IN RE: Bard Implanted Port Catheter Products Liability Litigation

1
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
IN RE: Bard Implanted Port Catheter
Products Liability Litigation
–––––––––––––––––––––––––––––––––
Robert Cook,
Individual Plaintiff,
v.
Becton Dickinson and Company, et al.,
Defendants.
MDL No. 3081
No. CV-23-01975-PHX-DGC
ORDER
The parties have filed motions in limine in preparation for the Cook bellwether trial.
This order will set forth the Court’s rulings on several of the motions. “DMIL” refers to a
motion in limine filed by Defendants, and “PMIL” to a motion filed by Plaintiff Cook.
DMIL 1 — FDA Warning Letter.
Defendants ask the Court to exclude evidence of a warning letter issued by the FDA
on July 13, 2015, with respect to Defendants’ IVC filters. Doc. 7520. Defendants argue
the letter has no application to the port catheter business at issue in this case and is
inadmissible under Federal Rules of Evidence 401, 402, 403, and 404 as irrelevant, unfairly
prejudicial, and improper propensity evidence. Id. at 2. Plaintiff argues that topic 3 of the
letter, concerning Bard’s complaint handling and reporting of adverse events with respect
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 1 of 19

2
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
to the G2 and Eclipse filters, and the adequacy of Bard’s evaluation of the root cause of
filter failures, is relevant to Bard’s internal procedures and not specific to a particular
product line. Doc. 7744 at 2-3. Plaintiff does not oppose exclusion of topics 1-2 and 4-8
of the letter. Id. at 2 n.1. With respect to topic 3, Plaintiff states he “will not rely on the
Warning Letter affirmatively” during trial, but argues topic 3 will become relevant for
impeachment or rebuttal if Defendants present complaint data to the jury, argue they have
always been in full regulatory compliance, or argue they have not been subject to FDA
enforcement actions. Id. at 4.
The Court grants Defendants’ motion (Doc. 7520) with respect to topics 1-2 and 4-
8 of the FDA warning letter. The Court will be better equipped to address the relevancy
of topic 3 at trial when it better understands the nature of the parties’ arguments and the
evidence they are presenting. If Plaintiff believes topic 3 becomes relevant during the
course of the trial, he should raise that issue with the Court outside the hearing of the jury
and when there is time for the Court to consider the issue without keeping the jury waiting.
DMIL 2 — Past Criminal Conviction.
Defendants move to exclude evidence of a 1994 criminal conviction of C.R. Bard,
Inc. Doc. 7521. Defendants argue the conviction is inadmissible under Rules 402, 403,
404, and 609 “because (a) the evidence is improper to impeach potential witnesses in this
case, (b) the evidence is not admissible as character evidence, and (c) the evidence has no
relevance to any disputed issue in this case.” Id. at 2. Defendants argue the conviction
was based on conduct that occurred in the late 1980s involving an angioplasty catheter sold
by the former USCI Division of C. R. Bard that was sold in 1998. Id. at 2 & n.4.
Defendants further argue that none of the employees involved in the conviction will be
witnesses at trial or are currently employed by Defendants. Id. at 2.
Plaintiff argues that the conviction is admissible to rebut Defendants’ reliance on
the FDA’s 510(k) clearance of their IPCs and assertions by several defense experts that
Defendants complied fully with FDA requirements. Doc. 7745 at 2-3. Plaintiff argues that
the conviction occurred while Defendants were obtaining clearance of an IPC that will be
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 2 of 19

3
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
addressed in this case and that was used as a predicate for later IPCs. Id. at 3-4. He seeks
to introduce the conviction to rebut Defendants’ heavy reliance on FDA regulations and
FDA clearance of products in this case. Id. at 2-4.
The Court cannot resolve this issue on the current pretrial record. On one hand,
introduction of the conviction could be highly prejudicial to Defendants, and unfairly so if
it is not closely related to evidence and issues in the case. Fed. R. Evid. 403. Depending
on how it is used, it could also constitute improper propensity evidence under Rule 404(b)
or improper impeachment under Rule 609. On the other hand, the 1994 conviction —
which in part concerned Bard’s deliberate disregard of FDA requirements and its knowing
and willful failure to comply with FDA disclosure rules — could be relevant if Defendants
rely heavily before the jury on their past compliance with FDA requirements and suggest
to the jury that they have always been exemplary and forthcoming in their dealings with
federal regulators. The issue is also factually complex, with Plaintiff submitting more than
70 pages of court records from 1994. Docs. 7745-7, 7745-8, 7745-9.
This issue must be resolved at trial, when the Court has a better understanding of
the parties’ evidence and arguments. The Court therefore will deny Defendants’ motion
(Doc. 7521). Because of the risk of unfair prejudice, however, Plaintiff should not mention
the conviction before the jury without first raising the issue with the Court, and far enough
in advance for the Court to address the issue with both parties and review relevant
documents without keeping the jurors waiting. Plaintiff’s request for oral argument is
denied.
DMIL 3 — Confidential Documents.
Defendants ask the Court to preclude Plaintiff from mentioning Defendants’
designation of documents as confidential during the discovery process. Doc. 7522 at 2.
Plaintiff agrees he should not comment during trial on such designations, but argues he
should not be precluded from mentioning Defendants’ assertion of confidentiality before
this litigation, such as in internal corporate documents. Doc. 7746 at 2. This is a matter
that should have been worked out between the parties; this motion is unnecessary. The
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 3 of 19

