Diabetes drug Avandia named in federal court action

Ann Knef Jan. 16, 2008, 8:16am


GlaxoSmithKline (GSK) is being sued in federal court over allegations its diabetes drug Avandia is defective.

Plaintiff Mamie Coleman of St. Louis County claims she suffered a cardiac injury after using Avandia, according to a suit filed Jan. 15 in U.S. District Court for the Southern District of Illinois.

Represented by John Driscoll of Brown & Crouppen in St. Louis, Coleman is seeking damages for personal injuries and economic losses as a result of using Avandia.

She alleges GSK failed to 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, according to the complaint.

Coleman also claims GSK marketed and promoted Avandia despite knowing there were safer methods and products for diabetes mellitus type 2.

Type 2 diabetes, which occurs when the body fails to properly use insulin, combined with relative insulin deficiency, is the most common type of diabetes, according to the complaint.

"GSK has misrepresented information concerning the safety and efficacy of Avandia for treating diabetes," the complaint states. "For instance, 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. Thus, GSK has prevented physicians and patients, including the Plaintiff and the Plaintiff's physicians, from properly and independently exercising informed judgment."

The complaint also alleges GSK failed to:

  • Include adequate warnings that would alert Avandia users to the potential risks and side effects;

  • Warn Coleman that use of Avandia carried a risk of death or permanent disability from cardiothrombotic events, cardiac injuries and other serious side effects; and/or

  • Advise the Food and Drug Administration, the health care industry, and the public about the adverse reports it had received regarding Avandia.

    According to a report in LawyersandSettlements.com last month, there have been approximately 50 state and federal Avandia cases filed across the country.

    An Avandia Multi-District Litigation (MDL) has been established in the Eastern District of Pennsylvania, where GSK's U.S. headquarters is located.

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