Duvall v. Bristol-Myers-Squibb Co.

• Decision Date: 25 September 1995
• Docket Number: BRISTOL-MYERS-SQUIBB,No. 94-1520,94-1520
• Citation: 65 F.3d 392
• Parties: , 27 UCC Rep.Serv.2d 1190, Prod.Liab.Rep. (CCH) P 14,352 Eugene DUVALL; Patricia Sue Duvall, Plaintiffs-Appellants, v.COMPANY, a Delaware Corporation; Medical Engineering Corporation, a/k/a Surgitek/Medical Engineering Corporation, Defendants-Appellees. Food & Drug Administration, Amicus Curiae.
• Court: U.S. Court of Appeals — Fourth Circuit

Page 392

65 F.3d 392

64 USLW 2197, 27 UCC Rep.Serv.2d 1190,

Prod.Liab.Rep. (CCH) P 14,352

Eugene DUVALL; Patricia Sue Duvall, Plaintiffs-Appellants, v. BRISTOL-MYERS-SQUIBB COMPANY, a Delaware Corporation Medical Engineering Corporation, a/k/a Surgitek/Medical Engineering Corporation, Defendants-Appellees Food & Drug Administration, Amicus Curiae.

No. 94-1520.

United States Court of Appeals Fourth Circuit.

Argued Nov. 1, 1994.

Decided Sept. 25, 1995.

ARGUED: Gary Lester Wilson, Robins, Kaplan, Miller & Ciresi, Minneapolis, MN, for appellants. William James Murphy, Murphy & Shaffer, Baltimore, MD, for appellees. ON BRIEF: Bruce Finzen, Robins, Kaplan, Miller & Ciresi, Minneapolis, MN; David B. Shapiro, Baltimore, MD; Lewis J. Saul, Bethesda, MD, for appellants. Robert T. Shaffer, III, Murphy & Shaffer, Baltimore, MD; John F. Brenner, McCarter & English, Newark, NJ, for appellees.

Before WIDENER and WILKINS, Circuit Judges, and MICHAEL, United States District Judge for the Western District of Virginia, sitting by designation.

Affirmed in part and reversed and remanded in part by published opinion. Judge WILKINS wrote the opinion, in which Judge WIDENER and Judge MICHAEL joined.

OPINION

WILKINS, Circuit Judge:

Eugene Duvall appeals a decision of the district court granting summary judgment to Bristol-Myers Squibb Company (Bristol-Myers) ¹ on the basis that Duvall's claims are preempted by 21 U.S.C.A. Sec. 360k (West Supp.1995), enacted as a part of the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act. ² We affirm the district court with respect to the majority of Duvall's claims. However, because we conclude that Sec. 360k does not preempt Duvall's express warranty claim to the extent that it may be based on Bristol-Myers' voluntarily-made representations regarding its product, we reverse in part and remand for further proceedings.

I.

In 1990, Duvall underwent surgery to implant a penile prosthesis as treatment for erectile impotence. The prosthesis, a "Surgitek Uni-Flate 1000," was manufactured and marketed by Bristol-Myers. The device ultimately failed and was explanted two years later. Duvall filed suit against Bristol-Myers in state court, claiming breach of express warranty; breach of implied warranties of merchantability and fitness for a particular purpose; strict liability for defective design, defective manufacture, and failure to warn; and negligence in design, manufacture, marketing, testing, promotion, and sale. Bristol-Myers removed the action to federal court on the basis of diversity of citizenship.

The district court, noting its recent decision in Griffin v. Medtronic, Inc., 840 F.Supp. 396 (D.Md.1994) (holding that the MDA preempted state-law claims involving a medical device marketed after premarket approval), appeal docketed, No. 94-1219 (4th Cir. Feb. 23, 1994), granted Bristol-Myers' motion for summary judgment, ruling that all of Duvall's state-law claims were preempted by Sec. 360k of the MDA. The material facts are not in dispute, and the issues before us are questions of law subject to de novo review. Higgins v. E.I. DuPont de Nemours & Co., 863 F.2d 1162, 1166-67 (4th Cir.1988).

II.