4
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
Court understands the motion to be focused on Defendants’ designation of documents as
confidential during discovery, and it will grant the motion (Doc. 7522) with respect to
such designations. Such designations should not be mentioned or become an issue before
the jury. That is the extent of the Court’s order.
DMIL 4 — Other Claims and Lawsuits.
Defendants ask the Court to exclude as irrelevant evidence of other claims or
lawsuits involving Defendants and their products, including other cases in this MDL. Doc.
7523 at 2. They also argue such evidence is inadmissible hearsay and that any probative
value is substantially outweighed by the risk of unfair prejudice. Id. Plaintiff opposes the
motion unless a host of limitations are imposed, many of them going beyond the scope of
Defendants’ motion. Doc. 7747 at 2-4. These issues should have been worked out between
counsel; this motion is unnecessary. Defendants’ motion (Doc. 7523) is granted. Plaintiff
should not mention other claims or cases against Defendants, including in this MDL. This
limitation does not prevent Plaintiff from cross-examining Defendants’ experts regarding
other work they have done for Defendants.
DMIL 5 — Sloan Kettering Email.
Defendants seek to exclude an email dated January 30, 2008, sent by Dr. George I.
Getrajdman, a radiologist at Memorial Sloan Kettering Hospital, to Kelly Powers, a Bard
employee. Doc. 7524 at 2. The email states that “[a]ll my doctors have come to love
silicone as much as I do. They hate the PowerPort because of the polyurethane.” Doc.
7524-1. It further states “I want to again encourage you to coat inside and outside of
catheters . . . . These are things that your competitors will use against you.” Id. Defendants
argue that these statements are hearsay and are not admissible as a business record or for
purposes of notice, and in fact are inadmissible expert opinions. Doc. 7524 at 3-4.
Plaintiff argues the email is admissible as an adoptive admission under Rule
801(d)(2)(B) because it was forwarded by a Bard employee to others within Bard (Docs.
7752-1, 7752-2), and is also admissible for purposes of notice, including on punitive
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 4 of 19

5
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
damages (Doc. 7752 at 2-4). They also argue it is not an inadmissible expert opinion. Id.
at 4.
The parties should be prepared to address this issue at the final pretrial conference.
The Court notes a few specific issues to be addressed by the parties.
• Rule 801(d) concerns hearsay “statements,” not entire documents. The emails
forwarding Dr. Getrajdman’s email within Bard all seem to focus on the
statement that doctors at his facility love the silicone product. The forwarding
emails appear to congratulate a Bard employee on her completion of the silicone
project. Docs. 7752-1, 7752-2. The emails do not mention or appear to respond
to either the statement that doctors hate the polyurethane PowerPort or the
statement encouraging development of a coated product. Rule 801(d)(2)(B)
requires adoption of the hearsay statement, and the internal Bard emails do not
appear to manifest adoption of either of these statements.
• Plaintiff argues that the commencement of a coating project 11 months after the
Getrajdman email also manifests adoption (Doc. 7752 at 3), but nothing in the
later documents provided by Plaintiff connect the project to the Getrajdman
email (Doc. 7752-4).
• It appears Plaintiff seeks to use the email to show the jury that doctors at Sloan
Kettering held the opinion that coating catheters inside and out would reduce
infections. This is an issue addressed in expert testimony in this case. If the
email were admitted for this purpose, the non-testifying doctors would in effect
be acting as experts on a disputed issue. Plaintiff cites Worsham v. A.H. Robins
Co., 734 F.2d 676, 686-87 (11th Cir. 1984), where evidence was admitted solely
for notice and the court specifically instructed the jury that out-of-court
statements of doctors were not to be taken as true. Doc. 7752 at 4. It appears
Plaintiff’s response to Defendants’ expert-witness objection rests on Plaintiff’s
argument that the email is admissible for notice. Plaintiff should confirm with
the Court if this is correct.
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 5 of 19

