Donna Delfino, Appellant,

This opinion will be unpublished and
may not be cited except as provided by
Minn. Stat. § 480A.08, subd. 3 (2018).

STATE OF MINNESOTA
IN COURT OF APPEALS
A18-1462

Donna Delfino,
Appellant,

vs.

Medtronic, Inc.,
Respondent.

Filed June 10, 2019
Affirmed
Florey, Judge

Anoka County District Court
File No. 02-CV-12-1786

Timothy J. Becker, Michael K. Johnson, Johnson Becker, P.L.L.C., St. Paul, Minnesota
(for appellant)

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

Benjamin W. Hulse, Charmaine K. Harris, Blackwell Burke, P.A., Minneapolis, Minnesota
(for respondent)

Considered and decided by Florey, Presiding Judge; Connolly, Judge; and
Bjorkman, Judge.
U N P U B L I S H E D O P I N I O N
FLOREY, Judge
On appeal from summary judgment, appellant Donna Delfino argues that the district
court erred by concludi ng that (1) her state -law claims relating to an implantable

2
cardioverter defibrillator (ICD) manufactured by respondent Medtronic, Inc. , were
preempted by the federal Medical Device Amendments (MDA) and (2) the report and
testimony of her expert witness were inadmissible. We affirm.
FACTS
In December 2006, a Virtuoso ICD Model D154AWG, designed and manufactured
by Medtronic, was implanted in appellant. An ICD treats abnormal heart rhythms by
shocking the heart back into normal rhythm with an electrical pulse delivered to the
patient’s heart through an insulated wire. ICDs are Class III medical device s, and their
design, manufacturing method, and labelin g are subject to premarket approval (PMA) by
the United States Food and Drug Administration (FDA).1
The ICD implanted in appellant was subject to a limited warranty and general
warning. The limited warranty provided that, if the ICD failed to operate wit hin the first
five years after implantation, Medtronic would either provide a replacement device or issue
a credit to the purchaser of the replacement device. The limited warranty expressly stated:
“THIS LIMITED WARRANTY IS NOT A REPRESENTATION THAT THE BATTERY
OF THIS DEVICE WILL LAST THE ENTIRE FIVE (5) YEAR WARRANTY PERIOD.”
Further, Medtronic’s general warning provided:
Medtronic devices are implanted in the extremely hostile
environment of the human body. This environment places
severe limitations on the design and function of the device and
lead. These limitations unavoidably reduce the potential

1 In October 1998, the FDA approved Medtronic’s original PMA application for the
Virtuoso ICD. Medtronic submitted to the FDA a PMA supplement in November 2005.
On May 12, 2006, the FDA approved the PMA supplement for the Virtuoso ICD Model
D154AWG.

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performance and longevity of the device and lead despite the
exercise of due care in design, component selection,
manufacture, and testing prior to sale.

In August 2009, Medtronic completed a Field Product Impact Report following the
return of several Concerto and Virtuoso devices2 due to premature battery depletion. The
report found that the premature depletion was caused by “[current] leakage through t he
X5R battery filter capacitors.” 3 The report found “an estimated 8,900 affected device [s]
were distributed to the field,” that “all of the premature depletions as of 22 July 2009 were
made with capacitors in which the end terminations were made with cop per from a
particular supplier,” Supplier A , and that the copper from Supplier A was “ more porous,
which ma[de] it more susceptible to the migration of hydrogen ions.” The report
recommended that Medtronic notify its customers of the issue.

2 As stated in appellant’s brief, “[t]he Virtuoso and Concerto are, in effect, the same device
albeit with different brand names,” and thus, “[f]or purposes of this appeal, they are treated
identically.”
3 As articulated by a federal district court:

[C]apacitors are one of the most basic functional units in
electronic circuits. While they can vary considerably in
specific application, capacitors generally operate to store
energy on a short -term basis, like a temporary battery, and
smooth out the flow of energy to avoid surges and deficits.
Capacitors are classified as “passive” components, which
means they do not generate power but store and condition it.
At heart, a capacitor consists of two electrical plates, one
positively and one negatively charged , that are sandwiched
together with a non -conductive insulator called a dielectric
between them. They are used universally in circuits. As the
result, virtually every electronic device we use, from toasters
to cellphones, has capacitors in it.

In re Capacitors Antitrust Litig., 106 F. Supp. 3d 1051, 1058 (N.D. Cal. 2015).

