Martin v. Telectronics Pacing Systems, Inc., 94-4003

• Decision Date: 31 January 1997
• Docket Number: No. 94-4003,94-4003
• Citation: 105 F.3d 1090
• Parties: , Prod.Liab.Rep. (CCH) P 14,850 Ada M. MARTIN and Harold L. Martin, Plaintiffs-Appellants, v. TELECTRONICS PACING SYSTEMS, INC.; TPLC, Inc. d/b/a Telectronics Pacing Systems; Telectronics PTY Limited, Defendants-Appellees.
• Court: U.S. Court of Appeals — Sixth Circuit

Page 1090

105 F.3d 1090

65 USLW 2547, Prod.Liab.Rep. (CCH) P 14,850

Ada M. MARTIN and Harold L. Martin, Plaintiffs-Appellants, v. TELECTRONICS PACING SYSTEMS, INC.; TPLC, Inc. d/b/a

Telectronics Pacing Systems; Telectronics PTY

Limited, Defendants-Appellees.

No. 94-4003.

United States Court of Appeals, Sixth Circuit.

Argued Dec. 3, 1996.

Decided Jan. 31, 1997.

Frank A. Ray (argued and briefed), Ray, Todaro & Alton, Terry L. Kilgore (briefed), Columbus, OH, for Plaintiffs-Appellants.

David C. Greer (briefed), Howard P. Krisher, Bieser, Greer & Landis, Dayton, OH, Michael J. Weber (argued), James A. Gale, Feldman, Gale & Weber, Miami, FL, for Defendants-Appellees.

Steven Glickstein (briefed), Kaye, Scholer, Fierman, Hays & Handler, New York City, for Health Industry Manufacturers Association, Amicus Curiae.

Before: KENNEDY and MOORE, Circuit Judges; JOHNSTONE, Senior District Judge. ^*

KENNEDY, Circuit Judge.

In this products liability suit, plaintiffs, Ada and Harold Martin, appeal the District Court's summary judgment in favor of defendants, awarded largely on the basis of preemption under 21 U.S.C. § 360k(a) of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act. We previously affirmed the judgment of the District Court. Martin v. Telectronics Pacing Sys., Inc., 70 F.3d 39 (6th Cir.1995). Thereafter, the United States Supreme Court granted plaintiffs' petition for writ of certiorari, vacated our prior judgment, and remanded the case to our Court for further consideration in light of its decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Martin v. Telectronics Pacing Sys., Inc., --- U.S. ----, 116 S.Ct. 2576, 135 L.Ed.2d 1091 (1996). Pursuant to the Supreme Court's order, the case is again before us for our determination.

I. Factual Background

The plaintiffs filed suit against Telectronics Pacing Systems, Inc. ("Telectronics") after Ada Martin suffered injuries resulting from the implantation of the Telectronics Guardian ATP 4210 Implantable Cardioverter-Defibrillator-Demand Pacemaker ("device"). The device, which combines the functions of a defibrillator, a cardioverter, and a pacemaker, was one of fifty such experimental devices. The device is implanted into the patient's body and generates electrical shocks, when necessary, to maintain a normal heart rhythm.

On the morning of March 31, 1992, Ada Martin signed a form consenting to implantation of the device to correct a heart ailment. Later that day, doctors at the Ohio State University Hospitals implanted the device into Ada Martin's chest. Plaintiffs claim that the device began to malfunction sometime after the operation and was therefore replaced in a subsequent operation on November 19, 1992. As a result of the alleged malfunction of the device, the Martins claim that they suffered $500,000 in damages.

Plaintiffs allege five causes of action under Ohio products liability law pursuant to Ohio Revised Code §§ 2307.74-.78. The Complaint alleges that the defendant (1) defectively manufactured the device; (2) defectively designed the device; (3) failed to adequately warn plaintiffs; (4) failed to conform to certain unidentified "express representations;" and (5) supplied the device in question to plaintiffs. Ada Martin's spouse also pleaded a derivative common-law tort claim alleging that he suffered loss of consortium and companionship as a result of the defendant's conduct.

