                                                                                                                           Opinions of the United
2004 Decisions                                                                                                             States Court of Appeals
                                                                                                                              for the Third Circuit


7-20-2004

Horn v. Thoratec Corp
Precedential or Non-Precedential: Precedential

Docket No. 02-4597




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Recommended Citation
"Horn v. Thoratec Corp" (2004). 2004 Decisions. Paper 434.
http://digitalcommons.law.villanova.edu/thirdcircuit_2004/434


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                        PRECEDENTIAL           Allison Zeive (Argued)
                                               Public Citizen Litigation Group
    UNITED STATES COURT OF                     1600 20 th Street, N.W.
            APPEALS                            Washington, D.C. 20009
     FOR THE THIRD CIRCUIT
           __________                          John M. Humphrey
                                               Rieders, Travis, Mussina, Humphrey,
              No. 02-4597                      Harris, Waters & Waffenschmidt
              __________                       161 West Third Street
                                               P.O. Box 215
     BARBARA E. HORN, Executrix                Williamsport, PA 17703
of the Estate of Daniel Ray Horn,
             Deceased,                         Attorneys for Appellant Barbara E. Horn

                                               Gary A. Winters
                    Appellant                  Mayer, Brown, Rowe & Maw
                                               1909 K Street, N.W.
                   v.                          Washington, D.C. 20006

    THORATEC CORPORATION.                      Alan E. Untereiner (Argued)
          __________                           Robbins, Russell, Englert, Orseck &
                                               Untereiner LLP
    On Appeal from the United States           1801 K Street, N.W., Suite 411
              District Court                   Washington, D.C. 20006
 for the Middle District of Pennsylvania
      Civil Action No. 00-CV-00779             Charles W . Rubendall, II
   District Judge: Honorable James F.          Keefer, Wood, Allen & Rahal
               McClure, Jr.                    210 Walnut Street
               __________                      P.O. Box 11963
                                               Harrisburg, PA 17108-1963
             Argued on
          December 11, 2003                    Arnd N. von Waldow
            ___________                        Reed Smith
                                               435 Sixth Avenue
   Before: AMBRO, FUENTES, and                 Pittsburgh, PA 15219
       GARTH, Circuit Judges
                                               Attorneys for Appellee Thoratec
     (Opinion Filed: July 20, 2004)            Corporation




                                           1
Douglas Letter, Appellate Litigation             (hereinafter “TCI”1 ), based on its
Counsel                                          determination that Horn’s claims against
Peter R. Maier, Attorney                         TCI are preempted by the express
Civil Division, Room 9012                        preemption provision in the Food Drug
601 D Street, N.W.                               and Cosmetic Act (the “Act”), 21 U.S.C.
Department of Justice                            § 360k(a).2 We affirm.
Washington, D.C. 20530-0001
                                                                      I.
Attorneys for Amicus Curiae United                       TCI manufactured and distributed
States of America                                the left ventricular assist device known as
                                                 the HeartMate. The HeartMate is a pump
Robert N. Weiner                                 that assists the blood flow between the
Arnold & Porter                                  heart’s ventricle and the aorta in patients
555 12th Street, N.W.                            with cardiac conditions. The inlet side
Washington, D.C. 20004                           tube is surgically attached to the heart via
                                                 the ventricle, and carries blood from the
Attorneys for Amicus Curiae                      heart into the pump. The outlet side tube
Product Liability Advisory Council, Inc.         brings blood from the pump to the aorta,
                                                 where it is dispersed to the body. There is
Daniel G. Jarcho                                 a tube attached to the pump that exits the
McKenna Long & Aldridge LLP                      body and connects to an external console.
1900 K Street, N.W.                              The console contains an air compressor
Washington, D.C. 20006                           which powers the HeartMate.
                                                        The facts underlying this case
Attorneys for Amicus Curiae
                                                 pertain to the outlet side tube, which
Chamber of Commerce of the
United States of America
                                                        1
              __________                                  Thoratec Corporation, formerly
                                                 known as Thermo Cardiosystems, Inc., is
               OPINION                           referred to by the parties and the District
              __________                         Court Judge as TCI. Therefore, we will
                                                 also refer to defendant-appellee as TCI.
                                                        2
Garth, Circuit Judge:                                    The Medical Device Amendments
                                                 to the Act allow the Food and Drug
     Barbara Horn (“Horn”) appeals               Administration (“FDA”) to regulate
from the District Court’s grant of               medical devices. See 21 U.S.C. §§ 360c et
summary judgment to Thoratec Corp.               seq. For ease of reference throughout this
                                                 opinion, we refer to the Act as the source
                                                 of preemption.

                                           -1-
connects the pump to the aorta. The                 which Dr. Benjamin Sun discovered that
connection between the pump and the                 the suture on Mr. Horn’s HeartMate had
tube, called the “elbow,” is                        worn off and the screw ring linking the
                                                    pump to the output side elbow had
inserted into an adapter conduit, which is
                                                    disconnected. The disconnection had
screwed into the open port of the pump. A
                                                    allowed an air embolus to travel to Mr.
screw ring is secured over the elbow to
                                                    Horn’s brain.       Although Dr. Sun
ensure that it remains connected to the
                                                    reconnected the screw ring and once again
adapter conduit and the pump. A suture is
                                                    linked the pump to the elbow, it was too
tied over the screw ring and secured to the
                                                    late.    Mr. Horn suffered a brain
adapter conduit to ensure it will not
                                                    hemorrhage, and he was rendered brain
rotate.3 The HeartMate was approved by
                                                    dead. On May 8, 1998, his organs were
the FDA pursuant to the Pre-Market
                                                    donated for transplant and he was
Approval (“PMA”) process set forth at 21
                                                    pronounced dead.
U.S.C. § 360e(c) (discussed in depth,
infra).                                                     On April 28, 2000, Horn filed a
                                                    Complaint against TCI in the United
       On January 17, 1998, Horn’s
                                                    States District Court for the Middle
husband, Daniel Horn, was admitted to
                                                    District of Pennsylvania. The Complaint
Williamsport Hospital suffering a heart
                                                    alleged defective design and manufacture
attack. He was later transferred to
                                                    of the HeartMate and failure to warn of
Hershey Medical Center. Doctors there
                                                    the alleged defects; it was based on Horn’s
determined that Mr. Horn required a heart
                                                    claim that the HeartMate’s output side
transplant, and they waited for a suitable
                                                    elbow was defectively designed. TCI
donor heart to become available. On
                                                    moved for summary judgment, arguing
January 22, 1998, Mr. Horn’s condition
                                                    that Horn’s state law claims are expressly
deteriorated and a HeartMate was
                                                    preempted by 21 U.S.C. § 360k(a).
implanted in him to provide circulatory
support. He was then transferred to an                     The District Court granted TCI’s
assisted living facility.                           motion on November 7, 2002, holding that
                                                    Horn’s state common law claims were
       On May 3, 1998, Mr. Horn began
                                                    preempted. The District Court applied a
to bleed from the spot where the
                                                    two-prong test endorsed by the Sixth and
HeartMate tube exited his body.
                                                    Eleventh Circuits,4 which instructs that a
Thereupon, he underwent exploratory
                                                    state claim attacking the safety of a
surgery at Hershey Medical Center, during


       3                                                   4
         The HeartMate arrives at the                       See Kemp v. Medtronic, Inc., 231
surgeon pre-assembled. The surgeon need             F.3d 216, 224-25 (6th Cir. 2000); Goodlin
not manipulate the screw ring or suture             v. Medtronic, Inc., 167 F.3d 1367, 1371
when he implants the HeartMate.                     (11th Cir. 1999).

                                              -2-
medical device is preempted if (1) the                party the benefit of all reasonable
FDA has established specific federal                  inferences from the record. Saldana v.
requirements that are applicable to that              Kmart Corp., 260 F.3d 228, 232 (3d Cir.
particular device, and (2) the state claim is         2001); Gray v. York Newspapers, Inc.,
different from, or in addition to, the                957 F.2d 1070, 1078 (3d Cir. 1992).
specific federal requirements.
                                                             This Court also exercises plenary
       In granting TCI’s motion for                   review over a district court’s preemption
summary judgment on express preemption                determination, as it is a question of law.
grounds, the District Court found that (1)            Travitz v. Northeast Dep’t ILGWU Health
the HeartMate’s PMA approval process                  & Welfare Fund, 13 F.3d 704, 708 (3d
imposes a specific federal requirement                Cir. 1994), cert. denied, 511 U.S. 1143
applicable to the HeartMate, and (2) if               (1994); Michael v. Shiley, Inc., 46 F.3d
Horn were successful on her state law                 1316, 1321-22 (3d Cir. 1995).
claims, “any judgment that the HeartMate
                                                                         III.
was unsafe or otherwise substandard
would be in direct conflict [with]—i.e.,                     At issue is whether Horn’s suit
different from—the FDA’s determination                against TCI, alleging causes of action
that the product was suitable for use.”               under Pennsylvania common law, is
Dist. Ct. Op. at 20. This timely appeal               expressly preempted.      We need not
followed.                                             examine the doctrine of implied
                                                      preemption, because the Act under which
                     II.
                                                      the FDA preempted the state causes of
        We have jurisdiction to hear this             action contains an express preemption
appeal pursuant to 28 U.S.C. § 1291.                  clause, which obviates any reference to the
Review of a district court’s decision to              doctrine of implied preemption. The
grant a motion for summary judgment is                express preemption clause, 21 U.S.C. §
plenary. Goodman v. Mead Johnson &                    360k(a), provides:
Co., 534 F.2d 566, 573 (3d Cir. 1976),
                                                             [N]o State or political
cert. denied, 429 U.S. 1038 (1977);
                                                             subdivision of a State may
Hilfirty v. Shipman, 91 F.3d 573, 577 (3d
                                                             establish or continue in
Cir. 1996).
                                                             effect with respect to a
       Summary judgment is appropriate                       device intended for human
only when there is no genuine issue as to                    use any requirement –
any material fact and the moving party is
entitled to a judgment as a matter of law.
See Fed. R. Civ. P. 56(c); see also                          (1) which is different from,
Armbruster v. Unisys Corp., 32 F.3d 768,                     or in addition to, any
777 (3d Cir. 1994). In examining the                         requirement applicable
record, the court gives the nonmoving                        under this chapter to the

                                                -3-
       device, and                                         15. . . . The continual
                                                           pumping action of the TCI
                                                           HeartMate, together with
       (2) which relates to the                            natural body movements,
       safety or effectiveness of                          caused the wearing away of
       the device or to any other                          the suture so placed, and
       matter included in a                                once the suture was worn
       requirement applicable to                           through, said movement of
       the device under this                               the pump caused the screw
       chapter.                                            ring to become unscrewed.
        In this case, Horn contends that her
state common law claims would impose
                                                           16.Had the screw ring been
generally applicable duties to use good
                                                           of an appropriate and
care in manufacturing and to warn users of
                                                           feasible design which would
the product’s attendant risks. They would
                                                           not permit the screw ring to
not, she argues, impose specific
                                                           become unscrewed as a
requirements with respect to the
                                                           result of pump movement,
HeartMate. Paragraphs 15 and 16 of
                                                           or had something more
Horn’s Complaint set forth the gravamen
                                                           durable than a suture been
of her action as follows:5
                                                           used to secure the tightened
                                                           screw ring, or had the
       5
        The FDA has summarized Horn’s                      threaded sleeve with the
claims in the following manner:                            eyelet been placed in such a
                                                           way that the retaining suture
       [P]laintiff makes two main                          did not run across the
       claims: first, that TCI                             interior portion of the screw
       should have employed a
       [suture] design to prevent
       the screw rings used to hold                        the product labeling or
       the device in place inside                          correspondence to health
       the patient’s chest from                            care professionals
       becoming disconnected                               (commonly called “Dear
       (plaintiff asserted that TCI                        Doctor letters”), against
       overlooked better                                   using the device if the
       alternatives to the design it                       suture as placed in the
       chose); [and] second, that                          device packaging would
       TCI should have issued                              face the patient’s sternum.
       warnings to docto rs,
       through either revisions in                   FDA Amicus Curiae Letter Br. at 4-5.

