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Pharmaceutical Fraud: GlaxoSmithKline Enters Guilty Plea to Allegations It Marketed Wellbutrin and Paxil for Unapproved Uses and Didn’t Report Avandia Clinical Data; Will Pay $3B, Forfeit $43 million

According to filings by the US government in federal court in Boston, GlaxoSmithKline has entered a guilty plea to misdemeanor charges that it illegally promoted Wellbutrin and Paxil for uses not that were not FDA-approved, as well as failed to report clinical data about the diabetes drug Avandia. As part of the settlement, Glaxo will pay $3 billion, including a $956.8 million criminal fine and a $300 million civil settlement for not providing best prices and underpaying rebates under the Medicaid drug program. The pharmaceutical company will forfeit $43 million.

This is considered the largest health care fraud case in the US and it involves the biggest UK drug maker. Four Boston whistleblower lawsuits relating to this case will also be resolved from this settlement.

Federal prosecutors started investigating Glaxo’s drug marketing practices with nine of the company’s biggest sellers in 2004. Paxil, which was only approved by the FDA for adult use, was promoted by the drug maker for use by teens under age 18 who were suffering from depression. Glaxo also promoted depression med Wellbutrin for the unapproved treatment of substance abuse, weight loss, and sexual dysfunction. (Although doctors can prescribe medications for uses that are not approved, drug companies are not allowed to market drugs for unapproved uses. To do so means a manufacturer has promoted a drug for off-label uses, or “misbranded” it.)

The US government also contended that Glaxo did not give certain safety data about Avandia between 2001 and 2007. Since then, the FDA now mandates that there be two black box warnings on the diabetes medication’s label warning doctors about the possible risks of heart attack and congestive heart failure.

Massachusetts Whistleblower Lawsuits
According to the lawyer of two of the whistleblowers, they were the ones that first told Glaxo it was marketing the drugs illegally in 2001. Now, as part of its settlement, Glaxo will pay $210 million to the states and $832 million to the US government. The Massachusetts whistleblowers are entitled to a percentage of the recovery.

GlaxoSmithKline settles healthcare fraud case for $3 billion, Reuters, July 2, 2012
GlaxoSmithKline Reaches Plea Agreement Over Drug Labeling, Bloomberg, July 2, 2012


More Blog Posts:

Virologists File Whistleblower Lawsuit Against Merck Over MMR Vaccine, Boston Injury Lawyer Blog, June 16, 2012

Pharmaceutical Fraud May Be Grounds for Filing a Massachusetts Whistleblower Lawsuit, Boston Injury Lawyer Blog, July 23, 2011

$25M Whistleblower Settlement Reached in Hospice Fraud Case Against Odyssey Healthcare Inc., Boston Injury Lawyer Blog, March 5, 2012
Contact our Boston injury lawyers to find out whether you have grounds for a Massachusetts pharmaceutical fraud case.