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 Michael G. Beatrice
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 Michael G. Beatrice,
Ph.D. Doc. 4826. The motion is fully briefed and no party requests oral argument. See
Docs. 5320, 5550. 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. 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
the IPC was defective and caused serious injury. Plaintiffs allege that the barium sulfate
in the IPC degrades the mechanical integrity of the catheter, leading to surface irregularities
that cause catheter fracture, infection, and blood clots. Plaintiffs further allege that Bard’s
manufacturing process for the POM-containing IPCs lacks adequate measures to stabilize
the POM to prevent oxidative degradation, which causes cracks, fissures, and other
physical defects in the polymer and increases the risk of fracture, infection, and thrombosis.
Plaintiffs also allege that the palpation bumps on the power-injectable IPCs cause undue
compression stress on the tissue surrounding the port, leading to ulceration and tissue
necrosis. See Docs. 23, 1889.
Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
options. Plaintiffs assert a host of state law claims, including design and manufacturing
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defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See id.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. Bard further contends
that various factors impact the performance and wear of IPCs, including where the catheter
is inserted and how well the device is maintained by medical professionals and the patient.
See Docs. 23, 2023-1.
The parties plan to use various expert witnesses at trial, including FDA experts. 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,
typically referred to as a “predicate” device. 21 U.S.C. § 360c(f)(1)(A).
Because the FDA regulatory process for medical devices is complex and 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). Plaintiffs have identified Dr.
Beatrice as an FDA expert. Beatrice has prepared a 57-page report which discusses the
FDA’s regulation of medical devices and standards for device labeling (Doc. 4826-1 at
5-15); the regulatory history of implantable vascular devices, including Bard IPCs (id. at
16-18); and the effect of the FDA’s clearance of Bard IPCs under 510(k) review instead of
the PMA process (id. at 22-27). Beatrice provides various opinions throughout the report,
which he summarizes at pages 54 through 57. He opines that: (1) Bard made the decision
not to seek a safety and effectiveness determination for its IPCs through the PMA process
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and instead elected 510(k) clearance (id. at 11; 54 ¶¶ 227-28); (2) Bard did not report all
IPC complaints to the FDA (id. at 18-22; 54 ¶ 229); (3) Bard did not recall its IPCs after
receiving reports of complications (id. at 18; 54 ¶ 230); (4) certain adverse events Bard
reported through the FDA’s Alternative Summary Reporting (“ASR”) program should
have been submitted as individual Medical Device Reports (“MDRs”) (id. at 19; 54 ¶ 231);
(5) Bard failed to report “unconfirmed” and “inconclusive” complaints to the FDA,
resulting in low complaint rates (id. at 20-22; 54 ¶¶ 232-33); (6) Bard failed to warn about
risks associated with its IPCs (id. at 27-37; 54-56 ¶¶ 234-35); (7) Bard failed to comply
with FDA design control regulations and industry standards meant to prevent material
degradation (id. at 37-48; 56 ¶¶ 236-38); and (8) Bard failed to follow up on known defects
in its IPCs (id. at 48-53; 57 ¶¶ 239-41). Defendants argue that many of these opinions are
inadmissible under Federal Rule of Evidence 702. Doc. 4826.
II. Legal Standard.
Rule 702 provides that “[a] witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify in the form of an opinion” if the
proponent of the expert’s testimony “demonstrates to the court that it is more likely than
not that” (a) “the expert’s scientific, technical, or other specialized knowledge will help the
trier of fact to understand the evidence or to determine a fact in issue,” (b) “the testimony
is based on sufficient facts or data,” (c) “the testimony is the product of reliable principles
and methods,” and (d) “the expert’s opinion reflects a reliable application of the principles
and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent must show
by a preponderance of the evidence that the testimony satisfies each of these requirements.
Fed. R. Evid. 104(a); Fed. R. Evid. 702 advisory committee’s note to 2023 amendment
(“[T]he rule has been amended to clarify and emphasize that expert testimony may not be
admitted unless the proponent demonstrates to the court that it is more likely than not that
the proffered testimony meets the admissibility requirements set forth in the rule.”); Engilis
v. Monsanto Co., 151 F.4th 1040, 1050 (9th Cir. 2025) (“Consistent with the 2023
amendment, our precedent establishes that Rule 702 requires a proponent of expert
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testimony to demonstrate each of the requirements of Rule 702 by a preponderance of the
evidence.”).
The Court acts as a gatekeeper to ensure that expert testimony satisfies 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.
