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
–––––––––––––––––––––––––––––––––––––
Kimberly Divelbliss,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01627-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.
Plaintiff Kimberly Divelbliss brings one of the MDL cases. She received a Bard
IPC that fractured. Her case has been chosen as one of several bellwether cases and is set
for trial in August 2026.
Defendants have filed a motion for summary judgment. Doc. 7092. The motion is
fully briefed and no party requests oral argument. See Docs. 7418, 7663. For reasons
stated below, the Court will deny the motion.
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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.
II. Plaintiff Divelbliss.
Plaintiff Divelbliss has received seven IPCs for intravenous immunoglobulin
infusions to treat an immunodeficiency. The Bard IPC at issue in this case (Plaintiff’s
second) is a PowerPort with a Groshong silicone catheter. Plaintiff received the PowerPort
on July 13, 2017, at Gerald Champion Medical Center in Alamogordo, New Mexico. Dr.
Gregory Richardson, a general surgeon, implanted the PowerPort. On December 13, 2019,
Plaintiff was hospitalized after the catheter fractured. A catheter fragment had embolized
to the right atrium of Plaintiff’s heart and was removed on December 19, 2019.1
Plaintiff claims the fractured catheter fragment caused her to suffer heart muscle
injuries and cardiac arrhythmia. She alleges the PowerPort was defectively designed
because the silicone used in the Groshong catheter is weak and prone to flex fatigue, and
1 Dr. Jorge Aguila performed the removal procedure. He subsequently implanted
five more IPCs in Plaintiff.
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the barium sulfate in the catheter (which makes it visible on diagnostic imaging) degrades
its mechanical integrity, leading to surface irregularities and fracture. Plaintiff also alleges
that Bard failed to warn about and concealed the PowerPort’s fracture risks, and made
misrepresentations about the PowerPort.
Plaintiff asserts various claims under New Mexico law, some of which have been
withdrawn.2 The following claims remain: design defect (Counts I and II), failure to warn
(Counts III and IV), manufacturing defect (Counts V and VI), misrepresentation and
concealment (Counts IX, X, and XI), unjust enrichment (Count XIII), and punitive
damages. See Doc. 175 (amended short-form complaint); Doc. 1889 (amended master
complaint).3 Defendants move for summary judgment on these claims. Doc. 7092 at 2.
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
2 The parties agree that New Mexico law governs Plaintiff’s claims. See Docs. 7092
at 5, 7418 at 2.
3 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 Divelbliss 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 breach of warranty (Counts VII and VIII), deceptive trade practices
(Count XII), and successor liability (Doc. XVII). See Doc. 7092 at 2 n.1.
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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. 175 ¶ 15,
1889 ¶¶ 268-300. Under New Mexico law, “[a] negligence claim is premised on the notion
that ‘the supplier of a product has a duty to use ordinary care to avoid a foreseeable risk of
injury caused by a condition of the product or manner in which it is used.’” Magoffe v.
JLG Indus., Inc., No. CIV 06-0973 MCA/ACT, 2008 WL 2967653, at *9 (D.N.M. May 7,
2008) (quoting New Mexico Uniform Jury Instruction – Civil (“UJI”) 13-1402). A strict
products-liability theory does not depend on the degree of care exercised by the supplier.
The focus is on the product, not the supplier, and considers the risk of injury the product
presents. Thus, “‘under the strict products liability theory, a supplier of products is liable
for harm proximately caused by an unreasonable risk of injury resulting from a condition
of the product or from a manner of its use.’” Id. (quoting Smith ex rel. Smith v. Bryco
Arms, 33 P.3d 638, 644 (N.M. Ct. App. 2001)); see also UJI 13-1406 (“Under the ‘products
liability’ claim, a supplier in the business of putting a product on the market is liable for
harm caused by an unreasonable risk of injury resulting from a condition of the product or
from a manner of its use. Such a risk makes the product defective.”); Rimbert v. Eli Lilly
& Co., 577 F. Supp. 2d 1174, 1202 (D.N.M. 2008) (“To recover under the strict liability
theory, a plaintiff must prove that a defect in the product as manufactured, designed, or
marketed created an unreasonably dangerous risk of injury.”).
Defendants argue that Plaintiff’s design defect claims fail because: (1) the
PowerPort is an “unavoidably unsafe product” under comment k to Restatement § 402A
and UJI 13-1419; and (2) Plaintiff has presented no evidence that the PowerPort’s risks
outweigh its benefits. Doc. 7092 at 3, 12-17.
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1. Comment k and UJI 13-1419.
Comment k to Restatement § 402A provides an exemption from strict liability for
certain “unavoidably unsafe products,” explaining:
There are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. . . .
