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
This multidistrict litigation proceeding (“MDL”) involves thousands of personal
injury cases related to implanted port catheters (“IPCs”) 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 opinions of Plaintiffs’ experts Bernard C.
Camins, M.D., M.Sc. and William R. Jarvis, M.D. Doc. 4833. The motion is fully briefed.
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, usually to very sick
patients. 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 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. Bard IPCs contain barium
sulfate, a radiopaque substance that makes the IPC visible 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
the IPC 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
options. Plaintiffs assert a host of state law claims, including design and manufacturing
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defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See id.
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 call various expert witnesses at trial. Plaintiffs have identified
Drs. Camins and Jarvis as infectious disease experts. These doctors have jointly produced
a single expert report. Doc. 4833-1. Defendants move to exclude the doctors’ 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
and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent 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
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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 the rule.
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
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.
Dr. Camins is a Professor of Medicine at the Icahn School of Medicine and the
Medical Director of Infection Prevention at Mount Sinai Health System in New York City.
He was trained in internal medicine and infectious diseases, receiving his M.D. and a Master
of Science in Clinical Research from Emory University. He has published more than 60
peer-reviewed articles, books, and book chapters addressing various types of infections and
interventions before, during, and after surgery to reduce infections. He has investigated
and reported on complications associated with healthcare devices, including infection and
thrombosis. He has led multiple grant-funded research projects on reducing catheter-
related bloodstream infections and improving antimicrobial use through various means,
including the utilization of medical devices. Doc. 4883-1 at 5.
Dr. Camins has advised hospitals around the world on prevention of healthcare-
associated infections, serves on the editorial boards of infection-related journals, and
participates in various medical societies and committees related to infectious diseases. As
part of his practice, he regularly evaluates methods to reduce the risk of infection, including
the modifiable and unmodifiable risks of infection associated with implanted medical
devices generally and central venous catheters specifically, including IPCs. He regularly
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treats patients who have developed infections related to central venous catheters, including
IPCs. Id.
Dr. Jarvis served as a Pediatric Infectious Diseases Fellow at the University of
Toronto’s Hospital for Sick Children; as a Pediatric Infectious Diseases, Virology and
Epidemiology Fellow at Yale University School of Medicine; and as an Epidemic
Intelligence Service Officer and a Preventive Medicine Resident at the Centers for Disease
Control and Prevention’s (CDC’s) Hospital Infections Program. He has worked in various
leadership roles at the CDC in Atlanta, Georgia, focusing on the investigation and
prevention of infectious diseases – particularly infections and other complications
associated with healthcare. He has held a number of titles during his 23 years at CDC,
including Assistant Chief, National Nosocomial Infections Surveillance system (currently,
the National Healthcare Safety Network); Chief, Epidemiology Branch; Chief,
Investigation and Prevention Branch; Acting Director, Hospital Infections Program;
Assistant Director for Science, Division of Healthcare Quality Promotion; and Director,
Office of Extramural Research, Office of the Director, National Center for Infectious
Diseases. For 17 years he supervised all divisional outbreak investigations of healthcare
associated infections (HAIs) in healthcare settings, the development of HAI prevention
guidelines, and studies of HAIs and their prevention. Id. at 6-8.
Dr. Jarvis also served as a Clinical Associate Professor at the Emory University
School of Medicine and an Assistant Professor at the Emory University Rollins School of
Public Health, and as President of the Society for Healthcare Epidemiology of America.
He has published more than 400 peer-reviewed articles, book chapters, editorials, and CDC
surveillance reports, and has edited four books, including the latest edition of Hospital
Infections. He chairs the Food and Drug Administration’s (FDA’s) General Hospital and
Personal Use Committee. Id.
A. Exclusion of the Entire Report for Methodology Issues.
Defendants assert that Camins and Jarvis undertook a flawed literature review.
Defendants argue the doctors did not use objective metrics when conducting the review,
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and the review therefore cannot be replicated to confirm it is free of bias. Doc. 4883 at 2.
Defendants argue that Camins and Jarvis should have provided search criteria and
explained how they selected articles to review and discuss in their expert report. Id. at 5,
7. Defendants ask the Court to exclude all of their opinions on this basis. Id. at 2. This
argument clearly fails.
The opinions of Camins and Jarvis are not based solely on their literature search.
