JACK M C MULLEN and BARBARA M C MULLEN v. Medtronic , Inc .

In the
United States Court of Appeals
For the Seventh Circuit
____________
No. 04-3678
J ACK M C M ULLEN and B ARBARA M C M ULLEN ,
Plaintiffs-Appellants,
v.
M EDTRONIC , I NC .,
Defendant-Appellee.
____________
Appeal from the United States District Court
for the Southern District of Indiana, Terre Haute Division.
No. 03 C 5—Larry J. McKinney, Chief Judge.
____________
A RGUED J UNE 10, 2005—D ECIDED A UGUST 26, 2005
____________
Before F LAUM , Chief Judge, and P OSNER and K ANNE ,
Circuit Judges.
F LAUM , Chief Judge. Plaintiffs-appellants Jack and
Barbara McMullen filed suit against defendant-appellee
Medtronic, Inc., alleging state-law claims arising out of the
implantation of two of Medtronic’s Activa Tremor Control
Systems (“Activas”) in Jack McMullen’s brain. The district
court granted summary judgment in favor of Medtronic on
the ground that the McMullens’ claims are preempted by
federal requirements imposed by the Food and Drug
Administration (“FDA”) pursuant to the Medical Device
Amendments (“MDA”), 90 Stat. 539, to the Federal Food,
Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq.

-- 1 of 13 --

2 No. 04-3678
The McMullens appeal, and for the reasons stated herein,
we affirm.
I. Background
The Medtronic Activa is classified under the MDA as a
Class III medical device, which means that it “is purported
or represented to be for a use in supporting or sustaining
human life or for a use which is of substantial importance
in preventing impairment of human health, or . . . presents
a potential unreasonable risk of illness or injury.” 21 U.S.C.
§ 360c(a)(1)(C)(ii). Before a Class III device may be intro-
duced into the market, the manufacturer must provide the
FDA with a “‘reasonable assurance’ that the device is both
safe and effective.” Medtronic, Inc. v. Lohr, 518 U.S. 470,
477 (1996) (quoting § 360e(d)(2)). The process by which the
FDA decides whether a manufacturer has provided a
“reasonable assurance,” known as the “premarket approval”
or “PMA” process, is a rigorous one. Id. Manufacturers must
submit detailed information regarding the safety and
efficacy of their devices, which the FDA thoroughly reviews.
Id. Approval by the FDA may constitute acceptance of such
things as the product’s design, testing, intended use,
manufacturing methods, performance standards, and
labeling. Mitchell v. Collagen Corp., 126 F.3d 902, 913 (7th
Cir. 1997).
In 1997, following a full PMA review, the FDA approved
Medtronic’s Activa for use in the suppression of tremors in
patients diagnosed with Parkinson’s Disease. The Activa is
composed of three parts: the implantable pulse generator
(“IPG”), which is the power source; the lead, which is a thin
insulated wire with a series of tiny electrodes at one end;
and the extension, which connects the IPG to the lead.
Electrical impulses are conveyed through the device,
electrically stimulating areas of the brain that control

-- 2 of 13 --

No. 04-3678 3
1 While neither party provided precise definitions of these terms,
it appears that “electrocautery” is the burning or searing of tissue
by means of an electrically heated instrument, and “diathermy” is
therapeutic local heating by means of passing electric currents
through tissue. The distinction between the two procedures is not
important for the purposes of this case.
2 Before the district court, McMullen argued that he was not
implanted with an Activa, but instead with a different Medtronic
(continued...)
movement and muscle function.
Pursuant to its approval, the FDA required Medtronic to
track the name and contact information of patients im-
planted with the Activa. The FDA also required Medtronic
to list specific warnings regarding “electrocautery” and
“diathermy” 1 in its manuals for physicians and patients.
The patient manual was required to state:
Tell your dentist where your IPG is im-
planted, so he or she can take precautions
with dental drills and ultrasonic probes used
to clean your teeth. These devices should not
be used directly over the implant site.
Therapeutic ultrasound, electrolysis, radia-
tion therapy, and electrocautery also should
not be used directly over the implant site.
* * *
Diathermy treatments that are sometimes
used for muscle relaxation may affect the
neurostimulator output and/or damage its
electronics.
In May 2000, Jack McMullen, who has been experiencing
the symptoms of Parkinson’s Disease since 1985, was
implanted with two Activas, one on each side of his brain.2

