Patricia A. Jones, as Trustee for the Next of Kin of Kaitlyn M. Jones (deceased) and Personal Representative to be appointed for the Estate of Kaitlyn M. Jones (minor), Appellant,

This opinion will be unpublished and
may not be cited except as provided by
Minn. Stat. § 480A.08, subd. 3 (2016).

STATE OF MINNESOTA
IN COURT OF APPEALS
A17-1124

Patricia A. Jones,
as Trustee for the Next of Kin of Kaitlyn M. Jones (deceased)
and Personal Representative to be appointed
for the Estate of Kaitlyn M. Jones (minor),
Appellant,

vs.

Medtronic, Inc., et al.,
Respondents.

Filed March 26, 2018
Affirmed in part, reversed in part, and remanded
Florey, Judge

Hennepin County District Court
File No. 27-CV-16-17488

Gale D. Pearson, Stephen J. Randall, Pearson, Randall & Schumacher, P.A., Minneapolis,
Minnesota; and

Robert S. Peck (pro hac vice), Center for Constitutional Litigation, P.C., New York, New
York (for appellant);

Andrew E. Tauber (pro hac vice), Mayer Brown, L.L.P., Washington, D.C.; and

Michael C. McCarthy, Nicole E. Narotzky, Keiko L. Sugisaka, Erica A. Holzer, Maslon
L.L.P., Minneapolis, Minnesota (for respondents)

Considered and decided by Cl eary, Chief Judge; Larkin, Judge; and Florey, Judge.

