We are no longer accepting new Avandia cases.

Avandia® Heart Risks

Since 2007, the FDA (U.S. Food and Drug Administration) has added two boxed (“black box”) warnings to the Avandia label to alert doctors about the potential risk of congestive heart failure and heart attacks. The FDA’s own Dr. David Graham stated, during an FDA public advisory committee meeting held on July 30, 2007, that Avandia’s heart risks, combined with no unique short-term benefits in helping diabetics control blood sugar levels, fail to justify keeping Avandia on the market. Two Baum Hedlund attorneys attended that meeting. The meeting consisted of  a joint panel of outside experts convened to consider whether Avandia should be restricted to use in select patients and branded with prominent warnings or removed from the market altogether. It wouldn’t be until 2011 that the drug was finally restricted in use.

Avandia pulled from market

Avandia was Pulled from Pharmacies
on November 18, 2011

Read the FDA Safety Communication

The original Avandia label underwent several changes in the seven years leading up to the first black box warning, each time strengthening the label, warning of an increased likelihood of congestive heart failure. On August 14, 2007 the FDA finally issued the first black box warning for Avandia regarding the potential increased risk of heart failure. The warning emphasized that rosiglitazone-containing medicines like Avandia, may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

On November 19, 2007, a second black box warning, the FDA's strongest form of warning, was added to the Avandia label regarding the potential increased risk of heart attacks and other myocardial ischemic events. The FDA said that meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

Just 11 days before cardiologist Dr. Steven E. Nissen published a landmark study that linked Avandia with a raised risj of heart attacks, Dr. Nissen met face to face with four executives of GSK, the maker of avandia, in a private meeting. Dr. Nissen decided to secretly record the conversation and did not share the contents of the recording until recently during a sit down with the New York Times.

Avandia Pulled From Shelves

The FDA then announced that it would pull rosiglitazone medicines, like Avandia, from pharmacy shelves starting on November 18, 2011, restricting the prescription of the drugs. Medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must now enroll in a special program in order to prescribe and receive these drugs.

The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS) — a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

GSK Pleads Guilty to Criminal Charges Involving Avandia and Two Other Drugs

The U.S. Department of Justice (U.S. DOJ) announced on July 2, 2012 that GSK (GlaxoSmithKline) has agreed to plead guilty to health care fraud charges and has agreed to pay $3 billion in fines to settle civil and criminal allegations in the largest health care fraud settlement in U.S. history. The U.S. DOJ stated that the settlement deal requires GSK pay the fine and plead guilty to criminal charges involving three of the company’s drugs including Avandia, and the antidepressants, Paxil and Wellbutrin. The allegations regarding Avandia state that between 2001 to 2007, Glaxo failed to report certain safety data to the FDA from studies that looked at post-marketing studies and cardiovascular safety of the diabetes drug. The Justice Department also accused GSK of paying kickbacks to doctors in order to encourage off label uses of its drugs.

Avandia Lawsuits Against GSK

Baum, Hedlund, Aristei & Goldman's pharmaceutical drug litigation team has filed Avandia lawsuits against GlaxoSmithKline (GSK) alleging that GSK negligently and carelessly failed to fully disclose to physicians, patients, and regulatory authorities the results of testing and other information in its possession from its clinical trials that showed an association between Avandia and heart failure, heart attacks, myocardial ischemia and ischemic events such as cardiovascular mortality, myocardial infarction and stroke.

Our drug product injury litigation team is representing many individuals who were taking Avandia and suffered a heart attack or coronary artery blockage that required a stent or bypass surgery.  The firm is also representing individuals who suffered from a stroke or congestive heart failure while taking the drug.  Our firm has represented thousands of victims of pharmaceutical drug-induced injuries and death for more than twenty years.

Baum Hedlund’s Track Record Against GSK

Baum, Hedlund, Aristei, & Goldman has extensive experience in litigating personal injury, wrongful death and consumer class action cases against major drug companies and has been litigating a number of different types of cases against GSK, the maker of Avandia, for many years.

Over the course of this litigation, Baum Hedlund has collected hundreds of thousands of pages of internal GSK documents and conducted dozens of depositions of GSK executives, employees, physicians, researchers and academics. As a result, Baum Hedlund knows how GSK operates, knows its tactics, the players, and how to get the evidence needed to effectively litigate cases against GSK*.

In 2001, Baum Hedlund was appointed lead counsel in charge of the Plaintiffs’ Steering Committee for the Paxil Products Liability Litigation (Multidistrict Litigation MDL-1574) in which Baum Hedlund represented over 3,000 people across the United States in personal injury cases against GSK.

Baum Hedlund has also been litigating Paxil suicide and suicide attempt cases for the past several years.

Since 2004, Baum Hedlund has been litigating a Private Attorney General consumer fraud class action lawsuit against GSK on behalf of residents in the states of California, Florida, Massachusetts, Nevada, New Jersey, Pennsylvania, Texas and Washington related to GSK’s false promotion of Paxil as an effective medication for children and adolescents. A settlement was reached in April 2007 wherein GSK agreed to reimburse parents for the money they paid for their children’s Paxil prescriptions.

*Our past performance, verdicts or settlements do not constitute a guarantee, warranty, or prediction regarding the outcome of future cases.