-- 3 of 13 --

4 No. 04-3678
2 (...continued)
device called the Activa Parkinson’s Control Therapy, which had
not yet received FDA approval. The district court concluded that
the record could not support this assertion. On appeal, McMullen
still hints that he was not implanted with an Activa, but does not
challenge the district court’s conclusion directly. Accordingly, any
arguments based on this factual assertion have been forfeited. See
Tyler v. Runyon, 70 F.3d 458, 464-65 (7th Cir. 1995).
As a result of the bilateral stimulation, McMullen experi-
enced an excellent remediation of his Parkinson’s symp-
toms.
In January 2001, Medtronic learned of an anecdotal
report involving a 70-year-old Parkinson’s patient who had
been implanted with an Activa. According to the report, a
dentist treated the patient with diathermy following oral
surgery. During the procedure, the patient was found
unresponsive and it was determined that he was in a coma.
The suspected cause was damage to brain tissue surround-
ing his Activa leads, induced by the diathermy.
About two months later, in March 2001, Jack McMullen
underwent a dental procedure, which possibly involved
diathermy or electrocautery. Thereafter, McMullen experi-
enced a decline in the control of his Parkinson’s symptoms.
Despite further surgeries to replace components of the
implanted Activas, the reduced symptom control continues
to this day. McMullen suspects the cause to be damage to
brain tissue surrounding the leads of his Activas.
Following further investigation of the January 2001
anecdotal report, Medtronic sent letters by mail to both
physicians and patients in May 2001. Medtronic’s patient
letter stated:
CONTRAINDICATION: Inform anyone
treating you that you CANNOT have any

-- 4 of 13 --

No. 04-3678 5
shortwave diathermy, microwave diathermy
or therapeutic ultrasound diathermy (all now
referred to as diathermy) anywhere on your
body because you have an implanted
neurostimulation system. Energy from dia-
thermy can be transferred through your
implanted system, can cause tissue damage
and can result in severe injury or death.
Diathermy can also damage parts of your
neurostimulation system. This can result in
loss of therapy from your neurostimulation
system, and may require additional surgery
to remove or replace parts of your implanted
device. Injury or damage can occur during
diathermy treatment whether your
neurostimulation system is turned “on” or
“off.”
To make changes affecting the safety or effectiveness of a
device that has gone through the PMA process, a manufac-
turer must submit a PMA Supplement for review and
approval by the FDA. See 21 C.F.R. § 814.39(a). Medtronic
submitted a PMA Supplement, seeking FDA approval to
market the Activa with a new, stronger warning, like that
which was provided in the May 2001 patient letter. In June
2001, three months after McMullen’s injury, the FDA
approved the use of the new warning.
Thereafter, Jack McMullen and his wife, Barbara
McMullen, filed a complaint in the Vermillion County
Indiana Circuit Court alleging that Medtronic breached its
post-sale duty to warn of dangers arising from the use of
diathermy or electrocautery on a patient implanted with a
Medtronic Activa. Specifically, plaintiffs assert that the
January 2001 report about the 70-year-old Parkinson’s
patient triggered Medtronic’s duty to immediately issue a
new warning directly to patients about the increased risks

