Conklin v. Medtronic, Inc., CV-17-0322-PR

• Decision Date: 18 December 2018
• Docket Number: No. CV-17-0322-PR,CV-17-0322-PR
• Parties: Raymond R. CONKLIN, II, et al., Plaintiffs/Appellants, v. MEDTRONIC, INC., et al., Defendants/Appellees.
• Court: Arizona Supreme Court

431 P.3d 571

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

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

No. CV-17-0322-PR

Supreme Court of Arizona.

Filed December 18, 2018

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.

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 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, 418 P.3d 912, 915, 920 (App. 2017). The court determined that those claims were expressly preempted. Id. at 144–45 ¶¶ 14–17, 146–47 ¶ 26, 418 P.3d at 917–18, 19–20. 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, 418 P.3d at 918, 920–21. 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, 418 P.3d at 918–19.

¶ 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, 284 P.3d 863, 866 (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, 284 P.3d at 867 (internal quotation marks and alteration omitted) (quoting Fid. Sec. Life Ins. Co. v. Ariz. Dep’t of Ins. , 191 Ariz. 222, 224 ¶ 4, 954 P.2d 580, 582 (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, 107 P.3d 934, 936 (App. 2005).

¶ 8 As the court of appeals correctly observed, Medtronic has the burden of establishing preemption. Conklin , 244 Ariz. at 143 ¶ 8, 418 P.3d at 916. 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 , ––– U.S. ––––, 136 S. Ct. 1938, 1946, 195 L.Ed.2d 298 (2016) ; cf. Riegel v. Medtronic, Inc. , 552 U.S. 312, 315–30, 128 S.Ct. 999, 169 L.Ed.2d 892 (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, 121 S.Ct. 1012, 148 L.Ed.2d 854 (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 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, 128 S.Ct. 999. 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, 128 S.Ct. 999.

¶ 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, 128 S.Ct. 999 ; see also 21 U.S.C. §§ 360c, 360e ; Buckman , 531 U.S. at 348, 121 S.Ct. 1012 (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, 128 S.Ct. 999 ; 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, 128 S.Ct. 999 ; 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, 128 S.Ct. 999 (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, 121 S.Ct. 1012. In addition, "[t]he FDA has the power to withdraw [PMA] based on newly 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 319–20, 128 S.Ct. 999 (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...