IN RE: Bard Implanted Port Catheter Products Liability Litigation

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
IN RE: Bard Implanted Port Catheter
Products Liability Litigation
–––––––––––––––––––––––––––––––––––––
Robert Cook,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01975-PHX-DGC
ORDER
This multidistrict litigation (“MDL”) involves thousands of personal injury cases
related to implanted port catheters (“IPCs” or “ports”) designed, manufactured, and
marketed by Defendants Becton Dickenson and Company, C. R. Bard, Inc., Bard Access
Systems, Inc., and Bard Peripheral Vascular, Inc. (collectively, “Defendants” or “Bard”).
The MDL Plaintiffs received implants of Bard IPCs and claim they are defective and have
caused serious injury.
One of the MDL cases is brought by Plaintiff Robert Cook. He received a Bard IPC
in August 2022 and developed a port-related infection. His case has been chosen as one of
several bellwether cases and is set for trial in April 2026.
Defendants have filed a motion for summary judgment. Doc. 5832. The motion is
fully briefed and no party requests oral argument. See Docs. 6248, 6416. For reasons
stated below, the Court will grant the motion in part and deny it in part.
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I. Background.
An IPC is a medical device surgically implanted under the skin to provide repeated
access to a patient’s vascular system without the need for multiple needlesticks into
peripheral veins. IPCs are used to deliver chemotherapy and immunotherapy medication,
intravenous fluids, blood transfusions, and parenteral nutrition. IPCs can remain in place
for weeks, months, or even years until treatment is completed.
IPCs consist of a port and a catheter. The port is a small reservoir disc with a self-
sealing silicone center where a needle can be inserted to deliver medication. The port
typically is implanted beneath the chest skin and below the collarbone. The port is attached
to a catheter, which is a thin flexible tube for delivery of the medication to a vein. The
catheter is tunneled under the skin to an insertion point in a central vein. Catheters vary in
width and are made of silicone or polyurethane. IPCs typically are implanted by an
interventional radiologist or a vascular surgeon. A nurse or other medical professional then
accesses the IPC to inject the medication, which flows from the port to the catheter and
into the vein.
This MDL involves multiple versions of Bard IPCs, each of which received
premarket clearance from the Food and Drug Administration (“FDA”). The MDL
Plaintiffs allege that Bard IPCs are defective and have caused Plaintiffs to suffer serious
complications, including infection, thrombosis, and catheter fracture, migration, and
perforation. Plaintiffs claim that safer alternative designs and manufacturing processes
were available to Bard and that Bard IPCs are more dangerous than other treatment options.
See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
the risks associated with IPCs are understood by the medical community and are considered
by doctors when deciding whether to use them. Bard further contends that various factors
impact the performance and wear of IPCs, including where the catheter is inserted and how
well the device is maintained by medical professionals and the patient. See Docs. 23,
2023-1.
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II. Plaintiff Cook.
On August 24, 2022, Plaintiff Cook received a Bard PowerPort IPC with a
ChronoFlex polyurethane catheter at the Mayo Clinic in Rochester, Minnesota for
chemotherapy. Dr Richard Frimpong, an interventional radiologist, implanted the IPC.
Plaintiff developed a bloodstream infection and was diagnosed with sepsis ten days after
the implant.
Plaintiff claims the PowerPort caused his infection. He alleges the PowerPort was
defectively designed because the polyurethane used in the ChronoFlex catheter is a
hydrophobic material ripe for infection and Bard failed to coat the catheter with
antimicrobials or to use other non-fouling technologies. Plaintiff also alleges that Bard
failed to warn about and concealed the PowerPort’s risks, and that Bard made negligent
and fraudulent misrepresentations about the PowerPort.
Plaintiff asserts various claims against Defendants under Minnesota law, some of
which have been withdrawn.1 The following claims remain: design defect (Counts I
and II), failure to warn (Counts III and IV), misrepresentation (Counts IX and X),
concealment (Count XI), consumer fraud and unlawful trade practices (Count XII), unjust
enrichment (Count XIII), and punitive damages. See Doc. 216 (short-form complaint);
Doc. 1889 (master complaint, as amended).2
Defendants move for summary judgment on these claims. Doc. 5832 at 2. The
Court will grant summary judgment on the negligent misrepresentation claim and deny the
motion in all other respects.
1 The parties agree that Minnesota law governs Plaintiff’s claims. Docs. 5832 at 5,
6248 at 3.
2 The master complaint sets forth allegations and claims the MDL Plaintiffs assert
generally. See Doc. 145. Plaintiff-specific allegations are contained in individual short-
form complaints, profile forms, and fact sheets. See id.; Docs. 476, 477. The master
complaint asserts seventeen claims and seeks both compensatory and punitive damages.
Doc. 1889 ¶¶ 268-487. Plaintiff Cook does not assert loss of consortium, wrongful death,
or survival claims set forth in the master complaint (Counts XIV-XVI), and has withdrawn
claims for manufacturing defect (Counts V and VI), breach of warranty (Counts VII and
VIII), false advertising (Count XII), and successor liability (Doc. XVII). See Docs. 5832
at 2 n.1, 6248 at 3 n.2, 6416 at 2 n.1.
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III. Summary Judgment Standard.
Summary judgment is appropriate if the moving party shows there is no genuine
dispute as to any material fact and it is entitled to judgment as a matter of law. Fed. R. Civ.
P. 56(a). Summary judgment is also appropriate against a party who “fails to make a
showing sufficient to establish the existence of an element essential to that party’s case,
and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett,
477 U.S. 322, 323 (1986).
The moving party “bears the initial responsibility of informing the court of the basis
for its motion, and identifying those portions of [the record] which it believes demonstrate
the absence of a genuine issue of material fact.” Celotex, 477 U.S. at 323. Only disputes
over facts that might affect the outcome of the suit will preclude the entry of summary
judgment, and the disputed evidence must be “such that a reasonable jury could return a
verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
(1986). The Court must view the evidence in the light most favorable to the nonmoving
party, Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986), and
draw justifiable inferences in that party’s favor, Anderson, 477 U.S. at 255.
IV. Discussion.
A. Design Defect Claims (Counts I and II).
Plaintiff asserts strict liability and negligent design defect claims. Docs. 216 ¶ 15,
1889 ¶¶ 268-300. To recover under a strict liability theory, a Minnesota plaintiff must
establish three elements: (1) the defendant’s product was in a defective condition that
rendered it unreasonably dangerous for its intended use; (2) the defect existed when the
product left the defendant’s control; and (3) the defect was the proximate cause of the injury
sustained. Lee v. Crookston Coca-Cola Bottling Co., 188 N.W.2d 426, 432 (Minn. 1971);
Bilotta v. Kelley Co., 346 N.W.2d 616, 623 n.3 (Minn. 1984). To recover under a
negligence theory, the plaintiff must also show that the defendant had knowledge of the
product’s defective condition and the risks involved in that condition. See Bilotta, 346
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N.W.2d at 622 (noting the distinction between the two theories and explaining that such
knowledge is imputed to the defendant under the strict liability theory).3
Minnesota applies a “reasonable care” balancing test to determine whether a product
was designed in a defective condition that was unreasonably dangerous for its intended
use. Bilotta, 346 N.W.2d at 621 (citing Holm v. Sponco Mfg., Inc., 324 N.W.2d 207, 212
(Minn. 1982)). “[A] manufacturer is obligated to exercise that degree of care in his plan
or design so as to avoid any unreasonable risk of harm to anyone who is likely to be exposed
to the danger when the product is used in the manner for which the product was intended[.]”
