Brief of Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000)
|||UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT
|||November 1, 2000
|||ELIZABETH AND CLIFFORD KEMP,
|||Appeal from the United States District Court for the Southern District
of Ohio at Cincinnati. No. 97-00103--Sandra S. Beckwith, District Judge.
|||Counsel Argued: Gregory M. Utter, Keating, Muething & Klekamp, Cincinnati,
Ohio, for Appellants. Thomas M. Parker, Roetzel & Andress, Akron, Ohio,
for Appellee. ON Brief: Gregory M. Utter, Louis Francis Gilligan, Keating,
Muething & Klekamp, Cincinnati, Ohio, for Appellants. Thomas M. Parker,
Sanjay K. Varma, Roetzel & Andress, Akron, Ohio, Karen A. Carroll, Roetzel
& Andress, Cincinnati, Ohio, for Appellee.
|||Before: Moore and Gilman, Circuit Judges; McKEAGUE, District Judge.* *The
Honorable David W. McKeague, United States District Judge for the Western
District of Michigan, sitting by designation.
|||The opinion of the court was delivered by: David W. McKEAGUE, District
|||RECOMMENDED FOR FULL-TEXT PUBLICATION
|||Pursuant to Sixth Circuit Rule 206
|||File Name: 00a0381p.06
|||Argued: May 3, 2000
|||McKEAGUE, D. J., delivered the opinion of the court, in which GILMAN,
J., joined. MOORE, J. (pp. 40-42), delivered a separate concurring opinion.
|||This appeal requires us to determine whether the Medical Device Amendments
of 1976 ("MDA"), 21 U.S.C. §§ 360c et seq., to the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq., preempt plaintiffs' common
law and products liability tort claims alleging negligence per se, fraud
on the Food and Drug Administration ("FDA"), and failure to warn
under Ohio law. The district court found plaintiffs' claims were either
preempted by the MDA or failed to present a genuine issue of material fact,
and awarded summary judgment to defendant-appellee Medtronic, Inc. ("Medtronic").
For the reasons set forth below, we affirm the judgment of the district
|||In late December 1991, plaintiff Elizabeth
Kemp was admitted to the Bethesda North Hospital Emergency
Room complaining of profound dizziness, weakness, and malaise. Cardiac testing
revealed complete atrioventricular block. In order to regulate Mrs. Kemp's
heartbeat, on January 2, 1992, doctors surgically implanted a Model 4004M
pacemaker and lead, manufactured by defendant Medtronic, Inc.
|||More than three years later, in June 1995, Mrs. Kemp began experiencing
recurrent dizziness and fainting spells, attributable to the failure of
her Model 4004M pacemaker lead to properly regulate her heartbeat. Then,
on June 4, 1995, Mrs. Kemp fainted while in the garage of her home and fell
to the concrete floor. As a result of her fall, she hit her head, and awoke
suffering headaches, facial pain, and neck pain. It was later determined
that these symptoms were caused by bilateral subdural hematomas. These blood
clots required surgery to relieve the pressure in Mrs. Kemp's skull, and
even after surgery she continued to experience loss of sight, speech, and
cognitive and motor capability. Consequently, Mrs. Kemp spent some three
months in and out of hospitals and rehabilitation, and she continues to
suffer related disorders resulting from the injuries sustained in her fall.
|||A. Development of the Medtronic Model 4004M
|||At the center of this dispute is Medtronic's Model 4004M pacemaker lead,
the device implanted in Mrs. Kemp. A pacemaker lead is a medical device,
used in conjunction with a pulse generator (commonly referred to as a pacemaker),
that is designed to monitor and correct rhythm irregularities in the human
heart. Before a new pacemaker lead may be marketed and sold to the public,
the manufacturer must first receive one of various forms of governmental
clearance from the FDA. In 1982, the FDA granted Medtronic an investigational
device exemption from the premarket approval ("PMA") process to
permit clinical trials of the Model 4003, a predecessor to the Model 4004M.
Following clinical trials, Medtronic submitted the Model 4003 to the FDA
for a complete PMA review. After the FDA accepted, reviewed, and evaluated
the PMA application, it was referred to a panel of experts. The panel specifically
compared the performance of silicone and polyurethane as insulating materials
and concluded that both options should be available to physicians. The Model
4003 ultimately received PMA approval from the FDA on July 29, 1986.
|||Two years later, on July 18, 1988, Medtronic submitted a PMA Supplement
to the FDA for the Model 4004, which proposed several significant modifications
to the Model 4003. In addition to the Model 4003 specifications already
approved by the FDA, the Model 4004 PMA Supplement addressed, among others,
modifications incorporating the use of insulation made of pellethane 80A
|||On October 31, 1989, Medtronic filed a PMA Supplement application for
the Model 4004M lead. A bipolar lead like the Model 4004M pacemaker lead
consists of an inner conductor coil, outer conductor coil, inner insulation,
and outer insulation. Should the inner insulation fail, the lead may short
circuit, and fail to sense the heartbeat. If such a failure occurs, then
the pacemaker cannot regulate the heartbeat properly, and arrhythmia or
arrest may result. Medtronic manufactured the Model 4004M using pellethane
2326-80A as inner insulation material, and designed the 4004M lead to have
inner and outer conductor coils with a platinum sputter barrier coating.
Medtronic represented that the addition of the platinum sputter better prevented
the coils from metal-ion oxidation, a degradative process observed in earlier
pacemaker models employing polyurethane insulation (such as pellethane).
In its 4004M PMA Supplement, Medtronic represented that the platinum sputter
functioned as a barrier between the pellethane insulation and bodily fluids,
preventing direct contact and avoiding metal-ion oxidation. The addition
of this platinum sputter coating constituted a manufacturing and design
change necessitating the filing of a PMA Supplement with the FDA.
|||The FDA approved the Model 4004M PMA Supplement on March 28, 1990. Thereafter,
however, an FDA inspection revealed a significant risk of failure for the
4004M lead due to degradation of the polyurethane insulating material, and
in October 1993, Medtronic issued a Health and Safety Alert recalling some
74,000 Model 4004M leads.
|||B. Procedural Posture
|||On January 24, 1997, Elizabeth Kemp and her husband Clifford sued Medtronic,
alleging ten common law and statutory products liability tort claims under
Ohio law. Moving for summary judgment, Medtronic argued all of plaintiffs'
state law claims were preempted by the express preemption provision of the
MDA, § 360k. The United States District Court for the Southern District
of Ohio largely agreed, finding the MDA preempted plaintiffs' strict products
liability claims for defective design, failure to warn, and nonconformance
to representations, as well as their claims for negligent design, negligent
failure to warn, breach of express and implied warranties, and fraudulent
misrepresentation with respect to medical devices approved through the FDA's
premarket approval process. The district court did not find that the MDA
totally preempted plaintiffs' claims, however, and ruled that any claims
alleging the Model 4004M deviated from FDA specifications were not preempted.
The district court then permitted plaintiffs to file an amended complaint
to that effect.
|||Accordingly, on January 19, 1999, plaintiffs filed an eight-count amended
complaint. Count I of the amended complaint alleges negligence per se for
Medtronic's failure to manufacture the Model 4004M in accordance with the
FDA standards and requirements imposed by the Model 4004M PMA Supplement.
Count II alleges negligence per se for Medtronic's failure to (1) submit
an engineering change order that varied the thickness and coverage of the
platinum sputter coating; (2) provide Solution A test results to the FDA;
and (3) provide canine biostability test results to the FDA as required
by representations in the PMA Supplement. Counts III-VII allege claims that
arise in the event Medtronic manufactured a product different from that
approved by the FDA. Finally, Count VIII presents a derivative claim for
loss of consortium on behalf of plaintiff Clifford Kemp, which is entirely
dependent upon his wife's claims.
|||On January 22, 1999, Medtronic moved for judgment on the pleadings on
all counts of the amended complaint except Count I, arguing that plaintiffs'
claims were preempted pursuant to the analysis in the district court's January
12, 1999 order. In a separate motion filed that same day, Medtronic moved
for a judicial determination of the "specific federal requirements"
applicable to the Model 4004M. Ruling from the bench at a pretrial hearing,
the district court granted Medtronic's motion for judgment on the pleadings
on Counts II, IV, V, VI, and VII of plaintiffs' amended complaint. The district
court also granted Medtronic's motion for judgment on the pleadings on Count
III of the amended complaint, except to the extent that it could be read
to assert a claim for strict liability for a manufacturing defect.
|||Addressing Medtronic's motion to determine the specific requirements applicable
to the Model 4004M, the district court reviewed the Model 4004M PMA Supplement
and determined that the FDA approval process established six specific requirements.
