Monsanto v. Durnell · ¶53

The Court’s more recent decision in Riegel further confirms that Durnell’s failure-to-warn claim is expressly preempted. In Riegel, the Court addressed the preemption clause in the Medical Device Amendments of 1976, which is nearly identical to FIFRA’s preemption clause. 552 U. S., at 316; see 21 U. S. C. §360k(a). The Medical Device Amendments direct the Food and Drug Administration to approve medical devices for sale after analyzing their safety, just as EPA does for pesticides. 552 U. S., at 318. As part of the premarket approval process, FDA is required to review the device’s label and to determine that the label is neither false nor misleading, as EPA does for pesticide labels. Ibid. And after FDA approves a device, the manufacturer is required to use that label and is prohibited from making any changes to the device or label without additional FDA approval, as is the case with…

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