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March 3, 2010 > Santa Clara County sues drug manufacturer

Santa Clara County sues drug manufacturer

Submitted By Gwendolyn Mitchell and Laurel Anderson

The County of Santa Clara sued drug manufacturer GlaxoSmithKline (GSK) in federal court on February 26, 2010, alleging GSK conducted a decade-long campaign of false advertising to promote its diabetes drug Avandia as safe and effective, while it suppressed evidence the drug significantly increases patients' risks of heart attacks and other life-threatening cardiovascular problems.

The complaint asserts GSK ignored or concealed early data and studies that revealed Avandia's hazards and engaged in an aggressive and highly successful marketing strategy designed to persuade patients, doctors and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market. Avandia earned GSK billions of dollars but the complaint alleges it caused an estimated 60,000 to 200,000 heart attacks, strokes and other cardiovascular deaths nationwide between 1999 and 2006.

"GSK had a duty to warn patients and the US Food and Drug Administration about the serious health risks associated with Avandia," said Miguel M‡rquez, Acting County Counsel of Santa Clara County. "Instead, it chose to conceal that information. GSK's unlawful conduct has cost patients, their insurers and government payors millions of dollars and caused needless suffering for thousands of Californians. This is precisely the sort of corporate malfeasance California law prohibits."

The County's suit was filed just days after a new study by Harvard University scientists and a report from the US Senate Finance Committee confirmed Avandia's risks and GSK's intentional concealment of vital facts from the public.

The County alleges GSK was aware of Avandia's risks, even before the drug went on the market in 1999, but concealed them from the public, the medical community and the US Food and Drug Administration (FDA). It even threatened legal action against a leading diabetes expert, who publicly voiced his concerns about Avandia, and repeatedly ignored FDA's orders to cease certain deceptive and misleading marketing practices. At the same time, GSK disseminated misinformation about the drug to diabetics, their doctors and insurers.

"Diabetes puts people at risk for heart attacks and other cardiovascular problems," explained County Executive Jeffrey Smith, M.D. "Marketing a drug that itself causes one of the very harms diabetes management is designed to prevent is about as far from supporting patient care as a pharmaceutical company can get."

Diabetes is a major public health problem in Santa Clara County, in the State of California and throughout the nation. More than 3 million people suffer from diabetes in California, many of whom are low-income individuals, senior citizens and members of racial minority groups who have higher rates of diabetes in their communities.

"The actions of this drug company are simply unconscionable," said Supervisor Ken Yeager, President of the Santa Clara County Board of Supervisors. "GSK risked the lives of millions of diabetics in order to increase its profits."

The lawsuit was filed on behalf of the People of California and seeks monetary restitution for all Avandia purchasers in California based on GSK's alleged false advertising in violation of the California Business and Professions Code. The County, which runs a public hospital providing health care for indigent County residents, spent $2M on Avandia purchases between 1999 and mid-2007. The County, other providers and insurers have also had to absorb the substantial cost of treating patients who suffered heart attacks and other cardiovascular problems that could have been avoided had GSK warned of the health risks associated with Avandia.

Because GSK's Avandia campaign was aimed at diabetics, many of whom are senior citizens and all of whom are classified as disabled persons under California law, the complaint also seeks the treble damages authorized by the State Legislature when false advertising targets one of these vulnerable populations.

The County of Santa Clara County Counsel's office will be assisted by three private firms with extensive experience in pharmaceutical litigation: Kiesel Boucher Larson of Beverly Hills, Williams Kherkher of Houston, and Woodfill & Pressler of Houston.

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