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SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE (GSK) Defendant. DEMAND FOR JURY TRIAL CASE NO. 1:09-cv-262 COMPLAINT FOR PERSONAL INJURIES AND DAMAGES
COMPLAINT COMES NOW Plaintiff, by and through his undersigned attorney, and for his Complaint against Defendant SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE (GSK), and alleges as follows: 1. This action is brought by Plaintiff seeking damages for personal injuries including: mental anguish, past and future; pain and suffering, past and future; disfigurement, past and future; physical impairment, past and future; medical expenses, past and future; and lost income, past and future. Plaintiff alleges that those damages were legally caused by a defective and dangerous pharmaceutical product, Avandia, which was manufactured, marketed, distributed and/or sold by GlaxoSmithKline to the general public. PARTIES 2. Plaintiff Geral Lawhon is a citizen and resident of the State of Texas, County of Orange. Geral Lawhon was prescribed, purchased and took Avandia in Orange County, Texas. 3. SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) is incorporated under the laws of Pennsylvania and has its principal place of business in
Philadelphia, Pennsylvania, and may be served via certified mail, return receipt requested to wit: GlaxoSmithKline 1 Franklin Plaza 200 N. 16th Street Philadelphia, PA 19102 4. GSK is the surviving entity from the following mergers: On May 7, 1995, GSK merged into Burroughs Wellcome Co. In connection with that merger, Burroughs Wellcome Co. changed its name to Glaxo Wellcome, Inc. On March 31, 2001, Glaxo Wellcome, Inc. merged with GSK. As the surviving entity, GSK is liable for the actions and inactions of all the companies involved in the mergers GSK is engaged in manufacturing, marketing, promoting, selling and/or distributing the drugs Avandia, Avandamet and Avandaryl regularly conducts business within the State of Texas and within this district and substantial revenues from goods consumed in Texas and within this district. JURISDICTION AND VENUE 4. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332. There is complete diversity of citizenship between Plaintiff and the Defendant and the amount in controversy exceeds $75,000.00, exclusive of interest and costs. 5. Venue in this Court is proper pursuant to 28 U.S.C. § 1391(a)(2) and (3), that a substantial part of the events or omissions giving rise to the following claims occurred in this judicial district and/or the defendant is subject to personal jurisdiction as has inter alia availed itself of this court in other legal proceedings. FACTUAL ALLEGATIONS 6. GSK is a pharmaceutical manufacturer.
7. GSK has engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose to physicians and patients, including Plaintiff, information in its control concerning the safety and effectiveness of Avandia. 8. Avandia was initially approved by the United States Food and Administration (“FDA”) as safe and effective for treating diabetes mellitus type 2. 9. Type 2 diabetes occurs when the body fails to properly use insulin (insulin resistance), combined with relative insulin deficiency. Insulin, which is made in the pancreas, helps cells use sugar from the bloodstream. 10. Most people with diabetes have other health problems such as high blood pressure and cholesterol that increase the risk for heart disease and stroke. More than 65% of people with diabetes die from heart disease or stroke. With diabetes, heart attacks occur earlier in life and often result in death. Other risks include, but not limited to, blindness, kidney disease, nervous system diseases, amputation, sexual dysfunction, diabetic ketoacidosis, and diabetic coma. 11. Cardiovascular disease (CVD) is the main cause of death in diabetes patients. Thus, it is important that an anti-diabetic agent reduce, or at least not exacerbate the risk of cardiovascular injury. 12. During the past decade, numerous drugs have been introduced for the treatment of type 2 diabetes that, used by themselves or in combination therapy, are supposed to better control diabetes in patients and thereby reduce the health complications often associated with diabetes, such as heart attacks, strokes and other cardiovascular complications. 13. Plaintiff’s claims involve the drug Rosiglitazone manufactured, promoted, distributed, labeled, and marketed by GSK under the trade name(s) of Avandia® Tablets, Avandamet® Tablets, and Avandaryl® Tablets (hereinafter “Avandia” or
“Rosiglitazone”), and are a member of a class of drugs known as Thiazolidinediones (TZD’ s). 14. TZD’s are insulin-sensitizing anti-diabetic agents. In the USA and Canada two TZD’s are indicated for use in treatment of type 2 diabetes mellitus: Rosiglitazone and Pioglitazone. A third, Troglitazone (Rezulin) was removed from the market because of an association with significant hepatotoxicity. 15. The anti-diabetic actions of TZD’s are likely mediated by their interaction with the nuclear receptor peroxisome proliferator-activated receptor-gamma which is a DNA-binding nuclear hormone receptor that has been shown regulate bone mass, energy expenditure and glucose metabolism. 16. Plaintiff ingested prescription Avandia to treat diabetes. 17. GSK misrepresented information concerning the safety and efficacy of Avandia for treating diabetes. GSK has allowed positive information about Avandia to be disclosed publicly, but has withheld and concealed negative information concerning the safety and effectiveness of the drug as treatment for diabetic patients. GSK has prevented physicians and patients, including Plaintiff and the
Plaintiff’s physicians, from properly and independently exercising informed judgment. 18. The decision to prescribe or ingest a drug is based on the balance between the benefit the patient is likely to derive from the treatment and the risk that the treatment will cause the patient harm that outweighs the benefits conferred. 19. In deciding whether to prescribe or to ingest a drug, physicians and patients rely on their assessment of information they are given about the drug. Such information must be accurate and provide an unbiased picture of a drug’s safety and efficacy in treating a condition. If the information is false or misleading, neither the patient nor the physician can accurately assess the crucial risk/benefit.
