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SC Attorney General's Office Sues Maker of Avandia

SC Attorney General's Office Sues Maker of Avandia [Herald-Journal, Spartanburg, S.C.]

From Herald-Journal (Spartanburg, SC) (June 1, 2011)

June 01--Alleging a widespread pattern of fraudulent behavior, the South Carolina Attorney General's Office earlier this month sued the maker of diabetes drug Avandia seeking damages and penalties in addition to recouping millions of dollars paid for the drug and spent treating its side effects.

The lawsuit filed in 7th Judicial Circuit Court in Spartanburg claims that GlaxoSmithKline, the maker of Avandia, used false and illegal marketing, exaggerated the drug's effectiveness and hid its risks beginning when the drug was first approved by the Food and Drug Administration in 1999.

Despite an awareness of a significant association between use of Avandia and heart attacks, GSK continued to market the drug heavily without warning about the cardiovascular risks, the suit alleges.

According to the suit, the company "perpetuated its fraudulent scheme to defraud the state" and "bilked the state out of millions of dollars by making false representations that Avandia was better at lowering blood sugar than existing medications."

The state attorney general's office declined additional comment on the Avandia case beyond the content of the lawsuit.

The suit seeks penalties of up to $5,000 for each violation of the state's Unfair Trade Practices Act.

Several other state attorneys general have filed similar lawsuits against GSK related to Avandia.

A lawsuit represents one side of a legal argument, and the company rejects South Carolina's allegations.

"GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label," spokeswoman Mary Anne Rhyne said in a statement.

"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 state Medicaid program and health plan paid millions of dollars for Avandia, which will no longer be sold at most pharmacies in the U.S. starting in November because of the risk of heart attack.

Only certain patients will be allowed to use the drug under a new program announced by the FDA this month.

Efforts to ascertain the exact amount the state spent on Avandia since 1999 were unsuccessful before the end of the day Tuesday.

The drug has been the subject of controversy since 2007, when a study by an expert at the Cleveland Clinic showed the drug increased heart attack risk by about 40 percent in type 2 diabetes patients.

Other studies since have reached similar conclusions.

South Carolina's lawsuit against GSK is just the latest in a series of legal actions against drug makers.

Beginning in 2007, the state filed three suits against Johnson & Johnson, Eli Lilly and AstraZeneca for the marketing of antipsychotic drugs Risperdal, Zyprexa and Seroquel, respectively.

The state attorney general's office in 2009 reached a $45 million settlement with Eli Lilly in the Zyprexa case, and a ruling on damages in the Risperdal case is expected today, according to multiple sources.

The Seroquel case could head to trial as soon as later this year, according to the attorney general's office.

A spokesman for the office said each of the antipsychotic drug lawsuits and the new Avandia lawsuit have been filed in Spartanburg because the local law firm the office has contracted with for each of the cases, Harrison, White, Smith, and Coggins, is located here.


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Posted: June 2011