Drug Manufacturer Fails To Meet The Levine "Clear Evidence" Preemption Test
MASON v. SMITHKLINE BEECHAM (February 23, 2010)
Two days after twenty-three year old Tricia Mason began taking an antidepressant drug manufactured by defendant, she committed suicide. Mason's parents sued the manufacturer, alleging that it was negligent for not warning of an increased suicide risk. The district court granted summary judgment to the defendant, holding that the claims were preempted by federal law. The Masons appeal.
In their opinion, Circuit Judges Evans and Sykes and District Judge Simon reversed and remanded. The Court noted that conflict preemption was the type of preemption at issue in the case. The Supreme Court addressed conflict preemption in Levine, which was decided a year after the district court granted summary judgment. In Levine, the Supreme Court rejected the argument that state law failure-to-warn claims were generally preempted as a result of the FDA's drug labeling responsibilities. The Supreme Court stated that preemption could exist if a drug manufacturer presented "clear evidence" that the FDA would have rejected the proposed warning in the label but held that preemption did not exist in Levine. Since the Supreme Court did not clarify what it meant by "clear evidence," the Court simply compared the administrative history of the defendant's drug with the drug at issue in Levine. After that comparison, the Court concluded that the defendant had not met the burden established by Levine.