In determining the sixth requirement, the district court ruled:
|||The sixth requirement is that there must be a protective barrier coat
between the conductor coil and the insulation, which is composed of platinum
sputtering. And that appears at Pages VI-52 and VI-61.
|||There are other specifications within the PMA Supplement. I don't think
they are relevant because for the most part they relate to the electrodes
and the type of steroid to be emitted and things which are not at issue
in this case.
|||I would note that Paragraphs 57 through 60 of the amended complaint allege
that platinum sputtering must be consistent. And the plaintiffs allege this
requirement on the basis of Medtronic's description of the coil winding
process and the post winding examination of the wires. But I do not see
this as being a design specification.
|||There are also allegations in Paragraph 135 that Medtronic changed the
coverage and thickness requirements for the platinum sputtering. That is
not a part of the PMA Supplement. The specifications regarding platinum
sputtering in the PMA Supplement are very general, and it does not appear
to me that the FDA required a particular level of platinum sputtering.
|||J.A. at 2941-42. The district court then struck paragraphs in the amended
complaint alleging that Medtronic improperly altered the platinum sputter
barrier, failed to provide Solution A and canine biostability test results,
and failed to warn plaintiffs of defects in the Model 4004M learned after
FDA approval of the 4004M PMA Supplement.
|||Plaintiffs' remaining claims in Counts I and III asserted negligence per
se and strict liability, respectively, and alleged Medtronic failed to manufacture
the Model 4004M according to FDA specifications. The final claim in Count
VIII alleged a derivative loss of consortium claim on behalf of Clifford
Kemp. Thereafter, Medtronic again moved for summary judgment, and the district
court granted the motion in a written opinion dated April 30, 1999.
|||II. STANDARD OF REVIEW
|||This Court reviews a district court's grant of summary judgment de novo.
See Terry Barr Sales Agency, Inc. v. All-Lock Co., Inc., 96 F.3d 174, 178
(6th Cir. 1996). A motion for summary judgment should be granted "if
the pleadings, deposition, answers to interrogatories, and admissions on
file, together with the affidavits, if any, show that there is no genuine
issue as to any material fact and that the moving party is entitled to a
judgment as a matter of law." Fed. R. Civ. P. 56(c). On summary judgment,
the Court views the facts and all inferences drawn therefrom in the light
most favorable to the nonmoving party. See Matsushita Elec. Indus. Co.,
Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).
|||This appeal presents fractious issues which have sharply divided the various
circuit courts which have considered them: whether the express preemption
provision of the MDA, § 360k, preempts state law tort causes of action for
negligence, "fraud on the FDA," and failure to warn committed
by a defendant manufacturer of a Class III device both prior and subsequent
to having received FDA approval of a PMA Supplement.
|||In 1976, Congress enacted the Medical Device Amendments, which modified
the Federal Food, Drug and Cosmetics Act to allow the FDA to regulate medical
devices. The MDA divides medical devices into three categories, or classes.
The most strict FDA regulation is reserved for Class III devices, defined
as those which: (1) are to be used for supporting or sustaining human life
or that are of substantial importance in preventing impairment of public
health; or (2) present a potential unreasonable risk of illness or injury.
See 21 U.S.C. § 360c(a)(1)(C)(ii)(I-II). To market a Class III device within
the United States, the manufacturer must either submit its product to the
FDA for premarket approval ("PMA process"), or qualify for one
of two exceptions to this time-intensive regulatory review. The PMA process
involves close scrutiny of the device by the FDA, and approval requires
that the FDA conclude that it has received "reasonable assurances of
[the device's] safety and effectiveness" from the manufacturer. Id.
§ 360c(a)(1)(C). To that end, manufacturers must provide the FDA with samples
of the device, an outline of the device's components, a description of the
manufacturing process, copies of the proposed labels, and various other
information. See 21 C.F.R. § 814.20(b). The FDA then reviews such submissions
for an average of 1200 hours before either approving or disapproving the
device. Id. §§ 812.1-.150; see also Mitchell v. Collagen Corp., 126 F.3d
903, 905 (7th Cir. 1997).
|||A manufacturer may also gain regulatory clearance for a Class III device
through one of two exemptions from the PMA process. First, the statute permits
devices that are "substantially equivalent" to medical devices
in existence in 1976 to be marketed and sold without PMA approval, in order
not to stifle competition with technology existing at the time of the enactment
of the MDA. See 21 U.S.C. § 360j(g)(1). This limited form of review is known
as "premarket notification" or "the § 510(k) process,"
and averages only 20 hours of review as opposed to some 1200 hours in the
PMA process. See Martin v. Telectronic Pacing Sys., 105 F.3d 1090, 1095
(6th Cir. 1997); Reeves v. Acromed Corp., 103 F.3d 442, 446 (5th Cir. 1997).
|||Second, devices representing innovative technology may be marketed under
an investigational device exemption ("IDE"), an experimental regimen
that allows for unapproved devices to be utilized in human trials. An IDE
permits a manufacturer to market "a device that otherwise would be
required to comply with a performance standard or to have premarket approval
for the purpose of conducting investigations of that device." 21 C.F.R.
§ 812.1. Accordingly, a device operating under the IDE exemption need not
comply with premarket approval requirements during the trial period. See
21 U.S.C. § 360j(g); 21 C.F.R. §§ 812-813.
|||Should a manufacturer merely propose to modify a Class III device that
has already received approval pursuant to the PMA process, the manufacturer
may submit a PMA Supplement rather than re-submitting the entire device
for review. See 21 C.F.R. §§ 814.39, 814.80. The procedures applicable to
a PMA Supplement are the same as those applicable to an original PMA, although
the FDA only requires the manufacturer to provide that information necessary
to support the proposed modifications. See id. § 814.3(g). If the FDA grants
approval to a PMA application or a PMA Supplement, it does so subject to
conditions described in a document entitled "Conditions of Approval."
This three-page form (1) requires the manufacturer to submit proposed labeling
of the device prior to marketing; (2) limits advertising to the FDA-approved
labeling for the device; (3) specifies that "[b]efore making any change
affecting the safety or effectiveness of the device, [the manufacturer shall]
submit a PMA Supplement for review and approval by FDA;" (4) requires
the manufacturer to submit postapproval reports at one-year intervals from
the date of FDA approval; and (5) requires the manufacturer to report any
incidents of adverse reaction to, or known defect of, the approved device.
Furthermore, the manufacturer must report to the FDA, "[a]ny significant
chemical, physical or other change or deterioration in the device or any
failure of the device to meet the specifications established in the approved
PMA that could not cause or contribute to death or serious injury but are
not correctable by adjustments or other maintenance procedures described
in the approved labeling." J.A. at 997-99 (emphasis in original).
|||IV. PREEMPTION PRINCIPLES
|||A. Express Preemption Under Section 360k
|||The Supremacy Clause of the United States Constitution provides that the
"Laws of the United States . . . shall be the supreme Law of the Land."
U.S. Const. art. VI, cl.2. Hence, "state law that conflicts with federal
law is 'without effect.'" Cipollone v. Liggett Group, Inc., 505 U.S.
504, 516 (1992). Central to determining questions of preemption is divining
Congress' intent. Id. at 517-18. In view of the historic importance of federalism
in these areas, the states' police powers relating to public health and
safety are not preempted by federal law unless Congress' intent to do so
is clearly expressed. See Hillsborough County, Florida v. Automated Medical
Lab., Inc., 471 U.S. 707, 715 (1985). Moreover, where as here, Congress
has included an express preemption provision in a statute, a court may not
look beyond it to consider implied preemption. Rather, "Congress' enactment
of a provision defining the pre-emptive reach of a statute implies that
matters beyond that reach are not pre-empted." Cipollone, 505 U.S.
|||At the center of the instant dispute lies section 360k of the MDA, which
expressly preempts certain state law requirements governing medical devices:
|||[N]o State or political subdivision of a State may establish or continue
in effect with respect to a device intended for human use any requirement-
|||(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
|||(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under this
chapter. 21 U.S.C. § 360k(a).
|||B. Medtronic, Inc. v. Lohr
|||In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Supreme Court addressed
the question whether the MDA preempts various common law tort claims. The
device in Lohr had not undergone a PMA review, but had instead been approved
pursuant to the "substantially equivalent" exception found in
§ 510(k). In a five to four decision, the Court held that none of the plaintiffs'
common law tort claims were preempted by the MDA. Lohr, 518 U.S. at 501-02.
