WASHINGTON, February 1, 2008 - King & Spalding, a leading international law firm, has earned a significant victory for client GlaxoSmithKline (“GSK”) in a products liability case. On January 30, a federal district judge granted summary judgment in O’Neal v. SmithKline Beecham d/b/a GlaxoSmithKline and dismissed, with prejudice, all claims made by the plaintiff in a case involving the 1997 suicide of a 13 year-old. This is the fourth major win in a series of victories over the past several months regarding suits filed against the drug manufacturer of the antidepressant drug Paxil.

Judge Frank C. Damrell, Jr., of the United States District Court for the Eastern District of California, dismissed the case on the grounds that under state law all of the claims required showing that GSK should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality. The plaintiffs’ claims created a direct conflict with the federal labeling requirements for Paxil established by the United States Food & Drug Administration, preempting the plaintiffs’ tort claims.

Importantly, the court recognized that at the relevant time, in this case 1997, there was no reasonable scientific evidence to support the plaintiffs’ proposed warning. Agreeing with GSK, the court found that:

A direct conflict of law exists in this case because GSK could not have been in compliance with federal law in February 1997 and have included the suicidality warning plaintiffs urge. In other words, had GSK included the warning that plaintiffs insist upon, GSK would have risked misbranding Paxil in violation of the FDCA. Therein lies the actual and direct conflict presented in this case--comply with federal law and be held liable under state law tort claims, or, to avoid state tort liability, add a warning without reasonable evidence and violate federal law.

Absent reasonable evidence of a risk, GSK had no basis to petition FDA and simply did not have the option under federal law to include or secure a lawful warning for that risk in the drug’s labeling. Had it done so, GSK would have misbranded the drug in violation of the FDCA and subjected itself to a possible federal enforcement action against it or the withdrawal of its NDA by the FDA. Stated otherwise, the obligation under state law on GSK that plaintiffs advance is flatly contrary to GSK’s obligations under federal law. As such, plaintiffs’ claims must be found preempted.