We've reviewed the transcript of the oral argument in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.), e.g., the United States Supreme Court appeal from the horrible decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), which we ranked as the worst case in all of 2017. Our one sentence reaction – We'd rather be us than them.
The Fosamax plaintiffs have a lot of problems with their position in Albrecht, chief among them that the FDA itself, as amicus curiae in this case, disputes their interpretation of what the Agency knew and did.
Briefly, plaintiffs argued that: (1) the FDA's rejection of the defendant's "stress fracture" warning was because stress fractures and the injury at issue in the litigation – now called "atypical femur fractures" (or "AFF" for short) − were two different things; (2) the FDA only rejected the imprecise term "stress fracture," and didn't reject an AFF warning, and (3) the rest of the regulatory record consists of FDA "musings" that plaintiffs are free to contradict and juries would be free to disregard. Albrecht Tr. at 35-38, 42-44, 61-63.
Equally briefly, defendant argued that: (1) its rejected "stress fractures" warning encompassed AFF (a term only created later), demonstrated by language about "complete" and "non-traumatic" fractures; (2) the FDA's rejection was based on insufficient data about AFF, since a short time later the Agency set up a task force to study AFF before changing labels for this drug class (bisphosphonates); and (3) the FDA does not simply reject scientifically valid warnings for grammatical reasons. Albrecht Tr. at 3-5, 10-12, 16-19, 65-66.
The FDA, represented by the Solicitor General's office, agreed with the defendant's depiction of its regulatory actions regarding AFF, arguing that the Agency obeyed the law and did not reject the defendant's label for imprecise language, but rather because the link between AFF and bisphosphonates was not supported by sufficient scientific data at the time Albrecht Tr. at 20-22, 27-30.
At the oral argument another problem for the plaintiffs was evident: Justice Stephen Breyer. A member of the majority in Wyeth v. Levine, 555 U.S. 555 (2009), and an anti-preemption dissenter in the more recent PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), decisions, Justice Breyer is a "must get" vote for plaintiffs in Albrecht. They don't have him:
JUSTICE BREYER: I'm leading to this, that, when you talk about the standard, drugs are important to people. They cure millions, or thousands, anyway, of people who need to be cured or helped.
Now, when you put on, and at the same time there will be a smaller subset that can be hurt, so our solution to that is labels.
Now, when you say displacing state law or something, you're talking like a lawyer, which is what you're supposed to do, but what worries me is, if you go too far in allowing the tort jury to find mislabeling by not including things, you are hurting the vast majority of − of women here or −or whatever who can benefit from this medicine.
On the other hand, if you don't go far enough, you will hurt that minority. Now that's the general framework in which I'm trying to figure out the answer to the question. And that's why Justice Gorsuch's question was − was quite relevant.
All the earmarks here are that Merck took this as a letter saying we're not certain enough this is really going to hurt people and we don't want you to put it on.
Now, obviously, somebody must have picked up the phone when they got that letter and they must have phoned somebody in FDA and say: Do you really mean that? What do you mean? Because I can change those words, "stress fracture," in two seconds. Or do you mean you don't know enough about it?
Now the appointment of the later task force suggests that they felt they didn't know enough about it, and, therefore, Merck couldn't have done it.
Albrecht Tr. at 40-41 (emphasis added). That wasn't so much a question as it was a speech, and one that we very much applaud. But that's not all.
JUSTICE BREYER: . . . But what's actually bothering me about the approach that you're taking is that, in this particular area, in this particular area of medicines, I don't really see how we're going to benefit by 50 different states really giving different signals to the manufacturers, and I can see a lot of ways in which, from a health point of view, we're going to lose.
That doesn't mean the law is wrong. It doesn't mean − you know, it's just a question of emphasis. And, here, we have an emphasis.
The next page from the one you cited, the FDA says in 2010, FDA's review of the data did not show an increase in this risk, the relevant risk, in women using these medications.
So there are indications in this record . . . that they thought that it is more dangerous to put the label − to put the risk in the label than it is to leave it out. . . . And then they set up a task force and decide they were wrong.
Albrecht Tr. at 51-52 (emphasis added) (attempts by plaintiffs' counsel to get a word in edgewise omitted).
To us defense counsel, these comments by Justice Breyer were the highlight of the argument.