Id. (quoting Holm, 324 N.W.2d at 212). “What constitutes ‘reasonable care’ will, of
course, vary with the surrounding circumstances and will involve ‘a balancing of the
likelihood of harm, and the gravity of harm if it happens, against the burden of the
precaution which would be effective to avoid the harm.’” Id. The test is an objective
standard that “focuses on the conduct of the manufacturer in evaluating whether its choice
of design struck an acceptable balance among several competing factors.” Id. at 622; see
also CIVJIG 75.20 (listing factors for determining whether a product was “unreasonably
dangerous because of the manufacturer’s design choices”). “Generally, the question of
whether a product is defective is a question of fact; however, where reasonable minds
cannot differ, the question becomes one of law.” Drager by Gutzman v. Aluminum Indus.
Corp., 495 N.W.2d 879, 882 (Minn. Ct. App. 1993).
3 Defendants assert that strict liability and negligence merge into one theory.
Doc. 5832 at 5 (citing Bilotta, 346 N.W.2d at 623; 4A Minn. Prac., Jury Instr. Guides –
Civil CIVJIG 75.20 Design Defect (6th ed. 2025)). Plaintiff notes that “commentators,”
not the Minnesota Supreme Court, have “suggested” these “distinct theories . . . actually
merge into one theory.” Doc. 6248 at 3 (quoting Bilotta, 346 N.W.2d at 622); see CIVJIG
75.20 (“Bilotta acknowledged suggestions that strict liability and negligence theories
merge into a single theory in design defect cases.”). The Court need not resolve this issue
at the summary judgment stage and will determine the proper jury instructions for the
design defect claims at trial. See Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1300
(D. Minn. 1988) (declining to decide the issue on summary judgment); Bilotta, 346 N.W.2d
at 623 (“[A]ssuming proper instruction to ensure the broadest theory of recovery, a trial
court could properly submit a design-defect or failure-to-warn case to a jury on a single
theory of products liability. Submission of a single theory of recovery may avoid the
confusion and inconsistent verdicts spawned by submission of multiple overlapping
theories without restricting a plaintiff’s ability to benefit from the elements of proof which
make strict liability a broader theory of recovery than traditional negligence.”).
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Defendants argue that Plaintiff’s design defect claims fail because he lacks evidence
of a safer alternative design and an unreasonably dangerous defect. Doc. 5832 at 6-11.
1. Safer Alternative Design.
a. Requirements of Minnesota Law.
In Kallio v. Ford Motor Co., 407 N.W.2d 92 (Minn. 1987), the Minnesota Supreme
Court considered whether a design defect plaintiff “must establish as an element of his case
that at the time of manufacture a safer, practicable, and technologically feasible alternative
design existed[.]” Id. at 94. Kallio held that the plaintiff has no such burden, but explained
that “normally evidence of a safer alternative design will be presented initially by the
plaintiff” and such “evidence is relevant to, and certainly may be an important factor in,
the determination of whether the product was unreasonably defective.” Id. at 96-97.
In so holding, Kallio noted that “rare cases may exist where the product may be
judged unreasonably dangerous because it should be removed from the market rather than
be redesigned.” Id. at 97 n.8. Defendants contend that this is the one narrow exception to
Minnesota’s alternative design requirement, and that because Plaintiff does not claim that
this is a rare case where the PowerPort should be removed from the market, he must prove
that there was a safer alternative design to survive summary judgment. Doc. 5832 at 6-7.
Plaintiff counters that after Kallio there is no alternative design requirement under
Minnesota law and he must show only that the PowerPort was in a defective condition
unreasonably dangerous. Doc. 6248 at 4-5.4
Federal district courts in Minnesota have disagreed on whether a plaintiff asserting
a design defect claim must present evidence of a safer alternative design or show that the
product should be removed from the market. See Docs. 5832 at 7, 6248 at 4-5; CIVJIG
75.20 (discussing the disagreement). In Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d
1128 (D. Minn. 2011), the plaintiff sued the manufacturer of a catheter to recover for
4 Plaintiff also states that he has not disclaimed a removal-from-market theory.
Doc. 6248 at 10. Defendants argue in their reply that Plaintiff lacks removal-from-market
evidence. Doc. 6416 at 3-4. The Court will not consider an argument made for the first
time in a reply brief. See Zamani v. Carnes, 491 F.3d 990, 997 (9th Cir. 2007).
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injuries he sustained when the catheter tip broke off in his heart during a medical procedure.
Id. at 1132. The plaintiff’s expert disclaimed any intention to offer an opinion on
alternative design. Id. at 1161. The district court concluded that “[w]ithout evidence of a
proposed alternative design, a jury [could] not possibly engage in the ‘reasonable-care
balancing test’ called for by Minnesota law.” Id. The court then considered whether proof
of an alternative design is required given the language in Kallio that, while plaintiffs in
design defect cases will normally present evidence of a safer alternative design, “it is not
necessarily required in all cases.” Id. (quoting Kallio, 407 N.W.2d at 96-97). Relying on
the footnote in Kallio regarding rare cases where the product should be removed from the
market, 407 N.W.2d 92 at 97 n.8, the court in Kapps concluded that “Kallio did not
dispense with the requirement of proving an alternative design[.]” Id. The court explained:
Kallio simply explains that in conducting the reasonable-care balancing test
that applies in all design-defect cases, the relative costs and benefits of an
allegedly defective design must be weighed against the relative costs and
benefits of one of two different things: either (1) a proposed alternative
design, or (2) the removal of the challenged product from the market. But a
plaintiff cannot prevail in a design-defect case simply by arguing, in the
abstract, that a product is defectively designed. Instead, the plaintiff must
explain why, under the reasonable-care balancing test, the world would be a
better place if the product were either designed differently or taken off the
market.
Id. Kapps granted summary judgment on the plaintiff’s design defect claim because he
presented no evidence of a safer alternative design or that the catheter should have been
removed from the market. Id.; see also Thompson v. Zimmer Inc., No. 11-CV-3099
PJS/AJB, 2013 WL 5406628, at *4-8 (D. Minn. Sept. 25, 2013) (granting summary
judgment where the plaintiff did not contend that the product should be taken off the market
and failed to present sufficient evidence of safer alternatives); Am. Fam. Ins. Co., S.I. v.
Pecron, LLC, No. 21-CV-1749 (KMM/DJF), 2023 WL 8654202, at *4 (D. Minn. Dec. 14,
2023) (same).
Plaintiff relies on McDougall v. CRC Industries, Inc., No. CV 20-1499 (JRT/LIB),
2024 WL 4894656 (D. Minn. Nov. 26, 2024), which reached a different conclusion.
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Doc. 6248 at 4-5. The district court in McDougall interpreted the footnote in Kallio “to
merely represent an example of cases where no alternative design evidence is required[,]”
explaining that “[i]f the Minnesota Supreme Court had intended to require plaintiffs to
present alternative design evidence or else prove that the product is so unreasonably
dangerous that it should be taken off the market, it could have said so in its opinion.” 2024
WL 4894656, at *7. The district court denied the defendant’s post-verdict motion for
judgment as a matter of law, rejecting its argument that the plaintiff was required to present
alternative-design evidence or show that the product should be taken off the market. Id.