-- 5 of 13 --

6 No. 04-3678
of diathermy and electrocautery. The McMullens’ complaint
alleges that, as a result of the use of the electrical surgical
instrument during his dental procedure, Jack McMullen
suffered severe brain damage. In addition, Barbara
McMullen alleges a derivative claim for loss of consortium.
Medtronic removed the case to the United States District
Court for the Southern District of Indiana based on diver-
sity jurisdiction, after which the parties filed cross-motions
for summary judgment. Medtronic argued that plaintiffs’
claims were preempted under the express preemption
clause of the MDA and, in the alternative, that it was
entitled to judgment as a matter of law on the merits of the
McMullens’ claims. The McMullens disputed Medtronic’s
claim of preemption and argued that the uncontroverted
facts demonstrated that they were entitled to judgment as
a matter of law on both of their claims.
The district court granted Medtronic’s motion, holding
that the post-sale failure to warn claim is preempted and
that the derivative loss of consortium claim falls with it.
The McMullens appeal, asking us to reverse the district
court and direct it to enter summary judgment in their
favor.
II. Discussion
We review the district court’s grant of summary judgment
de novo, viewing all facts and drawing all reasonable
inferences in the non-moving party’s favor. Eisencorp, Inc.
v. Rocky Mountain Radar, Inc., 398 F.3d 962, 965 (7th Cir.
2005). Summary judgment is appropriate if the evidence
presented by the parties “show[s] 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.
569(c).
At issue in this case is whether Jack McMullen’s common-

-- 6 of 13 --

No. 04-3678 7
law claim against Medtronic for post-sale failure to warn is
preempted by federal law. The principle of preemption
arises from the Supremacy Clause of the Constitution which
states that “the Laws of the United States . . . shall be the
supreme Law of the Land . . . any Thing in the Constitution
or Laws of any State to the Contrary notwithstanding.” U.S.
Const. art. VI. “Pursuant to this authority, Congress may
preempt state law.” Chambers v. Osteonics Corp., 109 F.3d
1243, 1246 (7th Cir. 1997). “A federal law may preempt a
state law expressly, impliedly through the doctrine of
conflict preemption, or through the doctrine of field (also
known as complete) preemption.” Boomer v. AT&T Corp.,
309 F.3d 404, 417 (7th Cir. 2002); see also Hoagland v.
Town of Clear Lake, Ind., 415 F.3d 693 (7th Cir. 2005). The
MDA contains an express preemption provision, under
which, as we explain below, the state law that is the basis
for McMullen’s claim is expressly preempted. Accordingly,
we do not address the doctrines of conflict and field preemp-
tion.
The MDA’s preemption clause provides in relevant part:
[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 chap-
ter 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). This provision sets three conditions for
preemption: (1) there must be a “requirement” that a state
“establish[es] or continue[s] in effect, with respect to a
device intended for human use”; (2) there must be a rele-

-- 7 of 13 --

8 No. 04-3678
vant federal requirement under the FDCA applicable to the
device at issue; and (3) the state “requirement” must be
“different from, or in addition to,” the federal requirement.
See id.
Here, the parties agree that the first condition is satis-
fied. McMullen states that his post-sale failure-to-warn
claim arises either under the law of Indiana, where the
injury occurred, or under the law of Minnesota, where
Medtronic’s headquarters are located. We need not decide
which law governs or the scope of the applicable common-
law duty. It is enough to note that any state requirement
that would provide a basis for McMullen’s claim must have
imposed on Medtronic a duty to provide an additional
warning between January 2001, when Medtronic learned of
the anecdotal report, and March 2001, when McMullen
underwent the dental procedure and was injured. For the
purposes of our preemption inquiry, we may assume that
there is such a state-law duty and that McMullen’s claim
would be viable if not preempted. To the extent this duty
exists and could be a basis for a verdict in favor of
McMullen, it establishes a “requirement” with respect to
the Medtronic Activa, a device intended for human use, and
thus satisfies the first condition of preemption. See Mitchell,
126 F.3d at 910 (common-law causes of action may be
“requirements” as the term is used in § 360k(a)); see also
Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 867
(2000) (noting that a majority of the Supreme Court in Lohr
agreed that common-law tort actions may be preempted
under the MDA’s preemption clause); Bates v. Dow
Agrosciences LLC, 125 S. Ct. 1788, 1798 (2005) (holding
that the term “requirements” in the preemption clause of
the Federal Insecticide, Fungicide, and Rodenticide Act
(“FIFRA”) “reaches beyond positive enactments, such as
statutes and regulations, to embrace common-law duties”).
There also is no dispute as to the second condition. To
have preemptive effect under § 360k(a), a federal require-

