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
Darren R. Hurst, M.D. and Jeffery
Weinstein, 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.
and Jeffery Weinstein, M.D. Doc. 4832. The motion is fully briefed and no party requests
oral argument. See Docs. 4832, 5326, 5564. 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 can 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 (“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.
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 plan to use various expert witnesses at trial, including medical
professionals. Plaintiffs have identified Darren Hurst, M.D., and Jeffrey Weinstein, M.D.,
as medical experts. Drs. Hurst and Weinstein are interventional radiologists. Docs. 4832-
1 at 5, 4832-2 at 5. Dr. Weinstein practices in the Department of Radiology at the Beth
Israel Deaconess Medical Center and is an Assistant Professor in Radiology at Harvard
Medical School. Doc. 4832-1 at 42. Dr. Hurst practices as the Chief of Vascular and
Interventional Radiology for the St. Elizabeth Health System, among holding other
radiology-practice positions. Doc. 4832-2 at 5, 50. He is also an Assistant Professor of
Interventional Radiology at the University of Kentucky College of Medicine. Id. at 51. In
their medical practices, both doctors regularly implant and remove port catheters. See
Docs. 4832-1 at 5, 4832-2 at 5. Defendants move to exclude their 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
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.
A. Substantially Similar Reports.
Defendants argue the Hurst and Weinstein reports should be excluded entirely under
Federal Rule of Civil Procedure 26 because their strong similarities show the doctors did
not prepare their reports as required by Rule 26. Doc. 4832 at 6; see also Fed. R. Civ. P.
26(a)(2)(B) (instructing an expert report must be “prepared and signed by the witness”).
The Court is not persuaded.
The reports are similar. They state many of the same opinions, follow the same
general organization, have many of the same footnotes, and cite many of the same sources
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and authorities. Clearly, they were prepared in collaboration with Plaintiffs’ counsel to
present opinions supportive of Plaintiffs’ case.
But the reports are not identical; they contain meaningful differences. For example,
while the reports include much of the same language in their introductions and general
descriptions of port catheters and how they are placed, Weinstein’s report includes a
significantly more detailed description of port catheter complications than Hurst’s.
Compare Doc. 4832-1 at 16-31, with Doc. 4832-2 at 15-21. Hurst’s report contains a
detailed discussion of Bard’s internal data regarding serious complications and testing of
alternative designs that is not found in the same form or location in Weinstein’s report.
Compare Doc. 4832-2 at 23-35 (subsections II.E-F), with Doc. 4832-1 at 33 (no similar
subsections).
The doctors’ first opinions about Bard’s calculation of complication rates are
similar, but not identical (Docs. 4832-1 at 33-35, 4832-2 at 35-37). Their second opinions
also differ. Weinstein opines in three pages that doctors expect manufacturers to
implement design improvements (Doc. 4832-1 at 35-37), and he separately discusses
Bard’s potential design improvements for thrombosis prevention, infection prevention, and
fracture prevention in his background section (id. at 16-31). Hurst discusses the same in
his opinion section but also opines on the consequences of Bard’s decision not to
implement these improvements. Doc. 4832-2 at 37-43. Both doctors opine that Bard failed
to warn the medical community, but their presentations of these opinions differ in wording
and organization. Compare Doc. 4832-1 at 37-38, with Doc. 4832-2 at 43-45. The same
is true of their fourth opinion – that Bard failed to warn the medical community in a manner
expected by physicians. Compare Doc. 4832-1 at 38-40, with Doc. 4832-2 at 45-47.
Finally, Hurst’s report is eight single-spaced pages longer than Weinstein’s and contains
28 more footnotes.
The Court does not find that the reports’ similarities violate Rule 26. When the rule
was amended in 1993 to require retained experts to prepare detailed reports of their
opinions and testimony, the Advisory Committee on the Federal Rules of Civil Procedure
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specifically instructed that the new rule “does not preclude counsel from providing
assistance to experts in preparing the reports[.]” Fed. R. Civ. P. 26 advisory committee’s
note to 1993 amendment. The Advisory Committee further amended Rule 26 in 2010 by
providing that attorney-expert communications, including in preparing reports, were not
subject to discovery with the exception of a few narrow categories of information. See
Fed. R. Civ. P. 26(b)(4)(C); Fed. R. Civ. P. 26 advisory committee’s note to 2010
amendment (“Rule 26(b)(4)(C) is added to provide work-product protection for attorney-
expert communications regardless of the form of the communications, whether oral,
written, electronic, or otherwise.”). These amendments underscored the reality that
attorneys can work with experts in preparing their testimony. Courts thus recognize that
lawyers can assist experts in preparing reports, including counsel’s “editorial assistance on
the report, counsel’s composing of initial drafts of reports based upon communications
with the expert and allowing the expert to substantively revise the report to reflect the
expert’s opinions, or counsel’s drafting of the report with the expert’s substantive
assistance[.]” Accentra Inc. v. Staples, Inc., No. CV 07-5862 ABC (RZX), 2010 WL
11459205, at *4 (C.D. Cal. Oct. 7, 2010) (citations omitted) (collecting cases). But the
expert must “substantially participate in the preparation of his report.” Id. (citation
omitted).