2
U N P U B L I S H E D O P I N I O N
FLOREY, Judge
Appellant is a mother whos e daughter died due to an allegedly defective medical
device manufactured by responde nts. Appellant filed suit against respondents alleging
several claims, including manufacturing defect , failure to warn, ne gligence, negligence
per se, breach of express and implied warra nties, negligent misr epresentation, and
violations of various Minnesot a and Florida consumer-protec tion statutes. The district
court dismissed all claims as being either expressly or impliedly preempted by federal law.
We affirm in part, reverse in part, and remand.
FACTS
Appellant Patricia A. Jones (Jones) is a Fl orida resident and the mother of Kaitlyn
M. Jones (Kaitlyn). When she was young, Kaitlyn was diagnosed with cerebral palsy with
spastic quadriplegia, which caused her muscle spasms. To help manage the spasticity,
Kaitlyn had a device called the SynchroMed II Infusion Pump and System (SynchroMed II)
implanted in her body in March 2011. Th is device delivers a programmed amount of
medication into the patient’s spine and was implanted in Kaitlyn to reduce or eliminate the
need for oral medications to control her muscle spasms. Respondents (collectively referred
to as Medtronic) designed and manufactured the SynchroMed II.
On July 31, 2014, Kaitlyn was taken to a hospital emergency room for extreme
discomfort and pain. Doctors adjusted the medication dosage in her SynchroMed II, which
seemed to help, and she was discharged and sent home. But the next morning, Jones and
her husband discovered that Kaitlyn had died during the night. An autopsy showed that
3
the levels of medication in Kaitlyn’s system were lower than expected. The medical
examiner determined that Ka itlyn died from bowel ischemia, which was related to her
withdrawal from the medication she should have received from the SynchroMed II. An
analysis of the pump showed that there was a blockage in the device that likely caused it
to deliver less than the required dosage of medication into Kaitlyn’s body.
Jones, as trustee for the next of kin of Kaitlyn, filed a complaint alleging 12 claims
against Medtronic, including: (1) manufacturing defect; (2) failure to warn; (3) negligence;
(4) negligence per se; (5) breach of expre ss warranty; (6) breach of implied warranty;
(7) negligent misrepresentation; (8) viola tions of Florida law concerning deceptive,
unconscionable, and unfair trade practices; (9) violations of Florida regulations concerning
deceptive and unfair trade practices; (10) violations of Minnesota law prohibiting unlawful
trade practices; (11) violations of Minn esota law prohibiting consumer fraud; and
(12) violations of the Minnesota law regarding false advertising.
Medtronic filed a motion to dismiss Jones’ s complaint, which the district court
granted. In its order for dismissal, the distri ct court determined that all of Jones’s claims
were either expressly or impliedly preempte d by federal law, or were not sufficiently
pleaded to show an adequate causal c onnection between Medtronic’s behavior and
Kaitlyn’s death. Additionally, the district court determined that Jones was precluded from
bringing her claims under Minnesota’s consumer-protection statutes because these statutes
do not create a private right of action and Jone s failed to meet the requirements to sustain
claims under the private attorney general statute. Finally, the district court determined that
4
Jones’s fraud claims did not meet the heighten ed pleading requirements in Minn. R. Civ.
P. 9.02. Jones appealed.
D E C I S I O N
The question in this appeal is whether Jones’s claims are preempted by federal law,
specifically, the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399h (Supp.
2016). The district court held that all of Jones’s claims were either expressly or impliedly
preempted by this federal law. We review de novo a district court’s decision to grant a
motion to dismiss and whether federal law preempts state law. Angeles v. Medtronic, Inc.,
863 N.W.2d 404, 409 (Minn. App. 2015).
Analyzing the preemption issue in this case is impossible without explaining some
of the regulatory background. To start, a critical stat ute is the Medical Device
Amendments of 1976 (MDA). Pub. L. No. 94-295, 90 Stat. 539 (1976). In 1976, Congress
amended the FDCA by enacting the MDA whose purpose was to “provi de for the safety
and effectiveness of medical de vices intended for human use.” Medtronic, Inc. v. Lohr ,
518 U.S. 470, 474, 116 S. Ct. 2240, 2245 (1996) (quotation omitted). To help accomplish
this purpose, the MDA classifies medical devices into three distinct classes of risk. Id. at
476, 116 S. Ct. at 2246. Class I devices pose the least risk, Class II devices pose a “more
harmful” risk, and Class III devices—incl uding the SynchroMed II device—pose “a
potential unreasonable risk of illness or injury.” Id. at 476-77, 116 S. Ct. at 2246 (quotation
omitted).
Before a Class III medical device can ente r the market, it must undergo a rigorous
evaluation process from the Food and Drug Administration called premarket approval. Id.
5
at 477, 116 S. Ct. at 2246-47. Indeed, all pa rties agree that the SynchroMed II device at
issue in this case underwent this premarket approval process. Once a Class III device
emerges from premarket approval, the manufacturer cannot change any part of the device
that would affect its safety or efficacy without approval fro m the Food and Drug
Administration. 21 U.S.C. § 360e(d)(5)(A)(i).
Regulating these risky Class III medical devices is an enormously complicated task.
To deal with this complexity and to create uniform standards across the country, Congress
used its power under the Supremacy Clause to preempt state or local laws that would
regulate these Class III devices. See U.S. Const. art. VI, cl. 2. The preemption provision
in section 360k(a) of the MDA states:
[N]o State or political subdivisio n of a State may establish or
continue in effect with respect to a device intended for human
use 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 safe ty or effectiveness of the
device or to any other matte r included in a requirement
applicable to the device under this chapter.

21 U.S.C. § 360k(a).
Section 360k(a)’s provision is known as an “express preemption” provision, which
occurs when a federal statute explicitly states that federal law overrides state law. Brandt
v. Marshall Animal Clinic , 540 N.W.2d 870, 878 n.4 (Minn. App. 1995), review denied
(Minn. Feb. 9, 1996). The United States Supreme Court discussed section 360k(a) in
Riegel v. Medtronic, Inc. where it created a two- step inquiry to dete rmine if a state-law
cause of action is expressly preempted by the provision: First, c ourts “must determine
6
whether the Federal Government has establis hed requirements applicable” to the device,
and second, courts “must then determine whether the [plaintiff’s] common-law claims are
based upon [state] requirements with respect to the device that are different from, or in
addition to the federal ones, and that relate to safety and effectiveness.” 552 U.S. 312, 321-
22, 128 S. Ct. 999, 1006 (2008) (quotation omitted).
The Supreme Court in Riegel held that devices that pass through premarket
approval, like the SynchroMed II, establish “re quirements” under the first inquiry of the
Riegel test. Id. at 322-23, 128 S. Ct. at 1006-07. Neither Jones nor Medtronic dispute this,
and we may consider the first inquiry met for all of Jones’s claims.1 This focuses attention
on the second inquiry. To satisfy the second inquiry and escape express preemption under
the MDA’s preemption provision, Jones must show that her state common-law claims
“parallel” the requirements under federal law, specifically, the FDCA. Lamere v. St. Jude
Med., Inc., 827 N.W.2d 782, 790 (Minn. App. 2013) (quotation omitted) (citing Lohr, 518
U.S. at 496, 116 S. Ct. at 2256). In other words, Jones must show that her state-law claims
are not different from—nor do they add to—federal requirements.
But showing a parallel state-law clai m and escaping the express preemption
provision is not enough—there is another step. The United States Supreme Court held in
Buckman Co. v. Plaintiff’s Legal Comm. that the FDCA does not provide a private right of