4
In September 2009, Medtronic issued “Dear Doctor” and “Dear Patient” letters
informing doctors and patients of the device defect. The letters to doctors informed them
that certain ICDs “may not meet expected device longevity due to gradually increasing
current drain caused by low voltage capacitor degradation,” that Medtronic had not
received any reports of death or injury attributed to the issue, and the letters offered
recommendations for patients with devices in the affected subset. The letters to pati ents
advised them to contact their doctors for more information.
Consequently, on November 16, 2009, appellant’s ICD was removed. Medtronic’s
analysis of appellant’s returned ICD concluded that “the cause of the high current drain”
condition was “current leakage in the battery filter capacitors.” “Longevity calculations
showed the device lasted 36 [percent] of its projected longevity. Electrical analysis found
the cause of the shortened device longevity to be high current drain caused by current
leakage in a capacitor.” Medtronic issued a credit in the amount of $13,720 towards the
purchase of a Medtronic replacement device for appellant.
In September 2011, appellant commenced suit against Medtronic . Appellant’s
complaint included seven counts: (1) stri ct liability for manufacturing defect; (2) strict
liability for design defect; (3) strict liability for failure to warn; (4) breach of express
warranty; (5) breach of implied warranty ; (6) negligence; and (7) negligent i nfliction of
emotional distress. Medtronic moved to dismiss the action on preemption grounds.4

4 As of January 2018, appellant’s action was one of 44 individual claims against Medtronic
alleging premature battery depletion of the Concerto and Virtuoso devices. However,
because appellant and Medtronic agreed to litigate “the threshold issue of federal

5
Appellant opposed Medtronic’s motion to dismiss and filed a n expert report,
prepared by Dr. Suzanne Parisian, in support. Dr. Parisian concluded that (1) Medtronic’s
September 2009 advisory, concerning a “specific subset of devices, rather than the whole
product line ,” was “related to a manufacturing defect rather than a design defec t” and
(2) the manufacturing defect “represent[ed] a violation of the [PMA] and the FDA’s
approval of the device .” Thereafter, in July 2012, appellant filed a motion t o amend the
original complaint “in order to plead with more particularity her cause of action.” The
district court granted Medtronic’s motion to dismiss and appellant’s unopposed motion to
amend the original complaint.
Appellant filed an amended complaint on September 5, 2012. The amended
complaint included five counts: (1) strict liability for manufacturing defect; (2) breach of
express warranty; (3) breach of impl ied warranty; (4) negligence; and ( 5) negligent
infliction of emotional d istress. Medtronic filed an answer , asserting a collection of
defenses, including federal preemption.
In the fall of 2012, appellant moved to compel discovery, and on November 9, 2012,
appellant filed an affidavit of expert witness, David Schreiber, in support of her motion.
The credentials of Schreiber, a retired engineer, included: a B.S. in electrical engineering;
“[e]xpertise in manufacturing, electrical test and failure analysis of implantable cardiac
pacemakers and implantable cardioverter defibrillators”; and over thirty years’ experience

preemption” through appellant’s case individually, appellant’s case was the only action
that was filed.

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in the medical-device field, including employment as an engineer with the FDA, Cardiac
Pacemakers, Inc., Guidant Corporation, and Boston Scientific.
Medtronic opposed appellant’s motion to compel discovery and argued that,
because appellant “improperly introduce[d] expert opinion testimony on a purely legal
question,” the dist rict court sho uld disregard Schreiber’s affidavit. Appellant disputed
Medtronic’s characterization of the issue as a legal question. She argued that Schreiber’s
affidavit “simply states [his] opinion, relying on his extensive experience in the field, to
detail which documents will be necessary for [appellant] to ascertain which requirements,
if any, were not followed.” In February 2013, the district court issued a discovery order
negotiated and agreed upon by the parties. The deadline for discovery relating to the
federal preemption issue was scheduled for September 1, 2017.
On October 6, 2017, Medtronic filed a motion for summary judgment on preemption
grounds. Medtronic argued that count one (strict liability for manufacturing defect), count
two (breach of express warranty), count three (breach of implied warranty), and count four
(negligence) were expressly preempted; that appellant also failed to show that Medtroni c
breached the limited warranty; that count two (breach of express warranty) and count three
(breach of implied warranty) were also impliedly preempted; and that count five (negligent
infliction of emotional distress) was preempted.
Appellant opposed Medtronic’s summary-judgment motion. Appellant alleged that
Medtronic violated the PMA by (1) using copper in the ICDs’ capacitors, which was not
an FDA-approved material; (2) failing to meet the battery-leakage requirements set out in
the PMA; and (3) failing to meet the projected longevity set out in the PMA. Appellant

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argued that genuine issues of material fact regarding the three alleged violations precluded
summary judgment.
In support of her opposition to Medtronic’s summary-judgment motion, appellant
filed another report by expert witness Schreiber. Schreiber’s report, dated December 6,
2017, concluded that “Medtronic violated their PMA.” The report found:
First, [Medtronic] failed to comply with Specification
0114546 by using an X5R capacitor with end terminations that
were not “plated tin over nickel” as required by the
specification. Second, the leaky capacitors failed to meet PMA
specifications for capacitor leakage. This was a PMA
violation, leading to: a) prem ature battery depletion, and
b) failure to satisfy the minimum longevity requirements.
These failures independently amount to PMA violations.

