Drug Maker Pleads Guilty To Misbranding Drugs and Withholding Safety Data

An unprecedented $3 billion settlement with a pharmaceutical manufacturer ranks as the largest health care fraud case in U.S. history. For people injured by unsafe drugs, it’s a strong reminder that drug manufacturers should be held accountable.

According to the U.S. Justice Department release, pharmaceutical giant GlaxoSmithKline LLC agreed recently to plead guilty and pay $3 billion to resolve its criminal and civil liabilities stemming from the company’s unlawful promotion of prescription drugs Paxil and Wellbutrin and its failure to disclose certain safety data about the diabetes drug Avandia.

Under federal law, a company must specify each intended use for a drug in its application to the Food and Drug Administration. The company’s promotion of a drug must be limited to the intended uses that the FDA has approved for the drug. A manufacturer’s promotion of a drug for unapproved uses or off-label uses is known as misbranding.

The government alleges in a criminal information that from April 1998 to August 2003, GSK unlawfully promoted the anti-depressant Paxil for treating depression in patients under age 18, although the FDA had never approved it for pediatric use. The government alleges the manufacturer took part in preparing and publishing misleading medical journal articles that misreported clinical trial results of Paxil in patients under age 18 and also withheld the results of two other studies in which Paxil failed to prove effective in treating young patients for depression. Since 2004, Paxil, like other anti-depressants, has included warnings that it may increase the risk of suicidal thinking and behavior in patients under age 18.

GlaxoSmithKline agreed to plead guilty to misbranding Paxil. The government additionally alleges that GSK also misbranded Wellbutrin, an anti-depressant, paying doctors to speak and attend meetings to promote the drug for unapproved uses. For the misbranding of Paxil and Wellbutrin, GlaxoSmithKline agree to pay a criminal fine and forfeiture of $757 million.

According to the government, GlaxoSmithKline failed between 2001 and 2007 to include certain safety data about Avandia in reports to the FDA. The reports reveal safety trends and are reviewed to determine if a drug continues to be safe for its approved uses. The missing information included data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has required Avandia to carry a warning label to alert doctors to increased risks of congestive heart failure and heart attack in patients taking Avandia. GSK agreed to plead guilty to failing to report data to the FDA and to pay a criminal fine of $242 million for its conduct.

According to the Justice Department, the drug manufacturer also will pay $2 billion to resolve its civil liabilities under the False Claims Act with the federal government relating to Paxil, Wellbutrin and Avandia as well as additional drugs.

Patients should be able to rely on the prescription drugs they take to be safe and effective when used as intended. When the drugs cause harmful side effects, the manufacturers should be held accountable for the harm they caused.

The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe drugs and pharmaceutical manufacturers that put profits ahead of patient safety. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.

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