Defendants argue that several of Beatrice’s specific opinions are inadmissible.
Their specific arguments will be addressed in the sections that follow.1
A. Failure-to-Follow-Up Opinions.
Defendants move to exclude Beatrice’s opinions that Bard failed to follow up on
known defects in its IPCs. Doc. 4826 at 3-6 (citing Doc. 4826-1 ¶¶ 210-11, 220-22, 226,
236, 241-42; Doc. 4826-2 at 65-66). Defendants argue that these opinions are based on
insufficient facts and are unreliable because Beatrice “did not review all of Bard’s internal
assessments and investigation reports that it prepared about those issues.” Id. at 4.
Plaintiffs explain that Beatrice reviewed many Bard documents, including product
performance data, clinical evaluation reports, and failure investigation reports. Doc. 5320
at 7 (citing Doc. 5320-1 at 17-19). The portions of his report describing Bard’s internal
review and evaluation process encompass some 40 paragraphs and cite many Bard
documents. See Doc. 4826-1 at 44-51. Beatrice also relies on the testimony of several
1 The opening page of Defendants’ motion seems to argue that Beatrice is not
qualified to render his opinions (Doc. 4826 at 2), but Defendants do not ask the Court to
exclude his opinions on this basis (id.) and their reply brief faults Plaintiffs for spending
time addressing his qualifications (Doc. 5550 at 2 n.1). The Court accordingly will address
only Defendants’ opinion-specific requests for exclusion.
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Bard employees in forming his opinion that Bard did not follow up on design issues
identified in their product performance analysis. Id. (deposition citations in footnotes).
And he cited medical literature regarding failure rates of IPCs, including Bard IPCs. Id. at
27-29, 32-33, 35. The Court finds, by a preponderance of the evidence, that Beatrice’s
failure-to-follow-up opinions are based on sufficient facts and data.
Defendants identify various categories of documents Beatrice did not review and
argue that his failure to review them makes his opinions unreliable and inadmissible.
Doc. 5550 at 4-5. Plaintiffs disagree that the documents identified by Bard are essential,
and rely instead on other documents. The Court’s task is not to determine who is right, but
to confirm that Beatrice’s opinions, by a preponderance of the evidence, are based on
sufficient facts and data. The Court concludes this requirement is satisfied. “[T]here is no
legal requirement that experts review every document produced in litigation.” In re Takata
Airbag Prods. Liab. Litig., No. 15-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); In re Bard IVC Filters
Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 11696720, at *3 (D. Ariz.
Dec. 22, 2017) (similar). Defendants of course will be free to cross-examine Beatrice at
trial about documents he did not review.
Defendants also argue that Beatrice’s failure-to-follow-up opinions are irrelevant
because he cannot say whether the results of any follow-up investigation would have
resulted in a design or labeling change. Doc. 4826 at 5. But Beatrice is not offered as an
expert on whether there were alternative designs Bard should have adopted for its IPCs,
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and he does opine that some of Bard’s labelling was insufficient. See, e.g., Doc. 4826-1 at
27-36. Relevancy is a relatively low bar. See Fed R. Evid. 401 (“any tendency” to make
a fact of consequence more or less probable). Beatrice’s opinions that Bard knew of and
failed to act on problems with its IPCs could, if accepted by the jury, be relevant to
Plaintiffs’ claims for failure to warn, fraudulent misrepresentation, fraudulent concealment,
consumer fraud, and negligence. The fact that Beatrice’s opinions may not be sufficient
by themselves to establish any of these claims does not mean they are not relevant to the
claims. The Court will deny Defendants’ motion with respect to Beatrice’s failure-to-
follow-up opinions.
B. Opinions Regarding Design Projects and Safer Alternative Designs.
Defendants argue that Beatrice has no expertise or reliable basis to opine on whether
Bard should have pursued various design projects or whether such projects were
scientifically feasible. Doc. 4826 at 6-8. Plaintiffs state in their response that Beatrice
offers no such opinions. Doc. 5320 at 9. Plaintiffs explain that Beatrice discusses Bard’s
design projects related to potential alternative designs as factual support for his opinions
that Bard had notice of product issues that triggered obligations under FDA regulations
that Bard failed to meet, including the failure to implement a design control process. Id. at
9-10 (citing Doc. 4826-1 ¶¶ 138, 140).
