

8 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 8 of In November 2007, the Food and Drug Administration (FDA) announced the results of its preliminary assessment of CHANTIX. The FDA specifically highlighted the number of reports noting the association between suicide and attempted suicide within days to weeks of initiating CHANTIX treatment. 35. Many of the cases received and reviewed by the FDA were reported for patients without any prior history of psychiatric illness. 36. The adverse drug event reports for varenicline described other kinds of serious harm for which no warnings now exist, among the most prominent are: a. Accidents and injuries: A total of 173 serious events described accidental injury, including 28 road traffic accidents and 77 falls, some leading to fractures of rib, facial bones, hand, ankle, spine and lower limbs. In these cases a variety of potential causes were identified, including loss of consciousness, mental confusion, dizziness and muscle spasms. b. Vision disturbance: At least 148 reports contained medical terms indicating vision disturbances, including 68 cases described as blurred vision and 26 terms indicating transient or other forms of blindness. This reported effect could also describe a mechanism that could or did contribute to accidents and injuries. c. Heart rhythm disturbances: The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have noncardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms. d. Seizures and abnormal muscle spasms or movements: Serious reported events included 86 cases of convulsion (seizures), 372 reports of a wide variety of movement disorders, including tremors, muscle spasms, twitching, tics, drooling, and motor hyperactivity. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from this data. e. Moderate and severe skin reactions: Reported serious events included 338 cases of hives or swelling of the tongue, face, eyes, lips and other areas. In addition, 65 cases were classified as severe and included blisters, exfoliation of the skin and lips and Stevens-Johnson Syndrome. f. Diabetes: The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified 8

9 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 9 of 30 numerous cases of symptoms and laboratory tests consistent with new onset diabetes. 37. On November 20, 2007, the FDA issued a Changes Being Effected ( CBE ) for CHANTIX requiring: Modification of the patient package insert to address possible drug adverse effects [including] depression, agitation, suicidal thoughts On February 1, 2008, Pfizer amended the information contained in the drug label. 39. Contemporaneous with the February 1, 2008 label change, the FDA issued a Public Health Advisory alerting health care providers, patients, and caregivers to new safety warnings related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior The European Medicines Agency (EMEA), as part of the routine pharmacovigilance activities noted receiving cases of suicidal ideation and suicide in July, October and November The following month, the EMEA concluded that updated warnings to doctors and patients [were necessary] to increase awareness of cases of suicidal ideation and suicide attempts in patients using varenicline. 41. Defendant knew or should have known the risks and/or potential risks of serious injury and/or death because of knowledge it had from other drugs with similar mechanisms of action (i.e. Zoloft ). 42. Several clinical trials demonstrate the increased risk of serious injury and death associated with CHANTIX. 8 FDA Public Health Advisory, FDA Public Health Advisory-Important Information on Chantix (varenicline) (February 1, 2008) at 9 EMEA Press Release, EMEA, European Medicines Agency concludes new advice to doctors and patients for Champix needed (Dec. 14, 2007) at 9

10 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 10 of In the studies severe adverse events were experienced by 9.8% of the varenicline group and 7.3% of the NRT (nicotine patch) group. Three participants experienced serious adverse events during the non-treatment follow-up phase... [One study participant] A woman in the varenicline group experienced suicidal ideation resulting in hospitalization for 11 days after completing the varenicline treatment. [She had no previously diagnosed mental and/or psychological disorder.] The study investigator considered this case to be attributable to the study drug. (emphasis added.) 44. On July 5, 2006, JAMA published the results of a Pfizer sponsored study completed in February 2004 almost two years earlier one of the subjects participating in the study committed suicide On July 5, 2006, JAMA published the results of a randomized controlled trial completed more than one year earlier March, 2005 which reported cases of serious adverse events associated with varenicline including: acute psychosis, emotional liability, insomnia and abnormal dreams. 46. Available data is inconclusive at best and suggests that the efficacy of CHANTIX appears to be no better than placebo or the nicotine patch. 47. Given all available data, experts remain unconvinced of relative efficacy of CHANTIX (varenicline) and continually express concern about the potential risk associated with using the drug Tonstad, S. et al. Effect of Maintenance Therapy With Varenicline on Smoking Cessation A Randomized Controlled Trial, JAMA 296 no. 1 (July 5, 2006), Kleges, et al, Varenicline for Cessation: Definite Promise But No Panacea; JAMA 296, no. 1 (July 5, 2006)