Such a product, properly prepared, and accompanied by proper directions
and warning, is not defective, nor is it unreasonably dangerous.
Restatement § 402A, cmt. k.4
New Mexico has adopted the strict product liability standards in Restatement
§ 402A, with some exceptions and modifications. See McDonald v. Zimmer Inc., 461 P.3d
930, 944 (N.M. Ct. App. 2019). New Mexico’s “unavoidably unsafe products” exemption
from strict liability is set forth in UJI 13-1419, which provides:
There are some products which, even when properly prepared and
labeled, cannot be made safe for their intended and ordinary use. Because
of the nature of ingredients or natural characteristics of the products, use
of these products involves substantial risk of injury, and some users will
necessarily be harmed. Such products are said to be unavoidably unsafe.
Unless the product unreasonably exposes users to risk of injury, there is
no liability for supplying an unavoidably unsafe product. Whether users
are unreasonably exposed to risk of injury turns upon a balancing of the
dangers and benefits resulting from the product’s use.
UJI 13-1419; see also Zimmer, 461 P.3d at 945 (noting that UJI 13-1419 is “New Mexico’s
iteration of comment k”).
Defendants contend that Plaintiff’s design defect claims are precluded under
comment k and UJI 13-1419 because fracture is an inherent risk of all IPCs and the
PowerPort’s generic condition gave rise to the risk of injury alleged by Plaintiff. Doc. 7092
at 14. Plaintiff counters that comment k and UJI 13-1419 do not categorically shield
4 Comment k further explains that unavoidably unsafe products “are especially
common in the field of drugs.” Id. “An outstanding example is the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very serious and damaging
consequences when it is injected. Since the disease itself invariably leads to a dreadful
death, both the marketing and the use of the vaccine are fully justified, notwithstanding the
unavoidable high degree of risk which they involve.” Id.
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Defendants from liability on the design defect claims. Doc. 7418 at 3-5. The Court agrees
with Plaintiff.
UJI 13-1419 applies only where a product “cannot be made safe” for its intended
use and its “generic condition . . . gives rise to the risk of injury[.]” UJI 13-1419, use note.
It does not apply where the risk arises “from inadequacies of design, manufacture or
labeling.” Id.; see Zimmer, 461 P.3d at 945. Plaintiff claims the risk of injury in this case
arises from inadequate design, manufacturing, and labeling. See Docs. 175 ¶ 15, 7418 at
4-5. And she has presented evidence from which a jury reasonably could agree. See
Doc. 7418-1 ¶¶ 75, 91-99, 102-07, 119-36, 159-75, 231-60.
As the Zimmer court noted, UJI 13-1419 “expressly adopts a case-by-case inquiry,
as it contains a caveat that there may be strict liability even for an unavoidably unsafe
product, where the product ‘unreasonably exposes users to risk of injury.’” 461 P.3d at
945 (quoting UJI 13-1419). The risk-benefit determination “is a question of fact for the
jury[.]” Id. (quoting UJI 13-1419, comm. cmt.).
Defendants note that New Mexico courts have applied comment k to medical
devices. Doc. 7092 at 13 (citing Perfetti v. McGhan Med., 662 P.2d 646 (N.M. Ct. App.
1983)). In Perfetti, however, there was no evidence of an inadequate design, and whether
the subject product (a mammary prosthesis) was unavoidably unsafe was a question of fact
for the jury. 662 P.2d at 650. Defendants cite no New Mexico case finding as a matter of
law that a medical device is an unavoidably unsafe product. Cf. Zimmer, 461 P.3d at 945
(“As the evidence in this case makes clear, a finding that all modular hip implants present
some risk of corrosion is not a finding that all modular hip implants present an unavoidable
risk of metallosis.”); Aguirre v. Atrium Med. Corp., No. 2:18-CV-0153-WJ-GBW, 2019
WL 2210801, at *6 (D.N.M. May 22, 2019) (denying motion to dismiss where the
defendant cited no case concluding as a matter of law that all hernia mesh is incapable of
being made safe).
The Court will deny Defendants’ motion based on comment k and UJI 13-1419.
Doc. 7092 at 12-14.
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2. Risk-Benefit Analysis.
Under New Mexico law, “an unreasonable risk of injury resulting from a condition
of the product . . . makes the product defective.” UJI 13-1406. “An unreasonable risk of
injury is a risk which a reasonably prudent person having full knowledge of the risk would
find unacceptable.” UJI 13-1407. “In determining whether a product design poses an
unreasonable risk of injury, the fact-finder conducts a risk-benefit analysis, and considers
‘the ability to eliminate the risk without seriously impairing the usefulness of the product
or making it unduly expensive.’” Zimmer, 461 P.3d at 940 (quoting UJI 13-1407).
