Avandia Litigation and FDA Developments

Avandia increases risk of heart attack, according to recent lawsuits and the FDA.

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Avandia, or rosiglitazone maleate, is a prescription drug used to control blood sugar in adults with type 2 diabetes. A 2007 study indicated that Avandia significantly increases the risk of heart attack. Since then, over 13,000 lawsuits have been filed (or are pending) against Avandia's manufacturer, GlaxoSmithKline. The lawsuits allege that the drug increases the risk of heart attack and other serious side effects and that GlaxoSmithKline failed to warn users of this increased risk.

The bulk of the lawsuits against GlaxoSmithKline were settled prior to a review of Avandia's safety by a U.S. Food and Drug Administration (FDA) advisory panel in July 2010, which voted to restrict the sale of Avandia. The FDA will decide at a later date whether to allow Avandia to stay on the market.

Read on to learn more about Avandia's side effects, the significance of the FDA review, and the current status of Avandia litigation. (For answers to basic questions about defective product liability claims, see Nolo's Product Liability FAQ.)

September 2010 update: The FDA has put in place a harsh set of restrictions on the sale of Avandia. Learn more in Nolo's Legal Update FDA Orders Severe Restrictions on Avandia.

What Is Avandia?

Avandia is a prescription drug manufactured by GlaxoSmithKline. The active ingredient in Avandia is rosiglitazone maleate. Avandia is in the class of thiazolidinedione drugs that lower blood sugar by making cells more sensitive to insulin. The FDA approved Avandia in 1999 to treat high blood sugar in people with type 2 diabetes mellitus. Type 2 diabetes is a condition in which the body fails to properly use insulin, a natural substance that helps control blood sugar levels.

The active ingredient in Avandia is also used in two other GlaxoSmithKline drugs, Avandamet and Avandryl. At the peak of Avandia's popularity, 13 million prescriptions were written for the drug and sales of its active ingredient topped $3 billion.

Side Effects of Avandia

A study published in The New England Journal of Medicine in May 2007 indicated Avandia significantly increases the risk of heart attack. An advisory panel to the FDA reviewed the study and concluded that Avandia does increase heart attack risk. The FDA declined to remove Avandia from the market, however, opting instead to beef up the drug's warning label to notify users of the increased risk. A follow-up to the 2007 study, published in the June 2010 issue of the Archives of Internal Medicine, confirmed the conclusions of the 2007 study -- that Avandia increases the risk of heart attack.

A separate study published in June 2010 in the Journal of the American Medical Association (JAMA) showed that, in patients over the age of 65, Avandia increases the risk for stroke, heart failure, and death.

Other possible serious side effects of Avandia include:

  • fractures in women, particularly in the hands, arms, feet, ankles, and lower legs
  • edema (fluid retention) that may lead to or worsen congestive heart failure (a condition in which the heart is unable to pump enough blood to the other parts of the body)
  • angina (chest pain) and other problems caused by myocardial ischemia (reduced blood flow to heart)
  • macular edema leading to problems with vision
  • liver problems, including hepatotoxicity (acute hepatitis), and
  • weight gain.

Avandia Lawsuits -- Legal Claims

Typically, people who have been injured by a pharmaceutical medication bring a defective product liability lawsuit against the drug's manufacturers and marketers. In a product liability claim, plaintiffs argue that they were injured by a pharmaceutical drug because of one or more of the following:

  • the drug was manufactured improperly
  • the drug caused unreasonably dangerous side effects, or
  • the manufacturer, doctor, or pharmacy did not adequately warn the consumer or prescribing physician of the dangers of the drug. (To learn more about inadequate warnings in defective product claims involving pharmaceutical drugs, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

The plaintiffs in the Avandia lawsuits make the following claims:

  • Avandia causes heart attacks and strokes
  • GlaxoSmithKline knew that Avandia increases the risk of heart attack and stroke, and
  • GlaxoSmithKline failed to warn consumers of these risks.

Legal Defenses in Avandia Cases

Drug manufacturers almost always mount a vigorous defense when they are sued under product liability laws. Often, they challenge plaintiffs' claims by arguing that either the drug is not dangerous or the plaintiffs' injuries were caused by something other than the drug.

Although no Avandia lawsuit has made it to the trial stage, GlaxoSmithKline has publicly stated that:

  • Avandia does not increase the risk of heart attack, stroke, or death
  • plaintiffs who suffered from heart attacks or strokes cannot link their conditions to their Avandia use, and
  • GlaxoSmithKline did not hide the known health risks of Avandia.

Status of Avandia Litigation

Since 2007, over 13,000 federal and state lawsuits have been filed or are pending against the maker of Avandia.

Approximately 5,000 federal claims were consolidated in multidistrict litigation in a Philadelphia court. In multidistrict litigation (MDL), cases involving similar issues of fact are transferred to one court for pretrial and discovery proceedings (the process where each side finds out everything they can about the other side's case). Once that process is finished, attorneys try the cases in the court where the case was originally filed or in the MDL court. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug Lawsuits and Other Cases.)

GlaxoSmithKline settled more than 700 Avandia lawsuits in May 2010 for approximately $60 million. About 10,000 additional lawsuits were settled in July 2010 for $460 million. At least 3,000 claims are still pending. The first Avandia trial is scheduled to take place in federal court in Philadelphia in October 2010.

FDA Review of Avandia

An FDA advisory panel evaluated the safety of Avandia in 2007. The FDA review was prompted by the publication of a study indicating the use of the diabetes drug leads to an increased risk of heart attack. Although the FDA panel concluded that Avandia does increase the risk of heart attack, the majority of panel members voted to recommend that the drug remain available. Votes by the FDA advisory panel are not binding on the FDA, but the agency followed the advisory panel's recommendations and kept Avandia on the market.

The FDA's Black Box Warning

In 2007, the FDA required GlaxoSmithKline to use a black box warning on the package inserts of Avandia and other drugs containing rosiglitazone maleate. A black box warning -- so named because of the black border surrounding the text -- notifies consumers that a drug may have serious, adverse side effects. It is the strongest warning the FDA can require.

The required FDA black box warning for Avandia and other rosiglitazone-containing drugs states that:

  • Rosiglitazone (Avandia) may cause myocardial ischemia (reduced blood flow to the heart), and
  • Rosiglitazone may cause or exacerbate congestive heart failure.

2010 FDA Review

In July 2010, the FDA convened another advisory panel to review the safety risks of Avandia. The majority of panel members voted to restrict the sales of Avandia. The votes of the FDA advisory panel were as follows:

  • twelve votes to remove Avandia from the market
  • ten votes to continue sales of Avandia, but with a revised warning label and possible sales restrictions
  • seven votes to continue sales of Avandia with additional warnings, and
  • three votes to keep Avandia on the market without any additional warnings or restrictions.

At a later date, the FDA will make a final decision on whether to allow GlaxoSmithKline to continue selling Avandia.

Getting Help

The legal and medical issues in pharmaceutical drug cases are sophisticated and complex. So if you've suffered health problems after taking Avandia, and you think you have a case, you may want to hire a lawyer who specializes in products liability litigation (or, even better, one who has experience with cases involving Avandia). You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

For help with choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer. Or go straight to Nolo's Lawyer Directory for a list of personal injury attorneys in your geographical area.

by: , J.D.

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