Richard Stengel v. Medtronic Incorporated

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

RICHARD STENGEL; MARY LOU No. 10-17755

STENGEL,

Plaintiffs-Appellants, D.C. No.

4:10-cv-00318-

v. RCC

MEDTRONIC INCORPORATED , a

foreign corporation, OPINION

Defendant-Appellee.

Appeal from the United States District Court

for the District of Arizona

Raner C. Collins, District Judge, Presiding

Argued and Submitted

September 19, 2012—San Francisco, California

Filed January 10, 2013

Before: Alex Kozinski, Chief Judge; Sidney R. Thomas,

Barry G. Silverman, Susan P. Graber, M. Margaret

McKeown, William A. Fletcher, Ronald M. Gould, Johnnie

B. Rawlinson, Richard R. Clifton, N. Randy Smith, and

Paul J. Watford, Circuit Judges.

Opinion by Judge W. Fletcher;

Concurrence by Judge Watford

2 STENGEL V . MEDTRONIC, INC.

SUMMARY*

Preemption / Medical Device Amendments

The en banc court reversed the district court’s order

dismissing appellants’ state-law failure-to-warn claim as

preempted by the Medical Device Amendments to the Food,

Drug, and Cosmetic Act.

The en banc court held that the Amendments do not

preempt a state-law claim for violating a state-law duty that

parallels a federal-law duty under the Amendments.

Therefore, the en banc court held that the Amendments did

not preempt, either expressly or impliedly, appellants’ state-

law failure-to-warn claim contained in the amended

complaint.

Judge Watford concurred. Judge Watford wrote

separately to provide additional thoughts as to why the state

law failure-to-warn claim alleged in the proposed amended

complaint was not preempted.

COUNSEL

Thomas G. Cotter, Haralson Miller Pitt Feldman &

McAnally, PLC, Tucson, Arizona, for Appellants.

*

This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

STENGEL V . MEDTRONIC, INC. 3

Michael Kevin Brown, Lisa Marie Baird, Reed Smith, LLP,

Los Angeles, California; Timothy James Casey, Schmitt,

Schneck, Smyth & Herrod PC, Phoenix, Arizona, for

Appellee.

Elizabeth Jean Erwin, Office of the Washington Attorney

General, Seattle, Washington; Steve Bullock, Office of the

Montana Attorney General, Helena, Montana; Lawrence

Garth Wasden, Office of the Idaho Attorney General, Boise,

Idaho; Mary-Christine Sungaila, Snell & Wilmer LLP, Costa

Mesa, California; Kelly Harrison Dove, Snell & Wilmer LLP,

Las Vegas, Nevada; Jessica E. Yates, Snell & Wilmer LLP,

Denver, Colorado; Mary Massaron Ross, Plunkett Cooney,

Bloomfield Hills, Michigan; Alan Jay Lazarus and Sally F.

White, Drinker Biddle & Reath, LLP, San Francisco,

California; Hugh F. Young, Jr., Product Liability Advisory

Council, Inc., Reston, Virginia, for amici curiae.

OPINION

W. FLETCHER, Circuit Judge:

Plaintiffs Richard and Mary Lou Stengel sued Medtronic

under state law when a medical device manufactured by

Medtronic rendered Richard permanently paraplegic.

Medtronic moved to dismiss the Stengels’ complaint,

contending that the Medical Device Amendments (“MDA”)

to the Food, Drug, and Cosmetic Act (“FDCA”) preempted

their state-law claims. The Stengels moved to amend their

complaint to add a new state-law negligence claim. That

claim alleged that Medtronic had violated a state-law duty of

care by failing to report known risks associated with use of its

medical device to the Food and Drug Administration

4 STENGEL V . MEDTRONIC, INC.

(“FDA”). The MDA required Medtronic to report those risks

to the FDA. Medtronic contended that the MDA also

preempted the Stengels’ new negligence claim.

The district court held that the MDA preempted all of the

Stengels’ claims, including the new negligence claim.

Stengel v. Medtronic, Inc., No. CV 10-318-TUC-RCC, 2010

WL 4483970, at *3–4 (D. Ariz. Nov. 9, 2010). It denied the

Stengels’ motion to amend the complaint and dismissed their

suit under Federal Rule of Civil Procedure 12(b)(6). Id. The

Stengels appealed the denial of their motion to amend, as well

as denial of an evidentiary ruling. A panel of this court

affirmed over a dissent. 676 F.3d 1159 (9th Cir. 2012). We

granted rehearing en banc. 686 F.3d 1121 (9th Cir. 2012).

