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
Dr. Amir Sheikhi
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 Amir Sheikhi, Ph.D.
Doc. 5209. The motion is fully briefed and no party requests oral argument. See
Docs. 5209, 5765, 6023. 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 Amir Sheikhi, Ph.D. as a chemical and biomedical
engineering expert. Dr. Sheikhi earned his Ph.D. in Chemical Engineering in 2015.
Doc. 5209-1 at 3. Thereafter, he completed post-doctoral fellowships with a focus on
biomaterials. See id. During his postdoctoral fellowship in bioengineering at UCLA,
Sheikhi “developed several types of biomaterials” and “conducted research on
characterizing zwitterionic coatings to render catheters antibiofouling.” Id. Since 2024,
he has served as an Associate Professor of Chemical Engineering at Penn State, “with
courtesy appointments in Biomedical Engineering, Chemistry, and Neurosurgery[.]” Id.
“With a multidisciplinary background spanning chemical engineering, chemistry, and
biomedical engineering,” Sheikhi is “recognized for [his] innovative work on biomaterials
and regenerative medicine[.]” Id. at 3-4. Sheikhi has authored “more than 80 peer-
reviewed publications” in “the fields of biomaterials, biointerfaces, tissue engineering, and
sustainable materials.” Id. at 5. Defendants move to exclude Sheikhi’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
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is based on sufficient facts or data,” (c) “the testimony is the product of reliable principles
and methods,” and (d) “the expert’s opinion reflects a reliable application of the principles
and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent of the
expert testimony must show by a preponderance of the evidence that the testimony satisfies
each of these requirements. Fed. R. Evid. 104(a); Fed. R. Evid. 702 advisory committee’s
note to 2023 amendment (“[T]he rule has been amended to clarify and emphasize that
expert testimony may not be admitted unless the proponent demonstrates to the court that
it is more likely than not that the proffered testimony meets the admissibility requirements
set forth in the rule.”); Engilis v. Monsanto Co., 151 F.4th 1040, 1050 (9th Cir. 2025)
(“Consistent with the 2023 amendment, our precedent establishes that Rule 702 requires a
proponent of expert testimony to demonstrate each of the requirements of Rule 702 by a
preponderance of the evidence.”).
The Court acts as a gatekeeper to ensure that expert testimony satisfies Rule 702.
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). The Court’s task is not
to decide whether the expert is right or wrong, but to ensure the proposed opinions satisfy
Rule 702. Alaska Rent-A-Car, Inc. v. Avis Budget Grp., 738 F.3d 960, 969-70 (9th Cir.
2013); Engilis, 151 F.4th at 1050. If the proponent does not meet its Rule 702 burden, the
expert testimony is not admissible. See Davis v. McKesson Corp., No. CV-18-1157-PHX-
DGC, 2019 WL 3532179, at *3 n.2 (D. Ariz. Aug. 2, 2019) (“[T]he Court may admit expert
opinions only if it can determine, under Rule 104(a), that Plaintiffs have shown each of the
Rule 702 requirements to be satisfied by a preponderance of the evidence.”).
III. Discussion.
A. Design Defect Opinions.
Defendants argue Sheikhi’s design defect opinions “are neither relevant nor reliable.
He is not qualified to offer them, they will not assist but will rather mislead the jury, and
they are based on insufficient facts and data.” Doc. 5209 at 4 (citations omitted).
Defendants move for exclusion under Rule 702(a)-(b) and Rule 403. Id.
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Defendants first challenge Sheikhi’s qualifications. They contend “Sheikhi lacks
the expertise necessary to opine on medical device or IPC design, standard of care, industry
standards, or on manufacturing capability.” Id. at 5. Defendants challenge broad
categories of opinions.
They first challenge Sheikhi’s design defect opinion that “Bard’s IPCs are
‘unreasonably dangerous and defectively designed’ because the catheters are not coated,
modified, or reinforced, which he claims ‘increase the risk of thrombosis, infection, [and]
fracture” (Doc. 5209-1 at 166-67). Doc. 5209 at 3 (footnote omitted). Defendants argue
that “[w]hile he may be qualified to testify about the chemical properties of the coatings he
promotes . . . , he has no expertise in applying any of these technologies to any medical
device for commercialization.” Id. at 4 (footnote omitted). Defendants cite no case law or
explain why Sheikhi must have direct experience commercializing alternative designs.
Defendants acknowledge Sheikhi “conducted lab research on a zwitterionic coating that
may have been used and commercialized on a Foley catheter[.]” Id. at 4 n.5 (citation and
emphasis omitted). His experience does not become irrelevant because the Foley catheter
is not an IPC, or the fact that it was commercialized in “only 2,000 products since 2022”
by the company of Plaintiffs’ other expert, Dr. McVerry. Id.