Medtronic moved to exclude Schreiber’s report and testimony as inadmissible under
Minnesota Rule of Evidence 702. Medtronic argued that Schreiber’s curriculum vitae (CV)
did “ not indicate that he has any experience or qualification in interpreting federal
requirements for medical devices,” and that “[t]he major factual errors and faulty legal
premises in his report demonstrate his lack of qualification.” A hearing on Medtronic ’s
motions was held.
In May 2018, the district court issued an order granting Medtronic’s motion s for
summary judgment and to exclude testimony of Schreiber. The district court concluded
that appellant failed to show that Medtronic violated a federal requ irement during the
device’s manufacture , and, therefore, appellant’s state -law claims were preempted by
federal law; that appellant’s breach of warranty claims were both barred by implied
preemption as well as by the express terms of Medtronic’s limited wa rranty; that the

8
opinions of Schreiber were disclosed in an untimely manner, and, were, nevertheless,
inadmissible under rule 702; and that there were no genuine issues of material fact
precluding summary judgment. This appeal followed.
D E C I S I O N
I. The district court did not err by determining that appellant’s state -law claims
were preempted by the federal MDA.

Appellant argues that the district court erred by granting Medtronic’s motion for
summary judgment and concluding that her claims were barred by federal preemption. The
district court shall grant a summary-judgment motion “if the movant shows that there is no
genuine issue as to any material fact and the movant is entitled to judgment as a matter of
law.” Minn. R. Civ. P. 56.01. “A party need not show substantial evidence to withstand
summary judgment.” Carlson v. SALA Architects, Inc., 732 N.W.2d 324, 327 (Minn. App.
2007) (quotation omitted), review denied (Minn. Aug. 21, 2007). Rather, to defeat a
summary-judgment motion, the nonmoving party must present sufficient evidence to allow
reasonable persons to find in its favor. Id. On a motion for summary judgment, the district
court must not weigh the evidence or make factual determinations. DLH, Inc. v. Russ, 566
N.W.2d 60, 70 (Minn. 1997).
On appeal, we review de novo both whether there is any genuine issue of material
fact and whether the district court erred in its application of the law. STAR Ctrs., Inc. v.
Faegre & Benson, L.L.P., 644 N.W.2d 72, 76-77 (Minn. 2002). In doing so, we must view
the evidence in the light most favorable to the party against whom judgment was granted.

9
Id. Whether federal law preempts state law is also an issue that we review de novo.
Angeles v. Medtronic, Inc., 863 N.W.2d 404, 409 (Minn. App. 2015).
A. MDA of 1976 and Federal Oversight
In 1976, Congress enacted the MDA to the Food, Drug, and Cosmetic Act (FDCA)
“to provide for the safety and effectiveness of medical devices intended for human use.”
Lamere v. St. Jude Med., Inc., 827 N.W.2d 782, 789 (Minn. App. 2013) (quoting Medtronic
v. Lohr, 518 U.S. 470, 474, 116 S. Ct. 2240, 2245 (1996)); see also Riegel v. Medtronic,
Inc., 552 U.S. 312, 315, 128 S. Ct. 999, 1002 (2008). Before the enactment of the MDA,
“the introduction of new medical devices was left largely for the States to supervise as they
saw fit.” Riegel, 552 U.S. at 315, 128 S. Ct. at 1002.
The passage of the MDA “imposed a regime of detailed federal oversight,”
including “various levels of oversight for medical devices, depending on the risks they
present.” Id. at 316, 128 S. Ct. at 1003 ; see also 21 U.S.C. § 360c (2012 & Supp. 2017).
“Devices that pose the least risk are designated as Class I, devices that pose a more harmful
risk are designated Class II, and devices that present a potential unreasonable risk of illness
or injury are designated Class III.” Lamere, 827 N.W.2d at 789 (quotations omitted). Class
III devices are subject to the FDA’s “strictest regulation.” Buckman Co. v. Plaintiff’s Legal
Comm., 531 U.S. 341, 344, 121 S. Ct. 1012, 1015 (2001); see 21 U.S.C. § 360c(a)(1)(C).
Appellant’s Virtuoso ICD is a Class III medical device.
Before Class III devices may be marketed, they must undergo a thorough review
process with the FDA. Buckman, 531 U.S. at 344, 121 S. Ct. at 1015 ; see generally 21
U.S.C. § 360e ( 2012 & Supp. 2017 ). The PMA process “requires the applicant to

10
demonstrate a reasonable assurance that the device is both safe and effective under the
conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.”
Buckman, 531 U.S. at 344, 121 S. Ct. at 1015 (quotations omitted).
The PMA process “is a rigorous one.” Medtronic, 518 U.S. at 477, 116 S. Ct. at
2247. “A manufacturer must submit what is typically a multivolume application.” Riegel,
552 U.S. at 317, 128 S. Ct. at 1004. The application must include, among other things, “a
full statement of the device’s components, ingredients, and properties,” the device’s
proposed labeling, and other information about the device’s manufacturing processes and
performance standards. Id. at 318, 128 S. Ct. at 1004 (quotations omitted).
The FDA spends an a verage of 1,200 hours on each submission. Buckman, 531
U.S. at 34 5, 121 S. Ct. at 1015. The FDA must “weig[h] any probable benefit to health
from the use of the device against any probable risk of injury or illness from such use.”
Riegel, 552 U.S. at 31 8, 128 S. Ct. at 1004 (quoting 21 U.S.C. § 360c(a)(2)(C)). “It may
thus approve devices that present great risks if they nonetheless offer great benefits in light
of available alternatives.” Id.
If the FDA approves the PMA application , the manufacturer is prohibited from
“mak[ing], without FDA permission, changes in design specifications, manufacturing
processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at
319, 128 S. Ct. at 1005. If a manufacturer wishes to make such changes, it must submit an
application for supplemental premarket approval (a PMA supplement), which the FDA
evaluates under the same rigorous standards of review as an initial application. Id.

