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Ky. Attorney General Sues Glaxosmithkline

From Associated Press (February 21, 2013)

LOUISVILLE, Ky. -- Kentucky’s attorney general has joined in the flurry of legal action against GlaxoSmithKline, filing a lawsuit accusing the company of concealing the cardiovascular risks associated with a diabetes drug.

The suit claims that GlaxoSmithKline LLC violated the state’s Consumer Protection Act by overstating the effectiveness of the prescription drug Avandia and hiding its risks from consumers. Instead of reducing cardiovascular risks faced by diabetics, as the drug maker claimed, the one-time blockbuster drug actually increases those risks, Attorney General Jack Conway said Thursday.

"We will not stand idly by as drug companies operate outside of the law and put Kentuckians’ health at risk," Conway said.

As of 2010, more than 370,000 Kentuckians were diagnosed with diabetes, Conway’s office said. Kentucky was near the top nationally in diabetes cases and cardiovascular deaths, according to 2011 statistics supplied by the state Cabinet for Health and Family Services.

The suit filed this week in Franklin County Circuit Court in Frankfort seeks an injunction against the company’s allegedly deceptive business practices. It also seeks civil penalties up to $10,000 per violation.

GSK spokesman Kevin Colgan said the company was reviewing the lawsuit.

"We believe we acted diligently and properly in studying Avandia, in sharing study results with regulators and health-care providers and in marketing the medicine," he said in a statement. "We welcome the opportunity to defend ourselves and our medicines before a jury, and we are committed to continuing to develop medicines that will improve the health and lives of patients with serious illnesses."

The Kentucky lawsuit is the latest in a series of costly legal entanglements for the drug company.

Last year, GlaxoSmithKline agreed to pay $3 billion in fines -- the largest health care fraud settlement in U.S. history -- for criminal and civil violations involving 10 drugs, including Avandia. The company also reached an agreement with multiple states regarding its promotion of Avandia.

Kentucky opted out of the multi-state settlement "because we thought the amount was insignificant compared to the value of the case," Conway spokeswoman Shelley Johnson said Thursday.

The diabetes drug triggered patient lawsuits and a U.S. Department of Justice investigation. In 2011 the company updated the labeling of Avandia to include safety restrictions ordered by federal health authorities because of the drug’s links to heart attack.

The Food and Drug Administration first approved Avandia in 1999, and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But its use plummeted after a 2007 analysis first linked the drug to heart attacks.


Posted: February 2013