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Conklin v. Medtronic, Inc.

Court of Appeals of Arizona, First Division

October 19, 2017

RAYMOND R. CONKLIN, II, et al., Plaintiffs/Appellants,
v.
MEDTRONIC, INC., et al., Defendants/Appellees.

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

          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

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

          OPINION

          HOWE, 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).

         ¶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.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 ...


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