Sheikhi holds a Ph.D. in Chemical Engineering. Doc. 5209-1 at 3. As a tenured
associate professor of Chemical Engineering with an appointment in Biomedical
Engineering among other appointments, he has experience in biomedical engineering with
a focus on biomaterials and biointerfaces. Id. Sheikhi has “developed several types of
biomaterials, including shear-thinning hydrogels for catheter-based endovascular
therapies,” and he has “conducted research on characterizing zwitterionic coatings to
render catheters antibiofouling” (id.), a direct issue of this litigation. His previous
postdoctoral fellowships also involved a biomaterials focus. See id.
Sheikhi has experience conducting laboratory testing used in biomaterials research.
Id. at 4. This includes “biological and biocompatibility tests” which he has conducted “to
“determine antimicrobial thresholds,” and “blood-material interaction tests, . . . to assess
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how materials interface with blood components.” Id. His work has included both in vivo
and in vitro testing, and he has authored more than 80 peer-reviewed publications in the
fields of “biomaterials, biointerfaces, tissue engineering, and sustainable materials.” Id. at
4-5 (accumulating over 4,350 citations as of March 2025).
Through his research and lecturing in the field of biomaterials, Sheikhi has become
“familiar with biologics-biomaterial interactions, such as protein adsorption, platelet
adhesion, thrombus formation, bacterial colonization, biofilm formation, and foreign body
response.” Id. at 5. He has “practical knowledge of zwitterions and hydrophobicity/
hydrophilicity, as well as microfluidics and the synthesis of polymeric biomaterials,” which
he teaches in his CHE 555: Engineering Soft Materials course. Id. “Understanding
biodegradation, non-fouling moieties, and antimicrobial agents is also integral to some of
[his] research projects.” Id.
Given his specialized knowledge of biomaterials and biological complications, the
Court finds Sheikhi qualified by a preponderance of the evidence to opine that the lack of
coating on Bard’s IPCs increases the risk of thrombosis, infection, and fracture.
Defendants contend Sheikhi is unqualified to render his design defect opinions
because he (1) “has never worked for a medical device manufacturer or in the industry and
has never designed an IPC,” (2) “has no experience in designing, testing, or manufacturing
any medical device,” (3) and “has never commercialized any product or technology.” Doc.
5209 at 4 (citations omitted). As with other experts in this litigation, the Court does not
find this lack of industry experience disqualifying. Sheikhi has specialized training and
experience on several subjects directly related to the device design issues in this litigation.
Defendants can challenge his lack of industry experience through cross-examination.
Defendants separately challenge Sheikhi’s “standard of care” opinions under Rule
702(a) as based not on scientific or specialized knowledge, “but on his own personal views
about proper corporate behavior.” Id. at 5 (quoting In re Bard IVC Filters Prods. Liab.
Litig., No. MDL 15-02641-PHX DGC, 2018 WL 11446831, at *3 (D. Ariz. Jan. 22, 2018)).
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They cite the following standard-of-care opinions of Sheikhi as improperly opining on
proper corporate behavior:
• “[O]ne of [Bard’s] responsibilities, in my opinion as a scientist and a human is
to make these products safer.” Doc. 5209-2 at 43.
• “Bard could do and had to do a better job in making their catheter the safer
alternative design.” Id. at 92-93.
The Court agrees these opinions improperly opine on proper corporate behavior.
“Personal views on proper corporate behavior are not appropriate expert opinions” from
an expert such as Sheikhi. In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-
PHX DGC, 2018 WL 495187, at *3 (D. Ariz. Jan. 22, 2018) (citations omitted); see also
In re Bard IVC Filters, No. MDL 15-02641-PHX DGC, 2018 WL 823277, at *4 (D. Ariz.
Feb. 12, 2018). These opinions are excluded.
Defendants also move to exclude Sheikhi’s standard-of-care opinion under Rule
702(b) as lacking a reliable factual foundation. Docs. 5209 at 5, 6023 at 4. They refer
broadly to his opinion that “Bard[’s] uncoated unmodified unreinforced IPCs violate the
modern standard of care in catheter-related engineering.” Doc. 5209-3 at 3, 51; see also
Doc. 5209-2 at 38-50, 97-98 (testifying the same).
Defendants contend Sheikhi “made up his defect theory and the standard of care
that he claims Bard violated. He cannot identify any court, regulatory or testing body, any
medical or engineering community, or any other entity who adopts his defect theory or
defines this standard.” Doc. 5209 at 5 (citation omitted). They argue that because “no IPC
in the U.S. contains all of the safer alternative designs he claims set the standard of care,”
he “cannot reliably opine that a standard of care requiring use of any of his proposed
designs exists given there is no IPC in the U.S. that meets it.” Id. at 5-6 (citation omitted).