The risk-benefit analysis is guided by seven criteria identified in Brooks v. Beech
Aircraft Corp., 902 P.2d 54 (N.M. 1995), and incorporated into UJI 13-1407’s committee
commentary. See id. at 942. The criteria include: (1) the usefulness and desirability of the
product; (2) the availability of other and safer products to meet the same need; (3) the
likelihood of injury and its probable seriousness, i.e., “risk”; (4) the obviousness of the
danger; (5) common knowledge and normal public expectation of the danger (particularly
for established products); (6) the avoidability of injury by care in use of the product
(including the effect of instructions or warnings); and (7) the ability to eliminate the danger
without seriously impairing the usefulness of the product or making it unduly expensive.
See id.; UJI 13-1407, comm. cmt.; Brooks, 902 P.2d at 61 n.2 (citing John W. Wade, The
Nature of Strict Tort Liability for Products, 44 Miss. L. J. 825, 837-38 (1973)).
Defendants contend that summary judgment is warranted on the design defect
claims because Plaintiff cannot show the PowerPort is unreasonably dangerous under the
risk-benefit analysis. Doc. 7418 at 14. Specifically, Defendants argue that Plaintiff’s
experts did not consider all seven risk-benefit factors. Id. at 15-17. But as Plaintiff notes,
the factors are guideposts for argument at trial and jury deliberations, not a checklist for
summary judgment. Doc. 7418 at 2; see also UJI 13-1419, comm. cmt. (“Whether a risk
is reasonable is a question for the jury, balancing the benefits and hazards of the product.”).
“UJI 13-1407 states in the committee commentary that ‘criteria for determining whether a
risk of injury is unreasonable have not been provided in the instruction because the
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committee feels this falls within the unique domain of advocacy under the circumstances
of proof in each case.’ The commentary then lists the seven risk-benefit criteria suggested
by Professor John W. Wade[.]” Zimmer, 461 P.3d at 942 (quoting UJI 13-1407, comm.
cmt.). There is simply “no support for [Defendants’] contention that all seven factors must
be considered for every design defect claim.” Id.
Defendants assert that Plaintiff has identified no alternative design. Doc. 7092 at
15. “[C]onsideration of alternative designs is but one of several risk-benefit considerations
that a jury may balance in determining whether a product created an unreasonable risk of
injury.” Zimmer, 461 P.3d at 942-43 (quoting Bustos v. Hyundai Motor Co., 243 P.3d 440,
452 (N.M. Ct. App. 2010)). “[C]ontrary to Defendants’ argument, a specific finding on
this issue is not required.” Bustos, 243 P.3d at 452. Even so, Plaintiff’s experts do address
alternative designs, opining that catheters made of polyurethane or mesh reinforcements
would reduce the risk of fracture. Doc. 7092 at 15; see Doc. 7418 at 7. Plaintiff identifies
multiple ports already on the market that she claims are economically feasible and more
fracture resistant than the PowerPort. See Doc. 7418 at 7.5
Defendants further argue that Plaintiff offers no evidence of obviousness, common
knowledge, or inadequate warnings. Doc. 7092 at 16. But again, there is no checklist of
factors for summary judgment. The jury will decide whether the product was unreasonably
dangerous in light of Plaintiff’s evidence of allegedly high fracture rates in Defendants’
Groshong catheters and the availability of safer designs. The Court also finds a question
of fact on the adequacy of Defendants’ warnings, as explained below.
5 Contrary to Defendants’ assertion (Doc. 7092 at 15), the proposed alternative
designs need not completely eliminate the risk of fracture. See Doc. 7418 at 6; Zimmer,
461 P.3d at 943 (noting that the alternative design “virtually” eliminated the risk of
metallosis). And Defendants cite no legal authority suggesting that an alternative design
must be FDA-cleared or commercially available in the United States to be relevant to the
risk-benefit analysis under New Mexico law. See 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.”); In re Ethicon Inc. Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2327,
2020 WL 1060970, at *3 (S.D.W. Va. Feb. 13, 2020) (explaining that FDA-clearance “has
no bearing on whether PVDF mesh is a safer alternative to other mesh products”).
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The Court will deny Defendants’ motion based on an alleged absence of evidence
that the PowerPort’s risks outweigh its benefits. Doc. 7092 at 14-17.
B. Failure to Warn Claims (Counts III and IV).
To establish a failure to warn claim under New Mexico law, a plaintiff must prove:
(1) no warning was provided or the warning was inadequate, and (2) the absence or the
inadequacy of the warning caused the plaintiff’s injury. See Suttman-Villars v. Argon Med.