6
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
• Defendants argue that notice is not required by Minnesota law and the email
therefore is not admissible for notice. Doc. 7524 at 3-4. Plaintiff does not
address this argument.
• Defendants should be prepared to address Plaintiff’s argument that the email is
relevant for notice on the punitive damages issue (Doc. 7752 at 4).
DMIL 6 — Dow and DuPont Medical Caution Statements.
This is another matter the parties should have resolved through reasonable
discussion. Defendants move to exclude Dow and DuPont’s medical caution statements in
various documents (Docs. 7526-1 through 7526-6). Doc. 7526. They note neither
company’s materials are used in the IPC primarily at issue in this case. Id. at 3. They
accuse Plaintiff of reneging on an agreement regarding deposition designations. Id.
Plaintiff argues at length about ambiguous communications between the parties. Doc. 7755
at 2-4. Because the IPC at issue in this case does not include the Dow or DuPont materials
related to the caution statements, the statements are irrelevant to this case and Defendants’
motion (Doc. 7526) is granted. The parties shall not mention the Dow or DuPont caution
statements during trial.
DMIL 7 — IPCs Not Available in the United States.
Defendants ask the Court to exclude evidence regarding proposed IPC designs that
were not available in the United States at the time of Plaintiff’s implant. Doc. 7533 at 2.
The Court has already ruled that an alternative design’s availability in the U.S. is not a
requirement of Minnesota product liability law. Doc. 7345 at 11. The Court has also
rejected Defendants’ argument that an alternative design must exist in product form to be
feasible. Id. at 12. Defendants say they filed this motion to preserve the issue for appeal.
Doc. 7533 at 2 n.1. It is denied for reasons previously stated by the Court.
Defendants also argue the evidence should be excluded under Rule 403 because it
would require extensive and confusing evidence at trial on whether the FDA would have
cleared the foreign products for use in the U.S., a showing needed for Plaintiff to prove the
alternative designs were feasible. Id. at 4. The Court is not persuaded. The three-week
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 6 of 19

7
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
trial will provide ample time to present this and other relevant issues, and the Court is
confident the parties can present their positions in a way that does not confuse the jury.
Defendants’ motion (Doc. 7533) is denied.
DMIL 8 — Japan Instruction for Use.
Defendants ask the Court to exclude evidence or testimony regarding the
Instructions for Use for Bard IPCs marketed in Japan (“Japan IFU”). Doc. 7534 at 2.
Defendants argue the impetus for the Japanese government’s directive on IPC warnings
was catheter breakage, an alleged defect not at issue in Plaintiff’s case. Id. This assertion
is supported by the Japanese directive, which focuses on breakage. Doc. 7534-1.
Defendants primarily argue the Japanese directive and Japan IFU are not relevant in this
infection case. Doc. 7534 at 2.
Plaintiff argues that Defendants’ Japan IFU also contains a warning about infection
and includes a copy (Doc. 7757 at 2), but he never argues that Defendants’ U.S. IFU does
not contain a warning about infection (see id.). Unless the U.S. IFU lacks such a warning,
it is not clear why the Japan IFU infection warning is relevant. Plaintiff should be prepared
to address this issue at the final pretrial conference.
Plaintiff argues that “[t]he Japanese IFU also instructs that when a port ‘is no longer
necessary, from a medical point,’ then ‘the port and catheter should preferably be
removed.’” Id. at 3 (citation omitted). But this warning is clearly tied to catheter breakage.
The preceding sentence says: “The long-term placement of the port and catheter may lead
to the catheter breakage and its migration to areas such as heart.” Doc. 7757-1 at 3. The
length-of-time warning is not addressed to the issue in this case — infection.
Nor is the Court persuaded, as Plaintiff suggests, that the Japanese instruction is
relevant to rebut Defendants’ criticism of the Iida and Suzuki studies. Doc. 7757 at 3.
In summary, the Court is inclined to grant Defendants’ motion (Doc. 7534) unless
the Japan IFU includes an infection warning not present in Defendants’ U.S. IFU. The
parties should be prepared to address this at the final pretrial conference.
/ / /
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 7 of 19

