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 Court took several matters under advisement during the final pretrial conference
last week. See Doc. 8035. The Court now rules on those matters.
1. Grainger Trial Deposition.
Defendants ask that their expert, Dr. Grainger, who will be unavailable during trial,
sit for a preservation deposition so his testimony can be played at trial. Plaintiff does not
object to a deposition, but argues that Grainger is solely a rebuttal witness to Plaintiff’s
experts Ratner and El-Ghannam, neither of whom will testify in the Cook trial. He argues
that Grainger, as a rebuttal expert, should not be permitted to testify when the experts he
rebuts will not be heard by the jury. Doc. 7933 at 36.
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 1 of 14

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
Defendants respond that Grainger’s report contains affirmative opinions separate
from his rebuttal opinions, and that he may testify about those affirmative opinions even if
Ratner and El-Ghannam do not testify. Id. at 53-54.
The Court has carefully reviewed Grainger’s expert report with Defendants’
argument in mind (Doc. 5208-1), and is satisfied he renders only rebuttal opinions in
response to Ratner and El-Ghannam. The report’s introduction says: “This report describes
my opinions related to the matters below. Though I do not address every opinion from Dr.
Ratner and Dr. El-Ghannam, I provide rebuttals to highlight the methodological flaws in
Dr. Ratner’s report . . . . Additionally, I show that Dr. El-Ghannam’s SEM analysis is
faulty.” Id. at 3.
Of the 38 substantive pages of Grainger’s report (Doc. 5208-1 at 8-45), 25 rebut the
opinions of Ratner (id. at 8-32) and 13 rebut El-Ghannam’s SEM analysis (id. at 32-45).
Every page of the Ratner rebuttal refers to Ratner several times. See, e.g., id. at 8
(“Contrary to Dr. Ratner’s unsupported assertions in his Report”), 9 (“Contrary to Dr.
Ratner’s assertions about coating technologies in his report”), 10 (“Dr. Ratner discusses
various surface coatings to improve biomaterials biocompatibility, but none have been
successfully commercialized.”), 12 (“Dr. Ratner provides no valid scientific evidence”),
15 (“Dr Ratner contradicts his writings”), 19 (“Dr. Ratner produces no evidence in his
report”), 20 (“Dr. Ratner ignores the risks posed by coating.”), 21 (“Dr Ratner speculates
about the viability of new coatings”), 23 (“Dr. Ratner makes no mention of the reported
inherent and documented clinical risks”), 26 (“Dr. Ratner fails to recognize the lack of
validation and lack of correlation of in vitro bacterial adhesion [models]”), 29 (“Endexo
has risks that Ratner does not address”).
Grainger renders no affirmative opinion that is separate from his rebuttal opinions.
Defendants argue he provides “affirmative opinions about the state of coating science,
translation barriers, regulatory costs, known coating risks, and testing limitations.”
Doc. 7933 at 54. But each of these opinions is in response to Ratner. See, e.g., Doc. 5208-1
at 9-11 (coating science opinion: “Contrary to Dr. Ratner’s assertions about coating
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 2 of 14

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
technologies . . . , his advocacy of applying strategies to improve biomaterials with coatings
go unrealized[.]”), 21-23 (translation barriers opinion: “The ‘medical implant technology
silence’ in responding to Dr. Ratner’s bold biomaterials predictions reveals . . . a notable
lack of any evident critical translation beyond academic fantasy[.]”), 10-11 (regulatory
costs opinion: “Dr. Ratner discusses various surface coatings . . . , but none have been
successfully commercialized. . . . [P]ublished data provides evidence for the translation
cost of bringing medical device technology through the various required processes[.]”),
17-20 (coating risks opinion: “Dr. Ratner fails to acknowledge the long history of known
in vivo risks . . . reported for . . . catheter coating failures.”), 24-26 (testing limitations
opinion: “Dr. Ratner fails to recognize the lack of validation . . . of in vitro . . . models with
clinical human infection incidence. This is a well-recognized limitation of such
correlations.”). Some of these opinions cover several paragraphs, but they still respond to
Ratner.
Plaintiff’s counsel stated affirmatively at the final pretrial conference that Ratner
will not testify at trial. El-Ghannam is not on Plaintiff’s witness list. See Doc. 7933-1.
Because Grainger is solely a rebuttal expert to these two witnesses, and they will not testify,
he is precluded from testifying in the Cook trial. As a result, his preservation deposition
for the Cook trial is not necessary.
2. Sloan Kettering Email.
Defendants seek to exclude an email dated January 30, 2008, sent by Dr. George
Getrajdman, a radiologist at Memorial Sloan Kettering Hospital, to Kelly Powers, a Bard
officer. 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.
The email further states: “I want to again encourage you to coat inside and outside of
catheters w[ith] the thought that early infection probably comes from outside and more
common late infection probably from inside. These are things that your competitors will
use against you.” Id. Defendants argue these statements are hearsay and not admissible as
a business record or for purposes of notice, and also that they are inadmissible expert
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 3 of 14