The central question in this appeal is whether the MDA

preempts a state-law claim in which the state-law duty of care

“parallels” a federal-law duty imposed by the MDA. We

conclude that such a state-law claim is not preempted and

reverse the district court.

I. Background

Congress enacted the MDA to extend the coverage of the

Food, Drug, and Cosmetic Act (“FDCA”) to medical devices.

See Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). The

MDA divides medical devices into three classes according to

user risk. Class I devices pose the least risk; Class III devices

pose the most. See id. at 316–17; see also 21 U.S.C.

§ 360c(a)(1). Class I devices are subject to “general controls”

such as labeling requirements. Id. § 360c(a)(1)(A); Riegel,

552 U.S. at 316. Class II devices are subject not only to

“general controls,” but also to “special controls” such as

“performance standards, postmarket surveillance, [and]

STENGEL V . MEDTRONIC, INC. 5

patient registries.” 21 U.S.C. § 360c(a)(1)(B); Riegel,

552 U.S. at 316–17. If a device cannot be determined to

provide a reasonable assurance of safety and effectiveness

under Class I or II controls and is either marketed as a life-

supporting device or may cause an unreasonable risk of

illness or injury, it is a Class III device. A Class III device is

subject to a pre-market approval process of the FDA.

21 U.S.C. § 360c(a)(1)(C); Riegel, 552 U.S. at 317. The

Medtronic pain pump and catheter that caused Richard

Stengel’s injury was a Class III device.

The FDA’s pre-market approval process of a Class III

device is “rigorous.” Riegel, 552 U.S. at 317. The FDA

performs a risk-benefit assessment of the device and

determines the adequacy of the manufacturer’s proposed

label. Id. at 318. The FDA then denies, approves, or

approves with conditions on distribution, marketing, or sale.

See 21 U.S.C. § 360e(d); 21 C.F.R. § 814.82; see also Riegel,

552 U.S. at 318–19. Once the FDA approves a device, the

manufacturer is required to report any information that

reasonably suggests that the device (1) “[m]ay have caused or

contributed to a death or serious injury” or (2) “[h]as

malfunctioned” and that any recurring malfunction “would be

likely to cause or contribute to a death or serious injury.”

21 C.F.R. § 803.50(a); see 21 U.S.C. § 360i(a); see also

Riegel, 552 U.S. at 319.

For purposes of this appeal, we assume that all allegations

in the Stengels’ proposed amended complaint are true.

Medtronic obtained pre-market approval of its SynchroMed

Pump & Infusion System in 1988. Medtronic obtained

supplemental pre-market approval for its SynchroMed EL

Pump and Catheter in 1999.

6 STENGEL V . MEDTRONIC, INC.

On October 10, 2000, Richard Stengel had a SynchroMed

EL Pump and Catheter surgically implanted in his abdomen

to deliver pain relief medication directly into his spine. In

February 2005, Stengel collapsed at home. At the hospital,

he reported feeling heaviness and decreased sensation in his

right leg. He was diagnosed with ascending paralysis in his

lower body. A neurosurgeon removed the catheter, but

Stengel was left permanently paraplegic. Medtronic’s

medical device caused the paralysis.

When it received FDA approval of its SynchroMed EL

Pump and Catheter, Medtronic was not aware of certain risks

associated with the device. Before Stengel was paralyzed,

however, Medtronic had become well aware of those risks but

had failed to inform the FDA, even though the MDA required

Medtronic to do so. The FDA discovered the risks, and

discovered that Medtronic already knew about them, when it

inspected a Medtronic facility in late 2006 and early 2007.

The FDA sent a Warning Letter to Medtronic in July 2007,

stating that Medtronic had “misbranded” its Class III device

by concealing known risks, in violation of 21 C.F.R.

§§ 803.50(a)(1), 806.10(a)(1). In response to the FDA’s

Warning Letter, Medtronic sent a Medical Device Correction

letter to doctors in January 2008. Medtronic recalled the

device in March 2008. This advice and recall came too late

to help Richard Stengel, who had been paralyzed in 2005.