-- 8 of 13 --

No. 04-3678 9
ment must be specific to a particular device and relevant to
the conduct that is the subject of the state requirement at
issue. Mitchell, 126 F.3d at 910 (citing Lohr, 518 U.S. at
500-01). We have held that federal requirements specific to
individual products are imposed through the PMA process.
Id. at 911. Here, there were specific federal requirements as
to the warnings given both before and after implantation of
the Medtronic Activa. For example, the FDA approved and
required the precise language of the dia-
thermy/electrocautery warning given to McMullen, and, in
its PMA approval letter, the FDA directed Medtronic to
track all Activa recipients. Medtronic also had a continuing
obligation to report to the FDA any adverse events which
would reasonably suggest that the device caused or contrib-
uted to a death or serious injury. See 21 U.S.C. § 360i; 21
C.F.R. §§ 803.10(c), 803.50. If Medtronic believed that a
warning different from the one approved by the FDA was
appropriate in light of an adverse event, it was required to
seek FDA approval of any proposed changes. See 21 C.F.R.
§ 814.39(a). These are relevant federal requirements
limiting Medtronic’s conduct as to the warnings it issued to
Activa recipients. The second condition of § 360k(a) preemp-
tion is satisfied.
As to the third condition, the only one contested in this
case, we must ask whether the state common-law duty
underlying McMullen’s claim would impose a requirement
that is “different from, or in addition to,” the relevant
federal requirements. A claim that a manufacturer failed to
provide an adequate warning at the time of sale would be
based on the assertion that the manufacturer should have
provided a different warning than the one approved by the
FDA. Such a state-law claim would impose a requirement
that was different from, or in addition to, the applicable
federal requirements and would be preempted. Cf. Mitchell,
126 F.3d at 913-14 (time-of-sale mislabeling claim pre-
empted); accord Horn v. Thoratec Corp., 376 F.3d 163, 177

-- 9 of 13 --

10 No. 04-3678
(3d Cir. 2004) (time-of-sale failure-to-warn claim pre-
empted); Brooks v. Howmedica, Inc., 273 F.3d 785, 796-98
(8th Cir. 2001) (en banc) (same); Martin v. Medtronic, Inc.,
254 F.3d 573, 585 (5th Cir. 2001) (same); Kemp v.
Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000) (same);
Papike v. Tambrands, Inc., 107 F.3d 737, 742 (9th Cir.
1997) (same); but see Goodlin v. Medtronic, Inc., 167 F.3d
1367, 1374-78 (11th Cir. 1999) (no preemption of common-
law claims involving PMA-approved devices); Oja v.
Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1997) (no
preemption of common-law claims where device undergoes
the less rigorous “Investigational Device Exception” pro-
cess).
McMullen, however, does not take issue with Medtronic’s
original warning. Rather, he claims that Medtronic violated
a post-sale duty to warn, under which it was required to
provide an additional warning in light of the January 2001
anecdotal report. Medtronic distributed just such an
additional warning in May 2001, but McMullen contends
that this was too late. He argues that Medtronic was
obligated, under parallel state and federal laws, to send a
“timely” additional warning, which he defines as one
delivered sometime before his dental appointment in March
2001. If he is correct that there are both state and federal
requirements to this effect, then the state requirements will
not be different from, or in addition to, the federal require-
ments and McMullen’s claim will not be preempted pursu-
ant to § 360k(a). See Mitchell, 126 F.3d at 909 (“[T]o the
extent a common law action mirrors the FDA regulations,
it would not be preempted.”); Lohr, 518 U.S. at 495 (“Noth-
ing in § 360k denies [states] the right to provide a tradi-
tional damages remedy for violations of common-law duties
when those duties parallel federal requirements.”); see also
Bates, 125 S. Ct. at 1800-01 (relying on Lohr in holding that
the phrase “in addition to or different from” in the FIFRA’s
preemption clause does not preclude states from providing

