In Re: Taxotere (Docetaxel) Eye Injury Products Liability Litigation

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UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
IN RE: TAXOTERE (DOCETAXEL) 	) 	MDL NO. 3023
EYE INJURY 	)
PRODUCTS LIABILITY LITIGATION 	)
)
This document relates to: 	) 	SECTION: “H” (5)
All cases naming Sanofi as a Defendant 	)
ORDER AND REASONS
Before the Court is the Joint Motion to Exclude Certain Opinions of
Kevin 	B. 	Knopf, 	M.D., 	MPH 	(Doc. 	459) 	filed 	by 	Defendant 	Sanofi 	and
since-dismissed Defendants Accord and Sandoz. For the reasons set forth
herein, the Motion is GRANTED IN PART and DENIED IN PART.
BACKGROUND
Plaintiffs 	in 	this 	multidistrict 	litigation 	(“MDL”) 	are 	suing 	several
pharmaceutical 	companies 	that 	manufactured 	and/or 	distributed 	a
chemotherapy drug, Taxotere or docetaxel, that Plaintiffs were administered
for the treatment of cancer, primarily breast cancer. Among these companies
are 	Defendants 	sanofi-aventis 	U.S. 	LLC 	and 	Sanofi 	U.S. 	Services 	Inc.
(collectively, “Sanofi”); Accord Healthcare, Inc. (“Accord”); and Sandoz Inc.
(“Sandoz”). 	Sanofi 	manufactures 	Taxotere, 	the 	brand 	name 	for 	the 	drug
docetaxel. Accord and Sandoz manufacture versions of docetaxel. Plaintiffs
allege that the drug caused them to sustain injuries to their lacrimal systems,
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including 	punctal, 	canalicular, 	and/or 	nasolacrimal 	duct 	stenosis, 	which
resulted in excessive tearing, otherwise known as epiphora.1
On May 2, 2023, this Court issued Case Management Order No. 16
(“CMO 16”).2 Among other things, CMO 16 set deadlines for discovery and
motion practice, and bifurcated general dispositive issues, including but not
limited to preemption, adequacy of the label, and general causation. Pursuant
to CMO 16, Plaintiffs provided the expert report of Kevin B. Knopf, M.D., MPH
(“Dr. Knopf”).
On February 28, 2025, Defendants Sanofi, Accord, and Sandoz jointly
filed the instant Motion to Exclude Certain Opinions of Dr. Knopf.3 Plaintiffs
oppose.4 On January 16, 2026, this Court granted Defendant Accord’s and
Sandoz’s Motions for Summary Judgment based on preemption.5 This Court
entered Judgment in favor of Defendants Accord and Sandoz on March 6, 2026,
dismissing Plaintiffs’ claims against them with prejudice.6 Accordingly, as to
the instant Motion, Sanofi is the only remaining Defendant.
1 For reference, this Court provided extensive background on the injury at issue and
facts giving rise to this case in its prior Order and Reasons addressing preemption. Doc. 583;
Doc. 591.
2 Doc. 115.
3 Doc. 459.
4 Doc. 483.
5 Doc. 591. On December 1, 2025, this Court denied Sanofi’s Motion for Judgment
based on Preemption. Doc. 583. On February 27, 2026, this Court entered an Order and
Reasons granting Sanofi’s Motion to Certify this Court’s December 1, 2025 Order and
Reasons for Interlocutory Appeal. Doc. 606.
6 Doc. 606.
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LEGAL STANDARD
The admissibility of expert testimony is governed by Federal Rule of
Evidence 702, which provides as follows:
A witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of an
opinion or otherwise if: (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
has reliably applied the principles and methods to the facts of the
case.
The current version of Rule 702 reflects the Supreme Court’s decisions
in Daubert v. Merrell Dow Pharmaceuticals, Inc.,7 and Kumho Tire Co. v.
Carmichael.8 The 	threshold 	inquiry 	is 	whether 	the 	expert 	possesses 	the
requisite qualifications to render an opinion on a particular subject matter.9
Having defined the permissible scope of the expert’s testimony, a court next
inquires whether the opinions are reliable and relevant.10 “Under Federal Rule
of Evidence 702 and Daubert, expert testimony is admissible if the reasoning
or methodology underlying the expert’s testimony is scientifically valid and can
properly be applied to the facts in issue.”11
7 509 U.S. 579 (1993).
8 526 U.S. 137 (1999).
