No preemption

The Philadelphia, PA court denied GSK’s request to dismiss a case brought by the parents of Harold Garrison, a 16 year-old who committed suicide after taking Paxil (generically known as paroxetine hydrochloride) for approximately nine months. According to the judge in the case, "The evidence suggests a triable issue of fact as to whether GSK indeed possessed information, not available to the FDA [U.S. Food and Drug Administration], upon which it could have unilaterally added a warning to its labeling, consistent with FDA regulations.”

The FDA’s position

The FDA has been investigating whether antidepressant drugs such as Paxil increase the risk of suicide in children. The FDA issued a warning in September 2004 for Paxil stating that the drug can cause suicidal behavior in minors. That warning followed a study from Great Britain which reported that over 1,000 children taking Paxil had an increased rate of suicidal behavior.

The FDA issued another warning for Paxil in May 2006 after a different study showed that young adults ages 18 – 30 also showed an increased rate of suicidal behavior. The court’s ruling to let the lawsuit go forward was partially based upon the fact that the FDA had not yet taken a position on antidepressants prescribed for children at the time of Garrison’s suicide in 2002. However, the issue of preemption and drug manufacturers will be decided by the U.S. Supreme Court in the next few months.

Why didn’t GSK warn consumers?

That’s what the parents of Garrison want to know. In fact, many others in the U.S., Canada and the Great Britain also want to know. While GSK states that it wasn’t required to warn consumers about suicidal behavior in children because the FDA hadn’t required it to, the court disagreed and stated that the FDA’s rules allow drug manufacturers to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.”

According to news reports, GSK faces several lawsuits in each country alleging that Paxil causes suicidal and homicidal behavior and is an addictive drug. They claim that GSK knew of the increased risks of suicide in minors, but kept that information to itself to boost sales.

If you or a loved one has been injured due to Paxil use, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.