II. Standards of Review

We review de novo a district court’s legal conclusions

regarding the sufficiency of a complaint. Martinez v. Wells

Fargo Home Mortg., Inc., 598 F.3d 549, 553 (9th Cir. 2010).

We ordinarily review for abuse of discretion a denial of a

motion to amend a complaint. Alvarez v. Chevron Corp.,

STENGEL V . MEDTRONIC, INC. 7

656 F.3d 925, 931 (9th Cir. 2011). But here, where the

district court denied the motion to amend because of its

conclusion that the claim in the proposed complaint was

preempted as a matter of law, we review de novo. We have

appellate jurisdiction pursuant to 28 U.S.C. § 1291.

III. Discussion

There is a presumption against federal preemption of state

laws that operate in traditional state domains. “In all

preemption cases, and particularly those in which Congress

has ‘legislated . . . in a field which the States have

traditionally occupied,’ we ‘start with the assumption that the

historic police powers of the States were not to be superseded

by the Federal Act unless that was the clear and manifest

purpose of Congress.’” Medtronic, Inc. v. Lohr, 518 U.S.

470, 485 (1996) (citations omitted) (omission in original).

Parties seeking to invalidate a state law based on preemption

“bear the considerable burden of overcoming ‘the starting

presumption that Congress does not intend to supplant state

law.’” De Buono v. NYSA-ILA Med. & Clinical Servs. Fund,

520 U.S. 806, 814 (1997) (citation omitted). “[T]he historic

police powers of the State include the regulation of health and

safety.” Id. “Throughout our history the several States have

exercised their police powers to protect the health and safety

of their citizens. Because these are ‘primarily, and

historically, . . . matter[s] of local concern, the ‘States

traditionally have had great latitude under their police powers

to legislate as to the protection of the lives, limbs, health,

comfort, and quiet of all persons.” Lohr, 518 U.S. at 475

(citations omitted) (omission and alteration in original).

8 STENGEL V . MEDTRONIC, INC.

The MDA contains an explicit preemption clause that

provides as follows:

Except as provided in subsection (b) of

this section, no 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). Subsection (b) is not relevant to this

appeal.

An implementing regulation provides:

State or local requirements are preempted

only when the Food and Drug Administration

has established specific counterpart

regulations or there are other specific

requirements applicable to a particular device

under the act, thereby making any existing

divergent State or local requirements

applicable to the device different from, or in

addition to, the specific Food and Drug

STENGEL V . MEDTRONIC, INC. 9

Administration requirements. . . . The

following are examples of State or local

requirements that are not regarded as

preempted by [§ 360k]:

....

(2) [Section 360k] does not preempt State or

local requirements that are equal to, or

substantially identical to, requirements

imposed by or under the act.

21 C.F.R. § 808.1(d).

The Supreme Court has decided three preemption cases

under the MDA. The rule that emerges from these cases is

that the MDA does not preempt a state-law claim for

violating a state-law duty that parallels a federal-law duty

under the MDA.

The first case is Medtronic, Inc. v. Lohr, decided in 1996.

After Lora Lohr’s pacemaker failed, the Lohrs sued its

manufacturer, Medtronic, under state law for damages.

518 U.S. at 474, 480–81. The Lohrs’ complaint included

numerous state-law negligence claims, including a claim

alleging failure to warn the “plaintiff or her physicians of the

tendency of the pacemaker to fail, despite knowledge of other

earlier failures.” Id. at 481. Medtronic moved for summary

judgment, contending that all of the Lohrs’ state-law claims

were preempted. Id. The Court held that none of the Lohrs’

state-law claims was preempted. Id. at 503. It wrote:

“Nothing in § 360k denies Florida the right to provide a

traditional damages remedy for violations of common-law

10 STENGEL V . MEDTRONIC, INC.

duties when those duties parallel federal requirements.” Id.

at 495.

Medtronic had argued that because the MDA provides no

damages remedy, it preempts states from providing such a

remedy, even for violations of parallel state-law duties. Id. at

486–87. In Part IV of his opinion, joined by three others,

Justice Stevens emphatically rejected Medtronic’s argument:

An examination of the basic purpose of

the legislation as well as its history entirely

supports our rejection of Medtronic’s extreme

position. The MDA was enacted “to provide

for the safety and effectiveness of medical

devices intended for human use.” . . . To the

extent that Congress was concerned about

protecting the industry, that intent was

manifested primarily through fewer

substantive requirements under the Act, not

the pre-emption provision; furthermore, any

such concern was far outweighed by concerns

about the primary issue motivating the

MDA’s enactment: the safety of those who

use medical devices.

