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
Expert Witness Keilye R. Pampillonia
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”).
Plaintiff Robert Michael Cook has filed a motion to exclude the expert opinions of Keilye
R. Pampillonia. Doc. 5784. The motion is fully briefed and no party requests oral
argument. See Docs. 5784, 6241, 6405. The Court will grant the motion in part.
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,
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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. Port bodies vary
in shape and size and are made of plastic, silicone, or titanium. 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”). Bard IPCs contain
barium sulfate, a radiopaque substance that can be seen on diagnostic imaging such as
X-ray, CT, and MRI scans. Several Bard IPCs are manufactured using polyoxymethylene
(“POM”), an acetal thermoplastic polymer, in the construction of the port. Many Bard
IPCs have a port with raised palpation bumps on the silicone center, which help identify
these IPCs as power-injectable devices.
Each Plaintiff in this MDL had a Bard IPC implanted in his or her body, and claims
it was defective and caused serious injury. Plaintiffs allege that the barium sulfate in the
IPC degrades the mechanical integrity of the catheter, leading to surface irregularities that
cause catheter fracture, infection, and blood clots. Plaintiffs further allege that Bard’s
manufacturing process for the POM-containing IPCs lacks adequate measures to stabilize
the POM to prevent oxidative degradation, which causes cracks, fissures, and other
physical defects in the polymer and increases the risk of fracture, infection, and thrombosis.
Plaintiffs also allege that the palpation bumps on the power-injectable IPCs cause undue
compression stress on the tissue surrounding the port, leading to ulceration and tissue
necrosis. See Docs. 23, 1889.
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Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
options. Plaintiffs assert a host of state law claims, including design and manufacturing
defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. 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.
Plaintiff Robert Michael Cook brings his lawsuit in this MDL. Doc. 216 (Case No.
CV-23-01975-PHX-DGC). On August 24, 2022, Plaintiff had a Bard port implanted, and
he subsequently suffered from an infection. Id. at 4. Plaintiff raises claims typical to this
MDL, alleging the infection was caused by the implanted Bard port. Id. at 5.
Defendants have identified Keilye R. Pampillonia, B.S.N., O.C.N. as an expert
witness in the Cook case. Pampillonia received a bachelor’s degree in nursing in 2018 and
certification as an Oncology Certified Nurse in 2020. Doc. 5784-1 at 15, 17. She currently
holds the positions of staff nurse and rotating charge nurse in an oncology unit, providing
direct patient care. Id. at 4, 15. Plaintiff Cook moves to exclude certain opinions of
Pampillonia under Federal Rule of Evidence 702. Doc. 5784 at 2-3.
II. Legal Standard.
Rule 702 provides that “[a] witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify in the form of an opinion” if the
proponent of the expert’s testimony “demonstrates to the court that it is more likely than
not that” (a) “the expert’s scientific, technical, or other specialized knowledge will help the
trier of fact to understand the evidence or to determine a fact in issue,” (b) “the testimony
is based on sufficient facts or data,” (c) “the testimony is the product of reliable principles
and methods,” and (d) “the expert’s opinion reflects a reliable application of the principles
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and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent of the
expert testimony must show by a preponderance of the evidence that the testimony satisfies
each of these requirements. Fed. R. Evid. 104(a); Fed. R. Evid. 702 advisory committee’s
note to 2023 amendment (“[T]he rule has been amended to clarify and emphasize that
expert testimony may not be admitted unless the proponent demonstrates to the court that
it is more likely than not that the proffered testimony meets the admissibility requirements
set forth in the rule.”); Engilis v. Monsanto Co., 151 F.4th 1040, 1050 (9th Cir. 2025)
(“Consistent with the 2023 amendment, our precedent establishes that Rule 702 requires a
proponent of expert testimony to demonstrate each of the requirements of Rule 702 by a
preponderance of the evidence.”).
The Court acts as a gatekeeper to ensure that expert testimony satisfies Rule 702.
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). The Court’s task is not
to decide whether the expert is right or wrong, but to ensure the proposed opinions satisfy
Rule 702. Alaska Rent-A-Car, Inc. v. Avis Budget Grp., 738 F.3d 960, 969-70 (9th Cir.
2013); Engilis, 151 F.4th at 1050. If the proponent does not meet its Rule 702 burden, the
expert testimony is not admissible. See Davis v. McKesson Corp., No. CV-18-1157-PHX-
DGC, 2019 WL 3532179, at *3 n.2 (D. Ariz. Aug. 2, 2019) (“[T]he Court may admit expert
opinions only if it can determine, under Rule 104(a), that Plaintiffs have shown each of the
Rule 702 requirements to be satisfied by a preponderance of the evidence.”).