It is not surprising that Plaintiffs would retain interventional radiologists who share
common opinions on key issues that support Plaintiffs’ claims. The Court has instructed
that parties may present only one expert per issue during trial, but both sides have retained
multiple overlapping witnesses to cover the six separate bellwether trials that will be held
over the course of the next year.
Hurst and Weinstein testified that they prepared their respective reports. See
Docs. 5326-1 (Hurst) at 5-6 (“Q. And did you write your report and rebuttal report? A. I
did.”; “Q. And the words and analysis contained in your report and rebuttal report are your
words, your analysis, and your opinions? A. Yes, sir.”; “Q. [Y]our report and your rebuttal
report contain the opinions that you are offering in this case, right? A. Correct.”), 5326-2
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(Weinstein) at 3-4 (“Q. [T]he actual analysis and facts and opinions contained in Exhibit 9
and Exhibit 10 you wrote? A. Correct.”; “Q. And your report and your rebuttal report state
the substance of your opinions that you’re expected to testify to? A. That’s my
understanding.”). Courts tend to find Rule 26 satisfied when an expert testifies that he
wrote his report or that it accurately reflects his opinions. See, e.g., Optronic Techs., Inc.
v. Ningbo Sunny Elec. Co., 20 F.4th 466, 477 (9th Cir. 2021) (affirming admission of expert
testimony where expert testified his report “accurately reflected his analysis and opinion
with regard to the case”); Keystone Mfg. Co., Inc. v. Jaccard Corp., 394 F. Supp. 2d 543,
567 (W.D.N.Y. 2005) (admitting expert testimony where the expert testified he was
“actively and substantively involved in the preparation and content of his report”).
The doctors’ reports state that they conducted medical literature reviews.
Docs. 4832-1 (Weinstein) at 6 (“I personally conducted a medical literature review and
analyzed literature relevant to the topics discussed in this report.”), 4832-2 (Hurst) at 6 (“I
personally performed a medical literature research and reviewed literature relevant to the
topics discussed in this report.”). Further, both doctors signed their reports, attesting that
the opinions described in their reports are based on their review of the documents and
materials provided to them, their own independent research, and their medical experience.
Docs. 4832-1 (Weinstein) at 40, 4832-2 (Hurst) at 47. And both doctors’ invoices to
Plaintiffs’ counsel show extensive communications with counsel before the reports were
completed. See Docs. 5326-3, 5326-4.
The Court finds these reports similar to those addressed by the Ninth Circuit in
Optronic Techs., Inc., 20 F.4th 466. Even though 60% of the expert’s report in that case
was written by counsel, the Court of Appeals held that the trial court properly admitted the
expert’s opinion. Id. at 477. As in this case, the introductory sections of the report were
heavily influenced by counsel, and the expert testified that he reviewed and edited the
report and that it accurately reflected his opinions. Id. The Court of Appeals noted that
Rule 26 “permit[s] counsel to assist experts in preparing reports[.]” Id.
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Defendants essentially argue that the Court should disbelieve the doctors’ assertions
regarding how their reports were prepared. Choosing to distrust the doctors’ accounts,
Defendants assert, should lead the Court to conclude not only that Rule 26 has been violated
but also that the doctors’ opinions are unreliable under Rule 702. But courts normally do
not make witness credibility determinations. That is the jury’s task.
The Court does not find that the similarities between the Hurst and Weinstein reports
renders their opinions inadmissible under Rule 26 or Rule 702. Each expert’s report
provides a detailed description of the opinions he will give at trial, fulfilling a primary
purpose of Rule 26 – to enable Defendants to prepare for trial. If Defendants believe the
similarities between the reports calls into question the doctors’ credibility, they are free to
cross-examine the doctors on this point at trial.
The Court has considered the cases cited by Defendants and is not persuaded to
reach a different conclusion. One of Defendants’ primary cases, GEICO v. The Right
Spinal Clinic, 608 F.Supp.3d 1184 (M.D. Fla. 2022), presented an extreme case of expert
neglect. The expert “did not contribute a single word” to the report, did “not know who”
wrote the report, and allowed others to write the report “from beginning to end.” Id. at
1189.