Camins’ and Jarvis’ opinions are based on “over 50+ years of collective education, training,
and experience in infectious diseases, healthcare epidemiology and infection prevention,”
depositions and documents produced in this case, and a systematic search of the medical
literature. Doc. 4833-1 at 8-9. This methodology, they assert, is “broadly accepted” and
the methodology they “have used and taught in [their] work as infectious diseases and
healthcare epidemiology-trained physicians, researchers, educators, and administrators.”
Id. at 8.
In addition to treating patients, their background includes publishing more than 460
peer-reviewed articles on infections and infection prevention; positions on scientific
advisory bodies that provide infection-prevention guidelines; infection surveillance
investigations; and co-authoring the CDC’s original definition of “central line associated
bloodstream infection” (“CLABSI”) – a significant form of infection in this case. Id.
Given this broad experience, the Court cannot conclude that all their opinions should be
excluded because of an alleged flaw in their literature search.
The case primarily relied on by Defendants, In re Lipitor (Atorvastatin Calcium)
Mktg., Sales Pracs. & Prods. Liab. Litig., 174 F. Supp. 3d 911 (D.S.C. 2016), is readily
distinguishable. The doctor in that case was not an epidemiologist and yet sought to give
epidemiological opinions. Id. at 929. “[N]either of his reports state[d] what methodology
he [was] using or attempting to use to reach his conclusions[.]” Id. The counsel offering
his testimony asserted the opinions were based on a literature search, making the search
the sole basis for his opinions. Id. In that context, flaws in the literature search would
seriously undermine the reliability of his opinions. This is not such a case.
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In addition to their qualifications described above, Camins and Jarvis reviewed over
420 peer-reviewed publications in developing their opinions. Doc. 4833-1 at 69-81. This
portion of Defendants’ motion does not identify any relevant publications they missed or
overlooked. And while Defendants argue that Plaintiffs’ counsel provided Camins and
Jarvis with scientific literature to support their opinions, the doctors explain they also
conducted their own searches. Doc. 4833-1 at 8 (“We individually searched the medical
literature systematically for relevant materials to formulate our opinions.”).1
The Court will not exclude all of the Camins and Jarvis opinions based on an alleged
flaw in their literature search, particularly when the doctors otherwise are very qualified to
opine on infections and treatment-related infection issues – qualifications Defendants do
not challenge.
B. Exclusion of Specific Opinions.
Defendants ask the Court to exclude several specific opinions in the doctors’ report.
1. Available Technologies and Alternative Designs.
This portion of Defendants’ motion challenges two opinions. First, that
“[t]echnologies exist that effectively reduce the key mechanism of infection (e.g.,
microbial adhesion) and/or effectively reduce one of the biggest facilitators of biofilm
formation (e.g. protein adhesion).” Doc. 4833-1 at 9. Second, that “[i]f Defendants had
used safer alternative designs, the incidence of IPC-related infections would have been
reduced.” Id. at 10.
The expert report produced by Camins and Jarvis is 65 single-spaced pages, with
more than 100 pages of exhibits. Doc. 4833-1. Defendants do not address specific portions
of the report that should be excluded. They highlight portions of the opinion summary at
the beginning of the report. Id. at 9-10. On the first opinion they cite two additional report
pages (id. at 10 (citing pages 29-30)) and on the second they cite 13 additional pages (id.
1 Defendants later cite a recent study they claim Camins and Jarvis ignored.
Doc. 4883 at 14. The Court will consider the effect of that study on specific opinions, but
cannot conclude that one study out of 420 reviewed reports and articles undermines every
opinion the doctors give in this case.
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at 10 (citing pages 48-61)), but they provide no discussion of what should be excluded
from those pages. Plaintiffs’ reply simply responds to the broad arguments made by
Defendants.
Because Defendants have not identified specific statements in the report other than
the general opinions, Plaintiffs do not attempt to demonstrate why specific statements
found in the pages identified by Defendants satisfy the requirements of Rule 702 by a
preponderance of the evidence. Doc. 5337. Given this broad-brush approach by the
parties, the undersigned judge has been required to read the entire 65-page report in an
attempt to identify what is said by the experts and what grounds they provide for those
statements. This review helped the Court understand Camins’ and Jarvis’ asserted bases
for their opinions, but the Court is not equipped by the briefing to rule on specific
statements. For this portion of Defendants’ argument, the Court therefore will rule on the
admissibility of general opinions. This will help the parties identify portions of the report
that are inadmissible, but any disagreements on specific statements will need to be resolved
through objections at trial.
