California’s Santa Clara County has filed suit against GlaxoSmithKline over Avandia. According to the MercuryNews.com, Santa Clara County’s lawsuit is the first governmental lawsuit claiming the drug maker falsely advertised Avandia’s benefits and concealed its risks.
The Avandia lawsuit alleges that Santa Clara County spent $2 million on Avandia from 1999 to mid-2007 for indigent patients and also absorbed the cost of treating heart patients whose problems could have been avoided had GlaxoSmithKline warned of the risks of its drug. It seeks to recover costs incurred by anyone in California who purchased Avandia, including patients, hospitals, clinics and counties, the MercuryNews.com said.
According to the MercuryNews.com, the lawsuit was spurred by a recent Senate report on Avandia that accused Glaxo of withholding information about the drug’s heart risks.
The Senate Finance Committee report was the result of a two-year investigation, and drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials, as well as interviews with Glaxo and Food & Drug Administration (FDA) officials and anonymous whistleblowers. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said.
Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta- analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.