Plaintiffs argue Defendants mischaracterize Sheikhi’s design defect opinions as
relying on a breach of a “modern standard of care in catheter-related engineering”
(Doc. 5209-3 at 3, 51). Doc. 5765 at 5. They contend Sheikhi “never offered ‘standard of
care’ opinions.” Id. They explain that because “he is not a lawyer or native English
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speaker,” then “he did not employ ‘standard of care’ in any legal sense[.]” Id. (citations
omitted).
The Court agrees with Plaintiffs that Sheikhi’s design defect opinions do not rely
on a purported breach of standard of care in catheter-related engineering. As explained by
Plaintiffs, his design defect opinions address the availability of safer alternative designs
that could have been applied to Bard’s IPCs. Id. at 6. These opinions are supported by the
literature and internal documents Sheikhi cites, coupled with his experience. 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.”).
But Sheikhi’s opinions that “Bard[’s] uncoated unmodified unreinforced IPCs
violate the modern standard of care in catheter-related engineering” (Doc. 5209-3 at 51),
and that “the scientific evidence establishes that non-fouling, antimicrobial, and
mechanically robust IPCs are not speculative upgrades; they are the modern standard of
care” (id. at 3), do present standard-of-care opinions not otherwise explained by Sheikhi.
These opinions are not supported by sufficient facts and data. Doc. 5765 at 5. Sheikhi
confirmed as much when he testified that his reference to the “modern standard of care” is
colloquial. See Doc 5209-2 at 39. Sheikhi’s standard-of-care opinion is excluded. Fed.
R. Evid. 702(b).
Defendants argue Sheikhi’s design defect opinions will be unhelpful and misleading
under Rules 702(a) and 403 because they tend to suggest Bard’s IPCs are “defective merely
because Bard was told about technologies that might make them safer,” but “that is not the
law in most jurisdictions.” Doc. 5209 at 7 (footnote omitted). Defendants cite the law of
several states. Id. (Florida, Missouri, New York, Michigan, Oklahoma, Texas, and New
Jersey). They acknowledge “this is a state specific issue” and reserve the right to raise this
argument on a case-specific basis. Id. at 7 n.7. As Defendants appear to recognize, the
Court cannot entirely exclude Sheikhi’s opinions when exclusion depends on applicable
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state law, and they have not specifically addressed the law that will apply in any of the six
bellwether trials.
B. Safer Alternative Design Opinions.
Defendants raise various challenges to Sheikhi’s alternative design opinions under
Rule 702(a)-(d). Id. at 8-9. They first argue that his “summary of studies related to coatings
or technologies that have never been tested, evaluated, analyzed or successfully used on
IPCs do not establish a viable alternative design for Bard’s IPCs.” Id. at 9. Defendants
contend Sheikhi “offers no evidence these technologies could be implemented on Bard’s
IPCs in a practical, safe, scalable, and clinically effective way other than ‘I see no reason
why they couldn’t,’” and that “[a]n alternative that exists only in theory – or in a different
context – is not feasible and will not help the jury determine whether Bard’s existing design
was defective” under Rule 702(a). Id.
In making their “summary of studies” argument, Defendants cites 85 pages of
Sheikhi’s report. See id. at 8 (citing Doc. 5209-1 at 9, 32-53, 64-80, 90-117, 120-131, 149-
156, 165-167). This is not proper argument. It is not the Court’s responsibility to scour
these pages trying to identify the opinions Defendants challenge and the bases for those
opinions.
And the Court disagrees with Defendants’ general contention that Sheikhi offers no
evidence that the technologies discussed in his report could feasibly be applied to Bard’s
IPCs. Sheikhi discusses technologies used in various central venous catheters (“CVCs”).
See, e.g., Doc. 5209-1 at 34 (discussing the HydroPICC); id. (discussing the Poly-2-
methoxyethylacrylate (PMEA) coating which “has been applied to the internal surfaces of
a port catheter system, including the chamber, catheter, and connecting stem, to prevent
thrombotic”); id. at 40 (discussing the application of the MPC polymer coating to catheters
including the Argon Careflow). Plaintiffs argue in this case that the biological interactions
giving rise to the medical complications at issue in this litigation are similar across IPCs
and alternate CVCs. Doc. 5765 at 10. Sheikhi’s opinions regarding these technologies are
not inapplicable to the jury’s task of evaluating Plaintiffs’ proposed alternative designs.
