Opposition Brief — McMullen v. Medtronic, Inc. (No. 05-682)

5

have approved marketing of the device and thus plaintiffs

would not have been injured. The Court explained that “al-

though [Lohr] can be read to allow certain state-law causes of

actions that parallel federal safety requirements, it does not

and cannot stand for the proposition that any violation of the

FDCA will support a state-law claim” (531! U.S. at 353), and

held the plaintiffs’ claims to be impliedly preempted by the

MDA. Fraud on a federal agency, the Court held, was not a

matter historically of state concem, and “fraud-on-the-FDA

claims would * * * cause applicants to fear that their disclo-

sures to the FDA, although deemed appropriate by the

Agency, will later be judged insufficient in state court.” /d. at

351.

B. The extensive regulatory history of the Activa

device prior to its PMA approval.

Both Lohr and Buckman stressed the “thorough review”

(Buckman, 53\ U.S. at 344; see also Lohr, 518 U.S. at 477)

that Class III medical devices must undergo before obtaining

approval from the FDA pursuant to the PMA process. The

path to approval of the Activa Tremor Control System (Ac-

tiva) at issue in this case demonstrates the thoroughness of

that review.

The Activa is a surgically implanted neurological device

designed to control tremors, especially those resulting from

Parkinson's Disease. The Activa is classified as a Class III

medical device under the MDA. Pet. App. 2a. Medtronic

submitted a PMA application for the Activa on April 30,

1996.’ The PMA application, as amended and supplemented

over the following 15 months, contained large quantifies of

scientific information, including data from preclinical, ani-

This description of the PMA process resulting in FDA approval

of the Activa is based on the affidavit of Lisa L. Prichard, which

is contained in Medtronic’s Supplemental Appendix in the Seventh

Circuit (SA), at 136-150. See also Pet. App. 2a—3a.

6

mal, and human studies, as well as material evaluation and

biostability studies. The PMA appiication also provided ex-

tensive information on the device’s hardware and software

design, in addition to the production and quality-control

processes that would be used in the device’s manufacture.

Similarly, the PMA application contained full copies of pro-

posed labeling materials, including product labels, physiciar

manuals, and patient manuals.

The Activa PMA appuication underwent exhaustive re-

view by the FDA staff. The FDA made various inquiries of

Medtronic, and the initial application was modified and sup-

plemented on several occasions in response.’ In addition, the

application was referred to an FDA Advisory Panel, a group

of outside experts—including physicians and biomedical en-

gineers—convened by the agency to review the application

and recommend whether it should be granted or denied.

Having “run{] the gauntlet of the PMA process,” Lohr,

518 U.S. at 494, the Activa PMA application was granted on

July 31, 1997. The FDA approval was subject to various

conditions, including the requirement that Medtronic, before

actually marketing the device, submit “copies of all approved

labeling in final printed form.” SA 159. As part of that label-

ing, “[t}he FDA *** required Medtronic to list specific

wamings regarding ‘electrocautery’ and ‘diathermy’ in its

manuals for physicians and patients.” Pet. App. 3a. The

For example, the “proposed labeling materials were amended to

meet the FDA's specific concems and requirements before [the

PMA application] was approved.” SA 142.

* The FDA-mandated warning for physicians stated:

Electrocautery—Electrocautery can cause temporary

suppression of pulse generator output and/or repro-

gramming of the pulse generator. If use of electro-

cautery is necessary, the current path (ground plate)

should be kept as far away from the pulse generator

and lead as possible.

FDA also required Medtronic, pursuant to 21 C.F.R. § 821.1,

to track the name and contact information of patients im-

planted with the Activa, and, pursuant to 21 C.F.R.

§ 814.82(a)(9), to submit written reports to the FDA if it be-

came aware of information reasonably suggesting that the

Activa “may have caused or contributed to a death or serious

injury.” Pet. App. 3a; SA 159, 164.

C. Petitioners’ case in the lower courts.

Petitioner Jack McMullen (McMullen) was implanted

with an Activa Tremor Control System in May 2000. Pet.

***

Diathermy-—The effects of diathermy on patients with

an implanted neurostimulation system are unknown,

Use of diathermy directly over an implanted lead or

pulse generator is not recommended since intemal

components may be damaged.

SA 171-172. The FDA-mandated warning for patients stated:

Tell your dentist where your IPG is implanted, so he

or she can take precautions with dental drills and ul-

trasonic probes used to clean your teeth. These de-

vices should not be used directly over the implant

site.

Therapeutic ultrasound, electrolysis, radiation ther-

apy, and electrocautery also should not be used di-

rectly over the implant site.

Diathermy treatments that are sometimes used for

muscle relaxation may affect the neurostimulator

output and/or damage its electronics.

Pet. App. 3a-4a.

* McMullen initially alleged that he had received a different de-

vice, the Activa Parkinson's Control Therapy, which at the time of

McMullen's implantation had been approved by the FDA through

App. 4a. As petitioners acknowledged in the district court

and again in the court of appeals, the Activa was, at least ini-

tially, “extremely effective in eliminating Jack McMullen’s

symptoms of Parkinson's disease.” SA 739. See also Appel-

lants’ Ct. App. Br., at 7 (same).

In March 2001, McMullen underwent a dental procedure

which possibly involved diathermy or electrocautery.” Pet.

App. 4a. Subsequent thereto, McMullen allegedly “experi-

enced a tremendous exacerbation of his Parkinson's symp-

toms.” Pet. 7.

Approximately two months before McMullen's dental

procedure, Medtronic received an anecdotal report that an-

other Activa recipient had been injured while receiving dia-

thermy treatment im the course of a dental procedure. Pet.

App. 4a, 22a. On May 18, 2001, approximately two months

after McMullen’s dental procedure, Medtronic, having inves-

tigated that anecdotal report, sent a letter to Activa recipients

and their physicians warning that exposure to diathermy

the “investigational device exemption” (IDE) process instead of

the PMA process. The district court concluded that “the medical

records of Mr. McMullen and other uncontroverted evidence estab-

lish the device implanted in Mr. McMullen on May 17, 2000, was

the Activa Tremor Control *** System.” Pet. App. 23a.

McMullen did not challenge that determination in the court of ap-

peals. As the Seventh Circuit noted, “[ajccordingly, any arguments

based on [the prior] factual assertion have been forfeited.” Pet.