The Eighth Circuit recently reversed the district court’s decision in McDougall,
explaining:
[Defendant] claims it is entitled to judgment as a matter of law because
[Plaintiff] failed to present evidence from which the jury could find that its
duster was unreasonably dangerous. [Plaintiff] responds that under
Minnesota law he didn’t have to present alternative design evidence. The
district court agreed with [Plaintiff], relying on a sentence from the
Minnesota Supreme Court’s decision in Kallio explaining that “evidence of
a safer alternative design . . . is not necessarily required in all cases.” [407
N.W.2d at 96-97]. But the footnote immediately following that sentence
explains its limited application: “Conceivably, rare cases may exist where
the product may be judged unreasonably dangerous because it should be
removed from the market rather than be redesigned.” Id. at 97 n.8. Kallio
clarified that in those “rare cases” where there is no feasible alternative
design, the jury can weigh the product’s potential harm against the burden of
removing the product from the market. But it is still the plaintiff’s burden to
either present alternative design evidence or assert that the product is so
unreasonably dangerous it should be removed from the market altogether.
McDougall v. CRC Indus., Inc., No. 24-3614, 2026 WL 367533, at *1 (8th Cir. Feb. 10,
2026) (citing Kapps, 813 F. Supp. 2d at 1161).
Because the law of the Eighth Circuit would be controlling if this case were to be
tried in a Minnesota federal court, the Court will follow the Eighth Circuit’s conclusion in
McDougall that the plaintiff has the “burden to either present alternative design evidence
or assert that the product is so unreasonably dangerous it should be removed from the
market altogether.” Id.; see also Wagner v. Hesston Corp., 450 F.3d 756, 760 (8th Cir.
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2006) (“Wagner did not assert that his was the ‘rare case’ involving a product so dangerous
that it should be removed from the market entirely,” so “the District Court would have
acted properly even if it had required the proffered experts to establish the existence of a
feasible alternative design.”) (citation modified). As explained below, however, Plaintiff
has presented sufficient evidence of a safer alternative design to create a genuine issue for
trial and avoid summary judgment.
b. Plaintiff’s Evidence of Safer Alternative.
Defendants concede that Plaintiff’s experts have identified many alternative designs
to the PowerPort with a ChronoFlex polyurethane catheter. Doc. 5832 at 7. These include
other IPCs such as the BioFlo, Avertex, Orphis, and Argyle, and different catheter materials
and coating technologies such as Biobloc, Chlorag+ard, “hydrophilic coatings and
nonfouling polymers,” and catheters coated with “minocycline and rifampin,”
“chlorhexidine, silver, and sulfadiazine,” and “silver alone, or silver combined with
platinum and carbon.” Id. at 8 (citing Doc. 5832-1 ¶¶ 49, 55).
Relying on Minnesota’s Jury Instruction Guides, Defendants contend that these
alternative designs are not sufficient because the experts have not identified the specific
costs of implementing them or weighed these costs against any potential benefit to Plaintiff,
as required to prove “feasibility.” Id. at 7-8 (citing CIVJIG 75.20). Defendants argue that
a jury would have no evidence from which it could reasonably find that any of the various
alternative designs were “‘feasible at the time the product was manufactured,’ because to
make that finding, it also ‘must find’ that when [Plaintiff’s] IPC was manufactured in 2021,
‘any increases in the cost or changes in the performance of the product would have been
outweighed by the added safety of the suggested alternative design.’” Id. at 9 (quoting
CIVJIG 75.20).
But the Jury Instruction Guides are not binding precedent. See Damgaard v.
McKennan, No. 13-CV-2192 (SRN/JSM), 2016 WL 215271, at *5 (D. Minn. Jan. 19,
2016); Miller v. Lewis on Behalf of Est. of Pavelich, No. A23-1937, 2024 WL 4195602, at
*3 (Minn. Ct. App. Sept. 16, 2024). And as Plaintiff notes, Defendants do not cite the
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committee’s standard instruction for design defect claims. Doc. 6248 at 5. Instead,
Defendants quote committee comments that cite Oregon law. See CIVJIG 75.20
(discussing a possible “feasible alternative design” instruction and explaining that “the
instruction is based upon Wilson v. Piper Aircraft Corp., 282 Or. 61, 577 P.2d 1332, 1326
(1978)”). The committee’s standard instruction for design defect claims identifies the “cost
and ease of taking effective precautions to avoid [the] harm” as a factor the jury should
consider in evaluating the manufacturer’s design choices, but this is one of several factors
the jury should consider among “all the facts and circumstances[.]” Id.; see also Omnetics,
Inc. v. Radiant Tech. Corp., 440 N.W.2d 177, 180-81 (Minn. Ct. App. 1989) (holding that
the trial court did not abuse its discretion in refusing to give the feasible alternative design
instruction set forth in the committee’s comments to CIVJIG 117 (now CIVJIG 75.20) and
explaining that counsel was free to argue the importance of a feasible alternative design in
closing arguments) (citing Kallio, 407 N.W.2d at 97); Bilotta, 346 N.W.2d at 622
(explaining that what constitutes reasonable care will “vary with the surrounding
circumstances” and the test is whether the defendant’s design choices struck an acceptable
balance “among several competing factors”). Defendants have not shown that they are
entitled to summary judgment simply because Plaintiff’s experts have not addressed
specific “costs of testing, developing, and manufacturing” the alternative designs or
undertaken a “complex economic analysis” of “the extensive 510(k) clearance process[.]”
Doc. 5832 at 8; see Krumm v. Bar Maid Corp., No. CIV. 11-2782 JNE/SER, 2013 WL
3064442, at *6 (D. Minn. June 18, 2013) (“Whether the increased cost of adding one or
both of the alternative designs is feasible . . . is a question for a jury. Thus, there is a
genuine dispute of material fact as to whether Krumm’s suggested alternative designs are
safer and feasible.”).
Defendants’ reliance on Pecron is misplaced. See Docs. 5832 at 7, 6416 at 4. The
expert in that case said “nothing about the relative costs and benefits” of his proposed
alternative design. 2023 WL 8654202, at *5. Here, Plaintiff’s expert Dr. Brian McVerry
opines that the alternative designs are “cost-effective” because “the cost of coating or
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additive technology remains a small percentage of the entire IPC kit[,]” and while “cost is
always a consideration, the reduced morbidity/mortality and improved patient quality of
life with the use of anti-fouling technologies outweighs incremental costs associated with
additional manufacturing processes.” Doc. 6248-37 at 43-44. Another expert, Dr. Bernard
Camins, opined that “an antimicrobial and/or anti-fouling catheter likely would have
prevented [Plaintiff’s] CRBSI and sepsis.” Doc. 5832-28 at 19; see also Docs. 6248 at 8-9,
6248-1 ¶¶ 59-63 (discussing similar expert testimony regarding costs and benefits of
alternative designs). Plaintiff also relies on Defendants’ own documents to show that
alternative designs are cost-effective. Doc. 6248-1 ¶ 59; see also McCormack, 154 N.W.2d
at 335 (upholding the jury’s verdict on a negligent design claim where the evidence
reasonably permitted a finding that an “inexpensive” alternative design would have
substantially reduced the danger that caused the plaintiff’s injuries).