8
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
DMIL 9 — IPC Monopoly.
Defendants ask the Court to exclude evidence or argument that Defendants’ share
of the market for IPCs and related devices constitutes a “monopoly,” as well as derivative
terms such as “virtual monopoly” or “monopolistic practices.” Doc. 7535 at 2. Defendants
primarily argue that such terms are irrelevant as there is no antitrust claim in this case,
would require irrelevant trial evidence about the extent of Defendants’ market share, and
would be unduly prejudicial. Id.
Plaintiff argues that Defendants’ market share (alleged to be 75%) and profitability
are relevant to an important argument in their case — that Defendants had the financial
ability to innovate, but lacked the incentive because of their dominant market share. Doc.
7758 at 2-3. But even if these facts are relevant as Plaintiff argues, he does not explain
why he needs to characterize Defendants’ market position as a monopoly, a word with a
specific legal meaning and pejorative understanding.
Plaintiff argues that Bard employees used similar phrases internally. Id. at 3. The
question, however, is not what wording employees used internally, but what wording in
the courtroom will accurately portray the evidence without prejudicing the jury.
The Court will grant Defendants’ motion (Doc. 7535). Plaintiff has ample ways to
accurately portray Defendants’ market share, which is relevant for the reason stated above,
without using a pejorative term like monopoly. The marginal relevancy of this specific
word (and its derivations) is substantially outweighed by the risk of unfair prejudice. Fed.
R. Evid. 403.
PMIL 10 — Law Firm Employment.
Plaintiff moves to exclude any argument that his wife, Ann Potter, is employed by
one of the Plaintiff law firms. Doc. 7531. He argues this evidence is irrelevant and
prejudicial. Id. at 2-4.
Defendants argue Ms. Potter’s employment goes directly to her credibility. Doc.
7754 at 2. She is a witness because she and a friend de-accessed Plaintiff’s port, a process
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 8 of 19

9
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
Defendants blame for Plaintiff’s infection. Defendants also contend her employment is
relevant to bias. Id. at 2-4.
The Court does not find Defendants’ arguments persuasive. Even if her
employment at the law firm is somewhat relevant, its probative value is substantially
outweighed by the risk of unfair prejudice, such as the jury concluding Plaintiff’s case lacks
merit because it was brought by his wife’s law firm. Fed. R. Evid. 403. Plaintiff’s motion
(Doc. 7531) is granted. Plaintiff’s request for oral argument is denied.
PMIL 9 — Medical History Matters.
Plaintiff moves to exclude evidence and argument regarding specific matters in his
medical history: (1) his unrelated medical conditions and surgeries; (2) his and his wife’s
alcohol, tobacco, and drug use; and (3) his mental-health conditions absent clinical
diagnoses. Doc. 7530. Plaintiff argues these matters are irrelevant to any issue in this case,
and their introduction would be unfairly prejudicial and distracting. Id. at 2-4. Defendants
contend these medical issues are relevant to Plaintiff’s damages claim, and in some degree
to his and his wife’s credibility. Doc. 7753.
After reviewing the parties’ briefing and each of the attachments to Defendants’
response, the Court reaches the following conclusions.
• Plaintiff’s diagnoses for hyperlipidemia, undescended testicle, sinusitis and
allergies, and his vasectomy, are irrelevant to the claims in this case, including
the damages claims, and will be excluded.
• Plaintiff testified that he used marijuana, CBD oil, and cannabis edibles to help
with sleep in 2020 and 2022. Doc. 7753-3 at 7. This was due to anxiety he was
experiencing due to his cancer. Id. The fact that Plaintiff was dealing with sleep-
interrupting anxiety at a time close to his port infection is relevant to his claim
for emotional distress damages. Defendants will be allowed to ask Plaintiff to
confirm he used sleep aids to deal with cancer-related anxiety in 2020 and 2022,
but there is no need for them to elicit evidence that the sleep aids were marijuana,
CBD oil, and cannabis edibles. The potential for unfair prejudice from those
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 9 of 19

10
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
facts substantially outweighs any marginal relevance in the specific method of
sleep aid Plaintiff used. Fed. R. Evid. 403. Those facts are excluded.
• The fact that Plaintiff’s wife used alcohol, marijuana, and cannabis edibles may
be slightly relevant to her credibility as a witness in this case, but the potential
for unfair prejudice from those facts substantially outweighs any slight
relevance. Id. This evidence will be excluded under Rule 403.
• Plaintiff’s testimony regarding his anxiety and depression, and Dr. Thomas’s
testimony regarding her diagnosis of Plaintiff with adjustment disorder, are
relevant to his claim of emotional distress damages and will not be excluded.
Plaintiff’s motion (Doc. 7530) is granted as set forth above, and otherwise denied.
PMIL 8 — Replacement Bard Port.
Plaintiff asks the Court to exclude evidence and argument regarding the fact that
Plaintiff’s post-infection replacement port was a Bard port and did not become infected.
Doc. 7528. Plaintiff argues the facts that the port was made by Bard and did not get infected
are irrelevant because they do not make it more or less likely that his infection was caused
by the previous Bard port. Id. at 2.
Defendants identify several other ways the replacement port is relevant. Doc. 7761.
Plaintiff should be prepared to address them at the final pretrial conference.
• Defendants argue the replacement port is relevant to Plaintiff’s failure-to-warn
claim because it shows Dr. Frimpong “(1) was aware of the information that,
according to the plaintiff-patient, a defendant drug company or medical-device
manufacturer wrongly failed to provide, and (2) would have taken the same
action even if the defendant had included that information in a warning.” Id.
at 2 (quoting Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128, 1152 (D.
Minn. 2011)). Defendants assert Dr. Frimpong’s decision to implant a Bard IPC
following the occurrence of an infection in the previous Bard port is highly
probative of the fact that Dr. Frimpong would have taken the same action even
if Dr. Frimpong had additional warnings about infections. Id.
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 10 of 19