App. 4a n.2.

6

In the district court, there was a dispute as to which of these

(wo procedures was involved. However, because the FDA had re-

quired Medtronic to issue specific wamings with respect to both

procedures, see note 4, supra, “|t}he distinction between the two

procedures”—both of which use electricity—‘is not important for

the purposes of this case.” Pet. App. 3a n.1.

9

could result in serious injury or death. Pet. App. Sa, 22a.’

Federal regulations permitted, but did not require, Medtronic

to send that warning without prior FDA approval. See 21

C.F.R. § 814.39(d) (providing that “[I]abeling changes that

add or strengthen an instruction that is intended to enhance

the safe use of the device” “may be placed into effect by the

applicam yrior to the receipt * * * of a written FDA order

approving the PMA supplement’) (emphasis added); see also

Pet. App. 13a."

1. The District Court proceedings.

On December 5, 2002, petitioners filed suit in Indiana

State court alleging that Medtronic violated a state-law “post-

sale duty to timely warn” of newly discovered dangers by not

issuing the revised diathermy warning until May 2001. Pet.

The warming sent to patients advised them to “[ijnform anyone

treating you that you CANNOT have any shortwave diathermy,

microwave diathermy or therapeutic ultrasound diathermy * * *

anywhere on your body because you have an implanted neu-

rostimulation system” and that “[e)nergy from diathermy can be

transferred through your implanted system” and thus “cause tissue

damage” which could “result in severe injury or death.” Pet. App.

Sa. That warning further advised that “[d]iathermy can * * * dam-

age parts of your neurostimulation system,” with a resultant “loss

of therapy from your neurostimulation system.” /bid.

As a general rule, the manufacturer of an approved Class II]

device must “submit a PMA supplement for review and approval

by FDA before making a change affecting the safety or effective-

ness of the device.” 21 C.F.R. § 814.39(a). Medtronic’s warning

letter was permitted under one of the limited exceptions to this

rule, contained in § 814.39(d)(2)(i), pursuant to which a manufac-

turer may strengthen certain types of warnings on a previously ap-

proved device upon submission ot a PMA Supplement explaining

the change. Thus, Medtronic also submitted a PMA Supplement

under 21 C.F.R. § 814.39(a) seeking FDA approval of permanent

labeling changes incorporating the new warning. On June 22,

2001, the FDA approved the new warning. Pet. App. Sa—6a.

10

9.” Medtronic promptly removed the action to the United

States Distnct Court for the Southern District of Indiana. Pet.

App. 17a.

The parties filed cross-motions for summary judgment.

Pet. App. 16a. Medtronic argued that it was entitled to sum-

mary judgment because petitioners’ state-law action was pre-

empted under 21 U.S.C. § 360k(a), which, with respect to

medical devices, provides that “no State * * * may establish

* * * any requirement * * * which is different from, or in ad-

dition to, any requirement applicable under this chapter.”

In resisting Medtronic’s motion for summary judgment,

petitioners did not dispute that the PMA process imposed

specific federal requirements applicable to the Activa; nor

did they dispute that the purported state-law duty to warn that

they sought to enforce would in application constitute a spe-

cific state requirement with respect to the Activa. Indeed, far

from denying the existence of either federal or state require-

ments, petitioners told the district court that “(t]he essence of

this case is Medtronic’s egregious failure to follow corre-

sponding state and federal requirements to timely warn re-

cipients of its deep brain stimulation systems of the dangers

of severe injury or death when Medtronic became aware of

such dangers.” SA 75 (emphasis added). According to peti-

tioners, their post-sale duty-to-warn claim was not preempted

because “these state requirements are fully consistent with

the federal tracking and notification requirements under FDA

regulations.” SA 68.

The district court rejected this argument, finding that

“there is a logical disconnect between the federal regulation

to track recipients of a device, and a duty, not set forth in any

federal regulation pertaining to this device, to contact all re-

cipients of that device upon the discovery of an adverse reac-

Petitioners also asserted a derivative claim for loss of consor-

tium. Pet. App. I 4a.

tion * * * that, as it appears to be in this case, was the subject

of product warnings approved by the FDA's PMA process.”

Pet. App. 36a. Noting that Congress intended § 360k(a) “to

be a ‘general prohibition on non-Federal regulation,’’’ Pet.

App. 28a (quoting H.R. Rep. No. 94-853, at 45), the district

court granted Medtronic summary judgment on preemption

grounds (and simultaneously denied petitioners’ cross-

motion), holding that “[t}he failure to warn claim asserted by

the McMullens presupposes a duty ‘in addition to’ the spe-

cific rederal requirements imposed on Medtronic through the

Activa’s PMA process and approval.” Pet. App. 36a.

2. The Court of Appeals’ decision.

On appeal to the Seventh Circuit, petitioners again con

ceded the existence of specific state and federal require-

ments, asserting that Medtronic had a post-sale duty to warm

“pursuant to both federal requirements and the requirements

of state law.” Appellants’ Ct. App. Br. 8-9. Rather than deny

the existence of either state or federal requirements for pur-

poses of preemption under § 360k(a), petitioners instead ar-

gued that their peost-sale duty-to-warn claim was not

preempted because it was a state common-law action pur-

portedly “seeking to enforce parallel federal requirements.”

Id. at 10 (emphasis added).

In affirming summary judgment for Medtronic on pre-

emption grounds, the Seventh Circuit recognized that

§ 360k(a)

sets three conditions for preemption: (1) there

must be a “requirement” that a state “estab-

lish[es] or continue[s] in effect, with respect to

a device intended for human use”; (2) there

must be a relevant federal requirement under

the FDCA applicable to the device at issue;

and (3) the state “requirement” must be “dif-

ferent from, or in addition to,” the federal re-

quirement.

1?

—

Pet. App. 8a. The court noted that “the parties agree that the

first condition is satisfied” and that “[t}here also is no dispute

as to the second condition.” /d. at 8a—9a. Thus, satisfaction of

the third condition—the existence of a state requirement “dif-

ferent from, or in addition to” the federal requirement—was

“the only one contested in this case.” /d. at 10a.