Defendants note that the Avertex, Orphis, and Argyle IPCs are not available in the
United States and that Plaintiff’s experts do not address the likelihood that the FDA would
clear the alternative designs given that there are no antimicrobial IPCs available in the
United States. Doc. 5832 at 8. But Defendants cite no legal authority suggesting that an
alternative design must be available in the United States to be feasible, or that a plaintiff
must show the FDA would clear the device for market. Plaintiff notes, correctly, that these
requirements are not contained in CIVJIG 75.20 or any Minnesota case law cited by
Defendants. Doc. 6248 at 5-6 (citing Kramer v. Ford Motor Co., No. 12-CV-1149
(SRN/FLN), 2016 WL 827746, at *9 (D. Minn. Feb. 29, 2016) (holding that the plaintiff
sufficiently demonstrated an alternative design where the defendant had used it in vehicles
sold in Europe); Thacker v. Ethicon, Inc., 47 F.4th 451, 464 (6th Cir. 2022) (“[I]t is illogical
to say that an alternative design – that, by definition, was never put on the market – must
have been approved by the FDA to support a design defect claim. To require FDA approval
for a design that never came to fruition would likely doom all design defect claims in the
medical device context.”)).
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Plaintiff also is correct that an alternative design need not exist or be sold to be
feasible. See id.; Kramer, 2016 WL 827746, at *9 (“An expert rendering an opinion
regarding a feasible alternative design in a design defect case is not required to manufacture
a new device or a prototype in order for the opinion to be admissible[.]”); Kallio v. Ford
Motor Co., 391 N.W.2d 860, 863-64 (Minn. Ct. App. 1986), aff’d, 407 N.W.2d 92 (Minn.
1987) (“[Kallio’s expert] testified that he had designed a device that would decrease the
likelihood of the gear selector lever slipping back into reverse. He indicated that this device
would cost between $2.00 and $10.00 and that the device could be manufactured. We
recognize that Ford presented evidence that questioned the effectiveness of this proposed
device, and highlighted the fact that the proposed device had not been tested. The jury
could, however, have accepted the testimony of Kallio’s experts. That testimony was
sufficient to permit a jury to find that a practical, inexpensive, alternative design was
available.”).
What is more, Plaintiff presents evidence that Defendants’ own Avertex port, coated
with Covalon’s antimicrobial, suffices as an alternative design even if Defendants were not
able to bring the port to market. Doc. 6248 at 6 (citing 6248-1 ¶ 54); see Sanny v. Trek
Bicycle Corp., No. 11-2936 ADM/SER, 2013 WL 1912467, at *10 (D. Minn. May 8, 2013)
(denying summary judgment because “the reasonableness of [the defendant’s] decision” to
“forgo” an alternative design it previously employed “is a question of fact best decided by
a jury”). Plaintiff also presents evidence that Defendants use antimicrobial coatings like
Bardex and Biobloc on their urinary and hemodialysis catheters, noting that they may
“point to use of the alternative design on similar products.” Id. at 7 (quoting Kramer, 2016
WL 827746, at *9); see also McRunnel v. Batco Mfg., 917 F. Supp. 2d 946, 953 (D. Minn.
2013) (“Batco argues that it is appropriate to exclude expert testimony regarding proposed
design changes that have never been developed, tested, or subjected to peer review. In this
case, Huitink avers that other manufacturers have equipped similar belt conveyors with
guarding like Huitink’s proposed alternative design and Batco itself has produced
conveyors with similar guarding. . . . Given that there is some evidence to support
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feasibility, any vagueness and lack of testing for Huitink’s particular recommended
modification can be addressed on cross examination.”).5
The Court will deny Defendants’ motion based on an alleged absence of evidence
of a safer and feasible alternative design. Doc. 5832 at 6-10.
2. Unreasonably Dangerous.
Minnesota’s test for determining whether a product is unreasonably dangerous
involves ‘a balancing of the likelihood of harm, and the gravity of harm if it happens,
against the burden of the precaution which would be effective to avoid the harm.” Bilotta,
346 N.W.2d at 621 (citation omitted). Defendants argue that Plaintiff lacks evidence of
“the likelihood of harm,” which Defendants claim is “the rate of early infections in the
PowerPort as designed.” Doc. 5832 at 10-11. But Defendants cite no legal authority
suggesting that a specific infection rate is necessary to determine whether the PowerPort is
unreasonably dangerous. And Plaintiff explains that his experts cite the Iida 2021 study
showing an infection rate of nearly 15 percent for Bard ports. Doc. 6248 at 10 (citing Doc.
6248-1 ¶¶ 42, 46); see Doc. 6248-18 at 4.6 Plaintiff also explains that Defendants
recognized port-related infections as a common complication, hence their efforts to design
an infection-resistant port. Doc. 6248 at 10 (citing Doc. 6248-1 ¶ 47); see Doc. 6248-25
(Bard project opportunity appraisal for a “PowerPort with anti-microbial coating that will
resist bacterial adherence for a minimum of 31 days”).
Defendants assert that Plaintiff’s expert Dr. Darren Hurst “cannot say what the
infection rate (i.e., ‘the likelihood of harm”) is for the PowerPort[.]” Id. at 10 (citing
5 The parties dispute whether Plaintiff’s experts ignore risks of alternative designs,
such as peeling of polymer coating (Docs. 5832 at 9, 6248 at 9), but this dispute goes to
the persuasiveness of Plaintiff’s alternative design evidence and provides no basis for
granting summary judgment on the design defect claims.
6 Defendants note that the Iida study compared the Orphis port to the Bard X-Port
with a silicone catheter, not the PowerPort with a ChronoFlex catheter, and that the study
did not address early infection rates because it had a six-month follow-up. Doc. 6416 at 6.
Plaintiff notes that Defendants found the study to be a “high-quality” study that “suggests
the preventative role of MPC coating in [central venous catheter] infection.” Doc. 6248-1
¶ 46 (quoting Doc. 6248-4 at 76). Defendants will be free to cross-examine Plaintiff’s
experts about their reliance on the Iida study, but the jury must determine how much weight
it deserves.
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Doc. 5832-1 ¶ 46). But Dr. Hurst stated only that he does “not have an infection study for
Bard.” Doc. 5832-26 at 11. Defendants also note that Dr. Hurst stated he would be
“happy” with an infection rate of 4.5 percent – the rate reported for the Orphis port in the
Iida study. Doc. 5432 at 10 (citing Doc. 5832-1 ¶ 47); see Doc. 5832-6 at 13-14. Dr. Hurst
made clear, however, that he would want the infection rate “to be zero, if possible.”
Doc. 5832-26 at 14. Plaintiff notes that Drs. Camins and Sheikhi cited studies that found
zero infections when antimicrobial catheters were used. Doc. 6248 at 8-9 (citing
Doc. 6248-1 ¶¶ 42, 58).
