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
Expert Witness Donna-Bea Tillman
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 the expert opinions of Donna-Bea Tillman, Ph.D.
Doc. 4829. The motion is fully briefed and no party requests oral argument. See
Docs. 5334, 5578. 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.
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 the FDA with a broad range of detailed
information showing the device is safe and effective. 21 U.S.C. § 360e(c). Medical devices
can also be cleared through the less rigorous section “510(k)” review. A manufacturer can
satisfy this review and be exempted 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, typically referred to as a “predicate” device. 21 U.S.C. § 360c(f)(1)(A).
Because the regulatory process for medical devices is beyond the ken of average
jurors, it will be helpful to have qualified FDA experts describe how the process works.
See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL
5625547, at *6 (D. Ariz. Nov. 22, 2017). Defendants have identified Dr. Tillman as an
FDA expert. Tillman has prepared a 134-page report which discusses her qualifications as
an FDA expert (Doc. 4829-1 at 7-8), the medical device regulatory background (id. at
9-49), the FDA’s regulation of implantable ports, including Bard IPCs (id. at 49-130), and
the opinions of Defendants’ FDA experts, Drs. Michael Beatrice and Madris Kinard (id. at
131-140). Plaintiffs argue that many of the opinions Tillman offers are inadmissible under
Federal Rule of Evidence 702. Doc. 4826.
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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
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.”).
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III. Discussion.
Plaintiffs argue that (1) Tillman should be precluded from opining on the ultimate
legal issue of safety (Doc. 4829 at 3-7); (2) she should be precluded from opining on the
FDA’s state of mind (id. at 7-8); (3) she cannot offer opinions beyond basic FDA regulatory
requirements and the exchange of information with the FDA because she failed to review
sufficient documents (id. at 9-10); (4) she is not qualified to offer certain opinions (id. at
10-15); and (5) she should not be permitted to opine that Plaintiffs’ experts are unqualified
or unreliable (id. at 15-17).
A. Safety Issue.
After the motion and response, Plaintiffs state that only two issues remain from this
section of their motion: (1) whether Tillman may testify that the ultimate design of Bard’s
ports was “safe”; and (2) whether Tillman may testify that by clearing Bard’s products, the
FDA found them to be “safe and effective.” Doc. 5578 at 3.
On the first issue, Tillman does not claim to be a design expert. She therefore may
not opine that the design of the IPCs was safe.
On the second issue, Tillman may not testify that the FDA found, through the 510(k)
process, that Bard IPCs were safe and effective. She may testify, as Plaintiffs agree, that
in clearing an IPC, the FDA determined that it was as safe and effective as its predicate
device. Doc. 4829 at 6.
B. FDA’s State of Mind.
Plaintiffs argue that while Tillman may opine that she believes Bard complied with
the FDA regulations, she cannot opine that the FDA considered Bard to be in substantial
compliance with those regulations. Id. at 7-8. Defendants concede that Tillman cannot
opine on the FDA’s state of mind. Doc. 5334 at 8; 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
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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”).
Defendants contend, however, that Tillman may testify that the FDA “was satisfied”
or “not convinced” or “concerned.” Doc. 5334 at 8. The Court does not agree. Such
testimony conveys what the FDA was thinking and is impermissible. See Robinson v.
Ethicon Inc., No. H-20-3760, 2022 WL 20689753, at *3 (S.D. Tex. Oct. 5, 2022) (expert
opinion about what FDA “understood” was impermissible state-of-mind testimony).
The Court will grant Plaintiffs’ motion and preclude Tillman from opining on the
FDA’s state of mind. She cannot opine that the FDA “was satisfied” or “not convinced”
or “concerned.” Nor can she opine that because the FDA did not ask Bard to change its
labeling, the FDA “determined that the labeling met regulatory requirements and provided
appropriate risk information and instructions.” Doc. 4829-1 at 70; see Docs. 4829 at 8,
5578 at 3-4.
C. Tillman’s Document Review.
Plaintiffs contend that Tillman should be limited to offering opinions about basic
FDA regulatory requirements and the documented exchange of information with the FDA.
Doc. 4829 at 9. Plaintiffs argue that any opinions beyond that limited scope are based on
insufficient facts or data and are unreliable because Tillman did not conduct a “fulsome
review of documents.” Id.
Defendants explain that Tillman strategically chose which documents to review and
she thoroughly reviewed every document she deemed important, including FDA Guidance
documents and Bard’s 510(k) submissions. Doc. 5334 at 8. Defendants also note that
Tillman’s 134-page report details her analysis in depth and cites hundreds of documents
supporting her opinions. Id. Plaintiffs do not address these points in their reply. See Doc.
5578.
