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
Kimberly Trautman
This multidistrict litigation (“MDL”) involves thousands of personal injury cases
related to implanted port catheters (“IPCs” or “ports”) designed, manufactured, and
marketed by Defendants Becton Dickenson and Company, C. R. Bard, Inc., Bard Access
Systems, Inc., and Bard Peripheral Vascular, Inc. (collectively, “Defendants” or “Bard”).
Plaintiffs have filed a motion to exclude the expert opinions of Kimberly Trautman, M.S.
Doc. 4830. The motion is fully briefed and no party requests oral argument. See
Docs. 5336, 5575. The Court will grant the motion in part.
I. Background.
An IPC is a medical device surgically implanted under the skin to provide repeated
access to a patient’s vascular system without the need for multiple needlesticks into
peripheral veins. IPCs are used to deliver chemotherapy and immunotherapy medication,
intravenous fluids, blood transfusions, and parenteral nutrition. IPCs can remain in place
for weeks, months, or even years until treatment is completed.
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IPCs consist of a port and a catheter. The port is a small reservoir disc with a self-
sealing silicone center where a needle can be inserted to deliver medication. The port
typically is implanted beneath the chest skin and below the collarbone. Port bodies vary
in shape and size and are made of plastic, silicone, or titanium. The port is attached to a
catheter, which is a thin flexible tube for delivery of the medication to a vein. The catheter
is tunneled under the skin to an insertion point in a central vein. Catheters vary in width
and are made of silicone or polyurethane. IPCs typically are implanted by an interventional
radiologist or a vascular surgeon. A nurse or other medical professional then accesses the
IPC to inject the medication, which flows from the port to the catheter and into the vein.
This MDL involves multiple versions of Bard IPCs, each of which received
premarket clearance from the Food and Drug Administration (“FDA”). Bard IPCs contain
barium sulfate, a radiopaque substance that can be seen on diagnostic imaging such as
X-ray, CT, and MRI scans. Several Bard IPCs are manufactured using polyoxymethylene
(“POM”), an acetal thermoplastic polymer, in the construction of the port. Many Bard
IPCs have a port with raised palpation bumps on the silicone center, which help identify
these IPCs as power-injectable devices.
Each Plaintiff in this MDL had a Bard IPC implanted in his or her body, and claims
it was defective and caused serious injury. Plaintiffs allege that the barium sulfate in the
IPC degrades the mechanical integrity of the catheter, leading to surface irregularities that
cause catheter fracture, infection, and blood clots. Plaintiffs further allege that Bard’s
manufacturing process for the POM-containing IPCs lacks adequate measures to stabilize
the POM to prevent oxidative degradation, which causes cracks, fissures, and other
physical defects in the polymer and increases the risk of fracture, infection, and thrombosis.
Plaintiffs also allege that the palpation bumps on the power-injectable IPCs cause undue
compression stress on the tissue surrounding the port, leading to ulceration and tissue
necrosis. See Docs. 23, 1889.
Plaintiffs claim that safer alternative designs and manufacturing processes were
available to Bard and that Bard IPCs are more dangerous than other available treatment
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options. Plaintiffs assert a host of state law claims, including design and manufacturing
defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer
fraud and unfair trade practices. See Docs. 23, 1889.
Bard disputes Plaintiffs’ allegations and contends its IPCs are safe and effective and
that the medical community is aware of risks associated with IPCs. Bard further contends
that various factors impact the performance and wear of IPCs, including where the catheter
is inserted and how well the device is maintained by medical professionals and the patient.
See Docs. 23, 2023-1.
The FDA applies different levels of scrutiny to medical devices before approving or
clearing them for market. The most rigorous level of scrutiny is known as “premarket
approval,” often referred to as the “PMA” process. 21 U.S.C. § 360e(a). To comply, a
manufacturer must file an application that provides a broad range of detailed information
to the FDA showing that 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). Defendants have identified Ms.
Trautman as an FDA expert. She has prepared a 134-page report which discusses her
qualifications as an FDA expert (Doc. 4829-1 ¶¶ 21-31); the FDA’s regulation standards
for Class II medical devices, including IPCs (id. ¶¶ 32-64); the FDA’s enforcement role
(id. ¶¶ 65-85); the regulatory history of Bard IPCs (id. ¶¶ 86-94); quality management
systems (“QMS”) and design controls for Bard IPCs (id. ¶¶ 95-208); and the reports of
Plaintiffs’ experts, Drs. Michael Beatrice, Madris Kinard, and Becky Smith (id. ¶¶ 209-97).