The Seventh Circuit acknowledged that if “Medtronic

was obligated, under parallel state and federal laws, to send a

‘timely’ additional warning” respecting the dangers of dia-

thermy to Activa recipients, “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 pursuant

to 360k(a).” /d. at Ila. However, the Seventh Circuit found

that this was not the case.

As the court of appeals explained, “McMullen point(ed]

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.” Pet. App. 12a. Specifically,

McMullen pointed to “2! 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 warn-

ing.” /bid. But, the court held, “[clontrary to McMullen’s

contention, *** neither of these regulations, considered

alone or together, imposed upon Medtronic a duty to issue an

additional warning between January and March 2001.” /bid.

In particular, the tracking requirement imposed by 21 C.F.R.

§ 821.1 “enables warnings to be issued and devices to be re-

called if the Secretary [of Health and Human Services| de-

cides that it is appropriate to do so,” but “does not impose on

the manufacturer the obligation to make warning or recall

decisions unilaterally.” /d. at 13a. Similarly, 21 C.P.R.

§ 814.39 “permits, but does not require, a manufacturer to

provide interim supplemental warnings pending approval by

the FDA.” /d. at 13a—14a (emphasis added).

13

Consequently, the court of appeals concluded, “[bJecause

McMullen’s claim based on the common-law post-sale duty

to warn would impose on Medtronic a requirement that is in

addition to federal requirements,” that claim “is preempted

pursuant to 21 U.S.C. § 360k(a).” /d. at 4a.

REASONS FOR DENYING THE WRIT

There is no reason for this Court to grant certiorari in this

case. As petitioners acknowledge, there is no division what-

soever among the lower courts on the question presented

here. Although petitioners allude to other issues on which

there is some, albeit minor, conflict among the lower courts,

petitioners have waived any argument based on those is-

sucs——which in any event would not warrant this Court's at-

tention. Finally, the decision below is plainly correct. Thus,

further review 1s not warranted.

I. There Is No Conflict Among The Lower Courts On

Any Question Presented In This Litigation.

Petitioners assert that “review is warranted to resolve the

conflict among the circuit courts and various state cow “s re-

garding the preemptive effect of the [Medical Device

Amendments] on state common law cavees of actiun.” Pet.

10. But in fact, this case does not implicaic any such conflict.

A. Petitioners acknowledge that there is no division

among the lower courts regarding the preemp-

tion of post-sale duty-to-warn claims.

As discussed above (at page 3), in Lohr this Court ex-

plained that there are three relevant issues for purposes of a

preemption analysis under § 360k(a)}—the existence of spe-

cific federal requirements on a medical device, the existence

of specific state-law requirements on the device, and some

difference between those two sets of requirements. See also

Pet. App. 8a.

Throughout this litigation, petitioners have litigated only

the third of these issues. They have never disputed that the

14

PMA process creates specific federal requirements as to the

Activa device or that liability in a state-law tort suit would

also impose requirements on the device. Rather, the only is-

sue here is whether the federal and state-law requirements

impose identical obligations on Medtronic to provide its cus-

tomers with post-sale warnings. See pages 10-11, supra; Pet.

9, 15, 20.

As to this question, petitioners readily admit that there is

no circuit split or other divide among the lower courts.

Rather, they acknowledge that, va the exception of the

Seventh Circuit in this case, the issue is one that “has not

really been directly addressed by the circuit courts.” See Pet.

20."" Nor has the question been addressed by state courts.

Absent some indication that this issue has caused confusion

among the lower courts, there is no reason for this Court's

—

In fact, post-sale duty-to-war claims have been addressed, at

least indirectly, by several circuits. In each instance, the court of

appeals found the claim to be preempted. In Cupek, the plaintiffs

sought leave to amend the complaint to include a post-sale duty-to-

warm claim. The district court denied the request, holding the claim

preempted and the proposed amendment therefore futile. The Sixth

Circuit affirmed. See 405 F.3d at 423-424. In Horn, the FDA, in

its amicus brief, characterized the plaintiff's complaint as includ-

ing a post-sale failure-to-wam claim. 376 F.3d at 166 n.5. The

Third Circuit, at the FDA's urging, held the plaintiff's claims to be

preempted. /d. at 177. In Kemp, the plaintiffs argued on appeal that

their failure-to-warn claim should have been construed as asserting

“a wholly separate and distinct claim that defendant acquired in-

formation subsequent to the FDA approval * * * and before im-

plantation of the device that would lead a reasonable manufacturer

to warn patients and the medical community.” 231 F.3d at 236-

237. However, the Sixth Circuit found the argument to be untimely

and therefore did “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 subse-

quent to FDA approval of the device.” /d. at 237.

revicew—especially given the obvious correctness of the deci-

sion below (see Part III, infra).

B. Petitioners have waived any argument based on

the vestigial circuit splits that do exist as to the

proper scope of preemption in the PMA context

under Lohr.

Notwithstanding the conceded absence of a circuit split

on the only question presented here, petitioners argue that

certiorari should be granted in order to address what petition

ers characterize as “the widely varying interpretation of the

Court’s decision in Lohr.” Pet. 10. Petitioners’ suggestion is

misguided. Whatever vestigial disagreements there may still

be in the lower courts over the proper application of Lohr in

the PMA context, those disagreements are not presented by

this case.

Although petitioners greatly exaggerate the extent and

significance of these conflicts, as we discuss in Part II below,

there is some, albeit minor, conflict among the lower courts

as to two of the three factors that, under Lohr, are to be con-

sidered when determining whether preemption exists pursu

ant to § 360k(a)—specifically, whether the PMA process

imposes specific federal requirements on a medical device,

and whether liability in a state-law tort suit would impose a

specific state-law requirement on a medical device

However, at every stage of the proceedings in this litiga-

tion—in the district court, in the court of appeals, and now in

this Court—petitioners have conceded that the PMA process

imposed specific federal requirements applicable to the Ac

tiva and that their common-law action would, if successful,

impose specific state requirements on the device. See Pet. 20

(referring to the “requirements promulgated by the FDA”

through the PMA process); id. at 9 (referring to “state law

requirement to timely warn’); see also pages 10-11, supra

(discussing petitioners’ concessions in the courts below); Pet

App. 8a-9a (noting that “the parties agree” that state-law tort

16

Suits impose requirements on medical devices and that

“[t}here also is no dispute” between the parties that the PMA

process imposes specific federal requirements on the device).

