PLIVA, Inc. v. Mensing - Oral Argument - March 30, 2011

PLIVA, Inc. v. Mensing

Media for PLIVA, Inc. v. Mensing

Audio Transcription for Opinion Announcement - June 23, 2011 in PLIVA, Inc. v. Mensing

Audio Transcription for Oral Argument - March 30, 2011 in PLIVA, Inc. v. Mensing

John G. Roberts, Jr.:

We'll hear argument first this morning in Case 09-993, Pliva, Incorporated v. Mensing, and the consolidated cases.

Mr. Lefkowitz.

Jay P. Lefkowitz:

Mr. Chief Justice, and may it please the Court:

This case involves the ordinary operation of the Supremacy Clause.

As the government agrees, Hatch-Waxman's plain text requires generic drugs to have the same warnings as their brand-name equivalents, so State law can't require generic drugs to use different warnings.

After all, generics can't simultaneously comply with a Federal duty to be the same and a State duty to be different.

John G. Roberts, Jr.:

Well, that makes a lot of sense, but we do have our Wyeth decision that seems to cut the other way.

Jay P. Lefkowitz:

Well, Your Honor, the Wyeth decision is premised on the fundamental conclusion that Federal law obligates and accommodates the brand manufacturer to utilize a specific regulation, the CBE regulation, in order to make a warning change, in order to comply with its obligations under 201.57.

And, as the government agrees, we don't have the opportunity or the authority to use a CBE regulation change.

Ruth Bader Ginsburg:

But you have another -- you have another route, and that's what the government is telling us: That you could propose a revision of the label, and if you did that, then you would be home free.

You would not be subject to the State suit.

Jay P. Lefkowitz:

Justice Ginsburg, the government agrees with us that we can't actually change the label.

What they say is, we could have an obligation, or they actually, in -- for the very first time ever in their brief in this Court at the merit stage, said that there is a--

Ruth Bader Ginsburg:

No, it was in the -- at the cert stage as well.

Jay P. Lefkowitz:

--Well, Your Honor, I didn't read the cert stage as saying we had quite the same duty to ask the FDA, although clearly they now believe that we have a duty to ask the FDA.

And of course that's not a duty that appears in any of their notice and comment rulemaking.

Anthony M. Kennedy:

Can we call this the take steps -- is this the take-steps doctrine, for purposes of discussion here?

Jay P. Lefkowitz:

Yes, Justice Kennedy, this is the take-steps.

Anthony M. Kennedy:

It's not clear to me whether you say that that is preempted or just that it was not well-pled.

I'm not -- I'm not sure of your position on that point.

Jay P. Lefkowitz:

Thank you, Justice Kennedy.

We maintain that a claim that under State law a generic company can be liable for not asking the FDA to make a labeling change is preempted under this Court's decisions both in Buckman and in ArkLa, because what the -- what the Court has said is that the disclosure obligations between a Federal agency and a Federally regulated party are inherently Federal in character, and this is not a subject of traditional State tort law.

Elena Kagan:

Well, Mr. Lefkowitz, why should--

Antonin Scalia:

Would the -- excuse me, Justice.

Would the Federally licensed drug manufacturer have a similar obligation to lobby the FDA for a change?

Jay P. Lefkowitz:

No, Your Honor, and in fact that was in part what was -- what came up in the briefing in the Wyeth case.

Wyeth initially said it didn't have the obligation and couldn't use the CBE, and then Ms. Levine said: Well, in that case you could have asked the FDA to make a change, and the Court didn't need to even address that issue, because the Court found that there actually was a regulation on point that gave the brand manufacturer the ability to change.

Antonin Scalia:

But assume there hadn't been.

Assume there hadn't been such a regulation.

Do you understand it to be the government's position that the licensed drug manufacturer is not protected from State suits, even though it has a Federal permission to give certain warnings, unless it has lobbied the FDA to change those warnings?