The following PPH lawsuit was filed in August of 2006 against Wyeth. The suit alleges that Becky Wright contracted Primary Pulmonary Hypertension after using Pondimin as a weight loss product:
52. Despite the fact that WYETH knew or should have known that fenfluramine and/or dexfenfluramine, and/or any combination of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine caused unreasonable, dangerous side effects which many users would be unable to remedy by any means, the AHP Defendants continued to market fenfluramine and/or dexfenfluramine and the combined use of fenfluramine and/or dexfenfluramine and phentermine to consumers, including Plaintiff, when there were safer alternative methods of weight loss.
53. WYETH knew or should have known that consumers, such as Plaintiffs, would foreseeably suffer injury as a result of the WYETH's failure to exercise ordinary care as described above.
54. Likewise, WYETH was negligent in ever seeking approval for the sale of dexfenfluramine, given WYETH's knowledge of the dangers associated with fenfluramine.
55. WYETH was negligent per se in violating 21 U.S.C. §§ 321, 331, 352, and 355. In particular, WYETH was negligent per se for violating the following laws:
a. Pondimin and/or Redux were labeled improperly, in that the labeling was misleading and inaccurate in violation of 21 U.S.C. §§ 321(n), 331(a), and 352(a) &(c);
b. Pondimin and/or Redux were misbranded in violation of 21 U.S.C. §§ 331(a), 352(a), (c), 0) & (p);
c. WYETH failed to establish and maintain records and to make reports to the Secretary of Health of data relating to clinical experience and other data or information, received or otherwise obtained with respect to fenfluramine and dexfenfluramine, and their association with pulmonary hypertension, primary pulmonary hypertension and valvular heart disease to allow the Secretary of Health to determine whether the drug applications for fenfluramine and dexfenfluramine should be withdrawn or suspended in violation of 21 U.S.C. § 355(k);
d. WYETH failed to disclose information to the public received or otherwise obtained with respect to the safety and effectiveness of fenfluramine and dexfenfluramine, and their association with pulmonary hypertension, primary pulmonary hypertension and valvular heart disease in violation of 21 U.S.C. § 3550.
56. WYETH was negligent per se in violating 21 C.F.R. §§ 1.21, 99.101, 201.56, 201.57, 202.1, 310.303, 314.70, 314.80, and 314.81. In particular, WYETH was negligent per se for violating the following regulations:
a. The labeling for Pondimin and/or Redux failed to contain a proper, complete and sufficient warning for pulmonary hypertension and/or primary pulmonary hypertension, and/or serious heart conditions as soon as there was reasonable evidence of its association with fenfluramine and dexfenfluramine in violation of 21 C.F.R. §§ 1.21 and 201.57(e);
b. The labeling for Pondimin and/or Redux failed to notify the patient that use of fenfluramine and/or dexfenfluramine individually and/or in combination with phentermine may have harmful effects in violation of 21 C.F.R. § 201.57(f)(2);
c. The labeling for Pondimin and/or Redux failed to list all adverse reactions reasonably associated with the use of the drugs and with drugs in the same pharmacologically active and chemically related class in violation of 21 C.F.R. § 201.57(g)(1);
d. The “Adverse Reactions” section of the Pondimin and/or Redux labeling failed to list first the most severe adverse reactions of death, pulmonary hypertension, and/or primary pulmonary hypertension, and/or valvular heart disease in violation of 21 C.F.R. § 201.57(g)(2);
e. The “Warnings” section of the Pondimin and/or Redux labeling failed to identify any potentially fatal adverse reaction in violation of 21 C.F.R. § 201.57(g)(3);
f. There was inadequate information for patients regarding use of Pondimin and/or Redux, individually, and/or the concomitant use with phentermine, in violation of 21 C.F.R. § 201.57(f)(2);
g. The labeling for Pondimin and/or Redux was not informative and accurate, and it was false and misleading and/or promotional in part, in violation of 21 C.F.R. §§ 1.21 and 201.56(b);
h. There was inadequate information for patients for the use of Pondimin and Redux, individually or in combination, with phentermine in violation of 21 C.F.R. § 201.57(f)(1);
i. The labeling for Pondimin and Redux lacked adequate and accurate information on the approximate “kind, degree and duration” of expected weight loss from for Pondimin and Redux by themselves and/or in combination with phentermine in violation of 21 C.F.R. § 201.57(c)(3)(i); providing accurate information on this subject would have alerted consumers, pharmacists and physicians to the fact that these drugs were only minimally effective, if at all;
j. The labeling for Pondimin and Redux did not state that there was a lack of evidence to support the common belief in the safety and efficacy of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine together in violation of 21 C.F.R. §§ 201.57(c)(2) and 201.57(c)(3)(i) & (iv);
k. WYETH failed to properly maintain records and make reports related to the clinical experience or other data to make or facilitate a determination of whether there were grounds to withdraw FDA approval of Pondimin and/or Redux in violation of 21 C.F.R. § 310.303(a);
l. WYETH failed to change the labeling for Pondimin to add or strengthen the language pertaining to pulmonary hypertension and valvu.lar heart disease without FDA approval as permitted by 21 C.F.R. § 314.70(c)(2)(i);
m. WYETH failed to promptly review all adverse drug experience information, including available scientific literature, and failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to the FDA in violation of 21 C.F.R. § 314.80(b);
n. Advertising for Pondimin and/or Redux did not contain a “[T]rue statement” of information, and was false, misleading, and failed to reveal facts material in the light of its representations or material with respect to consequences that may result from the use of the drug as recommended in violation of 21 C.F.R. § 202.1;
o. WYETH entirely failed to report serious and unexpected adverse drug experience information as defined by 21 C.F.R. § 314.80(a), regarding Pondimin and Redux to the FDA in some instances, and failed to report the information timely in others, in violation of 21 C.F.R. § 314.80(c)(1)(i);
p. WYETH failed to promptly investigate all the adverse drug experiences that were the subject of postmarketing 15-day “Alert Reports” regarding Pondimin and Redux in violation of 21 C.F.R. § 314.80(c)(1)(ii);
q. WYETH failed to properly report all the adverse drug experiences that were the subject of postmarketing 15-day “Alert Reports” regarding Pondimin and Redux in their periodic reports in violation of 21 C.F.R. §§ 314.80(c)(2)(i) & (ii);
r. WYETH failed to promptly report all adverse drug experience information available in the scientific literature pertaining to the association between Pondimin and Redux and pulmonary hypertension and primary pulmonary hypertension in violation of 21 C.F.R. §§ 314.80(d) & (e);
s. WYETH failed to properly summarize in their annual reports the adverse drug experiences related to pulmonary hypertension, primary pulmonary hypertension and valvular heart disease that would have affected the safety and effectiveness, or labeling of Pondimin and Redux in violation of 21 C.F.R. § 314.81(a)(2)(ii);
t. WYETH disseminated written information about fenfluramine and dexfenfluramine concerning the effectiveness and benefits of using the drugs in a manner not described in the approved labeling, which failed to comply with the procedure for disseminating such information in violation of 21 CFR § 99.101;
u. The labeling lacked adequate information on the use of Pondimin and/or Redux, in violation of 21 C.F.R. § 201.56(a)&(d);
v. The diet drugs labeling lacked adequate information on the approximate “kind, degree, and duration” of expected improvement, alone or in combination, in violation of 21 C.F.R. § 201.57(c)(3)(i);
w. The labeling did not state that there was a lack of evidence to support the common belief of the safety and efficacy of Redux or Pondimin, in violation of 21 C.F.R. § 201.57(c)(3)(l) and/or (c)(2);
x. The labeling failed to add an adequate warning for (a) pulmonary hypertension, (b) serious heart conditions, and (c) serious brain conditions as soon as there was reasonable evidence of its association with Redux and Pondimin, in violation of 21 C.F.R. § 201.57(e);
y. There was inadequate information for patients for the safe and effective use of Redux and Pondimin, in violation of 21 C.F.R. § 201(f)(2);
z. There was inadequate information regarding the special care to be exercised by the doctor for safe and effective use of Redux and Pondimin, in violation of 21 C.F.R. § 201(f)(1);
aa. The diet drugs labeling was misleading and/or promotional, in violation of 21 C.F.R. § 201.56(b);
bb. The diet drugs labeling did not advise of all adverse reactions, in violation of 21 C.F.R. § 201.57(g); and
cc. There was inadequate reporting of adverse events to the FDA, in violation of 21 C.F.R. § 314.80.