Id. at 490–491 (citation omitted). Justice Breyer did not

concur in Part IV, but specifically stated his reason for not

joining: “I do not join Part IV, which emphasizes the

differences between the MDA and the pre-emption statute at

issue in Cipollone [v. Liggett Group, Inc., 505 U.S. 504

(1992)], because those differences are not, in my view,

relevant in this action.” Id. at 508 (Breyer, J., concurring in

part and concurring in the judgment). Justice Breyer’s stated

STENGEL V . MEDTRONIC, INC. 11

reason for not joining Part IV did not include disagreement

with the passage quoted above.

The Court held that the MDA did not preempt the Lohrs’

state-law claim alleging that Medtronic negligently had failed

to warn “plaintiff or her physicians” of the known dangers of

its pacemaker. The generality of the state-law duty to warn

was important to the Court’s analysis. The Court wrote:

[T]he predicate for the failure to warn claim is

the general duty to inform users and

purchasers of potentially dangerous items of

the risks involved in their use. Th[is] general

obligation[] [is] no more a threat to federal

requirements than would be a state-law duty

to comply with local fire prevention

regulations and zoning codes, or to use due

care in the training and supervision of a work

force.

Id. at 501–02. The state-law duties upon which the Lohrs

relied escape preemption “because their generality leaves

them outside the category of requirements that § 360k

envisioned to be ‘with respect to’ specific devices such as

pacemakers.” Id. at 502.

The second case is Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341 (2001). The plaintiffs in Buckman

brought a state-law negligence suit for damages alleging

injuries resulting from orthopedic bone screws, a Class III

medical device. Id. at 343–44. Defendant Buckman was not

the manufacturer of the screws. Instead, it was a consulting

company that plaintiffs alleged had made fraudulent

misrepresentations to the FDA in the course of obtaining pre-

12 STENGEL V . MEDTRONIC, INC.

market approval for its client, the manufacturer. Id. at 343.

The Court characterized the plaintiffs’ state-law claims

against Buckman as “fraud-on-the-FDA claims.” Id. at 348.

It wrote that such claims

conflict with, and are therefore impliedly pre-

empted by, [the MDA]. The conflict stems

from the fact that the federal statutory scheme

amply empowers the FDA to punish and deter

fraud against the Administration, and that this

authority is used by the Administration to

achieve a somewhat delicate balance of

statutory objectives. The balance sought by

the Administration can be skewed by allowing

fraud-on-the-FDA claims under state tort law.

Id. (footnote omitted).

The Court in Buckman distinguished Silkwood v. Kerr-

McGee Corp., 464 U.S. 238, 241, 258 (1984), in which it had

held that a state-law negligence cause of action allowing

punitive damages was not preempted by the Atomic Energy

Act. The Court wrote, “Silkwood’s claim was not based on

any sort of fraud-on-the-agency theory, but on traditional

state tort law principles of the duty of care owed by the

producer of plutonium fuel pins to an employee working in its

plant.” Buckman, 531 U.S. at 352. The Court also

distinguished Medtronic v. Lohr, in which the Lohrs’ “claims

arose from the manufacturer’s alleged failure to use

reasonable care” and had not been concerned with

wrongdoing during the FDA’s pre-market approval process.

Id. In contrast to the plaintiffs in Medtronic v. Lohr, the

plaintiffs in Buckman alleged no state-law claim and were

concerned exclusively with alleged fraud on the FDA that had

STENGEL V . MEDTRONIC, INC. 13

occurred as part of that approval process. The Court found

that the pre-market approval process of a Class III device is

wholly federal—it “originates from, is governed by, and

terminates according to federal law.” Id. at 347–48. It

continued:

In the present case, . . . the fraud claims exist

solely by virtue of the FDCA disclosure

requirements. Thus, although Medtronic [v.

Lohr] can be read to allow certain state-law

causes of action 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.

In sum, were plaintiffs to maintain their

fraud-on-the-agency claims here, they would

not be relying on traditional state tort law . . . .

Id. at 352–53.

