Medical device preemption decision issued

A day late and hopefully not a dollar short. I have had limited computer internet access for the past two days.

Naturally, as these things go, yesterday, on a day that I was traveling and unable to get to a computer to post, the Supreme Court issued its highly anticipated decision in Reigel (read here). Some comments.   More to follow later.

Speaking for the Court, Justice Scalia was clear: Medical devices that have received pre-market approval (Class III devices) are entitled to preemption protecting the product from state court tort claims. The decision was 8 – 1, with Justice Ginsburg dissenting. Justice Stevens concurred in part, and most importantly concurred with respect to the concept that state tort law imposes different and additional requirements to the federal regulatory scheme. Thus, on this critical issue, the Court’s opinion was 8 -1.

The law of the land is now clear. Unlike the opinion in the Lohr case, the Reigel opinion is not fractured and split. Of course, in Lohr, the Court rejected preemption for Class II medical devices, which undergo a less intensive FDA review and ultimately achieve approval premised on a finding of substantial equivalence.

Any state law tort claims ‘different than, or in addition to’ FDA rules are now barred under Reigel. However, as Justice Scalia expressly observed, the plaintiff’s bar has been left with an out – state laws which “provid[e] a damages remedy for claims premised on a violation of FDA regulations” are ‘parallel’ requirements and not different requirements, and thus are not preempted. We can expect that the plaintiff’s bar will now recast claims as to Class III devices into claims that the FDA regulations were not followed. This will be a more limited volume of cases, but it will not prevent the mass tort, aggregation of claims. Until the parameters of this exception articulated by the Court have been tested in the courts, the high volume cases will continue to place large risks on medical device companies. It will be interesting to see how this plays out.

Justice Ginsburg’s dissent observes that the Court’s decision in Reigel does not address the situation of what happens if a defect in a Class III device becomes apparent only after the device has been approved. It seems to me that if that happens, and if the FDA regulations pertaining to handling the ‘defect’ once it becomes apparent still boils down to whether the device company follows federal law in connection with dealing with the defect. If it does not follow the FDA regulatory scheme, it is exposed under the exception to the preemption doctrine articulated by Justice Scalia.

I have to go run to a meeting, and will post further about my thoughts on this important decision, and what it bodes for the Kent v. Warner Lambert case that will be dealt with by the Court later in this Term.

As I have written before, the preemption wars continue.