1 The district court concluded that “[b]ecause Jones’ Device received [premarket approval],
the first step in the Riegel two-step analysis in this case is indisputably met.”
7
action. 531 U.S. 341, 352-53, 121 S. Ct. 1012, 1019-20 (2001). 2 This means that Jones,
as a private litigant, cannot br ing a state-law claim solely for a violation of the FDCA
because state-law claims ar e impliedly preempted. Id. Therefore, to avoid implied
preemption under Buckman, a plaintiff must rely on traditional state tort law which predates
the federal enactments in question. Riley v. Cordis Corp. , 625 F. Supp. 2d 769, 777 (D.
Minn. 2009).
This area is notoriously complex, and this issue was discussed at length in Riley,
which said that “Riegel and Buckman create a narrow gap through which a plaintiff’s state-
law claim must fit if it is to esca pe express or implied preemption.” Id. In order to fit
through that gap,
[t]he plaintiff must be suing for conduct that violates the FDCA
(or else his claim is expressly preempted by [21 U.S.C.]
§ 360k(a)), but the plaintiff must not be suing because the
conduct violates the FDCA (such a claim would be impliedly
preempted under Buckman). For a state-law claim to survive,
then, the claim must be pr emised on conduct that both
(1) violates the FDCA and (2) would give rise to a recovery
under state law even in the absence of the FDCA.

Id.
Jones alleged twelve different claims in her original complaint. We will analyze
each claim’s survivability under both expre ss and implied preemption in the following
discussion.

2 A provision in the FDCA stat es that an action “for the en forcement, or to restrain
violations, of [the FDCA] shall be by and in the name of the United States .” 21 U.S.C.
§ 337(a) (emphasis added).
8
I. Jones’s manufacturing-defect clai m survives both express and implied
preemption.

In count I of her complaint, Jones ar gues that the SynchroMed II contained a
manufacturing defect and that Medtronic was negligent in addressing that defect. To allege
a manufacturing defect claim in Minnesota, a plaintiff must show three elements: “(1) the
product was in a defective condition unreasona bly dangerous to the user, (2) the defect
existed when it left the manufacturer’s control, and (3) the defect was the proximate cause
of the injury sustained.” Drager by Gutzman v. Aluminum Indus. Corp., 495 N.W.2d 879,
882 (Minn. App. 1993), review denied (Minn. Apr. 20, 1993).
To escape express preemption, Jones must show that her manufacturing-defect
claim is parallel to—and not “different from” or “in addition to”—the requirements under
the FDCA. Riegel, 552 U.S. at 321-22, 128 S. Ct. at 1006. To support her claim and show
that it is parallel to federal regulations, Jones emphasizes that Medtronic manufactured the
SynchroMed II in violation of 21 U.S.C. §§ 331, 351(h) and 21 C.F.R. part 820. 3 Jones
claims that Medtronic manufactured the Sy nchroMed II device knowing that it did not
comply with federal regulations that allegedly prevent overinfusion and underinfusion and
ensure an accurate delivery rate of medication. The district court dismissed this claim as
being either expressly or impliedly preempted by the FDCA.

