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
–––––––––––––––––––––––––––––––––
Robert Cook,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01975-PHX-DGC
ORDER
Ravi Srinivasa, 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”).
Plaintiff Robert Cook has filed a motion to exclude the expert opinions of Ravi Srinivasa,
M.D. Doc. 5797. The motion is fully briefed and no party requests oral argument. See
Docs. 5797, 6245, 6409. The Court will grant the motion in part.
I. Background.
An IPC is a medical device surgically implanted under the skin to provide repeated
access to a patient’s vascular system without the need for multiple needlesticks into
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peripheral veins. IPCs are used to deliver chemotherapy and immunotherapy medication,
intravenous fluids, blood transfusions, and parenteral nutrition. IPCs can remain in place
for weeks, months, or even years until treatment is completed.
IPCs consist of a port and a catheter. The port is a small reservoir 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
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compression stress on the tissue surrounding the port, leading to ulceration and tissue
necrosis. See Docs. 23, 1889.
Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
options. Plaintiffs assert a host of state law claims, including design and manufacturing
defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. Bard further contends
that various factors impact the performance and wear of IPCs, including where the catheter
is inserted and how well the device is maintained by medical professionals and the patient.
See Docs. 23, 2023-1.
Plaintiff Cook brings his lawsuit in this MDL. Doc. 216 (Case No. CV-23-01975-
PHX-DGC). On August 24, 2022, Plaintiff had a Bard port implanted, and he subsequently
suffered from an infection. Id. at 4. Plaintiff raises claims typical of this MDL, alleging
the infection was caused by the Bard port. Id. at 5.
Defendants have identified Ravi Srinivasa, M.D., as a medical expert in Plaintiff’s
case. Dr. Srinivasa is a board-certified vascular and interventional radiologist with 20 years
of experience. Doc. 5797-1 at 4. He is certified in Diagnostic Radiology by the American
Board of Radiology and maintains a Certificate in Vascular and Interventional Radiology.
Id. at 101. In 2018, Srinivasa joined the University of California in Los Angeles (“UCLA”)
as an Associate Professor of Vascular and Interventional Radiology, and was subsequently
promoted to Professor of Vascular and Interventional Radiology. Id. at 4. Prior to his
professorship with UCLA, Srinivasa held assistant and clinical professor positions with
other major educational intuitions including the University of Pennsylvania, the University
of Texas (Houston), and the University of Michigan. Id. at 102. He was the Quality
Assurance and Safety Officer at the University of Michigan Health System between 2015
and 2018. Id. Srinivasa has “placed tens of thousands of ports” and de-accesses ports
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frequently. Docs. 5797-2 at 7-8, 6245-1 at 48. Plaintiff moves to exclude his 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 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
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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.
Plaintiff seeks to exclude several opinions of Srinivasa.
A. Causation and Diagnosis Opinions.
Srinivasa opines that Plaintiff “developed a bloodstream infection likely due to
suboptimal sterile technique by his wife and family friend at the time of flushing and
deaccessing his port.” Doc. 5797-1 at 15. Relatedly, he opines “the infection was most
likely introduced during the deaccessing of the port[.]” Id. at 11; see also id. at 10-12.
Plaintiff argues Srinivasa is not qualified to render these opinions because he is not an
infectious disease doctor. Doc. 5797 at 4.
Plaintiff claims that Srinivasa referring to Plaintiff’s infection as a “bloodstream
infection” instead of a “catheter-related bloodstream infection” amounts to a diagnosis,
which he contends Srinivasa is not qualified to render. Id. at 5. Defendants state Srinivasa
will not render a diagnosis opinion. Doc. 6245 at 6 (“There is no dispute that Mr. Cook
had an infection and that the infection was caused by MSSA. Rather, Dr. Srinivasa is
offering an opinion that the MSSA likely entered Mr. Cook’s bloodstream during the
deaccessing procedure performed by Ms. Potter, likely not during the implantation of the
port, and likely not during the access of the port at the hospital.” (footnote omitted)).
Plaintiff claims Srinivasa is not qualified to render a medical causation opinion
regarding the most likely source of Plaintiff’s infection. Doc. 5797 at 7. He contends
Srinivasa’s “lack of ‘specialized training in or knowledge of infectious diseases’ precludes
him from offering a causation opinion” where he is not Plaintiff’s treating physician. Id.
at 8 (quoting Berk v. St. Vincent’s Hosp. & Med. Ctr., 380 F. Supp. 2d 334, 340, 352 n.24
(S.D.N.Y. 2005)).
As with other 702 motions, Plaintiff cites Berk, 380 F. Supp. 2d 334, for the
proposition that Srinivasa must exhibit specialized training or knowledge in infectious
diseases, or otherwise be Plaintiff’s treating physician, to render his causation opinion. See
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id. at 352 n.24 (orthopedic surgeon likely not qualified to opine on the cause of infection
where he lacked “any unique training or qualifications,” but causation opinion admitted
because he was the treating physician). Plaintiff also cites Estate of Arama v. Winfield,
2017 WL 1951462, at *10 (N.D. Ind. May 11, 2017), for the proposition that Srinivasa is
not qualified to render a causation opinion because he did not “review key parts of the
factual record.” Doc. 5797 at 8-9; see also Doc. 5797-2 at 25 (Srinivasa incorrectly
claiming “[Plaintiff] wasn’t getting chemotherapy at home” despite his at-home
chemotherapy being an undisputed fact).