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Further, Sheikhi does not need to explain the feasibility of each technology he
discusses in his summary of studies because he does not propose each discussed technology
as a safer alternative design. Defendants acknowledge he proposes three specific alternate
designs: the Rhapsody IPC, the BioFlo IPC, and the Orphis IPC. See Doc. 5209 at 11-13.
Defendants separately argue Sheikhi’s alternative design opinions should be
excluded under Rule 702(c)-(d) because “he has done no testing to support his conclusion
that any alternative design is, in fact, safer.” Id. at 9-11 (emphasis omitted). But an expert
is not required to test their alternative designs in all cases. In Ramirez v. ITW Food Equip.
Grp., LLC, 686 F. App’x 435 (9th Cir. 2017), the Court of Appeals explained that while
the expert’s “alternative design was capable of being tested,” the plaintiff permissibly
“chose not to do so” because alternative design testing is not required by Rule 702. Id. at
440.
Defendants argue Sheikhi’s alternative design opinions are unreliable because
(1) “[h]e relies on literature that does not involve IPCs” (Doc. 5209 at 9) (citations
omitted), (2) he “conducted no risk benefit . . . analysis for his purported safer alternative
designs,” where he “cited tests or studies [that] looked only at isolated factors and did not
compare the full array of performance characteristics that matter for an IPC” (id. at 11),
and (3) he “has never published h[is] opinions or subjected them to peer review” (id. at 16)
(citation omitted). But Sheikhi’s training and experience, and his report’s detailed
discussion of the reasons for his alternative designs, clears the preponderance of the
evidence threshold for reliability under Rule 702. The Court’s role is not to determine if
Sheikhi’s opinions are correct. Alaska Rent-A-Car, Inc., 738 F.3d at 969-70. Defendants’
contentions are appropriate for cross examination.
The Court also finds Sheikhi’s alternative design opinions supported by a reliable
methodology. Sheikhi explains his methodology in his report. Doc. 5209-1 at 5. He
“rigorously gather[s] and analyz[es] the most pertinent data and evidence, sourced from
laboratory experiments, published literature, regulatory guidance, and/or industry reports.”
Id. He “appl[ies] the same scientific rigor, reproducibility, and relevance to conclude that
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[his] findings are well-supported, objective, and as unbiased as possible. The same
analytical methodology guides [his] interpretation of complex materials data and medical
device performance, forming the foundation of [his] opinions and conclusions in this case.”
Id. His methodology is further supported by his experience, including his familiarity with
conducting laboratory testing used in biomaterials research, his authorship of biomaterials
peer-reviewed publications, and his post-doctoral fellowship work developing types of
biomaterials. Doc. 5209-1 at 3-5; see McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-
DGC, 2021 WL 2709292, at *5 (D. Ariz. July 1, 2021) (“Although some expert testimony
‘rests upon scientific foundations,’ in other cases ‘the relevant reliability concerns may
focus upon personal knowledge or experience.’” (quoting Kumho Tire Co. v. Carmichael,
526 U.S. 137, 150 (1999))).
Defendants separately challenge Sheikhi’s opinions concerning specific alternative
designs. They first argue his opinions on the Rhapsody IPC as a safer alternative design
should be excluded because (1) “he does not know if [the Rhapsody IPC] was ever
commercially available,” (2) “[h]e did not cite and could not recall any literature comparing
the risks or benefits of Rhapsody to any other IPC,” and (3) he does not “know the source
for his claim that Rhapsody can help prevent kinking or pinch-off[.]” Doc. 5209 at 11
(citations omitted). Defendants have not cited any state law relevant to the bellwether trials
that requires an alternative design to be commercially available. Nor have they
demonstrated a risk-benefit analysis is necessary under any state law. And that Sheikhi
could not recall the source of his kinking/pinch-off claim during his deposition does not
disqualify his opinions under Rule 702.
Defendants next argue Sheikhi’s opinions on the BioFlo IPC as a safer alternative
design should be excluded because he unreliably compares the Piran 2014 and Suleman
2019 studies, which they contend “were separate observational studies (not a head-to-head
comparison), that differed in important ways[.]” Id. at 12. They list three differences
between the studies: (1) whether pulmonary embolisms were reported in the study, (2) the
follow up duration, and (3) whether patients on anticoagulants were excluded from the
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study. Id. They also note that neither study directly compares Bard IPCs and BioFlo IPCs.
Id. Defendants contend that “[w]hen analyzed with consistent endpoints; there is no
statistically significant difference” between the two studies. Id. Plaintiffs respond in
similar detail. Doc. 5765 at 15-16.
