Merck Sharp & Dohme Corp. v. Albrecht (17-290)
argument 17-290Merck Sharp & Dohme Corp. v. Albrecht
Supreme Court of the United States
1h 3m
6 speakers
8 chapters
transcribed 5 days ago
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What is the central legal issue in Merck Sharp & Dohme v. Albrecht?
We'll hear argument first this morning in case seventeen two hundred ninety, Merck, Sharp and Dome versus Albrecht. Mr. Dvoravsky?
Mr Chief Justice, and may it please the Court. Respondents' expressed theory is that the FDA, fully informed of the risk of atypical femoral fractures, ignored that risk and its own statutory and regulatory responsibilities because it didn't like the way Merck phrased its proposed warning. That cannot be right. If a manufacturer, as Merck did here, informs the FDA of a possible risk and unsuccessfully asks to revise its label in light of that risk. then failure to warn claims based on that risk are preempted as a matter of law. That rule follows from the statutory and regulatory framework governing the FDA's conduct, and from the presumption of regularity. The presumption of regularity, of course, assumes that federal agencies do their jobs correctly.
The FDA's job in this case includes protecting the public health by working with manufacturers to revise drug labels when necessary.
Mr. Dvoretsky, um me give you a a a hypothetical because I I think we can could all agree that if you had proposed a warning But let me just say major s major fractures versus stress fractures. And if you had proposed a warning, that dealt with major fra fractures And the FDA had said no, we don't think that the literature supports that. then there's nothing you can do and you should be immune from any suit. I think that that's pretty clear. The question is sort of you know, did did you propose a different kind of warning? So let me give you a hypothetical. Suppose that You manufacture a drug. And uh there's some evidence whether it's enough, hard to know, but there's some evidence that it causes ovarian cancer.
And you, the drug manufacturer, uh proposes a warning to the FDA, but instead of saying that the drug causes ovarian cancer, You say it causes ovarian cysts. No, ovarian cysts are nothing that anybody wants to have, but They're an inconvenience. They're not ovarian cancer. And the FTA says Uh no, we don't think that that's the issue at all. Does that mean that you're off the hook now with respect to revising your label? To say that your product causes ovarian cancer?
I don't think that you're necessarily off the hook in that situation because you haven't warned about the relevant risk. But in our case, there's no question that Merck did warn about the relevant risk. The United States has told us that that is how the FDA understood the warning. The Third Circuit acknowledged that Merck proposed to warn about atypical femoral fractures, and you have to look at the context in which this warning came about. Okay,
so that makes it a much smaller case, right? That we can agree on things on either side. We can agree that if the FDA said to you uh uh uh you don't have to warn against major fractures. You are off the hook. And on the other hand, we can agree if the FDA rejected a warning that had nothing to do with the thing that was really at risk. You're not off the hook. And then the whole question boils down to What was your proposal? What was their response? Were you both talking about the same things? In other words, were you both talking about major risks? Or Did the FDA look at your proposal and say They're not talking about major fractures, they're only talking about stress fractures, and there's no reason to think that stress fractures are a real risk, and no reason to put that
in the label.
I don't think that is quite right, Justice Kagan, because you have to look not only at the warning that was proposed, but also at the information that was in front of the FDA about the risk. And this is where, again, the FDA's complete response letter has to be understood in light of the FDA's statutory obligations. Under 35504 The the Secretary is obligated if it believes that something should be included in the lab included in the label of the warning, it shall promptly have a back and forth with the manufacturer.
But you see that's that that's the reason I asked that question about the ovarian cancer and the ovarian cysts, because I think you could say on a on a on something like that, well look
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Chapters
8 chapters
1
What is the central legal issue in Merck Sharp & Dohme v. Albrecht?
0:00–7:01
2
How does the FDA’s “presumption of regularity” affect preemption of failure‑to‑warn claims?
7:01–16:25
3
What hypothetical did counsel use to illustrate the difference between major and stress fractures?
16:25–24:09
4
How did the parties argue about the meaning of “stress fracture” versus “atypical femoral fracture”?
24:09–34:29
5
What does the Complete Response Letter say about Merck’s proposed warning language?
34:29–40:43
6
How do statutory provisions (35 U.S.C. § 35504) shape the FDA’s duty to work with manufacturers?
40:43–49:11
7
What concerns did counsel raise about a potential moral‑hazard from manufacturers overwhelming the FDA?
49:11–56:03
8
What is the Court’s ultimate question about whether the FDA’s actions made label changes impossible?
56:03–1:03:18