3 The FDCA prohibits adulterated devices. 21 U.S.C. § 331. Adulterated devices include
devices manufactured or installed in violation of good manufacturing practices. 21 U.S.C.
§§ 351(h), 360j(f)(1)(A). 21 C. F.R. part 820 sets forth current good manufacturing
practices (CGMP). 21 C.F.R. § 820.1(a) (2017). These regul ations are described as an
umbrella quality system provi ding general objectives for all device manufacturers. In re
Medtronic, Inc., 623 F.3d 1200, 1206 (8th Cir. 2010) (quotation omitted).

9
We believe that Jones sufficiently plea ded a manufacturing-defect claim that
escapes both preemption hurdles. First, Jones’s complaint escapes express preemption by
sufficiently pleading that the SynchroMed II device was “adulterated” as understood by 21
U.S.C. §§ 331, 351(h); this adulteration was unreasonably dangerous to users of the device;
this adulteration was present when it left Medtronic’s control; and the adulteration is what
caused Kaitlyn’s death—all of which meet the elements of a manufacturing-defect claim
in Minnesota and none of which are different from, or in addition to, federal requirements.
In other words, Jones’s manufacturing-defect cl aim is parallel to the requirements of the
FDCA and the claim survives express preemption. Riegel, 552 U.S. at 321-22, 128 S. Ct.
at 1006.
Additionally, the claim surv ives implied preemption because it is rooted in
traditional Minnesota tort law that would entitle Jones to rec overy even in the absence of
the FDCA. See Lee v. Crookston Coca-Cola Bottling Co. , 290 Minn. 321, 328-29, 188
N.W.2d 426, 432 (1971) (relying on the Restatement (Second) of Torts § 402A (1965) to
outline the elements of a Minne sota claim for a manufacturing defect). Because Jones’s
claim survives both express and implied preemption, we conclude that it has passed
through the “narrow gap” created by Riegel and Buckman. Riley, 625 F. Supp. 2d at 777.
Medtronic argues that Jones’s complaint is not sufficiently pleaded to survive a
motion to dismiss under Minnesota’s pleading rules. But Minnesota only requires a
plaintiff’s civil complaint to “contain a short and plain statement of the claim showing that
the pleader is entitled to relief and a demand for judgment for the relief sought . . . .” Minn.
R. Civ. P. 8.01. And the Minnesota Supreme C ourt interprets the purpo se of this rule as
10
“simply to give fair notice to the adverse party of the incident giving rise to the suit with
sufficient clarity to disclose the pleader’s theory upon wh ich his claim for relief is
based . . . .” Walsh v. U.S. Bank, N.A. , 851 N.W.2d 598, 602 (Minn. 2014) (quotation
omitted). We believe that Jones’s complaint gives more than “fair notice” to Medtronic
that the SynchroMed II device was defectively manufactured and, as a result of that defect,
harmed Kaitlyn. For all these reasons, the district court’s dismissal of this claim should be
reversed.
II. Jones’s failure-to-warn claim survives both express and implied preemption.

Jones also alleges that Medtronic faile d to warn about th e dangers of the
SynchroMed II in violation of both state law and premarket appr oval requirements.
Minnesota’s common law requires a plaintiff to prove a failure-to-warn claim by alleging
a manufacturer’s “failure to use reasonabl e care in giving adequate and accurate
instructions as to the use of the product and a warning as to any dangers reasonably
foreseeable in its intended use.” Peppin v. W.H. Brady Co., 372 N.W.2d 369, 374 (Minn.
App. 1985) (quotation omitted) (citing McCormack by McCormack v. Hankscraft Co. Inc., 278 Minn. 322, 332, 154 N.W.2d 488, 496 (1967)).
Jones generally alleges that Medtronic vi olated premarket approval requirements
and two federal reporting requirements. The first, 21 U.S.C. § 360i(a)(1), requires medical
device manufacturers to report to the FDA any malfunctions or defects in their devices that
may have resulted in injury. The second, 21 C.F.R. § 803.50(a) (2017), requires the
manufacturer to make these re ports within 30 days of notic e. Jones argues that her
complaint sufficiently alleged that these federal reporting failures hid issues from the FDA
11
that would otherwise have b een conveyed to medical professionals when Kaitlyn was
admitted at the hospital, and therefore, Medtr onic’s failure to report these issues resulted
in Kaitlyn’s death.
Again, we believe this failure-to-warn claim survives preemption. Jones’s
complaint essentially alleges that Medt ronic knew that the SynchroMed II was
“adulterated” within the meaning of 21 U.S.C. §§ 331, 351(h) and that Medtronic’s failure
to comply with federal reporting requirements illustrates that it did not use reasonable care
in warning about the foreseeable dangers of that adulteration. This parallels the reporting
requirements singled out by Jones’s compla int and survives express preemption. Riegel,
552 U.S. at 321-22, 128 S. Ct. at 1006. In addition, Jones’s failure-to-warn claim clearly
relies on a state-law claim that predates the FDCA, thereby surviving implied preemption.
See Lovejoy v. Minneapolis-Moline Power Implement Co., 248 Minn. 319, 325, 79 N.W.2d
688, 693 (1956) (stating that a manufacture r may be liable “if he knows or should know
that the chattel is apt to cause bodily harm if not used in a specific manner if he fails to
furnish adequate warning as to the dangers inherent in its use”).
As before, Medtronic’s argument that Jones’s complaint is not sufficiently pleaded
fails for the same reasons as before: the complaint adequately puts Medtronic on notice
that it knew, or should have known, that the SynchroMed II was adulterated and that
Medtronic failed to warn about the dangers of this adulteration. We conclude that Jones
sufficiently pleaded her failure-to-warn claim, and the dist rict court’s dismissal of this
claim should be reversed.
12
III. Jones’s breach-of-express- and implied-warranty claims survive both express
and implied preemption.

