Defendants’ Distortion of the Fosamax Ruling Fails to Impress the Court

The Supreme Court handed down its ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019 on May 20, 2019.

The day after the Supreme Court Ruled Mass Tort Nexus published our take on the ruling in an article entitled: Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs

It has been apparent that the defense bars takeaway from the Fosamax ruling differed from that of MTN in that almost every defendant in every current pharmaceutical MDL, has threatened to raise a defense sounding in the Supreme Courts ruling in Fosamax, despite the fact that they can not allege that they actually sought approval from the FDA to make a specific change to their warning label, and were the requested permission from the FDA. It appears that the defense bar has interpreted the Fosamax ruling as green lighting future implied impossibility or possibility of impossibility defenses, versus foreclosing on these defenses. It was MTN’s take on the ruling that the Court foreclosed on any theory sounding in implied impossibility or possibility of impossibility defense versus green lighting these defenses for application in other cases.

We are happy to report that at least one Circuit Court, faced with a motion sounding in the defense bars take on the Fosamax ruling, interpreted the SCOTUS jurisprudence in the same manner MTN interpreted the ruling the day after the Supreme Court ruled.

Crockett v. LUITPOLD PHARMACEUTICALS, INC., Dist. Court, ED Pennsylvania 2020
Hypertext the link below to the above
https://scholar.google.com/scholar_case?case=972595979562724211&q=avandia+adequacy+of+warning&hl=en&scisbd=2&as_sdt=40006

In deciding whether impossibility preemption requires the dismissal of a claim, the judge must evaluate the evidence presented and “simply ask … whether the relevant federal and state laws `irreconcilably conflict.'” Merck, 139 S. Ct. at 1679 (quoting Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982)). To put the Court in a position to conduct this evaluation, Defendants must identify the state law at issue (e.g. the requirement that drug manufacturers warn about particular risks of a drug) and the federal law with which it conflicts irreconcilably. To “show[] that federal law prohibited [a] drug manufacturer from adding a warning that would satisfy state law,” the drug manufacturer must demonstrate that (1) “the drug manufacturer fully informed the FDA of the justifications for the warning required by state law” by “submitt[ing] all material information to the FDA[,]” and (2) the FDA “informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1678. Such demonstration must be made with “clear evidence,” i.e., “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1672.

In making a preemption argument, it is not sufficient for the proponent to contend that if it had submitted a new label—with additional warnings—to the FDA, the FDA would have rejected the warning. See PLIVA, 564 U.S. at 624 n.8 (noting that the “possibility of impossibility” is not enough for preemption). In other words, the conflict must be real—”[t]he existence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute.” See Merck, 139 S. Ct. at 1679 (quoting Rice, 458 U.S. at 659).


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