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
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 Powers to others within
Bard (Docs. 7752-1, 7752-2), and is also admissible for purposes of notice, including on
punitive damages (Doc. 7752 at 2-4). They further argue that it is not an inadmissible
expert opinion. Id. at 4.
The Court is not persuaded that the email qualifies as an adoptive admission under
Rule 801(d)(2)(B). The rule concerns hearsay “statements,” not entire documents.
Powers’ email forwarding Dr. Getrajdman’s email within Bard focuses on the statement
that doctors at Sloan Kettering love the new silicone product. He congratulates Elizabeth
Richardson, a Bard employee, for completing the project. Docs. 7752-1, 7752-2. His email
does not mention or respond to either the statement that doctors hate the polyurethane
PowerPort or the statement encouraging development of a coated product. Emails that
respond to Powers’ email also congratulate Richardson for the silicone project.
Doc. 7752-1.
An adoptive admission occurs when the party against whom the evidence is to be
offered appears to have “adopted or believed [the evidence] to be true[.]” Fed. R. Evid.
801(d)(2)(B). Powers’ email says nothing about the original email’s reference to doctors
hating polyurethane or encouraging coated catheters. It is entirely silent on these issues.
See Doc. 7752-1. The same is true of responses the other Bard employees provide to the
email. They all focus on the original email’s congratulations of Richardson. See Docs.
7752-1, 7752-2.
Plaintiff argues that Powers showed adoption by merely forwarding the email.
Doc. 7752 at 2. The Court is not persuaded. Each of the cases cited by Plaintiff included
something more. See Transbay Auto Serv. Inc. v. Chevron USA Inc., 807 F.3d 1113, 1121
(9th Cir. 2015) (by delivering an appraisal to a bank for purpose of obtaining a bank loan,
party manifested an adoption or belief in the truth of the appraisal); Sea-Land Serv., Inc. v.
Lozen Intern., LLC, 285 F.3d 808, 821 (9th Cir. 2002) (party copied entire body of
memorandum into an email to a colleague and added, “Yikes, Pls note the rail screwed us
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 4 of 14

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
up,” manifesting an adoption or belief in the truth of information contained in the original
memorandum); Hardy v. Kish, No. 1:23-CV-00306-BLW, 2025 WL 2374329, at *6 (D.
Idaho Aug. 14, 2025) (party received a report on what Snell said to a reporter and responded
to Snell, thanking him for doing “damage control,” thereby manifesting an adoption or
belief in the truth of Snell’s report); Crawford-Brunt v. Kruskall, No. CV 17-11432-FDS,
2020 WL 5836299, at *3 (D. Mass. Sept. 28, 2020) (treasurer of company forwarded
capitalization table he had received from CFO of company with the comment, “Finally got
a copy from our CFO. Thanks again for your advice!”). These cases each show more than
mere forwarding of a document. They find adoption when a party delivers a document for
purposes of obtaining a loan, incorporates content from a document and specifically
comments as if it is true, responds to the creator of a document and thanks him for doing
damage control by making the comments reflected in the document, or, as company
treasurer, forwarding a financial document received from his company’s CFO and
specifically noting the source as the CFO.1
Powers’ email forwarding the Sloan Kettering email to other Bard employees does
none of these things with respect to the relevant information in the email – that doctors hate
polyurethane and request coating of catheters. Powers’ only comment focuses on a
different statement in the doctor’s email – his report that Sloan Kettering is pleased with
the silicone catheters. Powers congratulates Elizabeth Richardson for her work on the
silicone project. Doc. 7752-1 at 3. The Court cannot conclude that forwarding the email
with this unrelated congratulations – or the responsive congratulations from other Bard
employees – “manifested that [they] adopted or believed to be true” the statements about
doctors hating polyurethane or wanting a coating. Fed. R. Evid. 801(d)(2)(B).
Plaintiff also contends that Powers’ silence on the negative contents in the email
constituted an adoptive admission. Doc. 7752 at 3. Courts recognize that silence can
1 Plaintiff also cites Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd., 454 F.
Supp. 2d 966, 973 (C.D. Cal. 2006). This case cites Sea-Land for the bare proposition that
incorporation of content into an email represents adoption of the content for purposes of
Rule 801(d)(2)(B). Id. But the case provides no explanation for this overly-simple
characterization of Sea-Land and is not persuasive.
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 5 of 14