Jones’s complaint also alleges that Medt ronic breached both express and implied
warranties with the SynchroMed II. To establish a breach of express or implied warranty
in Minnesota, a plaintiff must prove (1) the ex istence of a warranty, (2) a breach of that
warranty, and (3) a causal link between the breach and the alleged harm. Peterson v.
Bendix Home Sys., Inc., 318 N.W.2d 50, 52-53 (Minn. 1982).
The district court dismissed Jones’s br each-of-warranty claims because they
imposed “state-law requirements, which are different from and in addition to” federal
requirements. But we recognized in Angeles that federal law plainl y prohibits false or
misleading warranties, so to avoid state-law liability, a manufacturer only needs to “refrain
from making misleading warranties, which a dds no burden beyond what federal law
already imposes.” 863 N.W.2d at 421 (quoting Beavers-Gabriel v. Medtronic, Inc. , 15
F. Supp. 3d 1021, 1042 (D . Haw. 2014)). Although Angeles involved promotion of off-
label uses of a medical device, we believe th e same reasoning holds true here. Jones’s
complaint alleges that Medtronic both expr essly and impliedly warranted that the
SynchroMed II was in compliance with federal regulations, even when it knew the device
was adulterated, which allegedly ca used Kaitlyn’s death. Like in Angeles, federal law
prohibited Medtronic from making misleading warranties about the SynchroMed II, and
Medtronic could have avoided liability by refraining from making those misleading
warranties—a parallel obligation to Minnesota la w. For these reasons, we conclude that
13
Jones sufficiently pleaded her breach-of-exp ress-and implied-warranty claims, and the
district court erred by dismissing those claims.
IV. Jones’s claims of negligence, negligen ce per se, negligent misrepresentation,
and state consumer-protection violations are preempted.

While we conclude that Jones’s previous ly discussed claims survive the preemption
analysis, the remaining claims do not. We first turn to Jones’s negligence and negligence
per se claims. A Minnesota negligence claim required Jones to allege that Medtronic owed
Kaitlyn a duty of care, Medtronic breached that duty of care, Kaitlyn was injured, and the
injury was caused by Medtronic’s breach. See State Farm Fire & Cas. v. Aquila Inc., 718
N.W.2d 879, 887 (Minn. 2006).
Jones’s negligence claims are primarily based on Medtronic’s failure to follow
federal current good manufacturing practices (CGMP). 4 Federal circuits are split on the
question of whether violations of CGMP create parallel claims to escape express
preemption. For instance, the district court noted that the Eighth Circuit has held that
CGMP violations, standing alone and without pointing to specific violations of the FDA’s
premarket approval process for the medical devi ce at issue, are simply too generic to be
considered parallel claims for a manufacturing defect. In re Medtronic, Inc., 623 F.3d at
1206-07 (holding that to survive express pree mption, a plaintiff must adequately plead a
violation of a specific step in the FDA’s premarket approval process for a Class III device,
not simply a CGMP violation); but see Bass v. Stryker Corp., 669 F.3d 501, 512 (5th Cir.