                                               -4-
       ring directly beneath the                             A manufacturer can
       underside of the sternum,                     obtain an FDA finding of
       the disconnection which                       ‘substantial equivalence’ by
       ultimately caused Mr.                         submitting a pre-market
       Horn’s death would never                      notification to the agency in
       have occurred.                                accordance with Section
                                                     510(k) of the [Act]. 21
                                                     U.S.C. § 360(k). A device
TCI responds that Horn’s state common                found to be ‘substantially
law claims would impose state                        equivalent’ to a predicate
requirements that are specifically                   device is said to be ‘cleared’
applicable to the HeartMate, and as such             by FDA (as opposed to
are expressly preempted.                             ‘approved’ by the agency
                                                     under a PMA). A pre-
       Horn relies on Medtronic v. Lohr,
                                                     market notificatio n
518 U.S. 470 (1996), a Supreme Court
                                                     submitted under Section
case which involved the FDA’s approval
                                                     510(k) is thus entirely
of a pacemaker. In that case, which we
                                                     different from a PMA,
discuss in more detail later, the FDA’s
                                                     which must include data
approval of the device did not result in
                                                     sufficient to demonstrate to
preemption of the plaintiff Lohr’s state
                                                     FDA that the device is safe
law claims because the approval process
                                                     and effective. See Lohr,
involved in that case was not the same
                                                     518 U.S. at 478-79 (“The §
detailed approval process that was
                                                     510(k) notification process
employed by the FDA to approve the
                                                     is by no means comparable
HeartMate. In Lohr, the FDA determined
                                                     to the PMA process.”).
that the pacemaker was “substantially
equivalent” to an existing FDA-approved
device pursuant to § 510(k) of the Act,
                                                            The number of
and therefore did not undergo the far more
                                                     medical devices that receive
thorough and rigorous PMA approval
                                                     PMA review each year is
process under § 360e(c) of the Act. It was
                                                     dwarfed by the number of
this latter type of approval that the
                                                     those that are marketed
HeartMate received.
                                                     pursuant to cleared Section
        The FDA, in its Amicus Curiae                510(k). In fiscal year 2003,
Letter Brief to this Court, contrasted the §         for example, original PMAs
510(k) “substantial equivalence” approval            represented only 54 of the
process with the § 360e(c) PMA process               9,872 major submissions
as follows:                                          received.     The previous
                                                     fiscal year, original PMAs

                                               -5-
       accounted for 49 of 10,323                     of implied warranty of merchantability and
       total submissions. 6                           fitness for a particular purpose, breach of
                                                      express warranty, and fraud on the FDA.
                                                      Id. at 1321. The heart valve manufacturer
       As it concerns the HeartMate, TCI              argued that the Act preempted all of the
contends that because it received FDA                 plaintiff’s claims. Id. at 1322. On the
approval of the HeartMate through the                 issue of preemption, we stated that:
PMA process, and not under the
                                                             [S]ection [360k(a)]
“substantial equivalence” clearance
                                                             pre-empts only state
standard of § 510(k), and because Horn’s
                                                             imposed requirements.
reading and analysis of the “specificity” of
                                                             Further, it pre-empts those
the state law requirement in Lohr is
                                                             requirements only when
flawed, the Lohr decision is not
                                                             they differ from or add to a
controlling. We agree.
                                                             previously established FDA
                    IV.                                      requirement and relate to
                                                             the safety or efficacy of the
        This Court has addressed the issue
                                                             regulated device. When a
of the Act’s express preemption before,
                                                             state law differs from or
and those decisions guide us here. In Gile
                                                             adds to an FDA requirement
v. Optical Radiation Corp., 22 F.3d 540,
                                                             and when a state law relates
541 (3d Cir.), cert. denied, 513 U.S. 965
                                                             to the safety or effectiveness
(1994), the plaintiff brought a state
                                                             of a device approved by the
common law products liability and
                                                             FDA, the state law is
negligence action against an intraocular
                                                             pre-empted. Conversely,
lens manufacturer. We determined in Gile
                                                             when a state law neither
that state common law claims may impose
                                                             imposes requirements nor
state “requirements,” as that term is used
                                                             differs from or adds to an
in § 360k(a) of the Act, and that the state
                                                             FDA requirement nor
law requirements were preempted by the
                                                             relates to the safety or
FDA. Id. at 541-42.
                                                             effectiveness of the device
       Thereafter, in Michael v. Shiley,                     or to any other matter
Inc., 46 F.3d 1316 (3d Cir. 1995), the                       included in an FDA
recipient of a heart valve brought an                        requirement, the state law is
action against the heart valv e                              not pre-empted by § 360k.
manufacturer for negligent manufacture
and design, strict products liability, breach
                                                      Id. at 1323. We concluded that Michael’s
                                                      claims for negligence, strict liability,
       6
       FDA Amicus Curiae Letter Br. at                breach of implied warranties, and fraud on
12 (emphasis added).

                                                -6-
the FDA were preempted. Id. at 1325-31.7            this holding was the plurality’s opinion
 Most significantly, we held that the PMA           that the § 510(k) process does not impose
process, as well as the labeling and “good          any federal “requirement” applicable to the
manufacturing” requirements to which the            device, but is rather a “generic federal
heart valve was subjected, constituted              standard.” Lohr, 518 U.S. at 486-87. The
proper bases for preemption under §                 Lohr Court did not consider whether the
360k(a). Id. at 1324.                               more rigorous PMA process under
                                                    § 360e(c) —as distinct from the § 510(k)
       The following year, the Supreme
                                                    process —constitutes “a specific federal
Court decided Medtronic v. Lohr, 518
                                                    regulation of the product” 8 (in this case the
U.S. 470 (1996). In that case, to which we
                                                    HeartMate), which, in turn, imposes strict
referred earlier, the plaintiff asserted
                                                    F D A requ irements upon the
common law negligence and strict liability
                                                    manufacturer. 9
claims and state law defective
manufacture and mislabeling claims
against the manufacturer of a pacemaker
that was given FDA clearance under the                     8
                                                            Mitchell v. Collagen Corp., 126
§ 510(k) “substantial equivalence”                  F.3d 902, 911 (7th Cir. 1997).
process. Lohr’s complaint stemmed from                     9
                                                               Most circuits have followed
a defective lead in her pacemaker.
                                                    Justice Breyer’s concurrence in Lohr,
        A plurality of the Lohr Court held          which suggests that § 360k(a) preempts
t h a t Loh r’s claim s aga inst th e               some, but not all, common law claims.
manufacturer of the § 510(k)-approved               518 U.S. at 506 (Breyer, J., concurring);
pacemaker were not preempted. Key to                see, e.g., M artin v. Medtronic, 254 F.3d
                                                    573 (5th Cir. 2001); Brooks v. Howmedica,
                                                    Inc., 273 F.3d 285 (8th Cir. 2001); Kemp
       7
           Michael’s claims for breach of           v. Medtronic, Inc., 231 F.3d 216 (6th Cir.
express warranty (based on the heart                2000); Mitchell v. Collagen Corp., 126
valve’s packaging materials) and fraud              F.3d 902 (7th Cir. 1997). Where the
( b a s e d o n t h e m a n u f a cturer’ s         federal requirement at issue is specifically
advertisements and promotional                      applicable to a particular device, Justice
materials), neither of which were the               Breyer concluded, any state common law
subject of the FDA’s PMA approval, were             claim implicating that device is preempted.
held not to be preempted because those              Id. at 505. Justice Breyer concurred with
claims arising out of p r i v ate                   the plurality’s decision that a common law
representations—as distinct from state              claim against a § 510(k)-approved device
requirements—were merely state-enforced             is not preempted, because
common law remedies, and not state-                 § 510(k) does not impose a federal
imposed common law remedies. 46 F.3d                requirement that is specifically applicable
at 1325-31.                                         to a particular device.

