Thursday, September 14, 2017

Back To The "Power Alley" Of This Blog: FDA & "Preemption", After Wyeth; Merck's Latest Fosamax® Appeals

We have covered -- on and off -- nearly the entire preemption FDA waterfront, starting now almost a decade ago -- all of which led to the Supremes' decision in Wyeth v. Levine. And we have covered a recent interim win, for Merck's opponents -- the Fosamax® plaintiffs -- in the federal appellate courts sitting over New Jersey -- here. That is the Third Circuit.

[Thoughts from a decidedly pro-industry, but very able, blogger may be found here. My backgrounders, by way of slight but substantial contrast, from June 2016, here, and a prior April 2014 one, is here. This matter -- as much as any other -- has also been the subject of at least $100 million of lobbyist efforts, industry wide, over the last decade or so. So it is a cause of particular moment -- as preemption all but closes the court house doors on many, many would be drug products liability class action suits. The most recent Merck prior Third Circuit opinion, in full, is under that link.]

And so we arrive at a moment where the Supremes are being asked to weigh in -- again. Here's a bit, from the current Merck cert. petition before the Supremes, now -- a bit:

. . . .Wyeth v. Levine, 555 U.S. 555 (2009), rejected an argument that the FDA’s mere approval of a drug’s label immunizes the manufacturer from any state tort liability for failure to warn. Rather, only if the FDA would have rejected a warning should the manufacturer be shielded from liability for failure to give it. In the latter scenario, it would truly be impossible to comply with both federal law (blocking the warning) and state law (mandating the warning). In Levine, however, there was no evidence that the FDA had paid more than “passing attention” to the risk at issue; no evidence that the drug manufacturer had provided the FDA with “evaluation or analysis” of the risk; no evidence that the manufacturer had “attempted to give the kind of warning” demanded by the plaintiff; and no evidence that the FDA had ever “made an affirmative decision” against allowing such a warning. Id. at 572-73.

In this case, by contrast, each of those factors is undisputed. Petitioner (“Merck”) submitted data and analysis to the FDA suggesting that its Fosamax drug may be associated with certain bone fractures. Merck also proposed a warning addressing that risk. After back-and-forth, the FDA ultimately rejected the proposed addition, stating that it was not supported by the data. Pet.App.59a-61a. Despite all of this, the Third Circuit held that respondents’ failure-to-warn claims were not legally preempted, because it believed that a jury could infer that the FDA’s objection had been only to Merck’s wording, and thus, as a “hypothetical” matter, that the agency might have approved the warning had it merely been phrased slightly differently. . . .

Unfortunately, the decision below is not unique in its hostility to preemption. Despite Levine’s recognition that preemption would be appropriate if the FDA would have rejected the label demanded by the plaintiff, courts have erected a series of procedural and substantive hurdles to this defense, making it virtually impossible to establish, certainly as a matter of law. This case presents a particularly extreme illustration, with the court inventing a “clear and convincing evidence” standard exclusively for drug manufacturers, demanding “smoking gun” proof of why the FDA had rejected Merck’s on-point warning, and leaving a lay jury to speculate about the intent of a federal regulatory authority. This Court should grant certiorari to revive failure-to-warn branded drug preemption in the wake of the lower courts’ interpretation of Levine. . . .

I certainly think additional clarity would be helpful -- and it is clear that Merck's fact pattern -- in these New Jersey MDL Fosamax® cases -- offers industry a very strong probability of expanding the limits on class action suits announced by the Supremes in Wyeth. So do stay tuned. With Justice Gorsuch firmly in his seat, and taking an activist's "pro-business interests" role -- I suspect the high court will take this case. . . and I additionally suspect the outcome will not be very good for would-be plaintiffs. It ought to be pretty good for Kenilworth though. Now you know -- both five years, and a full decade on. . . . Onward.


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