As the Court explained in prior orders in this MDL (Docs. 7374 at 17, 7767 at 18),
this level of granularity raises a credibility issue Defendants should address through
questioning and argument at trial, not through a Rule 702 motion. Defendants’ contention
that Sheikhi “ignored contrary peer-reviewed literature when forming his opinions that
found anti-thrombogenic coatings provide no benefit” (Doc. 5209 at 12 (footnote omitted))
is likewise not a basis for exclusion. McBroom, 2021 WL 2709292, at *4 (“The Court
cannot exclude Dr. Flynn’s opinions based on mere references to articles that Plaintiff
believes are contrary to the literature on which Dr. Flynn relies[.]”); Trevino v. Bos. Sci.
Corp., No. 2:13-CV-01617, 2016 WL 2939521, at *7 (S.D.W. Va. May 19, 2016) (“[I]f
there are certain device-specific publications that Dr. Galloway failed to review in
preparing his expert report, BSC is free to inquire about those publications on cross-
examination.”).
Defendants challenge Sheikhi’s opinions regarding the Orphis IPC as a safer
alternative design. They contend he cannot rely on the Iida study to support his Orphis
opinions because the study is “fundamentally flawed” based on (1) its lack of a
“randomization or standardized infection definition,” (2) its failure “to calculate whether
infection rates differed statistically between early and late periods,” and (3) where “no
assurance groups were comparable in disease severity or clinical practices.” Doc. 5209 at
13 (citation omitted). Yet prior to this litigation, Defendants consulted the Iida study when
conducting a clinical data evaluation of equivalent devices without mentioning the
methodological flaws they raise in this motion. See Doc. 5773-1 at 98-101. Further,
Plaintiffs confirm Sheikhi does not solely rely on Iida to reach his opinion. “For each
technology [Sheikhi considered], he scoured the literature and examined hundreds of
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sources to assess the ‘accuracy, consistency, and validity of the original data’ before relying
on it.” Doc. 5765 at 16 (quoting Doc. 5209-1 at 7-8).
The Court will not exclude Sheikhi’s opinions based on Defendants’ criticism of
one study when his opinions otherwise have a “reasonable factual foundation[.]” Smilovits
v. First Solar, Inc., No. CV12-00555-PHX-DGC, 2019 WL 6875492, at *5 (D. Ariz. Dec.
17, 2019) (“[U]nless an expert’s opinion lacks enough accurate factual information to
provide a reasonable factual foundation, criticism of an expert’s decision to base an opinion
on some facts but not others should be challenged through the traditional means at trial,
not through a Daubert motion.” (citation modified)). This too is a credibility issue the
Court will not decide through a Rule 702 motion.
Defendants argue Sheikhi’s opinions on alternative designs that have not been
cleared for use on IPCs by the FDA will not help the jury because designs that are neither
sold, tested, nor approved in the U.S. cannot serve as the benchmark for what is reasonably
feasible or safe, and that relying on such designs would unfairly suggest the existence of
designs that are not realistically available. Doc. 5209 at 14. They contend “[a] reasonable
alternative design is both technologically and legally feasible for use in the U.S. market,”
and that “Courts around the country have found that products that are not available for use
in the U.S. cannot suffice as evidence of a safer alternative design.” Id. at 15 (citations
omitted).
Defendants cite cases where the expert was precluded from testifying about
alternative designs not commercially available on the U.S. market. See, e.g., Gomez v. Am.
Med. Sys. Inc., No. CV-20-00393-PHX-ROS, 2021 WL 12313068, at *8 (D. Ariz. June 17,
2021); Wood v. Am. Med. Sys. Inc., No. 120CV00441DDDKLM, 2021 WL 1178547, at
*10 (D. Colo. Mar. 26, 2021). Other courts have declined to exclude testimony based on
alternative designs not cleared by the FDA or commercially available. See, e.g., In re
Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. MDL 2327, 2020 WL 1060970, at
*3 (S.D.W. Va. Feb. 13, 2020) (“[That] PVDF was not cleared by the FDA . . . has no
bearing on whether PVDF mesh is a safer alternative to other mesh products.”); cf. Kelley
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v. C.R. Bard, Inc., 644 F. Supp. 3d 1316, 1330 (N.D. Ga. 2022), on reconsideration in part,
No. 2:20-CV-00045-SCJ, 2023 WL 2370109 (N.D. Ga. Jan. 24, 2023) (declining to sustain
an objection on expert testimony regarding an alternative design not available at the time
of the plaintiff’s implant because it would “require assessing the contours of Georgia law
on design defects – an inquiry exceeding Rule 702’s analysis of qualification, reliability,
and relevance”). And some jurisdictions are split on whether an alternative design must be
commercially available at the time of injury. Compare Bell v. Ethicon Inc., No. 4:20-CV-
3678, 2021 WL 1111071, at *7 (S.D. Tex. Mar. 23, 2021), with Pizzitola v. Ethicon, Inc.,
No. 4:20-CV-2256, 2020 WL 6365545, at *4-5 (S.D. Tex. Aug. 31, 2020).