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B. Federal preemption
Regulating medical devices is an enormously complicated task. In order to create
uniform standards across the country, Congress used its power under the Supremacy Clause
to preempt, or override, certain state or local laws. See U.S. Const. art. VI, cl. 2. Congress
added what is known as an express preemption provision to the MDA that states:
[N]o State or political subdivision 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 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) (2012); see also Brandt v. Marshall Animal Clinic, 540 N.W.2d 870,
878 n.4 (Minn. App. 1995) (“Express preemption occurs where Congress’ intent to preempt
is explicitly stated in the statute’s purpose.”), review denied (Minn. Feb. 9, 1996).
Determining whether claims are expressly preempted involves a two -step process.
First, this cou rt “must determine whether the [f]ederal [g] overnment has established
requirements applicable to” the specific device at issue. Riegel, 552 U.S. at 321 -22, 128
S. Ct. at 1006. Second, this court must “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 tha t relate to safety and effectiveness.” Id.
(quoting section 360k(a)).
The Supreme Court in Riegel held that the PMA process imposes federal
requirements specific to the particular device under review. Id. at 322-23, 128 S. Ct. at

12
1007; see also In re Medtronic, Inc., Implantable Defibrillators Litigation , 465 F. Supp.
2d 886, 894 (D. Minn. 2006) (“[T]hrough the PMA process, the FDA has established
specific federal requirements for the . . . devices’ design, testing, intended use,
manufacturing methods, performance standards, and labeling.”). There is no dispute that
appellant’s Virtuoso ICD underwent a rigorous PMA process. Thus, this court’s focus is
on the second inquiry of the two -step test. To satisfy the second inquiry and survive
express preemption under section 360k(a), appellant must show that her state common-law
claims “parallel” the requirements under federal law. See Lamere, 827 N.W.2d at 790.
In other words, appellant must show that her state -law claims “are equal to, or
substantially identical to” federal requirements. Id. (quotation omitted). State-law claims
premised on a violation of FDA regulations survive express preemption. See Riegel, 552
U.S. at 330, 128 S. Ct. at 1011 (“[Section] 360k does not prevent a [s]tate from providing
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.”); see also Lohr, 518 U.S.
at 513, 116 S. Ct. at 2264 (O’Connor, J., concurring in part and dissenting in part) (“Section
360k does not preclude [s]tates from imposing different or additional remedies, but only
different or additional requirements.).”
Surviving express preemption by showing a state-law claim merely parallels, rather
than adds to, a federal requirement is not enough. In addition to being expressly preempted,
a state-law claim may be impliedly preempted. The Supreme Court held in Buckman that
the FDCA does not prov ide a private right of action. 531 U.S. a t 349 n.4, 121 S. Ct. at
1018 n.4. Section 337(a) of the FDCA provides: “all such proceedings for the enforcement,

13
or to restrain violations, of this chapter shall be by and in the name of the United States.”
21 U.S.C. § 337(a) (2012). “[T]o avoid being impliedly preempted under Buckman, a claim
must ‘rely[] on traditional state tort law which had predated the federal enactments in
question[].’” Riley v. Cordis Corp. , 625 F. Supp. 2d 769, 777 (D. Minn. 2009) (quoting
Buckman, 531 U.S. at 353, 121 S. Ct. at 1012). Otherwise, “the plaintiff is effectively
suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the
plaintiff’s claim is thus impliedly preempted under Buckman.” Id.
Consequently, under Riegel and Buckman, the gap through which a state-law claim
must fit in order to survive express or implied preemption is narrow. Id.
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). For a state -law claim to survive, then, the claim
must be premised 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. (emphasis in original).
Appellant argues that “Medtronic violated a ‘parallel requirement’ by failing to
comply with three mandatory PMA obligations.” First, appellant contends that Medtronic
failed to comply with Specification No. 0114546, which, appellant alleges, is an FDA-
approved manufacturing specification that was part of the PMA. 5 Specification 0114546

5 Appellant’s belief that Specification 0114546 was part of the PMA supplemen t is based
on the following, as articulated in her appellate brief:

The PMA supplement for the Virtuoso included a
Product Qualification Report for the CRM -C Hybrid used in

