Lawhon Avandia Lawsuit

IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS

BEAUMONT DIVISION

GERAL LAWHON Plaintiff, vs. SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE (GSK) Defendant.

CASE NO. 1:09-cv-262

COMPLAINT FOR PERSONAL INJURIES AND DAMAGES

DEMAND FOR JURY TRIAL

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 meta-

analysis 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 meta-

analysis, 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 “well-

informed 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



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.





NEGLIGENT DESIGN



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.







NEGLIGENT FAILURE TO WARN



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.







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

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Lawhon Avandia Lawsuit