COMES NOW, Becky J. Wright and Ernest T. Wright and file this Complaint and would respectfully show this Honorable Court as follows:
1. Becky J. Wright suffers from a fatal disease called Primary Pulmonary Hypertension (“PPH”). There is no cure for PPH. The mean survival from the onset of symptoms is two to three years. Mrs. Wright has undergone the most aggressive PPH treatment, Flolan, for over four years. Flolan is administered by a surgically implanted catheter through your chest and a portable battery-operated pump, and since the medicine works only 3-5 minutes, it must be worn 24 hours a day. In addition, persons with fenfluramine-induced PPH have been found to have a poorer survival rate. Rich S, et al., Am J Cardiol. 2003 Dec 1; 92(11): 1366- 1368. Mrs. Wright's PPH was fenfluramine-induced. Due to the extremely high risk of Mrs. Wright's imminent death, Plaintiffs will seek a rapid remand of this case from MDL 1203 and the first available trial setting herein upon remand.
PARTIES TO THIS CIVIL ACTION
2. Becky J. Wright and Ernest T. Wright reside at 1007 Leslie Blvd., Jefferson City, Cole County, Missouri 65101. This personal injury and products liability complaint is brought on behalf of Becky J. Wright. Mrs. Wright suffers from PPH resulting from her ingestion of fenfluramine, sold as Pondimin.
3. This civil action is also brought on behalf of the spouse, Ernest T. Wright, of Mrs. Wright, who has suffered loss of consortium as a result of the injuries caused by the fenfluramine.
4. Defendant American Home Products Corporation (“AHP”) is a Delaware Corporation with its principal place of business in Madison, New Jersey and it and Wyeth, Inc. can be served with the Complaint and Summons at Prentice Hall Corporation System, Inc., 221 Bolivar Street, Jefferson City, Missouri, 65101 or at Five Giralda Farms, Madison, New Jersey, 07940. At all relevant times, AHP was in the business of promoting, marketing and distributing the pharmaceutical fenfluramine, sold as Pondimin. On information and belief, AHP does business in Missouri, including the Eastern District of Missouri, and at all relevant times developed, promoted and manufactured and/or sold in Missouri, the drug Pondimin ingested by Mrs. Wright. On information and belief, defendant Wyeth is exactly the same as AHP, is liable for all wrongdoing of AHP and is simply a new AHP name and Plaintiffs shall therefore refer to Wyeth as AHP and/or use the names Wyeth/AHP interchangeably.
5. Defendant Wyeth-Ayerst International, Inc. (also referred to as “Wyeth”), is a New York corporation and has its principal place of business in Philadelphia, Pennsylvania said defendant can be served with the Complaint and Summons at The Prentice-Hall Corp. System, Inc., 2704 Commerce Drive Harrisburg, PA 17110.
6. Defendants American Home Products, n/k/a Wyeth, Inc. and Wyeth-Ayerst International, Inc. (collectively referred to herein as “AHP” or “Wyeth”) were at all times relevant hereto, engaged in the business of licensing, manufacturing, distributing, labeling, marketing, promoting and/or selling, either directly or indirectly, through third parties or related entities, the pharmaceuticals fenfluramine and/or dexfenfluramine under the names “PONDIMIN” and “REDUX” among others. Plaintiffs allege on information and belief that Wyeth does business throughout the United States, and at all relevant times developed, manufactured and sold in interstate commerce, the aforementioned drugs. Wyeth engages in interstate commerce and does business in the state of Missouri.
JURISDICTION AND VENUE
6. Plaintiffs are residents of Cole County, Missouri. The injuries of Mrs. Wright were caused by the wrongful acts, omissions, fraudulent inducements and fraudulent misrepresentations of the Defendants which occurred in substantial part in the Western District of Missouri, Jefferson City Division.
7. This action is brought in federal court under 28 U.S.C. § 1332, Diversity of Citizenship. Complete diversity of citezenship exists between Plaintiffs and the named Defendants. Damages in this action exceed $75,000.
INTRODUCTION
8. Plaintiff identified above is a victim of the Defendants' decision to manufacture, market, design, and/or distribute two popular diet drugs. Plaintiff would show that Defendants manufactured, marketed, and distributed anorectic inducing, weight-loss drugs popularly known, advertised, promoted and referred to as “fen/phen.” The drugs were commonly prescribed in combination with each other and with dexfenfluramine. The Defendants knew or should have known the risk to patients of taking such medications. Plaintiff's problems are caused by Pondimin.
9. At all relevant times WYETH, themselves, or by use of others, did manufacture, create, design, test, label, sterilize, package, distribute, supply, market, sell, advertise, and otherwise distribute, in interstate commerce the diet drugs Pondimin (fenfluramine) and Redux (dexfenfluramine). Fenfluramine and/or dexfenfluramine, both alone and in combination, has been widely promoted by WYETH as effective and safe for weight loss.
10. Plaintiff, Becky Wright, is complaining of injuries sustained as the result of the use of the weight loss medications fenfluramine and/or dexfenfluramine.