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provides that “[t]he end terminations shall consist of plated tin over a nickel barrier layer.”
Appellant argues that, “[n]otwithstanding this clear directive,” Supplier A “manufactured
the end terminations using a plated tin over nickel barrier with an i ntermediate porous
copper alloy”—the use of which “was never discussed with FDA, let alone approved for
use.” She contends that Medtronic’s Director of Quality and Reliability, Nancy Willems,
agreed in her deposition that the specification required a tin-over-nickel configuration, and
that copper was not listed in the capacitor’s description.6
Second, appellant argues that her Virtuoso ICD failed to satisfy the battery-leakage
requirements set forth in the PMA “ due directly to the use of the unapproved por ous
copper.” She argues that Medtronic’s tests of the returned ICD “concluded that
[a]ppellant’s capacitor was leaking at a rate thirty-seven to forty times higher than allowed
under the PMA.” Pointing to other jurisdictions, appellant argues that “[c]ou rts

the Virtuoso, which was assigned part number A00263. See
Doc 31. The Product Qua lification Report stated the
component parts of the A00263 Hybrid are set forth in
Specification Number 0414492 Revision B, titled Bill of
Materials for the A00263 Hybrid , dated August 18, 2005. Id.
at 1. Specification 0114546 -002, in turn, was identifie d in
Specification 0414492 Revision B, as the “Component
Specifications” (i.e., the manufacturing requirements) for the
capacitors that failed in Appellant’s device. See Doc. 33 at
MDT-ConVirt-0009293.

6 Willems also testified in her deposition that “Medtronic [is] not the subject matter expert[]
on how to manufacture ceramic capacitors.” Willems testified that Medtronic relies on its
suppliers, such as Supplier A, to be subject-matter experts on what Medtronic is procuring
from them.

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considering this issue have overwhelmingly found performance standards are part of the
PMA.”
Third, appellant contends that the capacitor failed to comply with the mandatory
longevity and aging requirements set out in the PMA. She contends that, although “[t]he
PMA directed that the device was to last at least 5.1 years,” her ICD “lasted 34.5 months—
more than 25 months less than that required by the PMA.” Pointing to Willems’ s
deposition testimony, appellant argues that Medtronic “readily acknowledged that the
PMA imposed a binding longevity requirement” when Willems stated: “[T]he early battery
depletion devices are not acceptable, because they don’t meet the longevity requirements
that are set out in our PMA.” Appellant argues that , “where FDA impos es longevity
requirements, the failure to satisfy those requirements is a PMA violation.” 7 She further
argues that , despite the district court’s failure to address the following in its order,
“Medtronic manufactured a product that failed to comply with th e capacitor aging
requirements,” set forth in section 4.6 of the specification, thereby constituting another
PMA violation.

7 Appellant also argues that Medtronic did not present any evidence that the longevity
requirement was a mere estimate until it submitted its reply brief in suppo rt of its motion
to exclude Schreiber’s testimony. She conten ds that the district court’s order “was
predicated upon a document that was not supplied in connection with Medtronic’s Rule 56
motion,” and that the court’s “reliance on this document was clear error given Medtronic
did not raise the issue in its Motion for Summary Judgment.” Appellant does not cite any
caselaw in support of this proposition. Nevertheless, our review of the record establishes
that Medtronic did represent in its motion for summary judgment that the expected
longevity of the device was a mere estimate. In its memorandum in support of its summary-
judgment motion, Medtronic quoted language from the limited warranty and stated, “The
Limited Warranty makes clear that Medtronic does not warrant that the Virtuoso ICD will,
in fact, operate normally for five years.”

16
In the alternative, a ppellant argues that there are genuine fact iss ues precluding
summary judgment. Appellant alleges that the parties dispute whether Medtronic used
copper, whether the use of copper was part of the end terminations’ construction, and
whether Med tronic admitted that the PMA included certain performance standards.
Consequently, according to appellant, the district court’s dismissal of her claims was error.
We conclude that the district court did not err by determining that appellant’s state-
law claims were preempted by the federal MDA. Under the narrow exception to express
and implied pr eemption, appellant must show that her state -law claims are premised on
conduct that both (1 ) violates federal requirements and (2) would give rise to recovery
under traditional state tort law. See Riley, 625 F. Supp. 2d at 777. Appellant has not met
her burden.
1. Violation of federal requirements

Appellant’s claims are not premised on conduct that violate s federal requirements.
As the district court determined, appellant presented insufficient evidence that Medtronic
violated any federal requirement in the manufacture of her Virtuoso ICD. Indeed, the
affidavit and deposition testimony of Willems —testimony that appellant cites in support
of her argument —actually demonstrates that Medtronic’s manufacture of the ICD
complied with its requirements under the MDA. Willems testified that, when the hybrid
contained in appellant’s ICD was shipped from Medtronic, “it met all product requirements
and specifications,” and “all the design and manufacturing requirements.” A copy of the
test results was included with Willems’s affidavit.