Having conceded the existence of specific federal re-

quirements imposed through the PMA process, and having

conceded that their tort action would, if successful, impose

specific state-law requirements, petitioners have waived any

argument that the PMA process does not impose preemptive

requirements as well as any argument that common-law

claims, by their nature, cannot impose state requirements

subject to preemption under 21 U.S.C. § 360k(a).'' As a re-

sult, even if the Court wished to do so, this case does not

provide an opportunity to resolve the vestigial disagreements

over the proper interpretation of Lohr.

Il. Even Absent Petitioners’ Waiver, Review Of The

Vestigial Circuit Splits That Exist As To The Appli-

cation Of Lohr In The PMA Context Would Not Be

Warranted.

Review would not be warranted even if this case pre-

sented the Court with an opportunity to resolve the minor

circuit splits that exist as to the application of § 360k(a) in

the PMA context. In fact, on at least four occasions 1m the last

five years this Court has denied petitions for certiorari that

provided the Court an opportunity to address these issues.

See Knisley v. Medtronic, Inc., 126 8. Ct. 420 (2005), Brooks

v. Howmedica, Inc., 535 U.S. 1056 (2002), Martin v. Med-

tronic, Inc., 534 U.S. 1078 (2002), Kemp v. Medtronic, Inc.,

534 U.S. 818 (2001).

This Court will not consider questions presented in the petition

for a writ of certiorari that were not presented below. See, ¢.¢.,

Sprietsma v. Mercury Marine, 537 U.S. 51, 56 9.4 (2002), Delta

Airlines v. August, 450 U.S. 346, 362 (1981), United States v

Ortiz, 422 U.S. 891, 898 (1975)

17

A. Any disagreements among the lower courts are

minimal and diminishing.

This Court held in Lohr that § 360k(a) has preemptive ef-

fect only where there is a “specific” state requirement that is

“different from, or in addition to” a “specific” federal re-

quirement. 518 U.S. at 500. See also id. at 506-507 (Breyer,

J., concurring). We acknowledge that there is some dis-

agreement in the lower courts over whether the PMA process

establishes “specific” federal requirements. There is also

some disagreement in the lower courts over whether a state

common-law action would, if successful, impose “specific”

state requirements.

These disagreements, however, are the increasingly stale

product of a few aberrational decisions issued shortly after

Lohr. Moreover—given the guidance provided by this

Court's subsequent decisions in Bates v. Dow Agrosciences

LLC, 125 S. Ct. 1788, 1798 (2005), Buckman, and Geier v.

American Honda Motor Co., 529 U.S. 861 (2000), and the

additional guidance provided by the FDA tm an amicus brief

it filed in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.

2004)—whatever minimal disagreements still remain are di-

minishing and likely to disappear altogether without further

intervention by this Court.

1. The great weight of authority, and a// recent authority,

holds that the PMA process imposes specific federal re-

quirements that have preemptive force. See Pet. App. 9a-

10a, Cupek, 405 F.3d at 424; Horn, 376 F.3d at 171-73;

Brooks, 273 F.3d at 799, Martin, 254 F.3d at 585; Kemp, 231

F.3d at 226-27; Mitchell, 126 F.3d at 911; see also Worthy v.

Collagen Corp., 967 S.W.2d 360, 376 (Tex. 1998); Fry v.

Allergan Med. Optics, 695 A.2d 511, 516 (R.1. 1997); Green

v. Dolsky, 685 A.2d 110, 117 (Pa. 1996).

In contrast to the decisions of the Third, Fifth, Sixth,

Seventh, and Eighth Circuits, as well as those of the Penn-

sylvania, Rhode Island, and Texas supreme courts, there is

18

only one federal court of appeals decision and only one state

supreme court decision, cf. S. Ct. R. 10, to hold that the re-

quirements imposed through the PMA process are not pre-

emptive—Guvodlin v. Medironic, Inc., 167 F.3d 1367 (11th

Cir. 1999), and Weiland v. Telectronics Pacing Systems, Inc.,

721 N.E.2d 1149 (Ill. 1999). Those decisions, however, are

relatively old, internally confused, and unlikely to survive

even absent this Court's intervention.

For example, the Goodlin court found that the PMA

process “is clearly specific to the device under review” and

that the FDA’s Conditions of Approval “constitute specific

federal requirements,” 167 F.3d at 1376, yet then somehow

concluded that the requirements were not “applicable under

{the MDA] to the device,” ibid. (quoting 21 U.S.C.

§ 360k(a)(1)), and did not establish “a specific requirement

that applies to a particular device,” id. at 1377. The decision

is not only internally inconsistent and factually incorrect, but

also contrary to Lohr. The Goodlin court denied preemptive

effect to the concededly specific federal requirements, appar-

ently because the FDA's Conditions of Approval were “not

promulgated * * * with respect to [a] ‘particular device.’”

Ibid. Yet, so long as the specific federal requirement is appli-

cable to a given device, Lohr does not demand that the re-

quirement be applicable exclusively to that device. In fact, the

FDA has frequently held that federal requirements have pre-

emptive effect even though they apply to a wide array of de-

vices. See, e.g., Final Rule, Medical Devices, 45 Fed. Reg.

67,321, 67,322 (Oct. 10, 1980).

Weiland, in contrast, found that no aspect of the PMA

process is specific. See 721 N.E.2d at 1152. It based that

conclusion on two false premises, however: First, the court

held that “|pjremarket approval imposes no ascertainable

substantive requirement on the manufacture or design of the

device” (ihid.)—a statement that is untrue both in general

(see 21 C.F.R. § 814.80 (prohibiting the manufacturer from

making any change without FDA authorization to a device

19

that has been approved by the agency through the PMA proc-

ess if such change would affect the device's safety or effec-

tiveness)), and in this case, whee the FDA required specific

modifications of the Activa’s labeling prior to PMA approval

(see note 3, supra). Second, the court held that the PMA

process allows the FDA to assure only “the minimal safety of

medical devices” (id. at 1153) (emphasis added), a holding

inconsistent with Lohr, which understood the “reasonable

assurance” of safety and effectiveness to be a significant hur-

die. In light of Buckman’s repetition of the significance of

PMA review, see 531 U.S. at 343, the Weiland decision is

plainly incorrect.

in the seven years since they were decided, no other court

of appeals and no other state supreme court has joined either

the Eleventh Circuit's decision in Goodlin or the Illinois Su-

preme Court’s decision in Weiland. Given their internal

flaws, this Court's reminder that the PMA process subjects a

device to “thorough review,” Buckman, 531 U.S. at 344, and

the FDA’s recent declaration that “through the PMA ap-

proval process [the FDA] certainly establishes ‘specific re-

quirements’ applicable to a ‘particular device,”” Brief for

United States as Amicus Curiae (U.S. Br.), 2004 WL

1143720, at *16, filed in Horn v. Thoratec Corp., 376 F.3d

163 (2004) (see also pages 22-24, infra). there is no reason

to believe that any court will repeat the errors in Goodlin or

Weiland.