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
manifest adoption when the circumstances reasonably would lead one to believe that the
silent party would respond if he disagreed with the statement. See United States v. Monks,
774 F.2d 945, 951 (9th Cir. 1985). Plaintiff argues that Powers, Bard’s vice president of
research and development, reasonably would be expected to say something about the
negative contents of the email if he disagreed with them. While this is a close question,
Powers’ clear purpose in forwarding the email was to congratulate a colleague. No other
purpose is evident from his e-mail. See Doc. 7752-1 at 3. The Court cannot conclude that
such a communication reasonably would be expected to include Powers’ comments on
other portions of the email. The Court concludes that his silence on those portions should
not be taken as a manifestation that he “adopted or believed [them] to be true.” Fed. R.
Evid. 801(d)(2)(B).
Plaintiff argues the email should be admitted to show Defendants had “notice” of
“danger” and “safer designs.” Doc. 7752 at 4. But the parties’ proposed jury instructions
do not identify notice as an element of any of Plaintiff’s claims. See Doc. 7932.
Plaintiff also argues the email is relevant for notice on the issue of punitive damages.
The Court will address this argument in the punitive damages phase of this case, if there is
one.
Defendants’ Motion in Limine 5 (Doc. 7524) is granted in part as set forth above.
3. Japan Instructions for Use.
Defendants’ Motion in Limine 8 asks 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.
at 2-3. This assertion is supported by the Japanese directive, which focuses on breakage.
See Doc. 7534-1. Defendants primarily argue the Japanese directive and Japan IFU are not
relevant in this infection case. Doc. 7534 at 2.
Plaintiff responds that Defendants’ Japan IFU also contains a warning about
infection (Doc. 7757 at 2), but he never argues that Defendants’ U.S. IFU does not contain
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 6 of 14

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
such a warning (see id.). The Court accordingly directed counsel to address this issue at
the final pretrial conference. Doc. 7945 at 7 (rejecting other portions of Plaintiff’s
argument). The Court noted that unless the U.S. IFU lacks an infection warning, it is not
clear why the Japan IFU infection warning is relevant.
At the final pretrial conference, the parties noted that both the U.S. and Japan IFUs
identify “Catheter or Port-related Sepsis” as potential adverse events from use of
Defendants’ products. Docs. 7757-1 at 19, 7757-2 at 5. The warnings are the same. In
this respect, the Japan IFU is not relevant.
Plaintiff also argues that the Japan IFU mentions “Infection Related to the Placed
Device” (Doc. 7757-1 at 19), and asserted the U.S. version does not (see Doc. 7757-2).
But the U.S. IFU has a “Possible Complications” list that includes “Infection, including
but not limited to, pocket, catheter tunnel, and/or blood stream.” Id. at 5. This warning
appears to cover the subject briefly identified in the Japan IFU, with even greater detail.
Because it appears the U.S. IFU includes all of the infection warnings contained in
the Japan IFU, the Court concludes that the Japan IFU is not relevant. Defendants’ Motion
in Limine 8 (Doc. 7534) is granted. Plaintiff may raise this issue with the Court if he
believes the Japan IFU somehow becomes relevant during trial.
4. Bard Replacement 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 these facts 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. The Court directed
the parties to address this at the final pretrial conference. Doc. 7945 at 11-12 (rejecting
some of Defendants’ other arguments).
Defendants argue that Dr. Frimpong’s use of another Bard port is relevant to the
learned intermediary doctrine. That defense requires Defendants to prove that the
prescribing physician would have taken the same course of action even if Defendants had
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 7 of 14