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Trautman opines that: (1) the FDA has stated that the Class II regulatory process for
IPCs has been effective in providing reasonable assurance of safety and effectiveness (id.
¶ 17); (2) by classifying IPCs as Class II medical devices, the FDA instructed IPC
manufacturers to use 510(k) review for market entry (id. ¶ 18); (3) Bard substantially
complied with regulatory requirements in the United States, including requirements for
QMS, medical device reporting, 510(k) review, and risk management systems (id. ¶¶
17-19, 298); (4) the FDA continues to allow Bard IPCs to remain on the market, has
expressed no concerns about the safety, design, or labeling of the IPCs, and has the power
to take regulatory actions if it found the IPCs were unsafe (id. ¶¶ 299-300); and (5) Bard
made reasonable efforts to take the FDA requirements seriously and to address issues as
they arose over the many decades that its IPCs have been marketed (id. ¶ 301). Plaintiffs
argue that some 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
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amendment, our precedent establishes that Rule 702 requires a proponent of expert
testimony to demonstrate each of the requirements of Rule 702 by a preponderance of the
evidence.”).
The Court acts as a gatekeeper to ensure that expert testimony satisfies Rule 702.
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). The Court’s task is not
to decide whether the expert is right or wrong, but to ensure the proposed opinions satisfy
Rule 702. Alaska Rent-A-Car, Inc. v. Avis Budget Grp., 738 F.3d 960, 969-70 (9th Cir.
2013); Engilis, 151 F.4th at 1050. If the proponent does not meet its Rule 702 burden, the
expert testimony is not admissible. See Davis v. McKesson Corp., No. CV-18-1157-PHX-
DGC, 2019 WL 3532179, at *3 n.2 (D. Ariz. Aug. 2, 2019) (“[T]he Court may admit expert
opinions only if it can determine, under Rule 104(a), that Plaintiffs have shown each of the
Rule 702 requirements to be satisfied by a preponderance of the evidence.”).
III. Discussion.
Plaintiffs argue that (1) Trautman is not qualified to opine on the alleged benefits of
ports or on port complication rates (Doc. 4830 at 3-4); (2) she should be precluded from
opining on the ultimate legal issue of safety (id. at 4-7); (3) she should be precluded from
opining on the FDA’s state of mind (id. at 8-9); (4) she cannot offer opinions beyond basic
FDA regulatory requirements and the exchange of information with the FDA because she
failed to review sufficient documents (id. at 9-10); (5) she is not qualified to offer certain
opinions (id. at 10-16); and (6) she should not be permitted to opine that Plaintiffs’ experts
are unqualified or unreliable (id. at 16-17).
A. Port Benefits and Complication Rates.
Plaintiffs argue Trautman is not qualified to opine on port benefits and complication
rates. Doc. 4830 at 3-4. Specifically, Plaintiffs contend that Trautman should not be
permitted to testify that ports “are both safer and cheaper” than other central venous access
devices, to delineate the purported “[k]nown benefits” of ports, or to opine that ports have
a “low complication rate.” Id. at 3 (quoting Doc. 4830-1 ¶¶ 10-11). Defendants concede
that Trautman may not compare ports to other access devices or opine that ports have
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benefits compared to the other devices. Doc. 5336 at 2-3. The Court will grant Plaintiffs’
motion in this regard.
With respect to complication rates, the parties’ briefs are ships passing in the night.
Defendants argue Trautman is qualified to explain the topic of complication rates to the
jury, having written the FDA regulations that requires medical device manufacturers to
review and evaluate all complaints. Id. at 3. They further argue she can testify on the
importance of complaint handling and investigation and her thorough review of Bard’s
complaint handling procedures. Id. Plaintiffs do not address these issues. Doc. 5575 at
2-3.
Plaintiffs, on the other hand, focus on Trautman’s single-sentence assertion that
IPCs have “low complication rates.” See Doc. 4830-1 at 10. Defendants never address
this specific statement. Doc. 5336 at 2-3.
The Court concludes that, based on her FDA experience and her detailed review of
Bard documents and procedures, Trautman can explain the topic of complication rates to
the jury and can testify on the importance of complaint handling and her review of Bard’s
complaint handling procedures. Trautman cannot opine on general IPC complication rates,
a topic for which she provides little foundation in her report. See Doc. 4830-1 ¶ 11.
