Louisiana has filed a lawsuit against GlaxoSmithKline for fraud involving the diabetes drug Avandia, alleging that the drug maker hid information about potential side effects of Avandia.
The Avandia suit was filed last week by Louisiana Attorney General Buddy Caldwell, claiming that GlaxoSmithKline collected more than $36 million in Medicaid reimbursements from the state as a result of actions that violated consumer protection and unfair trade practices laws in Louisiana.
Utah filed a similar Avandia lawsuit in November, seeking $7.8 million from GlaxoSmithKline, which is the amount the state says it paid for the drug from January 1, 2002 through June 30, 2010. Many of the Avandia prescriptions paid for by Utah were part of a Medicaid prescription drug program that provided “medically necessary” drugs to the poor that they could not afford.
Avandia (rosiglitazone) was first approved in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics in the U.S., but sales began to plummet in mid-2007, following the concerns about potential Avandia heart risks.
Avandia’s devastating side effects prompted the U.S. Food and Drug Administration in May 2007 to issue a public health warning about the product, advising users of the increased risks of heart and liver failure associated with the drug. In 2008, the FDA ordered Avandia’s makers to alert users with prominent “Black Box” warnings in the product’s packaging.
In September 2010, the FDA decided not to recall Avandia, allowing the medication to remain on the market with severe restrictions on who can use the product. The agency determined that only patients who have failed to control their diabetes through every other available medication should be given access to the medication, and ordered the drug’s maker, GlaxoSmithKline, to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted.
GlaxoSmithKline has faced thousands of injury lawsuits over Avandia that were filed by people who allege that the drug maker placed their desire for profits before patient safety by failing to adequately warn about the risk of heart problems from Avandia. A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the litigation.