11 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 11 of After reviewing three clinical trials, the experts noted: Importantly, the majority of participants in these three studies did not quit smoking even with varenicline. 12 Additionally, the authors reviewing the studies concluded much research needs to be conducted to establish the effectiveness of varenicline... Although the efficacy evaluation was inconclusive, the greater risks associated with CHANTIX (varenicline) were clear....the adverse effect profile of varenicline... reported a rate significantly higher than with either bupropion or placebo The results of a head-to-head open label trial were published, on February 8, The results of the study were insignificant and only demonstrate slightly better efficacy associated with varenicline compared to the nicotine patch. (After 24 weeks, the efficacy of varenicline was reported to be 32.4% compared to the nicotine patch at 27.3%. The results after 52 weeks are worse. After 52 weeks the efficacy of varenicline was reported to be 26.1% compared to the nicotine patch at 20.3%. Moreover, the results reflecting minimal improvement are not reliable (i.e. [T]he difference [reflecting minimally improved efficacy] was not statistically significant. ) Despite any minimally reliable efficacy advantage, the safety analysis conducted in the study reveals greater risks associated with varenicline as compared to the nicotine patch. Severe adverse events were experienced by 9.8% of the varenicline group and 7.3% of 12 Id. 13 Id. 14 Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomized open label trial. Thorax published online 8 Feb Id. 11

12 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 12 of 30 the NRT (nicotine patch) group. 16 Three participants experienced serious adverse events during the non-treatment follow-up phase...[one study participant] A woman in the varenicline group experienced suicidal ideation which resulted in hospitalization 11 days after completing the varenicline treatment. [She had no previously diagnosed mental and/or psychological disorder. The study investigator considered this case to be attributable to the study drug Although the results of the head-to-head comparison study referenced above were published in January 2008, the study was sponsored by Pfizer and completed on June 28, Pfizer has previously been criticized for delaying publication of unfavorable study results. For example, Pfizer sponsored a study of one of its blockbuster Cox-2 inhibitor drugs Bextra (valdecoxib) which was completed in May, The unfavorable results were not published until In 2006, Pfizer earned $48.4 billion in revenue. 54. CHANTIX is one of Pfizer s best-selling new drugs. 55. Pfizer published its 10K filing noting that CHANTIX revenues rose 773% in one year (from $101 million in 2006 to $883 million in 2007). 56. Pfizer earned $241 million in the third quarter of 2007 from CHANTIX sales. 16 Id. 17 Id. 18 Ott et al., J Thorac Cardiovasc Surg 2003; 125: The safety analysis revealed 12

13 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 13 of Before approval by the FDA, Pfizer began marketing CHANTIX as the first new prescription treatment for smoking cessation in nearly a decade. 58. On or about June 15, 2006, with a year after being launched onto the open market in the United States, nearly 2.5 million U.S. consumers purchased CHANTIX. 59. Pfizer, through its officers, agents, directors and specifically the Chief Executive Officer, Jeffrey Kindler touted CHANTIX as the solution to help offset $12 billion in sales that Pfizer lost to generic competitors over the sale of Lipitor. 60. In the U.S., Chantix revenues declined to $109 million, a decrease of 35% compared with the prior-year quarter, while international revenues grew to $98 million, an increase of 197%. U.S. results were negatively impacted by the recent updates to the Chantix U.S. label to include additional safety information, as well as certain events relating to Chantix." FDA regulations require any pharmaceutical company to seek and obtain FDA approval before any new drug may be marketed. Once approval is granted, a drug may only be promoted for the approved use at the approved dosage. 62. The Food and Drug Administration Act of 1997, 21 U.S.C. 360 aa, et seq. provides for the dissemination to physicians and other health care practitioners qualified forms of written information concerning the safety and effectiveness of a drug, provided it is authorized information in the form of unabridged peer-reviewed articles or qualified reference publications. Id. This law also requires pharmaceutical companies to furnish 20 See Pfizer, Inc.'s, SEC Form 8 K report, filed July 23, 2008, accessed on July 28, 2008, available at 13