B. Safety Issue.
After the motion and response, Plaintiffs state that only two issues remain from this
section of their motion: (1) whether Trautman may testify that the ultimate design of Bard’s
ports was “safe”; and (2) whether Trautman may testify that by clearing Bard’s products,
the FDA found them to be “safe and effective.” Doc. 5575 at 3.
On the first issue, Trautman does not claim to be a design expert. She therefore may
not opine that the design of the IPCs was safe.
On the second issue, Trautman may not testify that the FDA found, through the
510(k) process, that Bard IPCs were safe and effective. She may testify, as Plaintiffs agree,
that in clearing an IPC, the FDA determined that it was as safe and effective as its predicate
device. Doc. 4830 at 7.
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C. FDA’s State of Mind.
Plaintiffs argue that Trautman should be precluded from opining on the FDA’s state
of mind, explaining that while Trautman may opine that she believes Bard complied with
FDA regulations, she cannot opine that the FDA considered Bard to be in substantial
compliance with the regulations. Doc. 4830 at 8. Defendants concede that Trautman
cannot opine on the FDA’s state of mind. Doc. 5336 at 8; see In re Bard IVC Filters Prods.
Liab. Litig., No. MDL 15-02641-PHX DGC, 2017 WL 6523833, at *9 (D. Ariz. Dec. 21,
2017) (“Inferences about the intent or motive of . . . others lie outside the bounds of expert
testimony.” (citation omitted)); In re Traylsol Prods. Liab. Litig., No. 09-MD-01928, 2010
WL 4102247, at *6 (S.D. Fla. Sept. 10, 2010) (excluding opinions about “the FDA’s
motive, knowledge, intent, and state of mind” because they fell outside “the scope of [the
witness’s] knowledge and expertise and are classic jury questions”). The Court will not
permit Trautman to opine on what the FDA thought or believed, but she may describe the
FDA’s actions and the circumstances under which such actions are taken. This distinction
will require the Court to draw lines at trial.1
D. Trautman’s Document Review.
Plaintiffs contend that Trautman should be limited to offering opinions about basic
FDA regulatory requirements and the documented exchange of information with the FDA.
Doc. 4830 at 9. Plaintiffs argue that any opinions beyond that limited scope are based on
insufficient facts or data and are unreliable because Trautman did not conduct a “fulsome
review of documents.” Id.
Defendants explain that Trautman strategically chose which documents to review,
reviewed almost every document identified in her report, and thoroughly reviewed every
1 As an example, Plaintiffs challenge one of Trautman’s specific opinions: “If the
FDA found [Bard ports] were unsafe or posed an unreasonable risk to patients, it was within
FDA’s power to have taken one of the regulatory actions discussed above, which it did
not.” Doc. 4830-1 ¶ 300. Defendants argue that this opinion addresses only objective
facts, not FDA’s motivations. Doc. 5336 at 8 (citing In re Mirena IUD Prods. Liab. Litig.,
169 F. Supp. 3d 396, 466 (S.D.N.Y. 2016) (an expert can opine on what the FDA did and
what it said, but cannot opine on the FDA’s motivations)). Plaintiffs do not address this
argument in their reply. The Court agrees with Defendants’ argument and will not exclude
this opinion.
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document she deemed important. Doc. 5336 at 9. Defendants also note that Trautman’s
134-page report details her analysis in depth and cites hundreds of documents supporting
her opinions. Id. Plaintiffs do not address these points in their reply.
The Court finds by a preponderance of the evidence that Trautman’s opinions are
based on sufficient facts and data. “[T]here is no legal requirement that experts review
every document produced in litigation.” In re Takata Airbag Prods. Liab. Litig., No. 15-
MD-02599, 2022 WL 18956175, at *3 (S.D. Fla. Dec. 28, 2022); see also Kang v. Mayor
& Aldermen of City of Savannah, No. CV421-111, 2024 WL 150082, at *5 (S.D. Ga.
Jan. 12, 2024) (“The challenged opinions are not based on insufficient facts or data simply
because Register and Vowell did not review every available document before writing their
expert reports.”); Walsh v. Reliance Tr. Co., No. CV-19-03178-PHX-ROS, 2023 WL
1966921, at *11 (D. Ariz. Feb. 13, 2023) (“Defendants complain Wert’s opinions are not
based on ‘sufficient facts or data’ because he did not review ‘thousands of pages’ they
believe are relevant. . . . Defendants do not cite any authority establishing such a rule[.]”