Congress established a scheme for comprehensive regulation of medical devices in the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. Mendes v. Medtronic, Inc., 18 F.3d 13, 14 (1st Cir.1994). The MDA authorizes the Food and Drug Administration (FDA) to classify medical devices intended for human use into three categories "based on the degree of regulation necessary to assure safety and effectiveness." Id.; see 21 U.S.C.A. Sec. 360c (West Supp.1995). Class I devices, such as tongue depressors, which do not present an unreasonable risk of illness or injury, are subject only to general controls. 21 U.S.C.A. Sec. 360c(a)(1)(A); 21 C.F.R. Sec. 880.6230 (1994). Class II devices, such as bone-conduction hearing aids, for which "general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device," are subject to special controls. 21 U.S.C.A. Sec. 360c(a)(1)(B); 21 C.F.R. Sec. 874.3300 (1994). Class III devices are those devices: (1) for which there is insufficient information to determine that the controls applicable to Class I and II devices are alone enough to provide reasonable assurance of the safety and effectiveness of the device; and (2)(a) that are to be used for "supporting or sustaining human life" or that are "of substantial importance in preventing impairment of human health" or (2)(b) that "present[ ] a potential unreasonable risk of illness or injury." 21 U.S.C.A. Sec. 360c(a)(1)(C). This class of devices is subject to the most stringent MDA controls. See King v. Collagen Corp., 983 F.2d 1130, 1131 (1st Cir.) (Torruella, J.), cert. denied, --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993). Class III devices include implantable pacemakers and replacement heart valves. 21 C.F.R. Secs. 870.3610, 870.3925 (1994). Penile inflatable implants are classified as Class III medical devices. 21 C.F.R. Sec. 876.3350 (1994).

In order to market a Class III device, a manufacturer generally must obtain premarket approval from the FDA. Premarket approval requires submission of a detailed application, including clinical data, manufacturing processes, and proposed labeling, see 21 U.S.C.A. Sec. 360e(c) (West Supp.1995), and is intended "to provide reasonable assurance of [the] safety and effectiveness" of the device, 21 U.S.C.A. Sec. 360c(a)(1)(C). In the case of a Class III device for which the FDA does not yet require premarket approval, the manufacturer may market the item after showing that it is "substantially equivalent" to a device marketed before the effective date of the MDA. See 21 C.F.R. Sec. 807.100(a) (1994); Mendes, 18 F.3d at 14-15. To do so, 90 days before marketing a device a manufacturer must submit a premarket notification, known as a 510(k) Notification, including specified information; the FDA must then clear the device for marketing. 21 U.S.C.A. Sec. 360(k) (West Supp.1995); 21 C.F.R. Secs. 807.87, 807.90, 807.100 (1994).

Bristol-Myers' prosthesis reached the market through the substantial equivalence process. Upon completion of clinical trials of the device under an investigational device exemption (IDE), see 21 U.S.C.A. Sec. 360j(g) (West Supp.1995), Bristol-Myers submitted a 510(k) Notification that included information relating to the design and engineering of the device, clinical studies under the IDE, the similarity of the device to other penile prostheses marketed before passage of the MDA, and proposed packaging, labeling, and use instructions. At the FDA's request, Bristol-Myers supplied additional information on sterilization techniques, testing protocols, design of specific components of the device, package inserts, indicated uses, and fluid requirements. The FDA later cleared the device for marketing.

III.

Duvall argues that his state-law claims are not preempted by Sec. 360k for two reasons. He first maintains that Sec. 360k preempts only state-imposed requirements with respect to medical devices that are different from or additional to those of the MDA and that because common-law claims do not impose requirements, they are not preempted. Although we agree with Duvall that Sec. 360k preempts only state-imposed requirements, we cannot agree that common-law claims are not requirements within the meaning of Sec. 360k. Second, Duvall contends that even if Sec. 360k preempts state requirements imposed by judicial decision, any requirements applicable to Bristol-Myers' prosthesis under the MDA do not give rise to preemption.

A.

The doctrine of preemption is based on the Supremacy Clause of the United States Constitution. U.S. Const. art. VI, cl. 2. ³ It has been clear since M'Culloch v. Maryland, 7 U.S. (4 Wheat.) 316, 4 L.Ed. 579 (1819), that a state law is invalid to the extent that it conflicts with federal legislation. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 515-16, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992) (plurality). However, preemption should not be found too readily; " 'the historic police powers of the States [are] not to be superseded ... unless that [is] the clear and manifest purpose of Congress.' " Id. (alteration in original) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)).

A federal law preempts a state law in any of several situations. For example, state law is preempted when Congress expressly so provides, see Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309-10, 51 L.Ed.2d 604 (1977); when federal regulation of a legislative field is so comprehensive that there is no room for supplementary state regulation, see Rice, 331 U.S. at 230, 67 S.Ct. at 1152; or when the state law is in actual conflict with a federal provision, see Pacific Gas & Elec. Co. v. State Energy Resources Conservation & Dev. Comm'n, 461 U.S. 190, 204, 103 S.Ct. 1713, 1722, 75 L.Ed.2d 752 (1983). Because Congress included an express preemption provision in the MDA, we need address only the scope of the statutory language. See Cipollone, 505 U.S. at 517-18, 112 S.Ct. at 2618 (inclusion of an express preemption provision implies that matters beyond the reach of the provision are not preempted).

Section 360k of the MDA provides in pertinent part:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C.A. Sec. 360k(a). ⁴ The language of this section expressly...