A federal judge in Pennsylvania ruled on Wednesday, October 1, 2008 that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil can proceed to a jury trial. In doing so, the Court denied the motion for summary judgment filed by Paxil manufacturer GlaxoSmithKline (GSK).
This was GSK’s second attempt at stopping this particular Paxil suicide case arising from the death of Harold Stanley “Jake” Garrison. Just last month Senior Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania, rejected GSK’s preemption arguments recognizing the vital role tort litigation has played in protecting the health and safety of its citizens, Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D.Pa., Aug. 28, 2008).
In denying GSK’s latest motion to prevent the case from proceeding with a jury trial, the judge made the following statements relating to GSK’s legal arguments:
“Defendant’s arguments, however, offer a myopic view of the record and misconstrue the relevant jurisprudence. It is well-established that a plaintiff need not hear the misrepresentation from the defendant directly for there to be actionable fraud”
“Defendant cites to no law – nor can this Court find any case – that applies the New Jersey presumption of adequacy to use of a drug in an unapproved population. More importantly, it is contrary to all reasonable logic to adopt Defendant’s suggestion that it may hide behind an FDA-approved warning regarding adult use of Paxil, when the FDA never had the opportunity, during the pertinent period, to review the propriety of a proposed warning with respect to pediatric use of Paxil.”
“Moreover, the fact that, when given the crucial data, the FDA finally required Defendant to revise its label in October 2004, to reflect what Defendant possibly knew as of 1998, ‘provides powerful evidence’ that the label originally approved by the FDA, which contained no precautions or warnings regarding pediatric use, was inadequate, at least from 1998 forward.”
“Finally, the Court takes note of the inherent hypocrisy in Defendant’s argument. On one hand, Defendant contends that it had no duty to warn of known risks involved in off-label usage of the drug, whether or not it had reason to know of such off-label uses. On the other hand, it contends that once its drug was approved by the FDA for some indications, it was protected by the presumption of adequacy for FDA warnings for usage in all indications, even where the FDA had never considered the propriety of the warning. On a hypothetical third hand, it claims that any attempt to rebut the presumption by proof of nondisclosure is preempted by federal law, thereby making the presumption effectively unrebuttable. Applying such logic, a pharmaceutical manufacturer possessing information regarding hazards associated with off-label use of its drug would never have to warn the medical community of any off-label usage dangers or submit data regarding these dangers to the FDA. Such a result is contrary to New Jersey’s ‘strong interest in encouraging the manufacture and distribution of safe products for the public and, conversely, in deterring the manufacture and distribution of unsafe products within the state’…”
In allowing plaintiffs’ punitive damages claims to proceed, the Court commented that:
“Beyond the evidence already discussed throughout this opinion showing that GSK knew of the risk of pediatric suicidality as of 1998, internal GSK documents suggest that Defendant acted with a wanton and willful disregard for the safety of its consumers.”Read More