The final case is Riegel v. Medtronic, Inc., 552 U.S. 312

(2008). Plaintiffs sued Medtronic for damages under state

law after an FDA-approved Class III catheter in the lead

plaintiff’s coronary artery ruptured. Id. at 320. The catheter

had been inflated to a higher pressure than recommended on

the FDA-approved label. Id. Plaintiffs alleged that the

catheter was defective under state law. Id. The Court held

that plaintiffs’ claims were expressly preempted by the MDA

because state law imposed a more stringent safety

requirement than federal law. Id. at 325. However, the Court

was careful to state that Medtronic v. Lohr remained good

law. It wrote:

14 STENGEL V . MEDTRONIC, INC.

State requirements are pre-empted under

the MDA only to the extent that they are

“different from, or in addition to” the

requirements imposed by federal law.

§ 360k(a)(1). Thus, § 360k does not prevent

a State from providing a damages remedy for

claims premised on a violation of FDA

regulations; the state duties in such a case

“parallel,” rather than add to, federal

requirements. Lohr, 518 U.S., at 495[.]

Riegel, 552 U.S. at 330.

There are three categories of preemption: express, field,

and conflict. See Indus. Truck Ass’n v. Henry, 125 F.3d 1305,

1309 (9th Cir. 1997). Field and conflict preemption are

subcategories of implied preemption. Though the Court did

not say so explicitly, it is clear that its decision in Lohr was

an across-the-board holding that there was no preemption

under any of the three categories. The Court framed the issue

without any qualification as to category of preemption: “The

question presented is whether [the MDA] pre-empts a state

common-law negligence action against the manufacturer of

an allegedly defective medical device.” Lohr, 518 U.S. at

474.

During the course of its opinion, the Court addressed the

three categories. First, the Court held that there was no

express preemption. It wrote:

[A]ny understanding of the scope of a pre-

emption statute must rest primarily on “a fair

understanding of congressional purpose.” . . .

Congress’ intent, of course, primarily is

STENGEL V . MEDTRONIC, INC. 15

discerned from the language of the pre-

emption statute and the “statutory framework”

surrounding it.

Id. at 485–86 (citation omitted) (emphasis in original).

Second, the Court held there was no field preemption.

Justice Stevens wrote in Part IV:

[Medtronic] argues that the plain language of

the statute pre-empts any and all common-law

claims brought by an injured plaintiff against

a manufacturer of medical devices.

Medtronic’s argument is not only

unpersuasive, it is implausible. . . .

. . . Given the ambiguities in the statute and

the scope of the preclusion that would occur

otherwise, we cannot accept Medtronic’s

argument that by using the term

“requirement,” Congress clearly signaled its

intent to deprive the States of any role in

protecting consumers from the dangers

inherent in many medical devices.

Id. at 486–87, 489. Justice Breyer concurred on this point.

He wrote, “[I cannot] find any indication that either Congress

or the FDA intended the relevant FDA regulations to occupy

entirely any relevant field.” Id. at 508 (Breyer, J., concurring

in part and concurring in the judgment).

Third, the Court held that there was no conflict

preemption. Conflict preemption exists when a state

16 STENGEL V . MEDTRONIC, INC.

requirement actually conflicts with a federal requirement,

making impossible compliance with both requirements, see

Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132,

142–43 (1963), or when a state requirement “stands as an

obstacle to the accomplishment and execution of the full

purposes and objectives of Congress,” Hines v. Davidowitz,

312 U.S. 52, 67 (1941). The MDA’s implementing

regulation provides that state requirements are not preempted

if they “are equal to, or substantially identical to,

requirements imposed by or under the act.” 21 C.F.R.

§ 808.1(d)(2). Justice Stevens wrote in Part IV of Lohr that

state requirements that fall within the regulatory definition do

not conflict with the MDA:

Nothing in § 360k denies Florida the right

to provide a traditional damages remedy for

violations of common-law duties when those

duties parallel federal requirements. . . . The

presence of a damages remedy does not

amount to the additional or different

“requirement” that is necessary under the

statute; rather, it merely provides another

reason for manufacturers to comply with

identical existing “requirements” under

federal law.

518 U.S. at 495. Justice Breyer again concurred, writing, “I

can find no actual conflict between any federal requirement

and any of the liability-creating premises of the plaintiffs’

state-law tort suit[.]” Id. at 508 (Breyer, J., concurring in part

and concurring in the judgment).

