Late last year we highlighted steps the Food and Drug Administration (FDA) made in 2017 to reestablish its authority as uniform regulator of drugs and medical devices. That role, we explained, was in danger due to the ever-increasing list of state tort and consumer-protection lawsuits brought by plaintiffs’ attorneys on behalf of private litigants. In the post, we examined three instances where FDA independently stepped in to ongoing litigation to advance arguments supportive of regulatory uniformity.
In one instance, FDA submitted an amicus brief to the Third Circuit in a case where the plaintiff alleged that the manufacturer of his artificial hip promoted the device illegally. In its brief, FDA emphasized that the Food, Drug & Cosmetic Act (FDCA) expressly preempted state-law claims that would impose “different or additional requirements on approved devices.” Because each of the plaintiffs’ claims challenged the safety and effectiveness of an approved device, FDA argued that any state-law claim would “impose additional requirements” and was thus preempted by the FDCA.
In its March 1, 2018 opinion in Shuker v. Smith & Nephew, PLC, the Third Circuit agreed with FDA. Holding that the plaintiffs’ claims “would impose non-parallel state law requirements,” the appellate court found the state-law claims preempted.
The Third Circuit’s decision is just another example of the importance of FDA’s role as uniform regulator. Hopefully FDA’s current leadership will continue to lead the way in ensuring the consistency that all consumers expect when making choices about their medical products.