17
Willems’s deposition testimony also established that the copper material in the
capacitor was a separate, distinct component from the “end terminations” requiring tin and
nickel. She explained, copper is the “base material” that “is the underlying material
underneath those end terminations.” She explained that Medtronic’s supplier, Supplier A,
which is an “expert[] on ceramic capacitor manufacturing,” would have made the decision
to use copper, based on the specifications supplied by Medtronic. She further testified that
it was not copper generally, but porous copper that ultimately caused the premature battery
depletion. And, although Wi llems testified that Medtronic’s internal specifications are
“indirectly” approved by the FDA, and that “longevity requirements” are “set out in our
PMA,” she also testified, several times, to her limited knowledge about the PMA process .
She testified that she had limited knowledge about what PMA submissions entail and that
she was not involved in the preparation of the Virtuoso ICD’s PMA application.
The undisputed affidavit and deposition testimony of another Medtronic employee
also established that appellant’s ICD was manufactured in compliance with FDA-approved
requirements. Franky Santiago Rivera, a senior quality systems manager at Medtronic,
testified that Medtronic has additional, “more stringent procedures,” that go beyond
requirements mandated by the FDA. Rivera attested that, at the time appellant’s ICD left
Medtronic’s manufacturing facility, it “was free from any deviation from the applicable
FDA-approved requirements as well as any internal Medtronic requirements.”
Appellant also presented insufficient evidence, as the district court determined, that
copper was incorporated with the plated tin and nickel as part of the capacitor’s end
terminations. Specification 0114546 provides: “The end terminations shall consist of

18
plated tin over a nickel barrier layer.”8 As the district court articulated in its order, “Figure
2 in Specification 0114546 shows that the X5R capacitor consisted of a ceramic body with
‘metalization’ at ends.” The district court determined that Supplier A’s s chematic of the
capacitor demonstrated that copper was part of the metalization, not the end terminations,
and that copper “s[at] in between the ceramic body of [the] capacitor and [the] plated tin
and nickel at the end termination of the capacitor.” The district court determined that
Willems’s testimony, establishing that copper was used as a “base material,” separate from
the tin and nickel material comprising the end termination, confirmed that metalization and
end termination “are not the same.” In reviewing the evidence in the light most favorable
to appellant, we conclude that she failed to present sufficient evidence to allow reasonable
persons to find that copper was part of the capacitor’s end terminations.
Appellant also presented insufficient evidence, as the district court determined, that
the use of copper generally was prohibited. Citing to Medtronic’s investigative report, the
district court concluded that “copper per se was not the cause of the problem; rather, the
specific type of copper from Supplier A (used in about 4 percent of the devices) was
susceptible to greater porosity.” The district court reasoned, “[I]t was Supplier A’s copper,
which was more porous and perm eable—not copper generally—that caused [appellant’s]

8 Appellant appears to concede in her appellate brief that Specification 0114546 was never
directly submitted to the FDA. Rather, as appellant articulates, Specification 0114546 was
referenced as a component specification in the Bill of Materials for the A00263 Hybrid,
which was referenced in the Product Qualification Report submitted with the PMA
supplement.

19
device to deplete prematurely,” and appellant failed to present any evidence “that the PMA
specified the porosity or permeability of copper to be used in X5R capacitors.” We agree.
While Specification 0114546 includes a rather detailed list of prohibitions, the use
of copper is not among them. Furthermore, appellant failed to explain how the capacitors
could function if her interpretation of Specification 0114546 was correct. Citing to
Medtronic’s explanation, the district court determined that “without the electrodes between
the ceramic body and the end terminations, there is no capacitor—and therefore no way to
meet the performance requirements of Specification 0114546.” Thus, even if Specification
0114546 was part of the PMA supplement, making it a federal requirement, appellant
presented insufficient evidence that the mere use of copper would constitute a federal
violation.
We are also not persuaded that there are any material disputed fact issues regarding
the use of copper . Citing to the Third Circuit’s decision in In re Fosamax (Alendronate
Sodium) Prods. Liab. Litig., 852 F.3d 268 (3d Cir. 2017), vacated and remanded sub nom.
Merck Sharp & Dohme Corp. v. Albrecht , No. 17-290, 2019 WL 2166393 (U .S. May 20,
2019), appellant argues that there are factual disputes concerning whether Medtronic
believed it had to comply with Specification 0114546. Appellant contends that, although
In re Fosamax “arises in the context of pharmaceutical regulations und er the FDCA, it is
relevant here in that its clear holding is that factual disputes regarding the manufacturer’s
preemption defense are reserved for the jury.”
The Third Circuit , in In re Fosamax , held that the question of whether the FDA
would have approved a change to a prescription drug’s label was a question of fact for the

