concurred in part and in the judgment, and he joined five of the
seven parts of Justice Stevens's opinion. Accordingly, the five sections
of Justice Stevens's opinion in which Justice Breyer concurred (Sections
I, II, III, V and VII) form the opinion of the Court.
After discussing the history of the MDA and its three classifications
of medical devices, a majority of the justices determined that while
certain state common-law claims may be preempted under § 360k(a),
preemption is appropriate "only where a particular state requirement
threatens to interfere with a specific federal interest." Id. at 500.
Throughout different parts of the decision, the Court commented on the
character of both the federal interest and the state requirement.
In discussing the nature of the federal interest that must be present
to lead to preemption, the Court stated that the federal requirements
must be specific to the device in question: "federal requirements must be
`applicable to the device' in question, and, according to the
regulations, pre-empt state law only if they are `specific counterpart
regulations' or `specific' to a `particular device.'" Id.
The Court went on to conclude that the approval process that features
the "substantially equivalent" standard is not the type of specific
federal requirement that leads to preemption. The § 510k process,
stated the Court, "reflects important but entirely generic concerns about
device regulation generally, not the sort of concerns regarding a
specific device or field of device regulation which the statute or
regulations were designed to protect from potentially contradictory state
requirements." Id. at 501. Referring specifically to the pacemaker, the
Court noted that the § 510k process "did not `require' Medtronics'
pacemaker to take any particular form for any particular reason; the
agency simply allowed the pacemaker, as a device substantially equivalent
to one that existed before 1976, to be marketed without running the
gauntlet of the PMA process." Id. at 493-94.
The Court also considered under what circumstances a state-law claim
may be preempted. It concluded that when a state-law claim diverges from
the specific federal requirement, preemption is triggered. The majority
of the Court — Justices Breyer, O'Connor, Scalia and Thomas and
Chief Justice Rehnquist, — agreed that "a fair reading of §
360k indicates that state common-law claims are pre-empted, as the
statute itself states, to the extent that their recognition would impose
`any requirement' different from, or in addition to, FDCA requirements
applicable to [a] device." Id. at 510 (O'Connor, J., concurring in part
and dissenting in part); id. at 503-504 (Breyer, J., concurring in part
and concurring in the judgment and agreeing with Justice O'Connor on this
Along the same lines, the Court stated that as long as the plaintiffs'
claims sought to enforce only the specific regulations that the FDA
imposed upon the pacemaker, those claims did not constitute different or
additional requirements and were not preempted: "Nothing in § 360k
denies Florida the right to provide a traditional damages remedy for
violations of common-law duties when those duties parallel federal
requirements." Id. at 495.
Consistent with the above discussion, courts of appeals have adopted
generally accepted guidelines on when the MDA preempts state claims. A
state claim that focuses on the safety of a device is preempted only if
(1) the FDA has established specific counterpart regulations or other
specific federal requirements that
are applicable to the particular
device; and (2) the state claim is different from, or in addition to, the
specific FDA requirements. Kemp v. Medtronic, Inc., 231 F.3d 216, 224-225
(6th Cir. 2000) (citing, inter alia, Mitchell v. Collagen Corp.,
126 F.3d 902, 910 (7th Cir. 1997); Goodlin v. Medtronic, Inc.,
167 F.3d 1367, 1371 (11th Cir. 1999)). The key, then, is to focus first
on the specificity and applicability of the federal requirement and
second, if necessary, on whether the state claim is different from or in
addition to the federal requirement.
Our first task is to determine whether the PMA process is a specific
federal requirement applicable to the HeartMate. We believe that it is.
The HeartMate's PMA process was a determination by the FDA that the
HeartMate — and specifically the HeartMate — was safe and
effective. TCI submitted a voluminous amount of material related to the
design, manufacturing, and labeling of the specific product. The FDA gave
its approval to the marketing of the HeartMate, and TCI needed permission
to alter any of the HeartMate's specific design or safety features.
Consequently, the PMA process represents a federal "requirement" that is
specific to the HeartMate.
The vast majority of federal and state appellate courts that have
addressed the issue have held that the PMA process is an example of a
federal requirement that may trigger § 360k(a) preemption. See,
e.g., Brooks v. Howmedica, Inc., 273 F.3d 785, 795-796 (8th Cir. 2001);
Kemp, 231 F.3d at 226-27; Mitchell, 126 F.3d at 911-913; Martin v.
Medtronic, Inc., 254 F.3d 573, 584 (5th Cir. 2001); Worthy v. Collagen
Corp, 967 S.W.2d 360, 376 (Tex. 1998); Fry v. Allergan Medical Optics,
695 A.2d 511, 516 (R.I. 1997); Green v. Dolsky, 685 A.2d 110, 117 (Pa.
1996). In addition, many courts have distinguished the PMA process from
the § 510(k) process, holding PMA to be a specific requirement, even
after Lohr's holding that § 510(k) does not trigger preemption. They
point to the fact that while the § 510(k) process focuses only on
"equivalence" to an already-existing product, the PMA process is much
more rigorous and focuses on the safety of a new, specific product. See,
e.g, Martin, 254 F.3d at 584; Fry, 695 A.2d 516-17. We agree with these
courts, and we find that the HeartMate's PMA process is a specific
federal interest defined in the MDA's preemption clause. This conclusion
is consistent with pre-Lohr Third Circuit law, which decrees that the PMA
is a federal requirement that triggers MDA preemption. See Michael v.
Shiley, 46 F.3d 1316, 1324 (3d Cir. 1995).
Now that we have decided that the PMA process may preempt certain
claims, we must determine whether plaintiff's specific common-law claims
impose requirements that are different from or in addition to the PMA
process. We think they do. Plaintiff brings claims for negligence, strict
liability, and breach of warranty. Each claim is based on the premise
that the HeartMate was defectively designed or manufactured or contained
inadequate labeling. Most of her claims focus on the design and
effectiveness of the screw ring, which the FDA analyzed. According to
plaintiff, then, the HeartMate was unsafe in spite of the fact that the
FDA, after approving the product's design (including the use of the screw
ring and the accompanying suture), testing, intended use, manufacturing
methods, performance standards, and labeling, designated the product as
safe. Any judgment that the HeartMate was unsafe or otherwise substandard
would be in direct conflict — i.e., different from — the
FDA's determination that the product was suitable for use. Many courts
have used this logic in finding preemption.
See, e.g., Mitchell, 126 F.3d
at 913-14; Green, 685 A.2d at 118-19. Accordingly, the MDA expressly
preempts each of plaintiff's claims.
TCI argues in the alternative that because plaintiff's claims conflict
with the MDA, they are barred under the doctrine of conflict preemption.
Because we find that plaintiff's claims are expressly preempted, we need
not reach this issue.
The PMA process applicable to the HeartMate represents the type of
federal requirement that preempts under the MDA. Accordingly, each of
plaintiff's claims is preempted, and summary judgment is proper. An
appropriate order follows.
For the reasons set forth in the accompanying memorandum,
IT IS ORDERED THAT:
1. TCI's motion for summary judgment (Rec. Doc. No. 29) is granted.
2. TCI's motion for protective order (Rec. Doc. No. 22) is denied as
3. The clerk is directed to enter judgment in favor of defendant and
4. The clerk is directed to close the case file.
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