Defendants have not shown that state laws relevant to the bellwether trials in this
MDL require an alternative design to be commercially available in the United States. The
Court will not exclude Sheikhi’s opinions on the Orphis IPC or other non-U.S. alternative
designs for all purposes in this MDL when state laws vary on this issue.
Nor will the Court exclude Sheikhi’s alternative design opinions based on
Defendants’ contention that they “do not grow[] naturally and directly out of research[.]”
Doc. 5209 at 15 (citation modified). Defendants provide no further explanation as to why
Sheikhi’s opinions do not stem from the research described in his 195-page report
(Doc. 52091-1), 14-page document review list (id. at 222-35), and 7-page literature review
list (id. at 236-42).
In their reply, Defendants clarify that beyond their particularized challenges to
Sheikhi’s opinions on the Rhapsody, BioFlo, and Orphis IPCs, they also broadly seek
exclusion of those opinions under Rule 702(b)-(d). Doc. 6023 at 9. Sheikhi’s
methodology, as discussed above and described in his report (Doc. 5209-1 at 5), applies
with equal weight to his Rhapsody, BioFlo, and Orphis opinions. These opinions are
factually supported by the materials Sheikhi cites throughout his report, and his
biomaterials experience. See Elosu, 26 F.4th at 1024.
/ / /
/ / /
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C. Medical and Regulatory Opinions.
Defendants argue Sheikhi “is not qualified to offer medical or regulatory opinions.”
Doc. 5209 at 15. They contend that because he “is not a medical doctor, and admits he is
not qualified to treat or diagnose patients or provide medical advice,” then “he is not
qualified to offer his opinions on purported health risks or medical complications, ‘clinical
outcomes,’ ‘clinical performance,’ or what is ‘clinically relevant’ or important, or on
medical causation for ‘the various injuries and adverse outcomes sustained by Plaintiffs.’”
Id. at 15-16 (citations omitted). Plaintiffs argue that none of Sheikhi’s opinions “involve[]
medical diagnoses or requires a medical degree,” and instead “lie at the foundation of
biomaterials science: understanding how implanted materials provoke or resist the
biological reactions that cause device-related complications and designing safer materials
to mitigate those risks,” which they contend Sheikhi is qualified to render based on his
“expertise in biomedical engineering[.]” Doc. 5765 at 6, 8 (citations omitted).
The Court agrees with Plaintiffs. Sheikhi’s opinions cited by Defendants
(Doc. 5209 at 16) are within the scope of his expertise. His experience in biomaterials
includes laboratory testing used in biomaterials research, “biological and biocompatibility
tests,” and experience with “blood-material interaction tests, . . . to assess how materials
interface with blood components.” Doc. 5209-1 at 4. Sheikhi has become “familiar with
biologics-biomaterial interactions, such as protein adsorption, platelet adhesion, thrombus
formation, bacterial colonization, biofilm formation, and foreign body response.” Id. at 5.
He explained that “[u]nderstanding biodegradation, non-fouling moieties, and
antimicrobial agents is also integral to some of [his] research projects.” Id.
Sheikhi’s experience in the field of biomaterials qualifies him to opine about the
biological complications associated with biomaterials, clinical outcomes, and performance
of biomaterials, and on the causal effect of biomaterials on thrombosis, infection, and
related biological complications. Defendants reliance on Contreras v. Brown, No. CV-17-
08217-PHX-JAT, 2018 WL 7254917, at *3 (D. Ariz. Dec. 4, 2018), is misplaced because
in that case the court excluded a biomechanical engineer’s specific medical causation
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opinion, which Sheikhi does not render. So too is their reliance on Roeder v. Am. Med.
Sys., Inc., No. 20-1051-JWB, 2021 WL 4819443 (D. Kan. Oct. 15, 2021), where a doctor
of chemical engineering and doctor of polymer science were held “not qualified to offer
opinions regarding medical complications.” Id. at *4. Beyond his Ph.D. in Chemical
Engineering, Sheikhi has significant experience in biomaterials and biological
complications, as discussed above.
