Stengel v. Medtronic, Inc.

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

RICHARD STENGEL; MARY LOU 
STENGEL,
No. 10-17755
Plaintiffs-Appellants,
v.  D.C. No.
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
4088 STENGEL v. MEDTRONIC INC.

COUNSEL

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

Michael K. Brown, Ginger F.H. Pigott, and Lisa M. Baird,
Reed Smith LLP, Los Angeles, California, for the defendant-
appellee.

OPINION

WALLACE, Senior Circuit Judge:

Richard and Mary Lou Stengel brought several state causes
of action in Arizona state court against Medtronic Incorpo-
rated (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 pre-
scription medication through a catheter into the intrathecal
 STENGEL v. MEDTRONIC INC. 4089
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 Syn-
chroMed Pump & Infusion System. In 1999, the FDA gave
supplemental premarket approval for Medtronic’s Syn-
chroMed EL Pump and intrathecal catheter, which are the ver-
sions 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, Sten-
gel 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. Sten-
gel’s doctors surgically removed the hardware and most of the
granuloma, but not in time to prevent the granuloma from ren-
dering 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 Sten-
gel’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 com-
plied 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.
4090 STENGEL v. MEDTRONIC INC.
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 Cos-
metic Act (FDCA) by enacting the Medical Device Amend-
ments 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, sub-
ject 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 require-
ment 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” premar-
ket approval process for Class III medical devices:

A manufacturer must submit what is typically a mul-
tivolume 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
 STENGEL v. MEDTRONIC INC. 4091
applicant; a full statement of the device’s compo-
nents, 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 spec-
imen 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 review-
ing 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 effective-
ness under the conditions of use set forth in the label. Id. at
318. After a device is approved, “the MDA forbids the manu-
facturer 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 applica-
tion 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 consti-
tuted state “requirements,” and that the “safety and effective-
ness” 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 regula-
4092 STENGEL v. MEDTRONIC INC.
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 com-
plaint, are expressly preempted under section 360k and Rie-
gel. 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 com-
plaint.

[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 per-
mits 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 require-
ment is expressly preempted.

III.

[4] However, portions of the claims in the Stengels’ pro-
posed amended complaint could be interpreted to survive
express preemption. The proposed complaint alleged:
 STENGEL v. MEDTRONIC INC. 4093
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 perfor-
mance and any adverse health consequences of
which it became aware and that are or may be attrib-
utable to the product.

Substitute Amended Complaint, ¶ 13, ECF No. 22-1 (citing
21 U.S.C. § 360i (requirement to maintain and submit infor-
mation 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 com-
plaints)). 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 action-
able under state law, the state obligations parallel the federal
requirements, and thus are not expressly preempted.

[5] Nonetheless, this theory in the Stengels’ amended com-
plaint 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 fraud-
ulent 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 require-
ments, allowing the plaintiffs to bring a state cause of action
to remedy the injuries caused by the violations would inter-
fere 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
4094 STENGEL v. MEDTRONIC INC.
“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 Buck-
man fraud claims “exist solely by virtue of the FDCA disclo-
sure 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 Buck-
man, we hold that the Stengels’ claims are impliedly preempted.1
The Stengels’ theory is that if Medtronic had acted with rea-
sonable 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
1
The dissent argues that because the Stengels’ claims are not expressly
preempted under Lohr, they cannot be impliedly preempted under Buck-
man. This is not the law. Lohr does not determine the scope of implied
preemption because it never considered the issue.
 STENGEL v. MEDTRONIC INC. 4095
defendant allegedly misinformed the FDA overtly by provid-
ing 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 govern-
ment, 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 “fail-
ure 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 manufac-
turer 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 manufac-
turer can obtain by contacting the initial reporter or by testing
the device. Section 803.50(b). A manufacturer must investi-
gate each adverse event and evaluate the cause of the event.
Section 803.50(b)(3). If the manufacturer cannot submit com-
plete 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 pro-
cedures 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 doc-
umented 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 investi-
4096 STENGEL v. MEDTRONIC INC.
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 oth-
erwise 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 pub-
lic 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 man-
ufacturer 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 dis-
closure to the FDA in a particular manner so that the FDA can
make a decision whether notification of consumers is neces-
sary, 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, there-
fore, 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
 STENGEL v. MEDTRONIC INC. 4097
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 adulter-
ated medical devices is tied directly to the duty of manufac-
turers 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 infor-
mation 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 enforce-
ment 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 disclo-
sure 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 distin-
guish 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
4098 STENGEL v. MEDTRONIC INC.
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 opin-
ion). 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 Buck-
man. 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 enforce-
ment power of the federal government”).

