Duvall v. Bristol-Myers-Squibb Co.

• Decision Date: 18 December 1996
• Docket Number: Nos. 94-1520,BRISTOL-MYERS-SQUIBB,96-1358,s. 94-1520
• Citation: 103 F.3d 324
• Parties: , 31 UCC Rep.Serv.2d 1002, Prod.Liab.Rep. (CCH) P 14,808 Eugene DUVALL; Patricia Sue Duvall, Plaintiffs-Appellants, v.COMPANY, a Delaware Corporation; Medical Engineering Corporation, a/k/a Surgitek/Medical Engineering Corporation, Defendants-Appellees, and Food & Drug Administration, Amicus Curiae. Eugene DUVALL; Patricia Sue Duvall, Plaintiffs-Appellants, v.COMPANY, a Delaware Corporation; Medical Engineering Corporation, a/k/a Surgitek/Medical Engineering Corporation, Defendants-Appellees.
• Court: U.S. Court of Appeals — Fourth Circuit

Page 324

103 F.3d 324

65 USLW 2487, 31 UCC Rep.Serv.2d 1002,

Prod.Liab.Rep. (CCH) P 14,808

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,

and

Food & Drug Administration, Amicus Curiae.

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.

Nos. 94-1520, 96-1358.

United States Court of Appeals, Fourth Circuit.

Argued Oct. 29, 1996.

Decided Dec. 18, 1996.

ARGUED: David Benjamin Shapiro, Baltimore, Maryland, for Appellants. Peter Rolf Maier, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C., for Amicus Curiae. Robert T. Shaffer, III, Murphy & Shaffer, Baltimore, Maryland, for Appellees. ON BRIEF: Lewis J. Saul, Washington, D.C.; Bruce A. Finzen, Gary L. Wilson, David S. Toepfer, Robins, Kaplan, Miller & Ciresi, Minneapolis, Minnesota, for Appellants. Frank W. Hunger, Assistant Attorney General, Lynne Ann Battaglia, United States Attorney, Douglas N. Letter, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.; Margaret Jane Porter, Chief Counsel, Beverly Rothstein, Food and Drug Administration, Rockville, Maryland, for Amicus Curiae. William James Murphy, Murphy & Shaffer, Baltimore, Maryland; John F. Brenner, McCarter & English, Newark, New Jersey, for Appellees.

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

OPINION

WILKINS, Circuit Judge:

These appeals require us to consider anew the effect of the express preemption provision contained in the Medical Device Amendments of 1976(MDA), Pub.L. No. 94-295, 90 Stat. 539, on Eugene Duvall's state-law causes of action against Bristol-Myers-Squibb Company and its wholly owned subsidiary, Medical Engineering Corporation (collectively, "Bristol-Myers"). ¹ See 21 U.S.C.A. § 360k(a) (West Supp.1996). In light of the recent decision of the Supreme Court in Medtronic, Inc. v. Lohr, --- U.S. ----, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), we hold that § 360k(a) does not preempt Duvall's claims. We also conclude, however, that the district court correctly granted summary judgment to Bristol-Myers on Duvall's assertion that statements allegedly made to Duvall by a representative of Bristol-Myers constituted an express warranty. Accordingly, we affirm in part, reverse in part, and remand for further proceedings.

I.

In 1990, Duvall was implanted with a penile prosthesis manufactured and marketed by Bristol-Myers. The prosthesis never functioned to Duvall's satisfaction, and eventually Duvall had it removed. Thereafter, Duvall filed suit against Bristol-Myers in Maryland state court, alleging claims for breach of express warranties; breach of implied warranties of merchantability and fitness for a particular purpose; strict liability for defective design, defective manufacture, and failure to warn; and negligent design, manufacture, marketing, promotion, and sale. Bristol-Myers removed the action to federal court on the basis of diversity of citizenship.