Justice Stevens' plurality opinion was joined by Justices Kennedy, Souter,
and Ginsburg. Justice O'Connor concurred in part and dissented in part,
and her opinion was joined by the Chief Justice, and Justices Scalia and
Thomas. Justice Breyer concurred in part and in the judgment, and joined
five of the seven parts of Justice Stevens' opinion. Hence, the five sections
of Justice Stevens' opinion in which Justice Breyer concurred (Sections
I, II, III, V and VII) form the opinion of the Court in Lohr.
|||Because the MDA contains an express preemption provision, a majority of
the Justices agreed that the issue devolved to determining the extent to
which the MDA preempts a plaintiff's state law claims. Id. at 484. Furthermore,
speaking for a majority of the Court in Part V, Justice Stevens concluded
that the Lohr plaintiffs could maintain at least some state tort law actions
for violations of FDA regulations. Id. at 494-95. Proceeding from this point
of initial agreement, however, the Justices' understanding diverged. Justice
Stevens, writing for himself and three other Justices, rejected the defendant's
assertion that § 360k preempts all common law suits because such claims
always constitute "requirements." Stevens reasoned that the broad
construction urged by defendant would "require far greater interference
with state legal remedies, producing a serious intrusion into state sovereignty
while simultaneously wiping out the possibility of remedy for the [plaintiffs']
alleged injuries." Id. at 488-89.
|||Justice Stevens' opinion found support in the plain language of § 360k.
He reasoned that the use of the term "requirement," rather than
the term "remedy," indicated that Congress intended to preempt
"device-specific enactments of positive law by legislative or administrative
bodies, not the application of general rules of common law by judges and
juries." Id. at 487-88. Accordingly, the plurality concluded "that
when Congress enacted § 360k, it was primarily concerned with the problem
of specific, conflicting state statutes and regulations rather than the
general duties enforced by common-law actions." Id. at 489.
|||Reaching the opposite conclusion, Justice O'Connor wrote an opinion joined
by three other Justices in dissent. In their view, a common-law duty came
within the meaning of the term "requirement" as used in § 360k
because common law causes of action "operate to require manufacturers
to comply with common-law duties." Id. at 510. (O'Connor, J., concurring
in part and dissenting in part). Therefore, these four Justices would hold
that a "fair reading" of the statute "indicates that state
common-law claims are preempted . . . to the extent that their recognition
would impose 'any requirement' different from, or in addition to, FDCA requirements
applicable to the device." Id. at 512. In stark contrast to the Justices
joining Justice Stevens' opinion, the O'Connor block did not believe that
the state common law had to be "specific" to be preempted. Rather,
under their reasoning, common-law claims were preempted if they imposed
obligations "different from, or in addition to," any requirement
of federal law. Id. ("The statute makes no mention of a requirement
of specificity, and there is no sound basis for determining that such a
restriction on 'any requirement' exists.").
|||Justice Breyer, concurring in part and in the judgment, nevertheless explicitly
agreed with Justice O'Connor's interpretation that certain common law causes
of action could constitute state "requirements" that would conflict
with federal "requirements" and thus be preempted. To hold otherwise
would invite anomalous consequences, reasoned Justice Breyer, who set forth
a hypothetical to illustrate his analysis:
|||Imagine that, in respect to a particular hearing aid component, a federal
MDA regulation requires a 2-inch wire, but a state agency regulation requires
a 1-inch wire. If the federal law, embodied in the "2-inch" agency
regulation, pre-empts the state "1-inch" agency regulation, why
would it not similarly pre-empt a state-law tort action that premises liability
upon the defendant manufacturer's failure to use a 1-inch wire (say, an
award by a jury persuaded by expert testimony that the use of a more than
1-inch wire is negligent)? . . . .
|||Consequently, I believe that ordinarily, insofar as the MDA pre-empts
a state requirement embodied in a state statute, rule, regulation, or other
administrative action, it would also pre-empt a similar requirement that
takes the form of a standard of care or behavior imposed by a state-law
tort action. Id. at 504-05.
|||The various courts of appeals that have confronted issues of preemption
arising under the MDA have struggled mightily with Lohr's language in the
effort to discern its holding. Part V of Justice Stevens' opinion, however,
in which Justice Breyer concurred, provides helpful guidance.*fn1
First, both "[t]he ambiguity in the statute - and the congressional
grant of authority to the agency on the matter contained within it - provide
a 'sound basis' for giving substantial weight to the agency's view of the
statute." Id. at 496. Second, in attempting to determine what common
law duties constituted preempted "requirements," the Court took
pains to explain that:
|||it is impossible to ignore [the Act's] overarching concern that pre-emption
occur only where a particular state requirement threatens to interfere with
a specific federal interest . . . . The statute and regulations, therefore,
require a careful comparison between the allegedly pre-empting federal requirement
and the allegedly pre-empted state requirement to determine whether they
fall within the intended pre-emptive scope of the statute and regulations.
Id. at 499.
|||Consequently, those circuit courts that have considered the question of
the preemptive effect of § 360k of the MDA have translated Lohr's emphasis
on the FDA regulations to focus on whether (1) the FDA has established specific
counterpart regulations or other specific federal requirements; that are
(2) applicable to a particular device; and thus (3) make state regulations
different from, or in addition to, the specific FDA requirements. See Mitchell,
126 F.3d at 910; accord In re Orthopedic Bone Screw Products Liability Litig.
159 F.3d 817, 822 (3d Cir. 1998)("Bone Screw I"); Goodlin v. Medtronic,
Inc., 167 F.3d 1367, 1371 (11th Cir. 1999). However, state or local requirements
that merely "affect devices" are not preempted if such regulations
are not "requirements applicable to a device" within the meaning
of the MDA.
|||C. Specific Federal Requirements
|||Hence, as a threshold matter, we must first determine whether the FDA
has established specific federal requirements applicable to the Model 4004M
pacemaker through the PMA process. Plaintiffs draw our attention to the
recent decision of the Eleventh Circuit Court of Appeals in Goodlin v. Medtronic,
Inc., 167 F.3d 1367 (11th Cir. 1999), which addressed this exact issue on
nearly indistinguishable facts. In Goodlin, the Eleventh Circuit held that
FDA approval of a PMA Supplement does not establish federal requirements
specific to the device. Defendants flatly disagree, arguing that our decision
in Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090 (6th Cir.
1997), holding that IDE approval constitutes specific federal requirements,
applies a fortiori to the PMA process.
|||In Martin, we confronted the question whether common law and statutory
tort claims brought under Ohio law were preempted by FDA approval for a
Class III device granted under the IDE exemption. The plaintiff in Martin
filed suit after her implant - an experimental device that combined the
functions of a defibrillator, a cardioverter, and a pacemaker - malfunctioned.
See id. at 1092. The plaintiff then brought five claims under Ohio tort
law for the injuries that she suffered. In a unanimous opinion affirming
the district court's grant of summary judgment to the defendant, this Court
noted that, "unlike the general federal requirements discussed in Medtronic,
the regulations governing investigational devices are essentially device
specific." Id. at 1097. The Martin court further observed that "there
are no specific regulations governing pacemakers like the one at issue;
however, the application and approval process under the IDE is device specific."
Id. (emphasis added). Reasoning that the extensive review process undertaken
by the FDA explored "the methods, facilities, and controls used for
manufacture of the device," Martin went on to affirm the district court's
ruling that the plaintiff's manufacturing defect, design defect, inadequate
warning, supplier liability and derivative spousal claims were preempted
by § 360k. Id. With regard to the plaintiff's claim for nonconformance to
express representations, Martin found the plaintiff waived the claim by
failing to properly address the argument to the district court. See id.
|||Defendant contends the same logic that guided this Court in Martin compels
a finding that the FDA's approval of the PMA Supplement for the Model 4004M
lead established device-specific requirements, because PMA Supplement approval
(and the underlying PMA approval) is even more difficult to obtain than
IDE approval. Vehemently disagreeing, plaintiffs cite Goodlin and argue
the PMA Supplement application process generally, and the 4004M PMA Supplement
process particularly, do not establish federal requirements specific to
Because the Eleventh Circuit tackled the issue presented here on largely
indistinguishable facts in Goodlin, and held none of the plaintiff's claims
were preempted, we now consider the Goodlin analysis in relation to the
|||Like Elizabeth Kemp, Lisa Goodlin was implanted with a Medtronic Model
4004M pacemaker lead to regulate her heartbeat. Following receipt of the
October 1992 Health and Safety Alert letter issued by Medtronic at the instigation
of the FDA, Goodlin elected to have her pacemaker removed as a precaution.
