IN THE

SUPREME COURT OF THE STATE OF ARIZONA

RAYMOND R. CONKLIN, II, ET AL.,

Plaintiffs/Appellants,

v.

MEDTRONIC, INC., ET AL.,

Defendants/Appellees.

No. CV-17-0322-PR

Filed December 18, 2018

Appeal from the Superior Court in Maricopa County 

The Honorable Lori Horn Bustamante, Judge

No. CV2015-002965

AFFIRMED

Opinion of the Court of Appeals, Division One

244 Ariz. 139 (App. 2017)

VACATED IN PART

COUNSEL:

Paul D. Friedman, Jonathan V. O’Steen (argued), O’Steen & Harrison, PLC, Phoenix, 

Attorneys for Raymond R. Conklin, II and Joanne M. Conklin

Andrew E. Tauber (argued), Kenneth S. Geller, Mayer Brown LLP, Washington, D.C.; 

and E. Jeffrey Walsh, Michael T. Liburdi, Nicole M. Goodwin, Greenberg Traurig LLP, 

Phoenix, Attorneys for Medtronic, Inc., Medtronic PLC, and Medtronic Sofamor Danek 

USA, Inc.

Stanley G. Feldman, Miller, Pitt, Feldman & McAnally, P.C., Tucson; and David L. Abney, 

Ahwatukee Legal Office, P.C., Phoenix, Attorneys for Amicus Curiae Arizona 

Association of Justice/Arizona Trial Lawyers Association
CONKLIN V. MEDTRONIC

Opinion of the Court

2

Carlyle (Cary) W. Hall, III, John F. Barwell, Polsinelli PC, Phoenix; and Alan J. Lazarus, 

Drinker Biddle & Reath LLP, San Francisco, CA, Attorneys for Amicus Curiae Product 

Liability Advisory Council, Inc.

JUSTICE PELANDER authored the opinion of the Court, in which CHIEF JUSTICE 

BALES, VICE CHIEF JUSTICE BRUTINEL, and JUSTICES TIMMER, BOLICK, GOULD,

and LOPEZ joined.

JUSTICE PELANDER, opinion of the Court:

¶1 The issue here is whether federal law preempts an Arizona common law 

failure-to-warn claim based on a medical device manufacturer’s failure to submit adverse

event reports to the United States Food and Drug Administration (“FDA”). We hold that 

the claim is impliedly preempted.

I.

¶2 After injuring his hip years ago, Raymond R. Conklin, II experienced 

chronic pain. In 2008, a physician surgically implanted a Medtronic SynchroMed II 40 ml 

infusion pump and catheter (“Pain Pump”) into Conklin to manage pain. Medtronic, Inc.

and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic”) designed, 

manufactured, marketed, and sold the Pain Pump.

¶3 Conklin underwent hip surgery in 2013 and in the aftermath suffered 

permanent injury allegedly caused by drug over-infusion from his continued use of the

Pain Pump. Conklin and his wife sued Medtronic alleging several common law tort 

claims, including both strict liability and negligence claims for failure to provide 

adequate and timely warnings. In those claims Conklin alleged that before his 2013 

injury, the FDA sent warning letters to Medtronic, advising it that the Pain Pump was 

adulterated and misbranded and stating that Medtronic had failed to report adverse 

events to the FDA after the FDA approved the Pain Pump in its pre-market approval

(“PMA”) process. Conklin also alleged that before his 2013 injury, the FDA issued two

recalls of the Pain Pump regarding the unintentional injection or cessation of drugs, and 

that after his injury the FDA issued another recall relating to the Pain Pump’s unintended 

delivery of drugs that could result in a drug overdose. Conklin further 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.

¶4 Medtronic moved to dismiss the claims under Arizona Rule of Civil 

Procedure 12(b)(6), arguing that all Conklin’s claims are expressly and impliedly 

preempted under federal law. The superior court agreed and dismissed the action 
CONKLIN V. MEDTRONIC

Opinion of the Court

3

against Medtronic with prejudice.