In another of Defendants’ primary cases, Holley v. Gilead Scis., Inc., No. 18-CV-
06972-JST, 2023 WL 2440237 (N.D. Cal. Mar. 9, 2023), the district court made a
credibility finding, choosing to disbelieve the experts’ assertions about the extent of their
involvement in preparing their reports. Id. at *2. The Court does not make a similar finding
here. Applying the test used in many of Defendants’ cases – whether the expert
substantially participated in the preparation of his report, Accentra, 2010 WL 11459205,
at *4 – the Court declines to exclude the Hurst and Weinstein opinions for violating Rule
26. While Plaintiffs’ counsel played a significant role in the development of these expert
reports, it is clear the doctors substantially participated as well and signed the reports as
accurate statements of their opinions. The purpose of Rule 26 is satisfied.
/ / /
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B. Challenging Opinions Under Rule 702.
Defendants argue several of the doctors’ opinions should be excluded under Rule
702. Doc. 4832 at 11-21.
1. Opinions on Reporting Complication Rates.
Both doctors criticize Bard’s internal method of complication tracking. They opine
that medical device manufacturers historically underreport complication rates to the FDA,
Bard knew this fact but did nothing about it, and Bard used an inaccurate method of
calculating complication rates that resulted in artificially low rates. See Docs. 4832-1 at
33-35, 4832-2 at 35-37.
Defendants argue the doctors are unqualified under Rule 702(a) to render opinions
“regarding the accuracy of, or proper methodologies associated with, determining medical
device complication rates” because both “doctors concede a lack of any formal education,
training, or experience in designing or working with post-market adverse event systems”
and neither has “analyzed an IPC manufacturer’s complication rate in their private
practice” or “track[ed] adverse events associated with IPCs[.]” Doc. 4832 at 11-12.
Plaintiffs respond that the doctors’ opinions are quite limited: “as physicians, they expect
a manufacturer to track complication rates that accurately reflect clinical realities.”
Doc. 5326 at 9. But the doctors’ opinions are not so limited.
Hurst and Weinstein opine that Bard knew complication rates were historically
underreported by medical device manufacturers, and yet calculated its own rates using total
units sold rather than units implanted, artificially lowering the complaint rate. Docs. 4832-
1 at 34, 4832-2 at 36. Plaintiffs argue the doctors are qualified to render this opinion
because they are “experienced implanting physicians who have managed complications
directly and reviewed relevant literature.” Doc. 5326 at 9. True, but the doctors’ clinical
experience in managing IPC complications does not qualify them to opine on the proper
method for calculating corporate complication rates. As Defendants note, neither doctor
has any formal education, training, or experience in designing or working with post-market
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adverse event reporting systems and neither has calculated complication rates in their
private practice. Doc. 4832 at 11-12 (citing doctors’ depositions).
Plaintiffs also argue the doctors reached their opinions on Bard’s complication rate
by “applying reliable clinical logic and real-world experience to critique a metric that
affects their medical decision-making.” Doc. 5326 at 9-10. But Plaintiffs have not shown
that the clinical knowledge of interventional radiologists has anything to do with
calculating device complication rates.
Further, Defendants note that although Hurst and Weinstein criticize Bard’s use of
total units sold rather than total units implanted as the denominator in its internal complaint
systems, they offer no alternative methodology to calculate the rate. Hurst testified that a
registry could track every implant, but he acknowledged that he has no experience in setting
up such a registry. Doc. 4832 at 12. Hurst further asserted that Bard’s complaint tracking
systems fail to incorporate comparison with competitor devices, and that such a comparison
likely would have highlighted its IPCs as having higher-than-expected complication rates.
Id. at 13. But Hurst concedes that he does not know the internal complaint rates for any
other port manufacturer, rendering his opinion speculative. And Hurst did not undertake
any analysis of Bard’s adverse event data to arrive at what he believes is a reliable adverse
event rate beyond a brief evaluation during his deposition. Id.
Both doctors cite several studies to support their opinions, but an expert cannot
merely recite the findings of a study without independently verifying those findings. See
In re Roundup Prods. Liab. Litig., No. 16-MD-02741-VC, 2023 WL 7928751, at *3 (N.D.
Cal. Nov. 15, 2023) (“[I]t’s certainly not enough to read and report on the summaries of
the studies performed by other bodies or experts.”), aff’d sub nom. Engilis, 151 F.4th 1040;
Buck v. Ford Motor Co., 810 F. Supp. 2d 815, 844 (N.D. Ohio 2011) (“An expert must
make some findings and not merely regurgitate another expert’s opinion.” (citation
modified)). Neither doctor claims to have verified the studies he cites or to have the
expertise to do so. The Court will exclude the doctor’s opinions on Bard’s reporting of
complication rates.