9 Wagoner v. Exxon Mobil Corp., 813 F. Supp. 2d 771, 799 (E.D. La. 2011); see also
Wilson v. Woods, 163 F.3d 935, 937 (5th Cir. 1999) (“A district court should refuse to allow
an expert witness to testify if it finds that the witness is not qualified to testify in a particular
field or on a given subject.”).
10 See United States v. Valencia, 600 F.3d 389, 424 (5th Cir. 2010).
11 Ruffin v. BP Expl. & Prod., Inc., 137 F.4th 276, 280 (5th Cir. 2025) (citation
modified).
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First, 	in 	assessing 	reliability, 	the 	Court 	may 	consider 	several
nonexclusive factors, such as “whether the expert’s theory or technique: (1) can
be or has been tested; (2) has been subjected to peer review and publication;
(3) has a known or potential rate of error or standards controlling its operation;
and (4) is generally accepted in the relevant scientific community.”12 “The
reliability 	analysis 	applies 	to 	all 	aspects 	of 	an 	expert’s 	testimony: 	the
methodology, the facts underlying the expert’s opinion, the link between the
facts and the conclusion, et alia.”13
“Second, the Court must determine whether the expert's reasoning or
methodology ‘fits’ the facts of the case, and whether it will thereby assist the
trier of fact to understand the evidence. In other words, it must determine
whether it is relevant.”14
In 	undertaking 	this 	tripartite 	analysis, 	courts 	must 	give 	proper
deference to the traditional adversary system and the role of the jury within
that system.15 “Vigorous cross-examination, presentation of contrary evidence,
and 	careful 	instruction 	on 	the 	burden 	of 	proof 	are 	the 	traditional 	and
appropriate means of attacking shaky but admissible evidence.”16 As the
“gatekeeper” of expert testimony, the trial court enjoys broad discretion in
determining admissibility.17
12 Burleson v. Tex. Dep’t of Crim. Just., 393 F.3d 577, 584 (5th Cir. 2004) (citing
Daubert, 509 U.S. at 593–94).
13 Nestle v. BP Expl. & Prod., Inc., 627 F. Supp. 3d 577, 583 (E.D. La. 2022).
14 Id. at 583 (citing Daubert, 509 U.S. at 591).
15 See Daubert, 509 U.S. at 596.
16 Id.
17 Wellogix, Inc. v. Accenture, L.L.P., 716 F.3d 867, 881 (5th Cir. 2013).
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LAW AND ANALYSIS
Dr. Knopf is a practicing hematologist and medical oncologist and former
Division Chief of Hematology and Oncology at Alameda Health Systems in
Oakland, 	California. 	He 	is 	currently 	responsible 	for 	supervising 	the
Hematology and Oncology Division, treating patients, and teaching residents
and medical students. He is also an Assistant Clinical Professor of Medicine at
the University of California, San Francisco School of Medicine, an Associate
Professor 	at 	the 	University 	of 	South 	Carolina 	School 	of 	Pharmacy, 	and
conducts research in pharmaco-epidemiology. Plaintiffs proffer Dr. Knopf to
address the following issues: (1) Taxotere and docetaxel as treatment options
available to oncologists; (2) relationship between medical oncologists and their
patients, including responsibility of oncologists to communicate risks and
benefits of different treatment options; and (3) “accuracy and adequacy” of the
Taxotere/docetaxel label in communicating to oncologists the type and severity
of the risk of harm to the nasolacrimal drainage system.18
Sanofi moves to exclude three categories of Dr. Knopf’s opinions. First,
Sanofi seeks to exclude Dr. Knopf’s opinions regarding the Taxotere labeling,
arguing that Dr. Knopf is not qualified and that he lacks a reliable basis for
such an opinion. Second, Sanofi seeks to preclude Dr. Knopf from offering any
“general causation” opinion, arguing that Dr. Knopf did not disclose such an
opinion in his report and that regardless, he does not apply any reliable
methodology. Third, Sanofi seeks to preclude Dr. Knopf from opining about the
“motivations or conduct of pharmaceutical companies in general,” as well as
18 Doc. 459-1 at 4.
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“Sanofi-specific conduct” or regulatory compliance, arguing that such opinions
were not disclosed and that Dr. Knopf lacks a foundation or reliable basis for
such opinions. The Court addresses each argument in turn.
