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 MDL No. 3081
ORDER
Daniel Bergsagel, M.D., and Benjamin
Musher, M.D.
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”).
Plaintiffs have filed a motion to exclude the expert opinions of Daniel Bergsagel, M.D.,
and Benjamin Musher, M.D. Doc. 4818. The motion is fully briefed and no party requests
oral argument. See Docs. 4818, 5328, 5570. 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,
intravenous fluids, blood transfusions, and parenteral nutrition. IPCs may remain in place
for weeks, months, or even years until treatment is completed.
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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. 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.
Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
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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.
The parties intend to use various expert witnesses at trial, including medical
professionals. Defendants have identified Drs. Daniel Bergsagel and Benjamin Musher as
medical professional experts. The doctors are board-certified hematologist oncologists.
Docs. 4818-1 at 4, 26, 4818-3 at 4, 24-25.
Dr. Musher is a Professor of Medicine in the Hematology-Oncology Division of
Baylor College of Medicine, and the Director of the Gastrointestinal Cancer Program at
Baylor’s NCI-designated Dan L Duncan Comprehensive Cancer Center. Doc. 4818-1 at
4, 26. He is certified by the American Board of Internal Medicine in Internal Medicine
and Medical Oncology, and is a member of the American Society of Clinical Oncology
among other medical societies. Id. at 4, 28. Dr. Musher specializes in gastrointestinal
malignancies and has treated thousands of patients with ports. Id. at 5-6.
Dr. Bergsagel is an Associate Professor of Pediatrics at Emory University School
of Medicine, an Attending Physician at Children’s Healthcare of Atlanta, and a member of
Winship Cancer Institute of Emory University. Doc. 4818-3 at 24. He is certified in
Pediatric Hematology Oncology by the American Board of Pediatrics and a member of the
American Society of Pediatric Hematology Oncology among other medical societies. Id.
at 25. Dr. Bergsagel specializes in pediatric hematology oncology and has treated
thousands of patients with IPCs. Id. at 4-6.
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Plaintiffs do not dispute the doctors are qualified experts under Federal Rule of
Evidence 702. They move to exclude Dr. Bergsagel’s causation opinion and both doctors’
opinion that the benefits of using ports outweigh the risks. Doc. 4818 at 3-6.
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
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, at *3 n.2 (D. Ariz. Aug. 2, 2019) (“[T]he Court may admit expert opinions only if it
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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. Dr. Bergsagel’s Causation Opinion.
Bergsagel opines that port characteristics do not cause port-related infections:
This emphasizes to me that port related infections are not due to inherent
features of the port, but are the result of how they are handled and managed,
and with use of the lessons learned by the collaborative efforts of these
hospitals, the rate can be reduced to close to zero.
Doc. 4818 at 3 (quoting Doc. 4818-3 at 16).
Plaintiffs argue this opinion “attribute[s] all port-related infections exclusively to
hospital practices while categorically discounting design-related causes,” which they
contend he is not qualified to do under Rule 702(a). Id. at 4 (emphasis omitted). They
further contend that he does so without sufficient data or a reliable methodology under
Rule 702(b)-(c) because he “has no knowledge or experience with (and did not investigate)
whether and to what extent the material properties of ports might affect the rate of
infection[.]” Id. Defendants argue Bergsagel is qualified to provide this opinion based on
his education and clinical experience in hematology-oncology, his review of medical
literature, and his involvement in a national collaborative effort to reduce port-related
infections, which they argue also serves as sufficient data and a reliable methodology.
Doc. 5328 at 5-7.
Bergsagel explains in his report that he participated in a national collaborative effort
among 32 hospitals to reduce the rate of “catheter and line associated blood stream
infections (CLABSI).” Doc. 4818-3 at 15-16. For ease of reference, the Court will follow
the parties’ briefing and simply refer to CLABSI as “port-related infections.”1
The collaborative produced a set of principles to be followed by the participating
hospitals in installing, using, and maintaining “central line” methods of administering
1 It is not clear to the Court that CLABSI is limited to IPCs, but the Court will assume so
for purposes of this order.
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chemotherapy, medication, and nourishment.2 Bergsagel’s report states that the “early
results” of following these principles showed a 28% reduction in port-related infections.
Id. at 16. He then notes that “[i]n one recent report[,] application of the principles learned
through these collaborations has led to them achieving a rate of [port-related infections]
approaching zero.” Id. (footnote omitted). This sentence leads to Bergsagel’s single-
sentence opinion quoted above – “that port related infections are not due to inherent
features of the port, but are the result of how they are handled and managed[.]” Id.
Bergsagel’s opinion on this subject includes only this sentence. Other than his
description of the 32-hospital collaboration and citation to one study, he provides no
explanation of the basis for this causation opinion or the methodology he used in arriving
at it. Id.