Defendants argue Sheikhi is not qualified to render regulatory opinions, including
“whether Bard complied with FDA regulations or guidance, what FDA’s state of mind is
with respect to Dr. Sheikhi’s purported safer alternative designs or Bard’s regulatory
submissions, or the implications of 510(k) clearance and the types of data that may be used
to obtain regulatory clearance.” Doc. 5209 at 16. Plaintiffs do not respond to Defendants
argument and instead only contend Sheikhi “may identify FDA-cleared devices that
already employ similar catheter technologies that he proposes as alternative designs.”
Doc. 5765 at 5.
Sheikhi’s report states he is “familiar” with “the types of evidence that typically
underpin medical device evaluations” and “Food and Drug Administration (FDA)
processes such as 510(k) submissions, premarket approval (PMA), investigational device
exemptions (IDE), and pre-submissions[.]” Doc. 5209-1 at 5. But mere familiarity is not
enough to qualify Sheikhi as an expert on FDA processes, and his report provides no further
explanation for his familiarity.
In the pages of Sheikhi’s report and rebuttal report cited by Defendants (Doc. 5209
at 16), he discusses Bard’s lack of adherence to FDA guidance and Defendants’
interactions with the 510(k) clearance process based on Bard’s internal documents and
deposition testimony of Bard employees. See, e.g., Doc. 5209-1 at 67 n.7 (“Defendants’
port team did not follow the FDA’s guidance regarding the number of sheep to test or
proper implantation procedures [to use in their pilot sheep studies.]” (citations omitted));
id. at 123 (describing the contents of a 510(k) Premarket Notification and explaining that
“[g]iven those claims, Defendants anticipated 510(k) clearance” but “[t]he FDA . . .
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questioned the nanoparticles and leachate in the antimicrobial PowerPort catheters, which
resulted in the issuance of Not Substantially Equivalent letter,” but “Defendants did not
attempt to ‘address [the FDA’s] remaining 8 questions and resubmit’ their 510k
application” (citations omitted)). Sheikhi also explains what is – and what is not – achieved
through 510(k) clearance of a medical device. Doc. 5209-3 at 3 (“Regulatory
determinations of ‘substantial equivalence’ through the 510(k) pathway do not permit
medical device manufacturers to ignore safer designs and that optimal patient protection
demands both procedural sterility and material innovation.”); id. at 20 (“[T]he 510(k)
pathway is neither an approval of safety nor a test of clinical superiority. By statute it asks
only whether the new device is ‘substantially equivalent’ to a previously marketed
predicate.” (citation omitted)).
Plaintiffs do not argue Sheikhi is qualified to opine on Defendants’ interactions with
the FDA or other FDA-related issues in this case, and Sheikhi’s report does not explain
how he is qualified to provide such opinions. Plaintiffs have not shown by a preponderance
of the evidence that he is qualified to render FDA-related opinions.
Nor may Sheikhi opine that the “FDA does not have issues with coatings per se; it
was simply wary of Defendants’ incomplete submissions and assessments when attempting
to clear its antimicrobial IPC prototype.” Id. at 19. This opinion discusses the motive
behind the FDA’s decision, which lies outside the bounds of Sheikhi’s expertise. And
Sheikhi may not opine that “it [is] more likely than not . . . that the FDA would clear an
antimicrobial implanted port catheter.” Doc. 5209-2 at 105. As argued by Defendants
(Docs. 5209 at 16, 6023 at 11), this opinion was not disclosed in Sheikhi’s report (Doc.
5209-1 at 166-67) and was elicited by Plaintiffs’ counsel during his deposition (see Doc.
114 ¶ II.F). Such an opinion also exceeds his qualifications to opine on FDA regulatory
processes as discussed above.
Plaintiffs point to Defendants’ materials science and biomedical engineering
experts, Drs. MacLean and Grainger, arguing “Defendants [cannot] wield FDA evidence
as both a sword and shield[.]” Doc. 5765 at 5. But Plaintiffs never challenged whether
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MacLean or Grainger were qualified to render any purported FDA or regulatory
opinion. Docs. 5203, 5208. Further, MacLean has experience with regulatory processes
not demonstrated by Sheikhi. Doc. 7222 at 8 (“MacLean has experience in product
compliance assessments and in assessing risk during the product qualification stage. He is
‘well versed in product recall investigations’ across numerous federal agencies and is
‘familiar with testing and material standards[.]’” (citations omitted)). His 510(k) process
opinions were narrowly cabined to that experience. See id. at 17-18.
