Monsanto v. Durnell · ¶74

Last, Durnell’s §136a(f )(2) argument contravenes this Court’s decision in Riegel. In that case, FDA was statutorily authorized to withdraw premarket approval for a medical device based on “newly reported data or existing information.” 552 U. S., at 319. And FDA was obligated to withdraw approval if it “determine[d] that a device is unsafe or ineffective.” Id., at 319–320. But the possibility that FDA could withdraw its premarket approval based on new evidence or new analysis did not preclude this Court from concluding that FDA’s premarket approval imposed “requirements” on manufacturers that preempted state tort suits under the Medical Device Amendments’ materially identical preemption clause. Id., at 322–323.

slip opinion
Source edition
Passage preview. Read in context for the complete text, notes and references.