Conklin v. Medtronic, Inc.

• Decision Date: 19 October 2017
• Docket Number: No. 1 CA-CV 16-0252,1 CA-CV 16-0252
• Citation: 418 P.3d 912
• Parties: Raymond R. CONKLIN, II, et al., Plaintiffs/Appellants, v. MEDTRONIC, INC., et al., Defendants/Appellees.
• Court: Arizona Court of Appeals

418 P.3d 912

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

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

No. 1 CA-CV 16-0252

Court of Appeals of Arizona, Division 1.

FILED October 19, 2017

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, 128 S.Ct. 999, 169 L.Ed.2d 892 (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, 284 P.3d 863, 866–867 (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, 284 P.3d at 869.

¶ 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, 132 S.Ct. 2492, 183 L.Ed.2d 351 (2012). For federal questions such as preemption, United States Supreme Court decisions are binding, and we may look to circuit court cases as persuasive authority. See Weatherford ex rel. Michael L. v. State , 206 Ariz. 529, 532–33 ¶¶ 8–9, 81 P.3d 320, 323–324 (2003).

¶ 8 Medtronic has the burden to prove preemption. See E. Vanguard Forex, Ltd. v. Ariz. Corp. Comm'n , 206 Ariz. 399, 405 ¶ 18, 79 P.3d 86, 92 (App. 2003). While federal laws are presumed not to preempt state laws, courts do not invoke that presumption when the federal statute contains an express preemption clause. Puerto Rico v. Franklin Cal. Tax–Free Trust , –––U.S. ––––, 136 S.Ct. 1938, 1946, 195 L.Ed.2d 298 (2016) ; Cuomo v. Clearing House Ass'n, LLC , 557 U.S. 519, 554, 129 S.Ct. 2710, 174 L.Ed.2d 464 (2009) ; Riegel , 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (analyzing the MDA's express preemption provision without presuming preemption).

¶ 9 The MDA expressly preempts certain state-law requirements concerning medical devices. The MDA states in pertinent part that no state "may establish or continue in effect with respect to a device ... 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).

¶ 10 For express preemption to apply, two conditions must be met: (1) the federal government must have established requirements applicable to the device at issue and (2) the plaintiff's common-law claims concerning the device must include requirements that are "different from, or in addition to" those federal requirements. 21 U.S.C. § 360k(a) ; Riegel , 552 U.S. at 321–23, 128 S.Ct. 999. If these two conditions are met, common-law claims challenging the safety or effectiveness of a medical device that received PMA from the FDA are expressly preempted. Id. In addition to express preemption, the MDA also impliedly preempts any action for the enforcement or restriction of violations of the FDCA because such actions can only be brought by or in the name of the United States. 21 U.S.C. § 337(a) ; see Buckman Co. v. Plaintiffs' Legal Comm. , 531 U.S. 341, 352, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001).

¶ 11 Despite these preemption restrictions, a plaintiff's state-law claim concerning a medical device may be viable if it is a "parallel claim," a claim based on state requirements that are "equal to or substantially identical to, requirements imposed by or under the act." Medtronic, Inc. v. Lohr , 518 U.S. 470, 495–97, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Thus, a state-law claim is not preempted when it provides "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." Riegel , 552 U.S. at 330, 128 S.Ct. 999. As the Eighth Circuit explained in In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig. :

Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a) ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman ).

623 F.3d 1200, 1204 (8th Cir. 2010) (quoting Riley v. Cordis Corp. , 625 F.Supp.2d 769, 777 (D. Minn. 2009) ). Essentially, the state-law claim cannot exist "solely by virtue of the FDCA disclosure requirements." Buckman , 531 U.S. at 352–53, 121 S.Ct. 1012.

2. Claims Analysis

¶ 12 Because the Medtronic Pain Pump is a Class III medical device, as a matter of law the PMA process imposes federal requirements contemplated by § 360k(a) for express preemption purposes. Riegel , 552 U.S. at 322–23, 128 S.Ct. 999. The Conklins do not dispute that the Medtronic Pain Pump received PMA. As such, part one of the express-preemption test under Riegel is automatically satisfied. See id.

¶ 13 We must next analyze whether Arizona state law imposes on Medtronic a requirement different from or in addition to federal law or if the Conklins' state-law claims instead escape express and implied preemption. We address each claim in turn to determine if the claim is expressly or impliedly preempted, or if the claim is a viable parallel state-law claim.

2a. Product Liability—Design and Manufacturing Defect

¶ 14 The Conklins alleged that the Medtronic Pain Pump was defective when manufactured in design and formulation and when it dispensed an excess of narcotic drugs to Mr. Conklin. To the extent the Conklins pled a strict liability cause of action based on defective design and manufacturing, on appeal they do not challenge the trial court's finding that such claim is expressly preempted. Medtronic...