Defendants assert that the only evidence of early infection rates for IPCs is a study
done by Dr. Frimpong that found a 0.55 percent infection rate for patients who had IPCs
placed at the Mayo Clinic between May 2020 and June 2021. Doc. 5832 at 8-9 (citing
Doc. 5832-1 ¶ 43). Defendants assert that the study involved predominately Bard IPCs,
but the study does not support this assertion or otherwise discuss the specific port models
involved in the study. See Docs. 5832-24, 6248-1 ¶ 42, 6428-16 at 16-17. Nor did the
study involve a comparison between Bard IPCs and IPCs with an antimicrobial coating. It
compared short-term infection rates related to port placement with and without antibiotic
administration. See id.
The Court will deny Defendants’ motion based on an alleged lack of evidence that
the PowerPort was unreasonably dangerous. Doc. 5832 at 10-11.
B. Warning-Based Claims (Counts III-IV and IX-XI).
Defendants argue that the “learned intermediary” doctrine forecloses Plaintiff’s
failure to warn, misrepresentation, and concealment claims. Doc 5823 at 11-17; see Docs.
216 ¶ 15, 1889 ¶¶ 301-34, 394-438. Under Minnesota law, the learned intermediary
doctrine is a defensive doctrine, not an offensive one. Kapps, 813 F. Supp. 2d at 1152;
Gray v. Badger Min. Corp., 676 N.W.2d 268, 275-76 (Minn. 2004). The defense is raised
by manufacturers of drugs or medical devices who are sued for failing to adequately warn
about risks associated with their products. Id. Under the doctrine, manufacturers have a
duty to warn physicians, not patients, about dangers associated with a drug or medical
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device. Id.; see Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885 n.1 (Minn. 1970)
(“The manufacturer has no duty to warn the lay public regarding prescription drugs.”);
Mozes v. Medtronic, Inc., 14 F.Supp.2d 1124, 1130 (D. Minn. 1998) (finding that
“Minnesota courts would follow the large number of jurisdictions that have applied the
doctrine to cases involving medical devices”); Bruzer v. Danek Med., Inc., No. CIV. 3-95-
971/RHKJMM, 1999 WL 613329, at *6 (D. Minn. Mar. 8, 1999) (“Where the product at
issue is a medical device or product, . . . the manufacturer’s duty to warn does not run to
the lay public but to the medical professional who will be using the product or device.”).
The learned intermediary doctrine forecloses a plaintiff’s failure to warn claim if the
defendant shows the plaintiff’s doctor received an adequate warning from the defendant or
if the doctor was aware of the information the defendant failed to provide and would have
taken the same action even if warned. Kapps, 813 F. Supp. 2d at 1152; Cornfeldt v. Tongen,
262 N.W.2d 684, 698 (Minn. 1977); see In re Levaquin Prods. Liab. Litig., 726 F. Supp.
2d 1025, 1027-28 (D. Minn. 2010) (“If a defendant properly establishes the facts necessary
to support the learned intermediary defense, a patient will be unable to show that the
defendant’s failure to warn the prescribing physician is a proximate cause of the patient’s
injury.”).
Defendants argue that Plaintiff’s warning-based claims are foreclosed under the
learned intermediary doctrine because Dr Frimpong never read Bard’s warnings, was
aware of the information Bard allegedly failed to provide, and would have taken the same
action even if Bard had included different information. Doc. 5832 at 12-17.
1. Whether Dr. Frimpong Read the PowerPoint IFU.
Defendants contend that “Dr. Frimpong testified, point blank, that he never read any
information from Bard about IPCs[.]” Doc. 5832 at 13. The Court does not agree with
this characterization of his testimony. When asked at his deposition whether he recalled
“receiving any written or oral information about their port devices,” he answered “No.”
Doc. 5823-23 at 5-6. But when shown the PowerPoint Instructions for Use (“IFU”), he
confirmed that he had received a copy of the IFU before implanting Plaintiff’s port and it
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looked familiar to him. Docs. 5832-23 at 13. And when shown several sections of the
IFU, Dr. Frimpong testified that he “followed those warnings” and “instructions” and
“correctly” implanted Plaintiff’s port “per Bard’s directions.” Doc. 6248-16 at 8-11.
Construing Dr. Frimpong’s testimony in the light most favorable to Plaintiff, as
required on this summary judgment motion, see Anderson, 477 U.S. at 255, the Court
concludes that Dr. Frimpong’s receipt of the IFU and familiarity with it, and his following
of Bard’s warnings and instructions, support a justifiable inference that he read the
PowerPort IFU before implanting Plaintiff’s port. See Doc. 6248 at 12.7
2. Whether Dr. Frimpong Was Aware of the PowerPort’s Risks.
Plaintiff claims that Bard should have warned Dr. Frimpong that the PowerPort’s
catheter was made of ChronoFlex polyurethane, a material that increases the risk of
infection. Docs. 5823 at 13, 6248 at 12. Plaintiff further claims that Bard should have
informed Dr. Frimpong about other available catheter coatings and materials, such as
antimicrobial or antithrombogenic options, that would reduce the infection risk. Id.
Defendants argue summary judgment is warranted under the learned intermediary
doctrine because Dr. Frimpong was aware of the information Plaintiff claims Bard failed
to provide. Doc. 5832 at 14. Defendants cite Dr. Frimpong’s testimony that infection was
a “known complication” that can occur with any IPC “even in the most ideal situation,”
that infection “remains one of the feared complications of port placement,” and that
infection risk was “top of mind” among him and his colleagues in 2020. Id. (citing
Doc. 5832-1 ¶¶ 22-24). But this testimony shows Dr. Frimpong had general knowledge of
IPC infection risks, not that he knew the information Plaintiff claims Bard failed to provide
7 Noting that Dr. Frimpong was never directly asked whether he read the IFU,
Defendants assert that summary judgment is warranted because Plaintiff has not met his
burden of showing that Dr. Frimpong read the allegedly inadequate warnings. Doc. 6416
at 8 & n.8. But Defendants have raised the learned intermediary doctrine as a defense and
therefore have the burden of showing Dr. Frimpong never read the IFU. See Kapps, 813
F. Supp. 2d at 1152; In re Levaquin, 726 F. Supp. 2d at 1027-28; Est. of Boggess v. U.S.
Bank N.A., No. 24-MC-43 (DWF/DJF), 2024 WL 4647989, at *4 (D. Minn. Nov. 1, 2024)
(“Defendants have the burden of proof as to their own defenses.”).
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regarding the increased infection risks associated with the ChronoFlex catheter. See
Doc. 6248 at 12-13.
Dr. Frimpong testified that he was not aware that the catheter he implanted in
Plaintiff was “something called Chronoflex, a type of polyurethane” – he just knew “it was
a regular Bard catheter that [the Mayo Clinic] had in stock.” Doc. 6248-16 at 4-5. He
would “go into the specifics of the product” only where a patient may not “tolerate one
specific product” or may have an “allergy to latex [or] silicone.” Id. at 5. He was not
aware of “any different rates of infection that might be associated with different catheter
substrates or materials,” but would “want the manufacturer to share that information with
[him].” Id. at 6-7. He made clear that Bard never informed him that different catheter
materials like “polyurethane versus silicone might present different risks of infection” or
“different surface roughness.” Id. at 7.