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2. Alternative Design Opinions.
Weinstein opines that:
[A]ntimicrobial coatings have been shown to lower infection rates, structural
reinforcements improve catheter durability, and thromboresistant materials
reduce clot formation, all of which, in my opinion, could have contributed to
safer and more effective implantable port catheters. Despite this, Bard did
not incorporate these improvements into its marketed implantable port
catheters, leaving physicians without access to devices in the Bard line with
enhanced safety features.
Doc. 4832-1 at 36.
Similarly, Hurst opines that “coatings [on Bard ports] would have reduced the risk
of infection and thrombosis” (Doc. 4832-2 at 39), “incorporating mesh reinforcement into
Bard’s catheter design could have significantly reduced the risks of kinks and fractures”
(id. at 39-40), and “Bard’s decision not to implement these low-cost safer alternative
designs . . . exacerbated healthcare costs, compromised the integrity of the informed
consent process, and subjected patients to serious and preventable complications” (id. at
42-43).
Defendants argue the doctors are not qualified to render such opinions because
neither has “any formal training, education, or experience in the manufacturing processes
for implantable medical devices,” in polymer development, or in “developing materials
used for catheters or ports specifically.” Doc. 4832 at 14. Nor has either doctor “designed
an IPC, conducted any studies on IPCs, or published any peer-reviewed medical literature
regarding IPCs,” or conducted studies comparing polymer and non-polymer catheters. Id.
Plaintiffs cite three cases for the proposition that “practicing physicians, such as
Drs. Hurst and Weinstein, are qualified to opine from the physician’s perspective on
whether a design feature would be expected to reduce complications based on clinical
literature, their treatment experience, common medical knowledge, and internal corporate
documents.” Doc. 5326 at 10. The cases are distinguishable.
In In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig.,
No. 2:18-CV-01509, 2020 WL 6605612 (S.D. Ohio Sept. 11, 2020), the doctor was
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qualified to discuss the current design of the medical device based on his clinical
experience using the existing product. See id. at *5 (“Dr. Novitsky's knowledge of and
experience with hernia mesh devices, and specifically with the Ventralight ST, qualifies
him to opine on the design and function of the device from the perspective of a hernia
surgeon and end-user of the device.”). The doctors in this case are opining about possible
product changes they have never used in a port catheter.
In In re 3M Combat Arms Earplug Prods. Liab. Litig., No. 3:19MD2885, 2021 WL
6327375 (N.D. Fla. Sept. 2, 2021), the expert’s opinion was also based on personal
experience. The audiologist had experience selecting, fitting, and creating custom hearing
devices and was therefore “qualified to opine, from a clinical perspective, on how particular
aspects of the CAEv2’s design prevented proper fit and seal due to the variability in the
anatomy of the human ear and ear canal[.]” Id. at *14. The expert was “not qualified to
opine on the CAEv2’s design from an engineering perspective[.]” Id.
Finally, the Court disagrees with the legal standard applied in the third case for
finding an expert qualified under Rule 702(a). See Alonzo v. Biomet, Inc., No. 0:21-CV-
62232-WPD, 2023 WL 3484192, at *1 (S.D. Fla. Apr. 13, 2023) (“The qualification
standard for expert testimony is ‘not stringent[.]’” (citation omitted)).
Hurst and Weinstein have no experience designing ports or testing port materials.
See Docs. 4832-3 (Weinstein) at 4 (“Q. Have you ever designed an implanted medical
device? A. . . . I’ve never done it.”), 4832-4 (Hurst) at 4 (“Q. Have you ever designed an
implantable medical device? A. No.”). Neither doctor has produced any studies, research,
or literature on port materials or design. Docs. 4832-3 (Weinstein) at 4-5 (“Q. Have you
ever conducted clinical studies on implantable devices? A. Not that I recall, no.”; “[Y]ou
ha[ve] not written any articles in the peer-reviewed medical literature where the subject
matter of the article is ports? A. No, I have no recollection of anything like that.”),1 4832-
4 (Hurst) at 4 (“Q. Have you ever conducted any studies on implantable ports? A. No. Q.
1 The Court notes Weinstein mentored a resident who conducted a quality assurance project
on ports. See Doc. 4832-3 at 5-6. This alone does not qualify him to opine on port design.
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Have you ever published any articles in the peer-reviewed medical literature regarding
implantable ports? A. No.”; “Q. In your CV you don’t list any research that you have done
over the course of your career on implantable ports, do you? A. I do not.”).