Defendants argue that Camins and Jarvis, as infectious disease doctors, are not
qualified to opine on alternative technologies that could have been used in Defendants’
IPCs. They note the doctors are not trained in material science, engineering, product
development, or regulatory approval. And they cite portions of the doctors’ depositions
where they admit their proposed alternative designs have not been tested for use in IPCs.
Doc. 4883 at 10.
Plaintiffs argue that Camins and Jarvis do not opine on the design, engineering,
development, or regulatory approval of their proposed alternatives, leaving those opinions
to Plaintiffs’ other experts. Instead, their “opinions address whether commercially
available technologies reduce microbial adhesion, biofilm formation, and ultimately
bloodstream infections.” Doc. 5337 at 7. Plaintiffs also claim “[t]he experts center on the
clinical effect of incorporating these technologies (i.e., whether those features reduce
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infection risk), not on whether Bard could economically or technologically implement
them.” Id. at 11 (emphasis in original).
Plaintiffs’ position is not entirely correct. Camins and Jarvis describe the infection
and thrombosis process, how it occurs on Vascular Access Devices (VADs) like IPCs, how
the condition of VADs can inhibit or promote infection and thrombosis development, and
how technologies used in some devices help inhibit these developments. These opinions
are well within their expertise. Both doctors have years of training and experience in
infectious diseases, primarily HAIs like those at issue in this MDL. They not only see
patients suffering from these health issues, but have also managed hospitals and
organizations seeking to reduce HAIs, including through the use of selected devices.
Camins has consulted with hospitals around the world on how to control infections, and
Jarvis consults with medical devices manufacturers on how to improve their products. The
doctors are qualified to testify about the infection process, how it works with VADs, what
kinds of surfaces are more problematic, and how VAD surfaces and devices (such as
peripherally inserted catheters (PICCs) and central veinous catheters (CVCs)) have been
successfully modified to reduce infections.
But the doctors do more than render these infectious disease opinions. They also
provide opinions about Defendants’ products. They describe how Defendants failed to
incorporate commercially available technologies that would reduce the risk of infection.
Doc. 4833-1 at 44-48. And they opine that if Defendants had used these safer designs, the
incidence of infections and thrombosis would have been reduced in Defendants’ products.
Id. at 48-61. These opinions include discussions of how barium sulfate behaves when
combined with other catheter materials (id. at 25-26), alternative reservoir materials and
designs (id. at 26-27), and internal corporate communications, knowledge, and decisions
of Defendants (id. at 32-34). These opinions also implicitly assert that better materials
were commercially available to Defendants in the U.S. market, that these technologies
could have been incorporated into Defendants’ IPCs, that this incorporation could have
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been made in a commercially viable way, and that it could have been done in the time
frame of the alleged injuries at issue in this MDL.
These are not infectious disease opinions. They involve materials evaluation and
performance, commercial availability of technology for a specific manufacturer, product
design and manufacturing, commercial viability, regulatory approval, and market timing.
Defendants argue that Camins and Jarvis are not qualified to provide such opinions, and
Plaintiffs make no showing to the contrary. See Doc. 5337 at 7-8.
The Court reaches the following conclusions on this portion of Defendants’ motion.
Defendants seek to exclude the opinion that “[t]echnologies exist that effectively reduce
the key mechanism of infection (e.g., microbial adhesion) and/or effectively reduce one of
the biggest facilitators of biofilm formation (e.g. protein adhesion).” Doc. 4833-1 at 9.
But Camins and Jarvis are qualified to render these opinions with respect to technologies
they used or reviewed in their capacities as infectious disease doctors during the years at
issue in this case. They can testify to the infection-reducing capability technologies they
encountered.
For reasons explained above, however, the Court will grant Defendants’ motion on
the doctors’ opinions that these technologies could have been used in IPCs where they were
not used, or in Defendants’ IPCs specifically, and that their use in IPCs would have reduced
infections. The availability and viability of alternative technologies for Defendants’
products must be addressed by other experts.
The second challenged opinion is that “[i]f Defendants had used safer alternative
designs, the incidence of IPC-related infections would have been reduced.” Doc. 4833
at 10. This opinion implicitly assumes that commercially used technologies were available
to Defendants in the U.S. market, the technologies could have been incorporated into
Defendants’ IPCs, this incorporation could have been made in a commercially viable and
regulatorily acceptable way, and it could have been done in the time frame of the alleged
injuries at issue in this MDL. Camins and Jarvis are not qualified to opine on these
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nonmedical issues. The Court will grant Defendants’ motion and preclude Camins and
Jarvis from rendering this opinion.
