Medical Devices; Preemption of State Product Liability Claims

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 97N-0222]

Medical Devices; Preemption of State Product Liability Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it

is withdrawing a proposed rule that published in the Federal Register

of December 12, 1997 (62 FR 65384), relating to medical device

preemption of State product liability claims. FDA is making this

withdrawal because of concerns that have been raised regarding the

interplay between the FDA Modernization Act of 1997 (FDAMA) and the

proposed rule.

DATES: The proposed rule is withdrawn July 24, 1998.

ADDRESSES: Copies of the draft proposed rule and its comments may be

obtained from the Dockets Management Branch (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ-215), Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: Section 521 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360k) contains an express preemption

provision applicable to medical devices regulated by FDA. The Supreme

Court addressed whether section 521 of the act preempts State common

law tort claims arising from allegedly defective medical devices. (See

Medtronic, Inc. v. Lohr (Lohr), 116 S.Ct. 2240 (1996).) The Court

concluded that section 521 of the act did not supplant the State law

duties for devices marketed pursuant to a premarket clearance issued

under section 510(k) of the act (21 U.S.C. 360(k)). Since Lohr was

decided, the lower courts have interpreted section 521 of the act

inconsistently and have reached conflicting conclusions with respect to

whether section 521 of the act preempts State law claims for injuries

allegedly resulting from medical devices that have received premarket

approval under section 515 of the act (21 U.S.C. 360e), or have

received an investigational device exemption under section 520(g) of

the act (21 U.S.C. 360j(g)).

In light of the confusion among the lower courts in interpreting

section 521 of the act since Lohr, and in accordance with the Supreme

Court's recognition that FDA's interpretation of the preemptive effect

of section 521 of the act is entitled to substantial weight, the agency

issued the proposed rule in the Federal Register of December 12, 1997

(62 FR 65384), addressing the circumstances under which section 521 of

the act preempts State common law tort claims based on injury from

allegedly defective medical devices. The proposal is consistent with

the position that the agency has historically taken on issues related

to device preemption. The comment period on this proposed rule was open

until February 10, 1998. The agency received 41 comments from a variety

of associations, law firms, and individuals representing industry and

consumer interests.

FDA has decided to withdraw the rulemaking to amend its regulations

regarding preemption of State and local requirements applicable to

medical devices. FDA is taking this action because, even though the

proposed rule was issued after the enactment of FDAMA, it was

conceptualized and written prior to enactment.

Concerns have been raised by industry and congressional

representatives that the agency did not share its thinking on its

interpretation of section 521 of the act during FDAMA deliberations,

even though an early draft of the proposed rule was shared during the

spring of 1997 with attorneys for Public Citizen Litigation Group, who

represented Lohr in the Lohr case. The remedy under FDA's regulations

for disclosure of a draft regulation is ordinarily to issue a notice in

the Federal Register making the draft publicly available. See 21 CFR

10.80(b)(2). Such a contemporaneous notice was not, however, provided

in this case.

Because of the great policy significance of these preemption

issues, the concern that Congress was not aware of the agency's

thinking during FDAMA deliberations, and the potential interplay

between the FDAMA device provisions and device preemption, the agency

believes that it is imperative for all interested parties to have

confidence that the agency is addressing their concerns in an impartial

manner. Therefore, the agency is taking the unusual step of withdrawing

the proposed rule.

The early draft of the proposed rule that was disclosed, the

comments on it, and the correspondence raising

[[Page 39790]]

concerns about the disclosure are being placed in the Dockets

Management Branch (address above) and can be identified with the docket

number found in brackets in the heading of the document.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-19916 Filed 7-21-98; 5:07 pm]

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