11. Fenfluramine was one of the drugs prescribed in combination and promoted and referred to as “fen/phen.” WYETH marketed fenfluramine under the trade name, Pondimin. In doing so, WYETH actively encouraged, and/or failed to effectively discourage, the combined use of fenfluramine because they knew that the combined use would increase sales of fenfluramine.
12. Dexfenfluramine is the d-isomer of fenfluramine, containing the same active ingredient as fenfluramine. WYETH marketed dexfenfluramine under the trade name Redux.
13. Fenfluramine (Pondimin) and dexfenfluramine (Redux) were abruptly withdrawn from the market on September 15, 1997. Prior to that withdrawal, these drugs were sold to millions of people subjecting them to serious risk of bodily harm including pulmonary hypertension (“PH”) or primary pulmonary hypertension (“PPH”), an often-fatal lung disease, and heart valve damage.
14. WYETH knew of the serious side effects of fenfluramine and/or dexfenfluramine for a substantial period of time. These side effects were known or should have been known to WYETH at the time that they marketed the drags to the public based on, among other things, medical evidence of dangerous and potentially fatal side effects from the use of the drags in Europe and elsewhere, as detailed below. WYETH did not, however, conduct adequate testing to establish the safety of the drags before marketing them. Rather, WYETH aggressively marketed the drags and promoted their use, both individually and in combination with other drags, while downplaying evidence of the serious and potentially fatal side effects that consumers of these drags could face.
MARKETING STRATEGY
15. WYETH's strategy, beginning in the early 1990s, was to aggressively market fenfluramine often by encouraging combination use of the product with phentermine, by falsely misleading potential users about fenfluramine and by failing to protect users from serious dangers that WYETH knew or should have known could result from the use of fenfluramine.
16. WYETH widely and successfully marketed fenfluramine and/or dexfenfluramine in the United States.
17. WYETH undertook a promotional campaign that included the placement of numerous articles in scientific, medical and general interest magazines extolling the virtues of fenfluramine combined with phentermine in order to induce widespread use of the product. Many of these articles either cited or reported the results of studies that were funded by WYETH. Thus, WYETH actively encouraged, or failed to effectively discourage, combinations of these drags.
18. Further, WYETH actively encouraged, or failed to effectively discourage, combinations of these drags by employing and/or contracting with commission based salespersons to promote the widespread prescribing of fenfluramine and/or the combination of fenfluramine and phentermine to patients that were not clinically obese.
19. The marketing program as a whole, by affirmative misrepresentations and omissions, falsely and fraudulently sought to create the image and impression that the use of fenfluramine, both individually and/or in combination with phentermine, was safe for human use, had fewer side effects and adverse reactions than other methods of weight loss, constituted a convenient, safe form of weight loss and would not interfere with daily life.
20. WYETH purposefully downplayed and understated the health hazards and risks associated with fenfluramine and/or dexfenfluramine.
21. WYETH falsely and fraudulently concealed relevant information from doctors and potential fenfluramine and/or dexfenfluramine users regarding the safety of fenfluramine and/or dexfenfluramine.
22. In particular, WYETH's marketing efforts as well as their product inserts, falsely, fraudulently and negligently misrepresented a number of facts regarding fenfluramine and/or dexfenfluramine, including the following:
a. The presence of adequate testing of fenfluramine and the presence of adequate testing of any combination use of the product with phentermine.
b. Fenfluramine and/or dexfenfluramine's efficacy including but not limited to the severity, frequency and discomfort of side effects and adverse health effects caused by the drugs.
c. The relative risks associated with the drugs including the prevalence of pulmonary hypertension, primary pulmonary hypertension, and valvular heart disease.
EFFECTS OF USE
1. Primary Pulmonary Hypertension
23. In 1965, the diet drug Aminorex was introduced in Europe. Aminorex was touted as a wonder weight loss drug that worked by increasing brain serotonin and inhibiting reuptake of serotonin. However, by 1967 evidence began to surface that the ingestion of Aminorex was associated with pulmonary hypertension. Over the next six years, an Aminorex epidemic raged in Europe. There was a ten-fold increase in primary pulmonary hypertension cases. Half of the patients died within ten years and the rest of the patients suffered significant oxygen deprivation and are debilitated for the remainder of their lives. Aminorex was removed from the European market in 1972. WYETH knew, or should have known, of the European experience with Aminorex and how it would relate to WYETH's drugs Pondimin and Redux three (3) decades later.
24. In 1973, Pondimin was introduced into the United States market. Pondimin is a fenfluramine drug and is in the same family of drugs as Aminorex, and is very similar to Aminorex. Pondimin was touted as a wonder weight loss drug that worked by increasing brain serotonin and inhibiting reuptake of serotonin. However, because the drug when used alone made users lethargic and tired, sales of Pondimin languished.
25. On October 3, 1981, Dr. J.G. Douglas published Pulmonary Hypertension and Fenfluramine in the BRITISH MEDICAL JOURNAL. On January 25, 1986 an article entitled Irreversible Pulmonary Hypertension after Treatment with Fenfluramine, was published in the BRITISH MEDICAL JOURNAL. WYETH knew, or should have known, of the BRITISH MEDICAL JOURNAL articles and how those articles related to their drug Pondimin a decade later.
26. In 1984, Dr. Michael Weintraub published A Double-Blind Clinical Trial in Weight Control: Use of Fen. fluramine and Phentermine Alone and in Combination in ARCHIVES of INTERNAL MEDICINE. Dr. Weintraub's study was supported by A.H. Robins (which was later acquired by AHP). Despite noting some adverse effects associated with fenfluramine, Dr. Weintraub entirely failed to examine the long-term safety of fenfluramine. Instead, the study focused on the short-term effectiveness of the drugs used individually, and in combination.
27. In 1992, Dr. Weintraub published a series of articles in CLINICAL PHARMACOLOGICAL THERAPIES, in which he reported his research regarding the long term use of fenfluramine and phentermine for weight control. Dr. Weintraub's research was supported by WYETH.
28. Dr. Weintraub's research assumed the safety of fenfluramine, and did not examine the short-term or long-term safety of the drug. Further, WYETH failed to conduct or fund any studies or research regarding the long-term safety of the fenfluramine drug, Pondimin. Nevertheless, WYETH did promote to physicians and the public Dr. Weintraub's conclusion that long term combination use of fenfluramine and phentermine was effective for the management of obesity.
29. By 1993, WYETH's labeling for Pondimin indicated that there were only four reported cases of pulmonary hypertension reported in association with the drug. Yet, that same year, Dr. Frangois Brenot published Primary Pulmonary Hypertension and Fenfluramine in the BRITISH HEART JOURNAL. Dr. Brenot identified 25 cases of primary pulmonary hypertension associated with the use of fenfluramine and/or dexfenfluramine. WYETH knew or should have known of the Brenot article. WYETH should have known by at least 1993 that Pondimin was defective and unreasonably dangerous. WYETH should have known by at least 1993 that WYETH's labeling of Pondimin was false.