¶5 The court of appeals affirmed in part, upholding on preemption grounds 

the dismissal of Conklin’s product liability and negligence claims based on alleged design 

and manufacturing defects, as well as the claim for breach of express warranty. Conklin 

v. Medtronic, Inc., 244 Ariz. 139, 142 ¶ 3, 147 ¶ 33 (App. 2017). The court determined that 

those claims were expressly preempted. Id. at 144–45 ¶¶ 14–17, 146–47 ¶ 26. But the 

court of appeals vacated the superior court’s dismissal of Conklin’s failure-to-warn claim, 

finding it neither expressly nor impliedly preempted. Id. at 145 ¶ 18, 147–48 ¶ 33. In so 

ruling, the court of appeals followed Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), 

in which the Ninth Circuit found no federal preemption of an Arizona failure-to-warn 

claim like Conklin’s. See Conklin, 244 Ariz. at 145–46 ¶¶ 18–25.

¶6 The issue Medtronic presents for our review is whether federal law 

preempts a failure-to-warn claim predicated on a medical device manufacturer’s failure 

to submit adverse event reports to the FDA. We granted review because this legal issue 

is of statewide importance and likely to recur. Our jurisdiction is based on article 6, 

section 5(3) of the Arizona Constitution and A.R.S. § 12-120.24.

II.

¶7 We review a trial court’s dismissal of a complaint under Rule 12(b)(6) de 

novo. Coleman v. City of Mesa, 230 Ariz. 352, 355 ¶ 7 (2012). Dismissal under that rule is 

appropriate “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 (internal quotation marks 

and alteration omitted) (quoting Fid. Sec. Life Ins. Co. v. Ariz. Dep’t of Ins., 191 Ariz. 222, 

224 ¶ 4 (1998)). We also review de novo issues of law relating to alleged federal 

preemption of state law claims. Hutto v. Francisco, 210 Ariz. 88, 90 ¶ 7 (App. 2005).

¶8 As the court of appeals correctly observed, Medtronic has the burden of 

establishing preemption. Conklin, 244 Ariz. at 143 ¶ 8. In addition, although “federal 

laws are presumed not to preempt state laws, courts do not invoke that presumption 

when the federal statute contains an express preemption clause.” Id.; see also Puerto Rico 

v. Franklin Cal. Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016); cf. Riegel v. Medtronic, Inc., 552 

U.S. 312, 315–30 (2008) (analyzing federal statute’s express preemption provision without 

invoking a presumption against preemption); Buckman Co. v. Plaintiffs’ Legal Comm., 531 

U.S. 341, 347–48 (2001) (finding “no presumption against pre-emption” when device 

manufacturer’s “dealings with the FDA were prompted” and governed by applicable 

federal law). Medtronic argues that Conklin’s failure-to-warn claim is both expressly and 

impliedly preempted by federal law. Before addressing those assertions, we briefly

summarize the legal backdrop of Conklin’s claim and Medtronic’s argument.
CONKLIN V. MEDTRONIC

Opinion of the Court

4

III.

¶9 The Federal Food, Drug, and Cosmetic Act (“FDCA”), Pub. L. No. 75-717, 

52 Stat. 1040 (codified as amended at 21 U.S.C. §§ 301–399i), was enacted in 1938 to 

govern and require FDA approval for introduction of new drugs into the market. Riegel, 

552 U.S. at 315. Thereafter, states generally were left to supervise the introduction of new 

medical devices. Id. That changed in 1976 when Congress enacted the Medical Device 

Amendments (“MDA”), Pub. L. No. 94-295, 90 Stat. 539, which “swept back some state 

obligations and imposed a regime of detailed federal oversight” for medical devices. 

Riegel, 552 U.S. at 316.

¶10 The MDA’s most rigorous level of oversight, which includes an extensive 

PMA process and review of proposed product labeling, applies to medical devices 

categorized as Class III devices. Id. at 317–19; see also 21 U.S.C. §§ 360c, 360e; Buckman, 

531 U.S. at 348 (noting that PMA review “involves a time-consuming inquiry into the 

risks and efficacy of each device”); 21 C.F.R. § 814.44(a). Medtronic’s Pain Pump is a Class 

III device. The FDA granted PMA for the Pain Pump before the device was surgically 

implanted into Conklin’s body in 2008.