2. On the state side of the Lohr preemption equation, the

great weight of authority, and all recent authority, holds that

state common-law claims can impose specific requirements

and are thus subject to preemption under § 360k(a). See, e.g.,

Pet. App. 9a; Cupek, 405 F.3d at 424; Horn, 376 F.3d at

173-177; Brooks, 273 F.3d at 799; Martin, 254 F.3d at 584;

Kemp, 231 F.3d at 224; Mitchell, 126 F.3d at 913-914;

Papike v. Tambrands Inc., 107 F.3d 737, 741 (9th Cir. 1997);

Worthy, 967 S.W.2d at 376-377; Fry, 695 A.2d at 517;

Green, 685 A.2d at 117-118.

20

This view is plainly correct under Lohr and this Court's

subsequent decisions in Geier and Bates. In Lohr, a majority

of this Court held that the Medical Device Amendments, of

which § 360k(a) is a part, “will sometimes pre-empt a state-

law tort suit,” 518 U.S. at 503 (Breyer, J., concurring), be-

cause “insofar as the MDA pre-empts a state requirement

embodied in a state statute, rule, regulation, or other adminis-

trative 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.” /d. at 504-505; accord id. at 509

(“state common-law damages actions do impose ‘require-

ments’ and are therefore pre-empted where such require-

ments would differ from those imposed by the FDCA”)

(O'Connor, J., concurring in part and dissenting in part). Sig-

nificantly, Justice Stevens, who wrote the plurality opinion in

Lohr, has himself stated that Lohr “recognized that the statu-

tory reference to ‘any requirement’ imposed by a State * * *

may include common-law duties.” Geier, 529 U.S. at 897

(Stevens, J., dissenting). See also Geier, 529 U.S. at 867

(noting that “a majority of this Court” in Lohr recognized

that state tort actions may be preempted as imposing conflict-

ing “requirements”); cf. Bates, 125 S. Ct. at 1798 (noting

“the term ‘requirements in [7 U.S.C.] § 136v(b) reaches be-

yond positive enactments, such as statutes and regulations, to

embrace common-law duties’’).

Only one federal court of appeals or state court of last re-

sort, cf. S. Ct. R. 10, has relied on a contrary finding to limit

the preemptive scope of § 360k(a)—the Tenth Circuit in Oja

v. Howmedica, Inc., 111 F.3d 782, 789 (1997). Oja is one of

the earliest appellate decisions to interpret Lohr, did not in-

volve a device that had been approved through the PMA

process, and plainly misinterprets Lohr in a variety of ways.’

'? The device at issue in Oja was approved via the so-called

510(k) process As this Court noted in Lohr, “[t}he § 510(k) notifi-

cation process is by no means comparable to the PMA process.”

21

For example, the Tenth Circuit never directly considered

whether a finding of liability under a state common-law duty

would “have ‘the effect of establishing a substantive re-

quirement of a specific device’”—even though the court ac-

knowledged that such an inquiry was necessary. 111 F.3d at

788 (quoting Lohr, 518 U.S. at 500 (in tum quoting 21

C.F.R. § 808.1(d)(1))). More importantly, the court failed to

appreciate that a majority of this Court had expressly held in

Lohr that state common-law damages actions impose “re-

quirements” that can be preempted by federal requirements.

See Lohr, 518 U.S. at 503 (Breyer, J., concurring); id. at 509

(O’Connor, J., concurring in part and dissenting in part);

Geier, 529 U.S. at 867.

This single aberrant decision by a federal court of ap-

peals, rendered shortly after Lohr, does not warrant this

Court’s attention. In the nine years since Oja, there has been

no movement by any other court toward that court’s errone-

ous analysis. Moreover, given this Court’s recent holding in

Bates that the term “requirements” in the identically-worded

FIFRA includes common-law claims, see 125 S. Ct. at 1798,

the unanimous view of the other courts of appeals that such

claims may be preempted, and the FDA’s similar view as ex-

pressed in its amicus brief in Horn, see U.S. Br., 2004 WL

1143720, at *18 (“state tort law judgments do impose a re-

quirement for purposes of preemption under the MDA”) (see

also pages 22-24, infra), there is no reason to believe that the

Tenth Circuit would continue to follow Oja after further

analysis of this Court’s holding in Lohr.

518 U.S. at 478-479. On average, the FDA devotes only 20 hours

to a 510(k) review, but 1,200 hours to the far more exacting PMA

review. See id. at 477, 479.

22

B. The lower courts should be allowed to consider

the implications of the FDA’s amicus brief in

Horn,

In Lohr, this Court recognized that “Congress has given

the FDA a unique role in determining the scope of § 360k’s

pre-emptive effect.” 518 U.S. at 495-496. The Court further

recognized that, as the federal agency to which Congress has

delegated the authority to implement the MDA, the FDA “is

uniquely qualified to determine whether a particular form of

state law ‘stands as an obstacle to the accomplishment and

execution of the full purposes and objectives of Congress,’

and, therefore, whether it should be pre-empted.” /d. at 496

(quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

Given “the ambiguity in the statute” and “the congressional

grant of authority to the agency on the matter contained

within it,” the Court found it appropriate to “giv[e] substan-

tial weight to the agency’s view of the statute.” /bid.

The FDA has recently provided authoritative guidance on

the scope of § 360k’s preemptive effect in the PMA context.

At the request of the Third Circuit, the United States submit-

ted an amicus brief on behalf of the FDA in Horn v. Thoratec

Corp., 376 F.3d 163 (2004). The FDA’s amicus brief ex-

plains at length and in detail why “FDA pre-market approval

for a new medical device preempts state law tort judgments.”