Although her pacemaker did not demonstrate any indication of failure, Goodlin
brought suit against Medtronic claiming negligent design and strict products
liability under Florida common law. The district court ruled the MDA preempted
Goodlin's claims, because the FDA had approved the Model 4004M through the
PMA process, and granted summary judgment to Medtronic. On appeal, a panel
of the Eleventh Circuit reversed the judgment of the district court. See
Goodlin, 167 F.3d at 1368-69.
|||Parsing the Supreme Court's decision in Lohr, the Goodlin court inquired
whether "the FDA's PMA process, which produces a finding that the manufacturer
has provided the reasonable assurances of safety and effectiveness necessary
to market the device, translates into the necessary imposition of a 'specific
requirement.'" Id. at 1375. After reviewing the PMA process, the Goodlin
court concluded that PMA approval "represents only a finding that the
manufacturer's proposal to market a device has reasonably assured the FDA
of the device's safety and effectiveness" and that "[d]espite
the specificity and considerable rigor of [PMA review] . . . neither the
FDA's actual review of a device and its supporting information nor the agency's
eventual approval of the device imposes any ascertainable requirement upon
the device." Id.
|||In line with Goodlin, plaintiffs argue that in the absence of specific
requirements, FDA approval of a PMA Supplement should not be granted preemptive
effect. Plaintiffs further assert the issuance of a form approval letter
setting forth generic "Conditions of Approval" does not mean that
the FDA has established specific requirements applicable to the design and
manufacture of the Model 4004M. Indeed, plaintiffs note that the FDA has
never promulgated federal regulations regarding the manufacture of pacemaker
leads. Plaintiffs also disagree that the FDA involvement in the PMA Supplement
process is as involved as that in the IDE application, and thus propose
that the Court distinguish Martin on this rationale.*fn3
|||We are not persuaded by plaintiffs' arguments, and respectfully disagree
with the conclusions drawn by the panel of the Eleventh Circuit in Goodlin.
Most importantly, Goodlin's conception of what constitutes a "requirement"
is irreconcilable with our analysis in Martin holding that IDE approval
establishes specific federal requirements for the device in question. Although
the IDE process imposes no "ascertainable substantive prerequisite
for approval," this Court in Martin explained that the application
and approval process under the IDE is a device-specific requirement that
nevertheless has preemptive effect. See Martin, 105 F.3d at 1097. Our analysis
comports with that advanced by the Seventh Circuit, which has held that
"PMA approval by the FDA constitutes approval of the product's design,
testing, intended use, manufacturing methods, performance standards and
labeling" and is "specific to the product." Mitchell, 126
F.3d at 913; accord Martin, 105 F.3d at 1097.
|||Moreover, although the IDE process and the PMA process are not identical,
a comparison of the governing regulations reveals no material differences.*fn4
Furthermore, the PMA Supplement for the Model 4004M is composed of more
than a hundred-page submission, and like the PMA, if the FDA ultimately
grants approval to the modification in question, it means that the FDA has
"received reasonable assurances of [the device's] safety and effectiveness."
51 Fed. Reg. at 26355. The FDA does not reach such a conclusion in approving
a device pursuant to the IDE exemption, which by its very nature exists
to permit experimental devices to be implanted to gather data in human trials.
Hence, we agree with the district court's analysis that "preemption
analysis regarding products approved through the PMA process is fully applicable
to products approved through the PMA Supplement process." J.A. at 1369.
|||Plaintiffs further fail to adduce any evidence suggesting that a device
approved pursuant to the PMA Supplement process, which builds upon the rigorous
PMA process, receives any less scrutiny than does a device exempted from
PMA approval under the IDE exemption process that was found to constitute
specific requirements in Martin. Rather, plaintiffs' expert merely avers
that a PMA Supplement is not reviewed with the same rigor as a PMA. This
distinction is readily understandable because a PMA requires review of a
previously unapproved device that does not qualify for exemption either
as substantially equivalent to devices extant in 1976 or as an IDE. By contrast,
a PMA Supplement proposes changes to a device that has already received
rigorous review and approval during the original PMA process. Hence, because
the FDA has already made a determination as to the safety and effectiveness
of the underlying device in the original PMA, it can evaluate only the proposed
modifications presented in the PMA Supplement while relying on its earlier
approval of the original device.
|||Finally, plaintiffs' argument that the FDA has never promulgated specific
regulations governing pacemakers produces a result contrary to our understanding
of Lohr's holding. Under both plaintiffs' proposed analysis and under Goodlin,
no cause of action involving any Class III device approved pursuant to the
PMA process would ever be preempted because the FDA merely approves or disapproves
the device in question, and does not set forth the basis for its decision.
Hence, according to plaintiffs' position, preemption under § 360k would
be exceedingly rare. Motivating Justice Breyer's refusal to join Part VI
of Justice Stevens' opinion in Lohr, however, was his lack of conviction
that "future incidents of MDA pre-emption of common-law claims will
be 'few' or 'rare.'" Lohr, 518 U.S. at 508. (Breyer, J., concurring
in part and concurring in the judgment). Indeed, we agree with Justice Breyer
that, in enacting § 360k, Congress intended the preemption of some state-law
causes of action, an intent given effect by this Court's Martin ruling.
Following the logic of Martin, then, we hold that FDA approval of the Model
4004M PMA Supplement, taken together with the conditions of approval imposed
on the device by the FDA, constitutes a specific federal requirement applicable
to the device.
|||D. Specific Requirements Applicable to the Model 4004M
|||Having determined that the FDA's approval of the Model 4004M constitutes
a specific requirement invoking preemption under § 360k, we must next determine
what specific requirements are imposed by the FDA's approval of the Model
4004M PMA Supplement. Before the district court, the parties stipulated
that the determination of the FDA specifications applicable to the 4004M
pacemaker lead was a matter of law for the court's determination. At a hearing
on the issue, the district court ruled that six specifications were determined
by the FDA during the PMA Supplement process for the 4004M lead.*fn5
|||Although Medtronic does not appeal from the district court's decision,
it argues on appeal that the FDA's "PMA approval" and the "Conditions
of Approval," taken together, comprise the FDA's administrative response
to Medtronics' PMA Supplement, establishing the specific federal requirements
for the Model 4004M. As part of the PMA process, Medtronic submitted a detailed
request for approval of a specific device of a particular design, using
particular manufacturing processes and labels. Once approved, Medtronic
concedes that the design, manufacturing processes, and labels may not be
modified without further FDA approval, unless the modifications do not affect
the device's safety or effectiveness. See 21 C.F.R. § 814.39. Thus, Medtronic
argues it is the totality of the design, manufacturing processes, and labeling
- when coupled with the prohibition against modifying them - that represents
the specific federal requirement "applicable under [the MDA] to the
device." 21 U.S.C. § 360k(a)(1).
|||We agree. The district court's attempt to parse the relevant requirements
from Medtronic's PMA application and PMA Supplement, while an admirable
effort to discern the relevant portions of the voluminous submissions to
the FDA concerning the Model 4004M, does not comport with the actual PMA
approval process that Martin (impliedly) and Mitchell (explicitly) relied
upon to hold that the PMA process establishes specific federal requirements
for a Class III device. It is true that in granting approval for a Class
III device, the FDA does not set forth the reasons justifying its decision.
Impliedly, however, the FDA has relied upon both the PMA submission approved
for the original Class III device and the PMA Supplement providing specific
information on the proposed modification in question. These specific submissions
form the basis of the FDA's approval of the PMA Supplement. Thus, we conclude
the specific requirements applicable to the Model 4004M include the entire
relevant PMA and accompanying PMA Supplement, rather than certain portions
thereof. In the case of the Model 4004M, then, the information submitted
to and approved by the FDA in both the Model 4003 PMA and as modified by
the Model 4004M PMA Supplement comprise the specific federal requirements
applicable to Medtronic's Model 4004M pacemaker lead.
|||V. PLAINTIFFS' CLAIMS
|||A. Negligence Per Se
|||Having determined that the specific requirements for the Model 4004M are
established by the July 15, 1988, Model 4004M PMA Supplement combined with
the conditions of approval set forth by the FDA, we turn to take up plaintiffs'
particular claims in light of the above analysis to determine whether they
impose state-law requirements "different from, or in addition to,"
federal requirements. Counts I and II of plaintiffs' first amended complaint
allege negligence per se for failure to comply with the FDA requirement
to manufacture and sell the Model 4004M Pacemaker as FDA approved. In Count
I, plaintiffs generally allege Medtronic failed to manufacture the Model
4004M as required by the FDA and thus sold a misbranded and/or adulterated
product. Count I further alleges that Medtronic's failure to manufacture
the Model 4004M pacemaker lead as required by the FDA resulted in insulation
failure, which proximately caused Mrs. Kemp's injuries.
|||Building on Count I, Count II alleges that Medtronic was required by the
conditions of approval set forth in 21 C.F.R. § 814.84 to seek FDA approval
for any change affecting the "safety and effectiveness of the device."