(citation omitted)). Plaintiffs may cross-examine Trautman at trial about documents she
did not review. See Smilovits v. First Solar, Inc., No. CV12-00555-PHX-DGC, 2019 WL
6875492, at *5 (D. Ariz. Dec. 17, 2019) (“[U]nless an expert’s opinion lacks enough
accurate factual information to provide a reasonable factual foundation, criticism of an
expert’s decision to base an opinion on some facts but not others should be challenged
through the traditional means at trial, not through a Daubert motion.” (citation modified)).
E. Other Opinions Plaintiffs Seek to Exclude.
Plaintiffs argue that Trautman is not qualified to opine on: (1) cautionary statements
in a material data safety sheet (“MSDS”); (2) the sufficiency of Bard’s IPC labeling;
(3) complaint rates for Bard ports and Bard’s use of the FDA’s Alternative Summary
Reporting (“ASR”) program; (4) the feasibility of safer port products; (5) the FDA’s
“conservative” approach to antimicrobial coatings; (6) Dr. Smith’s experiences with IPC
complaint reporting practices; and (7) legislative history and the FDA’s intent. Doc. 4830
at 10-16.
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1. Cautionary Statements in MSDSs, Including DuPont’s.
Plaintiffs argue that Trautman should not be permitted to opine that the caution in
DuPont’s MSDS – that its product should not be used for medical devices implanted in the
body – is unscientific and consistent with “suppliers [being] hesitant to provide important
device components to the MedTech industry because of the risk of product liability
lawsuits.” Doc. 4830 at 10 (citing Doc. 4830-1 ¶¶ 165-68). Plaintiffs argue that Trautman
has no basis for knowing DuPont’s intentions and cites nothing for this opinion. Id.
Defendants argue that Trautman’s challenged opinion is based on her 24 years of
experience at the FDA’s Center for Devices and Radiological Health (“CDHR”), and note
that her opinion is consistent with the 1998 Biomaterials Access Assurance Act, which
states that some “suppliers have ceased supplying certain raw materials and component
parts for use in medical devices for a number of reasons, including concerns about the costs
of . . . litigation.” Doc. 5336 at 10 (citing 21 U.S.C. § 1601). Trautman states that
“[t]hroughout [her] career at FDA, [she] had knowledge of several different chemical
companies that would add unscientific and unsubstantiated language into [an MSDS]
simply to try to avoid liability lawsuits against the chemical company.” Doc. 4830-1 ¶ 168.
Trautman “knew of many such cases” when she was at the FDA, including a chemical
company that made bio-silicone used in breast implants in the 1990s. Id.
The Court finds Trautman’s experience sufficient to admit her opinion about why
chemical companies place disclaimers in their MSDSs. See McBroom v. Ethicon, Inc., No.
CV-20-02127-PHX-DGC, 2021 WL 2709292, at *5 (D. Ariz. July 1, 2021) (“Although
some expert testimony ‘rests upon scientific foundations,’ in other cases ‘the relevant
reliability concerns may focus upon personal knowledge or experience.’” (quoting Kumho
Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999))); Elosu v. Middlefork Ranch Inc., 26
F.4th 1017, 1024 (9th Cir. 2022) (“An expert’s specialized knowledge and experience can
serve as the requisite ‘facts or data’ on which they render an opinion.”).
The Court also concludes, however, that Defendants have not provided a sufficient
factual basis for Trautman to opine on the reasons for DuPont’s warning. She cites nothing
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to support this opinion (Doc. 4830-1 ¶ 168), and she conceded at her deposition that she
has never spoken with anyone at Bard or DuPont about the warning, never reviewed any
documents showing communications between Bard and DuPont about the warning, and
never reviewed any documents showing that Bard informed DuPont that its product would
be used in Bard IPCs. Doc. 4930 at 11. The Court will preclude Trautman from opining
on DuPont’s warning in its MSDS.2
2. IPC Labeling.
Plaintiffs argue Trautman should be precluded from opining on the sufficiency of
IPC labeling to prevent patient injury or on how it would impact treating physician
decisions. Doc. 4830 at 11. Defendants make clear that Trautman offers no opinion on
the sufficiency of Bard’s labeling to prevent injury or on how labeling would impact
treating physician product selection. Doc. 5336 at 12. The Court will deny Plaintiffs’
motion as moot on this issue.