III. Discussion.
Plaintiff seeks to exclude Pampillonia’s opinion that Plaintiff’s deaccessing of the
port – the procedure where the needle is removed from the port after treatment is complete
– was the most likely source of his infection, and her opinions on potential sources of
contamination and improper techniques used during deaccessing. Doc. 5784 at 2-3.
A. Causation Opinion.
Pampillonia testified during her deposition that “most likely [Plaintiff’s] infection
resulted of poor deaccessing at home.” Id. at 4 (quoting Doc. 5784-2 at 8); see also
Doc. 5784-2 at 18 (answering that “at-home deaccess[ing]” was “the most likely source of
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his infection”). Plaintiff argues this opinion was untimely, she is unqualified to render it,
and she fails to provide a differential diagnosis. Doc. 5784 at 5-10. The Court agrees that
Pampillonia is not qualified to opine on causation.
Plaintiff argues Pampillonia’s causation opinion should be excluded because as a
nurse, not an infectious disease doctor, she is unqualified to opine about the cause of an
infection. Id. at 7-9. Defendants argue Pampillonia does not opine on causation, and that
her testimony and report opine only that at home deaccessing “presented the ‘most likely’
opportunity for infection.” Doc. 6241 at 5-6 (emphasis added).
Defendants are correct that Pampillonia’s report opines that Plaintiff Cook’s
deaccessing created a “significant opportunity for infection.” Doc. 5784-1 at 5. But her
deposition goes further. She testified that at-home deaccessing was “the most likely
source” of Plaintiff’s infection. Doc. 5784-2 at 18; see also id. at 8. This is a causation
opinion.
As noted by Plaintiff, cases within the Ninth Circuit hold that nurses are unqualified
to render causation opinions. See, e.g., Flores ex rel. Clark v. United States, 780 F. App’x
420, 422 (9th Cir. 2019) (“Flores’ second expert, a nurse, was not qualified to offer an
opinion on medical causation.” (citation omitted)); Gordon v. Sunrise Senior Living Servs.,
Inc., No. 08-CV-02299-REB-MJW, 2009 WL 3698527, at *3 (D. Colo. Nov. 5, 2009)
(“Numerous opinions from both federal and state courts, including courts both in this
district and in California, . . . support the conclusion that registered nurses and nurse
practitioners are not competent to testify regarding medical causation[.]”); Earp v. Cnty. of
Tulare, No. 1:11-CV-0196-MJS PC, 2012 WL 1076217, at *4 (E.D. Cal. Mar. 29, 2012)
(“[R]egistered nurse Mary Dromi, is not competent to opine on the medical causation
issues raised in this case. . . . This Court agrees with the reasoning in the line of cases which
rejects opinion evidence from a registered nurse, rather than a qualified physician, on such
issues.” (citation omitted)); Scolaro v. Vons Companies, Inc., No. 217CV01979JADVCF,
2020 WL 8920999, at *1 (D. Nev. Mar. 2, 2020) (excluding nurse’s causation opinion
where she “lack[ed] experience diagnosing” the injury at issue).
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Pampillonia concedes that “diagnosing is not part of the safe nursing practice.”
Doc. 5784-2 at 3-4. And the “Expert Background and Qualifications” section of her report
does not mention any experience, education, or training in diagnosing sources of infection.
See Doc. 5784-1 at 32-33. Defendants have not demonstrated that Pampillonia has the
“scientific, technical, or other specialized knowledge” required by Rule 702(a) to opine on
the most likely source of Plaintiff’s infection. Her causation opinion is excluded.1
B. Sources of Contamination and Improper Technique Opinions.
Pampillonia renders opinions about the procedures for safely deaccessing, and
whether safe protocols were followed during Plaintiff’s deaccessing. Doc. 5784 at 11-12.
Plaintiff argues such opinions improperly rely on an absence of evidence and are prohibited
ipse dixit. Id. at 11-13. Plaintiff also argues Pampillonia’s opinions are unhelpful where
they are not connected to any causation theory. Id. at 14.
1. Absence of Evidence and Ipse Dixit Testimony.
Plaintiff argues that two specific opinions from Pampillonia’s report rely on an
absence of evidence.