                                              -7-
      1. The Federal Requirement                            the federal requirements
                                                            [imposed under § 510(k)]
   A. General Analysis of the Federal
                                                            reflect important but
             Requirement
                                                            entirely generic concerns
       The primary element distinguishing                   about device regulation
Lohr from the instant case is the fact that                 generally, not the sort of
the HeartMate received FDA approval                         concerns regarding a
through the rigorous § 360e(c) PMA                          specific device or field of
process, not through the § 510(k)                           device regulation that the
“substantial equivalence” process. The                      statute or regulations were
Lohr decision did not address the issue of                  designed to protect from
whether the PMA process imposed federal                     potentially contradictory
requirements under                                          state requirements.
§ 360k(a). It suggested, however, that the
analysis would have been significantly
                                                     518 U.S. at 501.
different if the device at issue in Lohr had
weathered a more exacting federal                           We hold that the requirements
investigation, such as the PMA process.              imposed by the FDA upon the HeartMate
Lohr, 518 U.S. at 501. Indeed, the Lohr              when it was granted PMA approval are
plurality distinguished the case from “a             precisely “the sort of concerns regarding a
case in which the Federal Government has             specific device” which the Supreme Court
weighed the competing interests relevant             intimated would give rise to preemption
to the particular requirement in question,           under
reached an unambiguous conclusion about
                                                     § 360k(a). This portion of our decision in
how those competing considerations
                                                     Michael v. Shiley, Inc., 46 F.3d at 1324,
should be resolved in a particular case or
                                                     remains unchanged by the Lohr decision.10
set of cases, and implemented that
conclusion via a specific mandate on
manufacturers or producers.” Id.
                                                            10
                                                               In re Orthopedic Bone Screw
      Furthermore, in response to the                Prods. Liab. Litig., 159 F.3d 817, 825 (3d
pacemaker manufacturer’s argument that               Cir. 1998), is not to the contrary.
Lohr’s state common law claims were                  Orthopedic, a § 501(k) case, in dealing
preempted by the FDA’s “good                         with the alternate holding of Michael
manufacturing practices” regulations, 21             respecting the claim of fraud on the FDA,
C.F.R. §§ 820.20-820.198 (1995), and by              concluded that Lohr had overruled the
the FDA labeling regulations requiring               alternate holding without affecting the
devices to carry warnings, 21 C.F.R. §               preemption determination or any other
801.109 (1995), the Lohr plurality stated:           holdings of the Michael opinion. This
                                                     aspect of Orthopedic came into question

                                               -8-
                                                    three years with a substantial amount of
                                                    amendments and responses to FDA
        In this case, the HeartMate’s PMA
                                                    questions.    In 1994, after extensive
process began in 1975 when its basic
                                                    review of TCI’s application, the FDA
design was completed. In 1985, after ten
                                                    approved the HeartMate for commercial
years of live animal and human cadaver
                                                    sale in the form specified in the
studies, the HeartMate was granted an
                                                    application.
investigational device exemption (“IDE”)
by the FDA in order to begin clinical                         There is no doubt that, as a
trials. Over the next seven years, clinical         practical reality, the PMA process
trials of the HeartMate were conducted at           imposed requirements that were
various hospitals. During this period, TCI          specifically applicable to the HeartMate,
submitted more than ninety supplements to           and that triggered preemption under §
the FDA, and the FDA made numerous                  360k(a). It imposed mandatory conditions
inquiries about the HeartMate and its               — created through a decades-long process
clinical trials, including correspondence           of correspondence, clinical testing and
concerning a leak from the HeartMate’s              device alteration — pertaining to the
screw ring and approval of subsequent               HeartMate’s manufacturing, packaging,
design changes (i.e., the addition of the           storage, labeling, distribution and
bonding agent and suture). In 1992, TCI             advertising. See 21 C.F.R. §§ 814.39,
submitted its PMA application to the                814.80 (setting forth requirement that
FDA, and supplemented it in the ensuing             PMA approval be obtained before device
                                                    may be manufactured or marketed, and
                                                    method for supplementing PMA
when the Supreme Court in Buckman Co.               application). Other Courts of Appeal have
v. Plaintiffs' Legal Comm., 531 U.S. 341            held that PMA approval by the FDA
(2001), held that a fraud on the FDA claim          constitutes approval of the product’s
brought as a state cause of action was              d e s i g n , testin g , i n t e n ded use ,
impliedly preempted without expressing              manufacturing methods, performance
any view on whether such a claim was                standards and labeling that is specific to
expressly preempted by § 360k(a). See id.           the product. See Brooks v. Howmedica,
at 348 n.2.                                         Inc., 273 F.3d 785, 795-96 (8th Cir.
                                                    2001); Kemp v. Medtronic, Inc., 231 F.3d
       See also Martin v. Medtronic, 254            216, 226-27 (6th Cir. 2000); Mitchell v.
F.3d 573, 583 (5th Cir. 2001), which held           Collagen Corp., 126 F.3d 902, 913 (7th
that Lohr did not overrule the Fifth                Cir. 1997). But see Goodlin v. Medtronic,
Circuit’s prior precedent established in            Inc. 167 F.3d 1367, 1377 (11th Cir.
Stamps v. Collagen Corp., 984 F.2d 1416
(5th Cir. 1993), and that the state law
claims asserted in Martin were preempted.


                                              -9-
1999).11                                                   While we acknowledge that the
                                                     FDA’s interpretation of statutes that it has
            B. The FDA’s Position12
                                                     been charged by Congress with enforcing

       11
         The Eleventh Circuit was alone
among the Courts of Appeals when it ruled            96. Here, the FDA’s position has been
in Goodlin that § 360k(a) does not preempt           expressly authorized by the Solicitor
common law claims involving PMA-                     General of the United States. Justice
approved devices. Goodlin, 167 F.3d at               Breyer was prescient in acknowledging
1368. The Tenth Circuit has ruled that the           the FDA’s position when he wrote:
Act did not preempt a plaintiff’s common                   The . . . FDA is fully
law tort claim against a medical device                    responsible             for
manufacturer, but the device at issue in                   administering the [Act].
that case did not undergo the § 360e(c)                    That responsibility means
PMA analysis, but rather underwent the far                 informed          agency
less rigorous Investigative Device                         involvement and, therefore,
Exception (IDE) process.           Oja v.                  special understanding of the
Howmedica, 111 F.3d 782 (10th Cir.                         likely impact of both state
1997).                                                     and federal requirements, as
                                                           well as an understanding of
       12
          The dissent in its footnote 2                    whether (or the extent to
argues that the FDA’s position on                          which) state requirements
preemption is entitled only to “near                       may interfere with federal
indifference,” thereby contending that we                  objectives. The FDA can
should disregard the FDA’s interpretation                  translate          these
of Lohr as well as its unique qualification                understandings into
to determine whether its regulations and                   particularized pre-emptive
interpretation of the FDA statute (21                      intentions accompanying its
U.S.C. § 360k(a)) fulfill the purposes and                 various rules and
objectives of Congress. In denying the                     regulations.       It can
import of the FDA’s position, which it has                 communicate those
particularized in its Amicus Brief with                    intentions, for example,
respect to the HeartMate, the dissent has                  through statements in
not given weight to the instruction                        regulations, preambles,
furnished to us by the Supreme Court in                    interpretive statements, and
Lohr.                                                      responses to comments.
       That Court stated that “Congress
has given the FDA a unique role in                   Id. at 505-06 (Breyer, J., concurring in
determining the scope of § 360k’s pre-               part) (internal citations and quotations
emptive effect.” Lohr, 518 U.S. at 495-              omitted).

                                              -10-
is not fully dispositive of the issues here,                 execution of the full
the Supreme Court has instructed us that                     purposes and objectives of
the FDA’s preemption determinations are                      Congress, and, therefore,
significant and should inform our                            whether it should be
interpretation of § 360k(a). Indeed, the                     pre-empted.
Supreme Court’s decision in Lohr was
“substantially informed” by the FDA, in
the context of § 510(k). Lohr, 518 U.S. at            Lohr, 518 U.S. at 495-96 (internal
495. Hence, we have no hesitation in                  citations and quotations omitted).
looking to the FDA for its interpretation of
                                                             Horn, in her brief before us, relied
§ 360k(a) in the medical device context.
                                                      heavily on an FDA amicus curiae
Lohr stated:
                                                      submission filed with the Supreme Court
       The FDA regulations                            in opposition to certiorari in Smiths
       interpreting the scope of §                    Industries Medical Systems, Inc. v.
       360k’s pre-emptive effect                      Kernats, 522 U.S. 1044 (1998). However,
       support the Lohrs’ view,                       those views have been expressly
       and our interpretation of the                  disclaimed and rejected by the FDA in its
       pre-emption statute is                         Amicus Curiae Letter Brief to this Court.
       substantially informed by                      In its current brief, the FDA has
       those regulations . . .                        unequivocally expressed the opinion that
       Congress has given the                         state common law claims such as those
       FDA a unique role in                           made by Horn against a PMA-approved
       determining the scope of §                     device are preempted.         With great
       360k’s pre-emptive effect .                    particularity, the FDA specifically
       . . [I]n most cases a state                    addressed the HeartMate and concluded
       law will be pre-empted only                    that because the device was the subject of
       to the extent that the FDA                     PMA approval under § 360e(c), and not
       has promulgated a relevant                     the subject of “substantial equivalence”
       federal ‘requirement.’                         clearance under § 510(k), the state law
       Because the FDA is the                         claims asserted by Horn are preempted.13
       federal agency to which
       Congress has delegated its
                                                             13
       authority to implement the                               This is the FDA’s present
       provisions of the Act, the                     opinion. See FDA Amicus Curiae Letter
       agency is uniquely qualified                   Br., Horn v. Thoratec Corp., No. 02-4597
       to determine whether a                         (3d Cir. May 11, 2004). It is consistent
       particular form of state law                   with the FDA’s statement of interest in
       stands as an obstacle to the                   Murphree v. Pacesetter, Inc., in which it
       a c c o mp l i s h me n t a n d                argued that PMA approval by the FDA
                                                      “triggers preemption of a wide array of

                                               -11-
        The FDA, when PMA approval is                 (emphasis added).
granted, imposes federal requirements
                                                             The FDA also clearly distinguished
based on the highly detailed and
                                                      the PMA process from the § 510(k)
prescriptive nature of the PMA process
                                                      substantial equivalence process, which
and the approval order that results from it.
                                                      was the subject of the Supreme Court’s
In its Amicus Curiae Letter Brief at pages
                                                      decision in Lohr, writing:
23-24, the FDA writes:
                                                                   Unlike a section
       F D A can impose
                                                            510(k) clearance, which
       requirements by rule or
                                                            only determines whether
       order, regardless of whether
                                                            two products are
       or not the requirements
                                                            substantially equivalent,
       were initially suggested to
                                                            P M A        a p p r o v al
       the agency by an outside
                                                            consummates an exhaustive
       party . . . . Although the
                                                            inquiry into the risks and
       PMA approval order does
                                                            efficacy of a device. . . .
       not itself expressly reiterate
       all of the specific features
       the d e v ice’s design,
                                                                   In     Lohr,      not
       labeling, and manufacturing
                                                            surprisingly, the Court
       processes must have, it
                                                            premised its holding against
       specifically approves as a
                                                            preemption on the fact that
       matter of law those features
                                                            the device had been cleared
       set forth in the application
                                                            only through the Section
       and binds the manufacturer
                                                            510(k) process, a “limited
       to produce and market the
                                                            form of review.” Lohr, 518
       product in compliance with
                                                            U.S. at 478.               A
       the specifications as
                                                            manufacturer may change
       approved by FDA.
                                                            the design and labeling of a
                                                            Section 510(k)-cleared
                                                            device as long as it
                                                            continues to be substantially
requirements imposed under state tort                       equivalent to its predicate.
law.” See Statement of Interest in Support                  21 C.F.R. § 807.81. In
of Defendant Pacesetter’s Petition for                      direct contrast to the PMA
Certification for Interlocutory Appeal of                   regime, FDA does not
the United States of America at 5 & 7,                      ‘approve’ changes to a
Murphree v. Pacesetter, Inc. et al, No.                     Section 510(k)-cleared
005429-00-3 (Tenn. Circuit Ct. Dec. 12,                     device.       Rather, the
2003).                                                      manufacturer simply has to