We were also paying attention to Justice Gorsuch, a conservative, but known skeptic of the administrative state, who might not have much deference to the FDA's actions. Indeed, Justice Gorsuch had some tough questions for defense counsel about creating a "moral hazard" that might encourage submission of "inartful" warnings, about the availability of unilateral CBE warning changes, and about when "new information" existed. Albrecht Tr. at 13, 18-19. But in each instance, counsel provided persuasive answers: (1) that the FDA's actions belied any such "moral hazard" here; (2) that CBE scientific support standards are identical to the pre-approval process the defendant used; and (3) that new evidence in this instance meant the findings of the FDA task force announced shortly after Agency's rejection of the warning at issue. Id. at 13-14, 18-19. If skeptical of the FDA, Justice Gorsuch didn't show it, not speaking during the SG's argument. Justice Gorsuch's later comments, during the plaintiffs' argument, were clearer:
We have, though, the March 2010 safety statement from the FDA which pretty clearly says that they do not think that there is science enough to support a causal link between the drug and atypical femoral fractures.
So whatever was missing in the complete response letter from the FDA seems to come in March of 2010.
Albrecht Tr. at 34-35.
[T]hat's why it [the FDA] set up the task force at the same time to go study the issue, and it said up to that point we don't have enough, but we're going to go study it. . . . And so why isn't that − tell us everything we need to know about what its complete response letter was about, as a matter of law?
Id. at 36-37.
As for the two specific holdings that the Third Circuit made in Fosamax – that "clear evidence" means preemption is decided under a "clear and convincing evidence" standard, and that determining what the FDA would have done is a question for the jury – the first was, surprisingly, not mentioned at all. Since plaintiffs abandoned this argument in their briefing, it will be interesting to see what (if anything) the Court holds about the standard of proof. The judge/jury issue received some scrutiny during the plaintiffs' argument, with plaintiffs backpedaling furiously in response to a question from Justice Alito.:
We agree with Merck that, because of the complete response letter . . . was a legal document that a judge can interpret. We believe that, based on a sound interpretation of the letter, it doesn't prove impossibility.
Albrecht Tr. at 58-59. Then the some other justices got into the discussion, after plaintiffs tried to have it both ways, with the remarkable statement that "the warning that the FDA has to reject has to be adequate to address the risks under state law." Id. at 59. Then was what the FDA had to do a legal question (for the judge) or a factual question (for the jury)?
JUSTICE KAGAN: . . . But that's the question. And that's a legal question, is that correct?
[Plaintiffs' Counsel]: It is a legal that question, but it has factual components.
JUSTICE KAGAN: But a judge can decide that question.
[Plaintiffs' counsel] : A judge can decide the core legal question, but in all constitutional questions, there are usually fact issues, and we consign those to juries to decide what the fact issues....
JUSTICE BREYER: Not always. There are a lot of mixed issues where, because they're predominantly legal, the judge does it; patents, for example, Markman [v. Westview Instruments, Inc., 517 U.S. 370 (1996)] is a case of that, and does coerced confessions. I mean, there are a number. . . . It seems to me that this is in that number because it's predominantly a legal question and there could be factual disputes on the brute [sic] facts. But, here, I don't think there are really.
Id. at 59-60 (plaintiffs' counsel's attempt to get a word in edgewise omitted). If, in the end, both Justices Kagan and Breyer are skeptical of the idea of preemption/FDA actions as a jury question as they seemed at the oral argument, then the defendant will prevail on this issue as well.
Finally, we'd be remiss not to mention the plaintiffs' "swing and a miss," where counsel missed a softball from Justice Sotomayor so badly that the Justice had to provide the right answer:
JUSTICE SOTOMAYOR: Well, we know that the FDA − assuming the theory that the FDA doesn't believe the label is adequate, what could they have done −
[Plaintiffs' Counsel]: They could −
JUSTICE SOTOMAYOR: − absent the study?
[Plaintiffs' Counsel]: They –
JUSTICE SOTOMAYOR: Meaning because the study obviously changed the FDA's mind. You're saying, you, [defendant], could have done it.
[Plaintiffs' Counsel]: Yes. . . .
Albrecht Tr. at 57. When that happened to Rick Perry, his response was "Oops." At least counsel recovered to answer the question more thoroughly.
Justice Ginsburg was absent, and Justice Thomas, as usual, asked no questions. The usual split would have Justice Ginsburg voting against preemption and Justice Thomas voting for it.
Anyway, we're not in the business of predicting Supreme Court results. But all in all, after the oral argument, I'd much rather be on our side than not.
This article is presented for informational purposes only and is not intended to constitute legal advice.