20. At all times material hereto, GSK, individually and/or collectively, did manufacture, create, design, test, label, package, distribute, supply, market, sell, advertise, warn, and/or otherwise cause Avandia to be placed into the stream of commerce, and ultimately to be ingested by Plaintiff. 21. Avandia has been widely advertised, marketed and represented by the Defendant as a safe and effective anti-diabetic agent that promised fewer side effects than other similar treatments. The Defendant marketed Avandia as the most effective means of treating Type 2 diabetes mellitus, claiming to be more effective than older antidiabetics and other TZD’s on the market. 22. GSK’s marketing efforts were designed and implemented to create the impression in the minds of physicians and diabetics that Avandia is safe and effective for patients, and that it carried/carries less risk of side effects than other available treatments. 23. The marketing and promotion efforts of GSK, its force served to overstate the benefits of Avandia, and minimize risks associated with the drug. These promotional efforts were made, while fraudulently withholding important safety information from physicians, the FDA, and the public. GSK was aware of numerous reports of congestive heart attacks, strokes, and other serious cardiovascular injuries and death associated with the use of Avandia that exceeded the background rate, and was well beyond the risks associated with other anti-diabetic agents. 24. Concealing or providing inaccurate or biased information to a prescribing physician misleads the physician and the patient. 25. The product warnings for Avandia in effect during the relevant time period were vague, incomplete or otherwise inadequate, to alert prescribing physicians as well as consumer patients of the actual risks associated with Avandia.
GSK’s Studies Concerning Avandia’s Safety and Efficacy 26. GSK claims that Rosiglitazone is a safe and effective anti-diabetic, and that Rosiglitazone is safer and more effective than older anti-diabetic agents. 27. GSK has overstated the efficacious value and understated the risks associated with Rosiglitazone. 28. GSK has promoted and marketed Avandia as being more effective than older antidiabetic agents and other TZD’s; however, there is no direct evidence that Rosiglitazone reduces the risks of microvascular or macrovascular disease or mortality in patients with type 2 diabetes. There is some evidence that other oral hypoglycemics do succeed in doing so. 29. Moreover, researchers recently concluded that older anti-diabetic agents are as effective or superior to Rosiglitazone. 30. To date, scientists have conducted three separate meta-analyses. Each metaanalysis has found that Avandia increases the risk of cardiovascular-related injury. 31. The first analysis was performed by GSK and was handed over to the FDA in August of 2006. The meta-analysis combined the results of 42 separate double-blinded, randomized, controlled clinical trials to assess the efficacy of Rosiglitazone for treatment of type 2 diabetes compared to either placebo or other anti-diabetic therapies. The combined studies included 8,604 patients on Rosiglitazone and 5,633 patients randomized to a variety of alternative therapeutic regimens, including placebo. 32. GSK’s own meta-analysis found an overall increase in the incidence of myocardial ischemia in Rosiglitazone-treated subjects. The risk equated to more than a 30 percent excess risk of myocardial ischemic events in Rosiglitazone-treated patients. 33. A second meta-analysis conducted by Dr. Steven Nissen and Kathy Wolski titled Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from
Cardiovascular Causes was published on May 21, 2007, in the New England Journal of Medicine. 34. Nissen and Wolski reviewed data available to them through published literature, the FDA website, and GlaxoSmithKline’s clinical-trials registry. The analysis included a review of 42 clinical trials involving nearly 28,000 patients. 35. Nissen and Wolski concluded that “Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.” 36. Patients suffering from type 2 diabetes mellitus have a higher risk of experiencing a heart attack than non-diabetic patients. A diabetic taking Avandia has a much greater risk (estimated at this time to be on the order of 43%) of suffering a heart attack or serious cardiovascular event when compared with other diabetes drugs or placebos. 37. On July 30, 2007, the FDA presented the results of its own meta-analysis. Similar to the GSK, and the Nissen and Wolski findings, the FDA found an increased risk of heart attack, cardiovascular death, stroke and other serious ischemic related adverse events in diabetics that took Rosiglitazone. The FDA recommended that a boxed
warning be placed in the Avandia label warning of those risks. 38. Thus, while GSK’s Rosiglitazone-containing drugs are marketed and sold by GSK as anti-diabetic agents that reduce a diabetic patient’s risk of heart attacks, studies, including one conducted by GSK showed that Rosiglitazone actually increased those risks.