Defendants note that, as of August 2022, Dr. Frimpong knew that the short-term
IPC infection rate could be as high as 16 percent. Doc. 5832 at 14 (citing Doc. 5832-1
¶ 26). Defendants contend that this fact is dispositive because a 16 percent infection rate
is nearly four times higher than the 4.5 percent infection rate Dr. Hurst said he would be
happy with and twice as high as the 8 percent infection rate Dr. Hurst contends Bard should
have included in its warnings. Id.; Doc. 6416 at 8. But Dr. Hurst testified that he would
want the infection rate “to be as low as possible,” and even “zero” percent. Doc. 5832-26
at 14. Similarly, when asked whether he had seen an infection rate with Bard ports that he
would deem “unacceptable,” Dr. Frimpong stated that “[he] would prefer [the] rate of
infection to be zero. . . . Our goal is to knock it down to zero.” Doc. 6248-16 at 21-22.
The fact that Dr. Frimpong knew generally that the short-term infection rate for IPCs could
be as high as 16 percent says nothing about whether he would have wanted, and relied on,
information about the alleged increased risk of infection with the ChronoFlex catheter.
Defendants have presented no evidence that Dr. Frimpong knew, as Plaintiff claims, that
Bard’s uncoated ports have a higher infection rate than non-fouling ports, that antimicrobial
ports help prevent bacterial adhesion and infection, or that polyurethane is worse than
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silicone. See Doc. 6248 at 13 (citing Doc. 6248-1 ¶¶ 2, 22, 52). Defendants of course
dispute these facts, but the evidence must be viewed in Plaintiff’s favor at this stage. If the
jury believes the evidence of these alleged risks in Defendants’ IPCs, Defendants have
presented no evidence that Dr. Frimpong knew about them.
Defendants have not shown, as a matter of undisputed fact, that Dr. Frimpong knew
the information Bard allegedly failed to provide.
3. Whether Dr. Frimpong Would Have Taken the Same Action.
Defendants argue that Dr. Frimpong would have taken the same action in Plaintiff’s
treatment even if Bard had included the information it allegedly failed to provide.
Doc. 5832 at 15-17 (citing Doc. 5832-1 ¶¶ 31-40). But Dr. Frimpong testified that he
would have liked to know the “difference in infection rates between polyurethane and
silicone catheters.” Doc. 6248-16 at 6-7. He further testified that if he had information
“suggesting that Bard ports have a greater risk[] of infection than other ports, such as a
competitor’s technology,” that information “could . . . have impacted [his] decision about
whether to reimplant another Bard port.” Doc. 6248-16 at 19-20. Defendants note that
this testimony addresses Plaintiff’s post-infection replacement port. Doc. 5832 at 15-16
n.8. But Dr. Frimpong testified that, “during [the] interim from August to September of
2022,” he received no “new information from Bard about the safety of their port catheter
devices.” Doc. 6248-16 at 18. Drawing all reasonable inferences in Plaintiff’s favor, if
the information could have impacted Dr. Frimpong’s decision to use a Bard port post-
infection in September 2022, it also could have impacted his decision to implant Plaintiff’s
original Bard port in August 2022. See Docs. 6248 at 14, 6248-1 ¶ 35.
Defendants note that Dr. Frimpong testified that nothing he saw at his deposition
made him “second guess” his decision to implant a Bard port in August 2022. Doc. 5832
at 15 (citing Doc. 5832-1 ¶ 36). But Defendants do not contend that Dr. Frimpong was
shown all of Plaintiff’s evidence that Bard ports have an increased infection risk, or that
Plaintiff was obligated to show him the evidence.
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Defendants also note that the Mayo Clinic has carried “predominately” Bard IPCs
since Dr. Frimpong began working there in 2018. Id. at 16. But contrary to Defendants’
suggestion, this does not show that Dr. Frimpong had no choice but to implant a Bard
PowerPort IPC in Plaintiff. See Doc. 6248-1 ¶¶ 37-39.
The learned intermediary doctrine requires Defendants to prove that “the
prescribing physician would have taken the same course of action even if the defendants
had provided additional warnings.” In re Levaquin, 726 F. Supp. 2d at 1027. Construed
in the light most favorable to Plaintiff, the evidence creates a triable issue as to whether
Dr. Frimpong knew the true nature of the risks of the PowerPort IPC and would have acted
differently if Defendants had provided additional warnings and information about these
risks. See id. at 1036 (“[A]fter reviewing Dr. Butner’s deposition transcript, the Court finds
that Dr. Butner’s testimony regarding what he would have done if he had received a more
complete warning of the risks of tendon toxicity presents an issue of credibility that is
within the province of the trier of fact.”); Kruszka v. Novartis Pharms. Corp., 19 F. Supp.
3d 875, 895-96 (D. Minn. 2014) (denying summary judgment where the defendant did not
“offer sufficiently compelling evidence that [the plaintiff’s] doctors would have taken the
exact same course of action with full warnings” and the plaintiff had presented evidence
that the doctor “may have altered” his conduct); Block v. Woo Young Med. Co., 937 F.
Supp. 2d 1028, 1036 (D. Minn. 2013) (denying summary judgment where “the doctor never
testified that he did not read labels or . . . that he would have been unresponsive to
warnings”); Johnson v. Ethicon, Inc., No. 2:12-CV-0498, 2016 WL 7379009, at *5
(S.D.W. Va. Dec. 20, 2016) (applying Minnesota law and explaining that whether the
doctor would have taken the same action with additional warnings is a “question[] of fact
to be resolved by the jury”).
The Court will deny Defendants’ motion based on the learned intermediary doctrine.
Doc. 5832 at 11-17.
/ / /
/ / /
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C. Misrepresentation Claims (Counts IX and X).
Plaintiff asserts negligent and fraudulent misrepresentation claims. Docs. 216 ¶ 15,
1889 ¶¶ 394-426. Defendants argue that summary judgment is warranted on the negligent
misrepresentation claim because Minnesota has not recognized a cause of action for
personal injury under a negligent misrepresentation theory. Doc. 5832. The Court agrees.
The Minnesota Court of Appeals has affirmed the grant of summary judgment for
this very reason:
[Appellants] argue that the district court erred in concluding that under
Minnesota law, a negligent misrepresentation will not support a personal
injury claim. Our supreme court has neither specifically adopted nor rejected
the tort of negligent misrepresentation involving physical harm. Smith v.
Brutger, 569 N.W.2d 408, 414 (Minn.1997). Although not foreclosing the
possibility of recognizing the tort, the Smith court expressly declined to do
so in that case. Id. We, likewise, decline to recognize the tort in this case.
The district court did not err in granting summary judgment in favor of
respondents on [the] claim for personal injury based on a negligent
misrepresentation.
Goeb v. Tharaldson, No. CX-98-2275, 1999 WL 561956, at *9 (Minn. Ct. App. Aug. 3,
1999), aff’d, 615 N.W.2d 800 (Minn. 2000).
Plaintiff notes that whether Minnesota would recognize the claim remains an open
question. Doc. 6248 at 16. That may be true, but the Court declines to guess that Minnesota
will recognize such a claim. Id.; see Grozdanich v. Leisure Hills Health Ctr., Inc., 25 F.