The Court has reviewed the paragraphs of Beatrice’s report cited by Defendants and
agrees with Plaintiffs that Beatrice offers no explicit opinion that Bard should have pursued
certain design projects or that such projects were scientifically feasible. See Doc. 4826-1
¶¶ 108-10, 112, 116-18, 120, 123-24, 127-34, 137-40, 142-44, 147-48, 234, 240. But
Beatrice implies as much by describing product deficiencies, describing Bard redesign
projects related to those deficiencies, and then stating that Bard never released safer
alternative designs. See id. ¶ 110 (“No Generation 2 braided or reinforced catheter was
ever released by Bard.”); ¶¶ 112, 234(c) (“No Groshong 2.0 was ever released.”); ¶¶ 117,
123 (“Bard . . . has never released a safer, more fracture resistant design.”); ¶ 134 (“Bard
at no time finished development and never marketed a port catheter product intended to be
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anti-microbial or anti-bacterial.”); ¶ 137 (“Bard also never launched an antibacterial or
antimicrobial port catheter product.”); ¶ 139 (“Bard . . . has never released a safer design
such as an antimicrobial coated catheter.”); ¶ 142 (“Despite knowledge of the risk
associated with thrombosis and significant development work on a safer alternative, Bard
eventually canceled the project and never released a port catheter with a thrombosis
resistant coating.”).
The Court will permit Beatrice to discuss Bard’s design projects as factual support
for his opinions that Bard had notice of product issues that triggered obligations under FDA
regulations, but the phrasing of this testimony will be important. Beatrice lacks expertise
to opine on whether any particular alternative design was feasible and should have been
pursued, and he will not be permitted to imply that opinion in his testimony. The Court
will hold Plaintiffs to their word that Beatrice will not opine that Bard should have pursued
various design projects or that such projects were scientifically feasible. If Defendants
believe the questioning of Beatrice is crossing that line, they may object.2
C. Opinions Regarding Bard’s Failure to Report Certain Complaints.
Beatrice opines that Bard failed to report unconfirmed and inconclusive complaints
to the FDA, resulting in low complaint rates. Doc. 4826-1 ¶¶ 76-78, 81-84, 96-98, 232-33.
Bard argues that this opinion is not based on sufficient facts and is not the product of a
reliable methodology. Doc. 4826 at 8-13.
Beatrice’s opinion is based solely on deposition testimony of former Bard employee
Shelly Gilbert. Beatrice states: “According to Shelley Gilbert, who worked for Bard and
BD in various roles in quality systems and field assurance, complaints are considered
‘unconfirmed’ if Bard is unable to verify the information and ‘inconclusive’ if a sample of
the product was not received or was considered compromised.” Doc. 4826-1 ¶ 77 (citing
Gilbert Depo. Tr. at 50:21-51:12; (Doc. 4826-5 at 11)). Beatrice then opines that “Bard
2 Defendants note in their reply that Beatrice testified that a pinch-proof catheter
should have been pursued and was feasible from an engineering standpoint. Doc. 5550
at 6 (citing Doc. 4826-2 at 42-44). The Court will not permit Beatrice to offer this opinion
at trial.
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does not consider a complaint reportable unless, by their definitions and determinations, it
has been confirmed.” Id. ¶ 78 (citing Gilbert Depo. Tr. at 100:9-11 (Doc. 4826-5 at 22)).
Defendants contend that Beatrice misconstrues Gilbert’s testimony and that the testimony
provides no factual basis for this opinion. Doc. 4826 at 8-12. The Court agrees.
At her deposition, Gilbert was shown a product complaint summary containing rate
calculations for certain complaint types. Doc. 4826-5 at 19-22; see Doc. 4826-6. She
testified that she had never seen the document or any other product complaint summary
and had no understanding of how rate calculations were made. Doc. 4826-5 at 20-22. She
agreed, however, that the document appeared to contain only confirmed complaints:
Q. And so this appears to only include the confirmed complaints; is that
correct?
A. Yes.
Id. at 22. This testimony is the only evidence Beatrice cites to support his opinion that
“Bard does not consider a complaint reportable unless, by their definitions and
determinations, it has been confirmed.” Doc. 4826-1 ¶ 78 & n.26; ¶¶ 97-98. But the
document about which Gilbert was testifying did not concern reports to the FDA. It was
an internal Bard email containing a product complaint summary which included confirmed
complaint types. Doc. 4826-6 (Ex. 14 to Gilbert Deposition). Gilbert had never seen the
document before (Doc. 4826-5 at 20), did not know if it was part of Bard’s tracking and
trending of product complaints (id.), and did not know how the document’s calculations
were made (id. at 22).