GSK Has Misled the Medical Community and the Public about the Efficacy and Safety of Avandia
39. The product warnings for the Avandia in effect during the relevant time period were vague, incomplete or otherwise inadequate, both substantively and graphically, to alert prescribing physicians as well as consumer patients of the actual risks associated with Avandia. GSK has and continues to market Avandia as a safer and more effective antidiabetic agent than other antidiabetics on the market. However, even prior to the approval of Avandia in the United States market, GSK knew or should have known of the significantly increased risks of heart attacks, cardiovascular-related deaths, strokes or other serious and life-threatening conditions, which it has concealed from the medical community and patients, including Plaintiff. 40. In fact, as early as 1999, Dr. John B. Buse (the current president-elect of the American Diabetes Association), a diabetes expert and head of Endocrinology at the University of North Carolina, Chapel Hill, raised concerns about Avandia and heart problems. 41. Instead of warning the public about the risk, GSK attempted to silence Dr. Buse by threatening him with a $4 Million lawsuit and by characterizing him as a liar according to his testimony before Congress. 42. On March 15, 2000, John Buse, MD wrote a letter to the FDA again raising concerns about a “worrisome trend in cardiovascular deaths and severe adverse events” associated with Avandia. He wrote in part: I would like you to know exactly what my concerns are regarding Rosiglitazone as a clinical scientist and my approach as a clinician. On the basis of the increase in LDL concentration seen in the clinical trial program (whether the number we accept as the truth is the 18.6% at 4 mg bid in the package insert or the “average of 12%” now being discussed) one would expect an increase in cardiovascular events....Based on studies with statins and plasmapheresis, changes in LDL concentration can be
associated with substantial changes in vascular reactivity and endothelial function over a time course of days to weeks. 43. Around the same time period, March of 2000, Public Citizen filed a petition for immediate class labeling changes for all marketed TZD’s. Public Citizen studied reviews by FDA Medical Officers, Statisticians, and Pharmacologists, transcripts of FDA advisory committee meetings, and scientific literature on Trolitazone, Rosiglitazone, and Pioglitazone. After that independent investigation, Public Citizen argued that
information associating Rosiglitazone with heart attacks and serious cardiovascular injuries “was never included in the label, or seriously understated.” 44. That was obviously a major concern since diabetics are already susceptible to an increased risk of cardiovascular injury. 45. Yet, even with this information available to it, GSK failed to warn consumers and the medical community about the increased risk of heart attacks and other serious injuries associated with Avandia. 46. Moreover, Defendant has repeatedly engaged in a pattern of conduct of deliberately avoiding FDA recommendations as to which warnings should have been passed on to the public. 47. For instance, after the FDA required GSK to change its label on February 8, 2001 to reflect a risk of heart failure observed in patients on Avandia and insulin, GSK defied FDA recommendations by engaging in false and misleading promotional activities. 48. In a letter dated February 22, 2001, the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) informed GSK that all promotional materials for Avandia should be revised to prominently include the new risks, no later than March 8, 2001.