The Court finds by a preponderance of the evidence that Tillman’s opinions are
based on sufficient facts and data. “[T]here is no legal requirement that experts review
every document produced in litigation.” In re Takata Airbag Prods. Liab. Litig., No. 15-
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MD-02599, 2022 WL 18956175, at *3 (S.D. Fla. Dec. 28, 2022); see also Kang v. Mayor
& Aldermen of City of Savannah, No. CV421-111, 2024 WL 150082, at *5 (S.D. Ga.
Jan. 12, 2024) (“The challenged opinions are not based on insufficient facts or data simply
because Register and Vowell did not review every available document before writing their
expert reports.”); Walsh v. Reliance Tr. Co., No. CV-19-03178-PHX-ROS, 2023 WL
1966921, at *11 (D. Ariz. Feb. 13, 2023) (“Defendants complain Wert’s opinions are not
based on ‘sufficient facts or data’ because he did not review ‘thousands of pages’ they
believe are relevant. . . . Defendants do not cite any authority establishing such a rule[.]”
(citation omitted)). Plaintiffs may cross-examine Tillman at trial about documents she did
not review. See 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)).
D. Other Opinions Plaintiffs Seek to Exclude.
Plaintiffs argue that Tillman is not qualified to opine on: (1) cautionary statements
in a material data safety sheet (“MSDS”); (2) the sufficiency of Bard’s IPC labeling;
(3) complaint rates for Bard ports; (4) the feasibility of safer alternative designs;
(5) antimicrobial coatings; and (6) determinations by Japanese regulatory agencies. Doc.
4829 at 10-15.
1. Cautionary Statements in an MSDS.
Plaintiffs challenge Tillman’s opinion that “some raw materials manufacturers put
cautionary information in an MSDS regarding the use of the material in medical devices to
protect themselves from possible product liability claims.” Doc. 4829 at 10 (quoting Doc.
4829-1 at 43). Plaintiffs assert that there is no support for this opinion on the intent of any
raw material supplier, let alone DuPont, the relevant supplier that Tillman fails to mention.
Id.
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According to Tillman, the fact that raw materials manufacturers put cautionary
statements in an MSDS to protect themselves from liability “is well known in the medical
device industry[.]” Doc. 4829-1 at 43. Tillman explains that she “was aware of this
practice” when she was at the FDA, and cites the 1998 Biomaterials Access Assurance Act,
which states that some “suppliers have ceased supplying certain raw materials and
component parts for use in medical devices for a number of reasons, including concerns
about the costs of . . . litigation.” Id. (citing 21 U.S.C. § 1601). Tillman also testified that
she has “seen instances where there are medical caution statements in MSDS’s . . . where
nobody has been able to show [her] any scientific basis for why those statements are in
there and that [she] believe[s] are due to litigation concerns.” Doc. 5334-1 at 23.
Defendants state that Tillman’s challenged opinion is based on her seventeen years of
experience at the FDA’s Center for Devices and Radiological Health, including several
years as the Director of the Office of Device Evaluation. Doc. 5334 at 9. The Court finds
this experience, and Tillman’s stated reasons for her challenged opinion, sufficient to
support the opinion. 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))); 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.”).
Plaintiffs argue that Tillman should be precluded from opining on DuPont’s warning
for Delrin, a POM resin that Bard used in some of its IPCs. Doc. 4929 at 10-11. DuPont
provides this warning in its MSDS for Delrin: “Caution: Do not use this product in medical
applications involving permanent implantation in the human body.”1 Plaintiffs explain that
Tillman conceded at her deposition that she has never spoken with anyone at Bard or
1 See Dupont, Delrin, https://www.professionalplastics.com/professionalplastics/
content/downloads/Delrin500Properties.pdf (last visited Mar. 16, 2026).
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DuPont about the warning, never reviewed any documents showing communications
between Bard and DuPont discussing the intent of the warning, and never reviewed any
documents showing that Bard informed DuPont that Delrin would be used in Bard IPCs.
Doc. 4929 at 10-11. Defendants do not address this argument in their response. See Doc.
5334 at 9-10. The Court will preclude Tillman from opining on DuPont’s warnings in its
MSDS for Delrin.2
2. IPC Labeling.
Plaintiffs challenge Tillman’s opinion that the “FDA does evaluate … the accuracy
of the labeling during its review of 510(k) submissions” and “ensure[s] that required
labeling” is “accurate” and “appropriate.” Doc. 4829 at 11 (citing Doc. 4829-1 at 26, 137).
Tillman provides numerous examples of the FDA requesting labeling revisions during
510(k) review to include additional risk information. Doc. 4829-1 at 136-37. Tillman
explains that “these examples clearly illustrate that [the] FDA does evaluate risk
information and the accuracy of the labeling during its review of 510(k) submissions.” Id.
at 137. The Court will not preclude Tillman from offering this opinion.3
Without identifying any specific opinion, Plaintiffs argue that Tillman should be
precluded from opining on how the sufficiency of labeling would impact treating physician
product selection. Doc. 4829 at 11. Defendants make clear that Tillman offers no such
opinion. Doc. 5334 at 12. The Court will deny Plaintiffs’ motion as moot on this issue.