First, Plaintiff contends Pampillonia “claims someone ‘may [have] cough[ed],
sneeze[d] or inadvertently spit . . . onto the clean area’” and there is no evidence of such
events. Id. at 11 (quoting Doc. 5784-1 at 11). Pampillonia makes no such claim. She
claims only that the instructional video followed by those who performed Plaintiff’s
deaccessing – Ms. Potter and Ms. McGuigan – “did not include guidance for the use of a
mask for the patient and individual deaccessing the port,” which “includes anyone in the
immediate area who may cough, sneeze or inadvertently spit . . . onto the clean area to
prevent the transmission of bacteria.” Doc. 5784-1 at 11. During her deposition,
Pampillonia testified that “[i]f the patient’s not wearing a mask and they turn to talk or . . .
spit when they’re talking, they contaminated their own device.” Doc. 5784-2 at 16. This
explanation was given in support of her opinion that “it’s best practice for everyone to wear
1 The Court notes that Pampillonia’s deposition causation opinion was not untimely
because it was elicited by Plaintiff’s counsel. See Doc. 114 at 3, ¶ F.
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a mask.” Id. at 15-16. Pampillonia thus opines on best practices, an opinion supported by
her training and years of experience. She does not rely on an absence of evidence to
speculate about whether anyone coughed, sneeze, or spat in Plaintiff’s case.
Plaintiff next contends Pampillonia improperly relied on an absence of evidence to
opine that tape attached to a “connection” during Plaintiff’s deaccessing “would have
potentially left sticky residue around the connection at the hub, increasing the risk of
bacteria.” Doc. 5784 at 11 (emphasis omitted) (quoting Doc. 57841-1 at 11). Plaintiff
argues there is no evidence of where the tape was attached or that any tape residue was
present, and Pampillonia’s opinion therefore is speculative and should be excluded as both
unreliable and lacking support from sufficient facts or data. Id. at 12.
Pampillonia’s opinion that tape attached to a connection during deaccessing “would
have potentially left sticky residue around the connection at the hub, increasing the risk of
bacteria” (Doc. 5784-1 at 11) is not unsupported by the evidence. Pampillonia names
“device contamination” as a primary cause of port-related infections, which she is qualified
to opine about as an oncology nurse whose role is the safe management of ports. Id. at 4,
7. And the evidence suggests that a connection was taped during Plaintiff’s deaccessing.
See Docs. 5784 at 12 (“Ms. Potter did testify that the ‘connection’ was ‘taped[.]’”), 5784-
1 at 11 (“In Ms. Potter’s testimony she states, ‘there was a connection that was also
taped.’”). From this evidence, Pampillonia may opine as to how the presence of tape during
deaccessing could create a risk of infection.
Plaintiff contends there is no evidence in the record “that any tape ever contacted
the needleless connector specifically, brushed against a contaminant source, or left any
residue” (Doc. 6405 at 8), which are the events most likely to create a risk of infection due
to presence of the tape. See Doc. 5784-1 at 7-8 (Pampillonia explaining that “the goal
should be to eliminate surface pathogens before accessing the needleless connector” to
reduce the risk of contamination (footnote omitted)). This argument would carry weight if
Pampillonia was testifying that the tape did cause the infection. But she opines only that
the tape “would have potentially left sticky residue . . . increasing the risk of bacteria.” Id.
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at 11. The presence of the tape provides a sufficient factual basis for her opinion that the
risk of bacteria would be increased.
Plaintiff also summarily contends that Pampillonia’s opinions “about not wiping the
table, not wearing a mask, and not scrubbing the hub for sufficient time” during
deaccessing are improperly speculative. Doc. 5784 at 11 (citing Doc. 5784-1 at 10-12).
But again, Pampillonia may opine about best practices known to her as an oncology nurse
– practices the record suggests were not followed in Plaintiff’s case. See Doc. 5784-1 at
11 (“The parties involved are unable to positively confirm that the surface area where the
deaccessing took place (dining room table) was wiped down prior to gathering supplies.
This is the first step of the ‘Deaccessing a Port’ video and a deviation from the instructions
provided in the video from Mayo Clinic.” (citation omitted)); id. at 12 (“Ms. [McGuigan]
mentions the use of alcohol wipes and states that Ms. Potter used them to ‘wipe, with an
alcohol swab, the tips of everything. . . . .’ While ‘wiping’ the line is reasonable, best
practice standards require the hub or end of the needleless connector to be vigorously
‘scrubbed’ for 15-20 seconds immediately prior to syringe connection.” (citation omitted));
id. (“Ms. [McGuigan] and Ms. Potter acknowledged not all parties involved wore a mask
which is considered best practice.”).