49. GSK responded on March 1, 2001 by committing to include the new risk information by March 8, 2001. 50. However, instead of complying with FDA requirements GSK’s sales representatives engaged in false or misleading promotional activities with respect to the new risk information in Avandia’s product labeling. 51. In a Warning Letter dated July 17, 2001, the FDA warned GSK that they had engaged in a continual violation of federal regulations in their promotion of Avandia. 52. In that July 17, 2001 letter, the FDA warned that the DDMAC had been monitoring its marketing of Avandia and had: …concluded that GSK has promoted Avandia in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. See 21 U.S.C. §§ 331(a),(b), and 352(a),(n). Specifically, during the Annual American Association of Clinical Endocrinologists (AACE) Meeting in San Antonio, Texas, on May 2-6, 2001, representatives of GSK made oral representations denying the existence of serious new risks associated with Avandia at GSK’s promotional exhibit booth. Additionally, GSK displayed Exhibit panels (AVO13G) at the meeting that minimized these new risks associated with Avandia. Your promotional activities that minimize serious new risks are particularly troublesome because we have previously objected, in two untitled letters, to your dissemination of promotional material for Avandia that failed to present any risk information about Avandia or minimized the hepatic risk associated with Avandia. Despite your assurances that such violative promotion of Avandia had ceased, your violative promotion of Avandia has continued. 53. Following the May 21, 2007 publication of the Nissen and Wolski metaanalysis, the FDA issued a safety alert for Avandia and advised patients who take it to consult their doctors.
54. On June 1, 2007, GSK published a “Dear Avandia Patient” letter, which responded to the “recent press coverage about the safety of Avandia.” Therein, GSK stated that it “stands firmly behind Avandia” and that “Avandia is the most widely studied medicine for type 2 diabetes” and that the evaluation of clinical trials by “wellinformed experts and researches has been encouraging.” 55. At a congressional hearing on June 6, 2007, the FDA indicated that a black box warning should be added to Avandia warning of the increased risk of heart failure. 56. On July 30, 2007, the FDA held a FDA Advisory Committee Hearing on the safety of Avandia. The panel was determining whether to recommend keeping the label the same, adding a black box warning, or taking Avandia off the market all together. 57. Dr. David Graham, testifying on behalf of the FDA, called for withdrawing Avandia and estimated that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006. For every month that Avandia is sold, Dr. Graham said, 1,600 to 2,200 patients will suffer more of those problems. 58. The FDA provided testimony that Avandia offers no unique benefits compared to other drugs in battling diabetes, but that all indications point to increased risks of heart attack and sudden death. 59. The panel of advisers to the Food and Drug Administration voted 20-to-3 that Avandia increases the risks of heart attacks. STRICT PRODUCTS LIABILITY DEFECTIVE DESIGN 60. Plaintiff repeats and re-alleges the allegations of the prior paragraphs as if set forth at length herein. 61. Defendant designed, produced, manufactured and injected into the stream of commerce, in the regular course of its business, the pharmaceutical drug Avandia, which it knew, would be used by Plaintiff and others.
62. At the time Avandia was manufactured and sold to Plaintiff by Defendant, it was defective in design and unreasonably dangerous, subjecting users to risks of cardiothrombotic events or cardiac injury, and other illnesses which exceeded the benefits of the product, and for which other safer products were available. 63. Alternatively, when the Avandia was manufactured and sold to Plaintiff by Defendant, the product was defective in design and formulation, making use of the product more dangerous than other drugs prescribed for diabetes mellitus type 2. 64. The Avandia sold to Plaintiff reached Plaintiff without substantial change. Plaintiff was unaware of the dangerous propensities of the product until well after his use and subsequent injury. Plaintiff ingested the Avandia without making any changes or alterations. 65. As a direct and proximate result of the defective and dangerous design of the Avandia Plaintiff ingested, Plaintiff has been damaged. 66. Defendant’s conduct was done with conscious disregard for the safety of users of Avandia, including Plaintiff. WHEREFORE, Plaintiff demands judgment in his favor and against Defendant in a sum in excess of the jurisdictional requirement of this court; for costs of court; interest as allowed by law; for such other and further relief as this Court deems just and proper; and demands that the issues herein contained be tried to a jury. STRICT PRODUCTS LIABILTY/FAILURE TO WARN
67. Plaintiff repeats and re-alleges the allegations of the prior paragraphs as if set forth at length herein. 68. The Avandia manufactured and supplied by Defendant was unaccompanied by proper and adequate warnings regarding all adverse side effects associated with the
use of Avandia, and the severity and duration of the adverse effects. The warnings given by Defendant did not accurately reflect the symptoms, type, scope, or severity of the side effects. 69. Defendant failed to give adequate post-marketing warnings or instructions for the use of Avandia. After Defendant knew or should have know of the risk of
injury from Avandia use, Defendant failed to provide adequate warnings to users or consumers and continued to aggressively promote the product to doctors, hospitals, and directly to consumers. 70. As a direct and proximate result of Defendant’s failure to warn of the potentially severe side effects of the Avandia products, as well as the other conduct mentioned in this Complaint, Plaintiff has been damaged. 71. Defendant’s conduct was done with conscious disregard for safety of users of Avandia, including Plaintiff. WHEREFORE, Plaintiff demands judgment in his favor and against Defendant in a sum in excess of the jurisdictional requirement of this court; for costs of court; interest as allowed by law; for such other and further relief as this Court deems just and proper; and demands that the issues herein contained be tried to a jury. NEGLIGENT DESIGN 72. Plaintiff repeats and re-alleges the allegations of the prior paragraphs as if set forth at length herein. 73. Defendant designed, produced, manufactured and injected into the stream of commerce, in the regular course of its business, the pharmaceutical drug Avandia which it knew would be used by Plaintiff and others.