Bergsagel’s single citation is to Daniel N. Willis et al., Eliminating Central Line
Associated Bloodstream Infections in Pediatric Oncology Patients: A Quality Improvement
Effort, Pediatric Quality & Safety, May 29, 2023. Id. at 16 n.28.3 The article reports on
findings at a single hospital – the St. Louis Children’s Hospital. See Willis et al., supra, at
1-2. The article describes a multi-year effort at the hospital to reduce the rate of port-
related infections among pediatric oncology patients by rigorously monitoring procedures
for installing, using, and maintaining central lines. Id. The article does state, as Bergsagel
notes, that these measures reduced port-related infections in pediatric oncology patients to
a level “approaching zero.” Id. at 1, 5. But the actual numbers behind this conclusion are
instructive.
The metric used by the article for measuring the rate of infections is the number of
port-related infections per 1,000 central line days (presumably, the days a central was in
2 It is not clear that “central line” methods are limited to IPCs either, but the Court will
assume so in this order.
3 Footnote 28 of Bergsagel’s report contains only an abbreviated citation to the Willis
article and refers the reader to footnote 16 of his report. But footnote 16 contains no
reference to the article. The full article reference is found in footnote 22. See Doc. 4818-
3 at 15 n.22. To follow the page numbers cited by the Court, the Willis article can be
reviewed in PDF format via https://journals.lww.com/pqs/toc/2023/05000.
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place in patients at the hospital). Id. at 1. The hospital recorded 11 port-related infections
during 2020, a year when the hospital had 5,814 central line days. Id. at 4. This results in
a rate of 1.89 infections per 1,000 central line days. Id. The “aim” of the hospital’s effort
“was to reduce the CLABSI rate by 50% from a baseline of 1.89/1000 central line days to
less than 0.9/1000 central line days” in 2021. Id. at 1. In fact, the hospital exceeded this
goal. It reduced the rate of infections to 0.73/1000 central line days in 2021. Id. This
represents a 61.4% reduction in the rate of infection.4 While this is a significant
improvement, and better than the 50% aim of the study, it also means that 38.6% of the
original infection rate was not eliminated by the careful hospital procedures.
The Court understands why the authors of the article would describe 0.73/1,000 as
a number “approaching zero.” It is a very small number. But it must be remembered that
the starting point – 1.89/1,000 – is also a very small number. This is due to the relative
infrequency of port-related infections. The article itself notes that the overall rate of port-
related infections for pediatric oncology patients is very small – “around 2.3 infections per
1,000 central line days[.]” Id.
Given the rareness of these blood infections, the focus must be on the amount of
improvement this single-hospital study achieved, not on the simple smallness of the
number. And as noted above, the study achieved a 61.4% reduction in pediatric oncology
infections rates. While this is highly commendable, it is not a robust basis on which to
conclude that inherent port features have nothing to do with port-related infections.
Bergsagel focuses only on the “approaching zero” reference in the article; he does not
address the fact that 38.6% of the original rate of infections was not eliminated by the
careful procedures adopted by the hospital. What does he do with these remaining
infections? How does he conclude they are not caused by inherent port features? His
single-sentence opinion never addresses these questions.
4 The 2021 result of 0.73 port-related infections per 1,000 central line days represents
38.6% of the 2020 number of 1.89 infections per 1,000 days. Thus, the hospital’s efforts
reduced the rate of infection by 61.4% between 2020 and 2021.
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The only other number mentioned by Bergsagel in connection with this opinion is
the 32-hospital collaboration’s three-year port-related infection reduction of 28%.
Doc. 4818-3 at 16. But Bergsagel provides no context for this number. He does not give
us the starting rate of infections or the rate that remained. Logically, a 28% reduction in
infections would mean that 72% of the infections remained after the collaboration’s efforts.
Bergsagel does not address this remainder or explain why it cannot be attributed to inherent
port features.
Added to this, Bergsagel does not purport to be an expert on port design or materials
or their effect on infections. He agreed in his deposition that he lacks expertise on the
impact of port design on infection rates. See, e.g., Doc. 4818-4 at 7 (“Q. So there are
features of ports that either have or don’t have that can affect the infection rate associated
with those ports, the infection risk associated with those ports. But you have not researched
that, and you don’t have any experience with that, right? A. Correct.” (objection omitted)).
Additionally, Defendants fail to address other questions arising from Bergsagel’s
reliance solely on the Willis article. They do not explain whether the article was peer-
reviewed, why a single-hospital study that covered relatively few port-related infections
can be extrapolated to support a broad causation opinion, whether pediatric oncology
patients are representative of the broad range of patients represented in this MDL, whether
the study was limited to IPCs, or whether the hospital used any particular type of IPC.
In short, Defendants have not shown by a preponderance of the evidence that
Bergsagel’s single-sentence causation opinion is based on sufficient facts and data or is
supported by a reliable methodology. Defendants contend Bergsagel’s “extensive training
and more than 30 years of clinical experience with IPCs and CVADs” serves as a reliable
methodology for his opinion. Doc. 5328 at 9. Defendants are correct that “a doctor’s
experience ‘can serve as a sufficient foundation for opinions about the medical devices the
doctor uses in his clinical practice.’” Id. at 10 (citing In re Bard IVC Filters Prods. Liab.
Litig., No. MDL 15-02641-PHX DGC, 2018 WL 993675, at *2 (D. Ariz. Feb. 21, 2018)).