I. 	Opinions Related to the Label
Dr. Knopf opines that the Taxotere label “does not adequately convey the
severity of [the] permanent risk of stenosis of the nasolacrimal drainage
system.”19 More specifically, he opines that the label fails to warn about the
“potentially permanent nature of lacrimation or excessive tearing” and “fails
to advise physicians of the importance of early recognition and treatment of
this side effect to avoid permanent injury.”20 In his report, Dr. Knopf explains
the history of the Taxotere label, which, since 2003, has included a warning
stating that “[e]xcessive tearing which may be attributable to lacrimal duct
obstruction has been reported.”21 He further notes that the same section of the
label 	included 	a 	sentence 	providing 	that 	“[t]hese 	were 	reversible 	upon
discontinuation of the infusion.”22 Dr. Knopf explains that this language
“remained deficient” until it was revised in 2020, and opines that during this
time, the label lead “the reader of the warning to believe” that “excessive
tearing” and “lacrimal duct obstruction” were temporary side effects that
would reverse upon discontinuation of treatment.23
Sanofi seeks to exclude these opinions (and all other opinions related to
the adequacy of the Taxotere label), arguing that Dr. Knopf is not qualified and
19 Doc. 459-1 at 29.
20 Id. at 35.
21 See Doc. 459-1; Doc. 483-3.
22 See Doc. 459-1 at 33–34.
23 Id.
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that he lacks a reliable basis for such opinions. As to his qualifications, Sanofi
asserts that Dr. Knopf acknowledged in his deposition testimony that he is not
an expert on FDA regulations or labeling. They point to Dr. Knopf’s deposition
testimony, wherein he stated that he is not retained as an expert in FDA
labeling requirements and that he was only offering opinions as an oncologist
who treats patients. Sanofi further argues that Dr. Knopf’s reliance on his own
experience, as well as the report and opinions of Plaintiffs’ ophthalmology
expert and oculoplastic surgeon Dr. Vikram D. Durairaj, do not provide a
reliable basis for his opinions.
Where, as is the case here, a medical expert relies on his or her personal
experience, 	the 	expert’s 	qualifications 	and 	the 	reliability 	of 	the 	expert’s
methodology go hand-in-hand. “The strength of an expert’s qualifications
provides circumstantial evidence of reliability.”24 Expert testimony may be
based on “experience alone–or experience in conjunction with other knowledge,
skill, training or education.”25 “In certain fields, experience is the predominant,
if not sole, basis for a great deal of reliable expert testimony.”26
If, however, “the witness is relying solely or primarily on experience,
then he or she must explain how that experience leads to the conclusion
reached, why that experience is a sufficient basis for the opinion, and how that
24 In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 179 (S.D.N.Y. 2009) (citing
Ambrosini v. Labarraque, 101 F.3d 129, 140 (D.C. Cir. 1996)); see also Kumho Tire, 526 U.S.
at 150 (explaining that “relevant reliability concerns may focus upon personal knowledge or
experience”).
25 FED. R. EVID. 702 advisory committee’s note to 2000 amendments.
26 Id.
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experience is reliably applied to the facts.”27 “Overall, the trial court must
strive to ensure that the expert, ‘whether basing testimony on professional
studies or personal experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert in the relevant
field.”’28
Courts regularly hold that “doctors are fully qualified to opine on the
medical facts and science regarding the risks and benefits of drugs, and to
compare that knowledge with what was provided in the text of labeling and
warnings for FDA approved drugs.”29 Absent experience in warnings labels
and/or FDA regulations, however, a medical expert may not offer opinions
“about whether the label complied with the FDA regulations.”30 Further, courts
have precluded more general testimony from expert-physicians “about what
information should or should not be included” on a drug’s label, or that a label
was 	“adequate,” 	reasoning 	that 	such 	experts 	“must 	possess 	additional
expertise” in FDA regulations and/or the development of warnings labels.31
27 Andrews v. Rosewood Hotels & Resorts, LLC, 575 F. Supp. 3d 728, 734 (N.D. Tex.
2021) (citation modified).
28 Id. at 735 (quoting Kumho Tire, 526 U.S. at 152).
29 See, e.g., Conn v. C.R. Bard, Inc., No. 4:14-CV-298, 2021 WL 2346036, at *3 (S.D.
Tex. June 8, 20210) (citation modified); see also In re Yasmin & YAZ (Drospirenone) Mktg.,
Sales Pracs., & Prods. Liab. Litig., No. 3:09-MD-02100, 2011 WL 6301625, at *11 (S.D. Ill.
