Lohr v. Medtronic, Inc.

• Decision Date: 03 July 1995
• Docket Number: No. 94-2516,94-2516
• Citation: 56 F.3d 1335
• Parties: Prod.Liab.Rep. (CCH) P 14,260 Lora LOHR, Michael Lohr, Her Husband, Plaintiffs-Appellants, v. MEDTRONIC, INC., a Foreign Corporation, Defendant-Appellee.
• Court: U.S. Court of Appeals — Eleventh Circuit

Page 1335

56 F.3d 1335

Prod.Liab.Rep. (CCH) P 14,260

Lora LOHR, Michael Lohr, Her Husband, Plaintiffs-Appellants, v. MEDTRONIC, INC., a Foreign Corporation, Defendant-Appellee.

No. 94-2516.

United States Court of Appeals Eleventh Circuit.

July 3, 1995.

Rehearing and Suggestion for Rehearing En Banc Denied Aug. 15, 1995.

Daniel C. Shaughnessy, Cowles & Shaughnessy, P.A., Robert F. Spohrer, Spohrer, Wilner & Maxwell, P.A., Jacksonville, FL, Brian Wolfman, Public Citizen Litigation Group, Washington, DC, for appellants.

Dennis P. Waggoner, Hill, Ward & Henderson, P.A., Tampa, FL, Marcus R. Magnuson, Medtronic, Inc., Minneapolis, MN, Daniel G. Jarcho, McKenna & Cuneo, Washington, DC, for appellee.

Appeal from the United States District Court for the Middle District of Florida.

Before BLACK and BARKETT, Circuit Judges, and RONEY, Senior Circuit Judge.

BLACK, Circuit Judge:

In this case we must decide whether the Medical Device Amendments of 1976 (MDA or Act), 21 U.S.C.A. Secs. 360c-360l (West Supp.1994) preempt Appellants' state law negligent design, negligent manufacture, failure to warn, and strict liability claims against the manufacturer of an allegedly defective pacemaker. The district court found that they did and dismissed the entire action. We hold that Appellants' negligent manufacture and failure to warn claims are preempted and affirm their dismissal. We also hold that Appellants' negligent design and strict liability claims are not preempted and therefore reverse their dismissal.

I. BACKGROUND

Because an understanding of the MDA's regulatory scheme is necessary to resolve the question of preemption, we begin with a brief outline of the Act.

A. The Regulatory Scheme

The market for medical devices was largely unregulated at the national level until the MDA's passage in 1976. With the MDA, Congress gave the federal Food and Drug Administration (FDA) comprehensive jurisdiction over all "devices intended for human use." 21 U.S.C.A. Sec. 360c(a)(1). The text of the MDA reveals two competing congressional purposes relevant to this case: ¹ (1) the MDA protects the public from unnecessary illness or injury by subjecting medical devices to a regulatory scheme designed to ensure that the devices are safe and effective, see, e.g., 21 U.S.C.A. Secs. 360c(a)(1)(A)(i); 360c(a)(1)(B); 360e(d)(2); and (2) the MDA protects the public by encouraging the development and marketing of medical devices by crafting a nationally uniform regulatory scheme that prevents overregulation and thus ensures that development can be economically feasible, see, e.g., 21 U.S.C.A. Secs. 360j(g)(1); 360k(a).

These twin purposes are confirmed by the legislative history of the Act. For example, the House Report on the Act states:

Those involved in the development, promotion, and application of medical devices generally agree that the public deserves more protection against unsafe, unproven, ineffective, and experimental medical devices. But this belief is counterbalanced by an equally strong conviction that excessive or ill-conceived Federal device regulation would stifle progress in this field.

H.R.Rep. No. 853, 94th Cong., 2d Sess. 10 (1976). Legislative history from the Senate reflects the same balancing of interests. See S.Rep. No. 33, 94th Cong., 1st Sess. 5, 12 (1975). The need to balance public safety with continued development was reiterated when Congress amended the MDA in 1990.

Simply put, the [MDA] sought to avoid overregulation, thus eliminating unnecessary resource costs to industry and the government, foster incentives to encourage innovation in a relatively youthful industry and, most importantly, provide the public reasonable assurances of safe and effective devices.

S.Rep. No. 513, 101st Cong., 2d Sess. 13 (1990). The MDA thus reflects the intent of Congress to scrutinize the medical device industry to a greater extent without stifling innovation and development.

All medical devices regulated by the MDA fall into three statutory categories. Class I devices are those which pose little threat to the safety of the consuming public. These devices, including everything from tongue depressors to acoustic chambers, are subject only to the Act's generally applicable regulations. See 21 U.S.C.A. Sec. 360c(a)(1)(A). Class II devices are those which pose enough of a safety hazard to require regulation beyond the general controls applicable to Class I devices. Class II devices, like tampons and oxygen masks, are consequently subject to device-specific special controls. See 21 U.S.C.A. Sec. 360c(a)(1)(B).

