GlaxoSmithKline Faces Louisiana Lawsuit Over Avandia; Reportedly Settles Other Lawsuits

Baton Rouge, LANow that the label for Avandia has been changed and stricter rules are in place regarding Avandia's uses, another lawsuit has been filed alleging GlaxoSmithKline hid Avandia side effects from users. This time, however, the plaintiff alleging serious Avandia risks is not a patient but Louisiana Attorney General Buddy Caldwell.

According to Bloomberg (02/17/11), Caldwell's lawsuit alleges GlaxoSmithKline, maker of Avandia, hid the harmful side effects of the diabetes drug and illegally marketed and promoted the drug. The lawsuit further alleges GlaxoSmithKline violated Louisiana's consumer protection and unfair trade practices laws, as well as Louisiana's Medical Assistance Programs Integrity Law.

In all, Caldwell alleges, Louisiana paid more than $36 million in Avandia reimbursements. The lawsuit seeks recovery of that $36 million plus fines and includes allegations about GlaxoSmithKline's marketing and sale of rosiglitazone maleate, sold under the names Avandia, Avandamet and Avandaryl.

Attorney General Caldwell stated, “I am committed to pursuing those who prey on our citizens and our state Medicaid program. This type of exploitation jeopardizes our economy, our health and in some cases our lives. Our focus on these perpetrators sends a message of zero tolerance for such fraud and abuse.”

Court documents allege that GlaxoSmithKline elevated profits over people, engaged in "false, misleading, reckless, and fraudulent acts and practices" in its promotion, marketing and sale of Avandia and, "orchestrated a campaign of misinformation concerning Avandia."

That campaign of misinformation, according to the lawsuit, included hiding, "the numerous and grave adverse health effects, including, but not limited to heart attacks and deaths, caused by Avandia." As a result, the lawsuit claims, patients used the more expensive—and potentially more harmful—medication over less expensive and less risky treatments. Because many patients were enrolled in Louisiana's medical assistance program, Louisiana paid "grossly excessive prices for Avandia, which, upon information and belief, is life-threatening, medically unnecessary and/or of substandard quality."

GlaxoSmithKline responded that Avandia is safe and effective when used according to its label.

Meanwhile, GlaxoSmithKline reportedly agreed to pay more than $250 million to settle approximately 5,500 lawsuits concerning Avandia. Under the settlement, claimants receive approximately $46,000 each. Bloomberg (02/07/11) notes that by agreeing to the settlement, GlaxoSmithKline avoids the first trial alleging Avandia can kill users. That trial, concerning the death of James Burford who died in 2006, was supposed to be heard in court in early 2011.