On September 14, 2002, 16-year-old Jake Garrison shot himself to death, eight months after first being prescribed the Paxil antidepressant. And so a lawsuit was filed against Glaxo, claiming the drugmaker knew there were risks associated with off-label use pediatric use of Paxil and, therefore, had a duty to warn of those risks.
However, Glaxo cited preemption as a reason for the suit to be dismissed. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
In this case, the drugmaker maintained that a direct conflict existed between failure-to-warn claims under New Jersey state law and the federal Food, Drug & Cosmetic Act. New Jersey law stipulates that a drugmaker must warn of all known adverse effects of a drug as soon as reasonably feasible after learning of any danger. Lawyers for the Garrison family rejected the argument in their motion.
However, Glaxo contended that, had it included warnings about an increased risk of pediatric suicide in the Paxil label, the pill would have been considered misbranded under federal law. And since Glaxo could have not remained in compliance with both state and federal law as it stood prior to September 2002, when Garrison committed suicide, Glaxo argued a conflict existed, triggering preemption of New Jersey law.
But Judge Ronald Buckwalter of the US District Court for the Eastern District of Pennsylvania rejected the argument by ruling FDA regs 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.” Here is his 53-page ruling, in which he also wrote:
“Arguably, Glaxo possessed such reasonable evidence of an association between Paxil and pediatric suicidality as early as 1998, at the conclusion of their own Studies 329 and 377, the data from which initially triggered the FDA’s concerns.
“The mere fact that Glaxo elected not to submit the results of those studies until April of 2002, when it filed a supplemental NDA seeking approval of an indication for pediatric use, does not detract from the fact that it may have had reasonable evidence of a hazard prior to that time…The mere fact that the FDA had not ordered Glaxo to include this warning prior to 2002, does not mean that it could not have legally done so.”
Preemption is a hot legal topic these days. The US Supreme Court will review a case on November 3, and if you have some time on your hands, open this link to you will find background material and numerous briefs backing and opposing preemption.
By the way, this is the second Paxil case this summer in which preemption was rejected as a defense. This is the other one.
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