-- 10 of 13 --

No. 04-3678 11
remedies for violations of FIFRA’s requirements). In order
for a state requirement to be parallel to a federal require-
ment, and thus not expressly preempted under § 360k(a),
the plaintiff must show that the requirements are “genu-
inely equivalent.” Bates, 125 S. Ct. at 1804 (emphasis in
original). State and federal requirements are not genuinely
equivalent if a manufacturer could be held liable under the
state law without having violated the federal law. See id.
McMullen points to two federal regulations as the basis
for his contention that federal law creates a duty that is
equivalent to the state-law duty underlying his claim: 21
C.F.R. § 821.1, which requires manufacturers to track
recipients of devices; and § 814.39, which permits manufac-
turers to enhance warnings pending approval of a proposed
change to an earlier-approved warning. Contrary to
McMullen’s contention, however, neither of these regula-
tions, considered alone or together, imposed upon Medtronic
a duty to issue an additional warning between January and
March 2001.
Section 821.1 states that “[e]ffective tracking of devices
from the manufacturing facility . . . to the patient is
necessary for the effectiveness of remedies prescribed by the
act, such as patient notification (section 518(a) of the act) or
device recall (section 518(e) of the act).” Sections 518(a) and
(e) of the MDA, codified at 21 U.S.C. §§ 360h(a) and (e), give
the Secretary of Health and Human Services the discretion
to issue or withhold warnings concerning medical devices
based on the Secretary’s assessment of the risks, and to
issue recall orders “[i]f the Secretary finds that there is a
reasonable probability that a device intended for human use
would cause serious, adverse health consequences or death.”
Thus, the required tracking enables warnings to be issued
and devices to be recalled if the Secretary decides that it is
appropriate to do so. It does not impose on the manufac-
turer the obligation to make warning or recall decisions
unilaterally, nor does it authorize the manufacturer to do

-- 11 of 13 --

12 No. 04-3678
3 McMullen cites to an FDA letter of opinion stating that
manufacturers are “urge[d]. . . to initiate a voluntary removal or
correction of marketed violative products.” An agency’s urging,
however, does not change a permissive provision into a mandatory
one.
so.
Section 814.39 permits a manufacturer to temporarily
amend a warning pending FDA approval of the proposed
changes. Once a temporarily amended warning has been
approved, modified, or denied, the manufacturer must
comply with the FDA’s decision. See Brooks, 273 F.3d at
796. McMullen discusses at length the fact that Medtronic
was “allowed” and “permitted” to issue an interim safety
alert while awaiting approval of its amended warning. He
argues that state common law requiring a post-sale warning
merely “complements” the federal policy of allowing such
warnings, and thus is not preempted. Recall, however, that
the MDA’s preemption clause provides that state require-
ments that are “in addition to” federal requirements are
preempted. 21 U.S.C. § 360k(a). Where a federal require-
ment permits a course of conduct and the state makes it
obligatory, the state’s requirement is in addition to the
federal requirement and thus is preempted. Because §
814.39 permits, but does not require, a manufacturer to
provide interim supplemental warnings pending approval
by the FDA, a common-law duty to provide such a warning
imposes an additional obligation. 3 Neither § 821.1 nor §
814.39 imposed on Medtronic a duty “genuinely equivalent”
to the state common-law duty to provide an additional
warning to McMullen between January and March 2001.
Because McMullen’s claim based on the common-law post-
sale duty to warn would impose on Medtronic a require-
ment that is in addition to federal requirements, we hold
that the claim is preempted pursuant to 21 U.S.C.

-- 12 of 13 --

No. 04-3678 13
§ 360k(a), and that the district court correctly granted
summary judgment in favor of Medtronic. Accord Cupek v.
Medtronic, Inc., 405 F.3d 421, 424-25 (6th Cir. 2005)
(holding that common-law post-sale duty to warn claim was
preempted by requirements imposed through the PMA
process). Accordingly, it also was proper for the district
court to grant summary judgment in favor of Medtronic on
Barbara McMullen’s derivative claim for loss of consortium.
See Chambers, 109 F.3d at 1244-45; Mitchell, 126 F.3d at
906; accord Kemp, 231 F.3d at 237. We need not reach the
parties’ arguments regarding possible alternative grounds
for summary judgment.
III. Conclusion
The district court’s entry of summary judgment in favor
of Medtronic is A FFIRMED .
A true Copy:
Teste:
________________________________
Clerk of the United States Court of
Appeals for the Seventh Circuit
USCA-02-C-0072—8-26-05

-- 13 of 13 --