14 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 14 of 30 federal regulators with advance copies of the information they disseminate. Id. Any deviation from these requirements violates FDA regulations. 63. Upon information and belief Pfizer employed a publication strategy that would allow it to promote CHANTIX by the massive distribution of publications allegedly written by independent researchers that purportedly described the scientific evaluation of CHANTIX. 64. Upon information and belief Pfizer selected a marketing strategy which would deliberately lead to increased sales of CHANTIX even though Pfizer knew that CHANTIX was unsafe and not effective. 65. Upon information and belief Pfizer required clinical studies to be published in journals from independent physicians where no such publications existed necessitating the retention and hiring of non-physician technical writers to write articles for medical journals and to seek publication of those articles. 66. Upon information and belief, Pfizer distributed payments to physicians who were interested in widely prescribing CHANTIX through consultant meetings, speakers bureaus, medical education seminars, grants, studies, advisory boards and teleconferences. 67. Upon information and belief Pfizer carried out this scheme through the following, among other things: a. Illegal kickbacks to physicians who prescribed large amounts of CHANTIX; b. The formation of a nationwide network of employees falsely referred to as medical liaisons whose actual assigned duties consisted entirely of conventional direct sales activities and which did not include any legitimate scientific activity; c. The making of false statements to physicians and pharmacists concerning the efficacy and safety of CHANTIX; 14

15 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 15 of 30 d. The payment or offering of gratuities to employees in order to procure their silence; and e. The active training of employees in methods of avoiding detection of their activities by the FDA. V. CLASS ACTION ALLEGATIONS 68. Numerosity of the Class: The proposed Class is so numerous that joinder is impractical. The disposition of these claims through this class action will be more efficient and will benefit the parties and the Court. The identities of the individual members of the class are ascertainable through, inter alia, medical and pharmaceutical records. Further, Class Members may be informed of the pendency of the class action by direct mail, internet or other means. 69. Predominance of the Common Question of Fact and Law: A well-defined community of interest in the questions of law and fact common to the CHANTIX Class predominate over questions affecting only individual Class Members including, but not limited to: a. Whether Pfizer s transmission of payments paid to physicians, ghost-authors and others to make fraudulent statements in furtherance of the scheme to promote CHANTIX constitutes wire fraud; b. Whether Pfizer s agreement and activities in furtherance of its agreement with members of the Chantix Marketing Enterprise in furtherance of the scheme to promote CHANTIX, constitute an enterprise as defined in 18 U.S.C. 1961(4) that is engaged in, or the activities of which affect, interstate or foreign commerce; c. Whether the policies and practices described herein constitute Pfizer s conduct or participation, directly or indirectly, in the conduct of such enterprise s affairs through a pattern of racketeering activity; 15