                                               -12-
demonstrate that its device                    effectiveness only with
is still subst antiall y                       FDA’s authorization.
equivalent to its predicate.
Moreover, the range of
changes that a manufacturer             Id. at 20-21 (emphasis added).
can make to a [§ 510(k)]
                                                The dissent, in discussing Lohr v.
cleared device without
                                        Medtronic (see Dissenting Op. at __), has
getting prior authority from
                                        ignored the very salient fact that Lohr was
FDA is broader than for a
                                        a § 510k “substantial equivalence”
[PMA] approved device. A
                                        decision and not, as this case is, a
manufacturer of a cleared
                                        §360e(c) PMA case. We have discussed
device must submit a
                                        the dramatic difference between these two
Section 510(k) notice to
                                        approval processes in both Sections III
FDA only for changes that
                                        and IV of this opinion. We have
‘could significantly affect
                                        emphasized that the PMA approval
safety or effectiveness of
                                        process mandates that the manufacturer (in
the device,’ or that represent
                                        this case, TCI) produce and market the
a ‘major change’ in the
                                        HeartMate in compliance, and only in
intended use of the device.
                                        compliance, with the requirements and
21 C.F.R. § 807.81.
                                        specifications approved by the FDA. This
                                        is a far cry from the § 510k process which
                                        was the subject of Lohr, and which
       . . . For [PMA
                                        notably the Lohr Court held was “by no
devices], after a very
                                        means comparable to the PMA process.”
lengthy process involving
                                        Lohr, 518 U.S. at 478-79.
thousands of pages of
documentation and many                         This significant distinction is
hours of expert analysis, and           understandably absent from the dissent’s
often including substantial             discussion because, as we point out in this
give-and-take between the               opinion, any effort by Horn to prove her
agency         and       the            general common law claims of negligence,
m a nu f acturer, FDA                   labeling or deficient design would
approves a new device,                  necessarily differ from, or add to, the
including detailed                      design, manufacturing or labeling
specifications for its design,          approved and pre-empted by the FDA.
manufacture, performance,               See 21 U.S.C. § 360k(a); 21 C.F.R. §
labeling, and use. Any of               808.1(b) (see p. 17, infra, for text of
these specifications may be             regulation); Kemp v. Medtronic, Inc., 231
changed in [a] way that                 F.3d 216 (6th Cir. 2000); Mitchell v.
affects safety and                      Collagen Corp., 126 F.3d 902 (7th Cir.

                                 -13-
1997), Papike v. Tambrands, Inc., 107                           Horn.
F.3d 737 (9th Cir. 1997), and Michael v.
                                                                       The only state requirements
Shiley, Inc., 46 F.3d 1316, 1323 (3d Cir.
                                                                asserted by Horn are general requirements
1995).
                                                                stemming from state common law: the
          Thus, the District Court’s position,                  HeartMate was designed in a defective
the FDA’s position, and our position are                        manner, it was manufactured in a
all in accord: the FDA’s PMA approval of                        defective manner, and the manufacturer
the HeartMate imposed specific federal                          had failed to warn of the alleged defects.
requirements upon the HeartMate under §                         The thrust of Horn’s Complaint was that
360k(a) which, as we explain infra,                             had the screw ring been of a better and
preempts Horn’s state common law                                more feasible design and had something
claims. Cf. Hawkins v. Leslie’s Pool                            more durable than a suture been used or
Mart, Inc., 184 F.3d 244, 250-51 (3d Cir.                       had the threaded sleeve with the eyelet
1999) (holding that labeling claims were                        been placed differently in Mr. Horn’s
preempted by similar preemption clause in                       body, his death would not have resulted.14
Federal Insecticide, Fungicide and
                                                                       Horn has never claimed that
Rodenticide Act because, in contrast to
                                                                Pennsylvania has established a
§ 510(k) approval, the EPA had
                                                                requirement of specific device content
i n c o r p o r a te d s p e c i f i c l a b e l i n g
                                                                pertaining to the HeartMate.15 She has
requirements that could not be changed
                                                                never alleged that Pennsylvania requires
without pre-approval).
                                                                all sutures for the HeartMate to be
          2. The State Requirement                              fabricated from a substance different than
                                                                the suture which the FDA has approved.
     A. General Analysis of the State
              Requirement
                                                                        14
        The remaining issue is whether                                    Horn does not allege that TCI
Horn’s state common-law claims                                  failed to comply with the requirements
constitute state requirements with respect                      imposed by the FDA when it approved the
to the HeartMate which are different from,                      HeartMate. At oral argument, counsel for
or in addition to, the federal requirements.                    Horn twice stated that Horn was not
See 21 U.S.C. § 360k(a). As we noted                            making such an allegation. Tr. at 7:20-
earlier, it is firmly established that a                        8:12 & 10:12-14.
“requirement” under § 360k(a) can                                       15
                                                                          Pennsylvania’s only medical
include legal requirements that arise out of                    device requirements which are specifically
state common-law damages actions. See                           exempt from preemption arise under the
Gile, 22 F.3d at 541-42. Consequently,                          Pennsylvania Hearing Aid Sales
the only matter that we must resolve is                         Registration Law, 35 P.S. §§ 6700-504(4),
whether § 360k(a) preempts the particular                       6700-506, 6700-507(2), see also 21
state common law claims brought by                              C.F.R. § 808.88.

                                                         -14-
Nor has she ever alleged that there are              regulations at 21 C.F.R. § 808.1(d).17
specific requirements mandated by the                They have also considered the impact
Commonwealth of Pennsylvania as to how               upon the FDA’s PMA approval of a
a medical device such as the HeartMate               medical device when general state tort law
must be fabricated or designed or                    claims alleging negligence, design defects,
implanted within the patient’s body.                 failure to warn, and the like, are filed
Indeed, if Horn had alleged any                      against the manufacturer of the device.
“requirement” similar to these it would              See, e.g., Martin v. Medtronic, 254 F.3d
have been fatal to her claims, because each          573 (5th Cir. 2001).
of them would have either been in
                                                             In Lohr, the plaintiff sued
addition to, or different from, the federal
                                                     Medtronic for negligent manufacture and
requirements imposed through the FDA’s
                                                     failure to warn, essentially the same claims
PMA approval of the HeartMate.
                                                     Horn has brought against TCI. The four-
       In the absence of any specific                judge plurality in Lohr concluded that
device requirements,16 we are left with              those claims “escape[d] pre-emption, not
Horn’s general common law claims of                  because the source of the duty is a judge-
negligence, defective design, etc. The               made common-law rule, but rather
question that remains is: can Horn’s                 because their generality leaves them
common law “general” claims, which are               outside the category of requirements that
not specific “with respect to” the
HeartMate, constitute “requirements” that
                                                            17
survive preemption under                                       21 C.F.R. § 808.1(d) provides:
                                                            State or local requirements
§ 360k(a)?                                                  are preempted only when
       Our analysis begins, as it must,                     the Food and Drug
with the Lohr decision. Both Horn and                       A d m i n i st r a t io n h a s
TCI, as well as the authorities that have                   e s t a b l i s h e d s p e ci f i c
considered FDA preemption under §                           counterpart regulations or
360k(a), have understandably read                           there are other specific
Medtronic v. Lohr as a starting point for                   requirements applicable to a
interpreting § 360k(a) and the FDA’s                        particular device under the
                                                            act, thereby making any
                                                            existing divergent State or
                                                            local r e q u i r ements
                                                            applicable to the device
                                                            different from, or in
       16
        In her June 2004 Letter Brief at                    addition to, the specific
10, Horn wrote: “In this case, Ms. Horn                     Food             and     Drug
does not rely on any device-specific                        Admi nistration
requirements.”                                              requirements. . .

                                              -15-
§ 360k envisioned to be ‘with respect to’            for the proposition that the lower federal
specific devices such as pacemakers.”                courts do not give “much precedential
Lohr, 518 U.S. at 502.                               weight” to a concurring opinion of the
                                                     United States Supreme Court, even where
        Although Justice Breyer joined in
                                                     the concurring opinion is compatible with
the section of the plurality’s opinion in
                                                     the majority opinion. See Dissenting Op.
which that statement appeared, he wrote
                                                     at ___. We disagree, as this principle has
separately to emphasize that, unlike the
                                                     no application to this case. Sandoval
plurality, he was “not convinced that
                                                     bears little resemblance to the situation in
future incidents of [§ 360k(a)] pre-
                                                     Lohr. In Sandoval, Justice Scalia merely
emption of common-law claims will be
                                                     observed that the opinion of a three-
‘few’ or ‘rare.’” Id. at 508 (Breyer, J.,
                                                     member concurrence in Lau v. Nichols,
concurring in part). As we read Justice
                                                     414 U.S. 563 (1974), was not binding
Breyer’s concurring opinion, a state
                                                     precedent on an issue that the five-member
common law claim need not be developed
                                                     majority in Lau did not reach. In Lohr, by
specifically “with respect to” a particular
                                                     contrast, Justice Breyer cast the so-called
medical device in order to be preempted.
                                                     “swing vote,” which was crucial to the
It would make little sense for Justice
                                                     outcome of the case and without which
Breyer to write separately to emphasize
                                                     there could be no majority. Moreover,
that duties arising under state law can
                                                     Justice Breyer did not discuss issues in his
regularly lead to preemption, but
                                                     concurring opinion that Justice Stevens,
simultaneously agree with the plurality
                                                     writing on behalf of the four-judge
that tort duties are almost always too
                                                     plurality, did not reach.
general to warrant preemption. See
Papike v. Tambrands, Inc., 107 F.3d 737,                    Splintered opinions by the Supreme
742 (9th Cir. 1997). The more logical                Court often result in some confusion as to
reading of Justice Breyer’s concurring               which opinion or rationale is binding on
opinion is that a court should carefully             the lower federal courts. In an attempt to
examine the state common law claim in                provide some guidance in such situations,
order to determine whether that claim                the Supreme Court has instructed that the
would impose a substantive requirement               lower courts should follow the rationale
that conflicts with, or adds a greater               “taken by those Members who concurred
burden to, a specific federal requirement.           in the judgments on the narrowest
See Mitchell v. Collagen Corp., 126 F.3d             grounds.” Gregg v. Georgia, 428 U.S.
902, 911-12 (7th Cir. 1997); Kemp v.                 153, 169 n.15 (1976) (plurality opinion);
Medtronic, 231 F.3d 216, 230 (6th Cir.               see also Marks v. United States, 430 U.S.
2000); Martin v. Medtronic, 254 F.3d                 188, 192-93 (1977) (stating that, “[w]hen
573, 581-83 (5th Cir. 2001).                         a fragmented Court decides a case and no
                                                     single rationale explaining the result
      The dissent cites to Alexander v.
                                                     enjoys the assent of five Justices, ‘the
Sandoval, 532 U.S. 275, 285 n.5 (2001),