30. On June 24, 1994, WYETH Safety Surveillance Monitor, Amy Myers, wrote a memo to WYETH Medical Monitor, Fred Wilson, and indicated that WYETH's database contained 37 cases of primary pulmonary hypertension associated with Pondimin. Further, in February 1994, the preliminary results of the International Primary Pulmonary Hypertension study (“IPPH Study”), entitled “Appetite Suppressants and the Risk of Primary Pulmonary Hypertension,” were released and available to WYETH. The preliminary results of the IPPH Study confirmed the association between fenfluramine and dexfenfluramine, and pulmonary hypertension and primary pulmonary hypertension. WYETH concealed the number of cases of primary pulmonary hypertension associated with Pondimin that WYETH knew existed in order to continue to market Pondimin for profit.
31. On June 15, 1995 AHP's James Ottinger, reported to Joseph Bathish the status of the European Committee on Proprietary Medicinal Product's (“CPMP”) pharmacovigilance discussion wherein the CPMP working party concluded that a causal relationship between anorectic agents, like fenfluramine and/or dexfenfluramine, and the occurrence of primary pulmonary hypertension had been established.
32. The August 26, 1996 issue of the NEw ENGLAND JOURNAL OF MEDICINE reported the final results of IPPH Study, which had been preliminarily released in February 1994. The IPPH Study concluded that fenfluramine-based anorexigens, such as fenfluramine and dexfenfluramine, increased the risk of PPH by a multiple of more than 23 times.
33. WYETH was aware of the result of the IPPH study by at least February 1994. Nevertheless, WYETH failed to apprise the public or physicians that the risk of contracting PH or PPH was many, many multiples of that previously reported by the WYETH in their literature. Even after the Brenot article and the preliminary release of the IPPH Study WYETH failed to remove Pondimin from the market when WYETH knew of the extreme danger, causal relationship and substantial risk of harm associated with the use WYETH's drag Pondimin.
34. WYETH continued to promote Pondimin after learning of the extreme danger associated with it. WYETH continued to promote Pondimin knowing the drag had no beneficial use. The WYETH labeling on the drag was totally inadequate to alert prescribing physicians and patients of the actual PH or PPH danger and risk associated with its fenfluramine drag, Pondimin. WYETH knew that danger and that risk.
35. Even after they knew of the danger WYETH did not remove Pondimin from the market and did not do any further testing of the drag. Instead, WYETH continued to market the drag to prescribing physicians like the physician that prescribed the diet drags to the Plaintiff in this case.
36. Further, in 1996 WYETH introduced their dexfenfluramine drag, Redux, into the U.S. market. This, despite the fact that WYETH knew of the danger and risks of valvular heart disease and primary pulmonary hypertension associated with Pondimin.
37. WYETH did not adequately or appropriately disclose fenfluramine and/or dexfenfluramine information or related drag information to physicians in the United States. Instead WYETH fraudulently concealed the pulmonary hypertension or primary pulmonary hypertension danger they knew of from physicians. As a result, physicians over-prescribed WYETH's fenfluramine and/or dexfenfluramine drags, Pondimin and Redux, to patients who were grossly under-informed regarding the risk of PH or PPH associated with the drags.
38. Although the FDA approved phentermine and fenfluramine separately, the FDA never approved the drags for combined use. WYETH knew of and encouraged the prevalence of off-label combined use of their drags, and failed to adequately and appropriately warn physicians and consumers that the combination drug regimen was not FDA approved, was hazardous due to the presence of fenfluramine, was not recommended and had not been systematically tested by appropriate clinical trials. Further, WYETH concealed, destroyed and removed written evidence and/or misrepresented evidence supporting the association between PH and/or PPH with fenfluramine and/or dexfenfluramine.
39. WYETH failed to fully and adequately warn doctors, the public and/or the Plaintiff about the risk of pulmonary hypertension from Pondimin and Redux.
2. Valvular Heart Dysfunction
40. In the early 1990s, WYETH received reports of valvular heart disease in patients taking fenfluramine and/or dexfenfluramine. However, WYETH failed to investigate the matter and failed to code their Adverse Drug Event reports appropriately so that valvular heart disease could be properly tracked and monitored. WYETH failed to conduct further testing of WYETH's drug Pondimin even after they knew of reports of valvular heart disease. WYETH continued to market their fenfluramine drug, Pondimin even after they knew of reports of valvular heart disease.
41. In 1997, a Safety Surveillance Monitor working for WYETH fraudulently destroyed, removed and concealed written Adverse Drug Event reports in the WYETH's database files that demonstrated the association between fenfluramine and/or dexfenfluramine and valvular heart disease by “deleting” and “re-coding” them. The Safety Surveillance Monitor deleted and re-coded the reports at the direction of the WYETH's senior management.
42. On or about July 8, 1997, the Mayo Clinic, located in Rochester, Minnesota, released an emergency report linking the use of fenfluramine to unusual, potentially life threatening, valvular morphology and regurgitation in 24 women. The report observed that cardiovascular testing procedures, principally the echocardiogram procedure, revealed that each of the 24 patients had one or more heart valves that were thickened and that blood was regurgitating (or “leaking” backwards), making the heart work harder to pump blood throughout the body.
43. In addition, the Mayo Clinic report observed that eight of the patients had newlydocumented pulmonary hypertension. Cardiac surgical intervention to replace bad valves was required in five of the twenty-four patients as of the date of the study.
44. The emergency release of the Mayo Clinic study, well in advance of its scheduled publication in the NEW ENGLAND JOURNAL OF MEDICINE, appears to have been motivated by the extraordinary incidence of life-threatening valvular heart disease and primary pulmonary hypertension experienced in persons who were taking fenfluramine.
45. The Mayo Clinic's study concludes that fenfluramine users needed to be informed about the risks of pulmonary hypertension and valvular heart disease, particularly because these conditions are extremely rare in individuals under 50 years old.
46. Subsequent research suggests that pulmonary hypertension and/or valvular heart disease may exist in a very significant portion of those who took fenfluramine and/or dexfenfluramine and that some of those suffering pulmonary hypertension and/or valvular dysfunction may be totally asymptomatic.
47. WYETH knew, or should have known about the risk of valvular heart disease associated with use of fenfluramine and/or dexfenfluramine. Yet, WYETH failed to warn physicians, patients, including the Plaintiff, about the risk of valvular heart disease. Further, WYETH destroyed, removed and concealed written evidence and/or misrepresented evidence supporting the association between valvular heart disease and AHP's fenfluramine (Pondimin) and dexfenfluramine (Redux). The misrepresentations include, but are not limited to, the deletion, destruction, removal, concealment, miscoding and re-coding of written Adverse Drug Event reports.
