Glaxo Loses Another Paxil Preemption Case

A federal judge has sided with the family of  a teenager who committed suicide while on <"">Paxil, and has ruled that their lawsuit against GlaxoSmithKline can proceed.  The ruling rejects the drug maker’s claim that the Food & Drug Administration (FDA) approval of Paxil barred plaintiffs from filing product liability claims.  Recently, drug makers have been trying to convince courts that this concept – known as preemption – shields them from such lawsuits.

In September 2004, the Food & Drug Administration (FDA) issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain’s Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters showed an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.

On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30.  An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo.  Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

Critics of Glaxo have charged that the company knew about Paxil’s problems with suicidal behavior long before it ever made them public. Recently, British authorities concluded a four-year investigation into whether Glaxo failed to inform  drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal  charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data.

In the U.S., Sen. Charles Grassley (R-Iowa) has  asked the FDA to probe whether Glaxo knew of Paxil’s suicide risk when it first sought approval for the drug.  The Justice Department is also probing the company’s handling of the drug.

Jake Garrison was only 16 years old when he shot himself in September 2002.  The teenager had been prescribed Paxil  eight months before he took his life.  His parents sued Glaxo, claiming the drug maker knew there were risks associated with off-label pediatric use of Paxil and, therefore, had a duty to warn of those risks.

Glaxo had argued that the suit was preempted by FDA regulations which, at the time of Jake’s death, did not call for suicide warnings for pediatric patients on Paxil.

Senior U.S. District Judge Ronald L. Buckwalter of the Eastern District of Pennsylvania disagreed with the company. In a 55-page opinion, he wrote that FDA rules allow a drugmaker 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.”  Therefore, Judge Buckwalter wrote that jury must decide whether the drug manufacturer “indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling.”

Drug makers have been waging  a battle in the courts to win protection from product liability lawsuits.  A case pending before the U.S. Supreme Court, Wyeth vs. Levine, seeks just that.  The High Court ruled in favor of medical device makers, granting them such a lawsuit shield earlier this year.

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