2. Whether Defendants’ IPCs Increased the Risk of Infection.
The doctors opine that “Defendants’ IPC design increased the risk of IPC-related
infections. Defendant’s IPCs have rough and variable surfaces. Defendant’s uncoated
IPCs permit rather than inhibit microbial adhesion, thus increasing the risk of IPC-related
infection.” Doc. 4833-1 at 9 (emphasis omitted). Defendants ask the Court to exclude this
opinion. Doc. 4833 at 15.
Defendants contend that “[t]he doctors lack sufficient expertise to opine on polymer
science issues such as IPC surface properties and roughness, coating of IPCs, barium
sulfate diffusion, biodegradation, and port body design features.” Id. They assert that
“Drs. Camins and Jarvis lack any experience with materials science issues related to
medical devices generally or IPCs specifically,” and that they “simply draw inferences
from the company documents and literature assembled by counsel.” Id. at 15-16.
The Court agrees with much of this argument. Camins and Jarvis do not purport to
be materials scientists or product design experts, and yet they describe preferable port
designs (id. at 27-29); opine on the effects of Defendants’ including barium sulfate in their
catheter components (id. at 41-42); describe at length what Defendants’ product
development officers and employees “knew,” “believed,” “were aware” of, and could have
made (id. at 32-33); discuss Defendants’ internal research, testing, and acquisitions during
product design and development efforts (id. at 36-39); describe the materials degradation
that Defendants’ products experience once implanted in the body (id. at 42); and opine that
Defendants failed to incorporate commercially available technologies that reduce the risk
of infection and thereby increased the risk of infection for their patients (id. at 44-48).
These are not medical opinions. They are opinions of materials experts, design and
production experts, corporate behavior experts, and experts who can opine on the viability
of incorporating new technologies into IPCs during the time periods at issue in this case.
The Court will grant Defendants’ motion and exclude these opinions.
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The Court notes, however, that Camins and Jarvis are clearly experts on infection
processes and the effectiveness of existing medical products in reducing infections. They
are qualified to opine on the conditions that lead to infections (including the physiological
conditions that promote infection development and growth and the product conditions
(such as rough surfaces) that they have seen promote infections), and the measures that
have proven helpful in reducing infections, including coatings and other characteristics of
PICCs and CVCs they have seen and worked with.
Further, to the extent their opinions about the effectiveness of existing technologies
in reducing infections are based on medical literature rather than their personal experience,
the Court is not persuaded by Defendants’ arguments that their literature is unreliable and
selective. See Doc. 4833 at 14. The doctors rely on numerous relevant reports sufficient
to satisfy the preponderance of the evidence standard (see Doc. 4833-1 at 31-61), and the
weakness or insufficiency of those reports – or the strength of competing reports – are
matters for cross-examination. The doctors thus will be permitted to describe the infection
process and technologies that have helped curtail it. But they cannot cross the line and
testify about what Defendants could or should have done with it.
3. Whether Defendants Were Obligated to Research and Improve
Devices.
Defendants argue that the doctors are not qualified to opine that Defendants were
obligated to conduct further research and improve their products. Doc. 4833 at 18.
Defendants provide no citation for the location of these opinions. Id. Plaintiffs contend
the doctors will not provide such opinions and do not do so in their report. Doc. 5337 at 20.
The report does opine on corporate responsibility to improve products:
Medical device manufacturers are responsible for designing safe, effective,
and reliable products. Indeed, guidelines from the International Organization
for Standardization state that medical device manufacturers must reduce risk
as far as possible without economic consideration.
Patient safety must always be the highest priority for medical device
manufacturers. To achieve this, device manufacturers like the Defendants
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should always try to make their devices as safe as they reasonably can.
Indeed, the Defendants admit “training, education, labeling” are “less
effective than eliminating the failure mode outright”. Thus, the Defendants
must account for “user error”—like infection from placement or access—in
its design of its devices. If risks have not been reduced to an “acceptable
level”, the Defendants must determine if further reduction is possible and
take action. If safer technologies exist that can reduce that risk of harm, “both
from a moral standpoint and also from a commercial standpoint” the
Defendants must evaluate, and if feasible, incorporate that technology in the
design of its devices. This is true even if failure rates are “low”.
Doc. 4833-1 at 16-17.