And in particular, Gilbert did not say that Bard reported only internally-confirmed
complaints. To the contrary, she testified that even where a complaint is unconfirmed or
inconclusive, “we always will send the FDA the initial report.” Doc. 4826-5 at 25; see id.
at 29 (even if the complaint is inconclusive “we still have reported the complaint”). She
also explained that it is the type of event that determines reportability, not whether the
complaint has been confirmed. Id. at 12-13 (“The event is how they determine the
reportability. . . . So confirmed or not is not how they determine reportability. . . . And
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same with inconclusive.”).3 Gilbert also testified that just because a complaint was
unconfirmed or inconclusive does not mean it was not included in the complaint rate
calculations. Id. at 30. What is more, Beatrice agreed that the email about which Gilbert
testified does not indicate whether the complaints it identified “were reported or not
reported.” Doc. 4826-2 at 78. Gilbert’s testimony provides no sufficient basis for
Beatrice’s opinion that Bard failed to report unconfirmed and inconclusive complaints.
Plaintiffs assert that Beatrice cited instances where Gilbert identified complaints
that were not reported. Doc. 5320 at 11 (citing Doc. 4826-1 ¶ 100). But the cited paragraph
from Beatrice’s report addresses whether certain inconclusive complaints would “be
counted in the complaint rates Bard calculated,” not whether they would be reported to
FDA. See Doc. 4826-1 ¶ 100 (citing Gilbert Depo. Tr. at 170-85).4
Plaintiffs have not shown by a preponderance of the evidence that sufficient facts
or data support Beatrice’s opinion that Bard chose not to report unconfirmed and
inconclusive complaints to the FDA. This opinion will be excluded.
D. Madris Kinard’s Opinions and Data.
Defendants argue that Beatrice parrots and vouches for certain opinions stated by
Madris Kinard, another of Plaintiffs’ FDA experts, including the opinion that certain
adverse events Bard reported through the FDA’s ASR program should have been submitted
as individual MDRs. Doc. 4826 at 13-14 (citing Doc. 4826-1 ¶¶ 67-73 (recounting and
adopting Kinard’s findings), ¶ 231 (repeating Kinard’s findings); see also Doc. 4826-3 at-3
(“The adverse event data compiled by Madris Kinard and Device Events is yet another
example of how Bard failed in its responsibilities to adequately protect the safety of
patients[.]”)).
3 This is consistent the FDA regulations requiring manufacturers to report a device-
related “event” that may have caused or contributed to a death or serious injury. 21 C.F.R.
§§ 803.3(o)(2), 803.50(a)
4 Plaintiffs do not provide the deposition transcript Beatrice cites in paragraph 100.
In the portions of the transcript Defendants provide, Gilbert stated that it was “not correct”
that complaints are not included in the complaint rate unless confirmed. Doc. 4826-5 at 30
(Gilbert Depo. Tr. at 185).
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Beatrice vouches for the reliability of Kinard’s findings, stating that “I have
reviewed the methodology used by Madris Kinard to pull this dataset from Device Events,
as well as information about the construction of the Device Events database itself, and
believe this data to be equivalent to what I would have gathered from MAUDE and ASR
if I had been the one to do so.” Id. ¶ 68. His only citation for this assertion is “Report of
Madris Kinard.” Id. ¶ 68 n.17. Beatrice provides no explanation of the methodology he
reviewed or the information he received about the construction of the Device Events
database, and does not explain why the methodology and construction led him to conclude
that Kinard’s results were a reliable reproduction of what he would have found by studying
the FDA databases himself.
Experts are required to describe the bases for their opinions. See Farmers Ins. Co.
of Ariz. v. DNS Auto Glass Shop LLC, No. CV-21-01390-PHX-DGC, 2024 WL 1256042,
at *8 (D. Ariz. Mar. 25, 2024) (“Courts are not required to guess whether an expert has
relied on sufficient facts or data. ‘Experts must explain the basis for their conclusions in a
manner that allows the Court to determine whether they are using reliable principles and
methods and are applying them to the facts of the case in a reliable manner.’”) (citation
omitted). Expert opinions cannot be provided to the jury merely on the expert’s say-so.
Id. (“[N]othing in either Daubert or the Federal Rules of Evidence requires a district court
to admit opinion evidence that is connected to existing data only by the ipse dixit of the
expert.”) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)); Tetrault v. Cap.