Second, Hughes distinguished Buckman because the claims
“[did] not depend on speculation that the FDA would have
 STENGEL v. MEDTRONIC INC. 4099
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 (Ste-
vens, 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 estab-
lished only that such claims would not be expressly pre-
empted 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-to-
warn 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). How-
ever, the district court did not dismiss the Stengels’ complaint
on the ground that it did not conform to the Twombly stan-
dard, 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 Proce-
dure 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.
4100 STENGEL v. MEDTRONIC INC.
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 notice-
able 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 deter-
mined 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 judi-
cial 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 pro-
posed 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 anal-
ysis. 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.
 STENGEL v. MEDTRONIC INC. 4101
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 receiv-
ing 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 del-
icate 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 congres-
sional 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 dis-
trict court correctly held that the Stengels’ proposed amend-
ment 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:
4102 STENGEL v. MEDTRONIC INC.
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, Neurol-
ogy, 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. Nor-
mand, 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 implic-
itly 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 fed-
eral requirements. Even if it may be necessary as a
 STENGEL v. MEDTRONIC INC. 4103
matter of Florida law to prove that those violations
were the result of negligent conduct, or that they cre-
ated 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 dif-
ference would surely provide a strange reason for
finding preemption of a state rule insofar as it dupli-
cates the federal rule. The presence of a damages
remedy does not amount to the additional or differ-
ent “requirement” that is necessary under the statute;
rather, it merely provides another reason for manu-
facturers to comply with identical existing “require-
ments” 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 tradi-
tional 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: Ҥ 360k does not prevent a State from pro-
viding a damages remedy for claims premised on a violation
4104 STENGEL v. MEDTRONIC INC.
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 conclu-
sion 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 major-
ity, 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 impli-
cating ‘federalism concerns and the historic primacy of state
regulation of matters of health and safety,’ . . . — no pre-
sumption 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
 STENGEL v. MEDTRONIC INC. 4105
“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 demon-
strates 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 Educa-
tional 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 cor-
rection 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
4106 STENGEL v. MEDTRONIC INC.
2003 because it failed to adequately respond to events indicat-
ing 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 unrea-
sonably dangerous condition discovered post-market. See
Readenour v. Marion Power Shovel, 149 Ariz. 442, 448
(1986) (plaintiff could argue that manufacturer, upon discov-
ering “an unreasonably dangerous condition at any time dur-
ing the product’s history[,]” should have either retrofitted
“each of the models already sold or warn[ed] each of the buy-
ers of the existence of the latent danger”). That Medtronic dis-
covered 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 inju-
ries 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.
 STENGEL v. MEDTRONIC INC. 4107
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 “In-
formation about Inflammatory Mass,” to Syn-
chroMed customers (physicians). Also enclosed
were reprints of two articles published in the Decem-
ber 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 cus-
tomers using SynchroMed pumps, meets the defini-
tion 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 Educa-
tional 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
4108 STENGEL v. MEDTRONIC INC.
need for surgical removal.” The letter also specifi-
cally recommends catheter replacement, reposition-
ing, and other interventional procedures, depending
on the patient’s clinical condition. These recommen-
dations 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 con-
tained new “Post implant” warnings that suggest that
clinicians should routinely monitor patients for pro-
dromal 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; fre-
quent or large escalations of daily drug does to main-
tain the analgesic effect; and dose escalations that
may only temporarily alleviate the patient’s increas-
ing pain. These new warnings were not included in
the January 2001 letter or the pump’s original techni-
cal 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 Janu-
ary 2001 letter). The articles also state that an addi-
tional 51 events were identified after the 2001 letter
had been distributed to customers. The articles sug-
gest that the number of new adverse events has more
than doubled in one year of reporting. It is notewor-
thy 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 fig-
ure, which has not yet been communicated to your
 STENGEL v. MEDTRONIC INC. 4109
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.