Devices, Inc., 553 F. Supp. 3d 946, 961 (D.N.M. 2021); Richards v. Upjohn Co., 625 P.2d
1192, 1195 (N.M. Ct. App. 1980). In the context of a failure to warn claim involving a
medical device, the manufacturer must warn the doctor – the “learned intermediary” – not
the patient. Suttman-Villars, 553 F. Supp. 3d at 961 (citation omitted); see also Perfetti,
662 P.2d at 650 (“A manufacturer of a product which is obtainable only through the
services of a physician, fulfills its duty if it warns the physician of the dangers attendant
upon its use, and need not warn the patient as well.” (citation modified)); Richards, 625
P.2d at 1195 (“A drug manufacturer has a duty to warn the medical profession of the
dangers of its drugs which it knew or should have known to exist.”).
Plaintiff asserts strict liability and negligent failure to warn claims. Docs. 175 ¶ 15,
1889 ¶¶ 301-34. For purposes of a negligence claim, the medical device manufacturer
“must make reasonable efforts to warn.” Richards, 625 P.2d at 1196; see UJI 13-1415 (the
manufacture “must use ordinary care to warn of a risk of injury”). The manufacturer’s
failure to provide an adequate warning renders the medical device “unreasonably
dangerous, and the [device] is then a defective product for purposes of strict products
liability.” Richards, 625 P.2d at 1196; see UJI 13-1415 (“Under plaintiff’s claim of
‘products liability’, a product presents an unreasonable risk of injury if put on the market
without warning of a risk which could be avoided by the giving of an adequate warning.”).
Defendants argue that summary judgment is warranted because: (1) the warnings
provided in the PowerPort’s Instructions for Use (“IFU”) are adequate as a matter of law,
and (2) the learned intermediary doctrine forecloses the failure to warn claims. Doc. 7092
at 3, 7-12.
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1. Adequacy of the Warning.
Defendants contend that the IFU for Plaintiff’s PowerPort identifies the risks and
injuries that Plaintiff alleges she experienced. Id. at 7 (citing Doc. 7092-1 ¶¶ 57-63). The
IFU warns about certain catheter fractures and lists various cardiac injuries as possible
complications, including arrhythmia. See Doc. 7092-1 ¶¶ 58-61; Doc. 7092-6.
A warning is adequate only if it discloses both “the nature and extent of the danger.”
Suttman-Villars, 553 F. Supp. 3d at 961 (quoting Jones v. Minn. Min. & Mfg. Co., 100
N.M. 268, 669 (N.M. Ct. App. 1983)). The warning “must adequately indicate the scope
of the danger” and “reasonably communicate the extent or seriousness of the harm” that
could result from use of the device. Richards, 625 P.2d at 1196. “[A] simple directive
warning may be inadequate when it fails to indicate the consequences that might result
from failure to follow it[.]” Id.; see also UJI 13-1418 (“To be adequate, a warning . . . must
disclose the nature and extent of the danger . . . [and] there must be specified any harmful
consequence which a reasonably foreseeable user would not understand from a general
warning of the product’s danger or from a simple directive[.]”).
Plaintiff presents evidence that Defendants’ warnings were inadequate because the
IFU does not warn that catheter fracture can be catastrophic and life-threatening, that
fracture of their catheters commonly occurs, or that barium sulfate, weak silicone, flex
fatigue, and subclavian placement increase the risk of fracture. Doc. 7418 at 8 (citing Doc.
7418-1 ¶¶ 91-93, 102-07, 134-36, 231-60). Plaintiff also presents evidence that the IFU
inadequately warned about the risk of arrhythmia and misrepresented that the catheter
materials are biocompatible. Id. at 8-9 (citing Doc. 7418-1 ¶¶ 164, 231-33, 245). Plaintiff’s
evidence creates a question of fact on whether Defendants adequately warned about the
scope of the danger and the extent or seriousness of the harm that could result from use of
the PowerPort.
Defendants rely on Serna v. Roche Laboratories, 684 P.2d 1187 (N.M. Ct. App.
1984), but the plaintiff in that case “introduced no evidence which would support a factual
question as to the adequacy of the warnings.” 684 P.2d at 1190. When the nonmovant
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presents evidence of the inadequacy of the warnings, as Plaintiff does here, “it is improper
for the court to grant summary judgment for the . . . manufacturer.” Id.; see also Perfetti,
662 P.2d at 650 (“The Committee Comment to [UJI 13-1418] points out that the adequacy
of a warning is ordinarily a question of fact.”); Richards, 625 P.2d at 1196 (“Richards has
presented evidence that [the] warnings were inadequate. . . . There is also evidence that
the warnings which were given by Upjohn were unclear, and that they did not effectively
communicate to physicians the dangers from using the drug to irrigate wounds. In these
circumstances, there is a genuine issue as to whether Upjohn’s warnings were adequate.”);
Rimbert, 577 F. Supp. 2d at 1230 (“Rimbert has presented some evidence that the Prozac
warnings may have been inadequate. . . . The Court cannot say that, as a matter of law, the
Prozac warnings in 2003 were adequate. There is an issue of material fact regarding
whether the warnings were adequate, and thus Eli Lilly is not entitled to summary
judgment[.]”).