16 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 16 of 30 d. Whether Pfizer has violated 18 U.S.C. 1962(c); e. Whether Pfizer has conspired, under 18 U.S.C. 1962(d), to engage in activities and conduct described herein; f. Whether Pfizer concealed adverse information from Plaintiff and the CHANTIX Class regarding CHANTIX; g. Whether Plaintiff and the Class Members are entitled to recover compensatory, exemplary, punitive, and/or other damages as a result of Defendant s fraudulent and unlawful conduct; h. What is the proper mechanism for assessing and awarding damages and administering relief to Class Members, including the relief to reduce the threat of future harm to Class Members; i. Whether Defendant s conduct in selling and/or promoting and/or marketing and/or distributing CHANTIX fell below the duty of care owed by Defendant to Plaintiff and members of the Plaintiff class; j. Whether the Defendant negligently, recklessly, or intentionally concealed information about the safety of CHANTIX from the Plaintiff and Plaintiff Class, as well as their physicians, hospitals, healthcare professionals, and the FDA; k. Whether the Defendant under-reported the adverse events associated with CHANTIX; l. Whether Defendant s conduct constitutes fraudulent concealment; m. Whether Defendant s conduct constitutes fraudulent misrepresentation and/or fraud; n. Whether Plaintiff Class Members have sustained irreparable harm and whether they are entitled to equitable relief including restitution and/or refund and, if so, the nature and extent of such damages; o. Whether the Plaintiff Class is entitled to compensatory damages and, if so, the nature and extent of such damages; 16

17 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 17 of 30 p. Whether Defendant is liable for punitive damages and, if so, how much is necessary and appropriate to punish it for its conduct, deter others and fulfill the policies and purposes of punitive and/or exemplary damages; q. How any and all punitive and/or exemplary damages awarded to Plaintiffs should be equitably allocated among the Plaintiff and the Plaintiff Class; r. Whether the Defendant acted to defraud, misrepresent, and deceive the Plaintiff and/or the Plaintiff Class; s. Whether Defendant failed to adequately test its products; t. Whether the Defendant failed to adequately reveal the results if any, that were yielded by the testing of their product to the Plaintiff, Plaintiff Class, their physicians, hospitals, the FDA and other healthcare professionals; u. Whether the Defendant failed to adequately warn of the adverse effects of CHANTIX. 70. Typicality: Having been a victim of Defendants unlawful and negligent conduct, Plaintiff is a member of the Chantix Class. Plaintiff purchased and ingested CHANTIX. All members of the Class have purchased and ingested CHANTIX. Plaintiff and members of the Chantix Class have similarly suffered harm arising from Defendant s violations of law and negligent conduct as alleged herein. 71. Adequacy of Representation: Plaintiff is an adequate representative of the Plaintiff Class because he is a member of the Plaintiff Class and his interests do not conflict with the interests of the members of the Plaintiff Class he seeks to represent. Further, Plaintiff is represented by experienced and able counsel who has litigated numerous other mass torts and products liability class actions, and intends to prosecute this action vigorously for the benefit of the entire Plaintiff Class. Plaintiff and his counsel will fairly and adequately protect the interests of the members of the Plaintiff Class. 17

18 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 18 of Superiority: A class action is superior to other available methods for the efficient adjudication of this litigation since individual litigation of each Class Members claim is impracticable. It would be unduly burdensome to the courts in which individual litigations would proceed. Further, individual ligations present a potential for inconsistent and/or contradictory judgments and further increases the delay and expense to all parties and the courts. By contrast, the class action device presents far fewer management difficulties and provides the benefit of a single adjudication, economies of scale, and comprehensive supervision by a single court. Additionally, notice of the pendency and/or resolution of this class action can be provided to Class Members by direct mail, and upon information and belief, Defendant herein has kept detailed records as to its sale of CHANTIX. 73. This action is also properly certified under the provision of F.R.C.P. 23 because: a. The prosecution of separate actions by individual members of the Class would create a risk of inconsistency of varying adjudications with respect to individual Class Members, thus establishing incompatible standards of conduct for Defendant; and b. Due to the nature of the relief sought, the prosecution of separate actions by the individual members of the Class would create a risk of adjudications with respect to them that would, as a practical matter, be dispositive of the interests of the other members of the Class not parties to such adjudications or would substantially impair or impede the ability of such members of the Class to protect their interests. VI. EQUITABLE TOLLING OF APPLICABLE STATUTES OF LIMITATIONS 74. The running of any statute of limitations has been tolled by reason of Defendant s fraudulent concealment. Defendant, through failing to disclose a known defect to 18