Grp. Companies, No. 2:23-CV-05144-WLH-JPR, 2025 WL 3154657, at *3 (C.D. Cal.
Aug. 20, 2025) (“As the Ninth Circuit has explained, courts must ‘analyze not what the
experts say, but what basis they have for saying it.’”) (citing Daubert v. Merrell Dow
Pharms., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995)). Because Beatrice provides no
information with which to understand the basis for his adoption of Kinard’s findings,
Plaintiffs have not shown that his opinion about her findings is based on sufficient facts or
data and reliable principles or methods. Beatrice’s testimony about Kinard’s findings,
including his calculations using Kinard’s numbers, will be excluded.
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Defendants assert that Beatrice cannot present a narrative review of record evidence.
Doc. 4826 at 15. Narrative testimony is appropriate in some circumstances. See In re Bard
IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 11696724, at *8
(D. Ariz. Dec. 21, 2017) (citations omitted). Defendants may object at trial if Beatrice
begins simply reciting facts instead of using relevant facts to support his expert opinions.
See id.
E. Failure-to-Warn Opinions.
Beatrice opines repeatedly that Bard did not adequately warn about particular risks.
Doc. 4826-1 ¶¶ 104-06, 117, 123, 139, 148, 152, 235, 242. Defendants argue that these
opinions are improper legal conclusions on ultimate issues. Doc. 4826 at 16. The Court
does not agree. Defendants rely on this Court’s decision in In re Bard Filters Prods. Liab.
Litig., 2017 WL 6523833, at *6 (D. Ariz. Dec. 21, 2017), which in turn relied on United
States v. Diaz, 876 F.3d 1194 (9th Cir. 2017). Diaz established this rule for determining
when an expert is offering an improper legal opinion on an ultimate issue in the case: “We
hold that if the terms used by an expert witness do not have a specialized meaning in the
law and do not represent an attempt to instruct the jury on the law, or how to apply the law
to the facts of the case, the testimony is not an impermissible legal conclusion.” Id. at
1198-99. In this case, Beatrice opines that Bard omitted various warnings from its IFUs
(Doc. 4826-1 ¶ 106) and failed “adequately” to warn about various risks (id. ¶¶ 117, 123,
139, 148, 152, 235). This language does not have a specialized meaning in the law and
does not instruct the jury on how to apply the law to the facts. It therefore does not
constitute impermissible legal conclusions on an ultimate matter to be decided by the jury.
Defendants contend that Beatrice’s opinions on the adequacy of Bard’s warnings
are based on insufficient facts and data because he relies only on IFUs for Bard IPCs sold
outside the United States. Doc. 4826 at 16. But Beatrice testified that he reviewed 510(k)
submissions – which include IFUs – for at least 10 of the 16 Bard IPCs listed in his report.
Doc. 5320-1 at 5. The Court finds this to be a sufficient factual basis for his opinions.
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Defendants further contend that Beatrice’s opinion regarding the lack of redundant
warnings in Bard IFUs lacks a reliable basis because he identifies no applicable FDA
regulation or guidance document. Doc. 4826 at 17 (citing Doc. 4826-1 ¶ 149). Beatrice
testified in his deposition that there is an FDA regulation and guidance document
explaining that redundancy is important, but he could not identify them. Doc. 4826-2 at
33. Plaintiffs do not address this issue in their response. Doc. 5320 at 14. Beatrice and
Plaintiffs have failed to provide any basis for his opinion that Bard’s IFUs should contain
redundant warnings. This opinion will be excluded.
Defendants assert there is no basis for Beatrice’s opinion that the dwell-time
warning in the Japanese IFU should have been included in Bard’s U.S. IFU. Doc. 4826 at
17-18 (citing Doc. 4826-1 ¶¶ 104-06). But Beatrice explains that Bard knew that increased
dwell time correlates with increasing rates of the IPC complications, as evidenced by its
Japanese IFU (Doc. 4826-1 ¶ 105), and that he saw no research indicating that the dwell-
time problem occurred only in Japan (Doc. 4826-1 at 37). Bard’s warning in Japan
suggests Bard knew of a dwell-time risk and provides a sufficient basis for Beatrice’s
opinion that the warning should have been provided elsewhere.
The Court will exclude Beatrice’s redundancy opinion and deny Defendants’
motion with respect to Beatrice’s other opinions on the adequacy of Bard’s warnings.
