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
Darren R. Hurst, 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”).
Defendants have filed a motion to exclude the expert opinions of Darren R. Hurst, M.D.
Doc. 7091. The motion is fully briefed and no party requests oral argument. See Docs.
7091, 7420, 7664. 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
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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 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
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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
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 Divelbliss brings her lawsuit in this MDL. Doc. 26 (CV-23-01627-PHX-
DGC). On July 13, 2017, Plaintiff had a Bard port implanted. Id. ¶ 53. On December 13,
2019, Plaintiff discovered through an emergency room visit that a piece of the port catheter
had broken off and lodged in her heart. Id. ¶ 62. She underwent emergency surgery to
remove the port. Id. ¶ 63. Plaintiff raises claims typical of this MDL. Id. at 15-29.
The parties plan to use various expert witnesses at trial, including medical
professionals. Plaintiff has identified Darren Hurst, M.D., as a medical expert. Dr. Hurst
is an interventional radiologist. Doc. 7091-4 at 5. He practices as the Chief of Vascular
and Interventional Radiology for the St. Elizabeth Health System and holds other
radiology-practice positions. Id. at 5, 50-51. He is also an Assistant Professor of
Interventional Radiology at the University of Kentucky College of Medicine. Id. at 5, 51.
Hurst regularly implants and removes port catheters. Id. at 5. Defendants move to exclude
Hurst’s opinions under Federal Rule of Evidence 702.
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
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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, 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.
Defendants move to exclude several opinions of Hurst.
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A. Opinions on IPC Design and Alternative Designs.
Defendants argue Hurst is not qualified to opine on the design of its IPCs or any
alternative design. Doc. 7091 at 4. They refer to Hurst’s opinions that (1) the risk of
fracture reduces for a catheter made of polyurethane or with mesh reinforcement,
(2) Plaintiff’s catheter fractured from subclavian access, its weaker design, or both, and
(3) “the flexural fatigue mechanism” described in Bard’s records “is entirely consistent”
with a catheter that has undergone the “material degradation” present in Plaintiff’s port
catheter, “as degraded material would be more susceptible to fatigue failure under the
mechanical stresses present in this case.” See id. at 4-5.
In addressing Hurst’s general opinions, this Court ruled that he is not qualified to
opine on IPC alternative designs. See Doc. 7196 at 14. Plaintiff acknowledges the Court’s
prior ruling, but argues Hurst is qualified to opine on polyurethane catheters as an
alternative design because he has extensive clinical experience with the AngioDynamics
port, which has a polyurethane catheter. Doc. 7420 at 4.
Hurst “has used AngioDynamics ports exclusively for the last 10 or 11 years” and
has also used Bard ports. Id. at 4-5 (citing Doc. 7420-1 at 5-6)). He was involved in his
hospital’s decision to use the AngioDynamics port through his 10-year participation on the
product assessment committee. Id. The committee “vet[s] products” to determine which
will be used in the hospital, and it considers “products’ instructions for use, medical
literature, marketing materials, and pricing information.” Id.; Doc. 7664-1 at 3. The
committee “chose to stock a port with a polyurethane catheter, specifically the
AngioDynamics port, at least five years ago,” and that decision was “based on data that
they had regarding its catheter and the design of the port itself[.]” Doc. 7420 at 4 (citing
Doc. 7420-1 at 4).
But Hurst’s alternative design opinions go beyond his clinical experiences in
choosing and using the AngioDynamics port. He opines on mesh reinforcement as an
alternative design (Doc. 7091-1 at 13), that the “weaker silicone design” of the Bard port
catheter “increased the likelihood of fracture” in Plaintiff’s case (id. at 15), and that
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“degraded [catheter] material would be more susceptible to fatigue failure under the
mechanical stresses present in this case” (id.). Defendants challenge these opinions
(Doc. 7091 at 4), but Plaintiff does not address them in her response (see Doc. 7420).
Even Hurst’s opinions on the AngioDynamics port go beyond his clinical
experience. He opines, for example, about the comparative risk of catheter fracture in
AngioDynamics and Bard catheters. Doc. 7091-3 at 25 (“The Groshong catheter
demonstrates a higher risk of fracture . . . in comparison to the . . . polyurethane
catheters[.]”). But as Defendants note, Hurst has never implanted in his clinical practice a
Groshong catheter like the one used here, has implanted a port using the subclavian
approach that was used in this case only once or twice in his career, and has experienced a
fractured port catheter only with a subclavian placement. Docs. 7664-1 at 7, 10, 16, 22,
7664-2 at 3. Further, Hurst did not assess Bard ports for his hospital’s product selection
committee, “could not recall whether he was on the committee when [the hospital]
temporarily stopped stocking Bard ports in 2014 – or if he was, why that decision was
made – and he did not track adverse events related to any port products or review testing
documents from any other port manufacturers.” Doc. 7664 at 4 (citing Doc. 7664-1 at 5,
11-14, 15, 20-21). And to the extent Hurst relies on his personal review of literature (Doc.