Defendants assert that Trautman will opine that Bard’s IPC labelling complied with
21 C.F.R. § 820. Id. Plaintiffs respond by arguing that Bard fails to explain the relevancy
of this opinion (Doc. 5575 at 5), but relevancy was not part of Plaintiffs’ original argument
on Trautman’s IPC opinions (see Doc. 4830 at 11-12).
Trautman’s report contains a thorough analysis of FDA requirements for labeling in
the context of QMS, and her opinion on Bard’s compliance with labeling requirements is
based on her experience in the FDA’s CDHR Office of Compliance. This provides
sufficient factual foundation and reliability for Trautman’s opinion, and the Court cannot
conclude at this stage that the opinion will be irrelevant, particularly since it is offered in
response to Plaintiffs’ experts. See Doc. 4830-1 ¶ 210; see also In re Davol, Inc./C.R.
Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig., No. 2:18-CV-1509, 2021 WL
2643109, at *7 (S.D. Ohio June 28, 2021) (reciting Trautman’s FDA experience and
2 Defendants argue that Trautman is not offering any opinion on what DuPont
intended (Doc. 5336 at 10), but the Court disagrees. She specifically states that DuPont’s
warning is consistent with the trend of chemical suppliers seeking to avoid legal liability,
a clear assertion that DuPont issued its warning for that reason. Doc. 4830-1 ¶¶ 165-68.
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finding her qualified to opine that the defendants were “in compliance with the QMS
regulations”). The Court will deny Plaintiffs’ motion on this point.
3. Complaint Rates and ASR Program.
This portion of Plaintiffs’ motion is imprecise. Plaintiffs argue that Trautman uses
her report to “shoehorn in unsupported opinions,” citing an 18-page segment of her report.
Doc. 4830 at 12 (citing Doc. 4830-1 at 79-98). But they identify only one specific opinion
to which they object: “[I]n my experience, there is generally less underreporting for
implantable devices as compared to . . . durable medical equipment.” Id. (quoting Doc.
4830-1 ¶ 191). Plaintiffs argue generically that Trautman should not be allowed to “recite
Defendants’ litigation talking points,” but with no further specificity about which opinions
they seek to exclude. Id. at 13.
The one opinion Plaintiffs identify is based on Trautman’s years of FDA experience.
Doc. 4830-1 ¶ 191. She explains that lower underreporting for implantable devices is “due
to the direct involvement of surgeons and patient care professionals (including hospital risk
managers).” Id.; see also Doc. 4830-2 at 34 (testifying that “[w]hen they are direct
prescription devices, surgical devices, there is a better accountability for the complaints
getting to the manufacturers in general”). The Court finds this to be a sufficient basis for
her opinion.
Contrary to the argument in Plaintiffs’ reply (Doc. 5575 at 6), the Court can find no
place in Trautman’s report where she offers an opinion on specific complaint rates for Bard
ports. Plaintiffs provide the Court with no citation where the opinion is found. Id.
Plaintiffs also argue that Trautman should be precluded from opining about Bard’s
use of the ASR program because she does not know how many device manufacturers used
the program or whether other IPC manufacturers used the program. Doc. 4830 at 13. But
this lack of knowledge does not render her ASR opinions unfounded. Trautman devotes
several pages of her report to the ASR program, its purpose, which types of adverse events
manufacturers could submit through the program, and Bard’s compliance with its
requirements. Doc. 4830-1 at 25, 87-89, 118-26; see Doc. 5336 at 13. The Court finds by
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a preponderance of the evidence that her ASR opinions are supported by sufficient facts
and data and a reliable methodology arising from her experience.
The Court will deny Plaintiffs’ motion on these issues.
4. Feasibility of Safer Port Products.
Plaintiffs contend that Trautman should be precluded from opining on the feasibility
of Bard designing safer port products. Doc. 4830 at 13. Plaintiffs cite a few pages of
Trautman’s report, but fail to identify specific opinions they seek to have excluded. Id.;
see Doc. 4830-1 at 130-32. Defendants explain that while Trautman disputes the factual
basis of the opinions of Plaintiffs’ experts on safer alternative designs, she offers no opinion
on the feasibility of a safer alternative design from an engineering or technical perspective.
Doc. 5336 at 13. The Court will deny Plaintiffs’ motion on this issue.