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
provided the additional warnings Plaintiff claims are necessary. Doc. 7345 at 19.
Defendants argue in this case that Dr. Frimpong would have used a Bard port for Plaintiff’s
implant even if he had received Plaintiff’s additional warnings.
The Court finds Dr. Frimpong’s use of a second Bard port for Plaintiff is relevant
to this issue. Plaintiff will argue at trial that additional warnings would have deterred Dr.
Frimpong from using a Bard port in the first place. The fact that an actual blood infection
in Plaintiff while using a Bard port did not deter Dr. Frimpong from again using a Bard
port supports Defendants’ argument that Dr. Frimpong understood the infection risks that
come with ports and would not have been deterred from using a Bard port by additional
infection warnings in Defendants’ IFU. Plaintiff will of course be free to argue that Dr.
Frimpong did not understand the magnitude of infection risks presented by Bard ports and
would have acted differently had he known. The jury will decide this issue. The Court
concludes that Dr. Frimpong’s use of a second Bard port is relevant to Defendants’ learned
intermediary defense.
Plaintiff argues that the evidence, even if relevant, should be excluded under Rule
403. Plaintiff’s counsel emphasized the Boncher case during the final pretrial conference,
but that decision is unpublished and Plaintiff has provided no copy for the Court to review.
See Doc. 7528 at 4.
The Court does conclude, however, that Rule 403 precludes Defendants from
asserting that Dr. Frimpong’s decision to use a Bard IPC for the replacement device, and
the fact that Plaintiff did not contract a further infection, decrease the likelihood of harm
and the gravity of harm elements in the design-defect balancing test. One data point is too
thin a reed upon which to hang such arguments, and likely will confuse the jury and lead
to unfair prejudice. For the same reason, the Court concludes that Defendants cannot turn
Dr. Frimpong’s decision to use a Bard replacement device into expert evidence that
reasonable medical providers did not consider the likelihood of harm to be too high, or the
gravity of the harm too severe, when using Bard ports.
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 8 of 14

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
Use of the second implanted Bard port therefore will be admitted only on the learned
intermediary doctrine issue. Plaintiff can request a limiting instruction if he believes one
is warranted. Plaintiff’s Motion in Limine 8 (Doc. 7528) is denied, but with the
instructions contained in this order.
5. Bifurcation.
The Court, in its discretion under Federal Rule of Civil Procedure 42(b), concludes
that the issue of punitive damages should be bifurcated from the general liability portion
of the trial. Evidence of Defendants’ net worth and the Sloan Kettering email shall not be
admitted until the punitive damages portion of the trial, if any. Argument and instruction
on punitive damages will also be reserved for this later phase of trial. Each side must
reserve an hour of their trial time for a possible punitive damages phase.
6. FDA Evidence.
Plaintiff’s Motion in Limine 1 asks the Court to exclude evidence and argument
about the FDA, including 510(k) clearance of the PowerPort at issue in this case.
Doc. 7512. The parties argued this issue at the final pretrial conference.
In the IVC MDL litigation overseen by the undersigned judge, evidence of FDA
clearance of the blood filter at issue was admitted during trial. In re Bard IVC Filters
Prods. Liab. Lit., Sherr-Una Booker, 289 F. Supp. 3d 1045 (D. Ariz. 2018) (“Booker”).
The Court concluded that the relevancy of the evidence was not outweighed by the danger
of unfair prejudice. As Defendants note, several courts have followed this decision. As
Plaintiff notes, several others have excluded evidence of 510(k) clearance in medical
product litigation. Doc. 7512 at 3 n.2. Three federal courts of appeal have affirmed
exclusion of FDA evidence in such cases. See Kaiser v. Johnson & Johnson, 947 F.3d 996,
1018 (7th Cir. 2020); Eghnayem v. Bos. Sci., 873 F.3d 1304, 1318-19 (11th Cir. 2017); In
re C.R. Bard, 810 F.3d 913, 922 (4th Cir. 2016).
The Court views this as a close evidentiary question, as it did in the IVC litigation.
In this case, however, the Court finds evidence of the PowerPort’s 510(k) clearance less
relevant than it was in Booker.
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 9 of 14