CAUSES OF ACTION
COUNT ONE
(Negligence And Negligence Per Se)
48. Plaintiffs incorporate incorporates by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows.
49. WYETH had a duty to exercise reasonable care in the manufacture, sale and/or distribution of fenfluramine and/or dexfenfluramine into the stream of commerce, including a duty to assure that the product did not cause users to suffer from unreasonable, dangerous side effects and harm.
50. WYETH failed to exercise ordinary care in the design, marketing, manufacture, sale, testing, quality assurance, quality control, and/or distribution of fenfluramine and/or dexfenfluramine into interstate commerce in that WYETH knew or should have known that the product fenfluramine, and/or dexfenfluramine created a high risk of unreasonable, dangerous harm or, side effects, some of which, such as valvular heart defects and primary pulmonary hypertension, can only be alleviated by open heart surgery or other invasive procedures and which can cause extraordinary suffering and death.
51. WYETH was negligent in the design, marketing, manufacture, testing, advertising, warning, marketing and sale of fenfluramine and/or dexfenfluramine in that they:
a. Failed to remove fenfluramine and/or dexfenfluramine from the market and in continuing to market fenfluramine and/or dexfenfluramine (Pondimin and Redux) after they knew or reasonably should have known about the potentially fatal harm or side affects associated with fenfluramine and/or dexfenfluramine, including but not limited to valvular heart disease and/or pulmonary hypertension and/or primary pulmonary hypertension;
b. Failed to conduct adequate post-marketing surveillance and/or medical monitoring to determine the safety of fenfluramine and/or dexfenfluramine (Pondimin and Redux);
c. Failed to use due care in designing and manufacturing fenfluramine and/or dexfenfluramine (Pondimin and Redux) so as to avoid the aforementioned risks to individuals when fenfluramine and/or dexfenfluramine (Pondimin and Redux) was being used for weight loss;
d. Failed to accompany their product with proper warnings regarding all possible adverse side effects associated with the use of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and the comparative severity of and duration of such adverse effects - the warnings given did not accurately reflect the symptoms, scope or severity of the side effects;
e. Failed to conduct adequate pre-clinical and clinical testing and post-marketing surveillance to determine the safety of fenfluramine and/or dexfenfluramine (Pondimin and Redux);
f. Failed to provide adequate training and/or information to medical care providers for appropriate use of fenfluramine and/or dexfenfluramine (Pondimin and Redux) either individually or in combination with phentermine;
g. Failed to warn physicians and/or the Plaintiffs, prior to actively encouraging the sale of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and/or any combination of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine, either directly or indirectly, orally or in writing, about the following: (1) about the need for comprehensive, regular medical monitoring to ensure early discovery of potentially fatal pulmonary and cardiac side effects; (2) the possibility of becoming disabled as a result of the drug use and/or having to undergo heart surgery in order to correct resultant pulmonary hypertension and/or valvular heart defects; (3) that such surgery may leave an unsightly scar or scars; or (4) that heart procedures, heart defects and/or primary pulmonary hypertension may become protracted, debilitating, difficult, and painful, necessitating long term medical care;
h. Failed to warn that the dangers associated with fenfluramine and/or dexfenfluramine (Pondimin and Redux) could exceed other comparable fortes of weight loss, particularly for those who were not clinically obese. Failed to advise physicians and the public that the drugs Pondimin and Redux had no beneficial use;
i. Failed to effectively warn about the possible danger and unapproved status of combination use of these drugs; and
j. failing to advise the U.S. Medical Profession in general, and Plaintiff's physician in particular, of important information including, but not limited to, the following:
1) that the FDA had not approved concurrent use of “Phen-Fen”;
2) that no adequate pre-marketing studies or investigation had been conducted on the “Phen-Fen” combination or Pondimin or Redux to determine their safety and efficacy;
3) that most people regained weight lost while on Pondimin and/or Redux.
52. Despite the fact that WYETH knew or should have known that fenfluramine and/or dexfenfluramine, and/or any combination of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine caused unreasonable, dangerous side effects which many users would be unable to remedy by any means, the AHP Defendants continued to market fenfluramine and/or dexfenfluramine and the combined use of fenfluramine and/or dexfenfluramine and phentermine to consumers, including Plaintiff, when there were safer alternative methods of weight loss.
53. WYETH knew or should have known that consumers, such as Plaintiffs, would foreseeably suffer injury as a result of the WYETH's failure to exercise ordinary care as described above.
54. Likewise, WYETH was negligent in ever seeking approval for the sale of dexfenfluramine, given WYETH's knowledge of the dangers associated with fenfluramine.
55. WYETH was negligent per se in violating 21 U.S.C. §§ 321, 331, 352, and 355. In particular, WYETH was negligent per se for violating the following laws:
a. Pondimin and/or Redux were labeled improperly, in that the labeling was misleading and inaccurate in violation of 21 U.S.C. §§ 321(n), 331(a), and 352(a) &(c);
b. Pondimin and/or Redux were misbranded in violation of 21 U.S.C. §§ 331(a), 352(a), (c), 0) & (p);
c. WYETH failed to establish and maintain records and to make reports to the Secretary of Health of data relating to clinical experience and other data or information, received or otherwise obtained with respect to fenfluramine and dexfenfluramine, and their association with pulmonary hypertension, primary pulmonary hypertension and valvular heart disease to allow the Secretary of Health to determine whether the drug applications for fenfluramine and dexfenfluramine should be withdrawn or suspended in violation of 21 U.S.C. § 355(k);
d. WYETH failed to disclose information to the public received or otherwise obtained with respect to the safety and effectiveness of fenfluramine and dexfenfluramine, and their association with pulmonary hypertension, primary pulmonary hypertension and valvular heart disease in violation of 21 U.S.C. § 3550.
