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
Hybrid Witnesses Kelly Christian, John
Evans, Todd McFarland, and Kelly Powers
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”).
Plaintiffs have filed a motion to exclude opinions of Kelly Christian, John Evans, Todd
McFarland, and Kelly Powers. Docs. 5193, 5194. The motion is fully briefed and no party
requests oral argument. See Docs. 5766, 6029. 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.
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
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typically is implanted beneath the chest skin and below the collarbone. 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. 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”). 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. The MDL Plaintiffs allege, among other things, that Bard IPCs
are defective because Bard failed to coat the catheters with antimicrobial or antithrombotic
material. Plaintiffs assert a host of state law claims, including design and manufacturing
defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. Bard further contends
that various factors impact the performance and wear of IPCs, including where the catheter
is inserted and how well the device is maintained by medical professionals and the patient.
See Docs. 23, 2023-1.
The FDA applies different levels of scrutiny to medical devices before approving or
clearing them for market. The most rigorous level of scrutiny is known as “premarket
approval,” often referred to as the “PMA” process. 21 U.S.C. § 360e(a). To comply, a
manufacturer must file an application that provides a broad range of detailed information
to the FDA to show the device is safe and effective. 21 U.S.C. § 360e(c). Other medical
devices can be cleared through the less rigorous section “510(k)” review. A manufacturer
can satisfy this review and be exempt from the PMA process by providing premarket notice
to the FDA that its device is substantially equivalent to another device that is already on
the market. 21 U.S.C. § 360c(f)(1)(A).
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Bard sought premarket clearance through 510(k) review for its Avertex IPC with
antimicrobial coating. Bard filed a 510(k) submission for the Avertex IPC in May 2010
and received a “Not Substantially Equivalent” (“NSE”) determination from the FDA in
April 2011. Bard did not seek further 510(k) review for the Avertex IPC. See Docs. 5193
at 4-7, 5766 at 3-6.
Bard filed a 510(k) pre-submission for IPCs with dextran flycoconjugate polymer
(“DGP”) antithrombotic coating in September 2013 and received comments from the FDA
in December 2013 and October 2014. Bard experienced challenges developing DGP
coating, which hindered its ability to address the FDA’s comments. Bard decided in late
2014 that it would not continue to pursue DGP coating. See id.
Under Federal Rule of Civil Procedure 26(a)(2)(C), Defendants have identified four
former Bard employees – Kelly Christian, John Evans, Todd McFarland, and Kelly Powers
– as non-retained expert witnesses and have disclosed summaries of the facts and opinions
to which they are expected to testify. See Doc. 5193-1 at 8-10, 16-18, 21-37. These
individuals were part of Bard’s research and development (“R&D”) team and have
knowledge about Bard’s 510(k) submissions and efforts to develop catheters with
antimicrobial and antithrombotic coatings. See Doc. 5193 at 4-5. Bard asserts that they
can testify as percipient fact witnesses and as non-retained experts about Bard’s evaluation
of the coating technologies and the likelihood of FDA clearance. Doc. 5766 at 4-6.
Plaintiffs argue that they should be limited to offering opinions formed during their
employment with Bard based on percipient knowledge and observations. Doc. 5193 at 2-3,
9-12. Plaintiffs also argue that some of their opinions are inadmissible under Federal Rule
of Evidence 702. Id. at 3, 12-15.
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
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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
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. Proper Scope of the Hybrid Witnesses’ Testimony and Opinions.
Non-retained experts for whom opinion summaries are provided under subsection
(C) of Rule 26(a)(2) are sometimes referred to as “hybrid witnesses” because they often
provide both fact testimony as percipient witnesses and expert opinions based on
specialized knowledge. Alsadi v. Intel Corp., No. CV-16-03738-PHX-DGC, 2020 WL
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4035169, at *18 (D. Ariz. July 17, 2020); see Jodie v. Mountain W. Farm Bur. Mut. Ins.
Co., No. CV 20-30-BLG-SPW, 2023 WL 2584317, at *2 (D. Mont. Mar. 21, 2023) (“Along
the spectrum of the two kinds of expert witnesses is a hybrid fact/expert witness – ‘that is,
someone whose testimony turns in part on scientific, technical, or other specialized
knowledge, but who has a relationship to the subject matter of the action independent of
the litigation itself.’” (citation modified)). Examples include current or former “employees
of a party who do not regularly provide expert testimony.” Fed. R. Civ. P. 26(a)(2)(C),
advisory committee note to 2010 amendment.
