Serious cardiovascular side effects and potentially life-threatening complications from the diabetes drug Avandia prompted tens of thousands of patients in the United States to file lawsuits against GlaxoSmithKline, the drug’s manufacturer. GlaxoSmithKline could face up to $6 billion in liability for side effects litigation.
According to a scientist for the U.S. Food and Drug Administration (FDA), Avandia is linked to as many as 100,000 heart attacks. Clinical studies show that the drug increases the risk of heart attack by 43 percent and can double the risk of heart failure after one year of treatment.
During clinical trials, more people died as a result of a cardiovascular event taking Avandia than those taking a placebo, studies show. Despite these findings, Avandia’s black-box warning label did not mention an increased risk of cardiovascular death until the FDA warned about the risks in 2007.
A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication. 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.
FDA Reviews; No Recall
After reviewing data from a long-term safety study of rosiglitazone (Avandia), which is prescribed for people with type 2 diabetes, the FDA publicized heart risks linked to the drug in 2007. Although the FDA stopped short of recalling the drug, it ultimately found the drug’s warnings inadequate.
Since 2007, the FDA has required a black-box warning on Avandia concerning the risk of congestive heart failure and myocardial ischemia. The warning states that Avandia and other thiazolidinedione diabetes 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 also is associated with an increased risk of myocardial ischemic events, including chest pain (angina) and heart attack.
As concerns surrounding Avandia’s potential to cause cardiovascular complications continued to rise, some public officials called for the drug to be recalled. In 2010, regulators stopped Avandia sales in Europe because of the increased heart risks.
The FDA 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. Avandia was pulled from most pharmacy shelves, and was available only through a special government program. In late 2013, the FDA removed the restrictions.
Ongoing Avandia Lawsuits
More than 50,000 Avandia lawsuits have been filed in state and federal court across the United States, 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.
Federal Avandia claims were consolidated in Multidistrict Litigation No. 1871 in 2007. Since then, more than 4,500 cases have been assigned to a federal court in Pennsylvania. The first trials among these cases began in January 2011, before a new wave of Avandia settlements.
To save time and money, GlaxoSmithKline has settled many cases out of court. During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.
In November 2011, the federal judge presiding over Avandia MDL appointed a mediator to resolve the bulk of the pending MDL cases. In February 2012, the judge announced that the court was satisfied with the progress of settlements and would now focus on resolving remaining cases through litigation.
An estimated 50,000 Avandia cases have been settled so far.
Future Avandia Lawsuit Settlements
Many of the cases against Avandia’s manufacturer were resolved through settlement. However, criticism of GlaxoSmithKline has recently increased, potentially leading to a new wave of Avandia settlements in both federal and state court.
Soon after Avandia’s heart risks became public, news reports emerged suggesting that GlaxoSmithKline suppressed information about Avandia’s health risks.
In July 2012, the company pleaded guilty to federal charges that it failed to report clinical data on Avandia. GlaxoSmithKline reached an agreement with the Department of Justice to pay a $3 billion settlement. The agreement, which also includes charges over the company’s marketing of Paxil and Wellbutrin, is the largest health care fraud settlement in U.S. history. This news has only further agitated public criticism of the company.
GlaxoSmithKline has set aside funds in anticipation of the growing number of Avandia lawsuits. The company set aside $6.4 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. This includes at least some of the estimated 3,800 cases still pending in the federal MDL.