7091-3 at 26-27), he cannot simply repeat the findings of others as his opinions. See, e.g.,
In re Roundup Prods. Liab. Litig., No. 16-MD-02741-VC, 2023 WL 7928751, at *3 (N.D.
Cal. Nov. 15, 2023) (“It is not enough to simply read the . . . studies in the literature and
describe their findings.”), aff’d sub nom. Engilis, 151 F.4th 1040.
This Court in its prior order found Hurst has “no experience designing ports or
testing port materials,” and has not “produced any studies, research, or literature on port
materials or design.” Doc. 7196 at 12 (citations omitted). Hurst may testify about his
experiences on the committee in choosing the AngioDynamics port, and in his patient care
involving Bard and AngioDynamics ports. See Elosu v. Middlefork Ranch Inc., 26 F.4th
1017, 1024 (9th Cir. 2022) (“An expert’s specialized knowledge and experience can serve
as the requisite ‘facts or data’ on which they render an opinion.”); Geiger v. Creative
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Impact Inc., No. CV-18-01443-PHX-JAT, 2020 WL 3268675, at *6 (D. Ariz. June 17,
2020) (“An expert’s opinion can be based on ‘the application of extensive experience,’
which satisfies Rule 702(c)’s requirement that an expert opinion be based upon reliable
principles and methods.” (citation omitted)). But for the same reasons discussed in the
Court’s prior order (Doc. 7196 at 12-13), Hurst is not qualified to opine that the risk of
fracture is less for a catheter made of polyurethane or with mesh reinforcement
(Docs. 7091-1 at 13, 7091-3 at 15), that Bard’s port design may have contributed to
Plaintiff’s catheter fracture (Docs. 7091-1 at 15, 7091-3 at 29-30), or on the correlation
between the flexural fatigue mechanism and the alleged degraded material in Plaintiff’s
catheter (Doc. 7091-1 at 15). Those opinions go beyond the bounds of Hurst’s experience
with the AngioDynamics port.
B. Opinion on What Dr. Richardson “Would Have Done.”
Defendants seek exclusion of Hurst’s opinion “regarding what Dr. Richardson, the
implanting physician, would have done if he had been provided with additional
information[.]” Doc. 7091 at 8. But Hurst does not render this opinion at the pages of his
report and deposition transcript cited by Defendants. Id. (citing Docs. 7091-1 at 13-14,
7091-3 at 23, 25). Plaintiff confirms Hurst has not and will not opine “that Dr. Richardson
would not have used the Bard port if he had been provided with additional information.”
Doc. 7420 at 8. In their reply, Defendants do not address this response by Plaintiff.
Doc. 7664 at 2 n.1.
Defendants cite Hurst’s opinions about what information was and was not provided
in Bard’s IFUs and what information should have been provided, and the reasonable
expectations of physicians (Docs. 7091-1 at 13-14, 7091-3 at 23, 25). Defendants do not
challenge those opinions. Because they cited them, however, the Court restates its prior
rulings that Hurst is qualified to opine on the reasonable expectations of physicians and
“whether port-related risks known to the medical community were disclosed through
Bard’s IFUs,” but he may not opine on content he believes should have been included in
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the IFUs (Doc. 7196 at 16, 20), a subject he discussed during his deposition (Doc. 7091-3
at 25) and in his report (Doc. 7091-1 at 14).1
C. Opinions on Plaintiff’s Cardiac Injuries.
Defendants seek to exclude Hurst’s opinions on “Plaintiff’s purported cardiac
injuries because he is not qualified to offer cardiac opinions” and because such opinions
are unreliable and unsupported by sufficient facts and data. Doc. 7091 at 10. They
specifically challenge Hurst’s opinions “on any ongoing cardiac issues” of Plaintiff. Id. at
11-12. Plaintiff contends Hurst “has not opined, nor does he intend to opine,” on Plaintiff’s
ongoing cardiac issues, and confirms Hurst “will not offer . . . opinions regarding Plaintiff’s
ongoing cardiac complications[.]” Doc. 7420 at 10.
