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
Becky A. Smith, 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 Becky A. Smith, M.D.
Doc. 4827. The motion is fully briefed and no party requests oral argument. See Docs.
4827, 5321, 5552. 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.
Plaintiffs have identified Becky A. Smith, M.D., as a medical expert. Dr. Smith is
an epidemiologist board certified in Internal Medicine and Infectious Diseases, and a
Professor of Medicine at Duke University. Doc. 4827-1 at 2. She has “extensive education
and experience in the areas of infectious disease, healthcare epidemiology, and infection
control,” and has “held successive leadership roles in large healthcare systems with a focus
on the investigation, epidemiological analysis, and prevention of infectious diseases.” Id.
Dr. Smith currently serves as the Medical Director of Infection Prevention and Hospital
Epidemiology at Duke University and as Chair of the Hospital Infection Control
Committee. Id. She is also an ad hoc reviewer for two peer-reviewed medical journals
and has “published more than 60 peer-reviewed articles in the fields of healthcare
epidemiology and infectious disease.” Id. at 3. Defendants move to exclude Dr. Smith’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
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.
Defendants enumerate 15 opinions of Smith, which they move to exclude under
Rule 702.
A. Opinions on Safer Alternative Designs.
Defendants move to exclude 11 alternative design opinions offered by Smith —
opinions numbered 2 through 11 and 15 of her report. Doc. 4827 at 3-5. Defendants argue
that Smith “expressly disavowed” the opinions “and the requisite expertise to offer those
opinions” in her deposition. Id. at 5, 9. The Court has reviewed the deposition pages cited
by Defendants and largely agrees with their characterization of Smith’s testimony.
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Plaintiffs apparently do too, as they do not oppose exclusion of Smith’s alternative design
opinions. Doc. 5321 at 6. Based on concessions made in her deposition and Plaintiffs’
agreement that her alternative design opinions should be excluded, the Court will exclude
opinions 2-11 and 15 of Smith’s expert report. See Doc. 4287-1 at 4-6.
Beyond these opinions, Defendants seek to exclude all opinions highlighted in
yellow in Exhibit A to their motion. See Doc. 4827-1. This is too broad a request. The
yellow highlighting covers 15 single-spaced pages of Smith’s report. Id. at 11-26.
Defendants provide no detailed discussion of the content of these pages, and the Court will
not guess at their objections to specific sentences or words. Defendants can object at trial
if they think Smith’s testimony is covered by the rulings in this order or is otherwise
inadmissible.
Plaintiffs argue that Defendants’ challenge “is overbroad” and the Court should not
exclude her opinions “about the nature, causes, and burdens of catheter-related
complications.” Doc. 5321 at 6-7. They argue those opinions are supported by Smith’s
specialized knowledge and clinical experience as a hospital epidemiologist. Id. at 6 (citing
Doc. 4827-1 at 2-3, 6-11, 11-3). Specifically, Plaintiffs argue Smith’s clinical experience
“includes analyzing how complications such as catheter-related thrombosis, infection, and
mechanical failure arise and can be reduced in clinical practice.” Id. (citing Doc. 4827-1
at 2-3). They argue this experience supports her opinions about (1) “the real-world risks of
catheter-related complications, the mechanisms by which those complications occur, their
prevalence, and the burden they impose on patients and hospital systems,” and (2)
“modifiable and non-modifiable risk factors for catheter-related complications[.]” Id.
(citing Doc. 4827-1 at 6-11, 11-13). Plaintiffs identify four opinions they contend Smith
should be permitted to give:
▪ Defendants’ ports pose well-established risks of catheter-related thrombosis,
infection, and mechanical failure (Doc. 4827-1 at 4, 30);
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▪ The root causes and pathogenesis of catheter-related thrombosis, infection, and
mechanical failure, and the interrelation between catheter-related thrombosis
and infection (id. at 4-5, 9-11; Doc. 5321-1 at 21);
▪ Port complications significantly impact patient morbidity and healthcare costs
(Doc. 4827-1 at 7-9); and
▪ Modifiable and non-modifiable risk factors of catheter-related complications (id.
at 11-13).
Doc. 5321 at 6.
Smith is qualified to give the first opinion as she does in the body of her report (Doc.
4827-1 at 6 (part D.)), but she may not give it as part of an opinion that Defendants’
products should have been designed more safely as she does in other portions of her report
(id. at 4, 30), for reasons stated above.
In the second opinion, Smith addresses the root causes of catheter-related
thrombosis, infection, and mechanical failure only as part of her opinions on how
Defendants can improve their products – opinions she is not qualified to provide. See id.
at 4 (opinions 3, 4, 6), 13-14. This opinion therefore will not be admitted.
Smith is qualified to give the third opinion identified by Plaintiffs.
Smith’s fourth opinion includes catheter materials and design as part of how catheter
risks can be modified and the role to be played by manufacturers like Defendants –
testimony she is not qualified to give. Id. at 11-13. Smith may testify about steps hospitals
and medical providers can take to moderate catheter-related risks, but she may not opine
on steps Defendants or similar manufacturers should take.
B. Opinions on Corporate Conduct.
Defendants challenge Smith’s opinions numbered 12, 13 and 14 in her report, which
they categorize as opining on corporate conduct. Doc. 4827 at 9-11. The Court will
address them separately.
First, Smith opines that “Defendants have never funded a clinical study
demonstrating the efficacy of their IPCs compared to safer alternative designs, despite the
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substantial body of evidence — clinical studies, mechanistic analyses, and real-world
outcomes — demonstrating that their IPCs pose comparatively significant risks of CRT,
CRBSI, and mechanical failures.” Doc. 4827-1 at 5. Plaintiffs contend Smith’s opinion
“flows directly (and properly) from [her] training and experience as an infectious disease
physician and hospital epidemiologist who evaluates and relies on clinical data regarding
device safety and efficacy to guide patient care.” Doc. 5321 at 8. The Court disagrees.