The doctors rely almost exclusively on Bard’s internal documents, not medical
literature. See, e.g., Docs. 4832-1 (Weinstein) at 35 (“Bard’s internal testing demonstrated
that Dextran Glycoconjugate Polymer (DGP) technology reduced thrombus adherence by
90–99%, yet Bard did not integrate this technology into its IPCs.”), 4832-2 (Hurst) at 38
(“Bard’s internal documents confirm that the company had longstanding awareness of
antimicrobial coatings that could reduce catheter-related bloodstream infections
(CRBSIs).”). A mere reading of Bard internal documents does not qualify these physicians
to opine on feasible and effective port design. Nor can the doctors rely on published
literature or other expert opinions they have not verified. See In re Roundup Prods. Liab.
Litig., 2023 WL 7928751, at *3 (“[I]t’s certainly not enough to read and report on the
summaries of the studies performed by other bodies or experts.”), Buck, 810 F. Supp. 2d at
844 (“An expert must . . . not merely regurgitate another expert’s opinion.” (citation
modified)).
Plaintiffs argue the doctors’ opinions “do[] not address polymer chemistry, polymer
engineering, materials science, manufacturing processes, or device costs.” Doc. 5326 at
11. But the doctors specifically opine that Bard ports would have been safer if Bard had
used certain polymer materials and structural reinforcements. Docs. 4832-1 (Weinstein)
at 35-36 (“Had Bard implemented [Dextran Glycoconjugate Polymer] coatings, physicians
could have offered their patients devices with a lower risk of such complication[.]”;
“[A]ntimicrobial coatings have been shown to lower infection rates, structural
reinforcements improve catheter durability, and thromboresistant materials reduce clot
formation . . . . Despite this, Bard did not incorporate these improvements into its marketed
implantable port catheters[.]”), 4832-2 (Hurst) at 39 (“Competitor products such as Orphis
and AngioDynamics adopted hydrophilic coatings and non-fouling polymers to achieve
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lower infection and thrombosis rates. Despite this, Bard did not incorporate similar
antimicrobial coatings into its implantable port catheters.”).
Hurst further opines on the feasibility of design changes based on device costs. See,
e.g., Doc. 4832-2 at 41-43 (opining that “the DGP-based thrombosis-resistant coating was
projected to cost only $16.25 per unit, while Bard expected to charge a $45.00 premium.
The cost of antimicrobial coatings was reduced to $5 per unit through vendor agreements,
yet Bard planned a $65.00 upcharge. And reinforcing catheter tubing to prevent fractures
was estimated to cost $18.75 per unit, with an expected selling price increase of $75.00”
(footnotes omitted)).
Plaintiffs have not shown by a preponderance of the evidence that the doctors are
qualified to opine on alternative port designs with which they have no clinical experience.
Nor does mere review of Bard internal documents and a few studies constitute a reliable
basis for the doctors to opine on the efficacy and feasibility of alternative port designs.
Their alternative design opinions will be excluded.
3. Instructions for Use Opinions.
Both doctors opine that certain risks associated with IPCs were not disclosed in
Bard’s Instructions for Use (“IFUs”). Docs. 4832-1 (Weinstein) at 38-40, 4832-2 (Hurst)
at 45-47. Defendants argue the doctors are not qualified to render opinions on the adequacy
of Bard’s IFUs. Doc. 4832 at 16.
A medical professional expert may opine on knowledge generally held within the
medical community. McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2021 WL
2709292, at *16 (D. Ariz. July 1, 2021) (holding that “[e]xpert witnesses may properly
offer opinions” on “knowledge of the medical community in general” (citation omitted)).
Interventional radiologists such as Hurst and Weinstein rely on IFUs in their clinical
practice to learn about the risks associated with ports. Doc. 4832-1 at 39. The known risks
of ports and whether those risks are communicated in Bard’s IFUs are matters within the
knowledge of the medical community the doctors may opine on.
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The weight of the caselaw holds that a doctor’s clinical experience qualifies him to
discuss the adequacy of warnings in IFUs. Arevalo v. Coloplast Corp., No. 3:19CV3577-
TKW-MJF, 2020 WL 3958505, at *5 (N.D. Fla. July 7, 2020) (admitting “Dr. Kohli’s
opinions regarding the risks physicians expect to be included in IFUs and how those
compare to the risks actually included in the Aris IFU”), aff’d sub nom. Arevalo v. Mentor
Worldwide LLC, No. 21-11768, 2022 WL 16753646 (11th Cir. Nov. 8, 2022); Kelley v.