U.S. Br., 2004 WL 1143720, at *2.

With respect to the federal side of the equation, the FDA

stated unequivocally that “through the PMA approval process

[the FDA] certainly establishes ‘specific requirements’ appli-

cable to a ‘particular device.’” /d. at *16. The FDA noted that

“[a]lthough the PMA approval order does not itself expressly

reiterate all of the specific features the device's design, label-

ing, and manufacturing processes must have, it specifically

approves as a matter of federal law those features as set forth

in the application and binds the manufacturer to produce and

23

market the product in compliance with the specifications as

approved by [the] FDA.” /d. at *24.

With respect to the state side of the preemption equation,

the FDA endorsed the view—subscribed to by a majority of

the Justices in Lohr—that “state tort law judgments do im-

pose a requirement for purposes of preemption under the

MDA when a common law action ‘would impose a require-

ment different from, or in addition to, that applicable under

the FDCA.’” /d. at *18 (quoting Lohr, 518 U.S. at S11

(O’Connor, J., concurring in part and dissenting in part)).

The FDA observed that, absent an allegation that the device

in question deviated from the requirements imposed by the

FDA through the PMA process, “any finding of liability

*** would necessarily rest upon an implicit requirement

that [the] device be designed, manufactured, or marketed in a

way that differs from the way approved by [the] FDA.” /bid.

The FDA also emphasized in its brief the “very strong

public policy considerations” that support finding PMA ap-

proval preemptive of state common-law claims. /d. at *25.

According to the FDA—the agency charged with implement-

ing the MDA—“[s]tate common law tort actions threaten the

Statutory framework for the regulation of medical devices.”

Ibid. As the agency explained, during the PMA process it

conducts “a thorough review of a substantial scientific re-

cord,” id. at *16, and performs a “careful balancing” of the

benefits and risks associated with a particular device. /d. at

*29. State tort actions, however, usurp “the central role of

[the] FDA” by requiring “lay judges and juries to second-

guess the balancing of benefits and risks of a specific de-

vice.” /d. at *25. Because such second-guessing “may disrupt

the careful balancing performed by the FDA in the PMA

process,” id. at *29, state common-law claims such as those

24

asserted in Horn—and here—"“are preempted under federal

law.” Id. at *31."°

Given the agency’s “unique role in determining the scope

of § 360k’s pre-emptive effect,” Lohr, 518 U.S. at 495-496,

the FDA’s clear guidance in Horn further demonstrates that

there is no need for this Court to grant review in this case.

The FDA’s “reasoned analysis,” U.S. Br., 2004 WL

1143720, at *30, is entitled to substantial weight as “the

agency's fair and considered judgment on the matter in ques-

tion.” Auer v. Robbins, 519 U.S. 452, 462 (1997) (deferring

to agency interpretation of ambiguous regulation contained in

amicus brief submitted in dispute between private parties).

There is therefore no reason to believe that the few courts

that misinterpreted Lohr soon after it was decided will persist

in their error. With the benefit of the FDA’s amicus brief in

Horn—and this Court’s guidance in Bates, Buckman, and

Geier—those courts ate now likely to join the clear consen-

sus finding state common-law claims that would impose re-

quirements “different from” or “in addition to” the federal

requirements imposed through the PMA process to be pre-

empted by federal law. In the unlikely event that those courts,

upon reconsideration, choose to adhere to their prior deci-

sions, the Court can grant review at that time.

'* To the extent that it requires a manufacturer to issue warnings

directly to patients, a state-law post-sale duty to warn, such as that

asserted here, would directly conflict with 21 U.S.C. § 360h(a),

which expressly authorizes the Secretary of Health and Human

Services to withhold a safety notification from patients. See note

14, infra. As the FDA explained in Horn, patient warnings issued

in response to state-law requirements, as opposed to those evalu-

ated and approved by the FDA after careful cost-benefit analysis

by healthcare experts, “can harm the public health” by “dis-

courag|ing| appropriate product use,” with a resultant “underutili-

zation of beneficial treatments.” U.S. Br., 2004 WL 1143720, at

*26, *29.

25

Ill. The Decision Below Is Plainly Correct.

Review is also unwarranted in this case because the Sev-

enth Circuit was plainly correct in holding that petitioners’

state-law failure-to-warn claim is preempted under § 360k(a).

By its terms, § 360k(a) preempts, with respect to a medical

device, any state-law requirement that is “different from, or

in addition to, any requirement applicable * * * to the de-

vice” under federal law. Here, there is no dispute that the Ac-

tiva is subject to federal labeling requirements imposed

through the PMA process, and no dispute that petitioners’

common-law claim would, if successful, effectively impose a

state-law requirement on the device. See pages 10-11, supra.

Thus, the only issue is whether petitioners’ post-sale failure-

to-warn claim would, if successful, subject the Activa to a

state-law requirement “different from, or in addition to” the

federal labeling requirements imposed through the PMA

process. There can be no doubt that it would.

In an effort to avail themselves of the “parallel require-

ments” rule adopted by this Court in Bates, and thus to evade

the preemptive effect of § 360k(a), petitioners characterize

their state common-law action as “an action seeking to en-

force parallel federal requirements.” Pet. 15. However, this

characterization is patently false. Contrary to petitioners’

suggestion, neither 21 C.F.R. § 821.1 nor 21 C.F.R. § 814.39

“indicate|s] that Medtronic had a continuing duty to warn”

under federal law. Pet. 19.

By its general terms, and as it was applied to the Activa

in particular through the PMA process, 21 C.F.R. § 821.1

required only that Medtronic “adopt a method of tracking”

the devices that were implanted in patients. 21 C.F.R.

§ 821.1(a); see also SA 159. Nothing in the regulation re-

quired that Medtronic use the tracking data to issue a volun-

tary post-sale warning to Activa recipients. Indeed, the

regulation itself makes clear that no such requirement ex-

isted. As explained in § 821.1(b), the purpose of the tracking

26

requirement was to ensure “the effectiveness of remedies pre-

scribed by the act,” in particular “patient notification” as au-

thorized by 21 U.S.C. § 360h(a) and “device recall” as

authorized by 21 U.S.C. § 360h(e). Significantly, the patient

notification and the device recall authorized under § 360h

both lie within the sole discretion of the Secretary of Health

and Human Services; neither provision specifically permits,

let alone requires, that a manufacturer act on its own."

