Charlotte Kennedy and Robert L. Kennedy v. Collagen Corporation

67 F.3d 1453 64 USLW 2265 , Prod.Liab.Rep. (CCH) P 14,377 , 95 Cal. Daily Op. Serv. 8114 , 95 Daily Journal D.A.R. 13 ,953, 95 Daily Journal D.A.R. 15 ,589 Charlotte KENNEDY and Robert L. Kennedy, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, Defendant-Appellee. No. 94-15197. United States Court of Appeals, Ninth Circuit. Argued and Submitted Aug. 8, 1995. Decided Oct. 17, 1995. As Amended Nov. 27, 1995. Clinard Hanby, Michael M. Essmyer & Associates, Houston, Texas, for plaintiffs-appellants. Joe W. Redden, Jr., Beck, Redden & Secrest, Houston, Texas, for defendants-appellees. Appeal from the United States District Court for the Northern District of California. Before: FERGUSON, REINHARDT and THOMPSON, Circuit Judges. Opinion by Judge FERGUSON; Concurrence by Judge REINHARDT. FERGUSON, Circuit Judge: 1 In this appeal, Charlotte and Robert Kennedy challenge the district court's grant of summary judgment in favor of defendant, Collagen Corporation ("Collagen"). The Kennedys contend that their state common law claims are not preempted by the Medical Device Amendments of 1976 ("the MDA"), 21 U.S.C. Secs. 360c-360l (Supp.1995), and that genuine issues of material fact remain…

Opinion by Judge FERGUSON; Concurrence by Judge REINHARDT.

In this appeal, Charlotte and Robert Kennedy challenge the district court’s grant of summary judgment in favor of defendant, Collagen Corporation (“Collagen”). The Kennedys contend that their state common law claims are not preempted by the Medical Device Amendments of 1976 (“the MDA”), 21 U.S.C. §§ 360c-3601 (Supp.1995), and that genuine issues of material fact remain in issue in their suit against Collagen. We reverse the district court and remand for trial.

I. BACKGROUND

This action arises out of Charlotte Kennedy’s treatment with Zyderm Collagen Implant (“Zyderm”), a prescription medical product manufactured by defendant Collagen. Zyderm is used by physicians to treat soft tissue defects of the skin caused by disease, trauma, congenital defects, or aging. Following Charlotte Kennedy’s treatment with Zyderm, she developed systemic lupus erythematosus (“SLE”), an autoimmune disease.

Upon contracting SLE, Charlotte and Robert Kennedy brought suit against Collagen alleging negligence, strict liability, breach of warranty, battery, conspiracy and loss of consortium. Based on the Kennedys’ *1455 failure to present…

concurring:

I join fully in Judge Ferguson’s opinion for the court. I write separately to clarify further the meaning of the word “requirement” as it is used in 21 U.S.C. § 360k(a). The Medical Device Amendments of 1976 (the “MDA”) preemption provision states:

21 U.S.C. § 360k(a).

The first reference to “requirement” is to requirements imposed by states or local entities, while the second and third references are to federal requirements imposed under the MDA. It is the meaning of the first “requirement” — state or local requirements applicable to medical devices — that is at issue here.

Some courts have concluded that the term “requirement” as it relates to state or local regulation includes state common law of general applicability. These courts have either accepted that view without explanation, relied on a plurality holding endorsing the proposition in a different context in Cipollone v. Liggett Group, Inc., 505 U.S. 504 , 112 S.Ct. 2608 , 120 L.Ed.2d 407 (1992), or read 21 C.F.R. § 808.1 (b) in isolation from the rest of § 808.1. 2 As discussed in Judge Ferguson’s opinion for the court, the dicta and occasional holdings of the courts that have concluded that the MDA…