Defendants also argue Hurst is not qualified to “opine that the catheter fragment
caused Plaintiff’s arrhythmia.” Doc. 7664 at 6; see Doc. 7091-3 at 7 (“[T]here was
definitely arrhythmia that was caused by the catheter”). The Court agrees. Hurst is an
interventional radiologist, not a cardiologist. Doc. 7091-3 at 7. He treats catheter fractures
in his practice and observes cardiac arrythmia in such patients (id. 6-7), but this is not
sufficient qualification for him to opine on the cause of cardiac arrhythmias. “[T]he ability
to diagnose medical conditions is not remotely the same, . . . as the ability to deduce . . .
in a scientifically reliable manner, the causes of those medical conditions.” Wilson v.
Pinnacle Foods Inc., No. 3:19-CV-229-BJB, 2022 WL 419595, at *6 (W.D. Ky. Feb. 10,
2022) (citation modified)); see also Stambolian v. Novartis Pharms. Corp., No. CV 12-
04378 BRO FMOX, 2013 WL 6345566, at *6 (C.D. Cal. Dec. 6, 2013) (holding doctor
qualified to treat medical condition at issue but not qualified to diagnose the cause). Hurst
concedes he is not qualified to opine on Plaintiff’s ongoing cardiac complications. Doc.
7091-3 at 7-8. It follows that he is not qualified to opine on the cause of the complications.
Hurst’s causation opinion is excluded.
1 Although Hurst’s testimony about what information should have been included in Bard’s
IFUs was elicited by defense counsel (Doc. 7091-3 at 25), a fact that would have overcome
a nondisclosure objection by Defendants, Hurst’s testimony on this issue is precluded
because he is not qualified under Rule 702 to render the opinion.
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Hurst may, however, opine that cardiac arrythmia is a common complication of a
catheter fracture. Hurst supports this opinion with his experience as an interventional
radiologist treating fractured catheters. Doc. 7901-3 at 6-7 (“[A]rrhythmia is . . . one of
the first things that you're going to see if you have some sort of foreign body . . . within the
heart, in my experience with catheter fragments[.]”), 9 (Hurst testifying that he has
“personally removed catheter fragment from a patient’s heart” five or six times). It is
common knowledge in the medical community that cardiac arrythmia is a known
complication of a catheter fracture – Bard’s IFU warns about it. Doc. 4822-1 at 23. Hurst’s
opinion that cardiac arrythmia is a common complication of a catheter fracture is supported
by sufficient facts and data and is reliable. See Elosu, 26 F.4th at 1024; In re Bard IVC
Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018 WL 993675, at *2 (D.
Ariz. Feb. 21, 2018) (“[C]linical experience [can be] sufficient to satisfy the threshold
reliability requirements of Rule 702.”); In re Bard IVC Filters Prods. Liab. Litig., No.
MDL 15-02641-PHX DGC, 2018 WL 495188, at *4 (D. Ariz. Jan. 22, 2018) (“[E]xpert
testimony ‘is reliable if the knowledge underlying it has a reliable basis in the knowledge
and experience of the relevant discipline.’” (quoting Primiano v. Cook, 598 F.3d 558, 565
(9th Cir. 2010), as amended (Apr. 27, 2010))).
Defendants contend the following statement from Hurst’s report “suggests that he
might venture into cardiac opinions”: “Dr. Dim further confirmed that [Plaintiff’s]
recurrent palpitations were likely related to the prior right atrial foreign body, explaining
that although the fragment had been removed, the cellular damage it caused persisted,
leaving [Plaintiff] at risk for developing arrythmia.” Doc. 7091 at 11. The Court reminds
Plaintiff that an expert may not act as a conduit for another expert’s opinions. While
Plaintiff contends such statements from Hurst’s report are simply a summary of Plaintiff’s
medical chronology and not Hurst’s opinions (Doc. 7420 at 10), experts cannot “engage in
lengthy factual narratives not necessary to the jury’s understanding of their opinions[.]”
See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018 WL
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495187, at *4 (D. Ariz. Jan. 22, 2018). Defendants may object at trial where they deem
appropriate.
IT IS ORDERED Defendants’ motion to exclude the opinions of Darren R. Hurst,
M.D. (Doc. 7091) is granted in part and denied in part. Dr. Hurst may not opine on
(1) the design of IPCs or alternative designs as explained above, (2) what information he
thinks should have been included in the IFUs, or (3) the cause of Plaintiff’s cardiac
arrythmia.
Dated this 6th day of July, 2026.
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