Preemption Update: Knipe v. GSK Brings Another Victory for Plaintiffs

In yet another resounding victory for Plaintiffs in the battle against federal preemption, a federal district judge has rejected a drug manufacturer’s attempt to skirt liability by invoking the doctrine of implied conflict preemption. On August 29, 2008, in a 53-page memorandum opinion in Knipe v. SmithKline Beecham, d/b/a GlaxoSmithKline, 2:06-cv-03024 (RB) (E.D. Pa.), Senior Judge Ronald Buckwalter denied GlaxoSmithKlines’ (GSK’s) summary judgment motion based on preemption.

The plaintiffs in Knipe are New Jersey residents Marion Knipe and Harold Garrison, Jr., who are prosecuting a wrongful death action against GSK on behalf of their deceased son, Harold “Jake” Garrison. On September 14, 2002, at the age of only 16, Jake committed suicide by gunshot. The plaintiffs claim that Jake’s death was the result of his ingestion of Paxil and that GSK is liable for failing to warn them and Jake’s physicians about the risk of suicide posed by Paxil to children and adolescents. That risk is now prominently displayed in the drug label’s black-box warning. See Paxil Label (2008). GSK’s preemption argument in Knipe was essentially identical to the one raised in Colacicco v. Apotex, Inc. and GSK, 521 F.3d 253 (3d Cir. 2008), a case involving an adult suicide and a generic version of Paxil where the Third Circuit accepted conflict preemption.

Relying on recent Third Circuit precedent, the Knipe court reinforced the validity and applicability of what is commonly known as the “presumption against preemption,” concluding simply that, “… although the outcome of this case turns ultimately on the existence or non-existence of an actual conflict between state and federal law, the general presumption against preemption remains viable.” Slip op. at 23.

The Knipe court then examined Colacicco to decide if that case was controlling on the issue in question: whether, prior to Jake Garrison’s suicide in September 2002, the FDA had “prevented” GSK from strengthening Paxil’s suicide warning for children and adolescents. Recognizing that Colacicco was addressed strictly to the distinct question of whether GSK had been prevented from warning about adult suicidality, the Knipe court distinguished Colacicco and declined to reach a similar result in favor of preemption. See Slip op. at 26-30.

The court summarized its holding:

In sum, no clear conflict exists between the state law failure to warn claim raised by Plaintiffs in this case and the FDA’s power to regulate prescription drugs and warning labels. … [T]he FDA has taken the position that changes may be made to a label without prior approval only to correct concerns about newly discovered risks from the use of the drug based on important new information. This case, in its current posture, falls precisely in that category. During the relevant time period in this case, Paxil was not – and to date has not been – approved for pediatric use. As of the original approval in 1992, no evidence exists that the FDA received any pediatric clinical studies from any major SSRI manufacturers. In late 2001, the FDA first began receiving controlled studies of the seven major SSRIs in pediatric patients for the treatment of Major Depressive Disorder. On September 30, 2002, although the FDA had yet to affirmatively link increased suicidality in adolescents to Paxil, it declined to approve Zoloft, another SSRI, for treatment of pediatric Major Depressive Disorder, on the grounds that it could not prove efficacy. At no point did the FDA deem the proposed pediatric warning scientifically unsubstantiated. To the contrary, it ultimately required the inclusion of a black box warning linking pediatric use of SSRIs with an increased risk of suicidality. Quite unlike the cases finding state failure to warn cases preempted due to the FDA’s clear and considered position on the warning at issue, the FDA had not repeatedly and/or publicly stated its position as to this warning. Accordingly, if GSK had reasonable evidence of an association between Paxil and increased pediatric suicidality, nothing in the FDA regulations would have precluded it from adding that warning via a CBE, and subsequently seeking FDA approval, without facing any risk of misbranding the drug. Given the still viable presumption against preemption, the Court declines to find that any obvious conflict existed.

Slip op. at 42 (citations omitted) (emphasis in original).