Avandia (rosiglitazone) is used to treat "type-2" or "adult-onset" diabetes. It was approved by the Food and Drug Administration (FDA) in 1999 and is manufactured by GlaxoSmithKline. Although many Avandia patients have benefited from the drug, some have experienced serious health consequences such as heart attack and stroke. As a result, numerous lawsuits have been filed against Avandia's manufacturer GlaxoSmithKline.
Avandia and Adverse Health Complications
Avandia is composed of rosiglitazone. Some medical studies have linked rosiglitazone to an increased risk of heart attack and stroke. In 2007, the New England Journal of Medicine published a study that reviewed clinical data involving patients who took rosiglitazone. The study found that patients who took the drug had an increased risk of myocardial infraction (heart attack) in comparison to patients who weren't treated with rosiglitazone.
In another study, medical researchers examined elderly patients who had type 2 diabetes. One set of patients took rosiglitazone and the other set of patients took pioglitazone. The study found that patients who took rosiglitazone had a higher risk of stroke and heart failure than the patients who took pioglitazone.
In 2011, the FDA announced that it would be restricting the access and distribution of Avandia and other rosiglitazone drugs. The FDA based its decision on data showing an increased risk of heart attacks in patients who took rosiglitazone drugs. Under the FDA guidelines, patients and healthcare providers who prescribe Avandia must be enrolled in a special program called the Rosiglitazone Risk Evaluation and Mitigation Strategy (REMS) program. In addition, only pharmacies that meet special certification requirements are allowed to dispense Avandia.
In November 2013, the FDA announced that it would be rescinding its limitations on the use and distribution of Avandia and other rosiglitazone drugs. The FDA based this decision on a recent study showing that rosiglitazone didn't have an increased risk of heart attack and death when compared to other type 2 diabetes drugs. After certain drug labeling changes and other requirements are met, patients and doctors will no longer be required to register in the REMS program. In addition, distribution of Avandia will be no longer limited to specially certified pharmacies.
GlaxoSmithKline Guilty Plea and Settlement
In 2012, Avandia's manufacturer GlaxoSmithKline pleaded guilty to three criminal charges. The Department of Justice (DOJ) charged GlaxoSmithKline for allegedly failing to report certain safety data involving Avandia to the FDA. The other charges involved the company allegedly misbranding two other drugs for uses that the FDA hadn't approved. GlaxoSmithKline subsequently agreed to pay $3 billion to settle its criminal and civil liability regarding Avandia and other drugs.
Thousands of Avandia lawsuits have been filed in the state and federal courts. Many of the lawsuits are based on the theory of product liability. Under product liability law, drug manufacturers and sellers have a duty to ensure that their drugs are safe for patients. Many of the lawsuits claim that GlaxoSmithKline provided defective warnings about the risk of heart attack and stroke. If the lawsuits are successful, the plaintiffs could be awarded damages for lost wages, medical expenses, and pain and suffering.
Currently, the biggest Avandia litigation involves thousands of federal lawsuits that have been consolidated into multidistrict litigation in the United States District Court for the Eastern District of Pennsylvania. The assigned judge is coordinating the lawsuits during pretrial proceedings. Some of the lawsuits have settled, whereas others are still pending.