¶11 “Once a device has received [PMA], 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.” 

Riegel, 552 U.S. at 319; see also 21 U.S.C. § 360e(d)(5)(A)(i). “If the applicant wishes to 

make such a change, it must submit, and the FDA must approve, an application for 

supplemental [PMA], to be evaluated under largely the same criteria as an initial 

application.” Riegel, 552 U.S. at 319; see also 21 U.S.C. § 360e(d)(5); 21 C.F.R. § 814.39(c).

¶12 Even after the FDA grants PMA for a device, the device is “subject to 

reporting requirements.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360i). Those

requirements include “the obligation to inform the FDA of new clinical investigations or 

scientific studies concerning the device which the applicant knows of or reasonably 

should know of,” id. (citing 21 C.F.R. § 814.84(b)(2)), “and to report incidents in which the 

device may have caused or contributed to death or serious injury[] or malfunctioned in a 

manner that would likely cause or contribute to death or serious injury if it recurred,” id.

(citing 21 C.F.R. § 803.50(a)). The documents to which this latter requirement refers are 

called “adverse event reports.” Conklin’s failure-to-warn claim is based solely on 

Medtronic’s failure to submit reports in compliance with that requirement.

¶13 The FDA “has at its disposal a variety of enforcement options that allow it 

to make a measured response” to any product defect or wrongdoing, including “seeking 

injunctive relief, 21 U.S.C. § 332, and civil penalties, [id.] § 333(f)(1)(A); seizing the device,

[id.] § 334(a)(2)(D); and pursuing criminal prosecutions, [id.] § 333(a).” See Buckman, 531 

U.S. at 349. In addition, “[t]he FDA has the power to withdraw [PMA] based on newly 
CONKLIN V. MEDTRONIC

Opinion of the Court

5

reported data or existing information and must withdraw [PMA] if it determines that a 

device is unsafe or ineffective under the conditions in its labeling.” Riegel, 552 U.S. at

31920 (citing 21 U.S.C. § 360e(e)(1)). The Medtronic Pain Pump was subject to a recall in 

2011 and 2012, but the FDA has never rescinded the PMA and the device continues to be 

sold.

IV.

¶14 The MDA contains an express preemption provision. As relevant here, that 

provision states:

[N]o State or political subdivision of a State may establish or continue in 

effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement 

applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or 

to any other matter included in a requirement applicable to 

the device under this chapter.

21 U.S.C. § 360k(a); see also 21 C.F.R. § 808.1(d) (FDA’s implementing regulation for the 

MDA’s express preemption provision).

¶15 The United States Supreme Court has interpreted that provision as setting 

forth the following two-part test for determining whether the MDA expressly preempts 

a claim: (1) Has “the Federal Government . . . established requirements applicable to [the 

medical device]”? (2) If so, are the common law claims based on state law requirements 

“with respect to the device that are ‘different from, or in addition to,’ the federal ones, 

and that relate to safety and effectiveness”? Riegel, 552 U.S. at 321–22 (quoting 21 U.S.C. 

§ 360k(a)(1)). The first prong is indisputably met here. The PMA process “imposes 

‘requirements’ under the MDA” because that process “is specific to individual devices.” 

Id. at 322–23. Therefore, Congress has established requirements applicable to the 

Medtronic Pain Pump.

¶16 As for the second prong, if the state law requirements “are ‘different from, 

or in addition to’ the requirements imposed by federal law,” then the state law claims are 

expressly preempted. Id. at 330 (quoting 21 U.S.C. § 360k(a)(1)). If not, however, the 

claims are not expressly preempted because § 360k(a) “does not prevent a State from 

providing a damages remedy for claims premised on a violation of FDA regulations; the 

state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id.

