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Fiore v. Collagen Corp.6/25/1996
, with a reference to the date of enactment, promulgation, or issuance in final form . . . if the requirement has been subject to any judicial or administrative interpretations, the State or political subdivision shall furnish copies of such judicial or administrative interpretations.
(Emphasis added.) Nothing in this regulation suggests court decisions are regarded as a source of requirements. 642 N.E.2d at 213. A narrow interpretation of "requirements" tends to support Judge Reinhardt's interpretation of "court decisions" in 21 C.F.R. ยง 808.1(b) as comprehending "only . . . those court decisions that adopt special rules applicable to medical devices." Kennedy, 67 F.3d at 1461 (Reinhardt, J., Concurring).
In urging the courts to reconsider and to stop barring claims of persons injured by medical devices, Adler and Mann conclude: "Preemption of product liability claims . . . is misplaced--at least without . . . a precise plan for offsetting approaches to protect consumers. Innovation without protection hardly improves the lives of our citizens and, . . . the FDA by itself simply cannot provide an adequate source of safety to the public from dangerous medical devices." Adler & Mann, (supra) , 59 Mo. L. Rev. at 945.
In Kennedy, the Ninth Circuit has taken a well-grounded step to assure injured persons an avenue of redress for injures resulting from medical devices, and we join it. We reverse the judgment below and remand this matter for further proceedings consistent with this opinion.
PHILIP E. TOCI, Judge
Concurring
JOE W. CONTRERAS, Presiding Judge
SHELDON H. WEISBERG, Judge
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