Defining the Domain of Medical Device Preemption
(Medtronic V. Lohr 518 U.S. 470, 1996)

Briefed by: Nancy E. Isaac, Esq.

Abstract

In 1996, the Supreme Court addressed the scope of medical device preemption originally granted in Section 360k(a) of the 1976 Medical Device Amendments (MDA). Federal District Courts throughout the country were interpreting the clause to mean anything from total preemption to no preemption. In this case, the Court decided that 510(k) notification and general manufacturing and labeling requirements were not enough for preemption of the claims brought by the Lohrs but that sometimes the MDA will preempt a state law tort suit.

History

In 1987, Lora Lohr received a Medtronic pacemaker, equipped with Model 4011 pacemaker leads, to ensure the proper functioning of her heart. Approximately three years later the device failed, allegedly resulting in a “complete heart block” that required emergency surgery. Ms. Lohr’s physician felt that the failure was likely attributable to a defective lead. The pacemaker was a pre-1976 Class III device found substantially equivalent under the 510(k) process.

The Lohrs sued Medtronic in Florida state court in 1993 alleging negligence and strict liability. Their complaint contained both negligence and strict liability counts. Medtronic removed the case to Federal District Court, where it filed a motion arguing that the claims made by the Lohrs were preempted by 21 U.S.C. 360k(a). At first the District court denied Medtronic’s motion concluding that nothing in the MDA completely exempted Medtronic from liability noting also that Medtronic had violated FDA regulations. Later the Eleventh circuit concluded that 360k required a preemption of at least some common law claims and all of the Lohrs’ counts were dismissed. The Court of Appeals reversed in part and affirmed in part. The court found that the Lohrs’ negligent design claims were not preempted but the negligent manufacturing and failure to warn claims were. Medtronic filed a petition with the Supreme Court seeking review of the part of the decision affirmed by the District Court. The Lohrs cross petitioned the part of the judgment that upheld the preemption defense.

Findings

A state law will be preempted only to the extent that the FDA has promulgated a relevant federal “requirement,” that is, a “device-specific enactment of positive law” by an administrative or legislative body.*

Negligent design claims are not preempted – A 510(k) is not comparable to a PMA in that, under 510(k), Medtronic’s pacemaker was not required to take any particular form for any particular reason. The FDA’s substantially equivalent determination alone does not amount to a specific, federally enforceable design requirement. The focus of a 510(k) is equivalence, not safety. SE provides little protection to the public.

Manufacturing and labeling claims are not preempted – Preemption occurs only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be “with respect to” medical devices and “different from or in addition to” federal requirements. They must also relate “to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device . . .” They must be “specific” to a “particular device.” The manufacturing and labeling claims at issue here reflect generic concerns about generic regulations, not the sort of concerns regarding a specific device.

Justice Breyer added that the MDA will sometimes preempt a state tort law suit. For example, a standard of care or behavior imposed by a state tort law action could reasonably be a “requirement.”

Results

  1. The 510(k) process does not preempt liability or negligent design claims.
  2. Grand-fathered Class III devices that undergo 510(k) review are not formally reviewed under the MDA for safety or efficacy and also do not preempt state tort claims.
  3. State requirements of general applicability are not preempted except where they have the effect of establishing a “substantive requirement” for a specific device.
  4. The Federal requirements must be applicable to the device in question and, according to the regulations, can preempt state law only if they are specific counterpart regulations or specific to a particular device.
  5. General duties of manufacturing and labeling are not the type of requirements that Congress envisioned for 360k.
  6. It will be rare if any common law duties will be preempted by this statute. (Justice Breyer did not think the cases of preemption would be that rare. Justice O’Connor, in her dissent, stated she found that manufacturing and labeling requirements were specific enough to preempt state common law claims.)

Conclusions

While it is still unclear when state tort claims are preempted under 360k(a), it has been decided that undergoing a 510(k) is not enough, even for Class III devices. Labeling and manufacturing requirements, unless specific for a particular device, are also not enough to preempt state tort claims.

FDA published a draft rule on December 12, 1997 proposing to amend its regulation regarding preemption. In a very narrow interpretation of 360k, FDA proposed that PMA or IDE does not, by itself, have preemptive effect. FDA feels there is preemption only when it has expressly imposed a substantive requirement to a specific medical device and a state common law imposes a substantive requirement to the same medical device that is different from or in addition to the federal one.

* The use of mandatory standards may constitute a specific device requirement.