Friday, September 14, 2018

[U] Merck's Supremes Brief On "Fosamax® Femur Style" Preemption: "Clear And Convincing" Or Just "Clear"?

We have followed this. . . literally from the jump. A decade's worth, in fact. Merck now asks the Supremes to hold that Wyeth style preemption dismissals require only "clear" evidence that the label change/warning would not have been accepted -- not the tougher standard of "clear and convincing" evidence.

Merck's brief seeking just such a ruling from the Supremes -- related to the now decade-long Fosamax® femur fracture cases -- was filed yesterday (as a decidely hefty 117 page PDF file). Here's a bit (but in all candor, with the court's current "rightward shifting" make-up, I think Merck may well prevail here):

. . . .The Third Circuit nonetheless held that a jury could find that petitioner had not shown by “clear and convincing evidence” that the FDA would have rejected a warning label of the type that respondents claim state law required. . . .

Merck told the FDA what it knew about the link between its drug Fosamax and the risk of atypical femoral fractures; Merck filed a formal request seeking FDA approval to add a warning to Fosamax’s label addressing this risk; and the FDA rejected that request. In Wyeth v. Levine, this Court recognized that a pharmaceutical manufacturer cannot be held liable under state law for failure to warn about a health risk if the FDA would not have permitted the manufacturer to add that warning to its federally regulated label. 555 U.S. 555, 572–73 (2009). But unlike in Levine, here there is no need to guess what would have happened in a counterfactual world. It is clear that the FDA would not have allowed Merck to warn about the risk at issue because the FDA did not allow Merck to warn about it.

The Third Circuit nonetheless concluded that the preemption defense must be put to a jury -- to decide as a counterfactual matter, while applying a unique, heightened standard of proof, whether the FDA might have approved a warning had Merck phrased it differently. That is misguided. The FDA’s final agency action controls the preemption inquiry here as a matter of law. There is no room under either the Supremacy Clause or the federal drug labeling laws to speculate about why the agency blocked compliance with the alleged state-law duty. . . .

It is often said that the party that wins the argument on standard of proof / burden of carrying it -- wins the lawsuit. That adage seems like it will hold, in this one, before the Supremes.

Of course, we will post the plaintiffs' reply brief in late October, when it is filed. Onward -- to federal court asylum seekers' hearings -- on a flawless crystal clear 70 degree end of summer Friday. . . off-grid, through mid-, to end- of day.

[Oh. And just for fun -- here is the Bobby Three Sticks "Crossfire Hurricane" Superseding Information, to which Manafort is copping a plea deal (including complete, and ongoing cooperation), today -- right now, in fact, in DC. The depth and breadth of it means. . . 45 is going "bye-bye" (IMHO). It seems Mr. Mueller is bit-by-bit releasing his Trump Impeachable Offenses / Russian "Report(s)" as a series of sworn federal court filings. Ones to which various Trumpians are pleading. . . guilty. Delicious.]


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