RAYMOND R. CONKLIN, II, et al., Plaintiffs/Appellants,
MEDTRONIC, INC., et al., Defendants/Appellees.
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
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
& Roberts, PC, Scottsdale By David L. Abney Counsel for
Amicus Curiae Arizona Association for Justice/Arizona Trial
Presiding Judge Randall M. Howe delivered the opinion of the
Court, in which Judge Lawrence F. Winthrop and Judge Jon W.
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.
AND PROCEDURAL HISTORY
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.
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.
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.
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.
Preemption and Class III Medical Devices
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.
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