Plaintiff argues the instructional video did not even recommend all the best practices
discussed by Pampillonia, apparently to dispute their relevance. Doc. 5784 at 12. But
Pampillonia does not base her opinion on the instructional video. Her opinion is based on
her clinical experience as an oncology nurse. In fact, she cites the absence of these best
practices in the instructional video to support her opinion that Plaintiff’s deaccessing was
not conducted safely. See Doc. 5784-1 at 11 (“[T]he ‘Deaccessing a Port’ video lacks
essential information on how to safely deaccess a port in the home setting. . . . The video
did not include guidance for the use of a mask for the patient and individual deaccessing
the port. . . . The video lacks guidance for proper interventions when sterility is questioned.
The video also does not endorse best-practice pulsatile flushing technique.”).
Pampillonia’s opinions are not unreliable because they differ from or even criticize the
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video, provided she is otherwise qualified to give them and they are based on sufficient
facts or data and reliable methods. The Court concludes that these requirements of Rule
702 are satisfied by a preponderance of the evidence.
The Court also concludes, however, that Pampillonia’s opinion concerning the
adhesion of the port dressing must be excluded. She opines that Plaintiff’s port dressing
“detached easily” and that “reduced adhesion can be associated with the presence of
moisture beneath the dressing,” where “[m]oisture beneath a dressing can compromise the
sterile barrier and increase infection risk.” Id. at 13. In support, she cites Ms. McGuigan’s
testimony and a nursing report dated September 19, 2022 – approximately a month after
Plaintiff’s deaccessing of the port – which described Plaintiff as having “very sweaty skin.
His [PICC line] dressing does not stay on for a full week,” and “keeping the PICC line for
a long period would put him at increased risk for infection with the constant peeling up of
dressing.” Doc. 6405-1 at 4.
Ms. McGuigan testified that Plaintiff’s port dressing “was dry and adhered to the
skin.” Doc. 6405-2 at 3. Given this undisputed and port-specific testimony, the Court
concludes that a later report of sweaty skin during the PICC-line process in a different part
of the body does not provide a sufficient factual basis for Pampillonia to conclude that the
port dressing was subject to moisture and easy detachment. Her opinion concerning the
adhesion of the port dressing lacks a factual foundation and will be excluded.
2. Unhelpful Opinions.
Plaintiff argues several of Pampillonia’s opinions regarding how best practices were
breached during his deaccessing are not relevant under Rule 702(a) because no expert
qualified to render a causation opinion cites them in a theory of causation. Doc. 5784 at
14. Plaintiff points to Pampillonia’s opinions on wearing masks, the pulsating flushing
technique, and wiping of syringe tips. Id.
Plaintiff relies on his contention that only Dr. Allos is qualified to render causation
opinions. Plaintiff has filed motions to exclude the causation opinions of Drs. Musher and
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Srinivasa (id. at 15 n.3) and the Court has not yet ruled on those motions. Even relying
only on Allos for causation, Pampillonia’s opinions are relevant.
Allos opines that “Mr. Cook’s port infection . . . more likely than not was caused by
inadvertent contamination of the line when it was de-accessed by individuals (either [Ms.
Potter] or [Ms. McGuigan]) who were inexperienced with handling port lines.” Doc. 5784-
4 at 10; see also id. (“[Mr. Cook] experienced a complication that was likely the result of
imperfect sterile technique by an inexperienced family member accessing the port[.]”).
Allos does not specify the source of the inadvertent contamination during deaccessing.
Allos instead opines that contamination during deaccessing is “quite easy to do,” that there
is no way of knowing how sterile technique was breached, and that Ms. Potter would likely
be unaware of how she caused the contamination. Id. at 11-12. Where Allos opines that
Plaintiff’s infection more likely occurred during deaccessing, Pampillonia’s opinions about
the possible ways deaccessing could have increased the risk of infection are plainly
relevant. They will not be excluded for failure to satisfy Rule 702(a).
Plaintiff contends Pampillonia’s opinions regarding how Plaintiff could have caused
contamination by failing to wear a mask during deaccessing should be excluded because
Allos only opines that Ms. Potter or Ms. McGuigan, not Plaintiff, could have caused
contamination. Doc. 5784 at 15; see also Doc. 5784-4 at 10 (“Mr. Cook’s port infection
. . . more likely than not was caused by inadvertent contamination of the line when it was
de-accessed by individuals (either Ann or Megan) who were inexperienced with handling
port lines.”). But Ms. Potter and Ms. McGuigan were responsible for following sterile
technique during deaccessing, a responsibility they understood. They watched an
instructional video and reviewed an information sheet to inform them on how to safely
conduct deaccessing. See Doc. 5784-5 at 10-11 (Ms. Potter “recalled the Mayo Clinic step-
by-step video and said she watched it ‘more than once,’ . . . . In addition to the video, Ms.