Dec. 16, 2011).
30 In re Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2740, 16-17039, 2021 WL
111778, at *3 (E.D. La. Jan. 12, 2021) (Milazzo, J.) (allowing Dr. Miletello to testify about the
Taxotere label from his perspective as an oncologist but not about whether the label complied
with FDA regulations).
31 Conn, 2021 WL 2346036, at *3–4 (quoting In re: Ethicon Inc. Pelvic Repair Sys.
Prods. Liab. Litig., MDL No. 2327, 2016 WL 4556807, at *4 (S.D. W. Va. Aug. 31, 2016)); see
also In re: C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2018 WL
4220618, at *3 (S.D. W. Va. Sept. 5, 2018).
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On the other hand, courts have “recognized that a doctor’s experience
alone renders him a reliable witness to testify about a reasonable standard of
care 	or 	what 	a 	reasonable 	physician 	would 	do.”32 	“Consistent 	with 	that
principle, numerous cases have held that a doctor may, based on his or her
experience, ‘testify about what a reasonable doctor should know’ or ‘how a
reasonable doctor would interpret [a] safety warning.’”33 Indeed, courts have
allowed medical experts to opine on the “adequacy” of a label “from the
perspective of a medical practitioner who is familiar with” a drug or device or
similar drugs or devices.34 Further, courts have also allowed testimony from
medical experts to opine on the “completeness or accuracy” of a drug’s label
and/or “whether the label warned of known risks.”35 And in another MDL
involving the same drug at issue here, this Court allowed the defendant’s
32 In re Suboxone ((Buprenorphine Hydrochloride and Naloxone), MDL NO. 2445,
16-5073, 2020 WL 6887885, at *26 (E.D. Pa. Nov. 24, 2020) (collecting cases).
33 Id. (alterations in original) (quoting Bartlett v. Mut. Pharm. Co., 742 F. Supp. 2d
182, 196 (D.N.H. 2010)).
34 See In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 422–23 (S.D.N.Y.
2016); see also In re Davold, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab.
Litig., 546 F. Supp. 3d 679, 689 (S.D. Ohio 2021) (explaining that while experts may not opine
on the ultimate issues of “the legal or regulatory adequacy of warnings,” medical experts
“may offer opinions about whether the warnings sufficiently apprised medical doctors of the
risks”).35 See In re Baycol Prods. Liab. Litig., 532 F. Supp. 2d 1029, 1064, 1069 (D. Minn.
2007) (allowing medical expert to opine on completeness or accuracy of label and noting that
medical opinion on “whether the label warned of known risks” would be permissible, but
holding that medical expert could not opine on what the label should or should not have
included); see also In re: Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine), No.
MDL 1203, 2000 WL 876900, at *11 (E.D. Pa. June 20, 2000) (allowing medical experts to
opine on “completeness” and “accuracy” of the label “and—it follows from that—the extent to
which any inaccuracies or omissions could either deprive a reader or mislead a reader,” and
noting that “whether or not such an opinion would be admissible will depend on an
articulation by the trial judge of the issues to be decided and the law to be applied in that
proceeding”).
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expert 	to 	opine 	about 	“the 	Taxotere 	label 	from 	his 	perspective 	as 	an
oncologist.”36
The Court finds that Dr. Knopf is qualified to opine on the Taxotere label.
He is an oncologist with years of experience and regularly prescribes the drug.
By 	Dr. 	Knopf’s 	own 	admission, 	however, 	he 	is 	not 	an 	expert 	on 	FDA
regulations. Thus—to the extent he intends to do so—he may not opine on that
issue; nor may he opine about what the label should or should not have
included or opine that the label was “deficient,” as such statements appear to
cross the line into impermissible regulatory opinions.37
Further, Dr. Knopf may not offer an ultimate opinion that the label is
“inadequate” 	to 	warn 	physicians, 	as 	that 	conclusion 	may 	constitute 	an
impermissible legal conclusion under the relevant legal standard. In the Fifth
Circuit, an expert witness may give an opinion on an ultimate issue of fact if
the expert is qualified to do so, but the witness may not offer conclusions of law
or merely tell the jury what conclusion to reach.38 But while Dr. Knopf may not
venture that far, he may offer opinions about the label from his “perspective as
an oncologist.”39 Although Sanofi argues that Dr. Knopf fails to cite any
“industry standards, regulations, literature, or other sources” in support of his
36 See In re Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2740, 16-17039, 2021
WL 76398, at *3 (E.D. La. Jan. 8, 2021) (Milazzo, J.).
