Avandia Lawsuit

Serious cardiovascular side effects and potentially life-threatening complications have prompted thousands of patients taking Avandia in the U.S. to file lawsuits against GlaxoSmithKline, the manufacturer of Avandia, in recent months. GlaxoSmithKline could face up to $6 billion in liability for side effects litigation in the near future.

You may have legal options to seek compensation to cover the cost of medical expenses, pain and suffering if you have experienced serious side effects while taking Avandia. For additional information about Avandia lawsuits, please call 1-800-439-8180 or fill out the form on this page.

Did GlaxoSmithKline Knw of the Dangers Associated with Avandia?

A two-year investigation by the United States Senate Finance Committee revealed that GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication.

Additionally, a scientist who was actively involved in the New England Journal of Medicine study linking Avandia to heart problems was able to tape-record a meeting with GlaxoSmithKline in 2007. According to The New York Times, the recording demonstrated that “GlaxoSmithKline had threatened scientists who tried to point out Avandia’s risks.”

Many patients feel that GlaxoSmithKline should have made doctors and the public aware of the cardiac risks associated with Avandia at the time the company knew of the dangers, and many patients have since filed lawsuits against the company.

FDA Reviews

The FDA is currently reviewing data from a long-term safety study of rosiglitazone (Avandia), with results scheduled to be presented in July 2010. Depending on the results of the study, Avandia could face a nationwide recall in coming months if the agency determines that the medication’s risks far outweigh the benefits.

The FDA estimates that Avandia treatment caused at least 83,000 heart attacks from 1999 to 2007, and clinical studies have shown that Avandia increases the risk of heart attack by 43 percent and can double the risk of heart failure after just one year of treatment. There is no mention of an increased risk of cardiovascular death in Avandia’s black box warning label, however, in clinical trials more people died as a result of a cardiovascular event taking Avandia than those taking a placebo.

Avandia Recall/Black Box Warning Information

Since 2007, the FDA has required a Black Box warning on Avandia concerning the risk of congestive heart failure and myocardial ischemia. Avandia and other thiazolidinedione anti-diabetic medications may cause or worsen congestive heart failure in certain patients. At the beginning of Avandia treatment and after dose increases, patients should be observed for signs of heart failure which include rapid weight gain, swelling or difficulty breathing.

Avandia is associated with an increased risk of myocardial ischemic events including chest pain (angina) and heart attack.

Avandia Recall

As concerns surrounding Avandia’s potential to cause cardiovascular complications continues to rise, some public officials have called for the drug to be taken off the market.

According to a study published in the New England Journal of Medicine in 2007 by the Cleveland Clinic, Avandia increased the risk of heart attack by 43 percent.

The FDA has recently revised Avandia labels in September 2010 and February 2011 to indicate cardiovascular risks. The new labeling must also include information specifying that only those patients who have taken Avandia previously and cannot currently control their blood sugar levels by other means should undergo treatment with the drug.

Current Lawsuits

Approximately 13,000 Avandia lawsuits have been filed across the U.S., citing GlaxoSmithKline’s failure to inform patients about potentially life-threatening symptoms including stroke, heart failure, heart attack, bone fractures, vision loss and death that have been linked to Avandia treatment. Cases are currently being consolidated in a multidistrict litigation by a Pennsylvania court, with the first trial dates to be scheduled between June 2010 and October 2010.

Recent Developments in Avandia Settlements

Thousands of individuals have filed Avandia lawsuits against GlaxoSmithKline to seek compensation for injuries and suffering they believe were unjustly endured because of the medication. To save time and money, GlaxoSmithKline has decided to settle many of these cases out of court.

GlaxoSmithKline made the first round of Avandia lawsuit settlements in May, when the company agreed to pay approximately $60 million dollars to settle more than 700 cases. In July, Glaxo agreed to a $460 million settlement, which resolved approximately 10,000 cases against the drugmaker.

Future Avandia Settlements

To date, more than 13,000 lawsuits have been filed against Avandia’s manufacturer, and analysts expect this number to continue to grow in the coming months. New reports have emerged suggesting that GlaxoSmithKline has been suppressing information about Avandia’s health risks, which has only further agitated public criticism of the company.

GlaxoSmithKline has set aside funds in anticipation of the growing number of Avandia lawsuits. At the end of March, the company set aside $3.5 billion to pay for Avandia litigation and settlement costs.

While GlaxoSmithKline is expected to settle additional lawsuits out of court, the company is not expected to resolve all Avandia lawsuits in this manner. The first Avandia case set to go to trial is to be heard in a Philadelphia courtroom in October.