Defendants lastly contend Sheikhi’s medical and regulatory opinions should be
excluded because “he has no experience with any of these subjects” and therefore cannot
“explain how [his] experience leads to the conclusion reached, why that experience is a
sufficient basis for the opinion, and how that experience is reliably applied to the facts” as
instructed by Davis v. McKesson Corp., No. CV-18-1157-PHX-DGC, 2019 WL 3532179,
at *27 (D. Ariz. Aug. 2, 2019). Sheikhi’s experience, as laid out above, is relevant to his
medical opinions. The 166 substantive pages of his report demonstrate how his experience
in biomaterials and related biological complications leads to his conclusions, and how that
experience is both a sufficient basis for his related opinions and reliably applied to the facts.
See Doc. 5209-1.
D. Improper Legal Conclusions.
Defendants argue Sheikhi’s opinion that “Bard’s IPCs are ‘unreasonably dangerous’
and ‘defectively designed’” are “legal terms of art” and thus “improper legal conclusions.”
Docs. 5209 at 17 (citations omitted). They cite cases from the Eastern and Western
Districts of Missouri, the Central District of Illinois, and the District of Arizona in support.
See id. Plaintiffs assure Sheikhi “will not couch his opinions in legal jargon,” but contend
“he is permitted to use different words to convey his opinions.” Doc. 5765 at 17. The
question of whether Sheikhi’s use of the terms “unreasonably dangerous” and “defectively
designed” constitutes improper legal conclusions turns in part on the product liability law
of the relevant state. Yet Defendants discuss no state law relevant to the strict liability
claims brought in this MDL. See Doc. 5209 at 17. Defendants can object in specific cases
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if they believe Sheikhi’s testimony is venturing into legal terminology under the relevant
state’s law.
E. State of Mind Opinions.
Defendants cite numerous pages of Sheikhi’s report, rebuttal report, and deposition
testimony arguing Sheikhi improperly opines on “Bard’s ‘design choices’ and its
knowledge, intent, motive, or state of mind based on his review of a limited set of Bard
documents[.]” Id. They argue these opinions should be excluded under Rule 702(a) and
(b). Id. at 18.
The Court will not engage in an exhaustive review of the pages of Sheikhi’s reports
cited by Defendants where they cite no particular opinion they seek to exclude. But the
Court’s review did at times reveal opinions that crossed into corporate knowledge territory.
See, e.g., Doc. 5209-1 at 71 (“Defendants ‘shelved’ the Thrombus-Resistant Catheter
project because they lacked the in-house expertise to recreate the DGP coating . . . . In the
words of Mr. Thomas – Defendants’ project leader – the Thrombus-Resistant Catheter
project ‘fell apart at Bard’ because of lack of priority and resources as well as managerial
reasons.” (citations omitted)); id. at 124 (“Defendants have not used any antimicrobial or
antifouling coatings or additives on their hydrophobic IPCs due to cost and time.” (citations
omitted)).
Sheikhi is not qualified to opine on the state of mind or corporate knowledge of
Bard. In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018
WL 495188, at *6 (D. Ariz. Jan. 22, 2018). “Inferences about the intent or motive of parties
or others lie outside the bounds of expert testimony.” In re Bard IVC Filters Prods. Liab.
Litig., No. MDL 15-02641-PHX DGC, 2017 WL 6523833, at *9 (D. Ariz. Dec. 21, 2017)
(quoting In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 547 (S.D.N.Y. 2004)).
Sheikhi’s opinions must be cabined to his expertise as a chemical and biomedical engineer.
F. Improper Citations.
Defendants argue broadly that Sheikhi’s opinions are “unreliable and should be
excluded under Rule 702(c) and (d)” because “he repeatedly miscites Bard’s internal
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documents and corporate testimony and attributes statements or propositions to Bard that
are wholly unsupported by the cited evidence.” Docs. 5209 at 18, 6023 at 12. They
provide a chart cataloging these purported citation errors from his report. Doc. 5209-14
(Ex. N).
After reviewing the chart, the Court is unpersuaded these citation errors render
Sheikhi’s opinions unreliable under Rule 702(c)-(d). The chart reflects Sheikhi’s opinions
paraphrasing Bard’s internal documents. See Doc. 5209-14. Defendants’ criticisms
regarding the accuracy of the paraphrasing are appropriate for cross examination if the
chart is in some way mentioned at trial (absent stipulated admission, the expert reports are
inadmissible hearsay), but they are not a basis to exclude Sheikhi’s opinions. 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)).
IT IS ORDERED that Defendants’ motion to exclude the opinions of Dr. Amir
Sheikhi (Doc. 5209) is granted in part and denied in part. Dr. Sheikhi may not opine
about (1) Bard’s responsibilities to “make products safer,” (2) the standard of care in
catheter-related engineering, (3) FDA regulations and FDA interactions with Defendants,
and (4) Defendants’ corporate knowledge or state of mind. The motion is otherwise
denied.
Dated this 14th day of April, 2026.
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