The Federal District Court for the Northern District of California recently ruled that the FDA’s premarket approval (“PMA”) process for Class III devices does not preempt state law causes of action.  Notmeyer v. Stryker Corp., C.A. No. C 06-04096 (Aug. 6, 2007).

In the case, the plaintiff brought state law strict liability, negligence, breach of warranty, misrepresentation, concealment and consumer protection claims after his prosthetic hip replacement system shattered, requiring further surgery.  The manufacturer of the prosthesis sought summary judgment, arguing that the plaintiff’s state law claims were preempted by the FDA’s PMA process.  The court denied summary judgment, finding no preemption based upon its conclusion that the PMA process does not establish the sort of specific requirements for a particular medical device necessary to support preemption under the MDA.  Rather, the court ruled, the PMA process requires only that the device meet general (not product-specific) FDA requirements, which do not require preemption under the MDA.

The Medical Device Amendments (“MDA”), a 1976 amendment to the Food, Drug, and Cosmetic Act, gave the FDA authority to regulate medical devices.  Under the MDA’s regulatory scheme, a manufacturer seeking to introduce to the market a “Class III” medical device — one that poses a potential unreasonable risk of illness or injury, or that is purported to sustain life or prevent impairment of human health (such as the prosthesis) — must submit the device to an exhaustive PMA that takes an average of 1,200 hours for the FDA to complete.  In addition, devices that are “substantially equivalent” to pre-existing devices may be approved by a much faster “510(k)” process.  The MDA explicitly preempts any “state law requirements” that differ from FDA requirements regarding specific products.

In 1996, in Medtronic, Inc. v. Lohr, 518 U.S. 470, the United States Supreme Court considered whether the abbreviated 510(k) approval process preempts state law causes of action.  A majority of the Justices agreed that a state law cause of action does constitute a “state law requirement” of the sort preempted by the MDA.  However, a majority of the Justices also held that the 510(k) process does not preempt state causes of action because it does not establish specific regulations with respect to a particular device.  The Supreme Court’s decision left open the question whether the more extensive PMA process does establish such specific regulations sufficient to preempt state law causes of action.

The ruling in Notmeyer is the latest in a series of federal court decisions following Medtronic to address this open question.  To date, six circuit courts have examined the issue.  Of those six, five – the Second, Third, Fifth, Sixth, and Seventh – have held that the full PMA process creates FDA requirements for a particular device, preempting state law causes of action.  The Eleventh Circuit has disagreed, reasoning that, because the MDA resulted from several highly publicized incidents involving defective medical devices, it would be inconsistent to assume that Congress sought to bar parties injured by similar incidents from seeking relief.  The Notmeyer court endorsed the Eleventh Circuit’s rationale, but also found that a finding of no preemption was required by the Ninth Circuit’s pre-Medtronic decision in Kennedy v. Collagen Corp., 67 F.3d 1453 (1995).

A full copy of the Notmeyer decision is available here.  The manufacturer’s motion to certify the question for interlocutory appeal was subsequently denied on September 10, 2007, meaning that the Ninth Circuit will not have an opportunity to review the trial court’s holding until after trial.