RAYMOND R. CONKLIN, II, ET AL., Plаintiffs/Appellants, v. MEDTRONIC, INC., ET AL., Defendants/Appellees.
No. CV-17-0322-PR
SUPREME COURT OF THE STATE OF ARIZONA
December 18, 2018
245 Ariz. 501 | 431 P.3d 571
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
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.
¶1 The issue here is whether federal law preempts an Arizona common law failure-to-warn claim based on a medical device manufаcturer‘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 Pumр.
¶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 fеderal law gives rise to liability under Arizona common law.
¶4 Medtronic moved to dismiss the claims under
¶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 clаims 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 failurе 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
¶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 fеderal 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 рreemption); 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.
III.
¶9 The Federal Food, Drug, and Cosmetic Act (“FDCA“), Pub. L. No. 75-717, 52 Stat. 1040 (codified as amеnded at
¶10 The MDA‘s most rigorous level of oversight, which includes аn extensive PMA process and review of proposed product labeling, applies to medical devices categorized as Class III devices. Id. at 317–19; see also
¶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
¶12 Even after the FDA grants PMA for a device, the device is “subject to reporting requirements.” Riegel, 552 U.S. at 319 (citing
¶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,
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.
¶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 applicаble 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
¶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
¶17 The MDA also impliedly preempts certain state law claims. Specifically,the MDA provides that “all . . . proceedings for the enforcement . . . of this chapter shall be by and in the name of the United States.”
¶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 nоt 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 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
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 prеempted 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);
¶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¶ 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.” Watts, 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 Restatemеnt (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 аdverse 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
¶29 Because only federal law, not state law, imposes a duty on Medtronic to submit adverse event reports to the FDA, Cоnklin‘s failure-to-warn claim is impliedly preempted under
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 dangеrs 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.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
¶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 lеarned 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., 167 Cal. Rptr. 3d 300, 311 (Ct. App. 2014) 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.“And Fiore v. Collagen Corp. addressed only a claim of express preemption under
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.
JUSTICE PELANDER