FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

RICHARD STENGEL; MARY LOU 

STENGEL,

No. 10-17755 Plaintiffs-Appellants,

D.C. No.

v.  4:10-cv-00318-RCC

MEDTRONIC INCORPORATED, a OPINION foreign corporation,

Defendant-Appellee. 

Appeal from the United States District Court

for the District of Arizona

Raner C. Collins, District Judge, Presiding

Argued and Submitted

January 13, 2012—San Francisco, California

Filed April 16, 2012

Before: J. Clifford Wallace, John T. Noonan, and

Milan D. Smith, Jr., Circuit Judges.

Opinion by Judge Wallace;

Dissent by Judge Noonan

4085
COUNSEL

Thomas G. Cotter, Stanley G. Feldman, and Stephen T. Portell; Haralson Miller, Pitt, Feldman & McAnally, P.L.C., Tucson, Arizona, for the plaintiffs-appellants

Michael K. Brown, Ginger F.H. Pigott, and Lisa M. Baird,

Reed Smith LLP, Los Angeles, California, for the defendantappellee.

OPINION

WALLACE, Senior Circuit Judge:

Richard and Mary Lou Stengel brought several state causes

of action in Arizona state court against Medtronic Incorporated (Medtronic) for injuries sustained by Richard Stengel

(Stengel) from his use of a pain pump manufactured by

Medtronic. Medtronic timely removed the case to the United

States District Court for the District of Arizona. The district

court dismissed the Stengels’ claims as preempted by federal

law and the Stengels appealed. We have jurisdiction under 28

U.S.C. § 1291. We affirm.

I.

Medtronic’s pain pump is a medical device that infuses prescription medication through a catheter into the intrathecal

4088 STENGEL v. MEDTRONIC INC.
space within the spine to help control severe pain. In 1988,

the Food and Drug Administration (FDA) gave premarket

approval as a Class III medical device for Medtronic’s SynchroMed Pump & Infusion System. In 1999, the FDA gave

supplemental premarket approval for Medtronic’s SynchroMed EL Pump and intrathecal catheter, which are the versions of Medtronic’s device at issue in this action.

In 2000, Stengel had a Medtronic pump surgically

implanted in his abdomen and began receiving medication

through the catheter tip implanted in his spine. In 2005, Stengel began experiencing ascending paralysis in his lower

extremities caused by a granuloma (a type of inflammation)

in his spine that had formed at the tip of the catheter. Stengel’s doctors surgically removed the hardware and most of the

granuloma, but not in time to prevent the granuloma from rendering Stengel permanently paraplegic.

The Stengels’ complaint alleged four generic claims under

Arizona law: negligence, breaches of express and implied

warranties, and strict liability. The district court granted

Medtronic’s motion to dismiss the complaint on the ground

that federal law expressly preempted these claims.

While the motion to dismiss was pending, the Stengels

moved for leave to amend their complaint to re-allege the

same four claims under the newly-proffered theory that Stengel’s injury was caused by Medtronic’s failure to implement

procedures to evaluate complaints about the pump and failure

to report information to the FDA, as was required by FDA

regulations. The Stengels alleged that if Medtronic had complied with the regulations, Medtronic would have warned

physicians about the newly-discovered danger that the pump

might cause inflammation, which would have allowed a

quicker diagnosis of Stengel’s symptoms and prevented his

paralysis. The Stengels’ motion for leave to amend was

denied on the ground that this “failure-to-warn” claim was

impliedly preempted.

STENGEL v. MEDTRONIC INC. 4089
We review de novo the district court’s holding that all of

the Stengels’ asserted claims were either expressly or

impliedly preempted. Martinez v. Wells Fargo Home Mortg.,

Inc., 598 F.3d 549, 553 (9th Cir. 2010). We review its denial

of leave to amend for abuse of discretion. Alvarez v. Chevron

Corp., 656 F.3d 925, 931 (9th Cir. 2011).

II.

[1] In 1976, Congress amended the Food, Drug and Cosmetic Act (FDCA) by enacting the Medical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539

(codified as amended at 21 U.S.C. § 360c et seq.). The MDA

added a preemption clause to the FDCA which provides, subject to limited exceptions, that

no State . . . may establish . . . with respect to a

device intended for human use any requirement—(1)

which is different from, or in addition to, any

requirement applicable under [the FDCA], 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 [the FDCA].

