Medtronic Inc. v. Lohr Page 2

Medtronic Inc. v. Lohr general information

Media for Medtronic Inc. v. Lohr

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

Arthur R. Miller:

It seems to me it's a rational... maybe not the best, but a rational way of writing it to achieve Congress' goal of establishing primary jurisdiction in the FDA.

Antonin Scalia:

What if I bring a lawsuit saying that the device, although it was marketed under, what is it, 310(k) as being substantially identical to a preexisting device was, in fact, not, and that the application claiming that substantial equivalence was intentionally fraudulent, and therefore for violation of that 310(k) provision I want damages.

What additional requirement has that added?

What different or additional requirement has the State added when it allows that suit?

Arthur R. Miller:

Two preliminary points, Justice Scalia.

Number 1, there is no such claim in this case.

Number 2, several courts of appeals have struggled with questions like that and have agreed unanimously that the preemption provision embraces identical State claims or claims of noncompliance with the FDA requirements or even claims of fraud on the FDA, the most notable being a First Circuit--

William H. Rehnquist:

So there's no possible action in State court against the manufacturers of these devices?

Arthur R. Miller:

--There could be actions if they do not fall within the ambit of a Federal requirement.

William H. Rehnquist:

But so far as the Federal requirement, the State can't impose its own common law and it can't permit suit on the Federal requirement.

That's an extraordinary sweep.

Arthur R. Miller:

Well, Mr. Chief Justice, the reason that I think it's a perfectly appropriate conclusion is, number 1, the act itself provides for no Federal private right of action, so the notion--

Antonin Scalia:

Do you think that helps you?

I say, even worse.

Not only do you not allow a State cause of action, you allow it in a situation where there's no Federal cause of action.

Arthur R. Miller:

--That does not leave the situation remediless.

The bargain, or--

Ruth Bader Ginsburg:

Mr. Miller, before you proceed with your answer to that, I'd like to know what is within the coverage.

I understand that you're arguing about these devices that are substantially equivalent.

Does your argument go as well to the grandparented devices?

Are they, too, immune from tort liability if there is a Federal requirement?

Arthur R. Miller:

--Justice Ginsburg, if a matter being asserted in a State-based action falls within a Federal requirement, it seems to us the text of this statute precludes it.

Ruth Bader Ginsburg:

So your answer is, this covers devices that have not been preapproved... indeed, the grandparented devices have never been... gone through the 510(k) procedure, never been through any procedure.

Arthur R. Miller:

Let me clarify something.

There is an image that the pre-'76 devices are unregulated.

Counsel for the plaintiffs and the Solicitor General have indicated that there's never been a safety and effectiveness determination with regard to the 510(k) products.

Two points.

If you look at the appendix we have put in the back of our reply brief, you will see that basically every medical device on the marketplace is regulated.

It is simply wrong to assume that there are devices out there that are unregulated, that are... to use the pejorative word, that have been grandfathered, or grandpersoned.

The truth is, even a pre-'76 device, Justice Ginsburg, when it comes onto the market, must comply with the good manufacturing practices.