                                 IN THE
             ARIZONA COURT OF APPEALS
                              DIVISION ONE


         RAYMOND R. CONKLIN, II, et al., Plaintiffs/Appellants,

                                     v.

             MEDTRONIC, INC., et al., Defendants/Appellees.

                           No. 1 CA-CV 16-0252
                            FILED 10-19-2017


           Appeal from the Superior Court in Maricopa County
                          No. CV2015-002965
              The Honorable Lori Horn Bustamante, Judge

       AFFIRMED IN PART; VACATED IN PART; REMANDED


                                COUNSEL

O’Steen & Harrison, PLC, Phoenix
By Paul D. Friedman, Jonathan V. O’Steen
Counsel for Plaintiffs/Appellants

Maslon LLP, Minneapolis, MN
By Michael C. McCarthy, Erica A. Holzer
Pro Hac Vice Co-Counsel for Defendants/Appellees

Greenberg Traurig, LLP, Phoenix
By Nicole M. Goodwin, Nedda R. Gales
Co-Counsel for Defendants/Appellees
Knapp & Roberts, PC, Scottsdale
By David L. Abney
Counsel for Amicus Curiae Arizona Association for Justice/Arizona Trial
Lawyers Association



                                 OPINION

Presiding Judge Randall M. Howe delivered the opinion of the Court, in
which Judge Lawrence F. Winthrop and Judge Jon W. Thompson joined.


H O W E, Judge:

¶1             Raymond R. Conklin, II and his wife Joanne M. Conklin
appeal from the dismissal of their action against Medtronic, Inc. as
preempted by federal law. We affirm as preempted the trial court’s
dismissal of the Conklin’s product liability, breach of express warranty, and
negligence causes of action. We vacate the trial court’s dismissal of the
Conklin’s failure to warn, loss of consortium, and punitive damages claims
because we hold that those claims are not expressly or impliedly preempted
by federal law. We remand for further proceedings consistent with this
opinion.

                 FACTS AND PROCEDURAL HISTORY

¶2            Medtronic designed, manufactured, and marketed the
Medtronic SynchroMed II 40 ml infusion pump and catheter, Model
8637-40 (“Medtronic Pain Pump”). The Medtronic Pain Pump is a Class III
medical device the Food and Drug Administration (“FDA”) regulates
under the Medical Device Amendments (“MDA”) to the Food, Drug, and
Cosmetic Act (“FDCA”). A Class III medical device is subject to the FDA’s
rigorous pre-market approval (“PMA”) process. Riegel v. Medtronic, Inc., 552
U.S. 312, 317 (2008). After PMA, a device manufacturer must comply with
federal medical device reporting requirements. 21 U.S.C. § 360i(a)(1).
Specifically, a manufacturer must report to the FDA any information
reasonably suggesting that the device “[m]ay have caused or contributed to
a death or serious injury” or that “[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).



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                      CONKLIN v. MEDTRONIC et al.
                          Opinion of the Court

¶3           In March 2008, a physician surgically implanted a Medtronic
Pain Pump into Mr. Conklin to manage chronic pain. In February 2013,
Mr. Conklin underwent hip surgery and later suffered permanent injury by
drug over-infusion the Medtronic Pain Pump allegedly caused. The
Conklins sued Medtronic alleging several Arizona common law tort claims,
including product liability (design and manufacturing defect), failure to
warn, negligence, breach of express warranty, and loss of consortium. The
Conklins also sought punitive damages.

¶4             The Conklins alleged that before Mr. Conklin was injured, the
FDA had sent warning letters to Medtronic, advising that the Medtronic
Pain Pump was adulterated and misbranded and stating that Medtronic
had failed to report adverse events to the FDA after PMA. The Conklins
also alleged that before the February 2013 injury occurred, the FDA had
issued two Class I recalls of the Medtronic Pain Pump. The Conklins further
alleged that after Mr. Conklin was injured, the FDA issued another Class I
recall of the Medtronic Pain Pump regarding the unintended delivery of
drugs that could result in a drug overdose. The Conklins alleged that
Medtronic’s failure to report post-PMA adverse events to the FDA in
violation of federal law gives rise to liability under Arizona common law.

¶5             Medtronic moved to dismiss for the failure to state a claim on
the basis that federal law preempts the state-law claims. The trial court
granted Medtronic’s motion and dismissed the action with prejudice.
Although the court found all claims preempted, it found additionally that
the strict liability, breach of warranty, and derivative claims failed under
Arizona law. The Conklins moved for reconsideration, which the trial court
denied. The Conklins timely appealed.