Whether and when a corporation should fund clinical studies of its products on the
market is not a matter dictated by an infectious disease doctor’s clinical practice. It is a
matter of federal regulation, corporate ethics, and corporate risk mitigation, none of which
lie within Smith’s expertise. She agreed she is not an expert in corporate ethics (Doc. 4827-
2 at 23), or on what a company should or should not do in the field of product development
(id. at 27-28). She agreed she does not have the expertise to say whether a company should
be required to investigate new technologies or fund studies. Id. at 47-48. She is unaware
of any industry standard that would have required Bard to incorporate alleged design
improvements into its products and reiterated “this isn’t my area of expertise or anything.”
Id. at 53-54. And she agreed she is not an expert in FDA regulations or compliance. Id. at
19-20. This opinion will be excluded. 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”).
Second, Smith opines that “Defendants’ domestic instructions for use (IFUs) fail to
warn that their IPCs should be removed after treatment is complete, although their Japanese
IFUs contain that warning,” and that “Defendants’ IFUs fail to warn about the risk of
fracture due to material fatigue with long-term use of their IPCs, despite the fact that the
IFU includes a pinch-off warning.” Doc. 4827-1 at 5. Plaintiffs argue that a doctor’s
clinical experience in relying on IFUs qualifies her to opine on the adequacy of an IFUs’
warnings. See 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
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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); 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.”).
While it is true that Smith relies in part on IFUs when evaluating “complication
rates associated with [a medical] device” for purposes of her clinical analysis of infection
rates and prevention (Doc. 4827-1 at 4), she does not rely on IFUs for purposes of deciding
when an IPC should be implanted in a patient — the key issue in this case. Nor is Smith
qualified to opine on what modifications Defendants should make to their IFUs. See, e.g.,
id. at 26 (“Bard should also modify its Instructions For Use (IFUs) for these devices.”), 27
(“To fulfill their obligations to provide clear, accurate, and comprehensive warnings and
IFUs for their IPCs, Defendants should revise their IFUs to recommend IPC removal after
treatment is complete . . . and to explicitly warn about the risk of fracture[.]”). As explained
by this Court in priors order of this MDL (see, e.g., Doc. 7196 at 14-17), a doctor’s clinical
experience in relying on IFUs does not qualify her to opine on what information should be
included in an IFU. 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]
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[d]efendant was, for example, obligated to include in its IFUs, or whether an IFU complies
with regulatory standards.” (citation modified)).
Third, Smith opines that “Defendants justify their failure to implement safer
alternative design technologies by reference to the ‘acceptably low’ rates of IPC-related
complication complaints reported to them by customers in comparison to the annual sales
volume for their IPCs.” Doc. 4827-1 at 5; see also id. at 27. Although Smith has
experience “systematically evaluat[ing] . . . adverse events and customer complaint data”
for clinical evaluation purposes (id. at 4), she is not qualified to give this opinion. In
addition to the fact that it implicitly opines there are safer alternative designs — something
she concedes she is not qualified to address — her opinion impermissibly opines on
Defendants’ corporate obligations, state of mind, and regulatory and FDA requirements, as
discussed above.
The Court will exclude Smith’s opinions 12, 13, and 14. See Doc. 4827-1 at 5.
Beyond these three opinions, Defendants seek to exclude all corporate conduct opinions
that are “highlighted in blue in Exhibit A” of their motion. Doc. 4827 at 10 n.6. This is
too broad a request. The blue highlighting covers five single-spaced pages of Smith’s
report. Doc. 4827-1 at 26-30. Defendants provide no detailed discussion of the content of
these pages, and the Court will not guess at their objections to specific sentences or words.
Defendants can object at trial if they think testimony is covered by the rulings in this order
or is otherwise inadmissible.
C. Opinion on Generic Risks of IPCs.
Defendants move to exclude as “unreliable and unhelpful” Smith’s opinion that
“Defendants’ [IPCs] can cause serious clinical complications, including [CRT], [CRBSI],
and mechanical failure, such as kinking and fracture[.]” Doc. 4827 at 11 (quoting Doc.
4827-1 at 4). But Smith may reliably opine on the generic risks associated with all IPCs,
including Defendants’ IPCs, given her clinical experience in monitoring epidemiological
evidence of these healthcare associated complications, among others, to mitigate them in
her hospital system, and in evaluating new medical devices and technologies designed to
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reduce these complications among others (Doc. 4827-1 at 3). See Geiger v. Creative
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.” (quoting Fed R. Evid. 702 notes for the 2000 amendments));
McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2021 WL 2709292, at *5 (D.
Ariz. July 1, 2021) (“[C]linical experience [can be] sufficient to satisfy the threshold
reliability requirements of Rule 702.” (citation omitted)). This opinion is helpful because
these catheter-related complications are at issue across this MDL. Smith may not opine,
however, that a “significant proportion of the overall IPC complication rates reported in
the scientific literature necessarily involve Defendants’ IPCs” based on Bard’s market
share. Doc. 4827-1 at 7. This opinion is not supported by Smith’s clinical experience and
is a mere recitation of the literature. 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)).
IT IS ORDERED that Defendants’ motion to exclude the opinions of Becky A.
Smith, M.D. (Doc. 4827) is granted in part and denied in part. Dr. Smith may not render
opinions 2-15 of her report. Doc. 4827-1 at 4-6.
Dated this 12th day of August, 2026.
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