19 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 19 of 30 physicians or Class Members, and misrepresenting its drug as safe for its intended use, actively concealed from Plaintiff, the Class, Plaintiff s and the Class prescribing physicians the true risks associated with CHANTIX. 75. As a result of Defendant s actions, Plaintiff, the Class, and their prescribing physicians were unaware, and could not reasonably known or have learned through reasonable diligence of the manufacturing defects that Plaintiff and Class members had been exposed to the risks alleged herein and that those risks were a direct and proximate result of Defendant s acts and omissions. 76. Furthermore, Defendant is estopped from relying on any statute of limitations because of its fraudulent concealment of the defective nature of CHANTIX. Defendant was under a duty to disclose the true character, quality, and nature of CHANTIX because this was non-public information over which the Defendant had, and continues to have, exclusive control, and because Defendant knew that this information was not available to the Plaintiff and Class Members, medical providers and/or to their facilities. In addition, the Defendant is estopped from relying on any statute of limitations because of its concealment of these facts. 77. Plaintiff and the Class had no knowledge that Pfizer was engaged in the wrongdoing alleged herein. Because of the fraudulent acts of concealment of wrongdoing by the Defendant, the Plaintiff and the Class could not have reasonably discovered the wrong doing at any time prior to the filing of this action. Plaintiff, the Class and medical professionals could not have possibly conducted studies to determine the nature, extent and identity of related health risks dealing with the manufacturing defect of Defendant s drug and were forced to rely only on Defendant s representations. 19

20 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 20 of 30 VII. RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT (RICO) PREDICATE ACTS 78. Upon information and belief, prior to FDA approval, Pfizer embarked upon a marketing campaign claiming that CHANTIX was a safe and effective prescription drug for treatment in smoking cessation. 79. Upon information and belief, Pfizer prepared and caused to be prepared fraudulent and misleading marketing materials and caused those materials to be mailed out to physicians and other members of the medical community, as well as insurance companies and other entities that would distribute or sell CHANTIX. 80. Upon information and belief, Pfizer s mailings were made and mailed for the sole purpose of inducing physicians and other members of the medical community, as well as insurance companies into believing that CHANTIX was a safe and effective treatment for smokers, in order to realize profits, while turning a blind eye to patient safety. A. The Role of Third Parties in Defendant s Marketing Scheme 81. The major non-physician writers, authors, and vendors (collectively Third Parties ), were important participants in Pfizer s overall marketing plan. These third parties knowingly and intentionally, communicated and distributed the misrepresentations concerning CHANTIX. For instance, upon information and belief, the non-physician writers generated inaccurate and unscientific articles pertaining to the safety and efficacy of CHANTIX and the physicians loaned their names and thereby became authors to these articles. 20

21 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 21 of The vendors published articles containing the false and misleading information in medical journals across the nation. Also, physicians participated in so called studies that misrepresented facts and evidence pertaining to CHANTIX and utilized the mails and/or wires to distribute information concerning the results thereof to plaintiff physician, pharmacies, hospitals, insurance companies, and to Plaintiff and other consumers alike. 83. These third parties were participants in Pfizer s marketing scheme and were conscious of, and participated in, the illegal scheme. They also operated collectively, for a common purpose, and as a continuing unit to perpetuate Pfizer s scheme. 84. The Third Parties knowledge, involvement, and activity is exhibited by: a. The failure to alert physicians, patients, FDA officials, or consumers about the spread of misinformation concerning the use of CHANTIX; b. Their acceptance of incentives in exchange for supporting, authoring, or publicizing the above described misrepresentations knowing physicians, Plaintiff and members of the Plaintiff class and other consumers alike would rely on these misrepresentations; c. Their agreement to permit Pfizer to control the information relayed to the public in these articles. B. Use of the Mail and Wires 85. During the class period, Pfizer used the mail by deliberately causing to be mailed thousands of fraudulent communications designed to create and manage their fraudulent scheme. This scheme involved the mailing and distribution of materials essential to Pfizer s national marketing campaign to increase sales of CHANTIX and to implement its sales plans and programs, and encompassed physicians and victims across the country. 86. During the class period, Pfizer used the wires by deliberately communicating fraudulent communications designed to create and manage their fraudulent scheme. This scheme 21