The district court granted summary judgment to Bristol-Myers on the basis that all of Duvall's claims were preempted by § 360k(a). On appeal, we affirmed in part, reversed in part, and remanded. See Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir.1995) (Duvall I ). We held that the plain language of § 360k(a) mandated preemption of the majority of Duvall's state-law claims. See id. at 396-400. But, we reversed the grant of summary judgment on the express warranty claims and remanded for further proceedings, concluding that § 360k(a) preempted an express warranty claim only "to the extent that [the claim] is based on FDA-mandated labeling, packaging, and advertising." Id. at 401. Duvall then filed a petition for a writ of certiorari seeking review by the Supreme Court, which granted the writ, vacated our opinion in Duvall I, and remanded for further consideration in light of its decision in Medtronic. See Duvall v. Bristol-Myers-Squibb Co., --- U.S. ----, 116 S.Ct. 2575, 135 L.Ed.2d 1090 (1996) (mem.). While Duvall's petition for a writ of certiorari was pending before the Supreme Court, the district court granted summary judgment to Bristol-Myers on the express warranty claims, and Duvall appealed that ruling to this court.

We consolidated Duvall's appeal from the decision of the district court with the action on remand from the Supreme Court. Each case presents distinct issues. The remand from the Supreme Court requires us to decide whether, in light of Medtronic, Duvall's state-law claims for breach of implied warranties, design defect, manufacturing defect, and failure to warn are preempted by § 360k(a). Duvall's appeal from the grant of summary judgment to Bristol-Myers on the express warranty claims requires us first to decide whether the district court correctly held that Duvall failed to establish a genuine issue of material fact with respect to his assertion of an express warranty based on statements allegedly made by a Bristol-Myers representative. We must then determine the effect of Medtronic on our prior decision that § 360k(a) preempts express warranty claims that are based on FDA-mandated labeling, packaging, or advertising.

II.

Congress enacted the MDA in the midst of rising concern regarding the safety and effectiveness of the growing number of medical devices being introduced into the marketplace. See Medtronic, --- U.S. at ----, 116 S.Ct. at 2246. The MDA "provide[s] for the safety and effectiveness of medical devices" by classifying them according to the amount of risk they present to the public and imposing appropriate controls. Id. at ----, ----, at 116 S.Ct. at 2245, 2246 (internal quotation marks omitted); see 21 U.S.C.A. § 360c (West Supp.1996). Class I devices, such as tongue depressors, do not present an unreasonable risk of illness or injury and are subject only to general controls. 21 U.S.C.A. § 360c(a)(1)(A); 21 C.F.R. § 880.6230 (1996). 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. § 360c(a)(1)(B); 21 C.F.R. § 874.3300 (1996). 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. § 360c(a)(1)(C). Class III devices are subject to the most stringent MDA controls. See King v. Collagen Corp., 983 F.2d 1130, 1131 (1st Cir.) (Torruella, J.), cert. denied, 510 U.S. 824, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993). Penile inflatable implants are classified as Class III medical devices. 21 C.F.R. § 876.3350 (1996).

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. § 360e(c) (West Supp.1996), and is intended "to provide reasonable assurance of [the] safety and effectiveness" of the device, 21 U.S.C.A. § 360c(a)(1)(C). In the case of a Class III device for which the FDA does not yet require premarket approval, a 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 U.S.C.A § 360e(b)(1)(B) (West Supp.1996); Medtronic, --- U.S. at ----, 116 S.Ct. at 2247. To do so, a manufacturer must submit a premarket notification, known as a 510(k) notification, including specified information, at least 90 days before marketing a device; the FDA must then authorize the marketing of the device. 21 U.S.C.A. § 360(k) (West Supp.1996); 21 C.F.R. §§ 807.81-807.100 (1996).

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. § 360j(g) (West Supp.1996), 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 authorized Bristol-Myers to market the device on the basis that it was substantially equivalent to similar devices marketed before passage of the MDA. In its letter informing Bristol-Myers of the clearance, the FDA noted that "[a]n FDA finding of substantial equivalence ... does not mean that FDA approves your device."

A.

Before turning to an analysis of the holding in Medtronic, we first briefly review the applicable principles of preemption. The doctrine of preemption, which is based on the Supremacy Clause of the United States Constitution, ² provides that a state law is invalid to the extent that it conflicts with federal legislation. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992). Preemption occurs in...