                               DISCUSSION

              1. Preemption and Class III Medical Devices

¶6             We review de novo the trial court’s order granting a motion
to dismiss for failure to state a claim. Coleman v. City of Mesa, 230 Ariz. 352,
355–56 ¶ 7 (2012). We assume the truth of the complaint’s factual allegations
and will uphold dismissal “only if as a matter of law plaintiffs would not
be entitled to relief under any interpretation of the facts susceptible of
proof.” Id. at 356 ¶¶ 8–9.

¶7            Congress has the power to preempt state law pursuant to the
Supremacy Clause of the United States Constitution. U.S. Const. art. VI,
cl. 2. Congress may “withdraw specified powers from the States by
enacting a statute containing an express preemption provision.” Arizona v.


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                     CONKLIN v. MEDTRONIC et al.
                         Opinion of the Court

United States, 567 U.S. 387, 399 (2012). For federal questions such as
preemption, United States Supreme Court decisions are binding, and we
may look to circuit court cases as persuasive authority. See Weatherford ex
rel. Michael L. v. State, 206 Ariz. 529, 532–33 ¶¶ 8–9 (2003).

¶8            Medtronic has the burden to prove preemption. See E.
Vanguard Forex, Ltd. v. Ariz. Corp. Comm’n, 206 Ariz. 399, 405 ¶ 18 (App.
2003). While federal laws are presumed not to preempt state laws, courts
do not invoke that presumption when the federal statute contains an
express preemption clause. Puerto Rico v. Franklin Cal. Tax-Free Trust, 136 S.
Ct. 1938, 1946 (2016); Cuomo v. Clearing House Ass’n, LLC, 557 U.S. 519, 554
(2009); Riegel, 552 U.S. 312 (analyzing the MDA’s express preemption
provision without presuming preemption).

¶9            The MDA expressly preempts certain state-law requirements
concerning medical devices. The MDA states in pertinent part that no state
“may establish or continue in effect with respect to a device . . . 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).

¶10             For express preemption to apply, two conditions must be met:
(1) the federal government must have established requirements applicable
to the device at issue and (2) the plaintiff’s common-law claims concerning
the device must include requirements that are “different from, or in
addition to” those federal requirements. 21 U.S.C. § 360k(a); Riegel, 552 U.S.
at 321–23. If these two conditions are met, common-law claims challenging
the safety or effectiveness of a medical device that received PMA from the
FDA are expressly preempted. Id. In addition to express preemption, the
MDA also impliedly preempts any action for the enforcement or restriction
of violations of the FDCA because such actions can only be brought by or
in the name of the United States. 21 U.S.C. § 337(a); see Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001).

¶11            Despite these preemption restrictions, a plaintiff’s state-law
claim concerning a medical device may be viable if it is a “parallel claim,”
a claim based on state requirements that are “equal to or substantially
identical to, requirements imposed by or under the act.” Medtronic, Inc. v.
Lohr, 518 U.S. 470, 495–97 (1996). Thus, a state-law claim is not preempted
when it provides “a damages remedy for claims premised on a violation of
FDA regulations; the state duties in such a case ‘parallel,’ rather than add


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                      CONKLIN v. MEDTRONIC et al.
                          Opinion of the Court

to, federal requirements.” Riegel, 552 U.S. at 330. As the Eighth Circuit
explained in In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig.:

       Riegel and Buckman create a narrow gap through which a
       plaintiff’s state-law claim must fit if it is to escape express or
       implied preemption. The plaintiff must be suing for conduct
       that violates the FDCA (or else his claim is expressly
       preempted by § 360k(a)), but the plaintiff must not be suing
       because the conduct violates the FDCA (such a claim would be
       impliedly preempted under Buckman).

623 F.3d 1200, 1204 (8th Cir. 2010) (quoting Riley v. Cordis Corp., 625 F. Supp.
2d 769, 777 (D. Minn. 2009)). Essentially, the state-law claim cannot exist
“solely by virtue of the FDCA disclosure requirements.” Buckman, 531 U.S.
at 352–53.