21 U.S.C. § 360k(a).

The Supreme Court has examined the extent to which this

preemption clause “bars common-law claims challenging the

safety and effectiveness of a medical device given premarket

approval by the [FDA].” Riegel v. Medtronic, Inc., 552 U.S.

312, 315 (2008). The Court reviewed the “rigorous” premarket approval process for Class III medical devices:

A manufacturer must submit what is typically a multivolume application. It includes, among other

things, full reports of all studies and investigations of

the device’s safety and effectiveness that have been

published or should reasonably be known to the

4090 STENGEL v. MEDTRONIC INC.
applicant; a full statement of the device’s components, ingredients, and properties and of the principle

or principles of operation; a full description of the

methods used in, and the facilities and controls used

for, the manufacture, processing, and, when relevant,

packing and installation of, such device; samples or

device components required by the FDA; and a specimen of the proposed labeling. Before deciding

whether to approve the application, the agency may

refer it to a panel of outside experts and may request

additional data from the manufacturer.

The FDA spends an average of 1,200 hours reviewing each application and grants premarket approval

only if it finds there is a reasonable assurance of the

device’s safety and effectiveness.

Id. at 317-18 (internal citations and quotation marks omitted).

The premarket approval process includes review of the

device’s proposed labeling to evaluate safety and effectiveness under the conditions of use set forth in the label. Id. at

318. After a device is approved, “the MDA forbids the manufacturer to make, without FDA permission, changes in design

specifications, manufacturing processes, labeling, or any other

attribute, that would affect safety or effectiveness.” Id. at 319.

Any changes must be made after FDA approval of an application for supplemental premarket approval, “to be evaluated

under largely the same criteria as an initial application.” Id.

The Court then held that the premarket approval process for

Class III devices imposed federal “requirements” applicable

to the approved device, that common law tort duties constituted state “requirements,” and that the “safety and effectiveness” of the device was the subject of the plaintiff ’s common

law claims. Id. at 322-23. The Court recognized that section

“360k does not prevent a State from providing a damages

remedy for claims premised on a violation of FDA regulaSTENGEL v. MEDTRONIC INC. 4091
tions” because “the state duties in such a case ‘parallel,’ rather

than add to, federal requirements.” Id. at 330, quoting

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

the plaintiff asserted that the defendant’s device “violated

state tort law notwithstanding compliance with the relevant

federal requirements,” the Court held their claims to be

expressly preempted. Id.

[2] The Stengels’ claims, as they appear in the initial complaint, are expressly preempted under section 360k and Riegel. The claims generally challenged the safety and

effectiveness of Medtronic’s pump without any hint of an

allegation that Medtronic’s conduct violated FDA regulations.

To be successful, the claims would have required the trier of

fact, as a matter of state tort law, to conclude that the device

should have either been designed differently from what the

FDA required through premarket approval, or labeled with

warnings different from what the FDA required. Therefore,

the district court correctly dismissed the Stengels’ initial complaint.

[3] The claims alleged in Stengels’ proposed amended

complaint are also expressly preempted to the extent they rely

on the theory that Medtronic should have sent a medical

device correction notice to physicians, whether or not the

FDA ordered it, because FDA regulations permitted

Medtronic to send the notice without prior FDA approval. See

21 C.F.R. § 814.39(d). The Seventh Circuit has addressed this

precise question. It held: “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.” McMullen v. Medtronic, Inc., 421

F.3d 482, 489 (7th Cir. 2005). We agree that such a requirement is expressly preempted.

III.

[4] However, portions of the claims in the Stengels’ proposed amended complaint could be interpreted to survive

express preemption. The proposed complaint alleged:

4092 STENGEL v. MEDTRONIC INC.
Under federal law and regulation, [Medtronic] was

under a continuing duty to monitor the product after

premarket 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.

Substitute Amended Complaint, ¶ 13, ECF No. 22-1 (citing

21 U.S.C. § 360i (requirement to maintain and submit information as required by regulation); 21 C.F.R. § 803.50

(requirement to submit reports); 21 C.F.R. § 820.198(a)

(requirement to establish procedures for reviewing complaints)). Because of Medtronic’s negligent failure to perform

these duties, the Stengels alleged, its pump became defective

and unfit for its intended purpose. Id. ¶ 20. To the extent

Medtronic’s alleged violations of FDA regulations are actionable under state law, the state obligations parallel the federal

requirements, and thus are not expressly preempted.

