No Surprise: Merck Wins A New Hearing, In The District Courts, On Wyeth Preemption.
May 20, 2019

We’ve been covering this narrative arc pretty steadily for eleven and a half years — both as “Wyeth-style” pre-emption, as enunciated by the Supremes almost a decade ago, and in the Fosamax® femur fracture cases — more generally. [Those links are but three examples — of hundreds of posts here, just search Fosamax.]

This morning, the US Supreme Court agreed with Merck. It did all it could to enhance the Fosamax warnings expected of it, under state law, and the US FDA specifically rejected the warnings, as label copy, under federal law. SO no suit for failure to warn should lie, the Supremes have held [courtesy of the sublime]:

. . . .Thus, in a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it 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 changing the drug’s label to include that warning. These conclusions flow from this Court’s precedents on impossibility pre-emption and the statutory and regulatory scheme that the Court reviewed in Wyeth. See 555 U. S., at 578. . . .

Judgment: Vacated and remanded, 9-0, in an opinion by Justice Breyer on May 20, 2019. Justice Thomas filed a concurring opinion. Justice Alito filed an opinion concurring in the judgment, in which Chief Justice Roberts and Justice Kavanaugh joined. . . .

Now you know — onward, still with a houseful, of adult kids. . . Smile!