The Court will deny Defendants’ motion based on their argument that the
PowerPort’s warnings were adequate as a matter of law. Doc. 7092 at 7-8.
2. Learned Intermediary Doctrine.
Defendants contend that the failure to warn claims are foreclosed by the learned
intermediary doctrine because Dr. Richardson was aware of the information Plaintiff
claims Defendants failed to provide and because a different warning would not have
changed his decision to treat Plaintiff with the PowerPort. Doc. 7092 at 8-12. Plaintiff
argues that fact disputes preclude summary judgment based on the learned intermediary
doctrine. Doc. 7418 at 9-12.
a. Dr. Richardson’s Knowledge of the PowerPort’s Risks.
Dr. Richardson testified that he has implanted and removed hundreds of IPCs and
that when making treatment decisions, he primarily relies on his education, training, and
forty years of experience. Doc. 7092 at 8 (citing Doc. 7092-1 ¶¶ 23-25, 30-31, 34-35, 38);
see also Doc. 7092-16. Defendants note that Dr. Richardson also testified that he was
aware of the risk of fracture, catheter embolization, and cardiac arrhythmia, and that
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everything that occurred with Plaintiff was a known potential risk of having an IPC
implanted. Doc. 7092 at 8 (citing Doc. 7092-1 ¶¶ 24-35, 38, 47); see also Doc. 7092-16.
But as Plaintiff argues, this testimony shows Dr. Richardson had general knowledge of IPC
fracture risks and related complications, but not that he knew the specific information
Plaintiff claims Bard failed to provide regarding the increased risks associated with the
PowerPort’s Groshong silicone catheter. Doc. 7418 at 9-10; see also Jones, 669 P.2d at
750 (“[T]he radiotherapists knew the risks of excessive dosage – injury to structures in the
immediate area of the prostate, rectal injuries that could require colostomies, urethral
strictures that could require surgical correction, the development of fistulae. 3M states that
these risks were exactly the same as the injuries plaintiffs allege they received. Thus, 3M
asserts the actual knowledge requirement was met. We do not agree because this argument
goes only to general knowledge of the danger in implanting I-125 seeds.”).
Dr. Richardson testified that he read the PowerPort’s IFU, expected it to be accurate,
and would expect the manufacturer to have more information about the device and to let
him know if the device had problems. Doc. 7418 at 9 (citing Doc. 7418-1 ¶¶ 250-53). He
also testified that he was not aware of specific risks Plaintiff claims existed in the
PowerPort, including that (1) Groshong silicone catheters were weaker and more prone to
fracture than other catheters; (2) the potential for barium sulfate to separate from the
catheter made it more prone to fracture; (3) catheter fracture was not uncommon;
(4) lifelong cardiac arrhythmia (as opposed to reversible arrhythmia) is a possible
complication; and (5) subclavian placement should be avoided. Id. at 9-10 (citing
Doc. 7092-1 ¶ 255); see also Doc. 7419-57 at 16, 20, 22, 26-27. Plaintiff presents evidence
to support these alleged shortcomings. Doc. 7418-1 ¶¶ 85, 91-93, 102-03, 107, 120-22,
130, 135-42, 145-46, 160-65, 172, 233, 242, 247-48. Defendants dispute these facts, but
the evidence must be viewed in Plaintiff’s favor at this stage. See Anderson, 477 U.S. at
255. If the jury believes the evidence of these alleged risks in the PowerPort, Defendants
have presented no evidence that Dr. Richardson knew about them.
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Defendants have not shown, as a matter of undisputed fact, that Dr. Richardson
knew the information Defendants allegedly failed to provide. See Jones, 669 P.2d at 751
(finding “a factual issue as to the radiotherapists’ knowledge of the nature and extent of
the danger of excessive radiation in implanting I-125 seeds in treating cancer of the
prostate,” and that “summary judgment was improper”).
b. Dr. Richardson’s Decision to Implant a PowerPort IPC.
