Webster v. Pacesetter, Inc.

• Decision Date: 01 November 2001
• Docket Number: No. 01-00928 (ESH).,01-00928 (ESH).
• Citation: 171 F.Supp.2d 1
• Parties: Arnold W. WEBSTER, et al., Plaintiffs, v. PACESETTER, INC. Defendant.
• Court: U.S. District Court — District of Columbia

Page 1

171 F.Supp.2d 1

Arnold W. WEBSTER, et al., Plaintiffs, v. PACESETTER, INC. Defendant.

No. 01-00928 (ESH).

United States District Court, District of Columbia.

November 1, 2001.

Herbert Vincent McKnight, Jr., Ashcraft & Gerel, Washington, DC, for Plaintiffs.

Paul Joseph Maloney, Carr Goodson, P.C., Washington, DC, Derek V. Lewis, Michael J. Weber, James A. Gale, Feldman, Gale & Weber, P.A., Miami, FL, for Defendant.

MEMORANDUM OPINION

HUVELLE, District Judge.

This case presents one question: does Section 360k of the Medical Device Amendments of 1976, 21 U.S.C. § 360c et. seq. ("MDA"), to the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et. seq., as amended ("FDCA"), preempt plaintiffs' common-law claims? While the issue can be stated simply, its resolution is far from straightforward. Although the Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), found that there was no preemption for Class III medical devices that only receive Section 510(k) premarket notification review by the Food and Drug Administration ("FDA"), it left open the question whether FDA approval of a premarket approval application for a Class III device would constitute imposition of a "federal requirement" within the meaning of Section 360k of the MDA, and therefore preempt a plaintiff's state law tort claims. Following this decision by a fractured Court, the circuit courts have split when considering Class III devices that have received FDA premarket approval, with the Fifth, Sixth, and Seventh Circuits holding in favor of preemption,¹ and the Eleventh Circuit ruling against preemption.² Although there are substantial arguments on both sides of the debate, this Court finds the reasoning of the Eleventh Circuit to be more persuasive and more faithful to Congress's intent in enacting the MDA and the rationale of the Lohr majority. Therefore, defendant's motion for summary judgment will be denied.

BACKGROUND

Daniel W. Webster had a history of heart trouble described as sinoatrial node dysfunction. On July 24, 1998, to stabilize his heart, plaintiff underwent an operation to implant a cardiac pacing system, consisting of three components: the TRILOGY DR+ Implantable Pulse Generator, model no. 2360L (the "pacemaker"), a TENDRIL DX Permanent Pacemaker Electrode, Atrial Lead, model no. 1388TC (the "atrial lead"), and a Passive PLUS DX Permanent Pacemaker Electrode, Ventricular Lead, model no. 1346T (the "ventricular lead"). All three components, the pacemaker and the two lead wires, were manufactured by Pacesetter, Inc. After a post-surgery diagnostic examination, plaintiff was released with no complications from the Washington Hospital Center in Washington, D.C.

On August 5, 1998, plaintiff became weak and dizzy while riding in a car. He was rushed to an emergency room at the Lady of Lourdes Medical Center in Camden, New Jersey. After review of a CAT scan and echocardiogram, plaintiff's doctors concluded that the atrial lead had perforated the atrial chamber of his heart and diagnosed plaintiff with cardiac tamponade³ caused by a perforation of the heart wall. Plaintiff underwent a procedure known as median sternotomy and the perforation was repaired. On August 13, 1998, plaintiff was discharged from the hospital.

On April 2, 2001, Daniel W. Webster and his wife, Irene L. Webster, filed a complaint in the Superior Court for District of Columbia, alleging state law claims of strict liability; negligent warnings, design, manufacture, and follow-up evaluation; breach of warranty; and fraud and deceit on the part of Pacesetter, Inc. with respect to its atrial lead. Defendant filed a Notice of Removal on April 30, 2001, and the case was subsequently removed to this Court. On July 20, 2001, defendant filed a motion to dismiss or, in the alternative, for summary judgment. Defendant argues that the MDA expressly preempts plaintiffs' state law tort claims. In the alternative, defendant argues that plaintiffs' claims are impliedly preempted by the MDA. In order to address these arguments, the Court must first consider the MDA and the regulations promulgated thereunder, as well as the Supreme Court's seminal case in this area of the law — Medtronic, Inc. v. Lohr.

