The plaintiffs’ bar has long sought to impose duties under state law on doctors and manufacturers anytime there is an off-label use of a medical device. In Riegel v. Medtronic, the Supreme Court held that states may provide a damages remedy for any claims that “parallel” federal requirements, so long as such an award does not interfere with the federal regulatory scheme.
In a case that will be of keen interest to the medical device industry, the Ninth Circuit recently ruled that such common law claims for off-label use against the manufacturer of a pre-market approved (PMA) medical device are impliedly preempted.
In Perez v. Nidek Corp., a putative class action plaintiff filed suit on behalf of patients who received LASIK surgery for farsightedness between 1996 and 2006. Plaintiffs sued a group of eye surgeons and Nidek Co. Ltd., the manufacturer of a PMA surgical laser, for allegedly failing to inform patients that the laser used to perform their surgery was not specifically approved to treat far-sightedness. (Nidek had provided the surgeons with replacement chips, which would modify the lasers to treat farsightedness).
Dismissing the suit, the 9th Circuit panel held that the plaintiffs’ common law fraud claims invaded the authority of the FDA and thus were impliedly preempted by federal law governing medical devices. Specifically, the appeals court found that the state law claims were in conflict with the Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act. Relying on the Supreme Court’s holding in Riegel, the court rejected plaintiffs’ efforts to impose a duty on physicians and manufacturers to inform patients of any off-label use as little more than an attempt “to write in a new provision to the FDCA.”
The full opinion is available here.