11
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
• Defendants argue the replacement port is relevant to Plaintiff’s theory, proffered
by Drs. Camins and Jarvis, that the primary opportunity for further risk
mitigation rests in device design changes. Id. at 3. Defendants argue that the
fact the replacement IPC did not become infected after Dr. Frimpong utilized
prophylactic antibiotics shows that Bard IPCs are not unreasonably dangerous
because infection-reduction practices can further reduce the already low risk of
infection. Id.
• Defendants also contend the replacement port is relevant because Plaintiff seeks
damages related to implantation of the replacement device. Id.
The Court is not persuaded by Defendants’ argument that Dr. Frimpong’s decision
to use a Bard IPC for the replacement device, and the fact that the replacement IPC did not
cause a further infection, is relevant to the likelihood of harm and the gravity of harm
elements in the design-defect balancing test. But one data point is too thin a reed upon
which to hang such arguments. Nor does the Court believe Defendants can turn Dr.
Frimpong’s decision to use a Bard replacement device into expert evidence that a
reasonable medical provider did not consider the likelihood of harm to be too high, or the
gravity of the harm too severe, when using a Bard port. These conclusions are confirmed
by the fact that the Bard replacement port was a different model than the previous port.
See Doc. 7528 at 3.
PMIL 7 — Adverse Societal Impact of Verdict and Bard Good Acts.
Plaintiff asks the Court to exclude evidence and argument (1) suggesting that a
verdict for Plaintiff could negatively affect the cost or availability of research, medical
devices, or healthcare; adversely impact jurors or the general public; negatively affect
Defendants’ shareholders or employees; lead to terminations of Defendants’ employees;
discourage innovation; or otherwise harm the broader medical community; and (2)
referencing purported good character, activities, and conduct of Defendants and their
employees, including but not limited to charitable giving and volunteering. Doc. 7527 at 2.
Plaintiff cites argument during the punitive damages phase of an IVC bellwether trial, some
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 11 of 19

12
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
of which the Court permitted and other portions the Court corrected in a jury instruction.
Id. at 2-3.
This motion asks the Court to engage in line drawing that more properly is done
during trial. Arguments will be permitted on punitive damages that would not be permitted
on a simple liability determination, and the Court has not yet decided whether to bifurcate
punitive damages from liability. Furthermore, the extent to which Defendants will be
permitted to make arguments will depend in part on arguments made by Plaintiff. The
Court will rule on objections and provide guidance during the course of the trial.
Plaintiff’s motion (Doc. 7527) is denied.
PMIL 6 — Misleading Safety-Related Evidence.
Plaintiff asks the Court to exclude evidence and argument framed to mislead the
jury regarding safety-related evidence, including misrepresenting that (1) the FDA’s stance
on the safety of antimicrobial ports as having “rejected” the Avertex antimicrobial port,
and (2) the safety and technological functions of ports by characterizing them as “lifesaving
devices” or claiming “ports save lives.” Doc. 7525 at 2.
On the first issue, Plaintiff contends that the best evidence of the FDA’s reason for
denying Defendants’ Avertex 510(k) application is the letter sent to Defendants by the
FDA, which does not say the FDA rejected Avertex or its coating, but instead found the
proposed port not substantially equivalent to existing devices. Id. Plaintiff argues that
Defendants cannot engage in “mindreading” about the FDA’s position on Avertex, and the
the FDA does not contain a finding that Avertex was unsafe. Id. Plaintiff argues the letter
states only that the Avertex port was determined to be “not substantially equivalent” to a
specific predicate. Id.
The Court is not persuaded. The antimicrobial coating in the proposed port
contained ionic silver and Brilliant Green. Doc. 7759-2 at 4. The FDA letter stated Bard
had not shown its proposed product to be as safe and effective as legally marketed devices,
and specifically identified several issues Bard would have to address if it resubmitted a
request for clearance of the device. Id. at 2, 4. The first issue identified by the FDA was
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 12 of 19

