Raymond R. Conklin, II, et al., Plaintiffs/Appellants,
Medtronic, Inc., et al., Defendants/Appellees.
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
D. Friedman, Jonathan V. O'Steen (argued), O'Steen
& Harrison, PLC, Phoenix, Attorneys for Raymond R.
Conklin, II and Joanne M. Conklin
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.
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
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.
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.
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.
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
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 ...