22 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 22 of 30 involved the dissemination of fraudulent information over the wires essential to Pfizer s national marketing campaign to increase sales of CHANTIX and to implement its sales plans and programs, and encompassed physicians and victims across the country. 87. Pfizer s use of the mails to perpetrate their fraud involved thousands of communications throughout the class period, including: a. Marketing and advertising materials about the safety and efficacy of CHANTIX even though it is not safe and medically efficacious, such materials were sent to physicians across the United States. b. Communications, including financial payments, with the Vendors, nonphysician technical writers, and physician authors discussing and relating to the publication of articles touting the safety and efficacy of CHANTIX even though the drug is not safe and medically effective. c. Communication with the Vendors and physicians that fraudulently misrepresented that CHANTIX was scientifically proven to be safe and effective. d. Communications with patients and consumers, including Plaintiff and the Plaintiff Class, inducing payments for CHANTIX to be made in reliance on misrepresentations. e. Receiving the proceeds of Pfizer s improper scheme. 88. In addition, Pfizer s corporate headquarters have communicated by United States mail, telephone, and facsimile with various local district managers, medical liaisons and pharmaceutical representatives in furtherance of Defendant s scheme. VIII. COUNT ONE SUBSTANTIVE RACKETEERING 89. Plaintiff and the Plaintiff Class incorporates by reference the allegations contained in the preceding paragraphs of this Complaint as if fully set forth herein. 22

23 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 23 of At all relevant times, Defendant was persons within the meaning of RICO 18 U.S.C. 1961(3). 91. The CHANTIX Marketing Enterprise constitutes an association-in-fact enterprise as that term is defined in 18 U.S.C. 1964(4), that engages in, and the activities of which affect, interstate commerce. The members of the CHANTIX Marketing Enterprise are and have been associated through time, joined in purpose and organized in a manner amenable to hierarchal and consensual decision-making, with each member fulfilling a specific and necessary role to carry out and facilitate its purpose. Throughout the period beginning in 2006 through the present, Defendant took affirmative steps to hide its fraud and scheme from discovery by the public, Plaintiff, the Plaintiff Class, physicians, hospitals, pharmacies, insurance companies and the FDA. The planning and carrying out of the scheme would have been beyond the capacity of each member of the CHANTIX Marketing Enterprise acting singly and without the aid of each other. 92. The CHANTIX Marketing Enterprise, was comprised of Study Investigators, Clinicians, physicians, site employees, non-physician writers and vendors all of which engaged in and affected interstate commerce, because, inter alia, the Enterprise assisted Defendant in the furtherance of their scheme by marketing, selling and concealing the truth in order to induce American consumers, like Plaintiff and members of the Plaintiff class, to purchase CHANTIX. 93. Defendant is or has been employed by and/or associated with the CHANTIX Marketing Enterprise. Defendant and the CHANTIX Marketing Enterprise began implementing their fraudulent scheme on or before 2006; and, they have continued to execute the fraud and scheme through the present. 23

