Lawsuit Over Avandia Filed by Santa Clara County in California

The County of Santa Clara in California has filed a lawsuit over Avandia against GlaxoSmithKline on behalf of both diabetes patients and health care providers, claiming that the drug maker falsely advertised the diabetes drug and concealed the increased risk of heart attacks and other side effects.

The case, filed in the U.S. District Court in San Jose, is believed to be the first government lawsuit against the company over the diabetes drugs. According to a report in the San Jose Mercury News, County officials said they had been planning the Avandia class action lawsuit for some time, but decided it was time to file after a U.S. Senate Finance Committee report last month revealed that some drug safety officials inside the FDA have called for an Avandia recall. The Avandia lawsuit cites estimates that the drug has caused between 60,000 to 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

The county itself said that it has been especially affected by Avandia problems because of a county-run hospital that spent $2 million on Avandia between 1999 and 2007 for patients, and also floated the bill for numerous patients who suffered heart attacks and other side effects of Avandia. County officials did not have an estimate of the number of patients in the county who took the drug or allegedly died due to Avandia.

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia heart problems.

In May 2007, a meta-analysis of 42 different clinical trials published in the New England Journal of Medicine suggested that users face an increased risk of a heart attack from Avandia. The FDA has since added a black box heart attack warning to Avandia.

The Senate report released last month charged GlaxoSmithKline with covering up the heart side effects of Avandia for as long as they could, and determined that the company intimidated scientists who spoke out about the problems. In the report, they cited a 2007 report from FDA drug safety reviewers who said that the health risks of Avandia outweighed the benefits and said the drug should be withdrawn from the market.

GlaxoSmithKline issued a rebuttal of the report last week, saying it was unfair and mischaracterized scientific studies of the drug’s risks and the company’s actions.

Glaxo faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin this summer. County officials said that it is possible that the class action lawsuit over Avandia they filed will be made part of the MDL.