              2. Claims Analysis

¶12           Because the Medtronic Pain Pump is a Class III medical
device, as a matter of law the PMA process imposes federal requirements
contemplated by § 360k(a) for express preemption purposes. Riegel, 552 U.S.
at 322–23. The Conklins do not dispute that the Medtronic Pain Pump
received PMA. As such, part one of the express-preemption test under
Riegel is automatically satisfied. See id.

¶13           We must next analyze whether Arizona state law imposes on
Medtronic a requirement different from or in addition to federal law or if
the Conklins’ state-law claims instead escape express and implied
preemption. We address each claim in turn to determine if the claim is
expressly or impliedly preempted, or if the claim is a viable parallel state-
law claim.

                     2a. Product Liability—Design and Manufacturing
                     Defect

¶14          The Conklins alleged that the Medtronic Pain Pump was
defective when manufactured in design and formulation and when it
dispensed an excess of narcotic drugs to Mr. Conklin. To the extent the
Conklins pled a strict liability cause of action based on defective design and
manufacturing, on appeal they do not challenge the trial court’s finding that
such claim is expressly preempted. Medtronic argues that the claim is
expressly preempted absent an allegation that the Medtronic Pain Pump
was designed or manufactured in any manner other than what the FDA
required. We agree with Medtronic.


                                       5
                     CONKLIN v. MEDTRONIC et al.
                         Opinion of the Court

¶15            Success on these claims would require the jury to find that the
design and manufacturing process the FDA approved through the PMA
process was defective as a matter of state law, which would add
requirements to the process that the FDA established and is thus expressly
preempted. See Riegel, 552 U.S. at 325; In re Medtronic, 623 F.3d at 1206–07
(concluding that design and manufacturing defect claims were expressly
preempted because they attacked “the risk/benefit analysis that led the
FDA to approve an inherently dangerous Class III device”); Hughes v.
Boston Scientific Corp., 631 F.3d 762, 769 (5th Cir. 2011).

                     2b. Breach of Express Warranty

¶16            The Conklins further alleged that although Medtronic
expressly warranted that the Medtronic Pain Pump was “safe and
effective,” the pump that Medtronic manufactured and sold “did not
conform to these express representations because [it] caused serious
injury . . . when used as recommended and directed.” On appeal,
Medtronic argues that § 360k expressly preempts this claim because it
“would inescapably impose different or additional requirements than those
imposed by the FDA’s premarket-approved design, manufacturing, and
labeling specifications.” The Conklins do not argue on appeal that their
breach of warranty claim is a parallel state claim that survives preemption.
Instead, the Conklins argue only that the trial court incorrectly found on
alternative grounds that this claim was untimely due to lack of notice.

¶17            To succeed on their breach of express warranty claim, the
Conklins must persuade a jury that the Medtronic Pain Pump was not safe
and effective. Such a finding would be “contrary to the FDA’s approval of
the PMA” and is thus expressly preempted. See In re Medtronic, 623 F.3d at
1207–08. Because this claim is expressly preempted, we need not address
the trial court’s alternative basis for dismissing the claim.

                     2c. Failure to Warn

¶18           The Conklins contend that Medtronic violated federal law by
failing to report post-PMA adverse events concerning the Medtronic Pain
Pump to the FDA and others, which in turn violated its duty under Arizona
law to use reasonable care to warn Mr. Conklin of the dangers inherent in
using the defective Medtronic Pain Pump. Specifically, the Conklins allege
that Medtronic violated 21 C.F.R. § 803.50, 21 C.F.R. § 820.198(a)(3), and 21
U.S.C. § 360i. Because the Conklins’ failure-to-warn claim is not expressly
or impliedly preempted, the trial court erred by dismissing this claim.




                                      6
                      CONKLIN v. MEDTRONIC et al.
                          Opinion of the Court

¶19            Relying on the Ninth Circuit’s decision Stengel v. Medtronic
Inc., 704 F.3d 1224 (9th Cir. 2013), the Conklins argue that their
failure-to-warn claim is a permissible parallel claim. Medtronic, on the
other hand, contends that the post-sale duty to warn claim is expressly and
impliedly preempted and does not parallel federal requirements regarding
post-approval reporting because “the federal duty to submit [adverse
reports] to the FDA is not identical to the state-law duty to warn doctors or
their patients.”

