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California County Sues GSK Over Avandia

By R&D Editors | March 8, 2010

SAN JOSE, Calif. (AP) – A Northern California county has filed suit against GlaxoSmithKline accusing the pharmaceutical company of suppressing evidence that its diabetes drug Avandia causes increased risk of heart attacks.

The lawsuit filed by Santa Clara County seeks restitution for all Avandia purchasers in California claiming the company violated state false-advertising statutes.

“GSK’s unlawful conduct has cost patients, their insurers, and government payors millions of dollars, and it has caused needless suffering to thousands of Californians,” said Santa Clara County’s acting county counsel Miguel Marquez. “This is precisely the sort of corporate malfeasance that California law prohibits.”

County officials say their lawsuit is the first by a government entity against the company over Avandia. It was filed in U.S. District Court, Northern California District, on Friday.

The company, which is based in London, says the lawsuit has no merit and that scientific evidence shows the FDA-approved drug doesn’t increase heart attack risk.

The lawsuit follows the release of a U.S. Senate report last month charging that Glaxo minimized Avandia’s safety risks and withheld data from the Food and Drug Administration.

Senators said the Senate Finance Committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents.

The company said the report took data on Avandia out of context.

Santa Clara County officials said the county spent $2 million to provide Avandia for patients at its public hospital between 1999 and 2007.

The county said that because Glaxo’s Avandia advertising campaign was aimed at diabetics, who are classified as disabled under California law, they are seeking triple damages.

Date: March 1, 2010
Source: Associated Press

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