13
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
the possibility that the proposed product could leach out ionic silver and Brilliant Green.
Id. at 4. The FDA “believe[d] severe cytotoxic and hemolytic effects” could result from
the leaching, and that the information submitted by Bard was not “sufficient to ensure
biocompatibility.” Id. Defendants are entitled to argue that these statements show the FDA
had safety concerns about the substances used to make the device antimicrobial. Plaintiff
is entitled to make counterarguments. The Court cannot agree that Defendants’ arguments
would misstate the meaning of the letter.
Plaintiff also argues that the Court should preclude Defendants from asserting at
trial that their ports are “lifesaving devices.” Doc. 7525 3-4. Plaintiff essentially makes a
jury argument as to why this is not so. Id. Defendants note that their employees will testify
that ports can save the lives of patients who cannot safely receive essential treatment
through alternative vascular access devices. Doc. 7759 at 3. They also note that one of
Plaintiff’s experts agreed ports can save lives. Id. at 3-4. The Court will not preclude
Defendants from eliciting this evidence and arguing how the jury should evaluate it.
Plaintiff’s motion (Doc. 7525) is denied.
PMIL 5 — Unrelated Litigation.
Plaintiff asks the Court to exclude evidence and argument concerning other lawsuits
or claims involving Defendants’ competitors, including a prior antitrust action between
Bard and AngioDynamics and ongoing litigation regarding AngioDynamic ports. Doc.
7516. Specifically, Plaintiff asks the Court to exclude a stipulation entered between Bard
and AngioDynamics in separate litigation, namely that there is no clinical evidence that
establishes the superiority of AngioDynamics’ BioFlo PICCs. Id. at 2-3. Among other
arguments, Plaintiff contends the stipulation is inadmissible hearsay. Id.
Defendants argue the stipulation is not hearsay because it can be admitted for a
purpose other than to prove the truth of the matter asserted. Doc. 7762 at 3. Defendants
argue the stipulation can be used to prove that an agreement existed between Bard and
AngioDynamics. Id. at 3. But this fact — that Bard and AngioDynamics at some point
entered an agreement — has no relevance in this case. The only relevance of the stipulation
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 13 of 19

14
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
is what it says: that there is no clinical evidence that establishes the superiority of
AngioDynamics’ BioFlo PICCs. This is why the stipulation would be relevant. In fact, as
Defendants note, “[a] stipulation is a contract between two parties to agree that a certain
fact is true.” Id. (emphasis added; citation omitted). The Court finds that the only plausible
use of the stipulation at trial would be to prove the truth of the matter it asserts, and
therefore rejects this argument by Defendants.
Defendants also argue the stipulation is admissible under Rule 807. Id. at 3-4. That
rule requires Defendants to show the stipulation is supported by sufficient guarantees of
trustworthiness after considering the totality of circumstances under which it was made,
and any evidence corroborating the statement. Fed. R. Evid. 807(a)(1). Defendants do not
dispute Plaintiff’s assertion of how the stipulation came into existence. In May 2017,
AngioDynamics filed suit against C.R. Bard, Inc. and Bard Access Systems, Inc. alleging
Sherman Act antitrust violations. Doc. 7516 at 2. Before trial, the parties disputed whether
evidence on alleged PICC “superiority” was relevant to the antitrust claim. Id. After the
trial court directed the parties to try to reach an agreement that might avoid unnecessary
presentation of evidence to the jury, they stipulated that there is no clinical evidence that
establishes the superiority of AngioDynamics’ BioFlo PICCs. Id.
Defendants argue that the stipulation is supported by sufficient guarantees of
trustworthiness because Bard and AngioDynamics agreed to memorialize the statement in
a judicial stipulation admitted into evidence in another trial. Doc. 7762 at 3. The Court is
not persuaded. Stipulations are entered for a variety of strategic and litigation-related
reasons, and often are not meant to establish the truth of a matter outside of the litigation.
In the case between Bard and AngioDynamics, for example, the stipulation was entered at
the encouragement of the trial judge to avoid the unnecessary presentation of evidence in
an antitrust case. Doc. 7516 at 2. Further, stipulations generally are not binding on parties
outside of litigation if they were intended to apply only to the trial. Waldorf v. Shuta, 142
F.3d 601, 616 (3rd Cir. 1998). Defendants present no evidence that AngioDynamics and
Bard intended the stipulation to apply outside of the trial and for years to come.
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 14 of 19