56. WYETH was negligent per se in violating 21 C.F.R. §§ 1.21, 99.101, 201.56, 201.57, 202.1, 310.303, 314.70, 314.80, and 314.81. In particular, WYETH was negligent per se for violating the following regulations:
a. The labeling for Pondimin and/or Redux failed to contain a proper, complete and sufficient warning for pulmonary hypertension and/or primary pulmonary hypertension, and/or serious heart conditions as soon as there was reasonable evidence of its association with fenfluramine and dexfenfluramine in violation of 21 C.F.R. §§ 1.21 and 201.57(e);
b. The labeling for Pondimin and/or Redux failed to notify the patient that use of fenfluramine and/or dexfenfluramine individually and/or in combination with phentermine may have harmful effects in violation of 21 C.F.R. § 201.57(f)(2);
c. The labeling for Pondimin and/or Redux failed to list all adverse reactions reasonably associated with the use of the drugs and with drugs in the same pharmacologically active and chemically related class in violation of 21 C.F.R. § 201.57(g)(1);
d. The “Adverse Reactions” section of the Pondimin and/or Redux labeling failed to list first the most severe adverse reactions of death, pulmonary hypertension, and/or primary pulmonary hypertension, and/or valvular heart disease in violation of 21 C.F.R. § 201.57(g)(2);
e. The “Warnings” section of the Pondimin and/or Redux labeling failed to identify any potentially fatal adverse reaction in violation of 21 C.F.R. § 201.57(g)(3);
f. There was inadequate information for patients regarding use of Pondimin and/or Redux, individually, and/or the concomitant use with phentermine, in violation of 21 C.F.R. § 201.57(f)(2);
g. The labeling for Pondimin and/or Redux was not informative and accurate, and it was false and misleading and/or promotional in part, in violation of 21 C.F.R. §§ 1.21 and 201.56(b);
h. There was inadequate information for patients for the use of Pondimin and Redux, individually or in combination, with phentermine in violation of 21 C.F.R. § 201.57(f)(1);
i. The labeling for Pondimin and Redux lacked adequate and accurate information on the approximate “kind, degree and duration” of expected weight loss from for Pondimin and Redux by themselves and/or in combination with phentermine in violation of 21 C.F.R. § 201.57(c)(3)(i); providing accurate information on this subject would have alerted consumers, pharmacists and physicians to the fact that these drugs were only minimally effective, if at all;
j. The labeling for Pondimin and Redux did not state that there was a lack of evidence to support the common belief in the safety and efficacy of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine together in violation of 21 C.F.R. §§ 201.57(c)(2) and 201.57(c)(3)(i) & (iv);
k. WYETH failed to properly maintain records and make reports related to the clinical experience or other data to make or facilitate a determination of whether there were grounds to withdraw FDA approval of Pondimin and/or Redux in violation of 21 C.F.R. § 310.303(a);
l. WYETH failed to change the labeling for Pondimin to add or strengthen the language pertaining to pulmonary hypertension and valvu.lar heart disease without FDA approval as permitted by 21 C.F.R. § 314.70(c)(2)(i);
m. WYETH failed to promptly review all adverse drug experience information, including available scientific literature, and failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to the FDA in violation of 21 C.F.R. § 314.80(b);
n. Advertising for Pondimin and/or Redux did not contain a “[T]rue statement” of information, and was false, misleading, and failed to reveal facts material in the light of its representations or material with respect to consequences that may result from the use of the drug as recommended in violation of 21 C.F.R. § 202.1;
o. WYETH entirely failed to report serious and unexpected adverse drug experience information as defined by 21 C.F.R. § 314.80(a), regarding Pondimin and Redux to the FDA in some instances, and failed to report the information timely in others, in violation of 21 C.F.R. § 314.80(c)(1)(i);
p. WYETH failed to promptly investigate all the adverse drug experiences that were the subject of postmarketing 15-day “Alert Reports” regarding Pondimin and Redux in violation of 21 C.F.R. § 314.80(c)(1)(ii);
q. WYETH failed to properly report all the adverse drug experiences that were the subject of postmarketing 15-day “Alert Reports” regarding Pondimin and Redux in their periodic reports in violation of 21 C.F.R. §§ 314.80(c)(2)(i) & (ii);
r. WYETH failed to promptly report all adverse drug experience information available in the scientific literature pertaining to the association between Pondimin and Redux and pulmonary hypertension and primary pulmonary hypertension in violation of 21 C.F.R. §§ 314.80(d) & (e);
s. WYETH failed to properly summarize in their annual reports the adverse drug experiences related to pulmonary hypertension, primary pulmonary hypertension and valvular heart disease that would have affected the safety and effectiveness, or labeling of Pondimin and Redux in violation of 21 C.F.R. § 314.81(a)(2)(ii);
t. WYETH disseminated written information about fenfluramine and dexfenfluramine concerning the effectiveness and benefits of using the drugs in a manner not described in the approved labeling, which failed to comply with the procedure for disseminating such information in violation of 21 CFR § 99.101;
u. The labeling lacked adequate information on the use of Pondimin and/or Redux, in violation of 21 C.F.R. § 201.56(a)&(d);
v. The diet drugs labeling lacked adequate information on the approximate “kind, degree, and duration” of expected improvement, alone or in combination, in violation of 21 C.F.R. § 201.57(c)(3)(i);
w. The labeling did not state that there was a lack of evidence to support the common belief of the safety and efficacy of Redux or Pondimin, in violation of 21 C.F.R. § 201.57(c)(3)(l) and/or (c)(2);
x. The labeling failed to add an adequate warning for (a) pulmonary hypertension, (b) serious heart conditions, and (c) serious brain conditions as soon as there was reasonable evidence of its association with Redux and Pondimin, in violation of 21 C.F.R. § 201.57(e);
y. There was inadequate information for patients for the safe and effective use of Redux and Pondimin, in violation of 21 C.F.R. § 201(f)(2);
z. There was inadequate information regarding the special care to be exercised by the doctor for safe and effective use of Redux and Pondimin, in violation of 21 C.F.R. § 201(f)(1);
aa. The diet drugs labeling was misleading and/or promotional, in violation of 21 C.F.R. § 201.56(b);
bb. The diet drugs labeling did not advise of all adverse reactions, in violation of 21 C.F.R. § 201.57(g); and
cc. There was inadequate reporting of adverse events to the FDA, in violation of 21 C.F.R. § 314.80.
57. WYETH's negligence and/or negligence per se was a proximate cause of Plaintiff's injuries, harm and economic loss, which they suffered and will continue to suffer, as previously described.
COUNT TWO
(Design and Marketing Defect)
58. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth here and further alleges as follows.
59. The Pondimin and Redux drugs manufactured and/or supplied by WYETH and the Phentermine manufactured by the other corporate Defendant was defective in design or formulation in that, when it left the hands of the manufacturer and/or suppliers, the foreseeable risks exceeded the benefits associated with the design or formulation.
60. Further, the Pondimin and Redux drugs manufactured and/or supplied by WYETH was defective in design or formulation in that, when it left the hands of the manufacturer and/or suppliers, it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect and more dangerous than other available methods of weight loss.
61. The Pondimin and Redux drugs manufactured and/or supplied WYETH was defective due to inadequate warning or instruction because WYETH knew or should have known that the product created a risk of pulmonary and/or cardiovascular harm to consumers and WYETH failed to adequately warn of said risks.
62. The Pondimin and Redux drugs manufactured and/or supplied by WYETH was defective due to inadequate warning and/or inadequate testing.