¶20           Although Stengel involved a different Medtronic infusion
pump, the plaintiffs there alleged, as the Conklins similarly do here, that
Medtronic failed to report to the FDA adverse consequences involving its
product post-PMA and that, because Medtronic “failed to comply with its
duty under federal law, it breached its ‘duty to use reasonable care’ under
Arizona negligence law.” 704 F.3d at 1232. The Ninth Circuit concluded that
the Arizona “failure-to-warn” claim was not preempted because Arizona
law “impos[es] a general duty of reasonable care on product
manufacturers” and includes a cause of action for failure to warn. Id. at 1233
(citing Crouse v. Wilbur-Ellis Co., 77 Ariz. 359 (1954); and Wilson v. U.S.
Elevator Corp., 193 Ariz. 251 (App. 1998)).

¶21            In so doing, the Ninth Circuit noted that Arizona law requires
a manufacturer to “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.” Id. (quoting Rodriguez v. Besser Co.,
115 Ariz. 454, (App. 1977), abrogated on other grounds as recognized by Piper v.
Bear Med. Sys., 180 Ariz. 170 (App. 1993)). In discussing whether an Arizona
state-law failure-to-warn claim is preempted, the Ninth Circuit stated:

       If a more precise parallel were necessary, the Stengels have
       alleged it and Arizona law provides it. The Stengels’ . . . 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.”

               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,


                                       7
                     CONKLIN v. MEDTRONIC et al.
                         Opinion of the Court

       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.

Id.

¶22          The Stengel decision is based on the premise that a
manufacturer’s continuing duty to warn of dangers discovered after sale in
Arizona can be satisfied by warning a third party such as the FDA. Id. at
1233. We agree with Stengel that Arizona law contemplates that a warning
to the FDA could satisfy Medtronic’s general duty of reasonable care to
warn. See id. This is so because the FDA, in turn, could have notified
Mr. Conklin’s doctor, thus discharging Medtronic’s duty. See Watts v.
Medicis Pharm. Corp., 239 Ariz. 19, 24 ¶¶ 13–14 (2016) (adopting the learned
intermediary doctrine as set forth in Restatement (Third) of Torts: Prod.
Liab. § 6(d) as to prescription drug manufacturers and holding that a
manufacturer satisfies its duty to warn end users by giving appropriate
warnings to learned intermediaries).

¶23           The Conklins base their Arizona failure-to-warn claim on
Medtronic’s violation of the federal duty to report post-PMA adverse
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,’” which the Conklins
alleged. See Stengel, 704 F.3d at 1234 (Watford, J., concurring). As such, this
claim is not expressly preempted.

¶24           Moreover, the cause of action for failure to warn is not
impliedly preempted because the Conklins are not suing to enforce the
FDCA, but to recover under Arizona state law for Medtronic’s alleged
failure to warn of dangers discovered after sale. See Rodriguez, 115 Ariz. at
459 (continuing independent state-law duty); Buckman, 531 U.S. at 352 (to
avoid implied preemption, the claim must rely on “traditional state tort law
which had predated the federal enactments in question”). To the extent that
the Conklins allege a violation of any state-law duty to directly warn
Mr. Conklin or his physicians, however, such claims are expressly
preempted because those duties would be in addition to requirements
imposed by federal law. See Stengel, 704 F.3d at 1234 (Watford, J.,
concurring).




                                      8
                     CONKLIN v. MEDTRONIC et al.
                         Opinion of the Court

¶25           Medtronic argues that the Conklins did not adequately allege
a causal connection between the failure to report adverse events and
Mr. Conklin’s injuries. But that is incorrect. The Conklins sufficiently
alleged a causal connection under Arizona’s notice pleading standard
because the complaint alleged that (1) Medtronic had a continuing duty to
monitor the product after PMA and to report to the FDA any adverse events
attributable to the product; (2) Medtronic breached its Arizona duty to use
reasonable care because it failed in its duty under federal law to report
adverse events to the FDA; (3) a recall occurred post-injury; and
(4) Mr. Conklin was injured. We note, however, that the Conklins will
ultimately also 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. Conklin’s] doctors in time to prevent his injuries.”
See id.