[5] Nonetheless, this theory in the Stengels’ amended complaint which survives express preemption ultimately fails

because the claims are impliedly preempted under Buckman

Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). In

Buckman, the plaintiffs alleged that the defendant made fraudulent misrepresentations to the FDA regarding the intended

use of its bone screws and that the devices were improperly

given market clearance as a result. Id. at 346-47. The

Supreme Court held that the claims were preempted because,

although the defendant had allegedly violated federal requirements, allowing the plaintiffs to bring a state cause of action

to remedy the injuries caused by the violations would interfere with the congressional scheme. Id. As the Court

explained, “the federal statutory scheme amply empowers the

FDA to punish and deter fraud against the Administration,

and . . . this authority is used by the Administration to achieve

a somewhat delicate balance of statutory objectives” which

STENGEL v. MEDTRONIC INC. 4093
“can be skewed by allowing fraud-on-the-FDA claims under

state tort law.” Id. at 348.

The Court observed that “[t]he FDCA leaves no doubt that

it is the Federal Government rather than private litigants who

are authorized to file suit for noncompliance with the medical

device provisions.” Id. at 349 n.4, citing 21 U.S.C. § 337(a)

(no private right of action to enforce FDCA). The Court held

that “[s]tate-law fraud-on-the FDA claims inevitably conflict

with the FDA’s responsibility to police fraud consistently

with the Administration’s judgment and objectives.” Id. at

350. The Court distinguished Medtronic, Inc. v. Lohr, 518

U.S. 470 (1996), in which the Court previously held certain

negligence claims not to be expressly preempted under the

FDCA. 531 U.S. at 352-53. It reasoned that “the [Lohr]

claims arose from the manufacturer’s alleged failure to use

reasonable care in the production of the product, not solely

from the violation of FDCA requirements,” whereas the Buckman fraud claims “exist solely by virtue of the FDCA disclosure requirements.” 531 U.S. at 352-53.

There is no meaningful distinction between the Stengels’

failure-to-warn claims and the “fraud-on-the-FDA” claims

held to be preempted in Buckman. Therefore, following Buckman, we hold that the Stengels’ claims are impliedly preempted.1

The Stengels’ theory is that if Medtronic had acted with reasonable care in complying with the regulations that required

it to provide information to the FDA, the FDA would have

required Medtronic to warn physicians about the danger of

inflammation connected to its pump and Stengel could have

avoided the injury caused by the pump. See 21 U.S.C.

§ 360h(a). This is precisely the same theory that was rejected

in Buckman. The only difference is that, in Buckman, the

1The dissent argues that because the Stengels’ claims are not expressly

preempted under Lohr, they cannot be impliedly preempted under Buckman. This is not the law. Lohr does not determine the scope of implied

preemption because it never considered the issue. 

4094 STENGEL v. MEDTRONIC INC.
defendant allegedly misinformed the FDA overtly by providing false information, whereas here the defendant allegedly

misinformed the FDA tacitly by failing to report information

that it had a duty to report. The policing of such conduct in

both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such

conduct would conflict with the statutory scheme established

by Congress. Cf. Cupek v. Medtronic, Inc., 405 F.3d 421,

423-24 (6th Cir. 2005) (negligence per se claim due to “failure to comply with [FDA] conditions of approval” preempted

because it was a “disguised fraud on the FDA claim”).

The federal regulations that Medtronic is alleged to have

violated impose detailed reporting requirements with respect

to a broad category of information. For example, a manufacturer must report to the FDA information the manufacturer

becomes aware of, from any source, that reasonably suggests

that its device may have caused or contributed to a serious

injury. 21 C.F.R. § 803.50. This report must be made no later

than 30 days after the day the manufacturer receives or

becomes aware of the information. Section 803.50(a). The

FDA considers information that is reasonably known to the

manufacturer to include any information that the manufacturer can obtain by contacting the initial reporter or by testing

the device. Section 803.50(b). A manufacturer must investigate each adverse event and evaluate the cause of the event.