Defendants contend, as a matter of law, that a different warning would not have
changed Dr. Richardson’s decision to treat Plaintiff with the subject PowerPort. Doc. 7092
at 9-12. They argue that Dr. Richardson testified he did not rely solely on warnings
contained in the PowerPort’s IFU and gave more credence to his own experience
implanting IPCs, that he could not answer hypothetical questions about specific risks
“out of context,” and that it would be “pure speculation” as to whether he would have used
a better IPC if one had been available. Id. at 9-11 (citing Doc. 7092-1 ¶¶ 24-25, 38, 41,
45). Defendants emphasize that when asked whether, in retrospect, he would have changed
his decision to treat Plaintiff with the PowerPort, he answered: “I don’t believe so.” Id.
at 11 (citing Doc. 7092-1 ¶ 45); see also Doc. 7092-16 at 52.
But Dr. Richardson also testified that he would not implant an IPC in a patient if the
manufacturer had told him it was unsafe; that he would have considered placing a more
fracture-resistant catheter in his patients; and that if Defendants had made him aware that
Groshong silicone catheters were weaker and more prone to fracture than other available
catheters, he would have factored that into his decision-making. Doc. 7418 at 10 (citing
Doc. 7418-1 ¶¶ 255-57); see also Doc. 7419-57 at 27. Construed in the light most favorable
to Plaintiff, the evidence creates a triable issue as to whether Dr. Richardson would have
acted differently if Defendants had provided additional warnings and information. See
Richards, 625 P.2d at 1195 (explaining that “[p]roximate cause is a factual issue, unless all
facts regarding causation are undisputed”).
Defendants’ reliance on Silva v. Smithkline Beecham Corp., No. 31,276, 2013 WL
4516160 (N.M. Ct. App. Feb. 7, 2013), is misplaced. Doc. 7092 at 9. The undisputed
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evidence in that case established that the prescribing physician did not rely on any warning
provided by the defendant when she prescribed the drug to the plaintiff, that she was aware
of the specific risks that the plaintiff claimed should have been included in the warning,
and that she held an “unequivocal” position to prescribe the drug irrespective of the
adequacy of the warning. Silva, 2013 WL 4516160, at *3.
The Court will deny Defendants’ motion based on the learned intermediary doctrine.
Doc. 7092 at 8-12.
C. Manufacturing Defect Claims (Counts V and VI).
Plaintiff asserts strict liability and negligent manufacturing defect claims.
Docs. 175 ¶ 15, 1889 ¶¶ 335-66. Under New Mexico law, a product “contains a
manufacturing defect when the product departs from its intended design[,]” and strict
liability exists “even though all possible care was exercised in the preparation and
marketing of the product.” Parker v. St. Vincent Hosp., 919 P.2d 1104, 1108 (N.M. Ct.
App. 1996); see also Spectron Dev. Lab’y v. Am. Hollow Boring Co., 936 P.2d 852, 856
(N.M. Ct. App. 1997) (same).
Defendants argue that Plaintiff’s manufacturing defect claims fail as a matter of law
because she has produced no evidence that the PowerPort deviated from Defendants’
design specifications. Doc. 7092 at 17. Specifically, Defendants assert that Dr. Ahmed
El-Ghannam, Plaintiff’s biomaterials expert, admitted that he did not look at design
specifications. Doc. 7092-1 ¶ 10.
Viewed in the light more favorable to Plaintiff, she has identified Bard documents
showing that barium sulfate should be evenly distributed in the Groshong catheter to make
it less fragile. Doc. 7418 at 13 (citing Doc. 7418-1 ¶ 165); see also Docs. 7418-71 at 8,
7418-12 at 2. Dr. El-Ghannam states in his report that a common observation of his
catheter testing was the non-homogenous dispersion of barium-sulfate. Doc. 7418-14 at 8.
A jury reasonably could conclude from this evidence that the manufactured catheter
departed from its intended design.
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New Mexico law does not require a plaintiff to identify specifically how a
manufacturing defect occurred. Parker, 919 P.2d at 1108 (“When . . . a product comes off
the assembly line with a manufacturing defect, it may be very difficult for a plaintiff to
establish what went wrong on the assembly line, much less prove that the error was the
result of negligence. In this regard, strict products liability can be viewed as simply an
extension of the doctrine of res ipsa loquitur. [And the] existence of a manufacturing defect
in itself may imply that the manufacturer was negligent.”). Defendants’ citation to
Figueroa v. Ethicon, Inc., No. 2:19-cv-01188 KWR/KRS, 2020 WL 1434249, at *3
(D.N.M. Mar. 24, 2020), is misplaced because the plaintiff in that case did not allege that
the product deviated from its intended design.
The Court will deny Defendants’ motion on the manufacturing defect claims.
Doc. 7092 at 17.
