Medtronic Inc. v. Lohr

PETITIONER: Medtronic Inc.
LOCATION: Virginia Military Institute

DOCKET NO.: 95-754
DECIDED BY: Rehnquist Court (1986-2005)
LOWER COURT: United States Court of Appeals for the Eleventh Circuit

CITATION: 518 US 470 (1996)
ARGUED: Apr 23, 1996
DECIDED: Jun 26, 1996

Arthur R. Miller - Argued the cause on behalf of Medtronic, Inc
Brian Wolfman - Argued the cause on behalf of Lora Lohr, et vir
Edwin S. Kneedler - Department of Justice, argued the cause on behalf of the United States, as amicus curiae, in support of Lora Lohr, et vir

Facts of the case

The Medical Device Amendments of 1976 (MDA) provides for "the safety and effectiveness of medical devices intended for human use," and classifies such devices based on their level of risk. Class III devices pose the greatest risk and, thus, are subject to a rigorous premarket approval (PMA) process. However, two statutory exceptions to this process exist. Because Medtronic, Inc.'s pacemaker is a Class III device found substantially equivalent to a pre-existing device, it can avoid the PMA process. In 1990, Lora Lohr's Medtronic pacemaker failed, allegedly according to a defect. Lohr and her spouse filed a Florida state-court suit, alleging both negligence and strict-liability claims. Medtronic removed the case to federal district court. The court then dismissed the case as pre-empted by 21 USC section 360k(a), which provides that "no State...may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the Act]." Reversing and affirming in part, the Court of Appeals concluded that the Lohrs' negligent design claims were not pre-empted, but that their negligent manufacturing and failure to warn claims were. (This case was decided together with 95-886, Lohr et vir v. Medtronic, Inc.)


Do the Medical Device Amendments of 1976 pre-empt a state common-law negligence action against the manufacturer of an allegedly defective medical device?

Media for Medtronic Inc. v. Lohr

Audio Transcription for Oral Argument - April 23, 1996 in Medtronic Inc. v. Lohr

William H. Rehnquist:

We'll hear argument now in Number 95-754, Medtronic, Inc. v. Lora Lohr and the cross-petition, Lora Lohr v. Medtronic.

Mr. Miller.

Arthur R. Miller:

Mr. Chief Justice and may it please the Court:

This case brings before you the question of defining the scope of the express preemption provision in the Medical Device Amendments of 1976.

Medical devices are a heavily regulated industry.

That has been true since 1976, when the Congress enacted these Medical Device Amendments and brought them under the jurisdiction of the FDA and made it perfectly clear that it was designing a scheme by which the FDA had basic and complete jurisdiction to deal with medical devices.

Indeed, the legislative history said that this preemption provision which is before you this morning acted as a general prohibition on non-Federal regulation.

The provision, which is set out on page 4 of the initial brief, is very, very broad one, almost uniquely broad.

Reduced to what we think are its simplest terms, it basically says that any Federal requirement under the Medical Device Amendments preempts any State requirement which is different from or in addition to the Federal requirement, and which relates to the safety or effectiveness of the device or to any other matter included as a requirement applicable to the device.

Sandra Day O'Connor:

Mr. Miller, is there evidence that you have found that Congress thought it was eliminating all State common law claims and would the action of Congress just last year in proposing, at least, caps on punitive damages but not compensatory damages relating to these devices indicate that at a least Congress thought some claims were preserved?

Arthur R. Miller:

In all honesty, Justice O'Connor, there really is almost nothing in the legislative history.

One can divine from the scope of this provision, its words, its very words, where it uses any requirement, a word that is like all which this court has construed in Norfolk and Western as being very, very broad.

The language of this provision, coupled with the legislative purpose of establishing a unitary, uniform, national regulatory authority under the guidance of statutorily mandated expert advisory committees I think can lead only to the conclusion that the intent of Congress, although not expressed as such in the legislative history, is to preclude anything done by a State within the ambit of a Federal requirement--

William H. Rehnquist:

But the term requirement is by no means self-explanatory.

I mean, I don't think it's self-evidence that requirement means State common law provisions.

Arthur R. Miller:

--That is true, and we have, on the issue of requirement, the fact that 10 courts of appeals have looked at that word.

All except the Ninth Circuit has concluded that the word requirement is broad and, for example, embraces common law claims, a major point made by the plaintiffs in this case.

This Court has construed requirement in Cipollone, it has construed it in Morales, it has construed it in Easterwood.

It has never been construed as a word of restriction.


Mr. Miller--

Arthur R. Miller:

--the statute itself, almost as a leitmotif, continues to use the word requirement not simply in the preemption provision, it uses it in the remedies provision, it uses it in the 510(k) provision, it uses it in the manufacturing design provision--

Antonin Scalia:


--Mr. Miller, your position, as I understand it, is that the preemption provision not only excludes common law actions which seek to impose liability for a mater that is not unlawful under the Federal scheme, but even precludes a State cause of action for a violation of the Federal scheme for an identical requirement.

Arthur R. Miller:

--That is our position.

Antonin Scalia:

I know it is.

Why, then, would you even write this provision?

If that's the case, why wouldn't you just say, there shall be no State common... you know, lawsuits involving these issues, period?

Arthur R. Miller:

We believe that it was necessary to write the provision in this fashion in order to establish the fact that as a precursor to the preemption you had to have a Federal requirement.

Only when you had a Federal requirement, then a State requirement that fell within the subject matter of the Federal requirement would be preempted if it added to or differed from Federal requirements.