Section 803.50(b)(3). If the manufacturer cannot submit complete information in a report, it must provide a statement

explaining why the information was incomplete and the steps

taken to obtain the information. Id. Regulations also require

a manufacturer to maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints

by a formally designated unit. 21 C.F.R. § 820.198. These

procedures must ensure that all complaints are processed in a

uniform and timely manner, and that oral complaints are documented upon receipt. Section 820.198(a). A manufacturer

must review and evaluate all complaints to determine whether

an investigation is necessary, and if it chooses not to investiSTENGEL v. MEDTRONIC INC. 4095
gate, must record its reasons and the name of the individual

responsible for a decision not to investigate. Section

820.198(b). When a complaint describes an event that must be

reported to the FDA, the records of the investigation must

contain enumerated categories of information and must be

maintained in a separate portion of the complaint files or otherwise clearly identified. Section 820.198(d), (e). If the FDA

determines that a notification to physicians is necessary to

eliminate an unreasonable risk of substantial harm to the public health, the FDA can order the manufacturer to issue the

notification after consulting with the manufacturer. 21 U.S.C.

§ 360h(a).

In contrast, Arizona common law imposes liability on a

manufacturer that fails to exercise reasonable care to inform

a consumer of its product’s dangerous condition or of the

facts that make the product likely to be dangerous, if the manufacturer knows or has reason to know that the product is

likely to be dangerous and has no reason to believe that the

consumer will realize its dangerous condition. Anguiano v.

E.I. Du Pont De Nemours & Co., Inc., 44 F.3d 806, 811-12

(9th Cir. 1995). The federal regulations that Medtronic is

alleged to have violated, which require investigation and disclosure to the FDA in a particular manner so that the FDA can

make a decision whether notification of consumers is necessary, are not tied to this general duty to warn consumers under

Arizona law. Thus, the Stengels’ failure-to-warn claims, to

the extent they survive express preemption, exist solely by

virtue of the FDCA disclosure requirements and are, therefore, impliedly preempted.

[6] Nothing in our holding requires preemption of all state

claims challenging the safety of a medical device that has

received premarket approval. But as another court aptly put it,

it is “a narrow gap through which a plaintiff ’s state-law claim

must fit if it is to escape express or implied preemption.” In

re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig.,

623 F.3d 1200, 1204 (8th Cir. 2010), quoting Riley v. Cordis

4096 STENGEL v. MEDTRONIC INC.
Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). At least

some claims have proven capable of passing through that gap.

For instance, in Bausch v. Stryker Corp., the Seventh Circuit

held that state claims based on manufacturing defects were

not preempted under Buckman because, “[w]hile there may

not be a ‘traditional state tort law’ claim for an ‘adulterated’

product in so many words, the federal definition of adulterated medical devices is tied directly to the duty of manufacturers to avoid foreseeable dangers with their products by

complying with federal law.” 630 F.3d 546, 557 (7th Cir.

2010). We offer no opinion as to whether a particular state

claim that is tied directly to compliance with federal law

would be preempted under Buckman. In this case, the duty of

manufacturers under federal law to report to the FDA information regarding their devices is not tied directly to the duty

of manufacturers under state law to warn consumers of a

device’s dangerous condition. On the contrary, the enforcement of the duty to report is an element of the federal scheme

that is committed solely to the federal government.

The Stengels contend that Buckman is distinguishable

because it only requires preemption of fraud-on-the-FDA-type

claims where the FDA has not previously determined that the

manufacturer violated federal reporting requirements. A

warning letter from the FDA to Medtronic was attached to the

proposed amended complaint, and shows that the FDA had

already determined that Medtronic violated its federal disclosure obligations. Thus, the Stengels contend, they could prove

their claims without second-guessing the FDA’s decision

making.

We are not convinced by the Stengels’ attempt to distinguish Buckman because it is based on the concurrence in

Buckman, which disagreed with the majority specifically

because the majority did not take the position now advocated

by the Stengels. See 531 U.S. at 354 (Stevens, J., concurring

in the judgment). The Buckman majority’s rationale, unlike

the concurrence’s, was not solely based on a desire to avoid

STENGEL v. MEDTRONIC INC. 4097
jurors second-guessing the FDA’s decision making; it was

also based on the idea that state fraud-on-the-FDA claims

would “exert an extraneous pull on the scheme established by

Congress,” in which the FDA was supposed to enforce the

FDCA’s disclosure requirements. Id. at 353 (majority opinion). The majority’s rationale remains relevant in this case,

even where the FDA has issued a warning letter describing

Medtronic’s regulatory violations.