Potter recalled an ‘info sheet.’”); id. at 10 (“[Mr. Cook] also recalled that Mayo provided
a link to a video to watch, which he said that Ann watched prior to the first de-access
procedure.”); Doc. 5784-8 at 7 (“[Ms. Potter and Ms. McGuigan] said at their depositions
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that they watched a video about deaccessing the port[.]”). Ms. Potter even attended in-
person training for deaccessing. See Doc. 5784-5 at 11 (“[T]here was an in-person training,
which Mr. Cook described as [Ms. Potter] having the opportunity to practice flushing and
de-accessing[.]”). Ms. Potter and Ms. McGuigan were tasked with performing the
deaccessing safely, and Pampillonia’s opinion that they failed to have Plaintiff wear a mask
is relevant to the causation opinion provided by Allos.
Plaintiff contends Pampillonia’s opinion that the pulsatile flushing technique should
have been discussed in the instructional video, and should have been employed during
Plaintiff’s deaccessing, should be excluded as irrelevant under Rule 702(a) because she
only opines this technique is a “best-practice” as opposed to the “standard of care.”
Doc. 5784 at 16-17. But there is no malpractice case against Ms. Potter and Ms. McGuigan
in this case. The question is whether their deaccessing created an opportunity for Plaintiff’s
infection, and the opinion of a well-trained nurse on best practices for reducing the risk of
infection is relevant to whether there could have been such an opportunity.
Plaintiff also contends that neither Pampillonia nor Allos explain how failure to use
the pulsatile flushing technique could cause infection. Id. at 16. Defendants cite Plaintiff’s
expert, Nurse Joan Sorich, for the proposition that flushing may contribute to reduced risk
of catheter infection (Doc. 6241 at 11), but the actual testimony from Sorich is that this is
only a secondary possibility for which there are “no studies” (Doc. 6241-5 at 5). Sorich
states that the primary reason for flushing is to reduce the risk of clot formation. Id. Allos
includes Sloan Kettering guidance on steps for deaccessing and states that they constitute
“aseptic technique,” but he provides no explanation for why flushing (which is included in
the steps) reduces the risk of infection. See Doc. 5784-4 at 17. In short, Defendants cite
no evidence to show that flushing is an infection-reduction technique and fail to show by a
preponderance of the evidence that Pampillonia’s flushing opinion satisfies Rule 702(b).
Plaintiff next contends Pampillonia’s opinion that the instructional video should not
have instructed wiping of the syringe tip, and that this technique was inappropriately used
during Plaintiff’s deaccessing, is irrelevant because “[Pampillonia] fails to explain how
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that has anything to do with Plaintiff’s infection.” Doc. 5784 at 16-17. But Pampillonia
testified the syringe-wiping technique increases the risk of infection. See Doc. 5784-2 at
12 (“Ms. [McGuigan] in her deposition states that Mrs. Potter wiped the end of the syringe,
which you should never do, and then connected it to the hub. So you have the opportunity
now of the hub being a source of infection as well as this wiped syringe that she wiped,
which shouldn’t have been part of the instructions.”). As discussed above, this is relevant
to Allos’s causation opinion.
Plaintiff similarly argues that Allos does not cite the syringe-wiping technique
(Doc. 5784 at 16), apparently to suggest that no expert qualified to render a causation
opinion cites the technique as a potential cause of Plaintiff’s infection. But Allos does
opine that Plaintiff’s infection could be the result of the ““inadvertent[] contaminat[ion]
. . . [of] syringe tips.” Id.; see also Doc. 5784-4 at 14-15 (Allos Report). Pampillonia may
render opinions on the syringe-wiping technique because Allos cites inadvertent
contamination of syringe tips as a potential cause of Plaintiff’s infection.
Lastly, Plaintiff summarily contends that Pampillonia’s opinions should be
excluded under Rule 403 as “unduly confusing.” Doc. 5784 at 17. The Court disagrees.
Plaintiff does not explain the confusion that would result from Pampillonia’s testimony,
much less why it would substantially outweigh the probative value of her opinions as
required by Rule 403.
IT IS ORDERED:
1. Plaintiff’s motion to exclude the opinions of Nurse Keiley R. Pampillonia
(Doc. 5784) is granted in part and denied in part.
2. Nurse Pampillonia cannot opine (1) that Plaintiff’s at-home deaccessing is
the most likely source of his infection; (2) that the adhesion of the port dressing may have
been compromised by Plaintiff’s sweaty skin; (3) that failure to flush the catheter increased
the risk of infection.
Dated this 27th day of January, 2026.
Case 2:23-md-03081-DGC Document 6957 Filed 01/27/26 Page 12 of 12