C.R. Bard, Inc., 644 F. Supp. 3d 1316, 1341-42 (N.D. Ga. 2022) (“Culligan is qualified to
testify regarding the adequacy of the IFU warnings. . . . [A] doctor relying on a product
warning in his or her practice qualifies him or her to make conclusions on the adequacy of
the product’s warning.” (citations omitted)), vacating in part, No. 2:20-CV-00045-SCJ,
2023 WL 2370109 (N.D. Ga. Jan. 24, 2023); In re Bard IVC Filters Prods. Liab. Litig.,
No. MDL 15-02641-PHX DGC, 2017 WL 6554163, at *5 (D. Ariz. Dec. 22, 2017) (“The
Court cannot conclude from these cases that Drs. Kinney, Roberts, and Kalva should be
precluded from testifying about disclosures that reasonable radiologists expect to receive
from manufacturers of IVC filters.”); Wise v. C.R. Bard, Inc., No. 2:12-CV-01378, 2015
WL 521202, at *14 (S.D.W. Va. Feb. 7, 2015) (“Dr. [Raybon] . . . is qualified to evaluate
Bard’s warnings based on his knowledge of and experience with the risks of the Avaulta.”);
Godreau-Rivera v. Coloplast Corp., 598 F. Supp. 3d 196, 210-11 (D. Del. 2022) (adopting
Wise’s reasoning); Huskey v. Ethicon, Inc., 29 F. Supp. 3d 691, 719 (S.D.W. Va. 2014)
(“[A]s a urologist, Dr. Blaivas is qualified to testify about the risks of implanting the TVT–
O and whether those risks were adequately expressed on the TVT–O’s IFU.”).
In this case, however, the doctors’ opinions extend beyond concluding that certain
risks were not disclosed in Bard’s IFUs. They opine on what content the IFUs should have
included. See, e.g., Docs. 4832-2 (Hurst) at 46 (“[T]he IFU should have provided specific,
actional measures to minimize risks, while explicitly warning that these measures had not
been confirmed to reduce the likelihood of compression.” (emphasis omitted)), 4832-1
(Weinstein) at 39-40 (similar). The doctors’ clinical experience in relying on IFUs to learn
about port risks does not qualify them to opine on what content should have been included
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in Bard’s IFUs. See In re: Ethicon, Inc., No. 2327, 2016 WL 4958312, at *3 (S.D.W. Va.
Aug. 25, 2016) (“While an expert who is a urogynecologist may testify about the specific
risks of implanting mesh and whether those risks appeared on the relevant IFU, the same
expert must possess additional expertise to offer expert testimony about what information
should or should not be included in an IFU.” (citation omitted)); Foster v. Ethicon, Inc.,
No. 5:20-CV-06099-BCW, 2021 WL 1700062, at *2 (W.D. Mo. Mar. 26, 2021) (same);
Fields v. Ethicon, Inc., No. CV421-020, 2023 WL 348340, at *6 (S.D. Ga. Jan. 20, 2023)
(“Although an expert relying solely on his experience as a urogynecologist may be
qualified to opine on the risks associated with a product or procedure, and whether an IFU
adequately communicates those risks, he may not offer opinions as to what [a] [d]efendant
was, for example, obligated to include in its IFUs, or whether an IFU complies with
regulatory standards.” (citation modified)).
The doctors may opine on whether port-related risks known to the medical
community were disclosed through Bard’s IFUs. But they may not opine on content they
believe should have been included in the IFUs. Nor may they opine on whether Bard’s
IFUs complied with regulatory standards, as Plaintiffs concede. Doc. 5326 at 13
(“[N]either Dr. Hurst nor Dr. Weinstein will testify that Bard was legally required to
include certain information in the [IFUs].”).
Defendants also contend the doctors’ opinions on the adequacy of Bard’s IFUs
should be excluded as unreliable. Doc. 4832 at 17. But for medical experts, “clinical
experience is sufficient to satisfy the threshold reliability requirements of Rule 702.”
McBroom, 2021 WL 2709292, at *5 (quoting In re Bard IVC Filters Prods. Liab. Litig.,
No. MDL 15-02641-PHX DGC, 2018 WL 993675, at *2 (D. Ariz. Feb. 21, 2018)); see
also 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))). The doctors’ opinions regarding whether known risks of ports were
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disclosed through Bard’s IFUs are supported by their clinical experience in relying on
IFUs.
