We
recently examined one possible beneficial impact of the Supreme
Court's recent landmark decision in Loper Bright
Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that
it could bring about critical re-examination of the FDA's
questionably supported ban on truthful off-label speech.
Well here's another one:Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996).
We've
already
detailed a number of ways in which Lohr is of
questionable validity: (1) it relied on a presumption against
preemption that has since been repudiated; (2) it addressed an
anachronistic form of device clearance that no longer exists; (3)
Congress revamped device clearance in 1990 to provide preemptive
"reasonable assurance" of "safety"-based
special controls; and (4) Justice Gorsuch had written an opinion
questioningLohrbefore he was elevated to the Supreme
Court.
