The opinion of the court was delivered by: Ellen Segal Huvelle, United States 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 (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
and the Eleventh Circuit ruling against preemption.*fn2 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.
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 tamponade*fn3 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.
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.,
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 ...