We acknowledge that there is a division among the circuits

whether state failure-to-warn claims are preempted by Buckman. On one hand, the Eighth Circuit has held that federal

law impliedly preempts a state failure-to-warn claim to the

extent the claim is based on the defendant’s failure to provide

the FDA with sufficient information and failure to file adverse

event reports timely. See In re Medtronic, 623 F.3d at 1205-

06. On the other hand, the Fifth Circuit has held that a state

failure-to-warn claim is not preempted. See Hughes v. Boston

Scientific Corp., 631 F.3d 762, 775-76 (5th Cir. 2011).

Hughes is not persuasive. First, it erroneously distinguished

Buckman on the ground that the plaintiffs in Buckman “were

attempting to assert a freestanding federal cause of action,”

Hughes, 631 F.3d at 775, notwithstanding that Buckman

described the claims at issue as seeking damages “under state

tort law,” Buckman, 531 U.S. at 343. Buckman’s preemptive

reach clearly extends to state law causes of action. See Nathan

Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1206 (9th Cir.

2002) (interference with prospective economic advantage

claim preempted); see also PhotoMedex, Inc. v. Irwin, 601

F.3d 919, 924 (9th Cir. 2010) (“The Supreme Court made

clear in Buckman that [21 U.S.C. § 337(a)] also limits the

ability of a private plaintiff to pursue claims under state law

theories where such claims collide with the exclusive enforcement power of the federal government”).

Second, Hughes distinguished Buckman because the claims

“[did] not depend on speculation that the FDA would have

4098 STENGEL v. MEDTRONIC INC.
taken any particular regulatory action in response to violation

of the regulations at issue, as in Buckman.” Hughes, 631 F.3d

at 775. But this reasoning follows the rationale adopted by

Justice Stevens in his concurrence. See 531 U.S. at 354 (Stevens, J., concurring in the judgment). The Buckman majority

never adopted this limitation on its holding.

[7] Third, Hughes argued that allowing preemption would

be inconsistent with Riegel’s recognition that “parallel”

claims are not preempted. 631 F.3d at 775. But Riegel established only that such claims would not be expressly preempted by section 360k. 552 U.S. at 330. Since the claims

before the Court in Riegel failed under express preemption,

the Court had no reason to discuss implied preemption at all.

See id. We join the Eighth Circuit in holding that a failure-towarn claim based on failure to provide disclosures to the FDA

is impliedly preempted.

IV.

Finally, we turn to the additional grounds for reversal

offered by the Stengels. They argue that the district court

should have allowed them to amend their complaint after

removal to conform to the federal pleading standard set forth

in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). However, the district court did not dismiss the Stengels’ complaint

on the ground that it did not conform to the Twombly standard, but instead on the ground that the Stengels’ claims were

preempted.

[8] Next, the Stengels contend that the district court erred

by failing to convert Medtronic’s motion to dismiss into a

motion for summary judgment and then refusing to grant a

continuance for discovery under Federal Rule of Civil Procedure 56(f).2

 This contention fails as well. The district court

2

In the 2010 amendments to the Federal Rules of Civil Procedure, the

provisions of Rule 56(f) were moved to Rule 56(d) without substantial

change. 

STENGEL v. MEDTRONIC INC. 4099
took judicial notice of the fact that Medtronic’s pain pump

received premarket approval as demonstrated by FDA

records. A court may consider facts extraneous to a complaint

on a motion to dismiss, without converting the motion into

one for summary judgment, if such facts are judicially noticeable under Federal Rule of Evidence 201. Lee v. City of Los

Angeles, 250 F.3d 668, 688-89 (9th Cir. 2001). A court may

take judicial notice of a fact that “is not subject to reasonable

dispute because it . . . can be accurately and readily determined from sources whose accuracy cannot reasonably be

questioned.” Fed. R. Evid. 201(b). Because the accuracy of

FDA records cannot reasonably be questioned, the premarket

approval status of Medtronic’s pump is a fact subject to judicial notice. See Funk v. Stryker Corp., 631 F.3d 777, 783 (5th

Cir. 2011) (affirming judicial notice of FDA letter granting

premarket approval). The district court thus did not abuse its

discretion in considering this fact in connection with the

motions to dismiss.

Finally, the Stengels contend that the district court erred by

not ruling on their request to take judicial notice of

Medtronic’s correction letter and a document showing that the

pump was ultimately recalled in 2008. But the district court

did not need to take judicial notice of the correction letter

because that document was included as an exhibit to the proposed amended complaint and, therefore, was part of the

pleadings. Moreover, regardless of whether judicial notice

would have been proper, it was not necessary because the

facts that Medtronic sent a correction letter and that the FDA

issued a recall on the pump do not affect the preemption analysis. Any error in the district court’s failure to rule on the

request for judicial notice was harmless and, therefore, is not

reversible. See Sanchez v. Aerovias De Mexico, S.A. De C.V.,

590 F.3d 1027, 1029 (9th Cir. 2010).

V.