And the Court is satisfied that Bergsagel’s experience as a hematologist oncologist serves
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as a reliable basis for him to opine that many port-related infections “are the result of how
they are handled and managed[.]” Doc. 4818-3 at 16. But his opinion that inherent port
features do not contribute to infections is not support by adequate facts, data, or
methodology, and will be excluded under Rule 702(b) and (c).
IV. Opinion that Port Benefits Outweigh Risks.
Both doctors opine that the benefits of using ports outweigh the risks. Docs. 4818-
1 at 8, 22, 4818-3 at 14. Plaintiffs make two arguments for exclusion of these opinions:
they will not help the jury as required by Rule 702(a), and they are improper legal
conclusions. Doc. 4818 at 5-6. The Court disagrees.
Plaintiffs’ master complaint alleges that the risks of Defendants’ IPCs outweigh the
benefits. See Doc. 1889, ¶ 276 (“[T]he foreseeable risks [of Bard ports] exceeded the
alleged benefits associated with their use”), ¶ 309 (“Bard IPCs . . . [are] unreasonably
dangerous because the foreseeable risks exceeded the alleged benefits associated with the
use of Bard IPCs”). The risk-benefit comparison is thus part of Plaintiffs’ claims that the
jury will be required to address. This Court has found testimony about risk-benefit analysis
admissible in product liability cases. See, e.g., Triant v. Am. Med. Sys. Inc., No. CV-12-
00450-PHX-DGC, 2020 WL 4049844, at *2 (D. Ariz. July 20, 2020) (finding admissible
a board-certified urogynecologist’s opinion that “[t]he Elevate is a safe and useful device
. . . whose benefits far outweigh their risks,” and “[t]he MiniArc sling[’s] . . . benefits
outweigh its risks”).
Plaintiffs argue that the inquiry under some state laws is whether a product’s design
is outweighed by the risk, and that the doctors are not qualified to opine on design.
Doc. 4818 at 6 (citing Missouri and Florida examples). But Plaintiffs do not contend that
this is the law in every state or will be the law applied in every bellwether trial. The
relevancy of risk-benefit analysis likely will turn on a close look at the state law applied in
a particular case, and perhaps on how courts in the relevant state have dealt with the test.
This is not a decision that can be made now, in the abstract, for all cases.
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Portions of Plaintiffs’ arguments are somewhat confusing. They seem to agree that
a risk-benefit opinion could be relevant background information at trial. See Doc. 5570 at
5.5 And they acknowledge that some states apply a consumer-expectation test that may
call for evidence on whether the magnitude of a product’s risk outweighs its utility. Id. at
6.
Additionally, and as argued by Defendants, the doctors’ risk-benefit opinions might
be relevant to other claims brought by Plaintiffs. See Doc. 5328 at 13-14. Plaintiffs’ master
complaint alleges, in different claims, that the risks of using Bard ports outweigh the
benefits. See, e.g., Doc. 1889, ¶ 297(d) (alleging in support of negligence claim that
Defendants were aware “the risks outweighed any benefit or utility of Bard IPCs”); ¶ 309
(alleging in support of failure-to-warn claim that “the foreseeable risks exceeded the
alleged benefits associated with the use of Bard IPCs”); ¶ 408 (alleging in support of
negligent misrepresentation claim that “Defendants . . . misrepresent[ed] to Plaintiffs and
the medical community the safety and efficacy of Bard IPCs”).
The Court also rejects Plaintiffs’ second argument. Whether the risks of a product
outweigh its benefits is not a legal issue to be decided by the Court. The existence and
extent of a product’s risk is a factual issue to be decided by the jury from the evidence
introduced at trial, not a legal issue to be resolved by the Court. The same is true of the
5 The doctors routinely weigh the benefits and risks of using ports. See Docs. 4818-1 at 7-
8 (Dr. Musher’s Report) (“[O]ncologists use a combination of medical knowledge and
experience to weigh th[e] risks and benefits[.]”; “Like all clinical decisions I make, I
carefully weigh the potential risks and benefits of port placement in each patient.”); 4818-
3 at 6 (Dr. Bergsagel’s Report) (“I soon learned through first-hand experience that ports
were safe and that their benefits were much appreciated by patients and staff.”). This
testimony could help the jury understand why doctors recommend port placement over
other methods of venous access, a potentially relevant fact in evaluating the parties’ claims
and defenses under various legal theories. See In re Bard IVC Filters Prods. Liab. Litig.,
No. MDL 15-02641-PHX DGC, 2017 WL 11696724, at *4 (D. Ariz. Dec. 21, 2017)
(“Instruction on relevant matters beyond the understanding of a typical juror is an
appropriate function of an expert witness.”).
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existence and extent of a product’s benefits. The Court will not exclude these opinions as
improper legal conclusions.
IT IS ORDERED that Plaintiffs’ motion (Doc. 4818) is granted in part and
denied in part. Dr. Bergsagel is precluded from opining that port-related infections are
not due to inherent features of the port, but are the result of how they are handled and
managed. The motion is otherwise denied.
Dated this 9th day of January, 2026.
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