the Supreme Court's seminal case in this area of the law —
Medtronic, Inc. v. Lohr.
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. Plaintiff's Legal Comm., 121
S.Ct. 1012, 1017 (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 (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.,
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
(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).