Neither Camins nor Jarvis purports to have experience with the procedures or ethics
involved in manufacturing medical devices. Docs. 4833-1 at 5-8; 4833-2 at 16, 19; 4833-3
at 30. They do not claim any expertise on ethics and industry standards for device
manufacturers, including what factors must be accounted for when designing a device,
what obligations manufacturers have when selecting the technology to use, and the
acceptable level of risk in a medical device. Because Camins and Jarvis are not qualified
to give the opinions quoted above, the Court will grant Defendants’ motion and exclude
them. See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018
WL 823277, at *3 (D. Ariz. Feb. 12, 2018) (“[T]he Doctors have no expertise in the FDA
regulatory process, corporate compliance or ethics, or the design, testing, and marketing of
IVC filters. . . . Such opinions are outside the realm of their expertise and are not supported
by sufficient facts and data or evaluated through reliable principles and methods.”).
4. Whether Device Design is the Primary Area for Risk Reduction.
Camins and Jarvis opine that “[a]lthough scientific literature shows that infection
prevention protocols have been effective in reducing (but not eliminating) infection risk,
the primary opportunity for further risk mitigation rests in device design changes that
further reduce the risk of infection.” Doc. 4833-1 at 9. Defendants ask the Court to exclude
this opinion, asserting that it is not based on reliable methodology or scientific principles.
Doc. 4833 at 20. Defendants also assert that Jarvis has published an article that contradicts
this claim, stating that infection rates can be brought to near-zero with appropriate clinical
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practices. Id. Plaintiffs contend that this opinion is squarely within the doctors’ expertise
and Jarvis’ article is not to the contrary. Doc. 5337 at 20.
The Court concludes that Camins and Jarvis are qualified by their years of infectious
disease experience to opine that a primary opportunity to further reduce infection rates lies
in improved products, but it is not clear to the Court why this opinion will help the jury.
Fed. R. Evid. 702(a). The fact that an opportunity to improve medical outcomes exists
does not mean that a manufacturer has an obligation to seize that opportunity, or that its
existing products are defective. Defendants do not, however, make this argument. The
Court will deny Defendants’ motion to exclude this opinion as unreliable and will rule on
its relevancy at trial.
5. Accuracy of Defendants’ IPC-Related Infection Rate Claims.
Camins and Jarvis provide this opinion:
Defendants reported complaint rates for IPC-related infection were well over
1000x lower than the rate of IPC-related infection reported in scientific
literature. Defendants’ significantly lower IPC-related infection rate is due
to Defendants’ flawed methodology in risk assessment. When using a proper
methodology, Defendants’ IPCs are associated with an intolerable risk of
infection based on its own policies.
Doc. 4833-1 at 10. This opinion is supported by four pages of explanation in the doctors’
report. Id. at 62-66.
Defendants argue that Camins and Jarvis are not qualified to opine on Defendants’
calculated infection rates. They note the doctors claim no expertise in compiling corporate
infection rates, in policies and methodologies for device risk and assessment, and in what
constitutes an intolerable risk of infection for Defendants. Doc. 4833 at 21.
Plaintiffs claim the doctors will not calculate Defendants’ “precise complaint rates”
or opine on their adverse event responsibilities (Doc. 5337 at 21), and yet that is essentially
what the doctors do. They explain Defendants’ internal method of calculating complaint
rates, explain why the method is flawed, opine the internal rates are artificially low,
recalculate the rates using “proper methodology,” opine that the correct calculation shows
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Defendants “IPCs are associated with an intolerable risk of infection,” and opine that
“Defendants must determine if further reduction [in infection rates] is possible and take
action.” Doc. 4833-1 at 62-66.
Plaintiffs make no showing that Camins and Jarvis have any training or experience
in corporate complaint rate calculations or obligations. They argue the doctors “provide
clinical context on why Bard’s reported infection rates . . . are not reliable indicators of
real-world complication rates and potentially misleading to the medical community.”
Doc. 5337 at 21. But with the exception of one sentence, this portion of the doctors’ report
is not about the clinical context. The exception is this sentence: “In our clinical experience,
it would be extraordinarily rare for a clinician to send an explanted device from a patient
with a confirmed CLABSI to the manufacturer.” Doc. 4833-1 at 63 (emphasis in original).
The doctors can give this clinical opinion at trial, but the remainder of their discussion in
pages 62-66 of the report, and the summary in paragraph 6 on page 10, lie clearly outside
their expertise and will be excluded.
IT IS ORDERED that Defendants’ motion (Doc. 4833) is granted in part and
denied in part as set forth above.
Dated this 22nd day of December, 2025.
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