“While most federal and state courts that have considered similar arguments have concluded that the premark-et approval process satisfies the FDA’s preemption rule and preempts state common-law claims, we agree with the court in [Ken nedy v. Collagen Corp., 67 F.3d 1453, 1458-1459 (9th Cir.1995), cert. denied, 518 U.S. 1033, 116 S.Ct. 2579, 135 L.Ed.2d 1094 (1996) ] that these courts have failed to consider whether Class III medical devices as a group can constitute a ‘particular device’ within the FDA’s understanding of that term.”
How later courts described this case
- “While most federal and state courts that have considered similar arguments have concluded that the premark-et approval process satisfies the FDA’s preemption rule and preempts state common-law claims, we agree with the court in [Ken nedy v. Collagen Corp., 67 F.3d 1453, 1458-1459 (9th Cir.1995), cert. denied, 518 U.S. 1033, 116 S.Ct. 2579, 135 L.Ed.2d 1094 (1996) ] that these courts have failed to consider whether Class III medical devices as a group can constitute a ‘particular device’ within the FDA’s understanding of that term.”
- noting that “[s]tate common law is a law of general applicability”
- claims not preempted because premarket approval process not specific requirement applicable to particular device
Written by the judges who cited it.
Distinguished
Distinguished by Kraft v. Detroit Entertainment, LLC, 683 N.W.2d 200 (2004)
Id. at 709, 712-713, 552 N.W.2d 679. Walker is distinguishable from the present case.
Distinguished by Kraft v. Detroit Entertainment, LLC, 261 Mich. App. 534 (2004)
Id. at 709, 712-713. Walker is distinguishable from the present case.
The opinion
Griffin, J.
(concurring). I concur in the result. In my view, Medtronic, Inc v Lohr, 518 US _ ; 116 S Ct *722 2240 ; 135 L Ed 2d 700 (1996), is controlling. The rationale of Medtronic resolves the present issue whether 21 USC 360k(a) preempts state tort claims of breach of implied warranty, negligent design, and failure to warn arising from the use of medical devices that were subjected to the premarket approval process. For the most part, the majority’s analysis is moot in light of Medtronic, supra.