We recognize that it may seem harsh to deny compensation

to a person who alleges serious injury from a medical device.

4100 STENGEL v. MEDTRONIC INC.
But such is the direction from the Supreme Court for cases

like the one before us. We are required to follow the Court.

To the extent the Stengels’ claims are based on the theory

that state law required Medtronic to warn consumers about

the dangerous condition of its pain pumps without first receiving an order to do so from the FDA, the state law establishes

a requirement different from the requirements of the FDCA.

See 21 U.S.C. § 360k; Riegel, 552 U.S. at 325. To the extent

the Stengels’ claims are based on a theory that Medtronic

caused them injury by failing to comply with its duty to report

information to the FDA, their claims threaten to skew the delicate balance of statutory objectives sought to be achieved by

the FDCA. See Buckman, 531 U.S. at 348. Congress has

established the premarket approval process as an important

balance between getting help to patients who need it as soon

as possible and protecting patients who will use the newly

proposed help. Those who have benefitted from this congressional balancing are not before us, but they reap the benefit

of Congress’s insights. It is a balance we must observe. Any

change must be made by Congress itself.

Therefore, we hold that even if some of the Stengels’

claims can be interpreted to escape express preemption, they

cannot be interpreted to escape implied preemption. The district court correctly held that the Stengels’ proposed amendment was futile, and therefore did not abuse its discretion in

denying leave to amend. See Alvarez, 656 F.3d at 935.

AFFIRMED.

NOONAN, Circuit Judge, dissenting:

The issue that this court must address is serious and the

magnitude of its potential implications is great:

STENGEL v. MEDTRONIC INC. 4101
From 2000 through 2011, more than 150 new

high-risk medical devices were approved by the

Food and Drug Administration (FDA) through the

premarket approval known as PMA) process, and an

additional 600 devices were cleared through the less

demanding 510(k) process, in four medical specialty

areas (cardiovascular care, neurology, obstetrics and

gynecology, and orthopedics; see graph Numbers of

High-Risk (Class III) Medical Devices Approved or

Cleared by the FDA in Cardiovascular Care, Neurology, Obstetrics and Gynecology, and Orthopedics,

2000-2011.). 

“Postmarketing Surveillance of Medical Devices – Filling in

the Gaps,” Frederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D., February 14, 2012 (10.1056/NEJMp1114865).

Has Congress or the Supreme Court created such freedom

from liability for the manufacturers of such sensitive devices

that only in nonexistent cases are the manufacturers subject to

suit for damages? Are individuals injured by the malfunction

of such devices without remedy against the manufacturers of

them? That appears to be the conclusion of this court today

with its holding that the MDA explicitly preempts and implicitly preempts any state remedy of damages for violation of a

state requirement paralleling the MDA.

This conclusion, astonishing in its comprehensiveness, is

equally astonishing in the light of binding federal law as

determined by the United States Supreme Court.

The law. In a case involving the defendant in our case, the

Court held:

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. Even if it may be necessary as a

4102 STENGEL v. MEDTRONIC INC.
matter of Florida law to prove that those violations

were the result of negligent conduct, or that they created an unreasonable hazard for users of the product,

such additional elements of the state-law cause of

action would make the state requirements narrower,

not broader, than the federal requirement. While

such a narrower requirement might be “different

from” the federal rules in a literal sense, such a difference would surely provide a strange reason for

finding preemption of a state rule insofar as it duplicates the federal rule. 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. 

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

As the Supreme Court puts it, “common law duties” not

pre-empted by the express terms of the MDA may “parallel”

the MDA. Such “common law duties” cannot amount to zero

because the states may provide a remedy for their breach. See

id. Literally, as the Supreme Court also points out, the state

may add an element to the state cause of action without

destroying the parallel with the federal requirement. Id.

This magisterial exposition of the statute by the Supreme

Court sets out what the Supreme Court has consistently held

and what is necessary for the correct decision of our case.

Nothing in the statute prevents provision by a state of “a traditional damages remedy” for violation of “state duties” that

parallel the federal requirements.

