Wednesday, June 1, 2011

SC Attorney General Action Against GlaxoSmithKline

South Carolina Attorney General Alan Wilson has brought another lawsuit against a pharmaceutical manufacturer.  On May 17, the Office of the Attorney General filed a lawsuit against GlaxoSmithKline in which he alleges that the pharmaceutical manufacturer improperly marketed the diabetes drug Avandia.  I have not seen a copy of the complaint, but an article here at (and cut and pasted below) seems to suggest that this is another off-label promotion lawsuit, similar to past lawsuits brought by South Carolina against pharmaceutical companies.  (See blog posts about prior off-label promotion lawsuits here).  There are also some inadequate warning allegations according to the article. 

SC prosecutor suing GlaxoSmithKline over Avandia

SC prosecutor suing GlaxoSmithKline over Avandia

by MEG KINNARD / Associated Press

COLUMBIA, S.C. (AP) -- British drug maker GlaxoSmithKline PLC improperly marketed the diabetes drug Avandia to South Carolina consumers, hiding the medication's harmful side effects, according to a lawsuit filed by the state's top prosecutor.

Posted on June 1, 2011 at 8:56 AM

A spokeswoman for the company, however, said GlaxoSmithKline supports both its drug and the ways in which it was marketed.

In a lawsuit filed May 17 in Spartanburg County, Attorney General Alan Wilson argued that the drug maker acted negligently when it claimed that Avandia did not put patients' hearts at risks and could actually reduce the potential for heart problems.

"GSK did not just fail to disclose the potential cardiovascular risks Avandia posed, which include heart attacks and sudden cardiac death, it affirmatively represented that Avandia could reduce diabetics' cardiovascular risks," Wilson wrote. "GSK knew or should have known that these representations were not true and likely to deceive."

First approved by the Food and Drug Administration in 1999, Avandia quickly became the top-selling diabetes pill in the world. The drug works by increasing the body's sensitivity to insulin, a key protein needed for digestion that diabetics don't adequately produce.

But Avandia's popularity has diminished since 2007 when its heart risks were first publicized. That year, the New England Journal of Medicine printed an article that evaluated dozens of studies on Avandia, concluding that the drug increases the risk of heart attack and death.

In July 2007, the FDA ruled that Avandia could remain on the market, but sales had already taken a hit. At a safety panel meeting that month, FDA scientists said that Avandia had caused approximately 83,000 heart attacks since coming on the market, according to Wilson's lawsuit.

GlaxoSmithKline rolled out new labels in February to indicate that Avandia is intended only for patients who cannot control their blood sugar with any other diabetes medication on the market. Regulators in Europe have pulled the drug off the market altogether, and other authorities including Louisiana's attorney general are investigating the drug.

The exact amount South Carolina was seeking was not clear. Wilson is seeking a civil penalty of up to $5,000 for each action in violation of the state's unfair trade practices act, as well as unspecified punitive damages and $2,000 for each false claim or overstatement made to the state in connection with prescriptions for its Medicaid recipients.

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label," said Bernadette King, a spokeswoman for the company. "GSK acted properly and responsibly in conducting its clinical trial program for Avandia, in marketing the medicine, in monitoring its safety once it was approved for use and in updating information in the medicine's labeling as new information became available."

The lawsuit, which says millions of dollars in state funding was spent on prescriptions for Medicaid patients and state employees, also cites several warnings from the FDA for "false and deceptive advertising" that Wilson says attempted to minimize the required warnings.

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