Our sister circuits have uniformly held that, in cases

dealing with violations of the MDA outside the pre-market

STENGEL V . MEDTRONIC, INC. 17

approval process, the MDA does not preempt state-law

causes of action for damages in which the state-law duty

“parallels” the federal-law duty under the MDA. Two cases

are directly on point.

First, in Hughes v. Boston Scientific Corp., 631 F.3d 762,

765 (5th Cir. 2011), Jan Hughes suffered severe burns when

hot liquid leaked from a Class III medical device

manufactured by Boston Scientific. Hughes brought suit

under Mississippi law, alleging a violation of a state-law duty

to warn. Id. The Fifth Circuit held that Hughes’s state-law

failure-to-warn claim was not preempted “to the extent that

this claim is predicated on Boston Scientific’s failure to

comply with the applicable federal statutes and regulations.”

Id. at 764. The court stated explicitly that its holding

extended to both express and implied preemption: “We

conclude that Hughes’s failure to warn claim is neither

expressly nor impliedly preempted by the MDA to the extent

that this claim is premised on Boston Scientific’s violation of

FDA regulations with respect to reporting burns caused by

the [device].” Id. at 776.

Second, in Bausch v. Stryker Corp., 630 F.3d 546, 549

(7th Cir. 2010), cert. denied, 132 S. Ct. 498 (2011), Margaret

Bausch was injured by a Class III ceramic hip replacement.

Bausch brought suit against the manufacturer under Illinois

tort law, alleging a violation of state-law duties, premised

upon a violation of parallel federal-law duties under the

MDA. Id. at 549. The Seventh Circuit wrote:

The central issue in this appeal is whether

federal law preempts product liability claims

against manufacturers of Class III medical

devices where a patient claims that she was

18 STENGEL V . MEDTRONIC, INC.

harmed by the manufacturer’s violation of

federal law. That statement of the issue may

be a little startling. The idea that Congress

would have granted civil immunity to medical

device manufacturers for their violations of

federal law that hurt patients is, to say the

least, counter-intuitive.

Id. The court concluded that Bausch’s state-law claims were

neither expressly nor impliedly preempted, writing that

“federal law does not preempt parallel claims under state law

based on a medical device manufacturer’s violation of federal

law . . . .” Id. at 558.

The Eighth Circuit has also addressed preemption under

the MDA. In In re Medtronic, Inc., Sprint Fidelis Leads

Products Liability Litigation, 623 F.3d 1200, 1203 (8th Cir.

2010), plaintiffs in multidistrict litigation alleged that a Class

III cardiac defibrillator wire manufactured by Medtronic was

defective. Plaintiffs alleged various torts under state laws,

including failure to warn. The Eighth Circuit held that the

MDA preempted both of the plaintiffs’ failure-to-warn

claims. First, plaintiffs sought to enforce state-law

requirements that would have required Medtronic “to give

additional warnings, precisely the type of state requirement

that is ‘different from or in addition to’ the federal

requirement[.]” Id. at 1205 (quoting Riegel, 552 U.S. at 330).

Second, the plaintiffs sought to bring actions based solely on

the MDA rather than on state law, which the court found

foreclosed by Buckman. Id. at 1205–06. At no point did the

court address a state-law claim based on a state-law duty that

paralleled a federal-law duty, and thus Sprint Fidelis is not

inconsistent with Hughes and Bausch.

STENGEL V . MEDTRONIC, INC. 19

IV. The Proposed Amended Complaint

The new claim in the Stengels’ proposed amended

complaint alleges that, under federal law, Medtronic had a

“continuing duty to monitor the product after pre-market

approval and to discover and report to the FDA any

complaints about the product’s performance and any adverse

health consequences of which it became aware and that are or

may be attributable to the product.” It further alleges that

Medtronic failed to perform its duty under federal law to

warn the FDA. Finally, the complaint alleges that, because

Medtronic failed to comply with its duty under federal law,

it breached its “duty to use reasonable care” under Arizona

negligence law.