The relevant distinction arose from the history of Rule 26. In 1993, the rule was
amended to require, for the first time, that expert witnesses provide detailed reports of the
opinions they would offer at trial. The new requirement, found in subsection (B) of Rule
26(a)(2), applied only to expert witnesses “retained or specially employed to provide
expert testimony in the case or one whose duties as the party’s employee regularly involve
giving expert testimony.” Fed. R. Civ. P. 26(a)(2)(B). Party employees who did not have
such duties were not covered by the report requirement even if they provided expert
testimony under Rule 702. Rule 26 was amended in 2010 to add a second kind of expert
disclosure. This new requirement provided that “if the witness is not required to provide a
written report” under subsection (B) – in other words, if the witness was not retained or
specially employed and was not an employee whose duties regularly involve giving expert
testimony – then only a less detailed summary of the expert’s opinions was required by
new subsection (C) of the rule. See Fed. R. Civ. P. 26(a)(2)(C).
Because this new summary requirement applies “if the witness is not required to
provide a written report” under subsection (B), courts must decide when a witness is
“retained or specially employed” within the meaning of subsection (B) and when a witness
is not. The Ninth Circuit addressed this issue in Goodman v. Staples the Office Superstore,
LLC, 644 F.3d 817 (9th Cir. 2011), holding that a treating physician (a category of witness
historically not viewed as coming within subsection (B)) is exempt from the report
requirement only to the extent his or her opinions “were formed during the course of
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treatment.” Id. at 826. If the opinions instead were formed after the treatment and in
preparation for the litigation, the Ninth Circuit concluded that the witness reasonably could
be viewed as “retained or specifically employed” for the litigation and therefore subject to
subsection (B) report requirement. Id.
Courts have applied this distinction to employee and former employee witnesses –
another category that historically has not been viewed as coming within subsection (B).
See, e.g., Cooc v. Bureau Veritas N. Am. Inc., No. 2:24-CV-0906 TLN SCR, 2025 WL
2420000, at *2 (E.D. Cal. Aug. 21, 2025) (“‘The dispositive question’ in evaluating
whether an expert properly falls within Rule 26(a)(2)(C), ‘is whether the witness’s opinion
was developed either for purposes of litigation or as part of the witness’s duties as the
party’s employee.’” (citation omitted)); Meredith v. Int’l Marine Underwriters, No. CIV.A.
GLR-10-837, 2012 WL 3025139, at *5 (D. Md. July 20, 2012) (“[T]o the extent that a
witness’ opinion is based on facts learned or observations made ‘in the normal course of
duty,’ the witness . . . need not submit a report.” (citation omitted)). Thus, former
employees who will testify only to opinions formed during the course of their employment
are not required to provide reports under subsection (B), and the lawyers presenting them
can provide a summary of their opinions under subsection (C). But for opinions not formed
during the course of their employment, such witnesses are viewed as falling within the
scope of subsection (B) and can state opinions only if they were fully disclosed in a report
under subsection (B). See Alsadi, 2020 WL 4035169, at *14.
The witnesses at issue in this motion – Christian, Evans, McFarland, and Powers –
may therefore present opinions under Rule 702 that were formed during the course of their
employment with Defendants without having prepared detailed reports under subsection
(B) of Rule 26(a)(2). Plaintiffs do not dispute such opinions of these witnesses were
properly disclosed under subsection (C). And these witnesses may provide factual
testimony about their work for Defendants. Thus, for example, to the extent these
witnesses were involved with the FDA clearance process and formed opinions during that
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work, those opinions may be stated at trial, assuming Rule 702 and other evidence rules
are satisfied.
Defendants assert that they have “no plans to elicit new opinions based on
information reviewed in anticipation of trial from these witnesses[.]” Doc. 5766 at 7. But
it appears Defendants do intend to have at least some of the witnesses express opinions
formed outside of their work for Bard. Doc. 6029 at 2-3. Defendants state, for example,
that each witness’s testimony will be based on his experiences at Bard and “in the medical
device industry generally.” Doc. 5766 at 2; see id. at 7 (same). With respect to McFarland,
Defendants state his opinions are based on information obtained during his tenure at Bard
and in “his current role overseeing the design and potential regulatory approval of a coating
technology [at a different company].” Id. at 11; see id. at 15 (McFarland may testify about
the “current restrictiveness of the FDA’s standards” because he “did not leave the industry
in 2018 and is currently developing a coating for eventual 510(k) clearance in his present
role”).