Plaintiffs contend that Medtronic violated the conditions of approval for
the Model 4004M pacemaker lead and 21 C.F.R. § 814.84 by failing to submit
to the FDA a March 1989 deviation authorization and engineering change order
concerning the coverage of platinum sputter coating over the conductor coils,
by failing to provide results of canine biostability tests, and by failing
to provide data from clinical devices or laboratory studies involving the
|||Before the district court, plaintiffs elected to distill Counts I and
II down, focusing solely on Medtronic's alleged failure to manufacture the
Model 4004M pacemaker lead in conformance with the FDA-approved 4004M PMA
Supplement specifications, and alleging that such failure constituted negligence
per se. The essence of plaintiffs' argument is that Medtronic failed to
coat the lead with a uniform 500 angstroms of platinum sputtering, resulting
in the sale of a misbranded or adulterated product.*fn6
Before us, plaintiffs merely contend that under Lohr, a negligence per se
claim survives any application of preemption under § 360k.
|||To preempt these claims, the federal requirements must be "'applicable
to the device' in question . . . and 'specific' to a 'particular device.'"
Lohr, 518 U.S. at 500; see also Martin, 105 F.3d at 1098. To determine whether
plaintiffs' negligence per se claims are preempted, however, we must first
determine whether the specific requirements established by FDA approval
of the Model 4004M PMA Supplement establish a requirement as to the required
thickness and coverage of the platinum sputter barrier.
|||Addressing Count I, the district court granted summary judgment to Medtronic,
ruling that any claim that the platinum sputtering may have failed to prevent
insulation failure constitutes a claim for design defect, and is therefore
preempted. The district court further ruled that neither the Model 4003
PMA nor the Model 4004M PMA Supplement required Medtronic to manufacture
the Model 4004M lead with a particular thickness of platinum sputtering,
and that if plaintiffs' common law claims asserted otherwise, they would
constitute a requirement "different from, or in addition to,"
the non-specific federal requirement. Accordingly, such claims would be
preempted. With respect to Count II, the district court granted defendant's
motion for summary judgment on grounds of preemption, relying on our decision
in Bailey v. Johnson, 48 F.3d 965, 968 (6th Cir. 1995), which held no private
cause of action exists for a violation of the Federal Food, Drug and Cosmetics
|||In support of the district court's judgment, Medtronic makes three arguments.
First, Medtronic contends it manufactured the Model 4004M lead in conformance
with FDA requirements. Second, Medtronic argues that under Ohio law, an
action for negligence per se can only be predicated on a statutory violation.
Third, Medtronic asks us to affirm on the ground that plaintiffs' negligence
per se claims seek to circumvent the intent of Congress and should be preempted
as impermissible attempts to create private causes of action for alleged
violations of the Food, Drug and Cosmetics Act.
|||We agree with the result reached by the district court with respect to
plaintiffs' negligence per se claims, yet we do so for different reasons.
While we agree with plaintiffs that a claim premised on the violation of
FDA requirements established for a Class III device through the PMA process
is not automatically preempted, we nevertheless conclude that the district
court properly granted summary judgment to Medtronic on plaintiffs' claims
as presented, because we find that the specific federal requirements established
by FDA approval of the Model 4004M PMA Supplement do not include a requirement
as to the thickness or coverage of the platinum sputter barrier. To permit
a jury to find Medtronic negligent for failing to manufacture the Model
4004M with a platinum sputter barrier of uniform 500 angstroms thickness
would be to impose a requirement different from and in addition to those
established by the FDA. It follows that plaintiffs' negligence per se claims
|||Our review of the record leaves us firmly convinced that plaintiffs' argument
that the Model 4004M PMA Supplement included a specification that the platinum
sputter coat would be a uniform 500 angstroms thick represents at best a
tenuous assertion and, at worst, an outright mischaracterization of the
record. Both in their briefs and in oral argument, plaintiffs repeatedly
asserted that the Model 4004M specifications, as originally designed, called
for a platinum sputter barrier a "uniform 500 angstroms thick."
Plaintiffs' statements find no support in the record. Indeed, we find that
the record flatly contradicts plaintiffs' position. Instead of calling for
a uniform thickness of 500 angstroms, the ECO (engineering change order)
reveals that the original coating specification provided, "[c]oating
thickness shall be 500 ± 200 angstroms," and that Medtronic modified
the design to call for "100 to 1000 angstroms over a minimum of 85%
of the wire circumference." J.A. at 993. Therefore the original specification
was not for a uniform 500 angstroms as plaintiffs repeatedly assert, but
rather called for a range of 300 to 700 angstroms in thickness.*fn7
|||Furthermore, nowhere in the Model 4004M PMA Supplement do we find that
Medtronic made an express representation as to the thickness or coverage
of the platinum sputter barrier. Apparently recognizing this glaring impediment
to the success of their claims, plaintiffs nevertheless contend that Medtronic
made binding representations as to the thickness of the platinum sputter
barrier in submissions made to the FDA both prior and subsequent to the
July 15, 1988 Model 4004M PMA Supplement.
|||First, plaintiffs contend Medtronic represented to the FDA that the thickness
of the platinum sputter barrier would be 500 angstroms over 100% of the
conductor coils in the premarket notification to the Model 4016A, a pacemaker
not in the chain of development of the Model 4004M. Indeed, the Model 4016A
was given FDA clearance pursuant to a § 510(k) premarket notification, rather
than FDA approval pursuant to the PMA process. In answer to an FDA inquiry
regarding the effect of platinum sputter on the weight distribution of the
lead in the Model 4016A during its premarket notification process, Medtronic
represented that because "the thickness of the platinum coating is
only 500 Angstroms (), it is unlikely that it changes the weight distribution
throughout the lead, thereby affecting electrode stability." Id. at
852. Plaintiffs next point to mathematical calculations that plaintiffs
interpret as calling for 100% of the conductor coils to be sputtered at
a thickness of 500 angstroms. Plaintiffs argue that these representations
were incorporated into the Model 4004M PMA Supplement by Medtronic's statement
in the Model 4004M PMA Supplement concerning the sputter barrier that, "[t]he
Model 4016A pacing lead also incorporated these improvements." J.A.
|||We are utterly unconvinced that a statement in the Model 4004M PMA Supplement
which merely points out that the addition of a platinum sputter barrier
was incorporated in an earlier, unrelated model pacemaker is sufficient
to establish a requirement for the Model 4004M. As a background consideration,
the text from the Model 4004M PMA Supplement that plaintiffs claim incorporates
the 4016A premarket notification is not placed in full context. After describing
the modifications over the Model 4003, the Model 4004M PMA Supplement states
in summation: "Therefore, two improvements incorporated into the Models
4004/4504 are: [b]arrier coating the conductor coils with platinum, and
[t]hermal annealing tubing in an inert atmosphere (e.g., argon or nitrogen)."
Id. at 605-06. The text goes on to state that "[t]he Model 4016A pacing
lead also incorporated these improvements." Id. at 606. Combining these
references, plaintiffs maintain they amount to a representation that the
Model 4004M PMA Supplement incorporates all of the specifications submitted
with the Model 4016A premarket notification.
|||Given the differences between the Model 4016A and the Model 4004M, plaintiffs'
argument fails to persuade us. Underscoring the specious nature of plaintiffs'
claim is the fact that the Model 4016A was merely judged substantially equivalent
pursuant to the § 510(k) process, and was not reviewed and approved pursuant
to the PMA process.*fn8
Lohr rejected the notion that the § 510(k) approval process establishes
specific federal requirements for a device. Lohr, 518 U.S. at 493. By contrast,
the clear implication of the holding in Martin and the express import of
our decision today is that FDA approval pursuant to a PMA Supplement establishes
specific federal requirements for the device in question. Thus, we focus
on the representations Medtronic made in the Model 4004M PMA Supplement
which established its specific federal requirements to the exclusion of
Accordingly, any representations made in the September 28, 1987, 4016A premarket
notification, which did not receive FDA-approval, are inapplicable to the
FDA-approved Model 4004M which received FDA approval after undergoing the
|||The second submission plaintiffs rely on to establish a thickness requirement
for the Model 4004M is the voluntarily withdrawn 1991 PMA Supplement for
the Model 4003M.*fn10
On November 19, 1991, Medtronic submitted a PMA Supplement when it decided
to modify the Model 4003M to incorporate a platinum sputter barrier.*fn11
In an attachment to this submission, Medtronic states, "[t]he sputtering
process deposits only 500 angstroms of platinum on the conductor coil. Therefore,
the physical properties of the coil are virtually unchanged i.e., dimensions,
flexural and electrical properties. Therefore, the performance of the leads
will not change as a result of this sputtering process." J.A. at 2886.