4. Bard’s Knowledge, Conduct, and Duties Opinions.
Defendants argue the doctors are not qualified to render opinions “regarding Bard’s
knowledge, as well as any expert or narrative testimony regarding Bard’s conduct and
capabilities[.]” Doc. 4832 at 17-19. Defendants cite Weinstein’s opinions that “Bard had
extensive internal knowledge regarding [port catheter] complications” and that an
alternative design project “was deprioritized [by Bard] due to cost constraints and resource
allocation.” Doc. 4832-1 at 24, 37. For both opinions, Weinstein relies on Bard’s internal
documents or adverse event reports. Id. Defendants also cite Hurst’s opinion that “Bard’s
internal records show that the company had the knowledge and capability to implement
[certain] safety enhancements . . . at relatively low production costs.” Doc. 4832-2 at 41.
For reasons stated in previous cases, the Court will preclude these physician
opinions on corporate knowledge. See In re Bard IVC Filters Prods. Liab. Litig., No. MDL
15-02641-PHX DGC, 2018 WL 495187, at *3 (D. Ariz. Jan. 22, 2018) (“Dr. Eisenberg
also expresses opinions about what Bard knew based on various internal documents, how
Bard tracked adverse event reports, and what Bard failed to take into account in designing
its filters. But Dr. Eisenberg is not an expert on corporate communications, behavior, or
regulation[.]” (citations omitted)); In re Bard IVC Filters Prods. Liab. Litig., 2018 WL
495188, at *6 (“Dr. Muehrcke will not be permitted to opine about Bard’s knowledge,
intent, or ethics. He does not purport to be an expert on corporate information processing
and he has not conducted any study of Bard internal operations, information gathering, or
corporate ethics. Plaintiffs propose to have him opine about what Bard knew based on
selected documents, but identify no expertise that enables him to opine on Bard’s
knowledge.” (citation omitted)).
Plaintiffs argue the doctors’ “role is to explain what Bard’s internal documents mean
from the perspective of a clinician[.]” Doc. 5326 at 14. But it is not clear why a physician’s
perspective on corporate knowledge is relevant or necessarily reliable, and it remains an
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opinion on corporate knowledge the doctors are not qualified to provide. “Personal views
on proper corporate behavior are not appropriate expert opinions.” In re Bard IVC Filters
Prods. Liab. Litig., 2018 WL 495187, at *3 (citations omitted).
Plaintiffs contend the doctors’ opinions about what Bard’s internal documents mean
to a physician will “help the jury to understand the meaning and importance of terms such
as pinch-off risk, flexural fatigue, and catheter fracture.” Doc. 5326 at 15. But Hurst and
Weinstein need not discuss Bard’s knowledge or intent to explain medical terms that are
within their knowledge as practicing physicians.
Defendants also seek to exclude the doctors’ opinions on Bards “duties and
responsibilities” because the doctors are not qualified to render such opinions. Doc. 4832
at 18. The Court agrees. See In re Bard IVC Filters, No. MDL 15-02641-PHX DGC, 2018
WL 823277, at *4 (D. Ariz. Feb. 12, 2018) (explaining because “the Doctors are not
regulatory or corporate experts, . . . they will not be permitted to opine on Bard’s
obligations”).
Defendants further contend the doctors opining “that Bard IPCs are unreasonably
dangerous” is an impermissible legal conclusion because the term “unreasonably
dangerous” is a term of art. Doc. 4832 at 19 (quoting Neumann v. Home Depot U.S.A. Inc.,
No. CV-20-00387-PHX-JJT, 2022 WL 3042914, at *7 (D. Ariz. Aug. 2, 2022) (“Because
Plaintiffs assert strict liability claims related to Krause ladders, Dr. Morse should refrain
from characterizing them as ‘unreasonably dangerous’ and ‘defective.’ These are terms of
art that will be ultimately determined by the jury.” (citation omitted))). Plaintiffs bring
strict liability claims in this litigation (Doc. 1889 at 50, 54, 58), but the specific legal
requirements of those claims will depend on the applicable state law, something
Defendants do not discuss. Defendants will need to raise this argument in specific cases
when the relevant state law is known.
5. Narrative Testimony and State of Mind Testimony.
Defendants seek to exclude the doctors’ “narrative testimony regarding Bard’s
internal studies and investigations of alternative designs.” Doc. 4832 at 20. Defendants
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do not explain what parts of the doctors’ reports or deposition testimony are narrative. In
any event, “[t]he objection that testimony is ‘narrative’ is an objection as to form,
foundation, or responsiveness, and must be presented at trial.” In re Bard IVC Filters
Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 6523833, at *8 (D. Ariz.
Dec. 21, 2017) (quoting In re Actos Prods. Liab. Litig., No. 12-cv-00064, 2014 WL
120973, at *10 (W.D. La. Jan. 10, 2014)). The Court will rule on narrative testimony
objections at trial. See In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 495187, at *4
(explaining experts cannot “engage in lengthy factual narratives not necessary to the jury’s
understanding of their opinions” and that “[a]t trial, the Court will seek to strike the proper
balance between allowing experts to reasonably explain their opinions in a manner helpful
to the jury, and avoiding unnecessary factual recitation or argument”).