A medical doctor’s qualification to opine in one area “does not mean he is qualified
to testify on all other medical topics.” Gorney v. Safeway Inc., No. CV-23-01413-PHX-
SHD, 2025 WL 2586133, at *5 (D. Ariz. Sept. 8, 2025) (citation omitted). Srinivasa is not
an infectious disease physician. Defendants must show by a preponderance of the evidence
that his knowledge, skill, experience, training, or education equip him with the specialized
knowledge to opine on the original cause of Plaintiff’s infection. Fed. R. Evid. 702.
Defendants argue “Srinivasa’s experience – performing port placements and
removals, accessing and deaccessing ports himself, supervising trainees in these
procedures, and evaluating suspected port infections throughout his time at four major
academic centers – gives him precisely the kind of specialized knowledge courts in the
Ninth Circuit routinely” accept as sufficient under Rule 702(a). Doc. 6245 at 8. The Court
is not persuaded.
Srinivasa is an interventional radiologist, but a medical license is not enough to
opine on the cause of any medical issue. See Alsadi v. Intel Corp., No. CV-16-03738-
PHX-DGC, 2019 WL 4849482, at *4 (D. Ariz. Sept. 30, 2019) (explaining “the mere fact
that Dr. Garcia is a qualified pulmonologist who treated [the plaintiff] does not render his
opinions on causation admissible under Rule 702” (citation omitted)). Srinivasa agreed he
is not an infectious disease expert. Doc. 5797-2 at 6. Defendants point to his clinical
experience, which involves frequently accessing and de-accessing ports. Id. at 7. But
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Srinivasa’s familiarity with ports does not necessarily render him qualified to opine on the
cause of a blood infection.
Srinivasa testified that he identifies the presence of port-related infections and
informs the necessary course of action – whether a catheter “needs to be removed, or
replaced, or exchanged.” Id. at 9. But Defendants have not shown that identifying the
presence of an infection is the same as determining the infection’s original cause. As
Srinivasa acknowledges, “there are a multitude of factors that could cause an infection.”
Id. at 12. Courts recognize that a physician’s skill and experience in identifying and
treating an illness does not necessarily mean the physician can determine its cause. See,
e.g., Wilson v. Pinnacle Foods Inc., No. 3:19-CV-229-BJB, 2022 WL 419595, at *6 (W.D.
Ky. Feb. 10, 2022) (“Dr. Cumbo never connects his general experience treating Listeria
and enteritis with any experience deducing their causes. Causation, not clinical diagnosis
and treatment, is the question at issue. And ‘[t]he ability to diagnose medical conditions is
not remotely the same,’ . . . ‘as the ability to deduce . . . in a scientifically reliable manner,
the causes of those medical conditions.’” (citation omitted)).
Courts within the Ninth Circuit have similarly excluded causation opinions of
experts who have experience treating a medical condition but not deducing their cause.
See, e.g., Stambolian v. Novartis Pharms. Corp., No. CV 12-04378 BRO FMOX, 2013
WL 6345566, at *6 (C.D. Cal. Dec. 6, 2013) (finding doctor unqualified to render causation
opinion where doctor was qualified to treat a condition but not to opine on its cause).
Defendants have not shown by a preponderance of the evidence that Srinivasa is
qualified to opine on the cause of Plaintiff’s infection.
B. De-Accessing Training and Procedure Opinions.
Plaintiff argues Srinivasa is not qualified to render opinions about “de-accessing
training and procedures,” and that the opinions are not supported by sufficient facts or data.
Doc. 5797 at 11. Srinivasa testified that he frequently de-accesses ports. Doc. 5797-2 at
7-8 (“I frequently do deaccess ports[.]”; “[M]aybe twice a week or so, on average.”).
Plaintiff nonetheless argues Srinivasa is not qualified to opine on de-accessing training and
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procedures because he has no experience with at-home de-accessing. Doc. 5797 at 12.
Plaintiff contends that Srinivasa performing de-accessing “in a hospital suite protected by
institutional sterility protocols, specialized equipment, and ever-present nursing support
does not equip Dr. Srinivasa to speak to at-home de-access procedures or training for
patients and caregivers – particularly when Defendants have not carried their burden to
connect the dots between the two distinct exercises.” Doc. 6409 at 7.
The Court is not persuaded. Srinivasa clearly has years of experience de-accessing
ports and doing so without introducing infections. Such experience qualifies him to opine
on procedures and training for safe de-accessing. Srinivasa’s substantial experience with
de-accessing qualifies him to discuss de-accessing training and procedure.