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
Booker was governed by Georgia law. That law included negligence principles and
“the concept of reasonableness, i.e., whether the manufacturer acted reasonably in choosing
a particular product design.” 289 F. Supp. 3d at 1047 (citation modified). A factor the jury
could consider in evaluating reasonableness was “the manufacturer’s compliance with
federal regulations.” Id. “Given these principles of Georgia law, the Court [found] that
evidence of Bard’s compliance with the 510(k) process, while certainly not dispositive,
[was] nonetheless relevant to the reasonableness of Bard’s conduct and whether the
company defectively designed the G2 filter.” Id.
This case is governed by Minnesota law. A design defect claim under Minnesota
law does not include compliance with federal regulations as a factor for the jury to consider.
Indeed, Defendants’ proposed jury instructions on design defect do not include this factor.
See Doc. 7032 at 58-59. Minnesota’s design defect law requires Plaintiff to prove that
(1) the port was in a defective condition unreasonably dangerous for its intended use,
(2) the defect existed in the port when it left Bard’s control, and (3) the defect in the port
was a direct cause of Plaintiff’s injury. See Doc. 7345 at 4. A manufacturer has a duty to
use reasonable care to design a product that is not in a defective and unreasonably
dangerous condition. See id. at 5; CIVJIG 75.20 Design Defect, 4A Minn. Prac., Jury Instr.
Guides (6th ed. 2025). In determining whether a defendant did use reasonable care, the
jury may consider factors such as the danger presented by the product, the likelihood that
harm will result from its use, the seriousness of the harm, the cost and ease of taking
effective precautions to avoid the harm, and whether the manufacturer considered the
“knowledge and technology in the field.” CIVJIG 75.20. Defendants propose several
additional factors for this case, including the usefulness and desirability of the product, the
availability of a substitute product that would meet the same need and not be as unsafe,
Defendants’ ability to eliminate the unsafe character of the product without impairing its
usefulness or making it too expensive to maintain its utility, the users’ ability to avoid
danger by exercising care in use of the product, and the users’ anticipated awareness of the
dangers inherent in the product and their avoidability because of general public knowledge
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 10 of 14

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
of the condition of the product or of the existence of suitable warnings or instructions.
Doc. 7932 at 59. Compliance with government regulations is not in Minnesota’s standard
jury instruction or on Defendants’ list. See CIVJIG 75.20; Doc. 7032 at 58-59.
Thus, the factor that led the Court in Booker to conclude that 510(k) evidence was
relevant to a central claim in the case is not present in this case. Defendants argue, perhaps
by focusing on the Minnesota factor of whether the manufacturer considered the
“knowledge and technology in the field,” that 510(k) clearance sets an “industry standard”
for IPCs. See Doc. 7748 at 2-3 (citing Minnesota cases mentioning “industry standards”
and “state of the art” as relevant for a jury’s consideration of design defect). The Court
does not agree. Clearance of products under 510(k) does not set any kind of industry
standard for device design, or otherwise prescribe the knowledge and technology in any
particular field. As the Supreme Court has explained, “the FDA does not ‘require’ that a
device allowed to enter the market as a substantial equivalent ‘take any particular form for
any particular reason[.]’” Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (quoting
Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996)). The FDA simply determines that a
device is substantially equivalent to another device on the market without determining
whether the other device reflects the latest knowledge or technology of the field. The FDA
does not prescribe design or safety standards like the National Highway Traffic Safety
Administration’s standard for seatbelts or automotive design. Clearance under 510(k) is
“a qualification for an exemption rather than a requirement.” Id. at 322.
While it is true that 510(k) review requires applicants to show their device is
substantially equivalent to a predicate device, this is a comparative exercise, not a standard-
setting process. Indeed, if the predicate device itself received 510(k) clearance, the FDA
has never made a determination that it was safe or effective. In short, 510(k) clearance
does not set a standard for “knowledge and technology in the field” as relevant to the
Minnesota design defect claim asserted by Plaintiff.
Nor can the Court conclude that 510(k) clearance is relevant to an issue that will be
central in this case – the safety of the port received by Plaintiff. A different kind of FDA
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 11 of 14