The exception to pre-emption stated by the Court in Lohr

was restated by the Court in yet another case involving the

present defendant: “§ 360k does not prevent a State from providing a damages remedy for claims premised on a violation

STENGEL v. MEDTRONIC INC. 4103
of FDA regulations; the state duties in such a case ‘parallel,’

rather than add to, federal requirements.” Riegel v. Medronic,

552 U.S. 312, 330 (2008) (citing and quoting Lohr, 518 U.S.

at 495).

Pellucidly, the Supreme Court has twice interpreted the

MDA and held states may provide a damages remedy. In the

language of Lohr, it would be “strange” if the Court expressly

preserved state remedies from preemption but believed such

remedies were implicitly rejected by the statute.

Our court in our present case comes to this strange conclusion by its reading of Buckman, 531 U.S. at 353, where the

Supreme Court disparaged the notion of an “extraneous pull”

on the MDA. This reference to “extraneous pull” was surely

a make-weight. A dictum, it does not conform with Lohr or

stand after Riegel. State damages do exert an additional pull

for compliance with the MDA. 

Buckman, 531 U.S. 341, relied on in our case by the majority, predated Riegel and carefully distinguished Lohr. The

plaintiffs in Buckman alleged that Medtronic had committed

fraud on the FDA. Buckman, 531 U.S. at 347. That charge did

not allege a state cause of action. Fraud on a federal agency

was not a tort that the states had traditionally penalized. Id.

“To the contrary, the relationship between a federal agency

and the entity it regulates is inherently federal in character

. . . .” Id. “Accordingly — and in contrast the situations implicating ‘federalism concerns and the historic primacy of state

regulation of matters of health and safety,’ . . . — no presumption against pre-emption obtains in this case.” Buckman,

531 U.S. at 348 (quoting Lohr, 518 U.S. at 485). The Court

went on to stamp the state claims in the case as “conflict[ing]

with” the MDA and “therefore impliedly pre-empted[ ] by

federal law.” Id. (footnote omitted).

The fraud-on-the-FDA claims in Buckman “exist[ed] solely

by virtue of the FDCA disclosure requirements” and did not

4104 STENGEL v. MEDTRONIC INC.
“rely[ ] on traditional state tort law which had predated the

federal enactments in question.” Id. at 353; see also id. at 352-

53 (contrasting Buckman’s preempted fraud-on-the-FDA

claims with the claims in Lohr, 518 U.S. at 481, which “arose

from the manufacturer’s alleged failure to use reasonable care

in the production of the product”). The claims in the present

case are traditional, free-standing tort claims, analogous to

those in Lohr. 

Not a word in Buckman limits Lohr. The majority invoke

it but do not show that it has application here. Riegel demonstrates that Lohr is still binding law determined by the United

States Supreme Court.

The federal requirements. The federal statutory scheme

imposes on manufacturers of medical devices a continuous

reporting obligation that applies after a device goes to market.

21 U.S.C. § 360i. In its 2008 Warning Letter, detailing the

regulatory history, the FDA noted that Medtronic’s Educational Brief of July 2003 was “a reportable correction under

CFR 806.10(a)(1).” Whatever information Medtronic gave its

physician customers, it had not reported its action to the FDA

as a correction. The FDA Warning Letter told Medtronic the

incidents of formation of an inflammatory mass at the catheter

tip between November 2000 and July 2006 “had not yet been

communicated to customers,” that is, the physicians. The

FDA letter told Medtronic that the FDA “disagrees with your

conclusion that the July 2003 Educational Brief was not a correction or removal.” The new labeling in 2003, the FDA told

Medtronic, had not been communicated to physicians “whose

patients already had a SynchroMed pump implanted within

them.” Stengel’s doctor was in this category of physicians

uninformed of the new information.

These failures of Medtronic to report are identified in the

FDA letter as acts in violation of the federal statute and the

regulations applying it. Under the FDA’s assessment of its

conduct, Medtronic was in violation of federal law as early as

STENGEL v. MEDTRONIC INC. 4105
2003 because it failed to adequately respond to events indicating that its device posed a specific danger. 