15
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
As noted, Rule 807 expressly directs the Court to consider whether there is any
evidence corroborating the statement in the stipulation. Fed. R. Evid. 807(a)(1).
Defendants present none in their response.
Given the totality of the circumstances, the Court cannot find that the stipulation
from the 2017 antitrust case carries sufficient guarantees of trustworthiness. Stated
differently, because the 2017 case concerned antitrust issues and the stipulation apparently
addressed a matter of disputed relevancy and was entered at the judge’s urging to shorten
the trial, the Court cannot conclude that Defendants have shown it to be trustworthy outside
the antitrust case.
Rule 807 also requires Defendants to show that the stipulation “is more probative
on the point for which it is offered than any other evidence that the proponent can obtain
through reasonable efforts.” Fed. R. Evid. 807(a)(2). As noted above, the point on which
the stipulation is offered is that there is no clinical evidence that establishes the superiority
of AngioDynamics’ BioFlo PICCs. On this requirement of Rule 807, Defendants argue
only that they “cannot offer direct evidence proving a negative; that is, proof of the absence
of clinical data.” Doc. 7762 at 3-4. But Defendants could have retained an expert to say
there is no clinical data that establishes the superiority of AngioDynamics’ BioFlo PICCs.
Defendants have retained many experts in this case and do not argue they were unable to
obtain one on this issue through reasonable efforts.
Defendants have not satisfied the requirements of Rule 807. They identify no other
hearsay exception under which the stipulation is admissible, and the Court therefore will
grant Plaintiff’s motion (Doc. 7516) with respect to the stipulation.
Plaintiff also seeks to exclude complaints in other lawsuits involving competitors’
products as purported substantive evidence in this case. Doc. 7516 at 4. Plaintiff’s
argument focuses on complaints against AngioDynamics. Id. Defendants respond that
they will not, in Plaintiff’s trial, “seek to introduce evidence of product liability claims
against AngioDynamics[.]” Doc. 7762 at 2. This issue is moot.
/ / /
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 15 of 19

16
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
PMIL 4 — Undisclosed Risk-Benefit Opinion.
Plaintiff asks the Court to exclude the opinions of Dr. Frimpong regarding the risks
and benefits of Defendants’ ports. Doc. 7515. Defendants timely disclosed Dr. Frimpong
as an expert witness under Rule 26(a)(2)(C). Doc. 7515-2 at 7-11. Plaintiff claims that
some of Frimpong’s opinions were not formed during the course of his treatment of
Plaintiff and therefore had to be disclosed in an expert report under Rule 26(a)(2)(B). Doc.
7515 at 2 (citing Goodman v. Staples The Office Superstore, LLC, 644 F.3d 817, 826 (9th
Cir. 2011)). But the specific opinion in question — that the benefits of implanting the Bard
port in Plaintiff outweighed the risks — was in fact formed during his treatment of Plaintiff.
Dr. Frimpong confirmed this in his deposition. See Doc. 7515-1 at 10-11.
Plaintiff argues the doctor did not know the materials used in the port, but Dr.
Frimpong is not offering a materials-based opinion. Doc. 7515-2 at 7-11. Plaintiff argues
that at most he formed an opinion about the benefits of the surgical procedure, not the port.
But this is not what Frimpong said in his deposition. Doc. 7515-1 at 10 (confirming he
“believed at the time that the benefits of the Bard port catheter outweigh its potential risks”
(emphasis added)).
Plaintiff argues the opinion is irrelevant because Minnesota law does not require the
jury to weigh a product’s risks against its utility or benefit in evaluating Plaintiff’s design-
defect claim. Doc. 7515 at 3-4. But Defendants note that Dr. Frimpong’s testimony is
relevant to Plaintiff’s failure-to-warn claim, which involves the learned intermediary
doctrine and looks at what Dr. Frimpong knew and considered when he implanted
Plaintiff’s ports. Doc. 7751 at 4.
Plaintiff argues that the probative value of his testimony will be outweighed by the
risk that jurors will be confused and misled into believing that he assessed the risks and
benefits of Defendants’ port design. Doc. 7515 at 4. But Defendants do not propose to use
him on the question of port design. See Doc. 7515-2 at 7-11.
Finally, Plaintiff argues that Rule 26 was violated because, at the time of Dr.
Frimpong’s deposition, Defendants had not disclosed him as an expert. Doc. 7515 at 4.
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 16 of 19