20
jury to decide, rather than a question of law for the court. Id. at 289, 293. Accordingly,
the Third Circuit concluded, “A state-law failure-to-warn claim will only be preempted if
a jury concludes it is highly probable that the FDA would not have approved a label
change.” Id. at 293. Because the Third Circuit determined that a reasonable juror could
find it less than highl y probable that the FDA would not have approved the label change,
it concluded that the drug’s manufacturer was not entitled to summary judgment on its
preemption defense. Id. at 300.
Pending our decision in the matter before us, the United States Supre me Court
effectively reversed the Third Circuit’s holding. Albrecht, 2019 WL 2166393, at *9. The
Supreme Court held that issues concerning the nature and scope of FDA determinations
are questions of law to be decided by a judge. Id. Indeed, explained the Court, “sometimes
contested brute facts will prove relevant to a court’s legal determination about the meaning
and effect of an agency decision.” Id. Including, for example, that “the litigants may
dispute whether the drug manufacturer submitted all material information to the FDA.” Id.
However, the Court held:
[W]e consider these factual questions to be subsumed
within an already tightly circumscribed legal analysis. And we
do not believe that they warrant submission alone or to gether
with the larger pre-emption question to a jury. Rather, in those
contexts where we have determined that the question is “for the
judge and not the jury,” we have also held that “courts may
have to resolve subsidiary factual disputes” that are part and
parcel of the broader legal question.

Id. (quoting Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 838 (2015)).

21
Thus, c ontrary to appellant’s position, we conclude that the issue of whether
Specification 0114546 constituted a federal requirement is a question of law to be decided
by a judge. See id; see also S. Pine Helicopters, Inc. v. Phoenix Aviation Managers, Inc. ,
320 F.3d 838, 841 (8th Cir. 2003) (indicating that what constitutes a violation of federal
regulations is a matter of law) ; Denelsbeck v. Wells Fargo & Co. , 666 N.W.2d 339, 347
(Minn. 2003) (stating that “determining compliance with a regulation . . . is a question of
law”). And, if Specification 0114546 constituted a federal requirement, Medtronic would
be required to follow it, regardless of its subjective belief. We, therefore, reject appellant’s
contention that there are factual disputes concerning whether Medtronic believed
Specification 0114546 constituted a federal requirement with which it had to comply.
Appellant’s claims that the capacitors failed to meet battery leakage and longevity
requirements, as allegedly set forth in the PMA, are also without merit. As the record
indicates, appellant’s ICD underwent several different tests before it was sold to ensure the
device functioned properly. “PMA Supplement approval only constitutes approval of the
[device’s] design, testing, intended use, manufacturing methods, performance standards
and labeling—not the device’s success rate.” Hughes v. Cook, 452 F. Supp. 2d 832, 842
(W.D. Tenn. 2006). “The PMA process does not guarantee that every device is safe.”
Lamere, 827 N.W.2d at 792. “In fact, every case in which a court has held that § 360k(a)
of the MDA preempts state common law tort claims has invol ved a malfunctioning Class
III device.” Hughes, 452 F. Supp. 2d at 842 n.7.
Due to the inherent risks , unpredictable progression, and invasive nature of Class
III devices, Medtronic had in place express warnings advising its customers of the device’s

22
“severe limitations.” Medtronic’s general warning explained that the human body “places
severe limitations on the design and function of the device” that “unavoidably reduce the
potential performance and longevity of the device . . . despite the exercise of due care in
design, component selection, manufacture, and testing prior to sale.” (Emphasis added.)
Accordingly, Medtronic’s limited warranty expressly stated that it was, just that, a limited
warranty, and that Medtronic did not guarantee the de vice would last the entire five -year
warranty period. Furthermore, the Virtuoso ICD’s reference manual —which was
submitted as part of the PMA application —expressly used the terms , “projected service
life” and “estimate” throughout.
In sum, we conclude that , based on our review of the evidence in the light most
favorable to appellant, there is no genuine fact dispute that precluded the district court from
granting Medtronic’s motion for summary judgment. What constitutes a federal regulation
and, in turn, what constitutes a violation of that regulation are matters of law properly
determined by the court. See Albrecht, 2019 WL 2166393, at *9. And, while the issue of
whether a federal regulation has been violated may present a question of fact for the jury,
appellant presented insufficient evidence to allow a reasonable person to find that
Medtronic violated an FDA-approved regulation by using copper in the manufacture of her
Virtuoso ICD.
2. Recovery under traditional state tort law
Even if appellant had presented sufficient evidence to demonstrate a federal
violation, her claims would not give rise to recovery under traditional state tort law.
Minnesota requires a plaintiff to show that “(1) the product was in a defective condition

23
unreasonably dangerous to the user, (2) the defect existe d 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) . The undisputed affidavits and testimony of Willems and
Rivera establish, as the district court determined, that the device was not in a defective
condition when it left the manufacturer’s control . Indeed, as Willems attested, “several
tests or inspections were conducted during the manufacturing process to confirm that the
particular components and device as a whole functioned properly and met relevant
specifications.” Because appellant presented insufficient evidence to show that her claims
are premised on conduct that both violates federal requirements and would give rise to
traditional state tort recovery, the district court did not err by determining that her state-
law claims were preempted by the federal MDA, and, thus, subject to summary judgment.9
See Riley, 625 F. Supp. 2d at 777.
II. The district court did not abuse its discretion by determining that the report
and testimony of appellant’s expert witness were inadmissible.

