Avandia Injury Suits Could Cost Drug Maker $6B: Report

Financial analysts estimate that the pharmaceutical giant GlaxoSmithKline could face up to $6 billion in liability as a result of Avandia injury lawsuits filed over side effects of its diabetes drug, which has been linked to an increased risk of heart attacks, heart failure and other health problems.

UBS analyst Gbola Amusa issued the estimate in response to concerns caused by the release of a scathing U.S. Senate Committee report last week about problems with Avandia. Since then, the FDA has indicated that the agency is continuing to review the safety of Avandia, which many critics have argued should result in an Avandia recall.

Amusa indicates that since the drug currently only contributes about 1% to GlaxoSmithKline’s sales, the primary concern for the company stems from the liability it may face from the more than 13,000 Avandia suits that have been filed so far. The range of liability is currently estimated to fall between $1 billion and $6 billion, with the cost to the drug maker possibly hitting the top end of the range if Avandia is removed from the market.

Avandia (rosiglitazone) was 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 side effects. Some experts have estimated that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

The suits allege that GlaxoSmithKline failed to adequately warn users about the increased risk of serious and potentially life-threatening injuries, such as heart attack, stroke, congestive heart failure, liver failure, bone fractures, macular edema (vision loss) and death.

Federal Avandia litigation is consolidated for pretrial proceedings in an MDL, or multidistrict litigation, in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin in June. Amusa said that UBS would better be able to predict the drug maker’s liability for the personal injury lawsuits over Avandia once the first “bellwether” trials have completed, which will help narrow the range of liability.