37 Conn, 2021 WL 2346036, at *3; see also In re Baycol, 532 F. Supp. 2d at 1069.
38 See Robinson v. Ethicon, 588 F. Supp. 3d 726, 735 (S.D. Tex. Mar. 2022); see also
United States v. Oti, 872 F.3d 678, 691 (5th Cir. 2017).
39 See In re Taxotere, 2021 WL 111778, at *3; Deutsch v. Novartis Pharms. Corp., 768
F. Supp. 2d 420, 440 (E.D.N.Y. 2011).
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opinions, Rule 702 permits him “to draw a conclusion from a set of observations
based on extensive and specialized experience.”40
Sanofi further argues that Dr. Knopf’s experience is insufficient to
provide a reliable basis for his label-related opinions, pointing out that Dr.
Knopf testified that of the more than 1,000 patients that he has treated with
Taxotere/docetaxel, 	he 	has 	only 	referred 	“between 	five 	and 	ten” 	to 	an
ophthalmologist, only “three or four” patients had tubes placed, and no patients
“had to have severe surgery” or “had permanent tearing.”41 Sanofi also asserts
that Dr. Knopf did not “independently verify” Dr. Durairaj’s opinions—which
he 	relies 	on 	in 	his 	report—including 	that 	permanent 	damage 	to 	the
nasolacrimal drainage system is preventable with early intervention.
The Court disagrees. First, the fact that Dr. Knopf has only referred to a
specialist between five and ten patients (as opposed to some other, unspecified
number) with signs of tearing does not render him unqualified nor make his
opinion unreliable. Notably, in addition to his experience, Dr. Knopf relied on
the published scientific literature discussing this adverse effect and resulting
surgical interventions. That no patient Dr. Knopf has referred has required
“severe surgery” or experienced “permanent tearing” likewise does not render
him unqualified.
Second, Dr. Knopf’s reliance on Dr. Durairaj’s opinions is permissible. As
this Court has explained, Rule 703 makes clear that an expert may rely on the
work of another expert provided that such reliance is reasonable.42 That Rule
40 Kumho Tire, 526 U.S. at 156.
41 Doc. 506 at 4.
42 In re Taxotere, MDL No. 16-2740, 16-17144, 2019 WL 3997122, at *5 (E.D. La. Aug.
23, 2019) (Milazzo, J.) (citing FED. R. EVID. 703).
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“reflects 	a 	clear 	understanding 	that 	experts 	often 	rely 	on 	one 	another’s
specialties in order to come to an interdisciplinary conclusion in complex
matters.”43 	Plaintiffs state that Dr. Knopf regularly relies on the opinions of
other physicians in the cancer treatment setting, including opinions from other
specialists regarding appropriate treatment of side effects. It would of course
be reasonable for him to do so.
Nevertheless, while a medical expert may opine on the label as described
above, courts have precluded broader testimony about “whether physicians
generally read and comprehend drug labels, or whether doctors generally
understand the contents of” drug labels, reasoning that such testimony is
impermissibly speculative.44 Courts have found that medical experts “may
express opinions regarding the accuracy and adequacy of” a drug’s label
“without reference to the asserted perceptions of other doctors.”45 Thus, here,
while Dr. Knopf may offer opinions about the Taxotere from his perspective as
an oncologist, he may not offer speculative opinions about oncologists in
general.46
43 Tajonera v. Black Elk Energy Offshore Operations, L.L.C., No. 13-366, 2016 WL
3180776, at *10 (E.D. La. June 7, 2016).
44 In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769, 2009 WL 3806436, at *8 (M.D.
Fla. July 20, 2009) (allowing medical and regulatory experts to opine on the “accuracy and
adequacy” of the label but that such experts could not “testify regarding whether physicians
generally read and comprehend drug labels, or whether doctors generally understand the
contents of the . . . label” because such “opinions are impermissibly speculative”).