Appellant argues that the district court abused its discretion by granting Medtronic’s
motion to exclude the report and testimony of her expert witness, Schreiber. We review a
district court’s ruling on the admissibility of expert testimony for an abuse of discretion.

9 Appellant’s breach of warranty, negligence, and negligent infliction of emotional distress
claims are derivative claims that depend on the outcome of her primary claim of strict
liability for a manufacturing defect. Because her primary claim is preempted, so too are
her derivative claims. See Lamere , 827 N.W.2d at 785, 791 -92 (declining to address
plaintiff’s derivative claims , including breach of express and implied warranty and
negligence, where plaintiff’s primary claim of strict liability for a manufacturing defect
was held to be preempted by federal law).

24
Hayes v. Comm’r of Pub . Safety, 773 N.W.2d 134, 136 -37 (Minn. App. 2009). Absent a
clear abuse of discretion, this court will not reverse a district court’s evidentiary ruling.
Benson v. N . Gopher Enters ., Inc. , 455 N.W.2d 444, 445 -46 (Minn. 1990). “Even if
evidence has probative value, it is still within the district court’s discretion to exclude the
testimony because it is a very deferential standard.” Hayes, 773 N.W.2d at 137 (quotation
omitted).
Minnesota Rule of Evidence 702 provide s that a district court “may” admit expert
testimony if the expert’s “ scientific, technical, or other specialized knowledge will assist
the trier of fact to understand the evidence or to determine a fact in issue.” “The proponent
of scientific evidence has the burden to establish the proper foundation for [its]
admissibility.” Goeb v. Tharaldson, 615 N.W.2d 800, 816 (Minn. 2000).
Opinion testimony “involving a legal analysis or mixed questions of law and
fact . . . are not deemed to be of any use to the trier of fact.” Minn. R. Evid. 704 1977
comm. cmt; see Behlke v. Conwed Corp., 474 N.W.2d 351, 359 (Minn. App. 1991) (“Legal
analysis by an expert is ordinarily inadmissible.” (quotation omitted) ), review denied
(Minn. Oct. 11, 1991); see also S. Pine Helicopters, 320 F.3d at 841 (“[E]xpert testimony
on legal matters is not admissible.”).
Appellant challenges the district court’s determinatio ns that (1) the disclosure of
Schreiber’s report was untimely and (2) Schreiber was not qualified to testify under rule
702. First, she contends that the district court’s order finding that the report was untimely
was error because she “disclosed Schreiber as an expert in 2012, more than 5 years before

25
Medtronic moved for summary judgment.” Further, argues appellant, the district court’s
scheduling order did not contain a deadline for expert reports.
Second, appellant contends that the district court erroneously determined that
Schreiber was unqualified to testify. She argues that the bulk of Schreiber’s report “dealt
with interpretation and discussion of technical terms” —terms that he was qualified to
interpret pursuant to his three decades’ experience as an electrical engineer in the medical-
device industry. She argues that the report was disclosed “to provide technical clarification
on the engineering terms subsumed within this case,” and, at the least, Schreiber should
have been permitted to testify “about basic electrical engineering principals.” Appellant
argues that Schreiber’s CV “clearly established” that his testimony would help the trier of
fact evaluate the evidence or resolve factual issues, as required under rule 702.
We conclude that the district court did not abuse its discretion by determining that
Schreiber’s report and testimony were inadmissible. First, as an initial matter, the district
court did not abuse its discretion by finding that appellant’s disclosure of the report was
untimely. The district court’s scheduling order provided that “[d]iscovery rela ting to the
threshold issue of federal preemption” was to “be completed by September 1, 2017.”
Despite this clear directive, appellant did not disclose Schreiber’s report, which specifically
focused on the issue of whether Medtronic violated its PMA manda tes, until December 6,
2017. Whether Medtronic committed PMA violations directly relates to the threshold issue
of federal preemption. Accordingly, appellant was ordered to disclose Schreiber’s report
by September 1, 2017. See Minn. R. Civ. P. 26.01(b)( 4) (requiring a party to disclose
expert testimony “at the times and in the sequence that the court orders”).

26
Second, the district court correctly concluded that Schreiber’s report , primarily
comprised of legal conclusions, rather than statements of fact or opinion, was inadmissible
under rule 702. See Minn. R. Evid. 704 1977 comm. cmt. In his report, Schreiber states,
Specification 0114546 “is both the floor and the ceiling for construction of the end
terminations for the capacitors. . . . Because the capacitors did not comply with the design
specification[,] . . . the product as manufactured, violated the PMA.” As we explained in
the preceding section, “determining compliance with a regulation . . . is a question of law.”
Denelsbeck, 666 N.W.2d at 347; see also Albrecht, 2019 WL 2166393, at *9. And expert
opinion as to a legal matter is generally inadmissible. Behlke, 474 N.W.2d at 359; see S.
Pine Helicopters, 320 F.3d at 841. As such, the district court did not abuse its discretion
by prohibiting Schreiber from opining on a legal question.
Affirmed.