The Stengels’ proposed new claim under Arizona law,

insofar as the state-law duty parallels a federal-law duty

under the MDA, is not preempted. Arizona state law has long

been concerned with the protection of consumers from harm

caused by manufacturers’ unreasonable behavior. Plaintiffs’

claim is brought under settled Arizona law that protects the

safety and health of Arizona citizens by imposing a general

duty of reasonable care on product manufacturers. “‘The

whole modern law of negligence, with its many

developments, enforces the duty of fellow-citizens to observe

in varying circumstances an appropriate measure of prudence

to avoid causing harm to one another.’” Crouse v. Wilbur-

Ellis Co., 272 P.2d 352, 365 (Ariz. 1954) (quoting Pollock,

Law of Torts 17 (15th ed. 1951)). Arizona tort law includes

a cause of action for failure to warn. Under Arizona law,

“negligence standards impose a duty to produce products with

appropriate warning instructions.” Wilson v. U.S. Elevator

Corp., 972 P.2d 235, 237 (Ariz. Ct. App. 1998) (internal

quotation marks omitted). “A product may be unreasonably

20 STENGEL V . MEDTRONIC, INC.

dangerous in the absence of adequate warnings.” Dole Food

Co. v. N.C. Foam Indus., Inc., 935 P.2d 876, 880 (Ariz. Ct.

App. 1996). “The manufacturer of a product must warn of

dangers which he knows or should know are inherent in its

use. This duty may be a continuing one applying to dangers

the manufacturer discovers after sale.” Rodriguez v. Besser

Co., 565 P.2d 1315, 1320 (Ariz. Ct. App. 1977) (citations

omitted), abrogated on other grounds as recognized by Piper

v. Bear Med. Sys., 883 P.2d 407, 414 (Ariz. Ct. App. 1993).

If a more precise parallel were necessary, the Stengels

have alleged it and Arizona law provides it. The Stengels’

new claim specifically alleges, as a violation of Arizona law,

a failure to warn the FDA. Arizona law contemplates a

warning to a third party such as the FDA. Under Arizona

law, a warning to a third party satisfies a manufacturer’s duty

if, given the nature of the warning and the relationship of the

third party, there is “reasonable assurance that the

information will reach those whose safety depends on their

having it.” Anguiano v. E.I. DuPont de Nemours & Co.,

808 F. Supp. 719, 723 (D. Ariz. 1992), aff’d 44 F.3d 806 (9th

Cir. 1995).

We do not decide whether plaintiffs can prevail on their

state-law failure-to-warn claim. That question is not before

us. But we do hold, under Lohr, Buckman, and Riegel, that

this claim is not preempted, either expressly or impliedly, by

the MDA. It is a state-law claim that is independent of the

FDA’s pre-market approval process that was at issue in

Buckman. The claim rests on a state-law duty that parallels

a federal-law duty under the MDA, as in Lohr. In holding

that the Stengels’ failure-to-warn claim is not preempted, we

join the Fifth and Seventh Circuits, which reached the same

STENGEL V . MEDTRONIC, INC. 21

conclusion with respect to comparable state-law claims in

Hughes and Bausch.

In light of our decision on the merits of the state-law

claim in the Stengels’ proposed amended complaint, it is not

necessary to address their appeal of the district court’s

evidentiary ruling.

The Stengels have not appealed the dismissal of the state-

law claims in their original complaint. We agree with the

district court that those claims are preempted as they are

currently pled. The Stengels have not specified in those

claims a state-law duty that parallels a federal-law duty under

the MDA. Now that we have clarified preemption law under

the MDA, it is possible that the Stengels could plead non-

preempted versions of these claims. We leave it to the sound

discretion of the district court to determine whether, in light

of this opinion, the Stengels should be permitted to file a

further amended complaint if they wish to do so.

Conclusion

For the foregoing reasons, we conclude that the MDA

does not preempt the Stengels’ state-law failure-to-warn

claim contained in their proposed amended complaint. We

therefore reverse the decision of the district court and remand

for further proceedings consistent with this opinion.

REVERSED and REMANDED.

22 STENGEL V . MEDTRONIC, INC.

WATFORD, Circuit Judge, joined by KOZINSKI, Chief

Judge, and THOMAS, SILVERMAN, GRABER,

McKEOWN, and GOULD, Circuit Judges, concurring:

While I join Judge Fletcher’s opinion, I write separately

to provide a few additional thoughts as to why the state law

failure-to-warn claim alleged in the proposed amended

complaint is not preempted.