24 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 24 of On information and belief, Defendant received a financial benefit for their participation in the scheme. Such financial benefits were the product of the scheme and could not have been realized had the Defendant not joined the CHANTIX Marketing Enterprise. 95. Defendants has mailed or caused to be mailed thousands of mailings in furtherance of the scheme to realize profits at the expense of the safety of consumers and patients. Further, Defendant has conducted and/or participated in the conduct of the CHANTIX Marketing Enterprise s affairs through a pattern of racketeering activity in violation of RICO, 18 U.S.C. 1962(c) by engaging in numerous acts of mail fraud under 18 U.S.C and Defendant exerted control over the CHANTIX Marketing Enterprise and participated in the operation or management of the affairs of the enterprise, by a. Asserting direct control over the information and content disseminated to the vendors, physicians and the public regarding the medical safety and efficacy of CHANTIX in articles published across the country; b. Engaging in multiple instances of selling or otherwise dealing in dangerous drugs in a manner punishable under the laws of the United States; c. Asserting control over the creation and distribution of mass-marketing and sales materials sent to vendors and physicians throughout the United States and; d. Placed their own employees and agents in positions of authority and control in the CHANTIX Marketing Enterprise. 97. Each of Defendant s acts involved in the selling or otherwise dealing in dangerous drugs in a manner punishable under the laws of the United States and Defendant s fraudulent mailings and interstate wire transmissions constitute racketeering activity within the meaning of 18 U.S.C. 1961(1). Collectively, these violations constitute a pattern of racketeering activity within the meaning of 18 U.S.C. 1961(5). 24

25 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 25 of Defendant has conducted and participated in the affairs of the CHANTIX Marketing Enterprise through a pattern of racketeering activity by selling or otherwise dealing in a dangerous drug in a manner punishable under the laws of the United States, as well by acts indictable under 18 U.S.C and 1343 (mail and wire fraud). 99. In implementing their fraudulent scheme, Defendant was acutely aware that Plaintiff and members of the Plaintiff Class depended on the honesty of Defendant in representing the safety and medical efficacy of CHANTIX Defendant engaged in a pattern of racketeering activity intending to defraud Plaintiff and the members of the Plaintiff Class As detailed above, Defendant s fraudulent scheme consisted of, inter alia: a. Causing providers to misrepresent the safety and efficacy of CHANTIX; b. Deliberately misrepresenting the safety and efficacy of CHANTIX so that Plaintiff and the members of the Plaintiff Class paid for this drug to treat symptoms for which it was not scientifically proven to be safe and effective; c. Publishing or causing to have published materials containing false information upon which physicians, Plaintiff and members of the Class relied upon when choosing to prescribe or pay for CHANTIX; d. Actively concealing, and causing others to conceal, information about the true safety and efficacy of CHANTIX The above-described racketeering activities amounted to a common course of conduct intended to deceive Plaintiff and members of the Plaintiff class. The racketeering activities were related, had similar purposes, involved the same or similar participants and methods of commission, and had similar results affecting similar victims, including Plaintiff and members of the Plaintiff Class. Defendant s fraudulent 25

26 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 26 of 30 activities are part of their ongoing business and constitute a continuing threat to the property of Plaintiff and the Class Plaintiff and the Plaintiff Class have suffered injuries and financial loss, in the sum of billions of dollars in payments for CHANTIX that they would not have made had the CHANTIX Marketing Enterprise and Defendant not implemented its scheme to unlawfully gain profits at the expense of patient safety in violation of federal law. If the CHANTIX Marketing Enterprise and Defendant had not engaged in such conduct, Plaintiff and the Plaintiff Class would not have been injured by Defendant Plaintiff and the Class members injuries were directly and proximately caused by Defendant s racketeering activity as described above. WHEREFORE, Plaintiff and the Plaintiff Class respectfully prays for judgment against Defendant and for relief as follows: (a) (b) (c) Treble damages Reasonable attorneys fees and costs; and Such other relief as the Court deems just and proper. IX. COUNT TWO VIOLATION OF 18 U.S.C (c) GROUP ENTERPRISE 105. Plaintiff and the Plaintiff Class incorporate by reference the allegations of the above paragraphs of this Complaint as though fully set forth herein At all relevant times, Defendant was a person within the meaning of RICO, 18 U.S.C. 1961(3). 26

