Avandia Suit Filed by Utah Over Misleading Marketing for Diabetes Drug

The state of Utah has filed an Avandia suit against GlaxoSmithKline, accusing the drug maker of fraud for misleading marketing of its diabetes medication, which failed to adequately disclose the risk of heart attacks from Avandia side effects. 

The Utah Attorney General filed the Medicaid fraud lawsuit (pdf) in the Third District Court on November 9. According to the complaint, GlaxoSmithKline defrauded the state of Utah by promoting Avandia as a successful diabetes treatment, resulting in the state paying millions of dollars in Medicaid purchases and reimbursements for Avandia prescriptions. The state now wants that money back.

The suit follows an announcement last month by GlaxoSmithKline that the U.S. Department of Justice (DOJ) is investigating whether the drug maker knew Avandia increased the risk of heart attacks. The company received a subpoena for clinical data and marketing information and has received several Civil Investigation Demands from state attorneys general offices.

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales plummeted following the concerns about potential Avandia heart risks.

In September, after a number of studies and internal debate, the FDA stopped just short of an Avandia recall and determined that only patients who have failed to control their diabetes through every other available medication should be given access to the medication. The FDA has ordered GlaxoSmithKline to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted. The decision came after an FDA advisory committee voted this summer to recommend that Avandia stay on the market, but with strict warnings and restrictions.

Earlier this year, a Senate report accused GlaxoSmithKline of suppressing the risks of Avandia. The report claimed that the company intimidated scientists and withheld data; accusations that the company denies.

The Utah Avandia lawsuit seeks to reclaim $7.8 million from GlaxoSmithKline, which is the amount the state says it paid in Avandia purchases from January 1, 2002 through June 30, 2010. Many of the Avandia prescriptions paid for by the state were part of a Medicaid prescription drug program the state provided for poor residents who needed “medically necessary” drugs that they could not afford.

The complaint by the Utah Attorney General may be the first of several filed by states across the country. In addition, GlaxoSmithKline faces Avandia suits filed by individuals who allege that they suffered an injury as a result of the drug makers failure to adequately warn about the risk of heart problems.

Avandia settlements have been reached in about 10,000 of the cases, but several thousand cases are still pending and more continue to be filed by Avandia lawyers.