Conklin Et Ux v. Medtronic Inc

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
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
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CONKLIN V. MEDTRONIC
Opinion of the Court
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.
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CONKLIN V. MEDTRONIC
Opinion of the Court
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
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CONKLIN V. MEDTRONIC
Opinion of the Court
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. at31920 (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,
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CONKLIN V. MEDTRONIC
Opinion of the Court
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.
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CONKLIN V. MEDTRONIC
Opinion of the Court
¶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
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CONKLIN V. MEDTRONIC
Opinion of the Court
¶ 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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CONKLIN V. MEDTRONIC
Opinion of the Court
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
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 Stengel relied) 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
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.
11