Pharmaceutical giant, GlaxoSmithKline (GSK), will plead guilty and pay about $3 billion to resolve federal criminal and civil claims arising from the company's illegal, off-label marketing of some of its popular products as well as its failure to report important safety data.
GSK will plead guilty to two counts of introducing misbranded drugs, Paxil and Wellbutrin, and one count of failing to report safety data about Avandia to the FDA.
The $3 billion penalty is the largest penalty ever paid by a drug company. Additionally, GSK agreed to be monitored by government officials for five years to ensure the company's compliance with the ruling.
According to the prosecution, GSK illegally promoted the use of Paxil for treating depression in children from April 1998 to August 2003. The drug was only approved for use in adults over the age of 18.
GSK also illegally promoted the drug Wellbutrin, marketing the drug for attention deficit hyperactivity disorder, substance addictions, sexual dysfunction and weight loss. The FDA only approved Wellbutrin to treat major depressive disorders.
Additionally, GSK failed to report important safety information to the FDA regarding the drug Avandia from 2001 to 2007. Information from specific post-marketing studies and two studies regarding the cardiovascular safety of the diabetes drug were not reported to the FDA. This information could have prevented instances of heart failure. In 2007, the FDA added warnings to the Avandia label, alerting doctors of the potential of congestive heart failure and heart attack linked to the use of the drug.
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.
If you or a loved one has suffered an injury after using Paxil, Wellbutrin or Avandia, you may be eligible to file a dangerous drug claim to recover compensation for your losses.
For more information on the legal rights which may be available to dangerous drug injury victims, complete the Free Case Evaluation form on this page.