In the

United States Court of Appeals

For the Seventh Circuit

____________

No. 04-3678

JACK MCMULLEN and BARBARA MCMULLEN,

 Plaintiffs-Appellants,

v.

MEDTRONIC, INC.,

 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.

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ARGUED JUNE 10, 2005—DECIDED AUGUST 26, 2005

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Before FLAUM, Chief Judge, and POSNER and KANNE,

Circuit Judges.

FLAUM, 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.
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 introduced 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
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 implanted 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 implanted, 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, radiation 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
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 experienced an excellent remediation of his Parkinson’s symptoms.

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 surrounding 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 experienced 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
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 diathermy 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 manufacturer 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
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 diversity 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-
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 preemption.

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 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). 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-
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 satisfied. 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 commonlaw 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-
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 diathermy/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 contributed 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) preemption 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 preempted); accord Horn v. Thoratec Corp., 376 F.3d 163, 177
10 No. 04-3678

(3d Cir. 2004) (time-of-sale failure-to-warn claim preempted); 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 commonlaw 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” process).

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 requirements and McMullen’s claim will not be preempted pursuant 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 (“Nothing in § 360k denies [states] the right to provide a traditional 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
No. 04-3678 11

remedies for violations of FIFRA’s requirements). In order

for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under § 360k(a),

the plaintiff must show that the requirements are “genuinely 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 manufacturers to enhance warnings pending approval of a proposed

change to an earlier-approved warning. Contrary to

McMullen’s contention, however, neither of these regulations, 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 manufacturer the obligation to make warning or recall decisions

unilaterally, nor does it authorize the manufacturer to do
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 requirements that are “in addition to” federal requirements are

preempted. 21 U.S.C. § 360k(a). Where a federal requirement 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 postsale duty to warn would impose on Medtronic a requirement that is in addition to federal requirements, we hold

that the claim is preempted pursuant to 21 U.S.C.
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 AFFIRMED. 

A true Copy:

Teste: 

 ________________________________

Clerk of the United States Court of

Appeals for the Seventh Circuit 

USCA-02-C-0072—8-26-05