by Matthew A. Reed
Washington Legal Foundation
May 20, 2013
A growing number of courts have held that medical devices marketed pursuant to the Food and Drug Administration’s rigorous pre-market approval process are so heavily regulated by the federal government that nearly all state law claims regarding such devices are preempted, expressly or impliedly, by federal law. In Caplinger v. Medtronic, Inc., the plaintiff attempted to “preemption-proof” her state law claims by alleging that Medtronic engaged in “off-label promotion” of its medical devices. The federal district court dismissed the plaintiff’s complaint anyway, holding that, while such allegations might allow a few of her claims to escape express preemption, they were still impliedly preempted. In so doing, the court relied upon a logical construction of the Supreme Court’s much-debated implied preemption doctrine in Buckman Co. v. Plaintiffs’ Legal Committee, which other courts facing similar “off-label” allegations, and seeking to give full preemptive force to FDA regulatory authority, would do well to follow.



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