Pharmaceutical giant, GlaxoSmithKline has plead guilty to three misdemeanor counts, one count of failing to report safety data and two counts of introducing misbranded drugs. The company has also agreed to a pay a $3 billion fine.
According to prosecutors, GlaxoSmithKline illegally promoted the use of Paxil for treating depression in children from April 1998 to August 2003; the FDA had only approved the drug for adults. The company also promoted the medication Wellbutrin for weight loss, sexual dysfunction, substance addictions, attention deficit hyperactivity disorder, even though it was only approved to treat major depressive disorder. It is illegal to promote uses for a medication that have not been approved by the FDA; this practice is referred to as off-branding.
USA Today reports that GlaxoSmithKline failed to report safety data to the FDA about the drug Avandia from 2001 to 2007. The FDA has included warnings on Avandia’s label to alert doctors and patients about the increased risk for congestive heart failure and heart attacks since 2007.
GlaxoSmithKline will pay almost $1billion for a criminal fine and $2 billion to resolve civil claims under the False Claims Act.
Prosecutors said that the settlement was to punish the pharmaceutical company, recover tax dollars and to ensure the company will comply with the law in the future. They also hope that the case deters others from committing health care fraud.
GlaxoSmithKline has spent more than $700 million settling patient lawsuits that claim the drug Avandia caused heart attacks and strokes.
If you or a loved one has suffered an injury from Paxil, Avandia or Wellbutrin, you may be to file a dangerous drug lawsuit. Contact the defective drug attorneys at The Eichholz Law Firm to discuss your legal options.
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