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

¶17 The MDA also impliedly preempts certain state law claims. Specifically,
CONKLIN V. MEDTRONIC

Opinion of the Court

6

the MDA provides that “all . . . proceedings for the enforcement . . . of this chapter shall 

be by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court has

interpreted this provision to mean that “it is the Federal Government rather than private 

litigants who are authorized to file suit for noncompliance with the medical device 

provisions.” Buckman, 531 U.S. at 349 n.4. Thus, state law claims based not on 

“traditional state tort law which . . . predated the federal enactments in question[],” id.

at 353, but rather solely on noncompliance with the MDA are impliedly preempted

because “Congress intended that the MDA be enforced exclusively by the Federal 

Government,” id. at 352.

¶18 Read together, “[t]hese two types of preemption, operating in tandem, have 

created . . . a ‘narrow gap’ for pleadings.” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 

1327 (11th Cir. 2017) (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 

623 F.3d 1200, 1204 (8th Cir. 2010)). “To make it through, a plaintiff has to sue for conduct 

that violates a federal requirement (avoiding express preemption), but cannot sue only 

because the conduct violate[s] that federal requirement (avoiding implied preemption).” 

Id. (emphasis added).

¶19 Here, the question is whether Conklin’s failure-to-warn claim fits within 

the “narrow gap” so as to avoid express or implied preemption. Medtronic argues that 

it does not and that the claim is both expressly and impliedly preempted. Relying 

primarily on Stengel and the court of appeals’ opinion here, Conklin counters that his 

failure-to-warn claim is not expressly or impliedly preempted because Medtronic’s 

conduct violated Arizona’s “pre-existing state common law of negligence.” According 

to Conklin, that claim is not preempted because a manufacturer is required under federal 

and Arizona law to submit adverse event reports to the FDA.

¶20 As noted above, supra ¶ 12, Conklin’s failure-to-warn claim is based solely 

on Medtronic’s alleged failure to submit to the FDA post-PMA adverse event reports 

regarding the Pain Pump. The court of appeals correctly stated that to the extent Conklin

“allege[s] a violation of any state-law duty to directly warn [him] or his physicians, . . . 

such claims are expressly preempted because those duties would be in addition to 

requirements imposed by federal law.” Conklin, 244 Ariz. at 146 ¶ 24 (citing Stengel, 704 

F.3d at 1234 (Watford, J., concurring)). Conklin concedes that point and thus does not 

base his failure-to-warn claim on any failure by Medtronic to directly warn him or his 

health care providers about the Pain Pump. And to the extent Conklin argues that the 

FDA either has or assumed a duty to convey information from adverse event reports to 

treating physicians, patients, or more broadly public consumers (thereby implicating 

Medtronic for its failure to submit such reports), Conklin’s claim is expressly preempted 

because it likewise would impose under state law a requirement that is “different from, 

or in addition to,” any applicable federal requirement. 21 U.S.C. § 360k(a)(1); see Riegel, 

552 U.S. at 321–30.
CONKLIN V. MEDTRONIC

Opinion of the Court

7

¶21 For the reasons stated below, we conclude that, as framed, Conklin’s 

failure-to-warn claim is impliedly preempted under federal law, and therefore we do not 

address whether it is also expressly preempted. See Buckman, 531 U.S. at 348 & n.2 

(holding that “plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are 

therefore impliedly pre-empted by, federal law,” and thus “express[ing] no view on 

whether these claims are subject to express pre-emption under 21 U.S.C. § 360k”); cf. In 

re Medtronic, Inc., 623 F.3d at 1204 (noting that “[t]he contours of the parallel claim 

exception [to the MDA’s express preemption provision] were not addressed in Riegel and 

are as-yet ill-defined”).

V.

¶22 In our view, the dispositive issue is whether Conklin would have a claim 

under “traditional state tort law” based on Medtronic’s failure to submit adverse event 

reports to the FDA. Buckman, 531 U.S. at 352. If not—and the claim instead is one only 

for violation of FDA reporting requirements—then it is impliedly preempted because 

only the federal government can seek redress for a violation. Id. at 352–53.