3. Complaint Rates for Bard Ports.
Plaintiffs seek to exclude opinions on the complaint rates for Bard ports. Doc. 4829
at 12. Plaintiffs do not dispute Defendants’ assertion that Tillman’s report contains no such
opinions. Doc. 5334 at 12. The Court will deny Plaintiffs’ motion as moot in this regard.
2 Contrary to Defendants’ assertion (id. at 10), Tillman’s testimony as to whether
the FDA had “concerns” about the Delrin Master File constitutes impermissible testimony
about the FDA’s state of mind. The Court will not permit such testimony.
3 According to Plaintiffs, Tillman purportedly acknowledges that the FDA’s review
of labeling is limited to evaluating a device’s intended use rather than the sufficiency of
the instructions and warnings. Doc. 4829 at 11. But Tillman merely explains that
determining the intended use of a device is the FDA’s “first step in the substantial
equivalence process” and that a 510(k) submission must include labeling “sufficient to
describe the device [and] its intended use.” Doc. 4829-1 at 9, 18.
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4. Feasibility of Safer Alternative Designs.
Plaintiffs argue that any opinions regarding the feasibility of safer alternative
designs should be excluded. Doc. 4829 at 13. Plaintiffs cite several pages of Tillman’s
report, but fail to identify the specific opinions they seek to have excluded. Id.; see Doc.
4829-1 at 107-116. A review of the portion of Tillman’s report cited by Plaintiffs shows
that her opinions relate to Bard’s 510(k) submission for its port with an antimicrobial
coating. These opinions are based on her regulatory experience at the FDA and are
supported by sufficient facts and data. See Doc. 5334 at 14. Defendants make clear that
Tillman offers no opinion on the feasibility of safer alternative designs from a technical or
engineering perspective. Id. at 14-15. The Court agrees with Defendants, however, that if
proper foundation is laid, Tillman should not be precluded from opining about the
feasibility of the FDA clearing a safer alternative device. Id. at 14; see Doc. 4829 at 13.4
5. Antimicrobial Coatings.
Plaintiffs challenge Tillman’s opinions regarding the feasibility of the FDA clearing
ports with antimicrobial coatings given the FDA’s “raising the bar” with respect to the level
of evidence needed to support antimicrobial technologies. Doc. 4829 at 13-14. Tillman
provides the following opinion in this regard:
My assessment of this series of events is that FDA cleared a small number of
CVC catheters with antimicrobial agents in the time period prior to roughly
2010. Around this time, there was an increasing concern about the issue of
antimicrobial resistance (e.g., FDA’s Draft Guidance “Premarket
Notification [510(k)] Submissions for Medical Devices that Include
Antimicrobial Agents” published on July 19, 2007), and the regulatory bar
for clearance of CVC catheters with antimicrobial agents began to be
significantly raised. This conclusion is supported by the fact that several of
the devices I described are currently being marketed based on 510(k)
clearances that occurred in the 1990s.
Doc. 4829-1 at 39. Tillman similarly opines:
4 But as explained, Tillman will not be permitted to opine on the FDA’s state of
mind.
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[B]ased on my experience at FDA and on my review of the relevant
regulatory records (discussed above), the nanotechnology concerns do not
appear to be the only basis for FDA’s NSE decision. As discussed in detail
above in the Section on Antimicrobial Agents, it was around this time that
FDA started to publicly express concerns about the issue of Antimicrobial
Resistance, and FDA was raising the bar with respect to the level of evidence
needed to support antimicrobial claims. It is my opinion that this was a
period of transition for FDA requirements for clearance of devices with
antimicrobial agents, and [that] while the Agency had determined that what
it had accepted in the past was no longer sufficient, it was still not clear what
would be needed in the future.
Id. at 115. Plaintiffs contend that Tillman simply relies on unspecified discussions with
unnamed colleagues and that her opinions lack “fit” given the temporal disparity between
the time when Bard sought clearance of antimicrobial coatings and the events Tillman
discusses in her report. Doc. 4829 at 13-14; see Doc. 4829-1 at 33-34, 36, 107.
Defendants argue that Tillman’s opinions are well supported by facts and data and
clearly fit the facts of this case. Doc. 5334 at 15-15. Defendants note that Tillman’s report
provides a comprehensive regulatory history of three types of products cleared with
antimicrobial coatings from the 1990s to today: (1) wound dressings, (2) CVC catheters,
and (3) intravascular administration sets. Id. at 15 (citing Doc. 4829-1 at 32-40). Tillman
also explains that clearances for devices with antimicrobial coatings occurred in the 1990s
and the FDA did not clear any other device with antimicrobial coatings before 2010, when
Bard received the FDA’s “Not Substantially Equivalent” determination for its port with an
antimicrobial coating. Id.