Supp. 2d 953, 988 (D. Minn. 1998) (“Given the views of the majority of the Minnesota
Supreme Court, and the approaches taken by other Courts on the issue before us, prudence
counsels that we adhere to the Court’s rationale in Smith, and decline the Plaintiff’s
invitation to determine the viability of the tort of negligent misrepresentation which did not
involve the risk of physical harm.”); Forslund v. Stryker Corp., No. CIV. 09-2134 JRT/JJK,
2010 WL 3905854, at *6 (D. Minn. Sept. 30, 2010) (“Forslund has not stated a claim for
negligent misrepresentation as a matter of law. Forslund offers no support for the argument
that while the Minnesota Supreme Court has not foreclosed the possibility of recognizing
a negligent misrepresentation claim for physical harm, Minnesota law would permit such
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a claim here.”). The Court will grant Defendants’ motion with respect to the negligent
misrepresentation claim. Doc. 5832 at 17-18.
Defendants argue that Plaintiff’s fraudulent misrepresentation claim fails because
Bard made no representation to Plaintiff and Dr. Frimpong never read the PowerPort IFU.
Id. at 18. As explained, there is a triable issue as to whether Dr. Frimpong read the
PowerPort IFU before implanting Plaintiff’s port. See Doc. 6248-1 ¶¶ 27-28. The Court
will deny Defendants’ motion on the fraudulent misrepresentation claim. Doc. 5832 at 18.
D. Fraudulent Concealment Claim (Count XI).
Defendants cite Thornberg v. State Farm Fire & Casualty Co., No. 14-CV-122
SRN, 2015 WL 3612550 (D. Minn. June 9, 2015), for the proposition that fraudulent
concealment is not an independent cause of action in Minnesota. Doc. 5832 at 18.
Thornberg affirmed a magistrate judge’s conclusion that “fraudulent concealment is not an
independent cause of action, but is a doctrine that may toll the applicable statute of
limitations.” 2015 WL 3612550, at *5 (citing Hydra-Mac, Inc. v. Onan Corp., 450 N.W.2d
913, 918-19 (Minn. 1990)). But as Thornberg made clear, Hydra-Mac merely “discuss[ed]
application of the doctrine of fraudulent concealment to a statute of limitations [defense].”
Id. Neither the plaintiff in Hydra-Mac nor Thornberg asserted fraudulent concealment as
an independent cause of action. See id. (the magistrate judge “properly construed this claim
as an argument that the fraudulent actions of the Gerdins tolled the limitations periods of
Plaintiff’s claims”).
Other courts have found that a stand-alone fraudulent concealment claim is viable
in Minnesota. See Iverson v. Johnson Gas Appliance Co., 172 F.3d 524, 529 n.3 (8th Cir.
1999) (“Claims of fraud based on fraudulent concealment are distinct from the use of
fraudulent concealment to toll the statute of limitations.”) (citing Hydra-Mac, 450 N.W.2d
at 918; Cherne Contracting Corp. v. Wausau Ins. Co., 572 N.W.2d 339, 345 & n.2 (Minn.
Ct. App. 1998)); Cleveland v. Whirlpool Corp., 550 F. Supp. 3d 660, 678 (D. Minn. 2021)
(“A claim of fraudulent concealment must be based on an affirmative misrepresentation or
a failure to disclose certain facts rendering the facts disclosed misleading absent a party’s
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special duty to disclose.”); Qwest Commc’ns Co., LLC v. Free Conferencing, 990 F. Supp.
2d 953, 976 (D. Minn. 2014) (“To make a claim for fraudulent concealment, Qwest must
allege that Defendants deliberately concealed a material fact or were silent ‘in the face of
a duty to speak,’ that Defendants had knowledge, that Defendants intended for Qwest to
rely on the concealment, causation, and damages.”).
Defendants have not shown that they are entitled to judgment as a matter of law on
the fraudulent concealment claim. The Court will deny Defendants’ motion in this regard.
Doc. 5832 at 18.
E. Consumer Fraud and Unlawful Trade Practices Claims (Count XII).
Plaintiff asserts claims under the Consumer Fraud Act, Minn. Stat. § 325F.68, et
seq., and the Unlawful Trade Practices Act, Minn. Stat. § 325D.09 et seq. Docs. 216 ¶ 15,
1889 ¶ 444(x).8 Defendants argue that these claims must be brought under the Private
Attorney General Statute, Minn. Stat. § 831. Doc. 5832 at 18-19. But as Plaintiff explains
(Doc. 6248 at 17), Minn. Stat. § 325F.70 states that a person injured by a violation of
§ 325F.68 “may bring a civil action and recover damages . . . as determined by the court.”
And Minn. Stat. § 325D.15 provides that any person injured by a violation of § 325D.09 is
“entitled to sue . . . in any court of competent jurisdiction” for the “actual amount of
damages.” Plaintiff also makes clear that he is not pursuing these claims under the Private
Attorney General Statute (see Doc. 1889 ¶ 44(x)), and the public benefit requirement
Defendants cite therefore does not apply. Doc. 6248 at 17.9
The Court will deny Defendants’ motion with respect to the consumer fraud claim
under § 325F.68 and unlawful trade practices claim under § 325D.09. Doc. 5832 at 18-19.
F. Unjust Enrichment Claim (Count XIII).
Under Minnesota law, “[a]n unjust enrichment claim sounds in equity and requires
the plaintiff to establish the following elements: ‘(1) a benefit conferred; (2) the defendant’s
8 Plaintiff has withdrawn his false advertising claims under Minn. Stat. §§ 325D.43
and 325F.67. See Docs. 6248 at 17, 6416 at 2 n.1.
9 Defendants’ citation to In re Levaquin Prods. Liab. Litig., 752 F. Supp. 2d 1071,
1076 (D. Minn. 2010), is inapposite because the case did not involve § 325F.68 or
§ 325D.09. Doc. 6416 at 11.
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appreciation and knowing acceptance of the benefit; and (3) the defendant’s acceptance
and retention of the benefit under such circumstances that it would be inequitable for him
to retain it[.]’” Hull v. ConvergeOne, Inc., 570 F. Supp. 3d 681, 706 (D. Minn. 2021)
(quoting Dahl v. R.J. Reynolds Tobacco Co., 742 N.W.2d 186, 195 (Minn. Ct. App. 2007)).
Plaintiff pleads his unjust enrichment claim in the alternative. See Docs. 1889 ¶ 461,
6248 at 18. Contrary to Defendants’ assertion (Doc. 5832 at 19), a plaintiff may plead an
equitable claim as an alternative to a potential adequate remedy at law. See Fed. R. Civ.
P. 8(a)(3), (d)(2); Seutter v. Mead Johnson Nutrition Co., 763 F. Supp. 3d 783, 796 (D.
Minn. 2025) (“[U]njust enrichment is not available when there was an alternative adequate
remedy at law. Still, that does not necessarily preclude plaintiffs from pleading equitable
relief and other claims in the alternative.”) (citing Fed. R. Civ. P. 8(d)(2)-(3)); Kinetic Co.
v. Medtronic, Inc., 672 F. Supp. 2d 933, 948 (D. Minn. 2009) (“Under the federal rules, a
plaintiff may plead . . . alternative theories of recovery. At a later stage it may be necessary
for plaintiff to elect a theory, but at the pleading stage it is not.”) (citations omitted).
