Pliva, Inc. v. Mensing (09-993)
argument 09-993Pliva, Inc. v. Mensing
Supreme Court of the United States
1h 1m
5 speakers
8 chapters
transcribed 5 days ago
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What is the Supreme Court’s central issue in Pliva v. Mensing regarding the Supremacy Clause and Hatch‑Waxman?
We'll hear argument first this morning in case zero nine nine nine three, PLEVA Incorporated versus Mencing and the consolidated cases. Mr. Lefkowitz?
Mr. Chief Justice, and may it please the Court, this case involves the ordinary operation of the Supremacy Clause. As the government agrees, Hatchwaxman'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.
Well that makes a lot of sense, but there we do have our Wyath decision that seems to cut the other way.
Well Your Honor uh The WIS 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. But you have another you have another route and that's what the 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. 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
No, it was in the it was in the in the at the cert stage as well. Well, Your Honor, I I I didn't read the third 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 noticeable comments rules. Can we call this the take step is this the take steps doctrine for for purposes of discussion here? Yes, Justice Kennedy. It is not clear to me whether you say that that is preempted or just that it was not well pled. I I'm not I'm I'm not sure of your position on that point. 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 labelling change is preempted under this Court's decisions, both in Buckman and in Arkla. Because what the govern 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. Would the uh uh federally licensed drug manufacturer Have a similar obligation. To uh lobby the FDA for a change? No, Your Honor. And in fact, um that was in part what was what came up in the briefing in the Wyatt 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
Grand manufacturing the ability to change. Assume there hadn't been. Uh assume there hadn't been such a regulation. Do you understand it to be the government's position? that uh the the licensed uh drug manufacturer is not uh protected from state suits. uh even though uh it it has a federal uh permission to give certain warnings. Unless it has lobbied the FDA to change those warnings. Your Honor, I I don't see anything uh in the history, the twenty-seven year history of Hatchwaxman, where the Federal Government has ever said that there is a legal obligation to lobby the FDA for a labelling change.
Excuse me. There there is a legal obligation to advise the FDA when you have reports of adverse results that suggest the label may be wrong. Are you disavowing your your obligation to tell the FDA when something is wrong?
Absolutely not just. So please
describe what the difference between That obligation and the obligation to suggest a label change when you know it has been misbranded?
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Chapters
8 chapters
1
What is the Supreme Court’s central issue in Pliva v. Mensing regarding the Supremacy Clause and Hatch‑Waxman?
0:01–8:49
2
How do the parties argue whether generic manufacturers have a federal duty to request label changes from the FDA?
8:49–16:39
3
What role do the Buckman and Arkla decisions play in the pre‑emption analysis?
16:39–25:33
4
How does the Court address the question of state‑law failure‑to‑warn claims versus federal FDA obligations?
25:33–32:42
5
What evidence is presented about the FDA’s process for reviewing and approving labeling revisions?
32:42–38:56
6
How do the arguments consider the economic impact of imposing a labeling‑change duty on generic drug makers?
38:56–46:50
7
What is the significance of the “impossibility” pre‑emption defense in this case?
46:50–54:17
8
How do the justices and counsel conclude the debate over federal pre‑emption versus state liability?
54:17–1:01:47