Class III devices are those that the FDA determines are too unproven to be rendered safe by general controls or present a potential for unreasonable risk of illness or injury. Almost all life-sustaining medical devices, like pacemakers, are classified as Class III devices. In addition to the Act's general regulations and, in some instances, device-specific controls, Class III devices must generally undergo premarket approval (PMA) before the FDA will allow them into the marketplace. See 21 U.S.C.A. Sec. 360c(a)(1)(C). The premarket approval process is a vigorous one, requiring the applicant to present the FDA with "all information" known or reasonably knowable about the device, including detailed information about the design, manufacture, uses, and labeling of the device. 21 U.S.C.A. Sec. 360e(c)(1).

While the MDA contemplates that most Class III devices will reach the market through the PMA process, there are important exceptions. First, the MDA grandfathered into the market all devices introduced before May 28, 1976--the effective date of the Act. 21 U.S.C.A. Sec. 360e(b)(1)(A); 21 C.F.R. Sec. 814.1(c)(1) (1994). Second, the MDA contains an investigational device exemption (IDE) for new devices under clinical investigation to determine their safety or effectiveness. 21 C.F.R. Sec. 812.3(g). See 21 U.S.C.A. Sec. 360j(g). In order to foster the development of useful devices, IDE procedures allow manufacturers to begin limited marketing of new devices without undergoing the rigorous PMA process. 21 U.S.C.A. Sec. 360j(g)(1).

Finally, a Class III device may reach the market without undergoing the PMA procedures if the device is found to be the "substantial equivalent" of an already-marketed device, including a device grandfathered into the market. 21 U.S.C.A. Sec. 360e(b)(1)(B). For a device to qualify as the substantial equivalent of one which is already being marketed, the FDA must determine that the new device has the same intended use as the predicate device and either the same technological characteristics or the same safety and effectiveness as the predicate device. 21 U.S.C.A. Sec. 360c(i)(1)(A). Every device entering the market as a substantial equivalent is subject to a premarket notification process (510(k) process) which allows the FDA to classify the device and make its substantial equivalence finding. 21 U.S.C.A. Secs. 360(k); 360c(f)(1).

B. Facts ²

This case arises from the failure of a pacemaker manufactured by Appellee Medtronic, Inc. The pacemaker in question, the Model 8403 Activitrax (Activitrax), is a Class III device under the MDA. 21 C.F.R. Sec. 870.3610. The Activitrax has never been subject to the PMA process. See 21 C.F.R. Sec. 870.3610(c).

Appellant Lora Lohr was implanted with an Activitrax pacemaker in 1987. The pacemaker failed in 1990, forcing Ms. Lohr to endure emergency surgery to replace the Activitrax. According to Ms. Lohr's treating physician, the failure was caused by a defect in the pacemaker "lead"--the wire carrying electrical impulses from the pacemaker to the patient's heart tissues.

The Activitrax lead component, the Model 4011, is manufactured by Appellee as part of its pacemaker system. The FDA permitted marketing of the Model 4011 in 1982 after finding that it was the substantial equivalent of a device introduced prior to the effective date of the MDA. In other words, the Model 4011 entered the market through the 510(k) process as the substantial equivalent of a device grandfathered into the Act.

C. Procedural History

Appellants Lora and Michael Lohr originally brought this action in a Florida court, but Appellee removed the case to the Middle District of Florida based on diversity of citizenship. In their complaint, Appellants seek damages for injuries Lora Lohr allegedly sustained as a result of the Activitrax's failure and for Michael Lohr's alleged loss of consortium. The complaint contains four theories of liability: (1) negligent design; (2) negligent manufacture; (3) negligent failure to warn; and (4) strict liability in tort. ³

Shortly after removing the case, Appellee moved for summary judgment, asserting that Appellants' claims were preempted by the MDA. The district court denied the motion in December 1993, but reconsidered its decision in light of this Court's decision in Duncan v. Iolab Corp., 12 F.3d 194 (11th Cir.1994). Upon reconsideration, the district court granted Appellee's motion for summary judgment, interpreting Duncan as preempting all state law claims for negligence and strict liability. This appeal follows. ⁴

II. DISCUSSION

The sole issue on appeal is whether the district court erred in holding that the MDA preempts all common law tort claims against a Class III device which entered the market through the 510(k) process as the substantial equivalent of a grandfathered device.

A. Standard of Review

Statutory interpretation presents a question of law over which we exercise de novo review. Barnett Bank of Marion County, N.A. v. Gallagher, 43 F.3d 631, 633 (11th Cir.1995). We review an administrative agency's statutory interpretation de novo, but defer to an agency's interpretation if it is reasonable. Asencio v. I.N.S., 37 F.3d 614, 616 (11th Cir.1994).

B. Preemption Under the MDA

The Constitution makes the laws of the United States "the supreme Law of the Land; ... any Thing in the Constitution or Laws of any State to the Contrary...