                                              -16-
holding of the Court may be viewed as                 in other parts. Our dissenting colleague
that position taken by those Members who              emphasizes that Justice Breyer joined in
concurred in the judgments on the                     Part V of the plurality opinion, in which
narrowest grounds . . . .’”); Planned                 Justice Stevens concluded that the Lohrs’
Parenthood of Southeastern Pa. v.                     common-law claims did not constitute
Casey, 947 F.2d 682, 693 (3d Cir. 1991)               specific state requirements because they
(discussing in detail the “narrowest                  were not “specifically developed ‘with
ground” principle), modified on other                 respect to’ medical devices.” Lohr, 518
grounds, 505 U.S. 833 (1992).                         U.S. at 501. This was not a principle that
                                                      received Justice Breyer’s agreement. In
        If the “narrowest ground” approach
                                                      his concurring opinion, Justice Breyer
is applied to Lohr, Justice Breyer’s
                                                      states that he must address two issues: (1)
opinion takes on added significance.
                                                      whether the FDA can “ever pre-empt a
Whereas Justice Stevens concluded that “§
                                                      state-law tort action;” and (2) if so,
360(k) simply was not intended to pre-
                                                      whether the FDA pre-empts the claims
empt most, let alone all, general common-
                                                      brought by Lohr. Id. at 503 (Breyer, J.,
law duties enforced by damages actions,”
                                                      concurring in part and dissenting in part).
see Lohr, 518 U.S. at 491, Justice Breyer
concluded that “ordinarily, insofar as the
[FDA] pre-empts a state requirement                           In response to the first question,
embodied in a state statute, rule,                    Justice Breyer expressly states that he
regulation, or other administrative action,           “basically agree[d]” with Justice
it would also pre-empt a similar                      O’Connor’s discussion of that point in her
requirement that takes the form of a                  dissenting opinion. Justice O’Connor
standard of care or behavior imposed by a             concluded that “a fair reading of [§
state-law tort action.” Id. at 504-05                 360k(a)] indicates that state common-law
(Breyer, J., concurring in part and                   claims are pre-empted, as the statute itself
dissenting in part). Thus, Justice Breyer’s           states, to the extent that their recognition
rationale is the more narrow of the two               would impose ‘any requirement’ different
because, although the Lohrs’ claims were              from, or in addition to, FDCA
not preempted by § 360k(a), he was not                requirements applicable to the device.”
prepared to join in Justice Stevens’                  Id. at 512 (O’Connor, J., dissenting).
sweeping pronouncement that § 360k                    Interestingly, Justice O’Connor also
almost never preempts a state common                  observed that “[t]he statute itself makes no
law claim.                                            mention of a requirement of specificity,
                                                      and there is no sound basis for
       Of course, the splintered decision
                                                      determining that such a restriction on ‘any
in Lohr is unique because Justice Breyer
                                                      requirement’ exists.” Id.
joined in some parts of Justice Stevens’
plurality opinion (thus making it a                           Thus, on the state requirement
majority opinion at times), but did not join          issue, Justice Breyer joined with the four-

                                               -17-
member dissent to make a majority.18 It                come unscrewed in spite of the presence
seems that he merely parted ways with                  of the suture. This claim unquestionably
Justice O’Connor when it came time to                  would require TCI to alter the
apply that rationale to the state common-              HeartMate’s design by using either a
law claims (in a § 510(k) context) before              different suture or screw ring. Yet the
the Court.                                             HeartMate’s design as approved by the
                                                       FDA would remain approved by the FDA
       Although in Lohr the plurality
                                                       for national distribution and sale, and any
opinion did not inform us of when
                                                       changes to the design would require
common law requirements may become
                                                       further FDA review and approval.20
substantive requirements, we are satisfied
that Horn’s general state law claims19
would impose substantive requirements on
                                                              20
TCI that would conflict with, or add to,                        The Product Liability Advisory
the requirements imposed by the FDA                    Council writes in its amicus curiae brief:
involved in the design, manufacturing,                       Even supposing one jury could
fabrication and labeling of the HeartMate.                   provide manufacturers with proper
For example, Horn’s Complaint alleges                        incentives to make its products
that the HeartMate was negligently                           safer, what about every jury? If the
designed such that the screw ring could                      PMA process does not preempt
                                                             state product liability suits [and
                                                             general common law claims]
       18
           This can be characterized as a                    imposing requirements at odds with
“dual majority” case because Justice                         the approved PMA, then juries in
Breyer joined with the plurality on the                      every state will influence device
result (i.e., no pre-emption), but joined                    regulation, in numerous and often
with the dissent as to the rationale (i.e., a                conflicting ways. See Brooks [v.
state common law claim can be pre-                           Howmedica, Inc.], 273 F.3d at 797
empted by § 360k even though it was not                      (“The arguments advanced by
specifically developed “with respect to” a                   Brooks ignore the need for national
particular medical device). See Note, The                    uniformity in product regulation,
Precedential Value of Supreme Court                          one of the explicit goals of the
Plurality Decisions, 80 Colum. L. Rev.                       MDA.” (citing H.R. Rep. No. 853,
756, 767-69 (1980) (discussing dual                          45 (1976) (“If a substantial number
majority cases).                                             o f d i f f e r i n g r eq u i r e me n ts
                                                             applicable to a medical device are
       19
           Horn emphasized in her June                       imposed by jurisdictions other than
2004 Letter Brief at 7 that “the claims in                   the Federal government, interstate
this case are based on state law claims of                   commerce would be unduly
general applicability, not requirements                      burdened.”).         Unless products
specific to devices.”                                        liability claims [and general

                                                -18-
        As TCI has pointed out in its brief,           with § 360k(a) in that they are either in
“[Horn’s] design defect claims . . . would             addition to, or different from, the federal
require TCI either to use an entirely                  requirements established by the FDA in
different design than the screw ring to                approving the HeartMate, they are
connect the outlet elbow to the pump, or               necessarily preempted by federally
to use different materials instead of a                imposed PMA requirements under §
suture, or to place the eyelet in a different          360k(a).22 See, e.g., Kemp, 231 F.3d at
position. Similarly, her failure-to-warn
claims would require TCI to provide
different warnings and instructions from                      22
                                                                    Similarly, Horn’s claim
those approved by the FDA.” TCI Br. at                 respecting TCI’s negligence in not
45. TCI is prohibited, however, by the                 furnishing a ‘Dear Doctor’ letter “warning
FDA’s PMA approval order from making                   that the heart pump shouldn’t be installed
any such changes. See 21 C.F.R. 814.80.21              if the sutures would face upward, toward
       Because these state common law                  the sternum,” Horn, June 2004 Letter Br.
claims and duties are in severe tension                at 9, is preempted as it would either add
                                                       to, or differ from, the federal requirement
       common law claims] such as                      establishing the design of the HeartMate.
       plaintiff’s are preempted, the                  See Mitchell v. Collagen Corp., 126 F.3d
       FDA’s expert determinations will                at 913-14 (“[T]o the extent that [the
       be supplanted by a myriad of                    Mitchells’ mislabeling, misbranding and
       common law regulators, each one                 adulteration] allegations claim that
       less likely than the FDA to reach a             Collagen has incurred liability under state
       right result.                                   law despite its conformity to the
                                                       requirements of the PMA, the state law
       21
          21 C.F.R. § 814.80 provides that             claims must be considered preempted.”).
a device may not be manufactured,                              Insofar as Horn’s claim is premised
labeled, etc. in a manner inconsistent with            on the adequacies of the warnings
any conditions to approval specified in the            reviewed and approved by the FDA in its
PMA approval order. TCI would have to                  PMA approval order, it is also preempted.
submit a supplemental PMA application                  See Martin, 105 F.3d at 1100 (“To allow
setting forth its proposed changes and                 a state cause of action for inadequate
seeking FDA approval of those changes.                 warnings would impose different
21 C.F.R. § 814.3a(d). If the FDA were to              requirements or requirements in addition
reject TCI’s application, TCI would be left            to those required by federal regulations.”).
in the untenable and unenviable position               The PMA includes specimens of the
of having to comply with conflicting state             labeling proposed to be used for the
and federal requirements; precisely the                device, 21 U.S.C. § 360e(c)(1)(F), and this
conflict the § 360k(a) preemption                      labeling must provide “adequate directions
provision is meant to avoid.                           for use.” 21 U.S.C. § 352(f). Moreover,

                                                -19-
228-37; Mitchell, 126 F.3d at 911-15,                        requirement imposed by]
Papike, 107 F.3d at 741-42.                                  FDA. . .
              B. The FDA’s Position
        Our preemption conclusion is                                 There is no allegation
reenforced by the informed analysis found                    that the HeartMate’s design,
in the FDA’s amicus curiae brief. The                        labeling, or methods of
FDA has clearly expressed its view that                      manufacture deviated from
PMA approval in this particular case                         those set forth in the PMA
requires preemption. The FDA conceives                       approved by FDA.
of Horn’s state common law claims as                         Accordingly, any finding of
imposing a “requirement” which is                            liability based upon TCI’s
“different” from that imposed by the FDA                     failure to satisfy a standard
in the PMA process, and thus requiring                       differe n t f r o m those
preemption. In its Amicus Curiae Letter                      approved by FDA in the
Brief,23 the FDA wrote:                                      P M A process w o u ld
                                                             necessarily rest upon an
                 . . . Here, plaintiff
                                                             implicit requirement that
         seeks to impose liability
                                                             this device be designed,
         based on asserted flaws in
                                                             manufactured or marketed
         the design, labeling and
                                                             in a way that differs from
         manufacture of the
                                                             the way approved by FDA.
         HeartMate as approved by
         FDA despite the fact that it                  (emphasis added).
         c o mp l i e d w i t h F DA
                                                              With respect to the impact of state
         requirements.          Thus,
                                                       common law tort claims on the federal
         plaintiff does attempt to
                                                       regulatory framework for medical devices,
         impose a requirement
                                                       the FDA wrote:
         different from [th e
                                                                    State common law
                                                             tort actions threaten the
PMA approval expresses the FDA’s                             statutory framework for the
determination that the proposed labeling                     regulation of medical
meets the detailed labeling requirements                     devices, particularly with
set forth in its regulations. Any changes in                 regard to FDA’s review and
the design, labeling or manufacturing                        approval o f p r o d u ct
processes that affect safety and                             labeling. State actions are
effectiveness must receive FDA approval.                     not characterized by
                                                             centralized expert
         23
              FDA Amicus Curiae Letter Br. at                evaluation of devic e
17-18.