Defendants argue that unjust enrichment claims must be premised on an implied or
quasi-contract and there are no facts to infer such contracts between Bard and Plaintiff
because Bard sold its IPCs to the Mayo Clinic. Doc. 5832 at 19. But “[i]t is of no moment
that [Plaintiff] paid the hospital which purchased the device, as opposed to paying [Bard]
directly. The hospital has been made whole; [Plaintiff] has not; and [Bard] retains the
funds paid for the . . . product.” Kinetic, 672 F. Supp. 2d at 948; see also Herlache v.
Rucks, 990 N.W.2d 443, 447-52 (Minn. 2023) (affirming an unjust enrichment award
where the defendant was unjustly enriched not only by money the plaintiff paid directly to
the defendant but also by payments made to third parties); Warren v. ACOVA, Inc., 21
N.W.3d 218, 242-43 (Minn. Ct. App. 2025) (explaining that “the defining element of a
claim for unjust enrichment is the defendant’s wrongful retention of a benefit, without
regard to whether that benefit has been conferred by the plaintiff”).
The Court will deny Defendants’ motion on the unjust enrichment claim. Doc. 5832
at 19.
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G. Punitive Damages.
Plaintiff seeks an award of punitive damages. See Doc. 216 ¶ 15, 1889 ¶¶ 484-87.
Under Minnesota law, punitive damages may be awarded “upon clear and convincing
evidence that the acts of the defendant show deliberate disregard for the rights or safety of
others.” Minn. Stat. § 549.20(1)(a). A defendant acts with such deliberate disregard where
it “has knowledge of facts or intentionally disregards facts that create a high probability of
injury to the rights or safety of others” and “deliberately proceeds to act in conscious or
intentional disregard of” or “with indifference to the high probability of injury to the rights
or safety of others.” Id. § 549.20(1)(b). Relevant factors for determining whether an award
of punitive damages is warranted include “the seriousness of hazard to the public arising
from the defendant’s misconduct, the profitability of the misconduct to the defendant, the
duration of the misconduct and any concealment of it, the degree of the defendant’s
awareness of the hazard and of its excessiveness, [and] the attitude and conduct of the
defendant upon discovery of the misconduct[.]” Id. § 549.20(3).
Defendants argue that Plaintiff lacks clear and convincing evidence that Bard acted
with malicious, intentional, or deliberate disregard for his safety. Doc. 5832 at 20-21.
Plaintiff claims that Bard’s actions constitute a deliberate disregard for the safety of
Plaintiff and other patients given Bard’s knowledge of the high probability of increased
infection risks posed by the PowerPort and its other uncoated and outdated IPCs.
Doc. 6248 at 18. Plaintiff argues that a jury reasonably could award punitive damages
because evidence shows that Bard knew its IPCs were less safe than coated devices, and
yet never implemented known and feasible design improvements to address the serious risk
of infection. Id. at 18-19.
Minnesota courts have found that “willful indifference consist[s] of knowingly
continuing to market a profitable, but defectively manufactured, product.” Olson v. Snap
Prods., Inc., 29 F. Supp. 2d 1027, 1039 (D. Minn. 1998) (citing Gryc v. Dayton-Hudson
Corp., 297 N.W.2d 727 (Minn. 1980)). Plaintiff has presented evidence that IPCs made
without antimicrobial coatings or anti-fouling technologies, such as the PowerPort with a
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ChronoFlex catheter, have a significantly higher risk of infection than IPCs that include
such coatings or technologies. Doc. 6248-1 ¶¶ 42, 46. Plaintiff asserts that Bard knew that
antimicrobial coatings are common in the industry and have been sought by its customers
and recommended by the Centers for Disease Control and Prevention for years. Id. ¶¶ 47,
54-55. Plaintiff further asserts that Bard’s knowledge of the serious infection risk from
uncoated IPCs is what prompted it to design the Avertex coated port, but Bard refused to
spend less than $1 million to clear this life-saving technology and failed to act for more
than 15 years. Id. ¶ 54. Bard also represented that its IPCs are biocompatible, but knew
that the rough polyurethane catheters attract bacteria and are predisposed to microbial
colonization and infection. Id. ¶ 11.
This description of the evidence is made in the light most favorable to Plaintiff, as
required for a summary judgment ruling, and is disputed vigorously by Defendants. See,
e.g., Docs. 5832 at 20-21, 6416 at 11-12. But if believed by the jury, this evidence is
sufficient to support a finding that Bard’s uncoated IPCs “created a substantial danger to
the public” and that Bard “continued to market [the devices] even though there were
economically feasible measures which could have been taken to reduce this danger[.]”
Gryc, 297 N.W.2d at 741. A jury reasonably could conclude that Bard acted with deliberate
disregard for the safety of Plaintiff and other patients who received Bard IPCs. Minn. Stat.
§ 549.20(1)(a); see Kruszka, 19 F. Supp. at 898 (“Plaintiffs point to a long list of evidence
that, if true, could lead a reasonable jury to find that Defendant had acted with the requisite
disregard for the safety of patients taking Aredia. For example, Plaintiffs present evidence
of a number of instances that Defendant was made aware of concerns that bisphosphonates
caused ONJ prior to the time that labels and information to doctors communicated that
information. Plaintiffs also point to evidence that Defendant was aware doctors had seen
patients with ONJ and were concerned about a link to bisphosphonates.”) (citations
omitted).
Defendants note that they complied with applicable FDA regulations and the FDA
cleared their IPCs for market. Doc. 5832 at 21. But Defendants cite no legal authority
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suggesting that compliance with federal regulations precludes an award of punitive
damages, particularly where, as in this case, the device at issue was cleared by the FDA
under 510(k) review which focuses primarily on equivalence with other products, not
safety. Defendants also note that the Mayo Clinic where Plaintiff received his IPC
“achieved a 0.55 percent early infection rate using predominantly Bard IPCs.” Id. But as
explained, the short-term study Defendants cite does not indicate that Bard IPCs were used
predominantly and did not involve a comparison of IPCs with and without antimicrobial
coating or anti-fouling technologies. See Docs. 5832-24, 6248-1 ¶ 42.
The Court will deny Defendants’ motion on Plaintiff’s request for punitive damages.
Doc. 5832 at 20-21.
IT IS ORDERED:
1. Defendants’ motion for summary judgment (Doc. 5832) is granted in part
and denied in part. The motion is granted with respect to Plaintiff’s negligent
misrepresentation claim (Count IX). The motion is denied with respect to Plaintiff’s claims
for design defect (Counts I and II), failure to warn (Counts III and IV), fraudulent
misrepresentation (Count X), fraudulent concealment (Count XI), consumer fraud and
unlawful trade practices (Count XII), unjust enrichment (Count XIII), and punitive
damages.
2. A final pretrial conference is set for April 9, 2026 at 10:00 a.m. The trial is
set to begin on April 21, 2026 at 9:00 a.m. See Docs. 6028, 6875.
Dated this 5th day of March, 2026.
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