Nor is the tracking requirement transformed into a notifi-

cation requirement by 21 C.F.R. § 814.39, pursuant to which

a labeling change that enhances the safety of a device “may

'* See 21 U.S.C. § 360h(a) (“If the Secretary determines that * * *

a device * * * presents an unreasonable risk of substantial harm to

the public health [and] notification under this subsection is neces-

sary to eliminate * * * such risk, the Secretary may issue such or-

der as may be necessary to assure that adequate notification is

provided * * * to all health professionals who prescribe or use the

device * * * *”) (emphasis added); 2! U.S.C. § 360h(e) (“If the

Secretary finds that there is a reasonable probability that a device

intended for human use would cause serious, adverse health con-

sequences or death, the Secretary shall issue an order requiring the

appropriate person * * * to immediately cease distribution of such

device, and * * * to immediately notify health professionals * * *

of the order and to instruct such professionals * * * to cease use of

such device”) (emphasis added). Notably, § 360h(a) expressly con-

templates the possibility that a safety notification issued on orders

of the Secretary will be withheld from patients themselves, and

issued only to their doctors. See 2! U.S.C. § 360h(a) (“An order

under this subsection shall require that the individuals subject to

the risk with respect to which the order is to be issued be included

in the persons to be notified of the risk unless the Secretary deter-

mines that notice to such individuals would present a greater dan-

ger to the health of such individuals than no such notification.”)

(emphasis added). Thus, contrary to petitioners’ suggestion, a re-

quirement that Medtronic, acting on its own, issue a post-sale

waming directly to patients cannot be derived from 2! C.F.R.

§ 821.1.

27

be placed into effect by the applicant prior to” subsequent

FDA approval. 21 C.F.R. § 814.39(d) (emphasis added). The

regulation is, by its plain terms, permissive, not prescriptive:

it allows, but does not require, a manufacturer to issue post-

sale warnings. Indeed, notwithstanding their generalized as-

sertion that Medtronic was required by federal law to issue a

post-sale warning to Activa recipients, petitioners acknowl-

edge that § 814.39 “only permits Medtronic to timely warn

but doesn’t require Medtronic to do so.” Pet. 20. See also id.

at 5 (“Under the FDA regulations at 21 CFR 814.39(d)(1)

and (2), Medtronic was allowed to immediately send out

wamings * * * without prior FDA approval.”) (emphasis

added); id. at 9 (“CFR 814.39(d)(ii) permitted Medtronic to

issue new warnings to recipients”) (emphasis added).

Thus, as the Seventh Circuit properly concluded, neither

21 C.F.R. § 821.1 nor 21 C.F.R. § 814.39, “considered alone

or together, imposed upon Medtronic a duty to issue an addi-

tional warning between January and March 2001.” Pet. App.

12a. Absent a federal requirement affirmatively obligating

Medtronic to issue a post-sale warning to Activa recipients, a

state-law requirement that Medtronic do the same would be

“different from, or in addition to” the applicable federal re-

quirements.’” Since there was no such federal requirement,

petitioners’ state-law duty-to-warn claim is, as the Seventh

'S Petitioners assert that “{t}he real issue is whether any of the

regulations under the Act prevented Medtronic from warning re-

cipients of its deep brain stimulation systems.” Pet. 15. That is de-

cidedly not the issue. The issue, for preemption purposes, is not

whether federal regulations prevented Medtronic from issuing a

warming, but rather whether any of the requirements imposed

through the PMA process required Medtronic to issue a warming

earlier than it did. If the federal requirements did not require Med-

tronic to issue a warning, then a state requirement to that effect

would necessarily be “different from, or in addition to” the federal

requirements.

28

Circuit correctly held, “preempted pursuant to 21 U.S.C.

§ 360k(a).” Pet. App. 14a.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respecifully submitted.

MICHAEL K. BROWN KENNETH S. GELLER

LISA M. BAIRD Counsel of Record

Reed Smith LLP DAVID M. GOSSETT

355 §. Grand Avenue ANDREW TAUBER

Suite 2900 Mayer, Brown, Rowe & Maw

Los Angeles, CA 90071 LLP

(213) 457-8000 1909 K Street, NW

KEVIN R. KNIGHT Washington, DC 20006

Ice Miiler LLP (202) 263-3000

One American Square

Box 82001

Indianapolis, IN 46282

(317) 236-5828

JANUARY 2006

3 FILED

( 03) FEB 9 - 2006

No. 05-682

OFFICE OF THE CLERK

U.S.

IN THE

Supreme Court of the Cinited States

JACK McMULLEN and BARBARA McMULLEN,

Petitioners,

Vv.

MEDTRONIC, INC.,

Respondent.

On Petition For A Wait oF CERTIORARI TO TRE

Unrrep States Court or APPEALS

FOR THE SEVENTH CIRCUIT

REPLY TO BRIEF IN OPPOSITION

Joun Patrick HEALY

Counsel of Record

Steven A. Kurowski

Law Orrices oF Joun Patrick HeALy

29 S. LaSalle St.

Suite 640

Chicago, IL 60603

Attorneys for Petitioners

197959

PULL COURT PRESS

(312) 320-9292

REPLY TO BRIEF IN OPPOSITION

This case presents an important question of federalism. In

Bates v. Dow Aregrosciences LLC, 125 §.Ct. 1788 (2005) this

Court stated:

Even if Dow had offered us a plausible alternative reading

of § 136v(b) — indeed. even if its alternative were just as

plausible as our reading of that text — we would neverthe-

less have the duty to accept the reading that disfavors pre

emption. “|BJecause the States are independent sovereigns

in our federal system, we have long presumed that Con-

gress docs not cavalierly pre-empt state-law causes of ac-

tion.” Medtronic, 518 U.S., at 485. In areas of traditional

state regulation, we assume that a federal statute has not

supplanted state law unless Congress has made such an

intention “clear and manifest.”

While Medtronic, in its index to its Brief in Opposition,

notes its references to Bates as Passim (literally “everywhere”

in Latin), an examination of Medtronic’s Brief in Opposition

reveals that any analysis of the application of the Bates deci

sion to the instant action is literally “nowhere” to be found.