                                                -20-
regulatory issues. Instead,             Id. at 25-26.24
they encourage, and in fact
                                              The FDA’s views in its Amicus
require, lay judges and
                                        Curiae Letter Brief in this case echo the
juries to second-guess the
                                        opinion it has voiced in another recent
balancing of benefits and
                                        case. In a brief submitted to the Circuit
risks of a specific device to
                                        Court of Tennessee in Murphree v.
their intended patient
                                        Pacesetter, Inc., et al., the FDA expressed
population – the central role
                                        concerns about the consequences of not
of FDA – sometimes on
                                        preempting state common law claims such
behalf of a single individual
                                        as Horn’s:
or group of individuals.
That individualized                                   [I]t is inappropriate
redetermination of the                         for a jury to second-guess
benefits and risks of a                        FDA’s scientific judgment
product can result in relief –                 on such a matter that is
including the threat of                        within FDA’s particular
significant damage awards                      expertise. FDA determines
or penalties – that creates                    the scope of a device,
pressure on manufacturers                      including the components it
to add warnings that FDA                       comprises, and the
has neither approved, nor                      appropriate regulatory
found to be scientifically                     pathway for the device. . . .
required, or withdrawal of                     FDA subsequently
FDA-approved products                          determines whether the
from the market in conflict                    device meets the PMA
with the agency’s expert                       approval standard.       The
determination that such                        agency makes a reasoned
products are safe and                          and deliberate decision as to
effective. This situation can
harm the public health by
retarding research and                         24
                                                   Martin v. Telectronics Pacing
developme n t and by                    Sys., Inc., 105 F.3d 1090 (6th Cir. 1997)
encouraging ‘defensive                  (“Thus, because under the federal
labeling’ by manufacturers              requirement the FDA has determined that
to avoid state liability,               the benefits of the device outweigh the
resulting in scientifically             risks and, under the state requirement, a
unsubstantiated warnings                jury in a state court action could conclude
and underutilization of                 that the risks outweigh the benefits, the
beneficial treatments.                  state requirement is different from the
                                        federal requirement.”).

                                 -21-
       the correct pathway of                         that we should give no weight to the
       regulation and whether to                      FDA’s interpretation because the FDA
       approve the device. Juries                     previously argued that PMA approval did
       l a c k t h e sc i e n t if ic                 not support preemption, and in any event,
       knowledge and technical                        the FDA’s interpretation is entitled only to
       expertise necessary to make                    “near indifference.” See Dissenting Op.
       such judgments. . . .                          fn.2 and Maj. Op. fn.12, supra. We
                                                      cannot agree that the FDA’s position is
                                                      entitled to no deference, or “near
              [T]he prospect of                       indifference” simply because it represents
       hundreds of individual                         a departure from its prior position. In
       juries determining the                         Chevron U.S.A. Inc. v. Natural Resources
       propriety of particular                        Defense Council, Inc., 467 U.S. 837, 863-
       device approvals, or the                       64 (1984), the Supreme Court held that a
       appropriate standards to                       revised interpretation by an agency is
       apply to those approvals, is                   entitled to deference because “[a]n initial
       the antithesis of the orderly                  agency interpretation is not instantly
       scheme Congress put in                         carved in stone.” Accordingly, an agency
       place and charged the FDA                      may change its course so long as it can
       with implementing.                             justify its change with a “reasoned
                                                      analysis,” see Motor Vehicle Mfrs. Ass’n v.
                                                      State Farm Mut. Auto. Ins. Co., 463 U.S.
              Such uncertainty as                     29, 42 (1983), and we are fully persuaded
       to the status of medical                       that this standard has been met.25
       devices would create chaos
                                                                          V.
       for both the regulated
       industry and FDA.

                                                             25
                                                               See United States v. Mead Corp.,
Statement of Interest of the United States            533 U.S. 218, 228 (2001) (“The weight
of America at 7-9, Murphree v.                        accorded to an administrative judgment in
Pacesetter, Inc. et al, No. 005429-00-3               a particular case will depend upon the
(Tenn. Circuit Ct. Dec. 12, 2003).                    thoroughness evident in its consideration,
       As we discussed earlier, a majority            the validity of its reasoning, its
of the Court in Lohr emphasized that the              consistency with earlier and later
FDA is “uniquely qualified” to determine              pronouncements, and all those factors
whether a particular form of state law . . .          which give it power to persuade, if lacking
should be pre-empted” by § 360k. Lohr,                power to control.”) (internal citations and
518 U.S. at 496. Horn contends, however,              quotations omitted).


                                               -22-
      Horn has not asserted that TCI has              (“When Congress has considered the issue
in any way failed to conform with the                 of pre-emption and has included in the
FDA                                                   enacted legislation a provision explicitly
                                                      addressing that issue, and when that
 requirements prescribed by its PMA—nor
                                                      provision provides a reliable indicium of
that it deviated from, or violated, any of
                                                      congressional intent with respect to state
the FDA’s federal statutes or regulations.
                                                      authority, there is no need to infer
Because the design of the HeartMate, the
                                                      congressional intent to pre-empt state laws
labeling and the instructions for its use,
                                                      from the substantive provisions of the
and the specification of the suture and its
                                                      legislation.”) (citations and internal
location when the HeartMate is implanted,
                                                      quotations omitted). We therefore do not
as well as the other requirements imposed
                                                      address the dissent’s arguments predicated
by the PMA, were the subject of extensive
                                                      on “implied preemption.”
consideration by the FDA leading up to its
PMA approval, any finding in Horn’s                           As a consequence we, together with
favor based on her general claims of                  our sister Courts of Appeal who have read
negligence or defective design and                    Lohr in the same fashion as we have,26 and
manufacture—be it by a jury or a                      together with the FDA’s current position,
court—would necessarily amount to a                   hold that Horn’s claims are preempted by
state substantive requirement “different              § 360k(a). We will affirm the judgment of
from, or in addition to, the federal                  the District Court granting summary
requirements imposed by the FDA.” Any                 judgment to TCI.
such finding would “stand as an obstacle
to the accomplishment and execution of”
the objective of the safety and
effectiveness of the HeartMate specifically
and would conflict with the federal
requirements imposed by the PMA. Geier
v. American Honda Motor Co., 529 U.S.
861, 873 (2000).
       If, as we hold, the FDA’s express
preemption clause found at 21 U.S.C. §
360k(a) pre-empts Horn’s state law                           26
                                                               See Brooks v. Howmedica, Inc.,
claims, then there is no point in discussing          273 F.3d 785 (8th Cir. 2001); Martin v.
“implied preemption,” a doctrine which                Medtronic, Inc., 254 F.3d 573 (5th Cir.
our dissenting colleague addressed at                 2001); Kemp v. Medtronic, Inc., 231 F.3d
length in an attempt to bolster his                   216 (6th cir. 2000); Mitchell v. Collagen
conclusion that Lohr, a § 510(k) opinion,             Corp., 126 F.3d 902, 913-14 (7th Cir.
governs this case. See Cipollone v.                   1997); Papike, 107 F.3d 737, 742 (9th Cir.
Liggett Group, Inc., 505 U.S. 504 (1992)              1997).

                                               -23-
Barbara E. Horn v. Thoratec Corporation,                                  I.
No. 02-4597
                                                            I have no quarrel with the
FUENTES, Circuit Judge, dissenting.                  majority’s conclusion that the PMA
                                                     process is a specific federal regulation
        Following her husband’s death,
                                                     governing the HeartMate.27 I believe,
Barbara Horn filed a lawsuit in the U.S.
                                                     however, that the District Court erred by
District Court, under state common law,
                                                     looking only at whether the federal
alleging that her husband died as a result
                                                     regulation here (the PMA) was specific to
of TCI’s defectively designed heart pump.
                                                     a particular device, and not examining
In her complaint, she alleges that the
                                                     whether the state law under which Horn
suture on Mr. Horn’s HeartMate had worn
                                                     sued was device-specific. Horn argues
through and that the screw ring linking the
                                                     that a state common-law claim is
pump to the output side had disconnected.
                                                     preempted only if the state claim is device-
As a result, an air embolus traveled to Mr.
                                                     specific and the purportedly preempting
Horn’s brain, causing his death. The
                                                     federal regulation is device-specific. TCI
majority has concluded that Horn’s
                                                     responds that the District Court correctly
common-law claim s, grounded in
                                                     analyzed only the federal side of the
negligence and defective design, create
                                                     equation, because Medtronic, Inc. v. Lohr,
“specific requirements” under state law
                                                     518 U.S. 470 (1996), made that the only
and are therefore preempted by § 360k(a)
                                                     relevant inquiry. The Circuits are split on
of the MDA. I cannot agree, however, that
                                                     this question, with the Seventh and Ninth
Horn’s generalized common-law claims
                                                     Circuits holding that preemption requires
impose any spe cific sta te-law
                                                     only a device-specific federal regulation,
“requirements” on the HeartM ate. This is
                                                     Mitchell v. Collagen Corp., 126 F.3d 902,
because § 360k(a) preemption works only
                                                     912 (7th Cir. 1997); Papike v. Tambrands
against state requirements that are
                                                     Inc., 107 F.3d 737, 742 (9th Cir. 1997);
“different from, or in addition to” federal
                                                     and the Tenth Circuit holding that
requirements. In my view, because Horn’s
suit is not seeking to impose any specific
requirement on the HeartMate, it is not                     27
                                                               For this reason, the majority’s
preempted. Additionally, I believe that
                                                     discussion of the difference between the
allowing common-law liability would
                                                     PMA process and the § 510k “substantial
simply have the effect of encouraging TCI
                                                     equivalence” process is not relevant. Maj.
and other device manufacturers to go
                                                     Op. at 13. That difference only speaks to
above and beyond FDA standards, and this
                                                     why the PMA process is a specific federal
effect would clearly not contradict the
                                                     requirement; my disagreement with the
MDA’s purpose of enhancing medical
                                                     majority is not over the federal side of the
device safety. I therefore respectfully
                                                     equation at all, but rather over whether
dissent.
                                                     Horn’s suit implicates the state-law
                                                     specificity requirement in Lohr.