74. At the time the Avandia was manufactured and sold to Plaintiff by Defendant, it was defective in design and unreasonably dangerous, subjecting users to risks which exceeded the benefits of the product, and for which other safer products were available. 75. Alternatively, when the Avandia product was manufactured and sold to Plaintiff by Defendant, the product was defective in design and formulation, making use of the product more dangerous than other drugs for diabetes mellitus type 2. 76. The Avandia sold to Plaintiff reached Plaintiff without substantial change. Plaintiff was unaware of the dangerous propensities of the product until well after his use and subsequent cardiac injury. Plaintiff ingested the Avandia without making any changes or alterations. 77. In designing and testing Avandia, Defendant failed to exercise the ordinary care that a careful and prudent drug manufacturer would exercise in the same or similar circumstances. 78. As a direct and proximate result of the negligent design of the Avandia Plaintiff ingested, Plaintiff has been damaged. 79. Defendant’s conduct was done with conscious disregard for the safety of users of Avandia, including Plaintiff. WHEREFORE, Plaintiff demands judgment in his favor and against Defendant in a sum in excess of the jurisdictional requirement of this court; for costs of court; interest as allowed by law; for such other and further relief as this Court deems just and proper; and demands that the issues herein contained be tried to a jury. NEGLIGENT FAILURE TO WARN 80. Plaintiff repeats and re-alleges the allegations of the prior paragraphs as if set forth at length herein.
81. Defendant owed Plaintiff a duty to warn of any dangerous defects or side effects; a duty to assure its product did not cause users unreasonable and dangerous risks, reactions, side effects; and a duty to provide adequate post market surveillance and warnings as it learned of Avandia’s substantial dangers. 82. Defendant breached its duty of reasonable care to Plaintiff in that Defendant failed to: a. Conduct sufficient testing which, if properly performed, would have shown that Avandia had serious side effects, including cardiothrombotic events, cardiac injury, and other serious side effects, and warn users of those risks; and/or b. Include adequate warnings with the Avandia products that would alert users to the potential risks and serious side effects the drugs; and/or c. Warn Plaintiff that use of Avandia carried a risk of death or permanent disability from cardiothrombotic events, cardiac injuries and other serious side effects; and/or d. Advise the FDA, the health care industry, and the public about the adverse reports it had received regarding Avandia; and/or e. Include other appropriate warnings. 92. Defendant knew or should have known that Avandia was unreasonably dangerous and that it had serious side effects about which the general public would not be aware. Defendant nevertheless advertised, marketed and promoted its product knowing there were safer methods and products for diabetes mellitus type 2. 93. As a direct and proximate result of Defendant’s negligence and breaches of its duty of reasonable care, Plaintiff has been damaged. 94. Defendant’s conduct was done with conscious disregard for the safety of users of Avandia, including Plaintiff.
WHEREFORE, Plaintiff demands judgment in his favor and against Defendant in a sum in excess of the jurisdictional requirement of this court; for costs of court; interest as allowed by law; for such other and further relief as this Court deems just and proper; and demands that the issues herein contained be tried to a jury.
Respectfully submitted this 24th day of March, 2009. Respectfully submitted, PROVOST & UMPHREY LAW FIRM, L.L.P. 490 PARK STREET P. O. BOX 4905 BEAUMONT, TEXAS 77704 Phone: (409) 835-6000 FAX: (409) 838-8888 BY:___________________________ CHRISTOPHER T. KIRCHMER TEXAS STATE BAR NO. 00794099 ATTORNEYS FOR PLAINTIFFS