Lawsuit filed against makers of drug Avandia

MARSHALL — A wrongful death lawsuit has been filed in federal court here against the manufacturer of Avandia, a diabetes treatment drug believed to increase the risk of heart attacks.

(enlarge photo) LARRY ALAN STANFORD

The Drinnon Law Firm of Dallas took the action on behalf of Peggie Stanford and Ryan Alan Stanford, wife and son of Larry Alan Stanford, 60, who died of a heart attack.

The court document alleges negligence on the part of GlaxoSmithKline, a British pharmaceutical corporation with U.S. headquarters in Philadelphia, Pa. It markets the prescription drug, Rosiglitazone, under the brand names Avandia, Avandamet and Avandaryl.

An employee in U.S. District Judge T. John Ward's Marshall office said court action has not yet been scheduled. A jury trial is requested.

The "factual background" portion of the lawsuit notes that in January 1997, the FDA approved the drug to treat Type II diabetes. It "was promoted to the diabetic patient population as able to assist the body in using insulin more effectively," it adds.

In May 1999, Glaxo obtained FDA approval for its own brand-name products containing the drug and consequent sales were "phenomenal."

The lawsuit accuses the company of withholding from physicians, patients and the public information it had on adverse side effects.

"At least by September 2005, Glaxo was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug," the lawsuit adds. The information was not made public.

"During the following year of concealment, Glaxo pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the Unites States," the document notes.

"With a month's supply of Rosiglitazone costing between $90 and $200, Glaxo was able to rack up sales of $2.2 billion in 2006," it adds. Knowing by way of 42 different studies of patients using the drug that its product "was unreasonably dangerous ... Glaxo continued to expand sales."

However, on May 21, Dr. Steven Nissen, a cardiologist, published in the New England Journal of Medicine his analysis of the 42 Glaxo studies, which revealed "increased risk of heart attack."

New prescriptions for Avandia dropped, the press release said, and investors filed a class-action lawsuit against GlaxoSmithKline, claiming the company "failed to adequately disclose" information linking use of the drug to an elevated risk of heart trouble.

Stanford, a Beaumont resident, died of a heart attack the same day Nissen's report was published. He had taken the Glaxo-manufactured drugs since February 2005.

"I know Larry's family will never forget the date, and I sincerely hope neither does GlaxoSmithKline," said attorney Stephen Drinnon. "But what truly matters is what happened long before that.

"I believe evidence will show the company knew there were problems with Avandia, but decided to keep on selling it."

The lawsuit charges Glaxo with failing to inform the public and physicians of the risks associated with its products, with marketing a "defective" product "due to inadequate warnings, instructions and/or labeling," and of "inadequate testing."

The suit also alleges Glaxo is guilty of selling a product "defective in design" because the company was aware of "the foreseeable risks of serious harm posed by this drug" and that they were "sufficiently great in relation to its alleged benefits."

Had Stanford and the general public known of these risks, they "would not have ingested" the drug, the lawsuit adds.

Stanford's heirs are seeking recovery of attorney's fees, the awarding of "compensatory, punitive and exemplary damages," reimbursement for his "physical pain and suffering," mental anguish, medical and counseling expenses, loss of companionship, funeral expenses, pre- and post-judgement interest, and "such other applicable damage as the court deems appropriate."

The Drinnon Law Firm, "represents individuals and small businesses in a broad range of cases, including personal injury, wrongful death, medical malpractice, products liability negligence, commercial disputes, trademark infringement and employment discrimination," the press release said.