Telectronics filed for summary judgment on all of the plaintiffs' claims arguing that they were preempted by section 360k(a) of the Medical Device Amendments. The District Court granted Telectronics' motion. On appeal, we affirmed the judgment of the District Court and held that all of plaintiffs' claims were preempted. Additionally, we held that the finding of preemption did not violate the plaintiffs' Seventh Amendment right to a jury trial. Subsequently, plaintiffs petitioned the United States Supreme Court for a writ of certiorari. Their petition was granted and the Supreme Court remanded the case to our Court for reconsideration in light of the Court's decision in Medtronic, Inc. v. Lohr, supra.

II. Standard of Review

Despite the Supreme Court's order vacating and remanding the case for our redetermination, our standard of review remains unchanged. This Court's review of a grant of summary judgment is de novo; it uses the same test as used by the District Court. See Brooks v. American Broadcasting Cos., 932 F.2d 495, 500 (6th Cir.1991), cert. denied, 510 U.S. 1015, 114 S.Ct. 609, 126 L.Ed.2d 574 (1993). In reviewing summary judgment motions, courts must view the evidence in the light most favorable to the nonmoving party to determine whether a genuine issue of material fact exists. See Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 1608, 26 L.Ed.2d 142 (1970). Under FED.R.CIV.P. 56(c), summary judgment is proper if the evidence " 'show[s] that there is no genuine issue as to any material fact and that the moving party is entitled to [a] judgment as a matter of law.' " Canderm Pharmacal, Ltd. v. Elder Pharmaceuticals, Inc., 862 F.2d 597 601 (6th Cir.1988)(quoting FED.R.CIV.P. 56(c)).

III. Medtronic, Inc. v. Lohr

In Medtronic, Inc. v. Lohr, the Supreme Court was presented for the first time with the question of whether the MDA preempts state common law actions against the manufacturer of an allegedly defective medical device. Lora Lohr and her husband filed suit against Medtronic alleging strict liability, negligent design, negligent manufacturing, and inadequate labeling under Florida state law after Lora Lohr was implanted with a pacemaker manufactured by Medtronic which contained an allegedly defective lead. The pacemaker lead was exempted from the rigorous premarket approval ("PMA") process under the § 510(k) process for substantially equivalent devices. Medtronic at 2248. After the defendant removed the case to federal court, Medtronic moved for summary judgment arguing that all of the plaintiffs' claims were preempted under § 360k(a). That section provides:

§ 360k. State and local requirements respecting devices

(a) General rule

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. § 360k(a).

The district court initially denied the motion. However, soon after its decision, the United States Court of Appeals for the Eleventh Circuit in an unrelated case held that § 360k required preemption of at least some common law claims. Thereafter, the district court reconsidered its prior ruling and dismissed the plaintiffs' complaint. Id. at ----, 116 S.Ct. at 2249. The Eleventh Circuit reversed, in part, holding that the Lohrs' negligent design claim and their strict liability claim arising from an unreasonably dangerous design were not preempted by the MDA. The Eleventh Circuit upheld the dismissal of the Lohrs' negligent manufacturing and negligent failure to warn claims on preemption grounds. Id. The Supreme Court granted Medtronic's petition and the Lohrs' cross-petition for certiorari in light of the division amongst the circuit courts over the extent to which common law claims are preempted by the MDA. Id. at ----, 116 S.Ct. at 2250.

In a five to four decision, the Court held that none of the plaintiffs' common law claims were preempted by the MDA. Id. at ----, 116 S.Ct. at 2258. The plurality opinion was authored by Justice Stevens and was joined by Justices Kennedy, Souter, and Ginsburg. Justice Breyer wrote a separate opinion, concurring in part and concurring in the judgment, in which he joined in five of seven parts of Justice Stevens' opinion. Thus, the five sections joined by Justice Breyer (Sections I, II, III, V, and VII) constitute the opinion of the Court.

In determining the extent to which the MDA preempts state common law claims, the Court first noted that, while § 360k(a) is an express preemption provision in the MDA, the scope of federal preemption under § 360k(a) is ambiguous. Id. at ----, 116 S.Ct. at 2255. This ambiguity in addition to Congress' express grant of authority to the Food and Drug Administration ("FDA") to implement the MDA, in the Court's opinion, rendered the FDA's interpretation of the statute entitled to substantial weight. Id. at ----, 116 S.Ct. at 2256. According to FDA regulations:

State or local regulations are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.

There are other State or local requirements that affect devices that are not preempted by section 521(a) of the act because they are not 'requirements applicable to a device' within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:

(1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g. requirements such as general electric codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.

(2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by...