Krauss in Washington Post: Momentous Supreme Court Decision

Professor Michael Krauss told the Washington Post that last month's Riegel v. Medtronic was "the most momentous Supreme Court product liability decision in some time." Krauss's comments were carried in an article examining whether state lawsuits filed on behalf of individuals allegedly injured by pharmaceutical drugs and medical devices interfere with the Food and Drug Administration's federal regulatory scheme.

The Supreme Court found in Riegel that the FDA had approved the medical device at the heart of the case and its labeling through its extensive premarket approval process and therefore held that a state court claim was barred by federal law.

Leave It to the FDA, The Washington Post, March 15, 2008. By James Copland.

"Medtronic argued that whatever the law of New York, the FDA had approved the device's design and labeling -- the very question at issue -- under its extensive premarket approval process. And the Medical Device Amendments of 1976 specifically states that once a device has gone through that approval process, states may not 'establish or continue in effect ... any requirement ... which is different from, or in addition to, any requirement applicable under [federal law] to the device.'

"With such explicit preemption language, the Supreme Court found it easy to determine, by a viote of 8 to 1, that the Riegels' state tort claim was barred by federal law. The decision will not apply to all medical devices but rather only those that, like the catheter, are 'Class III' devices subject to the FDA's most rigorous testing procedures. Also, individuals can still sue if they can show that the device was manufactured in noncompliance with the design approved by the FDA, or if the FDA determines that the company committed fraud in the application process.

"In its second major preemption case, Warner Lambert v. Kent, the Supreme Court last week deadlocked 4 to 4 (Chief Justice John Roberts had recused himself). The court simply let the lower court decision stand without any written decision or even an indication of where each justice stood.

"Court watchers interested in preemption are therefore anxiously awaiting a case scheduled for this fall, Wyeth v. Levine, which promises to define the scope of preemption doctrine for FDA-approved products apart from the medical devices covered in Riegel. Levine involves a state 'failure-to-warn' claim: Wyeth's FDA-approved label noted the risk of Levine's injury, but the plaintiff argues that the label could have been stronger or more specific and that the FDA's label was merely a 'floor.'

"Thus, the court must decide whether Levine's claim is preempted by the FDA's extensive review and approval of pharmaceutical labeling. The case is more difficult than Riegel in part because the Food, Drug and Cosmetic Act contains no express preemption provision, so the court can reject Levine's failure-to-warn claim only if it determines that the federal regulatory scheme preempts such lawsuits. How the justices will rule in Levine is anyone's guess."

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