Given the Supreme Court’s preemption decisions in this

area, the Stengels faced a dilemma in framing their failure-to-

warn claim. The most direct way to state the claim would be

to allege that under Arizona law Medtronic owed a post-sale

duty to warn doctors when it learned of adverse events in

which the medical device at issue here caused a death or

serious injury. Regulations issued by the Food and Drug

Administration (FDA) permitted Medtronic to issue such

post-sale warnings, even without receiving prior approval

from the FDA, but those regulations did not require such

warnings. See 21 C.F.R. § 814.39(d). As a result, any

attempt to predicate the Stengels’ claim on an alleged state

law duty to warn doctors directly would have been expressly

preempted under 21 U.S.C. § 360k, which forbids state-

imposed requirements that are “different from, or in addition

to” the requirements imposed by federal law. See McMullen

v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (“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.”).

But the Stengels have not predicated their failure-to-warn

claim on a duty to warn doctors directly. They have instead

alleged that Medtronic breached its duty of reasonable care

under Arizona negligence law by failing to report adverse

STENGEL V . MEDTRONIC, INC. 23

events to the FDA. That requirement is not “different from,

or in addition to” the requirements imposed by federal law,

because FDA regulations required Medtronic to file an

adverse event report with the FDA if it learned of information

“reasonably suggest[ing]” that one of its devices “[m]ay have

caused or contributed to a death or serious injury,” as the

Stengels have alleged here. 21 C.F.R. § 803.50(a). Framed

in this fashion, the Stengels’ negligence claim is not

expressly preempted because it seeks to hold Medtronic

accountable only for failing to do what federal law mandated

— nothing more. The state law duty, as alleged by the

Stengels, is precisely parallel to the duties imposed by federal

law. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996).

Because they predicate their claim on Medtronic’s

reporting duty to the FDA, as they must to avoid express

preemption, the Stengels face a causation hurdle that would

not otherwise exist. To prevail, they will ultimately have to

prove that if Medtronic had properly reported the adverse

events to the FDA as required under federal law, that

information would have reached Mr. Stengel’s doctors in

time to prevent his injuries. See Hughes v. Boston Scientific

Corp., 631 F.3d 762, 770 n.5, 776 (5th Cir. 2011). But at this

juncture — a request for leave to amend their complaint —

the Stengels’ allegations of causation are adequate.

Medtronic argues that the Stengels’ choice to predicate

their claim on a reporting duty to the FDA renders the claim

impliedly preempted under Buckman Co. v. Plaintiffs’ Legal

Committee, 531 U.S. 341 (2001). In that case, the plaintiffs

asserted a state law fraud claim based on purported

misrepresentations made to the FDA during the premarket

approval process for the medical device at issue. Id. at 343.

The Supreme Court held that this claim was impliedly

24 STENGEL V . MEDTRONIC, INC.

preempted because it sought to enforce an exclusively federal

requirement and was not grounded in traditional state tort

law. Id. at 352–53. Likewise here, Medtronic argues, the

Stengels’ failure-to-warn claim seeks to enforce an

exclusively federal requirement and is not based on

traditional state tort law because Arizona law has never

required adverse events to be reported to the FDA.

In my view, accepting that argument would require an

unwarranted expansion of Buckman’s rationale. Central to

the Court’s reasoning in Buckman was that the state law claim

asserted there “exist[ed] solely by virtue” of the federal

enactments, id. at 353 (emphasis added), because state law

traditionally had no role to play in policing “the relationship

between a federal agency and the entity it regulates,” id. at

347. But Buckman left intact claims “relying on traditional

state tort law which had predated the federal enactments” in

question. Id. at 353.

In this case, Medtronic’s failure to report was more than

a mere misrepresentation to the FDA because it

simultaneously misled the device’s current and potential

users, to whom Medtronic owed an independent duty under

state law. There is no question that state law has an important

and legitimate role to play in regulating the adequacy of post-

sale warnings for products already on the market. That

Arizona law did not previously address reporting duties to the

FDA specifically is irrelevant; nothing in Buckman suggests

that the preexisting state law needs to mirror the federal

requirement at that level of specificity to avoid preemption.

It is sufficient here that, in contrast to Buckman, the Stengels’

claim is grounded in a traditional category of state law

failure-to-warn claims that predated the federal enactments in

STENGEL V . MEDTRONIC, INC. 25

question, and that the claim therefore does not exist solely by

virtue of those enactments.