Based on this language, included in a withdrawn application, plaintiffs
contend Medtronic represented that the thickness of the platinum sputter
barrier for the Model 4004M pacemaker lead was a uniform 500 angstroms.
|||Again, plaintiffs rely on statements that are inapplicable to the Class
III device in question, the Model 4004M. Most significantly, the Model 4003M
PMA Supplement was voluntarily withdrawn by Medtronic, and thus never received
FDA approval necessary to establish federal requirements. As we held in
Part IV(d), supra, it is the PMA Supplement, coupled with the conditions
of approval set forth in the FDA's approval letter, that establishes the
specific federal requirements for a Class III device. The PMA Supplement
for the Model 4003M, a unipolar lead, cannot reasonably be deemed to establish
the requirements for the Model 4004M, a bipolar lead. Furthermore, the Model
4003M was not in the Model 4004M's chain of development; rather, the proposed
modification adding the platinum sputter was submitted in 1991, after the
approval of the Model 4004M in 1988. Hence, any reference contained in the
withdrawn Model 4003M PMA Supplement cannot serve to establish requirements
applicable to the Model 4004M, established through its PMA Supplement.
|||Having carefully scrutinized the record, our initial observation is confirmed:
Medtronic represented that the Model 4004M would contain a platinum sputter
barrier, but did not represent that the barrier would have a particular
thickness. The specific federal requirements established by FDA approval
of the Model 4004M PMA Supplement thus contain a requirement that the Model
4004M have a barrier of platinum sputter, and a claim for negligence per
se premised on the lack of such a barrier would not be preempted. As pled
and argued by plaintiffs, however, Medtronic was negligent in failing to
manufacture a product that had a platinum sputter barrier with a uniform
500 angstroms in thickness. Because the specific federal requirements applicable
to the Model 4004M contain no thickness requirement, a jury verdict in plaintiffs'
favor on plaintiffs' negligence per se claims would amount to a state requirement
"different from, or in addition to," the federal requirements.
It follows that plaintiffs' negligence per se claims are preempted. Consequently,
we affirm the judgment of the district court in regard to this issue.
|||B. Fraud on the FDA
|||Count VII of the original complaint is entitled "Fraudulent Misrepresentation,"
and alleges "Medtronic, through its uniform course of conduct in the
advertising, promotion, and sale of the [Model 4004M] leads, knowingly and
purposely represented to the consumers of the product and to the medical
community that the leads were fit for their intended purposes, would function
without defect, and were appropriate for use in persons with heart conditions
J.A. at 42. In their brief, however, plaintiffs characterize this claim
as "Fraud on the FDA," and argue the district court erred by relying
on Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995), and Klein v. Biscup,
673 N.E.2d 225 (Ohio Ct. App. 1996), to find this claim was preempted by
As argued, plaintiffs' claim is similar to the fraud on the FDA claim presented
to a panel of the Third Circuit in In re Orthopedic Bone Screw Product Liability
Litig., 159 F.3d 817, 821-22 (3d Cir. 1998)(Bone Screw I), cert. granted,
No. 98-1768 (U.S. June 29, 2000), which concluded that "Lohr overrules
everything in Michael that would prevent a plaintiff from pursuing a cause
of action for fraudulent misrepresentation based on common law principles."
Bone Screw I, 159 F.3d at 825 (footnote omitted). Similarly, plaintiffs
cite Dutton v. Acromed Corp., 691 N.E.2d 738, 742 (Ohio Ct. App. 1997),
and argue that the district court's reliance on Klein is misplaced. Dutton
held that Klein does not survive the Supreme Court's holding in Lohr, and
concluded that the plaintiff's fraud on the FDA claim was not preempted
by the MDA.
|||Medtronic initially responds by arguing that Ohio law does not recognize
a common-law cause of action for alleged fraud on a federal agency. Moreover,
Medtronic contends that the district court properly extended our decision
in Martin to find preemption. Medtronic rejects the holding of the Third
Circuit in Bone Screw I, which it characterizes as a minority position adopted
by no other circuit court, and urges us to hold with the Seventh Circuit
in Mitchell that the earlier Third Circuit decision in Michael maintains
its vitality even after the Supreme Court's decision in Lohr. Alternatively,
Medtronic contends that the principle of implied conflict preemption dictates
that we hold plaintiffs' fraud on the FDA claim to be preempted.
|||Under Ohio law, a claim of fraudulent misrepresentation requires a plaintiff
to prove the following elements: "(a) a representation or, where there
is a duty to disclose, concealment of a fact, (b) which is material to the
transaction at hand, (c) made falsely, with knowledge of its falsity, or
with such utter disregard and recklessness as to whether it is true or false
that knowledge may be inferred, (d) with the intent of misleading another
into relying upon it, (e) justifiable reliance upon the representation or
concealment, and (f) a resulting injury proximately caused by the reliance."
Cohen v. Lamko, Inc., 462 N.E.2d 407, 409 (Ohio 1984) (per curiam). Once
again, to preempt this common-law claim, the federal requirements established
by the Model 4004M PMA Supplement "must be 'applicable to the device'
in question . . . and 'specific' to a 'particular device.'" Martin,
105 F.3d at 1098. (quoting Lohr, 518 U.S. at 500).
|||The issue presented here reaches to the heart of a sharp split between
the various Courts of Appeals.*fn14
The Seventh Circuit has steadfastly, albeit tersely, maintained that claims
alleging fraud committed through representations made to the FDA during
the PMA process are preempted even after the Supreme Court's holding in
Lohr. See Mitchell, 126 F.3d at 914 ("We continue to believe that this
issue was decided correctly by the Third Circuit in Michael v. Shiley, Inc.").
In stark contrast, the Eleventh Circuit in Goodlin has held that no preemption
of any state-law claims flows from FDA approval of a PMA Supplement, and
the Third Circuit's decision in Bone Screw I held that state-law claims
alleging fraud on the FDA are not foreclosed in light of the Supreme Court's
decision in Lohr. See Goodlin, 167 F.3d 1381-82; Bone Screw I, 159 F.3d
at 829. Recognizing the significance of the issue for thousands of plaintiffs
across the country, the Supreme Court recently granted certiorari, limited
to the following question: "Whether federal law preempts state-law
tort claims alleging fraud on the Food and Drug Administration during the
regulatory process for marketing clearance applicable to certain medical
devices." Buckman Co. v. Plaintiffs' Legal Committee, cert. granted,
No. 98-1768 (U.S. June 29, 2000).
|||We return to the language of Lohr to guide our determination whether a
common-law claim for "fraud on the FDA" amounts to a state-law
requirement, "different from, or in addition to," the specific
federal requirements. Five Justices held in Part V of the Lohr decision
that "[n]othing in § 360k denies [a state] the right to provide a traditional
damages remedy for violations of common-law duties when those duties parallel
federal requirements." Lohr, 518 U.S. at 495. Hence, we must determine
whether plaintiffs' claim alleging that Medtronic fraudulently obtained
PMA Supplement approval from the FDA by failing to submit Solution A test
results, by failing to perform canine studies, and by failing to submit
laboratory tests for the Model 4004M, merely "parallels" federal
requirements, or if, instead, it threatens to impose different or additional
requirements, and thus is preempted.
|||Concluding that a requirement imposed by a cause of action for fraud on
the FDA simply parallels federal requirements and thus is not preempted,
the Third Circuit noted that 18 U.S.C. § 1001 makes it a crime to make a
fraudulent statement to a federal agency, and that 21 C.F.R. § 807.87(j)
requires every pre-market notification to contain a statement that the information
contained therein is believed by the manufacturer to be truthful. See Bone
Screw I, 159 F.3d at 823. Based on these two federal requirements, the Bone
Screw I court concluded "the state common law relied upon [by the plaintiffs]
does not impose any obligation on [defendant] inconsistent with federal
|||Set against this analysis is the Third Circuit's holding in Michael v.