Defendants also seek exclusion of the doctors’ testimony “infer[ring] Bard’s intent
and state of mind.” Doc. 4832 at 20. The Court previously ruled that “[i]nferences about
the intent or motive of parties or others lie outside the bounds of expert testimony.” In re
Bard IVC Filters Prods. Liab. Litig., 2017 WL 6523833, at *9 (quoting In re Rezulin Prods.
Liab. Litig., 309 F. Supp. 2d 531, 547 (S.D.N.Y. 2004)). No expert may render opinions
on the intent or state of mind of either party.
6. Reasonable Expectations of Physicians.
Hurst and Weinstein refer to what “physicians reasonably expect” from the
manufacturers of medical devices. See, e.g., Docs. 4832-1 (Weinstein) at 7 (“[R]easonable
physicians would have chosen devices with these features had Bard made them available.
Furthermore, physicians reasonably expect manufacturers to prioritize safety
improvements when the costs are manageable and the benefits to patient outcomes are
substantial.”), 4832-2 (Hurst) at 37 (“Physicians reasonably expect that when
manufacturers identify design modifications that could reduce complications . . . , those
improvements will be implemented and communicated clearly.”). Defendants argue the
doctors may not opine about the “reasonable expectations of physicians” because “their
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opinions lack foundation and do not reliably flow from the application of any scientific
principle or method.” Doc. 4832 at 20-21.
This Court in prior litigation found Hurst qualified to opine on the reasonable
expectations of physicians. See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-
02641-PHX DGC, 2018 WL 495189, at *5 (D. Ariz. Jan. 22, 2018) (“Dr. Hurst’s training
and years of experience as an interventional radiologist qualifies him to opine on [what
reasonable physicians and patients expect from medical device manufacturers].”).
Defendants do not challenge whether the doctors are qualified to render such
opinions, but instead argue that “neither doctor cites any facts or data in support of their
assertions . . . regarding reasonable expectations.” Doc. 4832 at 20-21. They contend the
doctors “have no foundation beyond their own experiences for their ‘reasonable
expectations’ opinions.” Doc. 5564 at 12. The Court finds this experience sufficient to
support their opinions. 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.”).
Defendants also argue that “[n]either doctor cites to any methodology or industry
standard to measure what the ‘reasonable expectations’ of a physician include.” Doc. 4832
at 21. The Court is satisfied that the doctors’ clinical experience provides sufficient
foundation for their opinions about the reasonable expectations of physicians. See In re
Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 11696720,
at *5 (D. Ariz. Dec. 22, 2017) (permitting radiologists to “testify[] about disclosures that
reasonable radiologists expect to receive from manufacturers of IVC filters. Such
testimony, if relevant, appears to be well within their expertise and experience, and the
Court can identify no basis under Rule 702 for precluding it.”).
Defendants also challenge two specific “reasonable expectations” opinions rendered
by the doctors. They contend “[p]laintiffs cannot reconcile their experts’ assertion that
reasonable doctors expect manufacturers to communicate comparable device data within
IFUs when the doctors are not aware of any manufacturer that does so.” Doc. 4832 at 21.
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As discussed above, the doctors may not opine on what content should have been included
in Bard’s IFUs. This opinion is excluded.
Defendants also contend “the doctors [cannot] reliably opine that reasonable
physicians would select coated catheters if made available” because the doctors
acknowledge “there are numerous factors that go into purchase decisions and there is
insufficient data to determine whether coatings could carry additional risks.” Id. The Court
addressed this issue previously: “Whether the doctors should also be permitted to testify
about what doctors would have done with additional information seems more problematic.
Whether and when to use a particular product appears to be a more fact- and patient-
specific decision, not amenable to broad generalizations. The propriety of testimony on
this subject will depend heavily on the context and relevancy of the question.” In re Bard
IVC Filters Prods. Liab. Litig., 2017 WL 11696720, at *5. The Court will draw these lines
at trial.
IT IS ORDERED:
1. Defendants’ motion to exclude the reports of Drs. Darren R. Hurst and
Jeffery Weinstein (Doc. 4832) is granted in part and denied in part.
2. Drs. Hurst and Weinstein may not render opinions on (1) Bard’s reporting of
complication rates, (2) the alternative design of ports, (3) what content should have been
included in Bard IFUs, (4) the knowledge, intent, or state of mind of Bard, or (5) the
reasonable expectations of physicians as discussed above.
Dated this 20th day of February, 2026.
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