                                              -24-
preemption additionally requires a device-            preempted state common-law claims
specific state law. Oja v. Howmedica,                 premised on the unsuitability of a medical
Inc., 111 F.3d 782, 789 (10th Cir. 1997).             device under state standards more stringent
Although my colleagues acknowledge                    than the FDA standards governing the
some kind of state-law specificity                    device. Justice Breyer agreed with a four-
requirement, they effectively agree with              Justice bloc (Stevens, Kennedy, Souter and
the Seventh and Ninth Circuits in holding             Ginsburg) that the term “requirement” in §
that even the most generalized tort claims,           360k(a) is ambiguous, and does not entail
such as those in the case before us, are              the preemption of all common-law tort
preempted under § 360k(a).                            suits holding manufacturers to higher
                                                      standards than the FDA. Id. at 488-89
       I respectfully dissent from this
                                                      (Stevens, J., plurality (hereinafte r
conclusion.      The FDA regulations
                                                      “plurality”))28 ; id. at 505-06 (Breyer, J.,
concerning preemption clarify that
                                                      concurring (hereinafter “Breyer”)). The
preemption only occurs when the FDA
                                                      remaining four Justices disagreed, opining
“has established specific counterpart
                                                      that § 360k(a) bars all state-law claims,
regulations or there are other specific
                                                      common-law or otherwise, that hold
requirements applicable to a particular
                                                      manufacturers to a higher standard than
device under the act.” 21 C.F.R. §
                                                      federal regulations.        Id. at 511-12
808.1(d) (emphasis added).              The
                                                      (O’Connor, J., concurring in part and
preemption clause does not “preempt State
                                                      dissenting in part (hereinafter “dissent”)).
or local requirements of general
applicability where the purpose of the                       The plurality and Justice Breyer
requirement relates either to other products          turned to the above-quoted FDA
in addition to devices (e.g., [the UCC]) or           regulations to help determine when a
to unfair trade practices in which the                common-law claim constitutes a state
requirements are not limited to devices.”             “requirement” under § 360k(a). Id. at 498-
21 C.F.R. § 808.1(d)(1) (emphasis added).             99; id. at 505-06 (Breyer). Relying on
                                                      these regulations, the five Justices
        In 1996, the Supreme Court issued
                                                      concluded that preemption is only
Lohr, a fractured opinion that examined
                                                      triggered by specific FDA regulations
MDA preemption of state law. The
                                                      applying to a particular device, and not by
majority of the Lohr Court agreed that a
strong presumption exists in favor of a
narrow scope of preemption because                           28
                                                               To be precise, I will only use the
policing health is the traditional province
                                                      term “plurality” in reference to portions of
of the states. 518 U.S. at 485. Another
                                                      Justice Stevens’s opinion in Lohr that
key factor in analyzing the scope of
                                                      were joined by only four Justices. The
preemption is Congress’s intent in passing
                                                      portions of the Lohr opinion joined by five
the legislation. Id. at 485-86. The Court
                                                      Justices will not be accompanied by any
split, however, as to whether the MDA
                                                      parenthetical reference.

                                               -25-
generally applicable FDA regulations, i.e.,          device under the act.” 21 C.F.R. §
those governing the design or labeling of            808.1(d) (emphasis added).              The
medical devices as a whole. Id. at 500-01.           regulations go on to say that “there are
Part V of the plurality opinion, which               other State and local requirements that
Justice Breyer joined, also stated that the          affect devices that are not preempted by [§
MDA does not preempt generalized state-              360k( a ) ] b e c a u s e t h e y a r e n ot
law claims, such as negligence in                    ‘requirements applicable to a device’
manufacturing or failure to warn, as                 within the meaning of [§ 360k(a)],” id.,
opposed to state laws governing particular           and lists as an example “State or local
medical devices. Id. at 501-02.                      requirements of general applicability
                                                     where the purpose of the requirement
        Thus, Part V of the Lohr opinion,
                                                     relates either to other products in addition
which represents the views of five
                                                     to devices (e.g., [the UCC]) or to unfair
Justices, excepted generalized common-
                                                     trade practices in which the requirements
law claims like failure to warn and
                                                     are not limited to devices.” 21 C.F.R. §
negligent manufacture from the ambit of
                                                     808.1(d)(1).      This reference to the
MDA preemption. Id. at 501-02. The
                                                     specificity of state regulations would be
Lohr majority reasoned that “general state
                                                     superfluous if all that mattered was the
common-law requirements” that “were not
                                                     specificity of the federal regulation.
specifically developed ‘with respect to’
                                                     Moreover, the exemption of generalized
medical devices . . . are not the kinds of
                                                     state requirements is never qualified by the
requirements that Congress and the FDA
                                                     further condition that those requirements
feared would impede the ability of federal
                                                     infringe on a generalized federal
regulators to implement and enforce
                                                     requirement. Finally, the regulations belie
specific federal requirements.” Id. at 501.
                                                     my colleagues’ conclusion that generalized
Here, Horn’s four claims of negligence,
                                                     state requirements can be preempted if
strict liability, breach of warranty and
                                                     they merely affect the manufacture of
failure to warn are all general common-
                                                     medical devices. See Maj. Op. at 16-18
law tort claims that were not crafted
                                                     (state-law claim is preempted if it has the
specifically to govern medical devices, and
                                                     effect of imposing a greater burden on a
so are excepted from the scope of §
                                                     device manufacturer than the FDA). In
360k(a).
                                                     short, the regulations support the view that
       This conclusion is bolstered by the           state-level device-specificity is a requisite
FDA regulations on preemption, relied                for § 360k(a) preemption.
upon by the Lohr majority. As mentioned
                                                             TCI argues that the FDA has
above, the FDA has declared that
                                                     published regulations contravening the
preemption only occurs when the FDA
                                                     state specificity requirement, but the cited
“has established specific counterpart
                                                     regulations only state that in the context of
regulations or there are other specific
                                                     a particular California law “general
requirements applicable to a particular

                                              -26-
requirements not applicable to specific                        The main argument against the state
devices . . . are not preempted unless they           specificity requirement rests in the
are applied to a specific device in such a            language of Justice Breyer’s concurrence
way as to establish requirements” for an              in Lohr. After joining Part V of the
FDA-regulated device. 45 Fed. Reg.                    Stevens opinion, Justice Breyer wrote
67321, 67322. Thus, general requirements              separately that common-law claims could
are still not preempted under this                    in fact be preempted where they imposed
regulation; the only state requirements that          different standards for devices than the
are preempted are ones that affect specific           c o u n te r pa r t d e v i c e -s p e c if i c F DA
devices. Even if TCI’s interpretation of              regulations.         Lohr, 518 U.S. at 504
this statement were correct, one isolated             (Breyer).          Justice Breyer raised the
statement in the Federal Register would               example of a jury finding for a plaintiff in
not trump the actual regulations contained            a negligence suit on the grounds that a
in the C.F.R., especially when those                  hearing aid wire was longer than 1 inch,
regulations have been adopted by the                  even though FDA regulations had
Supreme Court as instructive.29                       approved wires up to 2 inches. Id. Justice
                                                      Breyer concluded that this jury award
                                                      would be preempted even though it was
       29                                             based on the generalized state tort law of
          My colleagues seem to put great
                                                      negligence because it effectively
emphasis on the FDA’s amicus brief,
                                                      established a device-specific state
which sides with TCI. Horn and Amicus
                                                      requirement of 1-inch wires for hearing
Product Liability Advisory Council have
                                                      aids. Id.
also both advanced arguments from
previous United States briefs on the scope                   My colleagues have found this
of 360k(a) preemption as evidence in                  language from Justice Breyer difficult to
favor of their views on preemption. As                reconcile with his agreement with Part V
TCI has itself pointed out, however,                  of the majority opinion, which exempted
arguments advanced by the United States               generalized state causes of action from
in a litigation brief are entitled to “near           preemption. Maj. Op. at 16. The Seventh
indifference,” and are only as persuasive             and Ninth Circuits also perceived a
as their own merits dictate. United States            contradiction and chose to ignore Justice
v. Mead Corp., 533 U.S. 218, 228 (2001)               Breyer’s vote for Part V, instead crediting
(cited in TCI Br. at 52). Notably, the Lohr           the apparently contrary reasoning in his
court gave deference to the FDA’s                     concurrence. Mitchell, 126 F.3d at 912;
regulations in particular, not to an amicus           Papike, 107 F.3d at 742. With all due
brief. 518 U.S. at 495-96. Consequently,              respect to my colleagues and these two
I believe that Lohr mandates that we obey             Circuit Courts, however, I do not believe
the regulations issued by the FDA, rather             that Justice Breyer’s concurrence is in
than the amicus brief relied upon by the              disagreement with Part V of the majority
majority.

                                               -27-
opinion.30 Justice Breyer’s opinion shows                concern that in certain situations a state
                                                         could fashion, through its common law, a
                                                         specific requirement for a particular
       30                                                device. For example, a plaintiff could sue
              My colleagues find it
                                                         under a theory of negligence per se, where
incongruous that Justice Breyer would
                                                         the negligence is premised on deviation
“write separately to emphasize that duties
                                                         from a specific state requirement for a
arising under state law can regularly lead
                                                         device (like a 1-inch hearing aid wire).
to preemption, but simultaneously agree
                                                         Similarly, a judge could give a jury
with the plurality that tort duties are
                                                         instruction telling the jury that, as a matter
almost always too general to warrant
                                                         of law, it should find a manufacturer
preemption.” Maj. Op. at 16. Not only is
                                                         negligent if it violated a certain standard
this an overstatement of Justice Breyer’s
                                                         for a device (i.e., “you should find the
language (“I am not convinced that future
                                                         manufacturer negligent if it used a hearing
incidents of MDA pre-emption of
                                                         aid wire longer than 1 inch”). Both of
common-law claims will be ‘few’ or
                                                         these examples involve a specific
‘rare’”), it also depicts a false conflict: the
                                                         requirement being imposed upon a device
plurality expressed its views on the
                                                         by the state through its common law. A
frequency of preemption in Part VI of its
                                                         simple negligence action, in contrast, does
opinion, which Justice Breyer explicitly
                                                         not impose any specific requirement on the
refused to join. Lohr, 518 U.S. at 508
                                                         device, but simply alleges that the device
(Breyer). Indeed, the fact that Justice
                                                         was designed/manufactured improperly.
Breyer explicitly declined to join Part VI
of the majority opinion highlights his clear                    In this case, because Horn’s suit is
intent to join Part V in full. Similarly, the            not seeking to impose any specific
majority somehow turns Justice Breyer’s                  requirement on the HeartMate, it is not
agreement with the Lohr dissent that “the                preempted. It is true that Horn’s cause of
MDA will sometimes pre-empt a state-law                  action may have the indirect consequence
tort suit,” id. at 503 (Breyer) (emphasis                of holding the HeartMate to a higher
added)–a statement that I entirely agree                 standard than does the FDA, but this
with–into an agreement with the Lohr                     consequence is sanctioned by Part V of the
dissent’s statement that there is no state-              Lohr opinion and not expressly barred by
law specificity requirement whatsoever.                  Justice Breyer’s concurrence. Moreover,
Id. at 512 (dissent) (quoted in Maj. Op. at              even if my colleagues were correct that the
17). To the contrary, Justice Breyer                     content of Justice Breyer’s concurrence
endorsed a state-law specificity
requirement by joining Part V of Justice
Stevens’s opinion, and this requirement                  the “narrowest ground” approach evoked
therefore “enjoys the assent of five                     by the majority is simply inapplicable to
Justices.” Marks v. United States, 430                   evade the holding of Part V of the Lohr
U.S. 188, 192-93 (1977). Accordingly,                    opinion.