27 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 27 of Defendant has willfully combined, conspired and agreed to violate 18 U.S.C. 1962(c) with the CHANTIX Marketing Enterprise, and their officers and principal to conduct and/or participate, directly or indirectly, in the conduct of the CHANTIX Marketing Enterprise s affairs through a pattern of racketeering activity based upon numerous acts of mail fraud An object of the conspiracy was to defraud the Plaintiff and the members of the Plaintiff Class in order to realize profits. A further object of the conspiracy was to hide the fraud and scheme from discovery by the public, physicians, hospitals, pharmacies, insurance companies and the FDA. Defendant embraced the object of the conspiracy and knowingly acted to support and facilitate the accomplishments of its goals. The conspiracy and fraudulent scheme began at least in 2006 and continues to the present Plaintiff and the Plaintiff Class would not have suffered injuries and financial loss had the CHANTIX Marketing Enterprise not implemented its scheme to realize increased revenue and profits through violations of the federal law. If the CHANTIX Marketing Enterprise and Defendant not engaged in such conduct, Plaintiff and the members of the Plaintiff Class would not have been injured by Defendant. WHEREFORE, Plaintiff and members of the Plaintiff Class respectfully pray for judgment against Defendant and for relief as follows: (a) (b) (c) Treble damages Reasonable attorneys fees and costs; and Such other relief as the Court deems just and proper. 27

28 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 28 of 30 X. COUNT THREE VIOLATION OF 18 U.S.C (d) BY CONSPIRING TO VIOLATE 18 U.S.C. 1962(c) 110. Plaintiff and the Plaintiff Class incorporate the allegations contained in the preceding paragraphs Section 1962(d) of RICO provides that it shall be unlawful for any person to conspire to violate any of the provisions of subsection (a), (b) or (c) of this section Defendant has violated 1962(d) by conspiring to violate 18 U.S.C. 1962(c). The object of this conspiracy has been and is to conduct or participate in, directly or indirectly the affairs of the 1962(c) Enterprises described supra through a pattern of racketeering activity As discussed supra, Defendant s co-conspirators have engaged in numerous overt and predicate fraudulent racketeering acts in furtherance of the conspiracy, including material misrepresentations and omissions designed to defraud Plaintiff and the Class of their money The nature of the above-described Defendant s co-conspirators acts, material misrepresentations, and omissions in furtherance of the conspiracy gives rise to an inference that they not only agreed to the objective of an 18 U.S.C. 1962(d) violation of RICO by conspiring to violate 18 U.S.C. 1962(c), but they were aware that their ongoing fraudulent and extortionate acts have been and are part of an overall pattern of racketeering activity. 28

29 Case 3:08-cv MJR-DGW Document 2 Filed 08/08/2008 Page 29 of As a direct and proximate result of Defendant s overt acts and predicate acts in furtherance of violating 18 U.S.C. 1962(d) by conspiring to violate 18 U.S.C. 1962(c), Plaintiff and the Class have been and are continuing to be injured in their business or property as set forth more fully above Defendant has sought to and has engaged in the commission of and continue to commit overt acts, including the following of unlawful racketeering predicate acts: a. Multiple instances of mail and wire fraud violations of 18 U.S.C and 1342; b. Multiple instances of selling or otherwise dealing in dangerous drugs in a manner punishable under the laws of the United States; c. Multiple instances of mail and wire fraud violations of 18 U.S.C and 1346; and d. Multiple instances of wire fraud violations of 18 U.S.C and Defendant s violations of the above federal laws and the effects thereof detailed above are continuing and constitute a pattern of racketeering activity. WHEREFORE, the Plaintiff respectfully prays that the Court enter judgment in favor of Plaintiff and the Plaintiff Class members and against the Defendant in the amount provided by law, together with punitive damages to deter such conduct in the future, plus treble damages and attorneys fees as provided by the Rackeeter Influenced and Corrupt Organizations act, and grant such further relief as may be proper. 29