45 Id.
46 Sanofi argues that “Dr. Knopf’s opinion that the label fails to inform prescribers
that lacrimal duct obstruction can be permanent” is unreliable because it “is contradicted by
his testimony that the Taxotere/docetaxel label is silent with respect to the duration of
lacrimal duct obstruction . . . and that a medical obstruction can be permanent absent
intervention.” Doc. 459-3 at 12. The Court disagrees that these statements necessarily
contradict one another. Regardless, Sanofi’s objections go to the weight of Dr. Knopf’s
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Finally, Sanofi appears to argue that Dr. Knopf may not testify as to
whether any of Plaintiffs’ treating oncologists would have found the warning
sufficient. The court agrees that Dr. Knopf may not offer such testimony, as it
is speculative.
In sum, Dr. Knopf may testify regarding the Taxotere label from his
perspective as an oncologist who regularly prescribes the drug, including his
opinions about the completeness or accuracy of the label. He may not opine,
however, as to Sanofi’s compliance with FDA regulations.
II. 	“General Causation” Opinion
Sanofi also seeks 	to preclude Dr. Knopf from offering 	any general
causation opinions, that is, that Taxotere/docetaxel is “capable of causing”
stenosis and/or permanent damage to the lacrimal drainage system in the
general population.47 Sanofi contends that while Dr. Knopf testified that
“cause and effect is implied” in his report, his report does not offer any general
causation analysis or opinion. Sanofi therefore argues that Dr. Knopf should
be precluded from offering opinions that were not previously disclosed.
Importantly, “the relevance and reliability of expert testimony turn upon
its nature and the purpose for which its proponent offers the testimony.”48
Here, though Sanofi suggests otherwise, a review of Dr. Knopf’s report and
testimony, not its admissibility. Rule 702’s emphasis on “‘sufficient facts or data’ is not
intended to authorize a trial court to exclude an expert’s testimony on the ground that the
court believes one version of the facts and not the other.” Andrews, 575 F. Supp. 3d at 735
(quoting FED. R. EVID. 702 advisory committee’s note to 2000 amendments).
47 See Wells v. SmithKline Beecham Corp., 601 F.3d 375, 378 (5th Cir. 2010) (“General
causation is whether a substance is capable of causing a particular injury or condition in the
general population, while specific causation is whether a substance caused a particular
individual’s injury.” (citation modified)).
48 Andrews, 575 F. Supp. 3d at 735.
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deposition 	testimony 	indicates 	that 	the 	purpose 	of 	his 	opinion 	is 	not 	to
establish causation. Accordingly, the Court will address any objections raised
by Sanofi on this issue at trial.49
III. 	Opinions 	Related 	to 	the 	Motivations 	or 	Conduct 	of
Pharmaceutical 	Companies 	in 	General 	and 	Sanofi-Specific
Conduct
Sanofi argues that Dr. Knopf “offered several vague criticisms” of drug
manufacturers generally, as well as Sanofi’s conduct specifically, during his
deposition.50 Because Dr. Knopf did not disclose any opinions on these issues,
Sanofi argues that he must be precluded from testifying about them. It further
contends that Dr. Knopf is not qualified to opine on FDA/regulatory compliance
and that he did not review sufficient facts or data.
As to precisely which opinions Sanofi seeks to exclude, Sanofi points to
deposition testimony where, when asked if he had “any issues with Sanofi,” Dr.
Knopf responded that Sanofi “charge[s] too much for their drugs.”51 Sanofi,
however, fails to identify any specific opinions in Dr. Knopf’s report that it finds
objectionable to permit this Court to review them with specificity. Accordingly,
Sanofi’s objections are denied as vague and/or premature. The Court will
consider these issues if and when Sanofi raises them at trial.52
49 On April 2, 2026, this Court denied Sanofi’s Motion for Summary Judgment based
on General Causation and addressed three related Motions to Exclude. Doc. 619. Unlike the
experts addressed in those Motions, Dr. Knopf was not addressed in Sanofi’s Motion for
Summary Judgment.
50 Doc. 459-3 at 15.
51 Doc. 459-2 at 67.
52 Accord and Sandoz also raised similar objections regarding “Sandoz-specific” and
“Accord-specific” opinions. See Doc. 493-3 at 17–18. Since Accord and Sandoz have since been
dismissed, those arguments are denied as moot.
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CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Sanofi’s Motion to Exclude Certain Opinions of
Kevin B. Knopf, MD, MPH (Doc. 459) is GRANTED IN PART and DENIED
IN PART, as described herein.
New Orleans, Louisiana this 29th day of April, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
Case 2:22-md-03023-JTM-MBN Document 631 Filed 04/29/26 Page 15 of 15