¶23 For purposes of our analysis, we assume without deciding that adverse 

event reports may constitute relevant “warnings” under Arizona law, as Conklin 

contends and the court of appeals implicitly ruled. But cf. McClain v. Metabolife Int’l, Inc., 

401 F.3d 1233, 1250 (11th Cir. 2005) (noting that adverse event reports 

may “reflect complaints called in by product consumers without any medical controls 

or scientific assessment” and describing such “anecdotal information” as “one

of the least reliable sources” of information); 21 C.F.R. § 803.16; Manufacturer and User 

Facility Device Experience Database - (MAUDE), FDA,

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRe

quirements/ReportingAdverseEvents/ucm127891.htm [https://perma.cc/E6U4-

FMKU] (last updated Sept. 11, 2018) (including on FDA’s website a disclaimer that an 

adverse event report “does not necessarily reflect a conclusion by the party submitting 

the report or by [the] FDA that the report or information constitutes an admission 

that the device, or the reporting entity or its employees, caused or contributed 

to the reportable event”); Medical Device Reporting (MDR), FDA, 

https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

[https://perma.cc/98V2-9D38] (last updated Sept. 25, 2018) (stating that although the 

FDA considers reports “a valuable source of information,” it cautions that some reports 

may be based upon “incomplete, inaccurate, . . . unverified, or biased data”).

¶24 In Arizona, “[m]anufacturers generally have a duty to warn consumers of 

foreseeable risks of harm from using their products.” Watts v. Medicis Pharm. Corp., 239 

Ariz. 19, 24 ¶ 13 (2016); see also Restatement (Third) of Torts: Prods. Liab. § 2 (Am. Law 

Inst. 1998). This is so whether, as in Watts, the failure-to-warn claim is couched as one of 

strict liability in tort based on an alleged informational defect, see Watts, 239 Ariz. at 23 
CONKLIN V. MEDTRONIC

Opinion of the Court

8

¶ 10, or instead as a negligence claim, see 2 Dan B. Dobbs, Paul T. Hayden & Ellen M. 

Bublick, The Law of Torts § 464, at 950–51 (2d ed. 2011) (stating “[i]n effect, warning claims 

are negligence claims, as a number of courts recognize” and citing cases in support, 

including Powers v. Taser Int’l, Inc., 217 Ariz. 398 (App. 2007) (footnote omitted)).

¶25 In Watts, this Court applied the learned intermediary doctrine (“LID”), 

which recognizes that “a manufacturer satisfies its duty to warn end users by giving 

appropriate warnings to the specialized class of persons who may prescribe or administer 

the product.” 239 Ariz. at 22 ¶ 1. Under those circumstances, the intermediary (often a 

treating physician) “assumes the duty to pass the necessary warnings on to the end 

users.” Id. at 23 ¶ 10 (quoting Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154 (Tex. 2012)). 

Watts adopted the Restatement (Third) of Torts provision that sets forth the LID for

prescription drug and medical device manufacturers. Id. at 24 ¶ 14; see Restatement 

(Third) of Torts: Prods. Liab. § 6(d).

¶26 Under Arizona law, therefore, a manufacturer may satisfy its “duty to warn 

consumers of foreseeable risks of harm from using their products,” Watts, 239 Ariz. at 24 

¶ 13, by warning a third party, but the LID does not permit (or require) a manufacturer 

to warn any and all third parties. Rather, the Restatement (Third) of Torts only extends 

the LID, as applied to prescription drug and medical device manufacturers, to 

“prescribing and other health-care providers.” Restatement (Third) of Torts: Prods. Liab. 

§ 6(d)(1). The FDA is not a health care provider and does not prescribe anything for 

patients. (Conklin cites no authority for his assertion at oral argument that the FDA 

should nonetheless be deemed a learned intermediary in this context.)