5. Antimicrobial Coatings.
Plaintiffs move to exclude Trautman’s opinion that the “FDA continues to be
conservative in allowing [antimicrobial] claims within cleared 510(k)s.” Doc. 4830 at 14
(quoting Doc. 4830-1 ¶ 285). Trautman explains that the basis for the opinion is the FDA’s
“Not Substantially Equivalent” determination for Bard’s IPC with an antimicrobial coating
and her own experience trying to obtain 510(k) clearance for devices with antimicrobial
coatings. Doc. 4830-1 ¶ 285. The Court finds this to be a sufficient basis for Trautman’s
opinion. She may state her opinion that the FDA has taken a conservative approach to
antimicrobial coatings, but she cannot opine on the FDA’s mindset or attitudes. See
Doc. 4830 at 14, 5575 at 7; In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 466
(S.D.N.Y. 2016) (FDA expert can opine on what the FDA did, what it said, and what
documents mean, but cannot opine on the FDA’s thoughts or motivations).
6. Dr. Smith’s Experiences with IPC Complaint Reporting.
Plaintiffs assert that Trautman criticizes Dr. Smith and the port complaint reporting
practices she observed at Duke University Hospital. Doc. 4830 at 14. Plaintiffs cite several
pages of Trautman’s report, but fail to identify specific opinions they seek to have
excluded. Id.; see Doc. 4830-1 at 132-36.
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Defendants explain that Trautman identifies specific errors in Dr. Smith’s
understanding of mandatory reporting requirements. Doc. 5336 at 14-15. For example,
Trautman disagrees with Smith’s opinion that “there is no systemic or mandatory reporting
of catheter-related complications and healthcare providers, including [her] hospital system,
do not typically report such complications to manufacturers.” Doc. 4830-1 ¶ 293.
Trautman explains that the “FDA has several systemic reporting systems, including the
Manufacturer’s MedWatch eMDR system,” and that the “Safe Medical Devices Act of
1990 requires user facilities to report device-related deaths and serious injuries to the
manufacturer or to FDA.” Id.
The Court will deny Plaintiffs’ motion on this issue because Trautman’s opinions
are sufficiently supported by her extensive FDA experience. Plaintiffs may cross-examine
Trautman at trial regarding her work with a cardiologist from Duke University Hospital
and material she purportedly relied on in forming her opinions. See Doc. 4830 at 14-15.
7. Legislative History and the FDA’s Intent.
Plaintiffs argue that Trautman should be precluded from discussing legislative
history and the FDA’s intent. Doc. 4830 at 15-16 (citing Doc. 4830-1 at 14 (an FDA
guidance document “was intended to assist manufacturers in understanding the intent of
the design control requirements”); id. at 21 (the preamble to a regulation “outlines [the
FDA’s] intent in its rulemaking”)). Defendants explain that Trautman permissibly
discusses the QSRs and what they mean based on her personal experience writing the
regulations, but concede that she cannot opine on the FDA’s intent and will not offer an
opinion on legislative history. Doc. 5336 at 17-18. The Court will grant Plaintiffs’ motion
on these specific points. Trautman may testify about the QSRs and what they mean based
on her personal experience writing the regulations, but she may not opine on legislative
history or the FDA’s intent. More precise line drawing must occur at trial.
F. Trautman’s Criticisms of Plaintiffs’ Experts.
Plaintiffs argue that while Trautman may disagree with Plaintiffs’ experts and even
criticize their qualifications and methodologies, she cannot opine that the experts are
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“unqualified” or “unreliable.” Doc. 4830 at 16-17. Defendants make clear that Trautman
offers no such opinions. Doc. 5336 at 15. The Court will deny Plaintiffs’ motion as moot
in this regard.
IT IS ORDERED that Plaintiffs’ motion to exclude opinions of Kimberly
Trautman (Doc. 4830) is granted in part and denied in part. The motion is granted as
follows: Trautman cannot (1) compare ports to other central venous access devices or opine
that ports have benefits compared to such devices; (2) opine on port complication rates;
(3) opine that the design of Bard IPCs was safe; (4) opine that the FDA found through the
510(k) process that Bard IPCs were safe and effective; (5) opine on the FDA’s state of
mind; (6) opine on DuPont’s warnings in its MSDS for Delrin; or (7) opine on legislative
history or the FDA’s intent.
Dated this 19th day of March, 2026.
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