D. Misrepresentation Claims (Counts IX and X).
Plaintiff asserts negligent and fraudulent misrepresentation claims. Docs. 175 ¶ 15,
1889 ¶¶ 394-426. Under New Mexico law, misrepresentation claims require proof that the
defendant made a material misrepresentation that was relied on to the plaintiff’s detriment.
See Robey v. Parnell, 392 P.3d 642, 652 (N.M. Ct. App. 2017); Robertson v. Carmel
Builders Real Est., 92 P.3d 653, 662 (N.M. Ct. App. 2003); UJI 13-1632, 13-1633. New
Mexico law does not require that a misrepresentation be made directly to the plaintiff. See
R.A. Peck, Inc. v. Liberty Fed. Sav. Bank, 766 P.2d 928, 932 (N.M. Ct. App. 1988). Rather,
the requirement is that “the defendant intend that the information be received by the
plaintiff or a group of persons of which plaintiff was a member.” Healthsource, Inc. v.
X-Ray Assoc. of N.M., 116 P.3d 861, 871 (N.M. Ct. App. 2005).
Defendants argue that summary judgment is warranted because neither Plaintiff nor
Dr. Richardson relied on a Bard representation in making the treatment decision. Docs.
7092 at 18, 7663 at 10-11. Plaintiff has presented evidence that Defendants’ IFU
misrepresents that all materials are biocompatible, that catheter fracture is preventable and
rare, and that pinch-off can be avoided by proper placement. Doc. 7418 at 14 (citing
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Doc. 7418-1 ¶¶ 231-241, 246-249). Plaintiff also presents evidence that Dr. Richardson
read and considered the IFU, would expect the information in the IFU to be accurate, and
implanted Plaintiff’s PowerPort in compliance with the IFU. Id. (citing Doc. 7481-1
¶¶ 241, 250-53, 256-57). This evidence creates a triable issue as to whether Defendants
made a material misrepresentation that Dr. Richardson relied on to Plaintiff’s detriment.
The Court will deny Defendants’ motion on the negligent and fraudulent
misrepresentation claims. Doc. 7092 at 17-18.
E. Fraudulent Concealment Claim (Count XI).
Plaintiff presents evidence that the IFU omits known risks – flex fatigue, silicone
weakness, and barium sulfate separation – that increase the risk of catheter fracture.
Doc. 7418 at 14 (citing Doc. 7418-1 ¶¶ 242-45). Defendants do not address these alleged
omissions, nor do they otherwise address the elements of a fraudulent concealment claim.
See R.A. Peck, 766 P.2d at 932 (“An action for fraud may be predicated on concealment
where there is a duty to disclose. Fraud may arise by omission as well as by commission.
Thus, where one is under a duty to speak but remains silent and fails to disclose a material
fact, he may be liable for fraud.”); Farmer v. Walmart, Inc., 729 F. Supp. 3d 1202, 1234
(D.N.M. 2024) (“Actionable fraud is found if a party to a transaction knows of material
facts, has a duty to disclose, and remains silent.”). The Court will deny Defendants’ motion
to the extent they seek summary judgment on Plaintiff’s concealment claim. See Doc. 7092
at 17; see also Docs. 175 ¶ 15, 1889 ¶¶ 427-38.6
F. Unjust Enrichment Claim (Count XIII).
“New Mexico has long recognized actions for unjust enrichment, that is, in quantum
meruit or assumpsit. To prevail on such a claim, one must show that: (1) another has been
knowingly benefitted at one’s expense (2) in a manner such that allowance of the other to
6 Defendants argue that summary judgment is warranted on the fraud claims (Counts
X and XI) because the claims are not pled with particularity under Federal Rule of Civil
Procedure 9(b). Doc. 7092 at 18. Defendants rightly withdrew this argument in their reply
brief. Doc. 7663 at 10 n.3; see Cable & Computer Tech. Inc. v. Lockheed Sanders, Inc.,
214 F.3d 1030, 1038 (9th Cir. 2000) (explaining that the district court “appears to have
inappropriately applied Fed.R.Civ.P. 9(b), requiring particularity in the pleading of fraud,
to a summary judgment motion where evidence, not pleading, was to be considered”).
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retain the benefit would be unjust.” Ontiveros Insulation Co. v. Sanchez, 3 P.3d 695, 698
(N.M. Ct. App. 2000) (citations omitted).
Plaintiff pleads her unjust enrichment claim in the alternative. Docs. 1889 ¶ 461,
7418 at 15. Contrary to Defendants’ assertion (Doc. 7092 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); Figueroa, 2020 WL 1434249, at *3 (“Defendants initially argue that [the
unjust enrichment] claim must be dismissed because there is an adequate remedy at law.
