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 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 (paroxetine Hydrochloride).
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.
Opinion at 19. Accordingly, the court found "plaintiffs' claims are preempted." Further, the court affirmed that "the record indicates that the type of warning which plaintiffs claim SB/GSK should have included in its Paxil label had been considered and rejected by the FDA because such a warning was not supported by reasonable evidence at the time of " the suicide. Id. at 23-24. And, that:
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.
The decision is significant and precedent setting because it is believed to be the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality. This ruling could potentially lead to the dismissal of similar cases on preemption grounds.
The King & Spalding team representing GlaxoSmithKline consisted of product liability partners Chilton Davis Varner, Andy Bayman, Todd Davis and Halli Cohn, and FDA/Healthcare partner Mark Brown, along with associates Nicole Taylor and Nathan Guest.
Varner, widely considered one of the nation's top product liability litigators, was appointed by the late Chief Justice Rehnquist to the Federal Civil Rules Advisory Committee in 2004, where she assisted in drafting new electronic discovery provisions. Brown, a former Associate Chief Counsel with the FDA, is recognized as one of the nation's most experienced lawyers on a wide range of FDA issues in pharmaceutical and medical device litigation.
The win comes on the heels of several successful decisions on the manufacturer's behalf; including a September 2007 decision in U.S. District Court in Indiana in Tucker v. SmithKline Beecham d/b/a GlaxoSmithKline which similarly granted summary judgment and dismissed on preemption grounds.
In December 2007, King & Spalding successfully argued before the California Second District Court of Appeal that a lower court decision to dismiss Lord v. SmithKline Beecham d/b/a GlaxoSmithKline on summary judgment should be upheld. The lower court found that the prescribing physician in the case did not read the manufacturer's warning before prescribing the drug and refused to adopt a "heeding presumption" that an adequate warning would have been followed. Most recently, the U.S. District Court for the District of Kansas dismissed Vanderwerf v. SmithKline Beecham d/b/a GlaxoSmithKline on January 9. King & Spalding argued successfully on the manufacturer's behalf to exclude the plaintiff's sole expert on causation under Daubert v. Merrell Dow Pharmaceuticals and then moved for summary judgment based on the fact that without this expert's testimony, the plaintiff could not prove its case.
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.
Opinion at 19. Accordingly, the court found "plaintiffs' claims are preempted." Further, the court affirmed that "the record indicates that the type of warning which plaintiffs claim SB/GSK should have included in its Paxil label had been considered and rejected by the FDA because such a warning was not supported by reasonable evidence at the time of " the suicide. Id. at 23-24. And, that:
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.
The decision is significant and precedent setting because it is believed to be the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality. This ruling could potentially lead to the dismissal of similar cases on preemption grounds.
The King & Spalding team representing GlaxoSmithKline consisted of product liability partners Chilton Davis Varner, Andy Bayman, Todd Davis and Halli Cohn, and FDA/Healthcare partner Mark Brown, along with associates Nicole Taylor and Nathan Guest.
Varner, widely considered one of the nation's top product liability litigators, was appointed by the late Chief Justice Rehnquist to the Federal Civil Rules Advisory Committee in 2004, where she assisted in drafting new electronic discovery provisions. Brown, a former Associate Chief Counsel with the FDA, is recognized as one of the nation's most experienced lawyers on a wide range of FDA issues in pharmaceutical and medical device litigation.
The win comes on the heels of several successful decisions on the manufacturer's behalf; including a September 2007 decision in U.S. District Court in Indiana in Tucker v. SmithKline Beecham d/b/a GlaxoSmithKline which similarly granted summary judgment and dismissed on preemption grounds.
In December 2007, King & Spalding successfully argued before the California Second District Court of Appeal that a lower court decision to dismiss Lord v. SmithKline Beecham d/b/a GlaxoSmithKline on summary judgment should be upheld. The lower court found that the prescribing physician in the case did not read the manufacturer's warning before prescribing the drug and refused to adopt a "heeding presumption" that an adequate warning would have been followed. Most recently, the U.S. District Court for the District of Kansas dismissed Vanderwerf v. SmithKline Beecham d/b/a GlaxoSmithKline on January 9. King & Spalding argued successfully on the manufacturer's behalf to exclude the plaintiff's sole expert on causation under Daubert v. Merrell Dow Pharmaceuticals and then moved for summary judgment based on the fact that without this expert's testimony, the plaintiff could not prove its case.