63. The Pondimin and Redux drugs manufactured and/or supplied by WYETH was defective due to inadequate post-marketing warning or instruction because, after the manufacturer knew or should have known of the risk of pulmonary or cardiovascular injury from fenfluramine and/or dexfenfluramine (Pondimin and Redux) and/or combination use of fenfluramine and/or dexfenfluramine (Pondimin and Redux) and phentermine, it failed to provide adequate warnings to prescribing physicians, users or consumers of the product and continued to promote the product.
64. As the producing cause and legal result of the (a) design defect of the Pondimin and Redux drugs; (b) the marketing defect of the Pondimin and Redux drugs due to the WYETH's failure to adequately warn physicians; and (c) the defective condition of the Pondimin and Redux drugs as manufactured and/or supplied by WYETH, and as a direct and legal result of the above, Plaintiffs have suffered injuries and damages, which are set forth in detail below.
COUNT THREE
(Failure to Warn, Inadequate and False Warnings)
65. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows.
66. WYETH was a manufacturer, developer and/or supplier of fenfluramine and/or dexfenfluramine.
67. The fenfluramine and/or dexfenfluramine manufactured and/or supplied by WYETH was unaccompanied by proper warnings regarding possible pulmonary or cardiovascular injuries associated with the use thereof and the comparative severity and duration of such injuries. The information given did not accurately reflect the symptoms, scope or severity of such injuries.
68. WYETH failed to perform adequate testing in that adequate testing would have shown that fenfluramine and/or dexfenfluramine used individually and/or in any combination, has the potential to cause serious potential pulmonary or cardiovascular injuries. Full and proper warnings that accurately and fully reflected the symptoms, scope and severity of the potential harm should have been made to physicians, both with respect to the use of the Pondimin and Redux drugs individually and with respect to any combination use of the drugs.
69. WYETH also failed to effectively warn users and physicians that numerous other methods of weight loss, including non-drug assisted methods such as diet control and exercise, should be the first line and/or exclusive methods of weight loss for non-clinically obese individuals.
70. The Pondimin and Redux drugs manufactured and/or supplied by WYETH were defective due to inadequate post-marketing warning or instruction because, after WYETH knew or should have known of the risk of pulmonary or cardiovascular injury from the drugs and/or their combined use, WYETH failed to provide adequate warnings to doctors, users or consumers of the product and continued to aggressively promote the product.
71. As the producing cause and legal result of the failure to warn physicians and/or patients regarding the defective condition of the Pondimin and Redux drugs as manufactured and/or supplied WYETH, and as a direct and legal result, Plaintiffs have suffered injuries and damages, which are set forth in detail below.
COUNT FOUR
(Misrepresentation and Fraudulent Misrepresentation)
72. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows. WYETH through advertising, labeling, and other communications, made misrepresentations to physicians and the public, including the Plaintiffs, about the safety and efficacy of the Pondimin and Redux drugs for weight loss. Physicians and their patients, including the Plaintiffs, justifiably relied on the WYETH's misrepresentations, and Plaintiffs were harmed as a result. Plaintiffs are entitled to recover damages for their injuries produced by tie WYETH's misrepresentations. See RESTATEMENT (SECOND) OF TORTS § 402B.
73. Further, WYETH through advertising, labeling, and other communications, made misrepresentations to physicians and the public, including the Plaintiffs, about the safety and efficacy of the Pondimin and Redux drugs for weight loss. From at least 1993 until 1997, WYETH's labeling for Pondimin stated that there had been only four cases of pulmonary hypertension associated with the use of fenfluramine and/or dexfenfluramine. WYETH knew that the number was misleading. WYETH also failed to warn and failed to report to the FDA, the incidence of pulmonary hypertension and valvular heart disease associated with Pondimin and Redux use.
74. Further, WYETH engaged in a cover up and destroyed, removed and concealed written documents from FDA investigators, physicians and their patients, including the Plaintiffs, in an attempt to hide WYETH's knowledge of the association between pulmonary hypertension and valvular heart disease and Pondimin and Redux. WYETH's attempt to hide their knowledge was accomplished by the deletion, destruction, miscoding and re-coding of Adverse Drug Event reports. Safety Surveillance Monitor Amy Myers has already testified that in 1997, she deleted, destroyed, miscoded and/or re-coded Adverse Drug Event reports that evidenced the association between valvular heart disease and fenfluramine and dexfenfluramine use. Mrs. Myers misconduct was authorized and approved by WYETH's senior management.
75. Physicians and their patients, including the Plaintiffs, relied on WYETH's misrepresentations, and were harmed as a result. Plaintiffs are entitled to recover actual damages for her injuries as a result of the WYETH's misrepresentations and fraud.
76. The Defendants are strictly liable to Plaintiffs pursuant to RESTATEMENT (SECOND) OF TORTS § 402(B)(1965) because they made certain material misrepresentations of fact which included, but were not limited to:
1. Pondimin and Redux are important because they are the only prescription medications that can help you lose weight and keep it off when used with a reduced calorie diet;
2. Pondimin and Redux can help you on your way to attaining and keeping a healthier lifestyle;
3. That the risk of primary pulmonary hypertension (“PPH”) associated with the use of prescription weight loss drugs was estimated at only 18 cases per 1 million patients per year, or less;
4. That there are warning signals of PPH;
5. That the side effects of Pondimin and Redux tend to be mild and usually disappear in a few weeks;
6. That with Pondimin and Redux, you may finally have the help you need to make weight control possible;
7. That there was adequate testing, pursuant to federal regulations, of Redux and Pondimin;
8. That there were minimal adverse effects caused by Redux and Pondimin;
9. That the side effects of these drugs are not serious;
10. That the side effects of these drugs are less severe and occur less frequently than with other weight loss drugs;
11. That these drugs could be safely used with other diet drugs; and
12. These diet drugs were safe and effective.
77. Defendants are in the business of manufacturing, marketing, distributing and/or selling these drugs. Through their advertising and through labels on their products, Defendants made misrepresentations to the public at large and specifically to Plaintiff and her physician.
78. Defendants breached their duty to Plaintiff under the RESTATEMENT (SECOND) OF TORTS § 402(B)(1965) regarding the misrepresentations set out above. Defendants represented the product to be safe to use. These were material misrepresentations of fact concerning the character, nature and dangerous propensities of the product manufactured, sold, and marketed by Defendants.
79. Plaintiff and her physician justifiably relied upon the misrepresentations made by the Defendants. Such conduct by the Defendants proximately caused injuries and damages to Plaintiffs for which Plaintiffs now seeks to recover an amount which exceeds the minimum jurisdictional limits of this Court.
COUNT FIVE
(Strict Products Liability)
80. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows. Defendants formulated, designed, manufactured, distributed, marketed, and/or sold Pondimin and Redux. These drugs were defective and unsafe for their intended purpose at the time they left the control of Defendants and at the time they were sold. The products were defective in that they posed an inherent danger and caused physical harm to Plaintiff and consequent damages. The products were defectively designed so as to render them unreasonably dangerous, their risks outweighing their utility as designed.