17
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
But the deadline for expert disclosures had not arrived. Plaintiff does not dispute that
Defendants provided their expert disclosures on the date required by the Court. The Court
has read Defendants’ disclosure of Dr. Frimpong as an expert, and it complies with Rule
26(a)(2)(C). Doc. 7515-2 at 7-11.
Plaintiff’s motion (Doc. 7515) is denied.
PMIL 3 — Personal Use of Ports.
Plaintiff asks the Court to exclude evidence and argument concerning personal use
of ports by witnesses, counsel, or their family members and friends. Doc. 7514. Plaintiff’s
motion is based on the Court’s ruling in In re Bard IVC Filters Products Liability
Litigation, No. CV-16-00782-PHX-DGC, 2018 WL 2095829 (D. Ariz. May 3, 2018). Id.
at 2. The Court will adopt the same ruling here:
The Court generally agrees with Plaintiff that any probative value of this
evidence is outweighed by the dangers set forth in Rule 403, at least to the
extent that a Bard witness offers gratuitous testimony that a relative received
a Bard filter implant. But such testimony may be appropriate if the line of
questioning suggests that the Bard witness viewed adverse event data only in
terms of “numbers” and “rates” rather than “people with names.”
The motion in limine is granted. Defendants shall not elicit testimony on
direct examination that Bard employees or their relatives have received Bard
filter implants. If Defendants believe such testimony becomes appropriate
during trial, they can raise that issue with the Court outside the hearing of the
jury.
Id. at *4 (citation modified). Witnesses similarly should not volunteer that a relative
received a port, and Defendants should not elicit (and witnesses should not volunteer) that
they would recommend Bard ports. Other line drawing must occur at trial. Plaintiff’s
motion (Doc. 7514) is granted as set forth above.
PMIL 2 — Particular FDA-Related Evidence.
Plaintiff asks the Court to exclude evidence and argument that would misrepresent
the FDA’s role and related federal and state laws. Doc. 7513. Plaintiff apparently failed
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 17 of 19

18
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
to consult with Defendants before filing this motion as required by the Court’s local rule.
Doc. 7749 at 2. Doing so could have saved time and effort.
Plaintiff asks the Court to exclude evidence or argument that FDA consent was
required for warnings or recalls. Doc. 7513 at 2. Defendants state in response that they
“do not intend to argue or elicit evidence to suggest that FDA approval was needed to
change IPC warning labels, send warning letters to physicians, or initiate a voluntary
recall.” Doc. 7749 at 2. This issue is moot.
Plaintiff asks the Court to exclude evidence or argument that other catheters cannot
serve as predicates for ports. Doc. 7513 at 2. Defendants respond that they do not dispute
that a different kind of CVC could serve as a predicate for an implantable port. Doc. 7749
at 2. To this extent, Plaintiff’s motion is moot.
Defendants do not concede, however, that a different kind of CVC could serve as
the sole or primary predicate for a port. Id. They cite one of their experts as supporting
this position. Id. Because Defendants have expert testimony in support of this assertion,
the Court will not preclude Defendants from asserting it. This portion of Plaintiff’s motion
is denied.
Plaintiff asks the Court to exclude evidence and argument that alternative designs
must be FDA-cleared and domestically available. Doc. 7513 at 3. Plaintiff argues that
Minnesota law requires only technological and practical feasibility, and designs developed
or used only outside of the United States can satisfy this standard. Id. at 3. They note that
Defendants may point out whether Plaintiff’s safer alternatives are FDA-cleared and
available domestically. Id. Defendants do not argue that Minnesota law precludes foreign
or non-FDA-cleared products from being introduced as alternative-design evidence. Doc.
7749 at 3. Like Plaintiff, they note that the unavailability of Plaintiff’s alternatives in the
U.S. and that they are not FDA-cleared can be relevant to the jury’s determination of the
feasibility of the alternatives. Id. This issue is moot.
Plaintiff asks the Court to preclude evidence or argument that the FDA’s lack of
recall or enforcement action reflects safety or effectiveness. Doc. 7513 at 3-4. They argue
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 18 of 19

19
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
such evidence is irrelevant and unfairly prejudicial. Id. They further state that if the Court
permits reference to those facts, it should not allow Defendants to state or imply that FDA
inaction establishes that their ports are safe, non-defective, or otherwise satisfy Minnesota
law. Id. at 4. The Court adopts the same ruling it entered in the IVC litigation: “Whether
evidence that the FDA took no enforcement action against Bard is relevant and otherwise
admissible will depend heavily on the context in which the evidence is offered . . . . The
Court will make this ruling during trial.” In re Bard IVC Filters Prods. Liab. Litig., 289 F.
Supp. 3d 1045, 1050 (D. Ariz. 2018). In this respect, Plaintiff’s motion is denied. If the
Court does allow Defendants to present evidence of lack of FDA enforcement, they shall
not argue that the lack of such action shows their IPCs are safe and effective. In this
respect, Plaintiff’s motion is granted.
PMIL 1 — FDA Evidence.
Plaintiff argues the Court should exclude all evidence regarding the FDA, including
510(k) clearance and FDA regulations. Doc. 7512. The Court will take this matter under
advisement due to the large number of cases it must read. In addition, Plaintiff has
requested oral argument on this motion, which the Court will grant. Argument will be
heard during the final pretrial conference. The ruling on this motion could affect some of
the rulings in this order.
IT IS ORDERED that the parties’ motions in limine are granted, denied, and taken
under advisement as set forth above.
Dated this 6th day of April, 2026.
Case 2:23-md-03081-DGC Document 7945 Filed 04/06/26 Page 19 of 19