F. Bard Made the Determination Not to Seek PMA for Its IPCs.
Beatrice states in his report that Bard “made the determination not to seek a
determination of safety and effectiveness for their devices (the PMA approval pathway)”
and instead “elected to pursue clearance via the 510(k) route.” Doc. 4826-1 ¶¶ 40, 227.
Defendants argue that this opinion is irrelevant and will not assist the jury. Doc. 4826
at 18. The Court agrees.
Beatrice does not claim that Bard violated FDA regulations by seeking 510(k)
clearance instead of PMA review. In fact, he testified that Bard’s decision was lawful and
appropriate. Doc. 4826-2 at 28. He further testified there are several reasons a company
might prefer the PMA route, including competitive advantages, liability protection, ease of
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obtaining approval in other countries, and avoiding the risk that 510(k) clearance may be
denied. Id. at 81-83.
Given that Bard’s 510(k) submission was lawful and appropriate and Beatrice’s
reasons for a corporation’s possibly preferring PMA review are not related to issues in this
case, Plaintiffs have not shown the relevancy of his testimony that Bard elected not to seek
PMA review. Such testimony will not help the jury decide any fact in issue and is therefore
inadmissible under Rule 702(a).
G. Opinions that Bard Relied on Improper Predicate Devices.
Beatrice opines that Bard relied on an improper predicate device in 510(k)
submissions for two of its IPCs. Docs. 4826-1 ¶¶ 61-62, 4826-2 at 96-103. Defendants
argue that these opinions are irrelevant and have no factual basis because Bard identified
multiple predicate devices in its 510(k) submissions and Beatrice has identified no
evidence the FDA found them improper. Doc. 4826 at-18.
In his rebuttal report, Beatrice notes that defense expert Tillman identified
additional predicate devices listed in the 510(k) submissions for the two IPCs mentioned
in Beatrice’s original report. Doc. 4826-3 at 4. But Beatrice does not address these
predicates or explain why they were inappropriate. Doc. 4826 at 17-18. His rebuttal report
declined to address them, saying simply that they were “were not an underlying basis of
any of my opinions[.]” Id.
Plaintiffs never explain why it is relevant that Bard’s 510(k) submissions included
some predicates Beatrice found inappropriate and others he simply chose to ignore (and
which may, in fact, have been appropriate). His opinion on the inappropriateness of some,
but not all, Bard predicates will not help the jury resolve any issue in dispute. The Court
will exclude this testimony under Rule 702(a).
H. Arguments to Which Plaintiffs Did Not Respond.
Defendants argue that Beatrice’s opinions about Bard’s knowledge, motive, state of
mind, and ethics are improper. Doc. 4826 at 15-16. Plaintiffs do not address this argument
in their response. Doc. 5320. The Court will not permit Beatrice to offer such opinions.
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See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018 WL
495187, at *3 (D. Ariz. Jan. 22, 2018) (“To the extent Dr. Eisenberg ‘offers opinions on
Bard’s intent, state of mind, or motivations, this testimony is outside the bounds of
appropriate expert testimony.’”); In re Bard IVC Filters, 2017 WL 11696724, at *9
(“Neither Dr. Kessler, nor any other expert (on either side of the case), will be permitted to
opine on intent or ethics.”).
Defendants argue that Beatrice’s opinions on federal preemption and case law are
improper. Doc. 4826 at 16 n.11. Plaintiffs do not address this argument in their response.
Doc. 5230. The Court will not permit Beatrice to give the jury these legal instructions.
IT IS ORDERED:
1. Defendants’ motion to exclude opinions of Dr. Michael Beatrice (Doc. 4826)
is granted in part and denied in part.
2. The motion is granted as follows. Beatrice cannot: (1) opine on whether
Bard should have pursued various design projects or whether such projects were
scientifically feasible (but he can rely on design projects as factual support for his opinions
that Bard had notice of product issues that triggered obligations under FDA regulations);
(2) opine that Bard failed to report unconfirmed and inconclusive complaints to the FDA;
(3) testify about the findings of Madris Kinard or his own calculations based on Kinard’s
data; (4) opine that Bard improperly failed to include redundant warnings in its IFUs;
(5) opine that Bard made the determination not to seek approval of its IPCs through the
PMA process and instead elected 510(k) clearance; (6) opine that Bard relied on improper
predicate devices in 510(k) submissions; (7) opine about Bard’s knowledge, motive, state
of mind, or ethics; and (8) testify about federal preemption and case law.
Dated this 29th day of January, 2026.
David G. Campbell
Senior United States District Judge
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