In Bates, relying upon this Court's seminal decision in Lohr,

this Court adopted a “parallel requirements” reading of the stat-

ute there involved. This Court there stated

The “parallel requirements” reading of § | 36v(b) that we

adopt today finds strong support in Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996). In addressing a similarly worded

pre-emption provision in a statute regulating medical de-

vices, we found that “[njothing in § 360K denies Florida

the right to provide a traditional damages remedy for vio

lations of common-law duties when those duties paralle!

t

federal requirements. /d., at 495. As Justice O'Connor

explained in her separate opinion, a state cause of action

that seeks to enforce a federal requirements “does not im-

pose a requirement that is ‘different from, or in addition

to,” requirements under federal law. To be sure the threat

of a damages remedy will give manufacturers an additional

cause to comply, but the requirements imposed on them

under state and federal law do not differ.

Justice Breyer, who has authored concise and clear (al-

though often misinterpreted) concurring opinions in this area,

noted in his concurring opinion in Bates:

up.

In Medtronic |citation omitted], | pointed out that an ad-

ministrative agency, there the Food and Drug Administra-

tion, had the legal authority within ordinary administrative

constraints to promulgate agency rules and to determine

the pre-emptive effect of those rules in light of the agency's

special understanding of “whether (or the extent to which)

state requirements may interfere with federal objectives.”

Id. (emphasis added)

ee

As suggested by Medtronic, the tederal agency charged

with administering the statute is often better able than are

courts to determine the extent to which state liability rules

mirror or distort federal requirements.

Statutes, as well as cases, are best read from the bottom

In the instant case, the McMuliens’ interpretation of the

MDA, aad the FDA regulations issued thereunder, are wholly

consistent with, and in furtherance of, the underlying purpose

of the MDA, Medtronic’s suggested interpretation is wholly an-

tithetical to it.

The preamble to the MDA sets forth the underlying pur-

pose of the Act: “te provide for the safety and effectiveness of

medical devices intended for uunan use,” (emphasis added) 90

Stat. 539. Moreover, the regulations adopted by the FDA were

adopted to further that purpose. Under those regulations, manu-

facturers of Class II] medical devices were to:

Track unexpected adverse events with a device. 21CFR

821.1.

Track devices to patients (including contact information

for each recipient) so that they could be quickly notified in

the event of unanticipated serious adverse health conse-

quences. 21 CFR 821.i and section 519(e) of the MDA.

Empower the manufacturer (o issue warnings to device re-

cipients (patients) — without any prior FDA approval.

2) CFR 814.39

Medtronic’s bricf is most telling for the points it does not

address. It does not, and cannot deny, that it issued a new warn-

ing under regulation 814.39 of the Medical Device Act without

any prior FDA approval. It does not, and cannot deny, that the

sole purpose of that regulation is to enable medical device manu-

facturers to timely warn of new and serious daugers associated

with its products. It does not and cannot deny that it issued the

warning in May on the basis of the report it knew of in Janu-

ary. It also should be noted that Medtronic wholly fails to ad-

dress ihe detailed letter of opinion of the FDA’s Casper E.

Uldricks, Special Assistant to the Director, Office of Compli-

ance, Center for Devices and Radiological Health. (Appendix

C to the Petition).

Medtronic’s position ts that, even though it did issue the

warning without FDA approval, even though it issued the warn-

ing using regulation 814.39 whose sole purpose is to facilitate

timely warning of new dangers, and , even though it waited four

months to issue the warning on a danger it Knew about in Janu-

ary, it cannot ever be held liable since its actions or imactions

are completely shielded from liability under the preemption

doctrine.

The purpose and intent of the MDA is to protect the pub-

lic, including patients like Jack McMullen. It is not to immu-

nize device manufacturers from liability. If the Act were to to-

tally immunize Medtronic and other device manufacturers from

civil liability, what incentive would the manufacturer have to

follow the scheme set up by the FDA to timely notify patients in

danger of serious injury or death? The answer is simple: there

would be none.

That answer is clearly demonstrated by the instant case.

When Medtronic belatedly — and without any FDA approval

— finally issued its warning to medical providers of the dan-

gers of “severe injury or death,” on May 16" of 2001, it was not

simply issued with regard to its Activa deep brain stimulation

implants, but with regard to a whole panoply of its neurological

stimulation recipients. (Exhibit F to the McMullens’ Response

to Medtronic’s Motion for Summary Judgment) Moreover, when

the warnings to the patients were sent by ordinary mail two days

later — again with any prior FDA approval — they were so

voluminous that mailings had to be staggered over days. It is

clear that there is a vast chasm between how the MDA is in-

tended to function and how Medtronic believes it should func-

von.

As Justice Stevens observed in Lohr at 518 US 486-487:

Medtronic suggests that any common-law cause of

action is a “requirement” which alters incentives and

imposes duties “different from, or in addition to,” the

generic federal standards that the FDA has promul-

gated in response to mandates under the MDA. In

essence, the company argues that the plain language

of the statute pre-empts any and all common-law

claims brought by an injured plainuff against a manu-

facturer of medical devices.

Meditronic’s argument ts not only unpersuasive, it is

implausible. Under Medtronic’s view of the statute,

Congress effectively precluded state courts for

affording state consumers any protection from injuries

resulting from a defective medical device

Medtronic in this action attempts to dismiss the McMullens

by disingenuously asserting contrived admissions that do not

survive the light of examination (see Pet. 20), and baldly

asserting that the issue advanced is “tired.” “stale” and “likely

10 disappear,” all as a substitute for logical argument. In reality

not only is there a serious and continuing split among the circuits,

but this split is also on an issuc that ts of increasing importance

with an aging population and an increasing use of medical

devices. Medtronic has not, and cannot, articulate any valid

federal interest under the MDA that is advanced by immunizing

device manufacturers from their failure to warn of scrious new

dangers discovered after the device has reached the patient.

CONCLUSION

For the above reasons, the petitioners respectfully pray that

the Supreme Court grant review in this maticr

Respectfully submitted,

John Patrick Healy

Counsel of Re ord

STEVEN KUROWSKI

Law Offices of John Patrick Healy

29 S. LaSalle St

Suite 640

Chicago, IL. 60603

Attorneys for Petitioners