Shiley, which the Seventh Circuit adopted after Lohr in Mitchell v. Collagen
Corp. In its pre-Lohr decision, the Michael court held that permitting the
plaintiff's claim for fraud on the FDA to go forward would impose a different
requirement under state law, and thus was preempted by § 360k. First, and
most significantly, the Michael court concluded that permitting the claim
to go forward would open a pandora's box of judicial scrutiny of FDA decision-making,
which "could ultimately require that a court determine whether the
information [the defendant] submitted was truthful, whether it was complete,
whether FDA procedures sufficed to avoid a material misrepresentation, and
whether the FDA should have or would have approved the device despite the
misrepresentations." Michael, 46 F.3d at 1329. In short, the Michael
court feared that district courts would be required to adjudicate claims
"applying state law, [and] to perform the same functions initially
entrusted to the FDA." Id. Secondly, the Michael court reasoned that
to permit a fraud claim based on allegedly false representations made by
a manufacturer would conflict with longstanding precedent against permitting
implied causes of action for violations of the Federal Food, Drug and Cosmetics
Id.; accord Bailey v. Johnson, 48 F.3d 965, 966 (6th Cir. 1995). Expressly
relying on this two-pronged analysis, a panel of the Seventh Circuit held
the plaintiff's claims for fraud on the FDA were preempted in a tersely-worded
ruling, stating its belief that Michael's holding on this issue maintained
its vitality even after the Supreme Court's ruling in Lohr. See Mitchell,
126 F.3d at 914.
|||Having carefully considered the question, we are convinced that the Third
Circuit's analysis in Michael, adopted by the Seventh Circuit in Mitchell,
correctly states the law and that nothing in Lohr's holding impairs Michael's
reasoning. As a background consideration, we note that the plaintiffs in
Lohr did not present a "fraud on the FDA" claim before the Supreme
Court. Furthermore, although tort claims for fraudulent misrepresentation
have long been part of the common law, claims alleging fraud on federal
agencies have never come within the "historic police powers of the
States," a consideration that becomes relevant when determining the
scope of preemption under §360k. Lohr, 518 U.S. at 495. It is one thing
to note, as did the majority opinion in Bone Screw I, that federal law provides
penalties for fraudulent statements made to government agencies. It is quite
another to say that because federal law criminalizes such conduct, private
litigants may bring a civil suit presenting a novel theory of liability
under state common law to enforce an alleged violation of federal agency
regulations. In our view, permitting plaintiffs to bring such actions does
not equate to a "parallel" state law requirement as contemplated
by Lohr; rather, such actions could conceivably impose both "different"
and "additional" state law requirements in addition to the federal
requirements specific to the Class III device established through the PMA
|||Initially, as noted by Michael, a jury presented with a common-law claim
of fraud on the FDA might conclude that, but for the alleged misrepresentations
made by the manufacturer, the FDA would have withheld approval of the device
because it had not received reasonable assurance of the device's safety
and effectiveness. To make such a showing, plaintiffs would have to adduce
expert testimony from those familiar with FDA procedures, conduct discovery
of FDA employees, and establish that the alleged misrepresentations rendered
the device not safe and effective for its intended use. Effectively, actions
for fraud on the FDA would allow individual juries to undertake a counterfactual
FDA review, and conclude that the FDA would not have approved the device.
However, "Congress allocated the FDA responsibility to design and manage
a process which would result in approval of the safest and most effective
medical devices possible. Congress also assigned the FDA the responsibility
to approve or disapprove of applications to market medical devices."
Michael, 46 F.3d at 1329. Furthermore, we agree that permitting the "searching
inquiry" of FDA internal procedures and personnel runs counter to both
congressional intent and sound policy. Hence, we hold that to allow common-law
suits for fraud on the FDA to go forward would permit juries to reach a
different conclusion than the FDA did in approving the device in question,
thereby imposing a different requirement than that required by the federal
|||Finally, permitting a fraud claim premised on false representations to
the FDA during the PMA process would conflict with well-established precedent
that no implied private right of action exists under the FDCA. As we have
|||[T]he determination that a violation of a federal statute such as the
FDCA will create state tort liability is not a matter solely of state law.
A state's ability to use a federal statute violation as a basis for state
tort liability and negligence per se depends on the intent of Congress,
and not merely on the intent of the state. Thus, the congressional decision
not to provide a private cause of action under the FDCA becomes quite important
in considering the propriety of a state negligence per se action for violation
of the FDCA. In re Bendectin Litig., 857 F.2d 313-14 (6th Cir. 1988).
|||Returning to answer this question when it was squarely before this Court,
we held that no private cause of action exists for a violation of the FDCA.
See Bailey, 48 F.3d at 967; see also 21 U.S.C. § 337(a) (restricting FDCA
enforcement to suits by the United States); accord In re Orthopedic Bone
Screw Products Liability Litigation, 193 F.3d 781, 788-89 (3d Cir. 1999);
PDK Lab., Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997); Mylan
Lab., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993). States are not
granted any authority to enforce compliance with the specific federal requirements
established by the PMA process. Any common-law suit premised on allegations
that Medtronic committed fraud on the FDA and thus violated MDA amendments
in its 4004M PMA Supplement submission conflicts with governing precedent
in this circuit holding that no implied right of action exists for a violation
of the Federal Food, Drug and Cosmetics Act. Plaintiffs cannot circumvent
our prior decision by characterizing their claim as "fraud on the FDA,"
which we hold is preempted in accordance with the foregoing analysis.
|||C. Failure to Warn
|||Plaintiffs' inadequate warning claim is brought under Ohio Revised Code
§ 2307.76, which generally provides that a product is defective where the
manufacturer fails to issue adequate warnings when the manufacturer knew,
or reasonably should have known, of a risk of harm to the consumer. It is
difficult to determine, however, the underlying basis of plaintiffs' claim
as presented to the district court below. As set forth in their original
complaint, Count IV is ambiguous: "At the time the Medtronic Models
4004 and 4004M leads were supplied to Plaintiffs, the products were defective
as a result of Medtronic's failure to give adequate warnings, regarding
polyurethane insulation, insulation failure, and lack of testing."
J.A. at 39.
|||This statement could be read as asserting that the warnings found in the
label and literature approved by the FDA for the Model 4004 and Model 4004M
were inadequate under Ohio law. As noted above, however, the information
submitted to and approved by the FDA in the Model 4004M PMA Supplement -
including information regarding warnings and disclaimers - comprise the
specific federal requirements applicable to defendant's pacemaker lead.
Accordingly, to the extent that plaintiffs' claim is premised on the adequacy
of the warnings reviewed and approved by the FDA, our analysis of the "fraud
on the FDA" claim applies equally to the failure to warn claim, and
the claim is similarly preempted. See Martin, 105 F.3d at 1100 ("To
allow a state cause of action for inadequate warnings would impose different
requirements or requirements in addition to those required by federal regulations.").
|||The statement in Count IV could also be read, however, to assert a wholly
separate and distinct claim that defendant acquired information subsequent
to the FDA approval of the Model 4004M and before implantation of the device
that would lead a reasonable manufacturer to warn patients and the medical
community. Unfortunately, plaintiffs did not attempt to resolve this ambiguity
until after the district court had already granted defendant summary judgment
on the claim, in which the court clearly construed the claim - consistent
with the parties' arguments - in accordance with the former understanding
and not this latter, alternative meaning.
|||Because plaintiffs had ample opportunity to clarify this ambiguity - both
in their original complaint and their brief in opposition to defendant's
first motion for summary judgment - yet failed to do so in a timely manner,
it is apparent that the claim they now argue on appeal was never properly
presented to the district court and is not properly addressed by this Court
in the first instance. Accordingly, we need not address the preemptive effect,
if any, of § 360k on a claim for breach of a manufacturer's duty under state
law to warn patients or the medical community of potential risks of a particular
medical device based on information obtained subsequent to FDA approval
of the device. Further, because of these pleading defects, we decline to
remand this issue to the district court for further proceedings.
|||D. Derivative Spousal Claim
|||In light of the foregoing analysis finding that Elizabeth Kemp's claims
are preempted by § 360k of the MDA, Clifford Kemp's derivative spousal claim
is similarly preempted.
|||For the foregoing reasons, we conclude that plaintiffs' claims are preempted
and we AFFIRM the judgment of the district court. Defendant has not shown,
however, good cause for continuing the seal on appellate briefs, and accordingly
the seal is hereby LIFTED.
|||KAREN NELSON MOORE, Circuit Judge, concurring.
|||I agree with the majority that pursuant to our decision in Martin v. Telectronics
Pacing Systems, Inc., 105 F.3d 1090 (6th Cir. 1997), the FDA's approval
of the Model 4004M PMA Supplement and the FDA's conditions of approval imposed
on the 4004M pacemaker lead constitute a specific federal requirement, thereby
triggering the possibility of preemption under 21 U.S.C. § 360k(a) of the
Kemps' state law claims to the extent that the state law claims are different
from or in addition to the federal requirements.
|||I also agree that the specific federal requirements established by the
FDA approval of the Model 4004M do not include a requirement as to the thickness
or coverage of the platinum sputter barrier. Because Mrs. Kemp's negligence
claim is premised on a failure of the device to achieve a uniform thickness
of the platinum sputter barrier, her negligence claim is preempted; a jury
could not find in favor of Mrs. Kemp on the negligence claim without imposing
a requirement "different from, or in addition to" the federal
requirement. 21 U.S.C. § 360k(a)(1).
|||I agree as well with the more general principle stated by the majority
that "a claim premised on the violation of FDA requirements established
for a Class III device through the PMA process is not automatically preempted."