Applying the distinction recognized by the Ninth Circuit in Goodman, the Court
concludes that Defendants’ witnesses cannot express opinions formed outside of their
employment at Bard without disclosing them in a report under subsection (B) of Rule
26(a)(2). Because the opinions were not so disclosed, they cannot be stated at trial. See
Fed. R. Civ. P. 37(c)(1);1 see also Fed. Trade Comm’n v. Amazon.com, Inc., No. 2:23-CV-
00932-JHC, 2025 WL 2460658, at *4 (W.D. Wash. Aug. 26, 2025) (explaining that as
hybrid witnesses, the FTC’s former employees could not offer opinions beyond their
“personal knowledge and observations they gained on the job”); Seoul Semiconductor Co.
v. Feit Elec. Co., No. 2:22-CV-5097-AB-SHK, 2025 WL 1145962, at *3 (C.D. Cal.
Mar. 14, 2025) (“percipient experts . . . may not offer ‘a current opinion for the purposes
of litigation’” (citation omitted)); KISS Nail Prods., Inc. v. Ardell Int’l, Inc., No. 2:25-CV-
02793-SVW-MBK, 2026 WL 180031, at *2 (C.D. Cal. Jan. 22, 2026) (“Hybrid fact/expert
1 The Court does not find a failure to disclose expert opinions substantially justified
or harmless under Rule 37(c)(1). In this expert-intensive MDL, full pretrial disclosure of
expert opinions is critical to fair and efficient bellwether trials.
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witnesses must testify from the personal knowledge they gained on the job and the district
court certainly may preclude these witnesses from testifying beyond the scope of facts they
learned and opinions they formed during the course of their project duties.” (citation
modified)). The Court specifically called the parties’ attention to this distinction in an early
case management order. See Doc. 114, ¶ II.E n.1. The Court will grant Plaintiffs’ motion
in this regard.
But the Court rejects Plaintiffs’ suggestion that Defendants are obligated at this
pretrial stage to present affirmative evidence that each expert’s opinion was formed during
his or her employment by Defendants. Doc. 6029 at 6. This is not a Rule 702 challenge,
but a challenge under Rule 26, and Plaintiff’s cite no authority for the proposition that
Defendants must make an affirmative showing in response to Plaintiff’s motion.
Defendants may lay this foundation at trial.
Nor does the Court accept Plaintiffs’ argument that certain opinions must be limited
to the time when Bard made its FDA submissions – specifically, to April 2011 when the
FDA issued its NSE determination for the Avertex IPC or to 2016 when the then-current
FDA director retired. Doc. 5193 at 10-11. These witnesses were not required to provide
subsection (B) reports for opinions formed during the course of their employment by
Defendants, and Plaintiffs do not claim their subsection (C) summaries were deficient.
Thus, there is no basis to limit their opinions under Rule 37(c)(1). If opinions formed
during their employment are relevant and admissible, the witnesses can state them
regardless of when during their employment the opinions were formed.
B. FDA’s Intent and State of Mind.
Plaintiffs identify certain opinions they contend are impermissible testimony about
the FDA’s intent and state of mind. Doc. 5193 at 5-7, 12-15. Defendants state that,
consistent with their subsection (C) disclosures, the witnesses may testify about Bard’s and
their own interpretations of the FDA’s positions regarding antimicrobial and
antithrombotic coatings, Bard’s and their own beliefs regarding the likelihood the FDA
would clear a device with such coatings, and the appropriateness of Bard’s decision to
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forgo further attempts to obtain FDA clearance of IPCs with such coatings. Doc. 5766 at 2.
The Court agrees.
Defendants make clear that the hybrid witnesses will offer no opinion on the FDA’s
intent or state of mind. Id. The Court will hold Defendants to their word. See In re Bard
IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 6523833, at *9
(D. Ariz. Dec. 21, 2017) (“Inferences about the intent or motive of . . . others lie outside
the bounds of expert testimony.” (citation omitted)); In re Traylsol Prods. Liab. Litig., No.
09-MD-01928, 2010 WL 4102247, at *6 (S.D. Fla. Sept. 10, 2010) (excluding opinions
about “the FDA’s motive, knowledge, intent, and state of mind” because they fell outside
“the scope of [the witness’s] knowledge and expertise and are classic jury questions”).