However, Plaintiff may plead alternative, conflicting theories. Fed. R. Civ. P. 8(d)(2),
(d)(3) . . . . It would be premature to dismiss the unjust enrichment claim and it is unclear
at this time whether Plaintiff has an adequate remedy at law.”).
Defendants also assert that there is no implied or quasi contract between Bard and
Plaintiff because Bard sold the PowerPort to Gerald Champion Medical Center, not
Plaintiff. Doc. 7092 at 19. But unjust enrichment “provide[s] relief where, in the absence
of privity, a party cannot claim relief in contract and instead must seek refuge in equity.”
Ontiveros, 3 P.3d at 698-99 (emphasis added); see also Arena Res., Inc. v. Obo, Inc., 238
P.3d 357, 361 (N.M. Ct. App. 2010) (explaining that unjust enrichment “implie[s]
obligations where, on the basis of justice and equity, the law will impose a contractual
relationship between parties, regardless of their assent thereto” (citation omitted)).
The Court will deny Defendants’ motion on the unjust enrichment claim. Doc. 7092
at 19.
G. Punitive Damages.
Plaintiff seeks an award of punitive damages. Doc. 175 ¶ 15, 1889 ¶¶ 484-87.
Under New Mexico law, punitive damages may be awarded to penalize “bad faith” or when
the defendant “acts with reckless disregard for the rights of the plaintiff – i.e., when the
defendant knows of potential harm to the interests of the plaintiff but nonetheless ‘utterly
fails to exercise care’ to avoid harm.” Allsup’s Convenience Stores, Inc. v. N. River Ins.
Co., 976 P.2d 1, 17 (N.M. 1998) (quoting Paiz v. State Farm Fire & Cas. Co., 880 P. 2d
300, 308 (N.M. 1994)); see also Couch v. Astec Indus., Inc., 53 P.3d 398, 411 (N.M. Ct.
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App. 2022) (“Because the purpose of punitive damages is to punish a wrongdoer, a
wrongdoer must have a culpable mental state to be liable for punitive damages.”); UJI
13-1827 (requiring the jury to find that that the defendant’s conduct was malicious, willful,
reckless, wanton, fraudulent, or in bad faith to award punitive damages).
Defendants argue that Plaintiff lacks evidence that they acted with malicious,
intentional, or reckless disregard for her safety. Doc. 7092 at 20. Plaintiff claims that
Defendants’ actions constitute a reckless disregard for the safety of Plaintiff and other
patients given Defendants’ knowledge of the increased fracture risks posed by the
PowerPort’s silicone catheter. Doc. 7418 at 17.
In Gonzales v. Surgidev Corp., 899 P.2d 576 (N.M. 1995), the New Mexico
Supreme Court held that a manufacturer could act “recklessly” by “failing to issue a
warning regarding the implantation” of a medical device via a particular procedure. 899
P.2d at 588. The Gonzales court looked to evidence of data indicating significant long-
term problems, data indicating much higher rates of complications, and evidence that the
company “was aware that its figures probably underestimated the percentage of
complications in patients.” Id.
Plaintiff has presented evidence that Defendants knew that their port catheters
commonly fracture and that the risk of catheter fracture is catastrophic and life-threatening.
Doc. 7814 at 17 (citing Doc. 7814-1 ¶¶ 78-81, 91-93, 102-07). Also, that despite knowing
the mechanisms that caused the fractures, Defendants disregarded their responsibility to
mitigate the risk of fracture and instead artificially lowered the complication rates
associated with fracture and manipulated their own risk assessment to avoid redesigning
ports. Id. (citing Doc. 7814-1 ¶¶ 94-99, 108-46). Plaintiff further presents evidence that
Defendants misrepresented the danger and concealed information from the FDA, doctors,
and patients. Id. (citing Doc. 7814-1 ¶¶ 147-158, 231-249).
This evidence, if believed by the jury, is sufficient to support a finding that
Defendants knew of potential harm to Plaintiff from the risk of catheter fracture but
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nonetheless utterly failed to exercise care to avoid such harm. See Allsup’s Convenience
Stores, 976 P.2d at 17.
Defendants note that they complied with applicable FDA regulations in bringing the
PowerPort to market. Doc. 7092 at 20. While compliance with FDA regulations is relevant
on the question of punitive damages, it is not dispositive. Gonzales, 899 P.2d at 590.
“[C]ompliance with federal regulations does not preclude a finding of recklessness or an
award of punitive damages.” Id. (citations omitted).
The Court will deny Defendants’ motion on Plaintiff’s request for punitive damages.
Doc. 7092 at 19-20.
IT IS ORDERED that Defendants’ motion for summary judgment (Doc. 7092) is
denied.
Dated this 22nd day of July, 2026.
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