¶27 Accordingly, even if we assume that adverse event reports may constitute

relevant warnings, Arizona law does not permit a manufacturer to satisfy its duty to warn

end-user consumers by submitting adverse event reports to the FDA. And conversely, a 

manufacturer does not breach its duty to warn end users under Arizona law by failing to 

submit adverse event reports to the FDA. Conklin cites no authority, and we are aware 

of none, for the proposition that Arizona law requires a manufacturer to warn a federal 

agency. Cf. Norabuena v. Medtronic, Inc., 86 N.E.3d 1198, 1207 (Ill. App. Ct. 2017) 

(“Although Illinois recognizes that a manufacturer may satisfy its duty to warn by 

conveying information to third-party learned intermediaries, this is not synonymous 

with an affirmative duty to warn a federal regulatory body.” (citation omitted)).

¶28 By adopting the LID as articulated in the Restatement (Third) of Torts, Watts

implicitly displaced further reliance on a parallel provision in the Restatement (Second) 

of Torts § 388 (Am. Law Inst. 1965), which the court of appeals has previously applied. 

See, e.g., Dole Food Co. v. N.C. Foam Indus., Inc., 188 Ariz. 298, 301–05 (App. 1996); Shell Oil 

Co. v. Gutierrez, 119 Ariz. 426, 432–34 (App. 1978). But even if § 388 applied, it would not 

change the result. First, that section has not been extended to require a manufacturer to 

submit warnings to a governmental regulatory body. Second, a manufacturer like 
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Opinion of the Court

9

Medtronic cannot have a “reasonable assurance” that the information in adverse event 

reports will reach end users (or end users’ health care providers), see Dole Food, 188 Ariz. 

at 302–03 (quoting Restatement (Second) of Torts § 388 cmt. n), because the FDA is not 

required to publicly release such reports, see 21 C.F.R. § 803.9(a) (stating that the FDA 

“may disclose to the public any [adverse event] report” (emphasis added)). Third, and 

relatedly, when the FDA exercises its discretion to release adverse event reports publicly, 

it does so only passively by uploading the reports to a database. See MAUDE -

Manufacturer and User Facility Device Experience, FDA, https://www.accessdata.fda.gov

/scripts/cdrh/cfdocs/cfMAUDE/search.CFM [https://perma.cc/NRJ2-USCC] (last 

updated Nov. 30, 2018). An end user (or an end user’s health care provider) must then 

affirmatively access the database and search for adverse event reports. See id.

¶29 Because only federal law, not state law, imposes a duty on Medtronic to 

submit adverse event reports to the FDA, Conklin’s failure-to-warn claim is impliedly 

preempted under 21 U.S.C. § 337(a). See Buckman, 531 U.S. at 352, 353 (stating that 

because “Congress intended that the MDA be enforced exclusively by the Federal 

Government,” a state law claim that exists “solely from the violation of [federal] 

requirements” is impliedly preempted). Absent an independent state law duty to submit 

adverse event reports to the FDA, Conklin’s failure-to-warn claim, at bottom, is an 

attempt to enforce a federal law requirement. That claim is impliedly preempted under 

the MDA. Id.; see also Mink, 860 F.3d at 1330 (finding failure-to-warn claim based on 

manufacturer’s failure to submit adverse event reports to the FDA impliedly preempted 

because such “duty is owed to the FDA,” and that liability theory “is not one that state 

tort law has traditionally occupied”); Marsh v. Genentech, Inc., 693 F.3d 546, 552–54 (6th

Cir. 2012) (same, stating that the “alleged wrong was perpetrated upon” the FDA and 

applying state’s immunity law to affirm dismissal of claim); In re Medtronic, Inc., 623 F.3d 

at 1205–06 (same, finding such “claims are simply an attempt by private parties to enforce 

the MDA, claims foreclosed by § 337(a) as construed in Buckman”); cf. Hughes v. Bos. Sci.

Corp., 631 F.3d 762, 769, 774–75 (5th Cir. 2011) (“[a]ssuming that a failure to warn claim 

may be pursued” under state law based on manufacturer’s failure to submit adverse 

event reports to the FDA, finding no implied preemption because the claim is based on 

an “underlying” and “recognized state tort claim”).

VI.