LEGAL ANALYSIS

I. The PMA Process

In 1976, Congress passed the MDA in response to public concern regarding the safety and efficacy of medical devices, most notably the Dalkon Shield intrauterine device. The MDA confers broad regulatory authority over medical devices on the FDA and establishes a regulatory framework that classifies devices by the degree of risk posed to the public, subjecting devices that pose the greatest risk to the most exacting level of FDA scrutiny. Class III devices, which are considered to pose the greatest risk to the public, consist of those devices which "present[] a potential unreasonable risk of illness or injury" or are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." 21 U.S.C. § 360c(a)(1)(C). Such devices are therefore subject to the most stringent level of regulation. Id.

Before a Class III device can be made publicly available, the manufacturer must submit its product to the FDA for premarket approval (the "PMA" process), and the FDA must conclude that it has received "reasonable assurance of [the device's] safety and effectiveness." Id. The PMA process is a rigorous and "time-consuming inquiry into the risks and efficacy of each device." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 1017, 148 L.Ed.2d 854 (2001). PMA applicants must submit detailed information pertaining to the device, including all studies, reports, and other publications regarding its safety and efficacy, its component parts and functions, and the processes necessary to manufacture and package the device, as well as samples of the device, its labeling, and packaging. 21 U.S.C. § 360e(c)(1); 21 C.F.R. § 814. The FDA reviews the submitted materials for an average of 1200 hours before either approving or disapproving the application. See Lohr, 518 U.S. at 477, 116 S.Ct. 2240 (citation omitted). The FDA may also advise a manufacturer of deficiencies in the PMA application and the measures necessary to render the application acceptable, including additional research. See 21 U.S.C. § 360e(d)(2). Once the FDA approves a PMA application, the medical device manufacturer may not change the labeling, design, or manufacture of an approved device in any way that would affect safety or effectiveness without submitting a PMA Supplement. See 21 C.F.R. §§ 814.39, 814.80. Changes unrelated to safety or effectiveness, however, may be made without pre-approval.

The atrial lead at issue in this case was subject to this extensive review as a Class III device under the MDA. On May 10, 1996, defendant submitted its PMA application for approval by the FDA. On June 20, 1997, the FDA approved defendant's application for the atrial lead by issuing a letter entitled "Conditions of Approval." (Def.'s Mot. at 6; Telep Aff., Ex. A.)

II. Express Preemption

To ensure national uniformity in the regulation of medical devices, the MDA expressly provides for preemption of certain state requirements:

[N]o 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 provision is straightforward, although its interpretation and application have proved otherwise: Section 360k preempts any state law "requirement" that "relates to [] safety or effectiveness" and is "different from, or in addition to" any federal "requirement" applicable to a medical device. Id. The FDA has promulgated regulations implementing this provision, which provide for preemption when the FDA has established "specific counterpart regulations" or other "specific requirements applicable to a particular device." See 21 C.F.R. § 808.1(d).

Under the Supremacy Clause of the United States Constitution, state laws that conflict with federal laws are simply without effect. See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (citation omitted). The Court's preemption analysis must be guided by two basic principles: first, there is a presumption against federal preemption of state regulation, and second, the "analysis of the scope of [a] statute's preemption is guided by ... [the principle] that `[t]he purpose of Congress is the ultimate touchstone' in every preemption case." Lohr, 518 U.S. at 485, 116 S.Ct. 2240 (quoting Retail Clerks Int'l Ass'n, Local 1625, AFL-CIO v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 11 L.Ed.2d 179 (1963)); accord Cipollone, 505 U.S. at 516, 112 S.Ct. 2608.

A. Lohr and Its Progeny

In its divided opinion in Medtronic, Inc. v. Lohr, the Supreme Court interpreted and applied Section 360k, holding that a less stringent form of MDA regulatory review did not preempt state common-law claims. Lohr concerned claims against the manufacturer of a failed pacemaker, a Class III medical device, which had reached the market by means of FDA approval under the Section 510(k) premarket notification process,⁴ an exception to the PMA process. Under the Section 510(k) process, if the FDA concludes on the basis of a manufacturer's premarket notification that the applicant's Class III medical device is "substantially equivalent" to a pre-existing device, the MDA permits marketing of the device without further regulatory analysis. 21 U.S.C. § 360e(b)(1)(B). In Lohr, a majority of the Court concluded that the plaintiff's negligence...