On August 29th Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania submitted a 53-page opinion on the ruling associated with Garrison v. GlaxoSmithKline (GSK) case. As background information, Jake Garrison, 16, was taking the drug Paxil, an anti-depressant and anti-anxiety drug when he committed suicide. The parents filed a lawsuit against GSK the manufactures of Paxil. GlaxcoSmithKline attempted to use a preemption argument, which simply means that if the U.S. Food and Drug Administration has approved a drug or product for use then any litigation brought against the manufacturer for adverse events associated with the drug or product should be dismissed because of said FDA approval. GlaxcoSmithKline’s attempt failed as Judge Buckwalter issued the arguments:
1. “Drug manufacturers have the best information about the safety of their own products and, thus, under the regulations, they have the ability to alter a drug label prior to FDA evaluation and approval.”
2. FDA regulations allow a drug manufacturer 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."
3. “Arguably, GSK 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 GSK elected not to submit the results of those studies until April of 2002, when it filed a supplemental NDA (new drug application) 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.”
4. “The mere fact that the FDA had not ordered GSK to include this warning prior to 2002, does not mean that it could not have legally done so.”
5 “A state failure to warn action will not usurp or undermine the FDA’s responsibilities to ensure an accurate label, but rather will close the void in the authority of the FDA, which can neither independently regulate off label use nor require additional clinical trials.”
6 “Tort law can play an important role in filling the gap, and it is consistent with a regulatory system that puts the obligation to warn on the party with the most comprehensive information available: the drug manufacturer.”
This is an extremely important win for plaintiffs’ and their attorneys as the tide in Big Pharma is tending to try and use preemption in an attempt to quash victims rights in seeking damages when a drug company willfully and irresponsibly puts patients at risk.