South Carolina Files Fraud Lawsuit Over Avandia Side Effects

South Carolina officials have announced that they are suing GlaxoSmithKline for fraud over failing to disclose heart attack risks and other side effects of Avandia, a diabetes drug that has been removed from the market in many countries and heavily restricted here in the U.S. 

The South Carolina Attorney General’s Office filed the Avandia fraud lawsuit against the pharmaceutical company on May 17 in the 7th Judicial Circuit Court in Spartanburg County.

According to the complaint, GlaxoSmithKline defrauded state drug reimbursement programs that helped subsidize Avandia prescriptions by overstating the drug’s effectiveness and hiding risks associated with the medication. The lawsuit charges the company with false and illegal marketing tactics.

GlaxoSmithKline allegedly cheated South Carolina taxpayers out of millions of dollars by convincing the state that the drug was safe and effective, the Attorney General’s Office claims. The state seeks to recoup $5,000 for every time Glaxo violated the state’s Unfair Trade Practices Act, and another $2,000 for each Avandia Medicaid claim reimbursed by the state, as well as unspecified punitive damages.

The lawsuit comes just days after the FDA announced that Avandia would only be available at select pharmacies and that special education will be required before health care professionals can prescribe the drug. The new restrictions on Avandia, which also apply to Avandamet and Avandaryl, were put in place after the FDA decided not to issue a recall for the diabetes drug, despite a known increased risk of heart attacks.

Avandia (rosiglitazone) was first introduced in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics throughout the world, but sales began to plummet in mid-2007, after potential Avandia heart risks were highlighted in a study published by the New England Journal of Medicine.

A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for an Avandia recall to be issued in the United States.

Despite heated internal debate, the FDA decided in September 2010 not to recall Avandia in the United States, allowing the medication to remain on the market with severe restrictions on who can use the product.

GlaxoSmithKline has faced thousands of Avandia lawsuits in the U.S. filed by people who allege that the drug maker failed 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, but thousands of cases are still pending in courts throughout the country.