Further, Srinivasa has training experience. This includes instructing medical
students and residents on proper de-access procedures (Doc. 5797-1 at 12) and developing
educational protocols to standardize training in this area (id. at 5).
Plaintiff contends that Srinivasa “explicitly disclaimed any personal experience
‘administer[ing] chemotherapy specifically through the port,’ and further admitted that his
institution does not ‘allow home deaccess[.]’” Doc. 5797 at 12 (quoting Doc. 5797-2 at 7,
12). He further argues that Srinivasa’s lack of experience is demonstrated by his factually
incorrect testimony that Plaintiff “wasn’t getting chemotherapy at home.” Id. (quoting
Doc. 5797-2 at 25). But the issue in this case concerns de-accessing, not chemotherapy,
and Srinivasa’s lack of experience administering chemotherapy has no bearing on his
qualification to discuss de-accessing. And the fact that his institution does not allow de-
accessing at home does not alter his years of experience performing de-accessing safely,
experience that supports his opinions on training and procedure. His deposition error on
when Plaintiff received chemotherapy (an error he did not make in his report (see
Doc. 5797-1 at 8)) is not a basis for excluding his opinion.
Plaintiff challenges the factual foundation of Srinivasa’s de-accessing training and
procedure opinions. Doc. 5797 at 12. But a doctor’s clinical experience alone can factually
support his opinions. See Elosu v. Middlefork Ranch Inc., 26 F.4th 1017, 1024 (9th Cir.
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2022). As discussed above, Srinivasa regularly performs de-accessing, trains others in
central venous access procedures, and develops central venous access protocols. His
detailed testimony explaining the de-accessing procedure (Doc. 6245-1 at 27-47) shows
his specialized knowledge thereof. Further, Srinivasa reviewed materials regarding the de-
accessing in Plaintiff’s case. Doc. 5797-1 at 7-9. The Court finds by a preponderance of
the evidence that Srinivasa’s opinions on de-accessing training and procedure are
supported by sufficient facts and data. Plaintiff’s other arguments, focusing on narrow
aspects of Srinivasa’s testimony (Doc. 5797 at 12-14), may be raised in cross-examination.
C. Sources of Contamination Opinions.
Plaintiff cites several opinions of Srinivasa regarding points of contamination
during Plaintiff’s de-accessing procedure and contends they are “pure speculation, they
lack sufficient facts or data and are ipse dixit that fails to meet Rule 702’s requirements for
reliability.” Id. at 15. Plaintiff focuses on Srinivasa’s identification of possible points of
contamination as part of his infection causation opinion. Id. For example, Srinivasa’s
report includes this discussion:
The fact that Mr. Cook had an infection with MSSA, a type of bacteria that
is associated with the skin and nose about a week after his wife and Ms.
Oglesbee deaccessed the port, suggests that a potentially incompletely sterile
deaccess technique – for example, coughing, touching her hands to her face
or nose and then touching the port, not having fully sanitized her hands,
among others – likely caused Mr. Cook’s infection.
Doc. 5797-1 at 10 (emphasis added). The Court concludes above that Srinivasa is not
qualified to opine on the most likely cause of Plaintiff’s infection. As a result, he cannot
discuss possible points of contamination that are part of his causation opinion.
But this is not the only context in which Srinivasa discusses possible points of
contamination. He also provides a rebuttal to Dr. Hurst’s opinions. Doc. 5797-1 at 12-15.
Hurst opines that the records show Ms. Potter and Ms. Oglesbee did not deviate from clean
technique when they de-accessed Plaintiff’s port at home. Doc. 5828-1 at 7-8. In rebuttal,
Srinivasa states that the training of Ms. Potter and Ms. Oglesbee was minimal and that, in his
experience, it is common for untrained individuals inadvertently to breach sterile technique.
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Doc. 5797-1 at 12-13. This opinion, which is based on Srinivasa’s substantial experience placing
and de-accessing ports and instructing medical students in proper technique, is supported by
sufficient facts and data and will not be excluded.
IT IS ORDERED:
1. Plaintiff’s motion to exclude the opinions of Ravi Srinivasa, M.D.
(Doc. 5797) is granted in part and denied in part. Dr. Srinivasa may not opine that
Plaintiff’s infection was most likely caused by the de-accessing procedure. This includes
opinions about various points in the procedure where Plaintiff’s infection likely was
introduced. Srinivasa may opine about the training and procedures connected with the de-
accessing, and may render his rebuttal opinion to Hurst’s assertion that Plaintiff’s at-home
de-accessing did not deviate from clean technique, if Hurst testifies. This testimony may
include Srinivasa’s experience on the ease with which untrained individuals may
unintentionally breach sterile technique.
2. There being no requests to seal the briefing on this motion, the Clerk’s Office
is directed to file the motion (Doc. 5797), Defendants’ response (Doc. 6245), and Plaintiff’s
reply (Doc. 6409) on the public docket with the same document number and filing date.
Dated this 24th day of March, 2026.
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