Kennedy v. Collagen Corp.

• Decision Date: 27 November 1995
• Docket Number: No. 94-15197,94-15197
• Citation: 67 F.3d 1453
• Parties: , 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.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 1453

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:

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 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' failure to present sufficient evidence of causation, the district court granted Collagen's original motion for summary judgment. This Court affirmed the decision of the district court in June 1992, but later granted the Kennedys' petition for rehearing, withdrew its earlier decision and reversed the district court. Kennedy v. Collagen, 967 F.2d 587 (9th Cir.1992), withdrawn, 974 F.2d 1342 (9th Cir.1992), cert. denied, --- U.S. ----, 113 S.Ct. 3037, 125 L.Ed.2d 724 (1993).

The present appeal stems from Collagen's motion for summary judgment filed on remand to the district court. In its second motion for summary judgment, Collagen asserts that all of the Kennedys' claims are preempted by the MDA, 21 U.S.C. Sec. 360k(a). The district court granted Collagen's motion, finding that the Kennedys' claims are preempted under Sec. 360k(a). This appeal timely followed.

On appeal, the Kennedys make two arguments. First, they contend that Sec. 360k(a) only preempts state law to the extent that state law establishes additional or divergent requirements for a particular medical device. Because neither the state common law nor the FDA has established any specific requirements unique to Zyderm, the Kennedys assert, their state common law claims are not preempted. In addition, the Kennedys assert that the state common law, pursuant to which they are suing, is a law of general applicability and therefore specifically not preempted by the MDA.

II. DISCUSSION

I. Standard of Review

This court reviews the district court's grant of summary judgment on a pure question of law, in which there are no disputed facts, de novo. Turner v. Prod, 707 F.2d 1109, 1114 (9th Cir.1983).

II. History of The MDA

The MDA was enacted largely in response to the public outcry following the injuries suffered in the 1960s and early 1970s by women using the Dalkon Shield contraceptive device. See Ministry of Health v. Shiley, 858 F.Supp. 1426, 1434 (C.D.Cal.1994). Federal investigations in the wake of the Dalkon Shield injuries confirmed that the "pace of the [medical device] industry far exceeded the FDA's ability to control it." Id. at 1434 (quoting Susan Barlett Foote, Loops and Loopholes: Hazardous Device Regulation Under the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, 7 Ecology L.Q. 101, 102-103 (1978)).

Congress subsequently passed the MDA in order "to assure the reasonable safety and effectiveness of medical devices intended for human use." H.Conf.Rep. No. 1090, 94th Cong., 2d Sess. reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1103. The MDA gives the FDA broad powers to classify and regulate medical devices. Under the MDA, the FDA must assign a medical device to one of three statutorily delineated categories. Class I devices are those devices which pose little or no threat to public health. They are subject to only general requirements concerned with their manufacture. Tongue depressors are one example of a Class I medical device. See 21 U.S.C. Sec. 360c(a)(1)(A); 21 C.F.R. Sec. 860.3(c)(1). Class II devices include items such as tampons and oxygen masks. Use of Class II devices involves some risk of injury and, as a result, the FDA establishes performance standards, postmarket surveillance programs and guidelines for their use. See 21 U.S.C. Sec. 360c(a)(1)(B); 21 C.F.R. Sec. 860.3(c)(2).

Class III devices are those devices which are implanted in the body or which pose a potentially unreasonable risk of injury. See 21 U.S.C. Sec. 360c(a)(1)(C); 21 C.F.R. Sec. 860.3(c)(3). They include Zyderm, as well as pacemakers, heart valves and replacement joints. Because of their inherent dangerousness, Class III devices are subject to the most stringent FDA regulation. All Class III devices are required to obtain premarket approval prior to being released for sale and use. 21 U.S.C. Sec. 360e; 21 C.F.R. Sec. 814.1(c).

In order to attain premarket approval, the manufacturer of a Class III device must submit all of its information on any investigations concerning the device's safety or effectiveness, a statement of the intended use of the product, a description of the expected manufacturing process, and any other requested information to the FDA. 21 U.S.C. Secs. 360e(c)(1)(A)-(G); 21 C.F.R Secs. 814.20(b)(2)-(12). Prior to approval by the FDA, the existence of an application for approval may not be publicly disclosed unless it has previously been publicly disclosed or acknowledged. 21 C.F.R. Sec. 814.9(b). There is no opportunity for public comment or for any public challenge to the information presented to the FDA by the device manufacturer.

III. General Preemption Principles

The principle of federal preemption of state law derives from Article VI of the Constitution, the Supremacy Clause. Article VI establishes the laws of the United States as "the supreme Law of the Land ... any Thing in the constitution or Laws of any state to the Contrary notwithstanding." Art. VI, cl. 2.

Federal law can preempt state law in one of two ways. Congress may either explicitly state its intent to preempt state law in the language of a statute or Congress may imply its intent to preempt through the structure and purpose of a statute. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977). Implicit preemption can itself take two forms. Congress may either occupy a field by passing a statutory scheme so extensive that it covers an entire legislative field or Congress may enact a federal law which makes compliance with a state law impossible. Fidelity Federal Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982).

Where Congress has made its intent to preempt explicit in a statute, the Supreme Court has held that:

'there is no need to infer congressional intent to preempt state laws from the substantive provisions' of the legislation ... Congress' enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not preempted.

Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517-18, 112 S.Ct. 2608, 2618, 120 L.Ed.2d 407 (1992) (citations omitted). Therefore, the question to be answered in instances of express preemption is the extent to which Congress intended to preempt state law.

Regardless of the form preemption takes, the Supreme Court has consistently imposed a strong presumption against preemption.

Consideration of issues arising under the Supremacy Clause 'start with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.'

Cipollone, 505 U.S. at 515-16, 112 S.Ct. at 2617 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). In its most recent decision on preemption, the Supreme Court held that the Employee Retirement Income Security Act of 1974 ("ERISA"), 29 U.S.C. Sec. 1001 et seq. (1988 ed. and Supp. V), did not preempt a New York law requiring hospitals to add "surcharges on bills of patients whose commercial insurance coverage is purchased by employee health-care plans governed by ERISA, and [requiring] ... surcharges on HMOs, insofar as their membership fees are paid by an ERISA plan." N.Y. Conference of Blue Cross v. Travelers Ins., --- U.S. ----, ---- - ----, 115 S.Ct. 1671, 1673-74, 131 L.Ed.2d 695 (1995). In N.Y. Conference, the Court reaffirmed that even a preemption provision in an expansive statutory scheme such as ERISA must be read narrowly, especially in areas of historic state concern such as health and safety. Id. at ----, 115 S.Ct. at 1676.

Similarly, in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), the Court applied the presumption against preemption to uphold a state punitive damage award in the face of comprehensive federal legislation addressing nuclear safety. In Silkwood, the Court noted the tension its holding created between federal legislation to regulate nuclear safety and a...