Defendants have shown, by a preponderance of the evidence, that Tillman’s
opinions about the FDA raising the bar with respect to antimicrobial technologies are based
on sufficient facts and data and a reliable methodology. See McBroom, 2021 WL 2709292,
at *5; Elosu, 26 F.4th at 1024. But as explained, Tillman may not opine on the FDA’s state
of mind, including the FDA’s “concerns” about antimicrobial technologies. See Holley v.
Gilead Scis., Inc., No. 18-CV-06972-JST, 2023 WL 2469632, at *7 (N.D. Cal. Feb. 27,
2023) (explaining that while experts can “testify about their interpretation of the meaning
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of documents in the regulatory history,” they may not opine “on the state of mind of the
FDA”); In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 466 (S.D.N.Y. 2016)
(an FDA expert can opine on what the FDA did, what it said, and what documents mean,
but cannot opine on the FDA’s thoughts or motivations).
6. Japanese Regulatory Agencies.
Plaintiffs move to preclude Tillman from opining on determinations made by
Japanese regulatory agencies. Doc. 4829 at 14-15. Defendants explain that Tillman’s
opinion is that there can be different warnings in different jurisdictions, and the fact that a
warning is required elsewhere does not mean it is required in the United States. Doc. 5334
at 17; see Doc. 4829-1 at 137. Plaintiffs do not challenge this opinion and it will not be
excluded. Doc. 5578 at 7.
Plaintiffs seek to exclude the opinions in which Tillman discusses the adverse event
reports that the Japanese regulatory agency observed for Bard’s IPCs, the additional
contraindications which it required to be placed on the IPCs sold in Japan, and her view
that it was reasonable for Bard not to issue the same warnings to doctors and patients in
the United States. Docs. 4829 at 14, 5578 at 7-8. Specifically, Plaintiffs challenge the
following opinion:
It is important to note that while there appeared to be increase in the rate of
Catheter Break at Stem in Japan, this was a regional issue that was not seen
elsewhere. The root cause analysis suggested that the failure was due to the
user “angling and/rocking the cath-loc as it is being advanced on the Ti
stem”. The IFU already included a Precaution that “The catheter must be
straight with no sign of kinking”, and the recommendation was that this be
repeated on a hang tag for the device when it is sold in Japan. It is my expert
opinion that Bard’s determination that it was not necessary to take any
additional measures regarding the devices sold in the US was consistent with
the observed facts and the relevant US medical device regulations.
Doc. 4829-1 at 106. Plaintiffs also challenge Tillman’s opinion that the warning to reduce
dwell time as instructed by the Japanese regulatory agency “was added to the labeling in
Japan due to an elevated adverse event rate that was only seen in Japan[,]” and that she has
“not seen any evidence that it was necessary for Bard to add a similar statement to the US
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labeling.” Id. at 137. Plaintiffs argue that Tillman has no experience with Japanese
regulatory agencies and she reached these opinions without sufficient facts or data and with
no reliable methodology. Docs. 4829 at 15, 5578 at 8.
This is not an opinion about Japanese regulatory agencies; it is an opinion about
what warnings should be provided in the United States, sufficiently supported by Tillman’s
years of experience at the FDA and her familiarity with U.S. medical device regulations.
Doc. 4829-1 at 106. The Court does not agree that Tillman lacks a sufficient factual basis
or methodology for these opinions. Her FDA experience provides a reliable methodology,
and she based her opinion on depositions and documents concerning the Japanese issues in
question. See id. at 105-06, 136-37. The Court will not exclude the challenged opinion.
E. Tillman’s Criticisms of Plaintiffs’ Experts.
Plaintiffs argue that while Tillman may disagree with Plaintiffs’ experts and even
criticize their qualifications and methodologies, she cannot opine that the experts are
“unqualified” or “unreliable.” Doc. 4829 at 15-17. Defendants make clear that Tillman
offers no such opinions. Doc. 5334 at 18. The Court will deny Plaintiffs’ motion as moot
in this regard.
IT IS ORDERED: Defendants’ motion to exclude opinions of Dr. Donna-Bea
Tillman (Doc. 4829) is granted in part and denied in part. The motion is granted as
follows: Tillman cannot: (1) opine that the design of Bard IPCs was safe; (2) opine that the
FDA found, through the 510(k) process, that Bard IPCs were safe and effective; (3) opine
on the FDA’s state of mind; or (4) opine on DuPont’s warning in its MSDS for Delrin.
Dated this 18th day of March, 2026.
Case 2:23-md-03081-DGC Document 7591 Filed 03/18/26 Page 13 of 13