Steele

Federal preemption is a relatively simple concept, especially when Congress has explicitly provided the terms of preemption. (See Brown v. Hotel Employees (1984) 468 U.S. 491, 500-501 [ 104 S.Ct. 3179, 3184-3185 , 82 L.Ed.2d 373, 382-383 ].) It provides order. Instead of having 50 or more standards with respect to a given human pursuit, there is one. When a preemptive federal standard is applied evenhandedly, it provides both the protection of the federal standard and some leeway to develop further state standards where the federal standard does not apply. With respect to medical devices that represent the highest risk to human life, the federal government imposes standards specific to each of those devices, and Congress has declared that the federal standard is preemptive.

Plaintiff Patricia Steele sued defendant Collagen Corporation, the maker of Zyderm Collagen Implants, because she developed an autoimmune disorder after receiving a test injection of Zyderm. The trial court concluded that all of her causes of action were preempted and granted Collagen Corporation’s motion for summary judgment. We reverse and remand because, even though there is an applicable federal…

I concur in the reversal of the summary judgment. However, I disagree with the majority opinion because it misreads or ignores the relevant text of Medtronic, Inc. v. Lohr (1996) 518 U.S. _ [ 116 S.Ct. 2240 , 135 L.Ed.2d 700 ] (Medtronic), with which five justices agree.

The majority opinion reverses the summary judgment granted Collagen on the ground it failed to show that “Zyderm was designed, manufactured, and labeled according to the specifications approved by the FDA.” (Maj. opn. ante, this page.) With this much I agree. However, this implies that the only ground upon which the product may be challenged is for lack of conformity with the FDA specifications. This amounts to a claim that the premarket *1491 approval of a device occupies the field relating to the device, precluding state regulations which differ from the specifications. Curiously, it reaches this conclusion by reading Medtronic from the point of view of the dissent.

The proper test of preemption of state tort actions of general applicability, consistent with Justice Breyer’s concurring views and part V of the plurality opinion, is that the Medical Device Amendments of 1976 (MDA) preempts a state law tort…

Federal preemption is a relatively simple concept, especially when Congress has explicitly provided the terms of preemption. (See Brown v. Hotel Employees (1984) 468 U.S. 491, 500-501 [ 104 S.Ct. 3179, 3184-3185 , 82 L.Ed.2d 373, 382-383 ].) It provides order. Instead of having 50 or more standards with respect to a given human pursuit, there is one. When a preemptive federal standard is applied evenhandedly, it provides both the protection of the federal standard and some leeway to develop further state standards where the federal standard does not apply. With respect to medical devices that represent the highest risk to human life, the federal government imposes standards specific to each of those devices, and Congress has declared that the federal standard is preemptive.

Plaintiff Patricia Steele sued defendant Collagen Corporation, the maker of Zyderm Collagen Implants, because she developed an autoimmune disorder after receiving a test injection of Zyderm. The trial court concluded that all of her causes of action were preempted and granted Collagen Corporation's motion for summary judgment. We reverse and remand because, even though there is an…