¶30 Conklin relies on the court of appeals’ opinion and Stengel to support a 

contrary conclusion. In finding no preemption of Conklin’s failure-to-warn claim, the 

court of appeals embraced Stengel’s “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.” Conklin, 244 Ariz. at 146 ¶ 22. The court agreed with Stengel that 

“Arizona law contemplates that a warning to the FDA could satisfy Medtronic’s general 

duty of reasonable care to warn,” reasoning that “the FDA, in turn, could have notified 

Mr. Conklin’s doctor, thus discharging Medtronic’s duty.” Id. (citing Watts, 239 Ariz. 
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Opinion of the Court

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at 24 ¶¶ 13–14). Although the court of appeals observed that Conklin’s failure-to-warn

claim is based on “Medtronic’s violation of the federal duty to report post-PMA adverse 

events to the FDA,” id. ¶ 23, the court determined that the claim “is not impliedly 

preempted” because he is “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,” id.

¶ 24.

¶31 We disagree with Stengel and consequently with the court of appeals’ 

reasoning and conclusion in this case. In Stengel, the Ninth Circuit held that the MDA 

did not expressly or impliedly preempt the plaintiffs’ Arizona common law 

failure-to-warn claim based on Medtronic’s alleged failure to submit adverse event 

reports to the FDA. 704 F.3d at 1226, 1233. That holding, however, was based on the 

unsupported premises that “Arizona law contemplates a warning to a third party such 

as the FDA” and that, “[u]nder 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.’” Id. at 1233 (quoting Anguiano v. E.I. DuPont de Nemours &

Co., 808 F. Supp. 719, 723 (D. Ariz. 1992)). Neither premise comports with Arizona law. 

Arizona law would recognize a claim for a failure to provide an adequate warning to the 

patient directly or through certain third parties (including health care providers), but

established law does not recognize a claim merely for failing to provide something like 

adverse event reports (which may not qualify as “warnings” under Arizona law) to a 

government agency that has no obligation to relay the information to the patient.

¶32 Because Stengel incorrectly recited and applied Arizona law, we decline to 

follow it. See Andrade v. City of Phoenix, 692 F.2d 557, 559 (9th Cir. 1982) (“The courts of a 

state alone can define the authoritative meaning of state law.”); Planning Grp. of Scottsdale, 

L.L.C. v. Lake Mathews Mineral Props., Ltd., 226 Ariz. 262, 267 ¶ 22 (2011) (noting that Ninth 

Circuit decisions “are not binding on this Court”). As discussed above, our case law

contemplates that a medical device manufacturer may satisfy its duty to warn consumers

by properly warning a third party, such as a learned intermediary. Watts, 239 Ariz. at 22 

¶ 1. But the FDA is not a learned intermediary or other relevant third party in that 

analysis. And we are not aware of any case that supports the proposition that a 

manufacturer is independently required under Arizona law to warn a governmental 

regulatory body.

¶33 Conklin’s other cited cases are inapposite or unpersuasive. Anguiano (the 

district court case on which Stengelrelied) involved a materially distinguishable issue and 

does not support the proposition that Arizona law imposes a duty on a manufacturer to 

warn the FDA or even that a manufacturer may satisfy its duty to warn consumers by 

warning the FDA. 808 F. Supp. at 726–27. Coleman v. Medtronic, Inc. largely hinged on 

Stengel’s reasoning, with which we disagree, that “state law [failure-to-warn] claims 

based on failure to file adverse event reports with the FDA are not subject to preemption.” 
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Opinion of the Court

11

167 Cal. Rptr. 3d 300, 311 (Ct. App. 2014). And Fiore v. Collagen Corp. addressed only a 

claim of express preemption under 21 U.S.C. § 360k(a), adopted a minority view 

espoused by the Ninth Circuit, and in any event likely does not survive Riegel. 187 Ariz. 

400 (App. 1996).

VII.

¶34 The superior court’s judgment dismissing this action with prejudice is 

affirmed. We vacate paragraphs 1, 18 through 25, and 28 through 31 of the court of 

appeals’ opinion, as well as any other statements relating to Conklin’s failure-to-warn 

claim that are inconsistent with this opinion.