4 As previously explained, these regulations create an umbrella qua lity system providing
general objectives for all device manufacturers. In re Medtronic, Inc., 623 F.3d at 1206.
14
2012) (holding that if a plaintiff pleads both a violation of CGMP in a Class III device and
that this violation caused the injury, then th at plaintiff has sufficiently pleaded a parallel
claim to survive express preemption).
We acknowledged this split in authorities over CGMP violations in Lamere, but we
decided the CGMP issue on ot her grounds. 827 N.W.2d at 790-91 (Minn. App. 2013).
Still, we note that there is no Minnesota authority stating that violations of CGMP, standing
alone, can sustain a negligence action. Furt her, we are not convinced that reliance on
generalized CGMP violations alleges a vi olation of a state-law duty—a necessary
ingredient in alleging a parallel claim that escapes express preemption. For these reasons,
we conclude that Jones’s negligence and negligence per se claims are preempted.5
Similarly, Jones’s claim for negligent misrepresentation does not survive the
preemption analysis. Jones rests this claim entirely on state law, wr iting, “[a]t all times
relevant hereto, Medtronic had a duty under Florida and Minnesota law to advertise and
represent correct information regarding the SynchroMed II Device, as such information
involves public welfare and safety.” This reliance on state law as the foundation of her
claims fails to escape express preemption si nce Jones is not alle ging any violation of

5 We affirm the dismissal of Jones’s neglig ence per se claim be cause the distinction
between negligence per se and common-law negligence is where the duty originates. With
negligence per se, the duty originates from st atute, whereas traditional negligence duties
originate in common law. Kronzer v. First Nat’ l Bank of Minneapolis , 305 Minn. 415,
423, 235 N.W.2d 187, 192 (1975). Because of this, the preemption analysis is not affected
either way. See In re Medtronic, 592 F. Supp. 2d 1147, 1163 (D. Minn. 2009) (explaining
that the doctrine of negligence per se merely sets the standard of care but does not affect
the preemption analysis), aff’d, 623 F.3d 1200 (8th Cir. 2010).
15
federal requirements and therefore, is making a claim in addition to or different from the
FDCA. Riegel, 552 U.S. at 321-22, 128 S. Ct. at 1006.
Finally, Jones alleges that Medtronic violated multiple consumer-protection laws in
Minnesota and Florida. These claims are similar to her other allegations in her complaint.
For instance, Jones alleges that Medtronic engaged in unfair trade practices under Florida
law by marketing and selling the SynchroMed II in ways “which shock the conscience,
offend established public policy, and are immoral, unethical, oppressive, unscrupulous, or
substantially injurious to consumers, acts a nd practices which are ma terial and are likely
to mislead consumers acting reasonably under the circumstances.”
But Jones’s complaint does no t specify the federal clai ms these statutes would
parallel in order to escape preemption. Instead, Jones appears to be using these consumer-
protection statutes to allege additional, stat utory claims as a way to hedge against the
preemption analysis of her main claims. This is supported by Jones’s reply brief where she
writes that she included thes e consumer-protection claims out of “an abundance of
caution.” However, the language in each of th ese consumer-protection statutes is very
different from any relevant federal rules that might run parallel. And while Jones is correct
that different language does not necessarily imply nonparallel requirements, our reading of
each statute leads us to the conclusion that they are not parallel to the FDCA and are
therefore preempted.
Jones’s allegations of negligence, negligen ce per se, negligent misrepresentation,
and violations of Minnesota and Florida consumer protecti on-laws are all preempted by
the FDCA, and the district court did not err in dismissing these claims. We affirm the
16
district court on these claims. However, Jo nes’s allegations of a manufacturing defect,
failure to warn, and breach of express and implied warranties are not preempted by federal
law, and the district court erred in dismissing these claims. For the reasons discussed, we
reverse and remand on these four claims.
Affirmed in part, reversed in part, and remanded.