While “an expert may not opine on the state of mind of the FDA,” they can “testify about
their interpretation of the meaning of documents in the regulatory history.” Holley v.
Gilead Scis., Inc., No. 18-CV-06972-JST, 2023 WL 2469632, at *7 (N.D. Cal. Feb. 27,
2023). If a proper foundation is laid, a hybrid witness can testify that he or Bard believed
“it was very unlikely that the FDA would clear the Avertex IPC 510(k) after issuing [an
NSE] determination.” Doc. 5193-1 at 9.
C. Plaintiffs’ Rule 702 Arguments.
Plaintiffs argue that these witnesses are not qualified to offer FDA-related opinions,
that their opinions are not supported by facts or data, and that their opinions are not based
on a reliable methodology. Doc. 5193 at 13-15.
1. Qualifications.
Plaintiffs argue that the witnesses are not qualified to offer “FDA-related opinions”
because they are experts in R&D, not regulatory affairs. Doc. 5193 at 13. But Plaintiffs
do not identify the opinions they seek to exclude, nor do they address this argument in their
reply brief. See Doc. 6029. Defendants have shown, by a preponderance of the evidence,
that the hybrid witnesses had extensive experience with Bard’s IPCs and coating
technologies, Bard’s 510(k) submissions to the FDA, and communications between Bard
and the FDA. Doc. 5766 at 8-13. These experiences include the Avertex and DGP coatings
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and the FDA’s Avertex NSE determination. With appropriate foundation at trial, these
experts will be permitted to provide FDA-related opinions formed during their employment
at Bard.
2. Facts and Data.
Plaintiffs challenge two opinions on the ground that they are not supported by facts
or data: (1) Evans’ opinion that “it was very unlikely that the FDA would clear the Avertex
510(k)”; and (2) McFarland’s opinion that “the FDA’s evolving stance on nanoparticles
and increasingly stringent antimicrobial requirements rendered certain coating
technologies infeasible and/or impractical[.]” Doc. 5193 at 14-15 (citing Doc. 5193-1 at
9, 17). Regarding the challenged opinion of Evans, Defendants state that the opinion is
based on experience and information he obtained during his time at Bard. Doc. 5766 at 9.
With respect to McFarland’s opinion, Defendants state that it is based on information
obtained during his tenure at Bard and his experience as the director of R&D for catheter
coating projects, during which time Bard continued to evaluate potential antimicrobial
devices. Id. at 11. The Court finds this experience sufficient to support their opinions. See
Elosu v. Middlefork Ranch Inc., 26 F.4th 1017, 1024 (9th Cir. 2022) (“An expert’s
specialized knowledge and experience can serve as the requisite ‘facts or data’ on which
they render an opinion.”).
3. Reliable Methodology.
Plaintiffs assert that the hybrid witnesses’ opinions about what the FDA would have
done are unreliable because they are based on “little more than their own feelings.”
Doc. 5193 at 15 (citing Doc. 5193-5 at 9 (“It felt like the FDA was misconstruing or not
. . . understanding aspects of our testing.”)). Plaintiffs argue that such opinions should be
excluded because the witnesses have not identified the “principles and methods” they used
to reach their conclusions. Id.
“Although some expert testimony ‘rests upon scientific foundations,’ in other cases
‘the relevant reliability concerns may focus upon personal knowledge or experience.’”
McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2021 WL 2709292, at *5 (D.
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Ariz. July 1, 2021) (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999));
see also In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018
WL 495188, at *4 (D. Ariz. Jan. 22, 2018) (“[E]xpert testimony ‘is reliable if the
knowledge underlying it has a reliable basis in the knowledge and experience of the
relevant discipline.’” (quoting Primiano v. Cook, 598 F.3d 558, 565 (9th Cir. 2010))).
Defendants have shown, by a preponderance of the evidence, that the hybrid
witnesses’ opinions are reliably based on knowledge and experience obtained during their
time at Bard. Doc. 5766 at 3, 8-13. They will not be excluded now, but proper foundation
for the opinions will still be required at trial.
IT IS ORDERED: Plaintiffs’ motion to exclude opinions of Kelly Christian, John
Evans, Todd McFarland, and Kelly Powers (Docs. 5193, 5194) is granted in part and
denied in part. These witnesses cannot (1) offer opinions formed before or after their
employment at Bard, or (2) opine on the FDA’s intent or state of mind. The motion is
otherwise denied.
Dated this 9th day of March, 2026.
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