                    2d. Negligence Causes of Action

¶26           The Conklins alleged several negligence causes of action,
including (1) negligent manufacture and design and (2) negligence per se.
The Conklins contend that Medtronic negligently “designed,
manufactured, tested, assembled, labeled, supplied, marketed, sold,
advertised and failed to warn against” the Medtronic Pain Pump. As
discussed above, the Conklins may bring their failure-to-warn claim against
Medtronic because that claim is not expressly or impliedly preempted. See
supra section 2c. As to the remaining allegations of negligent manufacture
and design, the Conklins do not argue on appeal that these claims were
improperly dismissed as preempted. As such, we consider any argument
to the contrary waived. Rice v. Brakel, 233 Ariz. 140, 147 ¶ 28 (App. 2013)
(failure to address basis of trial court’s decision waives claim on appeal).1

¶27           The Conklins argue next that Medtronic had a “continuing
duty to monitor the product after premarket approval and to alert the FDA
about complaints about the product’s performance, including any adverse
health consequences of which it became aware” pursuant to 21 C.F.R.
§ 820.198(a)(3) and to “submit medical device reports” to the FDA pursuant
to 21 U.S.C. § 360i and 21 C.F.R. § 803.50. According to the Conklins,
Medtronic’s failure to adhere to these regulations is negligence per se.



1      The Conklins also allege that to the extent they are unable to prove
specific acts of negligent manufacture and design, they will rely on the
doctrine of res ipsa loquitur. Because the claims for negligent manufacture
and design are preempted, res ipsa loquitur is unavailable.


                                     9
                      CONKLIN v. MEDTRONIC et al.
                          Opinion of the Court

¶28          The Conklins contend that a federal statute or regulation may
be adopted as a standard of conduct to support a negligence per se claim.
Medtronic argues that a negligence per se claim is impliedly preempted
because the failure to report adverse events is an attempt to enforce the
MDA. We agree with the Conklins.

¶29           If a court decides to adopt a standard of care designed to
protect the public safety that is set forth in a statute or regulation, a person
who violates that statute or regulation is negligent per se. Brannigan v.
Raybuck, 136 Ariz. 513, 517 (1983). Arizona law sets forth a specific
paradigm for determining whether a court should adopt a particular statute
or regulation as the standard of conduct for a negligence per se cause of
action. See Steinberger v. McVey ex rel Cty. of Maricopa, 234 Ariz. 125, 139
¶¶ 56–62 (App. 2014).

¶30           As previously explained, see supra ¶¶ 23–24, the Conklins’
failure-to-warn claim is not preempted. As such, nothing prevents the
Conklins from requesting that the trial court apply the negligence per se
doctrine to assist them in proving their failure to warn claim. See Hughes,
631 F.3d at 771–72 (concluding that “invoking the negligence per se doctrine
to support a negligence claim that is otherwise parallel to federal
requirements is not expressly preempted”). We express no opinion,
however, on the trial court’s ultimate resolution of that issue.

                     2e. Loss of Consortium and Punitive Damages

¶31            Because the Conklins’ failure-to-warn claim is not preempted,
the Conklins may proceed with their derivative claim for loss of
consortium. Moreover, although the Conklins did not allege an “evil
mind,” “[c]laims for punitive damages carry no special pleading
requirements[.]” Ezell v. Quon, 224 Ariz. 532, 538 ¶ 23 (App. 2010). Thus, the
trial court erred by dismissing these claims.

              3. Leave to Amend Complaint

¶32           The Conklins argue that the trial court improperly failed to
allow them to remedy any defect by amending their complaint. Although
the Conklins sought leave to amend as part of their response to Medtronic’s
motion to dismiss and at oral argument, a request for leave to amend must
be made by separate motion that complies with the Arizona Rules of Civil
Procedure. See Blumenthal v. Teets, 155 Ariz. 123, 131 (App. 1987). Moreover,
a party who moves for leave to amend must attach a copy of the proposed
amended pleading as an exhibit to a motion. Ariz. R. Civ. P. 15(a)(4). The
Conklins did not separately seek leave and the record does not contain a


                                      10
                    CONKLIN v. MEDTRONIC et al.
                        Opinion of the Court

proposed amended complaint. Thus, the trial court did not abuse its
discretion by impliedly denying leave. See Cagle v. Carr, 101 Ariz. 225, 227
(1966).

                              CONCLUSION

¶33           For the foregoing reasons, we affirm the dismissal of the
Conklins’ product liability, breach of express warranty, and negligence
causes of action. We affirm the denial of the Conklins’ request to amend the
complaint. We vacate the dismissal of their failure to warn, loss of
consortium, and punitive damages claims, however, and remand for
further proceedings consistent with this decision.




                           AMY M. WOOD • Clerk of the Court
                           FILED: AA




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