The parallel state claims. The Stengels sought to amend

their original complaint to allege that Medtronic negligently

failed “to provide adequate warnings, information, or both, of

the risks and hazards of the pain pump[.]” The Arizona

Supreme Court has recognized a cause of action based on a

manufacturer’s failure to remedy or give notice of an unreasonably dangerous condition discovered post-market. See

Readenour v. Marion Power Shovel, 149 Ariz. 442, 448

(1986) (plaintiff could argue that manufacturer, upon discovering “an unreasonably dangerous condition at any time during the product’s history[,]” should have either retrofitted

“each of the models already sold or warn[ed] each of the buyers of the existence of the latent danger”). That Medtronic discovered the danger of granuloma formation after the pain

pump went to market does not defeat the Stengels’ cause of

action under Arizona law. See id.

Whether the state law claim has elements that further

restrict its application is of no import. See Lohr, 518 U.S. at

495. The Stengels have alleged a valid parallel state law cause

of action. Arizona law imposes requirements that parallel the

requirements under federal law, and Arizona law provides a

remedy in damages for the violation of the state requirement.

The state claim for damages. In their proposed amendment,

the Stengels sought the state remedy of damages for the injuries suffered by Richard Stengel as a consequence of

Medtronic’s failure to warn of the danger posed by its pump.

To sum up, the Stengels seek to amend their complaint to

assert Arizona requirements that parallel federal requirements

under the MDA and for which Arizona provides a remedy in

damages. The amendments should be allowed.

4106 STENGEL v. MEDTRONIC INC.
Appendix

The FDA Warning Letter, addressed to the CEO of

Medtronic, July 3, 2008, setting out the history of reports of

the inflammatory mass, states:

A correction or removal conducted to reduce a

risk to health posed by a device was not reported

in writing to FDA, as required by 21 CFR

806.10(a)(1).

In July 2003 your establishment sent a letter with an

enclosed “EDUCATIONAL BRIEF,” entitled “Information about Inflammatory Mass,” to SynchroMed customers (physicians). Also enclosed

were reprints of two articles published in the December 2002 issue of Pain Medicine and revised labeling

for the SynchroMed Technical Manual. FDA defines

a “correction” in 21 CFR 806.2(d) as “ . . .the repair,

modification, adjustment, relabeling, destruction, or

inspection (including patient monitoring) of a device

without its physical removal from its point of use to

some other location.” FDA believes that the July

2003 Educational Brief, which was sent to all customers using SynchroMed pumps, meets the definition of “correction” in that the letter provided

updated labeling to customers for devices that were

already in distribution.

The FDA also believes that the July 2003 Educational Brief is a reportable correction under 21 CFR

806.10(a)(1) in that the letter contained specific

information intended to reduce the risk to health

posed by the device. For example, the July 2003

Educational Brief specifically states that “[i]f an

inflammatory mass is detected in its clinical course,

prompt discontinuation of opioid delivery into the

mass may cause it to shrink or disappear without the

STENGEL v. MEDTRONIC INC. 4107
need for surgical removal.” The letter also specifically recommends catheter replacement, repositioning, and other interventional procedures, depending

on the patient’s clinical condition. These recommendations were neither included in the pump’s original

labeling, nor conveyed to customers in a January

2001 communication regarding inflammatory

masses.

Additionally, the July 2003 Educational Brief contained new “Post implant” warnings that suggest that

clinicians should routinely monitor patients for prodromal clinical signs or symptoms of inflammatory

mass such as change in character, quality or intensity

of pain; reports of new radicular pain, especially at

or near the dermatomal level of the catheter tip; frequent or large escalations of daily drug does to maintain the analgesic effect; and dose escalations that

may only temporarily alleviate the patient’s increasing pain. These new warnings were not included in

the January 2001 letter or the pump’s original technical manual.

Furthermore, the journal articles included with the

July 2003 Educational Brief stated with regard to

adverse event reporting that 41 adverse events

regarding inflammatory mass were identified as of

November 2000 (conveyed to customers in the January 2001 letter). The articles also state that an additional 51 events were identified after the 2001 letter

had been distributed to customers. The articles suggest that the number of new adverse events has more

than doubled in one year of reporting. It is noteworthy that during the most recent inspection of your

facility, your firm calculated the current rate of

inflammatory masses to be approximately

[redacted] events per [redacted] implants. This figure, which has not yet been communicated to your

4108 STENGEL v. MEDTRONIC INC.
customers, suggests that the risk of inflammatory

masses occurring at or near the tip of intrathecal

catheters used with SynchroMed pumps is

[redacted] greater than the [redacted] rate indicated

in the January 2001 letter. 

STENGEL v. MEDTRONIC INC. 4109