81. In addition, or in the alternative, the products were defectively designed in that, when they left the hands of the manufacturer, distributor and/or seller, they were unreasonably dangerous, being dangerous to an extent beyond that which would be contemplated by the ordinary user of the products with ordinary knowledge common to the community and/or by a physician with the knowledge common to his/her profession or specialty. Said conduct of Defendants constitutes a breach of their duties as set forth in RESTATEMENT (SECOND) OF TORTS § 402(A)(1965), and was a producing cause of the injuries and damages suffered and sustained by Plaintiffs as set out herein.
82. Plaintiff would show that the products in question were defective and unreasonably dangerous in that while they were promoted and sold as being safe and effective for weight control, the products failed to contain warnings regarding the potential risk to users of their harmful side effects or adequate instructions for safe use of the products. Defendants failed to warn plaintiff or her physician of the risk to their patient, risks generally unknown to plaintiff or her physician. In addition and/or in the alternative, Defendants failed to provide plaintiff or her physician with adequate instructions for use of the product. The products were unaccompanied by proper warnings regarding pulmonary, valvular, and cardiovascular injuries associated with their use and the duration of such injuries. The warnings did not accurately reflect the symptoms, scope or severity of such injuries. Defendants failed to perform adequate testing in that adequate testing would have shown that the drugs possessed risks of serious potential pulmonary, valvular, and cardiovascular injuries. Full and proper warnings accurately and fully reflecting symptoms, as well as their scope and severity, should have been made with respect to the use of these drugs, individually, or in combination.
83. Defendants knew, or should have known, that the diet drugs in question individually, or in combination with other prescriptions, were, and are, dangerously defective products which pose unacceptable risks. These risks were unknown and unknowable by plaintiff or her physician. Defendants also failed to effectively warn plaintiff or her physician that numerous other methods of weight loss, including non-drug methods of weight loss, such as diet control and exercise, should be the primary and/or exclusive methods of weight loss, particularly for non-clinically obese individuals and for high-risk individuals.
84. The diet drugs in question were defective due to a failure to warn, inadequate warnings or instructions because, after Defendants knew or should have known of the risk of pulmonary and cardiovascular injury from their use, they failed to provide adequate warnings to plaintiff and/or her physicians and continued to aggressively promote the products which are dangerously defective. Defendants failed to give warnings (1) that could reasonably be expected to catch the attention of a reasonably prudent person and/or her physician, (2) that were comprehensible to the average user and/or her physician, and (3) that conveyed a fair indication of the nature and extent of the danger. The failure to give these warnings rendered the products dangerous to an extent beyond that which would be contemplated by the ordinary user of the product with ordinary knowledge common to the community and/or by a physician with knowledge common to his/her profession or specialty.
85. Defendants have a duty to adequately warn the user and/or a learned intermediary of the extent of danger inherent in the use of this product not generally known to the user or the learned intermediary. Defendants breached these duties. These marketing defects in the product were proximate and producing causes of the injuries to plaintiff and her respective consequential damages. Plaintiff would show that Defendants' conduct, described above, constitutes a further breach of their duties as set forth in RESTATEMENT (SECOND) OF TORTS § 402(A)(1965).
86. Plaintiff would show that Defendants are liable under the theory of Strict Products Liability as set forth in Section 402A of the Restatement of Torts 2d. Defendants were at all times material hereto engaged in the business of designing, formulating, manufacturing, distributing, marketing, selling, and/or otherwise placing the products into the stream of commerce. Defendants are in the business of selling such products with the expectation that such products will reach the user without substantial change in the condition in which they were sold. The drugs reached the ultimate users without substantial change in the condition in which they were sold.
87. Such conduct of Defendants proximately caused injuries and damages to Plaintiffs for which Plaintiffs now seeks to recover an amount which exceeds the minimum jurisdictional limits of this Court.
COUNT SIX
(Breach of Implied Warranty of Merchantability)
88. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows. It is also alleged that Defendants impliedly warranted to the public general, and specifically to Plaintiff and/or her physician that these drugs were merchantable quality and were safe and fit for the purpose intended when used under ordinary circumstances and in an ordinary manner. Defendants were merchants with respect to the products in question, the drugs, and the products, goods, were not merchantable as warranted because they were inherently dangerous and cannot be used for the purpose intended without serious risk of physical injury or death.
89. Such conduct of Defendants proximately caused injuries and damages to Plaintiffs, for which Plaintiff now seeks to recover an amount which exceeds the minimum jurisdictional limits of this Court.
DAMAGES
90. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows. As a result of Defendants' conduct outlined above, Becky and Ernest T. Wright suffered, sustained, and incurred, and will continue to suffer, sustain, and incur, the following injuries and damages, among others:
a. Physical pain and suffering in the past;
b. In reasonable medical probability, physical pain and suffering in the future;
c. Mental anguish and emotional distress in the past;
d. In reasonable medical probability, mental anguish and emotional distress in the future;
e. Reasonable and necessary medical expenses in the past;
f. In reasonably medical probability, reasonable and necessary medical expenses in the future;
g. Physical disability in the past;
h. In reasonable medical probability, physical disability in the future;
i. Impairment in the past;
j. In reasonable medical probability, impairment in the future;
k. Loss of earning capacity in the past;
l. In reasonable medical probability, loss of earning capacity in the future;
m. Disfigurement;
n. In reasonable medical probability, disfigurement in the future;
o. Loss of love, solace, care, comfort, household services and consortium in the past; and
p. In reasonable probability, loss of love, solace, care, comfort, household services and consortium in the future.
EXEMPLARY DAMAGES AND GROSS NEGLIGENCE
91. Plaintiffs incorporate by reference all other paragraphs of this petition as if fully set forth herein and further alleges as follows. Plaintiff alleges that the acts and omissions of Defendants whether taken singularly or in combination with others, constitute gross negligence, fraud, intentional fraud, malice, deceipt, and reckless and wanton conduct all of which proximately caused the injuries to Plaintiff. In that regard, Plaintiffs seek exemplary damages. Plaintiff seeks exemplary damages in an amount not to exceed the limits of Missouri law which would punish Defendants for their conduct and the conduct of its employees and which would deter other manufacturers from engaging in such misconduct in the future.
PLAINTIFFS DEMAND THAT THIS CASE BE TRIED BEFORE A JURY
WHEREFORE PREMISES CONSIDERED, Plaintiffs, Becky J. Wright and Ernest T. Wright, respectfully pray that upon final trial herein, that they be awarded final judgment against Defendants, for all actual, consequential and exemplary damages, equitable and/or injunctive relief, for pre and post judgment interest at the highest rate allowed by law, attorneys' fees and the costs of this action and for such other and further relief as this Court may deem just and appropriate.
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