                                                  -28-
contradicted Part V, the correct course of            reversed.31
action would be to follow Part V as the
                                                                          II.
majority opinion of the Supreme Court,
not to elevate a one-justice concurrence                    Because I would find no express
above the five-justice majority.       Cf.            preemption here, I would reach TCI’s
Alexander v. Sandoval, 532 U.S. 275, 285              implied preemption argument, and
n. 5 (2001) (concurrence is not given as              conclude that Horn’s claims are not
much precedential weight as majority                  impliedly preempted. Implied preemption
opinion, even if concurrence is compatible            can exist in either of two situations: (1)
with majority opinion).                               when Congress intended federal law to
        Finally, even if Justice Breyer’s
concurrence were given equal weight to
                                                             31
Part V, this jurisprudential “tie” should be                    TCI suggests in passing that Part
broken by reference to the presumption                V does not actually require state-level
against a wide scope of preemption. Lohr,             device-specificity, relying on the sentence:
518 U.S. at 485. TCI argues that this                 “Although we do not believe that this
presumption has since been discarded.                 statutory and regulatory language
However, all of the cases TCI cites for that          necessarily precludes ‘general’ federal
proposition either (1) fou nd th e                    requirements from ever pre-empting state
presumption irrelevant because the                    requirements, or ‘general’ state
language was clear, Sprietsma v. Mercury              requirements from ever being preempted,
Marine, 537 U.S 51, 62-63 (2002); Crosby              . . . it is impossible to ignore its
v. National Foreign Trade Council, 530                overarching concern that pre-emption
U.S. 363, 374 n. 8 (2000); or (2) found the           occur only where a particular state
presumption inapplicable to the particular            requirement threatens to interfere with a
statute in question because it did not deal           specific federal interest.” Lohr, 518 U.S.
with a traditional province of state law,             at 500. This quoted language, however,
Buckman Co. v. Plaintiffs’ Legal Comm.,               only states that the relevant statutory and
531 U.S. 341, 347 (2001); United States v.            regulatory texts do not compel the state-
Locke, 529 U.S. 89, 108 (2000). In                    level specificity requirement, but that the
conclusion, I would follow Part V of the              Lohr majority inferred the state-specificity
Lohr opinion, as I feel we are bound to do,           requirement from that language. Part V
and hold that a state common-law claim is             later makes it clear that state-level
preempted only if it establishes a specific           specificity is in fact a requirement for
requirement for a particular device, rather           preemption. Id. at 502 (“These state
than alleging breach of a generalized duty            requirements therefore escape pre-
of care. Accordingly, the District Court’s            emption, . . . because their generality
finding of express preemption should be               leaves them outside the category of
                                                      requirements that §360k envisioned to be
                                                      ‘with respect to’ specific devices”).

                                               -29-
occupy an entire field of law exclusively            devices.” Id. at 490 (plurality).32 This
(“field preemption”), or (2) when state law          clearly pro-regulatory, pro-consumer
actually conflicts with federal law                  safety purpose of the MDA compels the
(“conflict preemption”). E.g., Freightliner          conclusion that state common-law suits are
Corp. v. M yrick, 514 U.S. 280, 287                  not impliedly preempted by the MDA.
(1995). Conflict preemption can in turn be           This conclusion is supported by the
shown in two ways: (1) it is impossible for          presumption in favor of a narrow scope of
a party to comply with both federal and              preemption, mentioned above. Moreover,
state requirements, or (2) the state law             although the presence of an express
frustrates Congressional intent. Id. Here,           preemption clause (§ 360k(a)) does not
the only implied preemption claim at issue           conclusively rule out implied preemption,
is the frustration prong of conflict                 it does imply that “Congress did not intend
preemption: TCI and Amicus Curiae U.S.               to pre-empt other matters.” Myrick, 514
Chamber of Commerce (“USCC”) do not                  U.S. at 288.
a r g ue that field preemption or
                                                            None of TCI’s or USCC’s
impossibility conflict preemption apply.
                                                     arguments are persuasive toward finding
       Since there is no express language            implied preemption here. TCI relies on
to rely on in a frustration conflict                 Buckman, 531 U.S. at 350, for the
preemption analysis, the key factor to               proposition that the MDA allows for
consider is, unsurprisingly, Congressional           implied preemption. Buckman, however,
purpose. E.g., Barnett Bank of Marion                found implied preemption of a state-law
County, N.A. v. Nelson, 517 U.S. 25, 31              claim that the defendant had defrauded the
(1996). As the Lohr court observed, the              FDA by sending it false § 501(k)
purpose of the MDA was to protect                    equivalency information. Id. at 343. The
consumers by ensuring the safety and                 conflict in Buckman existed because the
effectiveness of medical devices. Lohr,              MDA had given the FDA full power and
518 U.S. at 476. Contrary to USCC’s and              discretion to remedy acts of fraud
PLAC’s assertions, protection of the                 perpetrated on it; a state-law suit seeking
medical device industry from excessive               to prosecute fraud against the FDA would
regulation was a minimal concern. Id. at             necessarily conflict with the FDA’s
490-91 (plurality); see also id. at 476              discretionary decision to forego a fraud
(MDA was motivated by concern on the                 prosecution against itself. Id. at 349.
part of consumers and regulators, not
industry).     The plurality specifically
                                                            32
disclaimed the idea of a Congressional                         Justice Breyer did not join the
“fear that product liability actions would           plurality’s detailed discussion of statutory
hamper the development of medical                    purpose because he found it unnecessary
                                                     for analysis of the case; he made no
                                                     statement agreeing or disagreeing with it.
                                                     Id. at 508 (Breyer).

                                              -30-
Indeed, the Buckman court distinguished                Horn’s suit declaring that the HeartMate is
fraud-on-the-agency claims from suits                  designed defectively.               USCC
based on “traditional state tort law                   mischaracterizes Barnett Bank, however:
principles of the duty of care,” which are             the Supreme Court did not lay down any
the principles involved in this case. Id. at           blanket rule on frustration conflict
352.                                                   preemption, but merely followed the
                                                       normal procedure of looking to the
        TCI’s other argument, echoed by
                                                       legislature’s intent to determine if
USCC, is that allowing state-law tort suits
                                                       frustration conflict preemption existed.
conflicts with federal law because it allows
                                                       Id. at 32-37. The Barnett Bank court
juries to second-guess the FDA’s
                                                       concluded that a federal statute permitting
determination that the PMA-approved
                                                       banks to sell insurance in small towns
device is safe. There is not necessarily any
                                                       preempted a state statute banning such
conflict, however, between the FDA’s
                                                       sales because the purpose behind the
allowing TCI to market the HeartMate and
                                                       federal statute was to empower banks. Id.
a state finding that the HeartMate is
                                                       Here, in contrast, the MDA was not
unsafe: the natural way to reconcile these
                                                       created to empower industry, but to protect
two positions is to see the PMA process as
                                                       consumers by ensuring safe devices. Thus,
a “floor” of minimum standards for Class
                                                       the conflict that existed in Barnett
III devices, but not a “ceiling.” Under this
                                                       Bank does not exist here.
view, a state could still raise the standards
of safety within its own jurisdiction. Cf.                     The instant case is a lso
Barnett Bank, 517 U.S. at 31 (federal law              distinguishable from Barnett Bank in that
permitting banks to sell insurance in small            Barnett Bank dealt with a state’s outright
towns does not necessarily conflict with               statutory ban of a permitted practice, while
state law banning such sales, since federal            there is no corresponding ban here (i.e.,
law could be read as permitting sales to the           the state of Pennsylvania outlawing heart
extent that they are permitted by state law).          pumps). In this case, TCI is not prohibited
                                                       from marketing the HeartMate, but must
                                                       simply live with the possibility of liability
        USCC argues that while Barnett
                                                       if the HeartMate does not live up to
Bank recognized that there was not
                                                       Pennsylvania’s applicable standards of
necessarily a contradiction between federal
                                                       care. Although the risk of liability may
permission and state prohibition of a
                                                       admittedly be a deterrent to TCI’s
practice, Barnett Bank produced a bright-
                                                       marketing efforts, the Supreme Court has
line rule that federal permission to engage
                                                       held that the incidental regulation incurred
in a practice preempts state law liability
                                                       by liability under generally applicable state
incurred by engaging in that practice.
                                                       law is less intrusive, and therefore less
Accordingly, USCC concludes, the FDA’s
                                                       prone to preemption, than “direct
permission to market HeartMate triggers
                                                       regulation on the operation of federal
frustration conflict preemption against

                                                -31-
projects.” Goodyear Atomic Corp. v.                   safety. 33
Miller, 486 U.S. 174, 185-86 (1988).
                                                                          IV.
        USCC also cites to Pokorny v. Ford
                                                             Five Justices of the Supreme Court
Motor Co., 902 F.2d 1116, 1123-25 (3d
                                                      have joined an opinion that requires
Cir. 1990), to support its proffered bright-
                                                      specificity of state claims in addition to
line rule that federal permission to engage
                                                      specific federal requirements for the
in a practice preempts state law liability
                                                      triggering of preemption under the MDA.
incurred by engaging in that practice.
                                                      Specificity of state claims is also mandated
Pokorny, however, is distinguishable for
                                                      by the applicable FDA regulations, to
the same reason as Barnett Bank: the
                                                      which we must show deference. My
purpose behind the federal regulation in
                                                      colleagues, however, have rejected both
Pokorny was specifically to give
                                                      the binding instructions of the Supreme
automobile manufacturers flexibility to
                                                      Court in Lohr and the FDA regulations
choose to equip their automobiles with
                                                      based on their perception of a single
manual safety belts instead of automatic
                                                      Justice’s opinion in Lohr and the FDA’s
belts and/or airbags. Id. As Horn points
                                                      current litigation position, to which we
out, the Pokorny court rejected the
                                                      owe no deference. Accordingly, I must
manufacturer’s claim that the regulation
                                                      respectfully dissent.
also preempted a claim based on a lack of
protective netting, because there was no
evidence that Congress or the Department
of Transportation contemplated protective
netting when the regulation was
promulgated. Id. at 1126. Indeed, the
Pokorny court allowed common-law
liability as a permissible way for the state
to “‘encourage’ automobile manufacturers
to provide safety features in addition to
those listed in” the federal regulation. Id.
Similarly, in the instant case, allowing
common-law liability would simply have
the effect of encouraging TCI and other
device manufacturers to go above and
                                                              33
beyond FDA standards, and this effect                            Of course, this only shows that
would clearly not contradict the MDA’s                common-law liability is in no way
purpose of enhancing medical device                   impliedly preempted by the MDA;
                                                      obviously, the express preemption clause
                                                      does preempt some common-law liability
                                                      for state standards above and beyond FDA
                                                      standards.

                                               -32-