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
review, known as the “premarket approval” process, actually determines whether a product
is safe and effective. It is, as the Supreme Court has noted, “federal safety review.” Id. at
323. The port at issue in this case did not undergo FDA premarket approval. It was cleared
through the 510(k) process, which requires only a showing of substantial equivalence. As
the Supreme Court has noted, “510(k) is focused on equivalence, not safety[.]” Id. (citation
omitted).
Defendants stated at the final pretrial conference that they will not argue to the jury
that the 510(k) process shows their product is safe, but they do intend to argue that it shows
their product is as safe and effective as its predicate devices. But this fact has little
probative value on the issue of safety. As Defendants’ counsel confirmed at the conference,
the predicate devices for Plaintiff’s port were also cleared through the 510(k) process. No
premarket-approval safety determination was made by the FDA with respect to those
devices. As a result, saying Plaintiff’s port is as safe and effective as its predicate devices
says little about the port’s actual safety.
The limited probative value of 510(k) clearance on port safety impacts the Court’s
balancing under Rule 403, a rule invoked by Plaintiff. If evidence and argument of the
port’s 510(k) clearance were admitted at trial on the issue of safety, it would consume
substantial time and evidence. Each side would present FDA regulatory experts to explain
the 510(k) clearance process from their point of view. Defendants would present evidence
of the port’s 510(k) application, Defendants’ exchanges with the FDA, and other details of
the clearance process. Plaintiff would present evidence and argument that Defendants’
disclosures to the FDA were not fully forthcoming and that Defendants’ subsequent
tracking and FDA reporting of port complications were deficient. The danger of confusing
the jury and wasting time substantially outweighs the limited probative value of the port’s
510(k) clearance on the issue of safety. Fed. R. Evid. 403. The Court will exclude evidence
of the PowerPort’s clearance by the FDA from trial.
But this does not address all FDA issues. Plaintiff claims that Defendants’ proposed
Avertex port, which included antimicrobial coating, was a feasible safer alternative design
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 12 of 14

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
Defendants could have used instead of Plaintiff’s PowerPort. (Plaintiff must show there
were safer alternatives to prevail on his design defect claim.) Defendants sought 510(k)
clearance for the Avertex, but the FDA found it not substantially equivalent and told
Defendants that more testing was required. Defendants ultimately decided not to pursue
the Avertex design. In responding to Plaintiff’s claim that it was a feasible and safer
alternative to the PowerPort, and in responding to Plaintiff’s argument that Defendants
decided not to pursue the Avertex design solely for profit reasons, Defendants should be
allowed to tell the jury that it sought 510(k) clearance and was denied. That denial,
including some of the testing the FDA required before further consideration, are relevant
to Defendants’ assertion that Avertex was not a feasible and safer alternative to the
PowerPort.
Relatedly, experts retained by Defendants will testify that the FDA became stricter
in reviewing 510(k) applications for antimicrobial products, in part out of safety concerns.
This evidence will respond to Plaintiff’s contention that a range of antimicrobial designs
were available for Defendants to use. It is relevant to Defendants’ contention that the
alternative antimicrobial designs identified by Plaintiff were, in fact, not feasible and safer
designs when Defendants sold the PowerPort implanted in Plaintiff.
The Court views this evidence as directly relevant to Defendants’ defense against
the design defect claim. The Court does not conclude that the FDA evidence on these
discrete issues will raise Rule 403 problems. This evidence will be permitted.
Finally, Defendants stated at the final pretrial conference that they intend to present
evidence they fully reported port failures to the FDA and the FDA never took regulatory
actions against them. The obvious intent of this evidence will be to suggest to the jury that
the FDA viewed Defendants’ ports as safe and effective products that could remain on the
market. The Court views this evidence as only marginally relevant. The FDA could have
had many reasons for not taking action against Defendants or the PowerPort. If admitted,
this evidence will prompt much evidence and argument about the thoroughness and
accuracy of Defendants’ complaint tracking and reports to the FDA, as the Court has seen
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 13 of 14

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
through proposed expert testimony. The danger of confusing the jury and wasting time
substantially outweighs the very limited probative value of the FDA-reporting and non-
action evidence. Fed. R. Evid. 403. The Court will exclude this evidence.
In summary, the Court will grant in part Plaintiff’s Motion in Limine 1.
Doc. 7512. Defendants may not present evidence regarding the 510(k) clearance or
clearance process for the PowerPort, may not argue the FDA found the PowerPort to be as
safe and effective as its predicate device or devices, and may not present evidence or
argument that they fully reported all incidents related to the PowerPort to the FDA and it
took no regulatory action against the PowerPort. Defendants may present evidence of the
510(k) application process and result for the Avertex port, and expert evidence that the
FDA raised the bar for clearance of antimicrobial IPCs.
So that the jury does not unfairly speculate that the PowerPort was sold without
FDA clearance, the parties can prepare a stipulation, or the Court will give an instruction,
that the PowerPort received 510(k) clearance from the FDA, which entailed a finding that
it was substantially equivalent to devices already on the market. The parties shall submit
a joint proposed stipulation or instruction to the Court by noon on April 17, 2026.
Dated this 14th day of April, 2026.
Case 2:23-md-03081-DGC Document 8076 Filed 04/14/26 Page 14 of 14