Maj. Op. ante ¶ 70. Thus as the majority recognizes, a claim for negligence
per se premised on the absence of a platinum sputter barrier as required
by the FDA approval would not be preempted because the state claim would
not impose requirements different from or additional to the federal requirements.
|||The claim that Medtronic committed a fraud on the FDA by improperly failing
to submit certain tests and laboratory data to the FDA during the approval
process raises federalism concerns. Rather than force the analysis of this
claim into the preemption framework of § 360k(a) and Medtronic, Inc. v.
Lohr, 518 U.S. 470 (1996), I would instead focus on the peculiar nature
of this claim. It appears from Kemp's appellate brief that she asserts that,
because of alleged misrepresentations by Medtronic to the FDA, the FDA erroneously
approved the 4004M, and she should therefore be able to recover damages
on a state-law fraud claim. A determination in favor of Kemp on this fraud
claim would effectively set aside the entire FDA approval process. Not only
would litigants be able to explore and challenge the administrative decisionmaking
process of the federal agency, but also conflicts could easily arise between
the results of state-law fraud litigation and federal enforcement through
federal civil and criminal penalties for false or misleading submissions
to the FDA. See, e.g., 21 U.S.C. §§ 331(q)(2), 333.
|||In any event, Kemp fails to point to any Ohio law upholding the viability
of a "fraud against a federal agency" claim for damages to an
individual user of a product. The case cited by Kemp, Dutton v. Acromed
Corp., 691 N.E.2d 738 (Ohio Ct. App. 1997), does not characterize the claim
as a claim of fraud on the FDA but rather involves a claim of misrepresentation
of a medical device's approval status to the affected individual. Such traditional
fraud claims certainly are not preempted by § 360k(a) or by Lohr, which
explained that "[n]othing in § 360k denies [a state] the right to provide
a traditional damages remedy for violations of common-law duties when those
duties parallel federal requirements." Lohr, 518 U.S. at 495. Moreover,
allowing a state fraud claim for misrepresentations made to the patient
would not conflict with our decision in Bailey v. Johnson, 48 F.3d 965 (6th
Cir. 1995), holding that the federal Food, Drug and Cosmetic Act does not
impliedly provide a private federal cause of action for a violation of its
provisions, since that state fraud claim would be premised on using the
federal law as a behavioral standard as endorsed by the Supreme Court in
Lohr. Kemp's fatal problem is that her fraud claim on appeal is solely presented
as a claim of fraud on the FDA rather than fraudulent misrepresentations
|||In sum, I disagree with the majority's theory regarding the claim of fraud
on the FDA but agree nonetheless with the conclusion that that claim must
be dismissed. I agree with the conclusion that the negligence per se claim
raised by Kemp is preempted because of the particular nature of her claim.
I agree that we need not address the issue of whether § 360k preempts a
claim of breach of a duty to warn patients of risks discovered after FDA
approval of a device.
When no single rationale commands the agreement of five Justices of the
Supreme Court, "the holding may be viewed as that position taken by
those Members who concurred in the judgment on the narrowest grounds."
Marks v. United States, 430 U.S. 188, 193 (1977). Hence, Justice Breyer's
concurrence takes on heightened significance in interpreting Lohr's holding.
In an opinion predating the Supreme Court's 1996 decision in Medtronic,
Inc. v. Lohr, a panel of the Ninth Circuit reversed a grant of summary judgment
in favor of a defendant manufacturer of a Class III device that had undergone
PMA approval. Focusing upon the regulations promulgated by the FDA, the
Ninth Circuit opined that PMA approval does not constitute a "specific
requirement applicable to a particular device" under 21 C.F.R. § 808.1(d),
and held § 360k of the MDA does not preempt state common law tort claims
of general applicability. Kennedy v. Collagen Corp., 67 F.3d 1453, 1459-60
(9th Cir. 1995) (emphasis in original).
Plaintiff offers the affidavit of Charles H. Kyper, Director of the Premarket
Approval Staff from 1981-1990. Kyper avers that: A PMA Supplement application
is not reviewed with the same rigor as a PMA. Review of a PMA Supplement
is much like a review of a 510(k) application in that both focus on the
change being presented and assume the accuracy of information being presented
and assume the accuracy of information presented in prior submissions. Typically,
reviews of PMA Supplement applications are allocated 1/7th the time allocated
for a PMA. J.A. at 311.
In fact, the Martin court found it significant that under the IDE process,
the FDA required information regarding "the methods, facilities, and
controls used for manufacture . . . of the device, in sufficient detail
so that a person generally familiar with good manufacturing practices can
make a knowledgeable judgment about the quality control used in the manufacture
of the device." Martin, 105 F.3d at 1097 (quoting 21 C.F.R. § 812.20(b)(2))
(internal quotation marks omitted). Similarly, a PMA applicant is required
to submit information regarding "[t]he methods used in, and the facilities
and controls used for, the manufacture, processing, packing, storage, and,
where appropriate, installation of the device, in sufficient detail so that
a person generally familiar with current good manufacturing practice can
make a knowledgeable judgment about the quality control used in the manufacture
of the device." 21 C.F.R. § 814.20(b)(4)(v).
The district court identified six requirements that it believed were directly
applicable to plaintiffs' claims, summarized as follows: (1) The lead must
have four polyurethane tines; (2) the conductor coils must be made of MP35N
nickel alloy; (3) the lead must have polyurethane insulation; (4) the conductors
must be constructed from MP35M nickel alloy, .005 inches in diameter and
sputter coated with platinum; (5) the insulation must be made of 2363-80A
polyurethane, of specified thicknesses; and, (6) there must be a protective
barrier coat between the conductor coil and the insulation which is composed
of platinum sputtering. See J.A. at 2941-42.
In their response to defendant's motion for summary judgment on March 9,
1999, plaintiffs characterized their claims as follows: Plaintiffs' negligence
per se and strict liability claims focus solely on Medtronic's failure to
manufacture the Model 4004M pacemaker with a "protective barrier coat
of [sic] between the conductor coil and the insulation, which is composed
of platinum sputtering." J.A. at 2801.
At oral argument, we explicitly asked plaintiffs to identify in the record
what they contended established a thickness requirement for the platinum
sputter barrier. In response, plaintiffs cited Medtronic's internal deviation
authorization and engineering change order. J.A. at 986-90; 991-93. These
pages do not contain any reference to the coverage of the barrier.
Medtronic submitted its § 510(k) notification for its Model 4016A bipolar
transvenous lead on September 28, 1987. The Model 4016A was a modification
of the Model 4016 which was judged substantially equivalent to leads marketed
prior to May 28, 1976, pursuant to the § 510(k) process on August 29, 1985.
J.A. at 774.
Of course, the Model 4003 PMA, the ancestor of the Model 4004M, also established
requirements applicable to the Model 4004M under our analysis, but any such
requirements are not at issue here.
Medtronic wrote to voluntarily withdraw its PMA Supplement for the Model
4003M on December 10, 1992, and the FDA acknowledged such withdrawal on
December 18, 1992. See 21 C.F.R. § 814.44(g)(3); J.A. at 2877.
The Medtronic Model 4003M, as PMA-approved on June 23, 1989, is a unipolar
polyurethane pacing lead with a conductor coil that was not barrier coated.
Medtronic submitted a PMA Supplement specifying the addition of a barrier
coat of platinum sputter on November 19, 1991. J.A. at 2883.
Plaintiffs' original complaint thus alleges that Medtronic fraudulently
misrepresented the Model 4004M to plaintiffs and their physicians. As argued
before the district court and on appeal, however, plaintiffs purport to
have claimed that Medtronic fraudulently obtained FDA approval by failing
to submit Solution A test results, canine test results, and other laboratory
data prior to receiving FDA approval.
In its ruling, the district court expressly relied on both Michael and Klein,
and also noted that our decision in Bailey, 48 F.3d at 968, supported its
conclusion that state-law claims for fraud on the FDA are preempted. J.A.
Count VII of plaintiffs' original complaint does not explicitly allege that
Medtronic fraudulently obtained approval of the Model 4004M by presenting
false information to the FDA. Rather, plaintiffs merely claim that Medtronic
misrepresented the Model 4004M to plaintiffs and their physicians. To prove
the falsity of Medtronic's representation as required under the third element
of the claim, however, plaintiffs must establish that the Model 4004M was
falsely represented to be safe and effective - the very determination made
by the FDA in granting PMA approval. Consequently, although plaintiffs'
Count VII claim does not expressly allege "fraud on the FDA,"
such a claim is necessarily implied in plaintiffs' allegations.
This position has also been advanced by the Solicitor General for the United
States as Amicus Curiae recommending the Supreme Court grant certiorari
in Buckman Co. v. Plaintiffs' Legal Committee, cert. granted, No. 98-1768
(U.S. June 29, 2000) ("'fraud on the agency' claims could subject federal
agencies to countless, highly intrusive inquiries into their internal deliberations").
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