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 	Defendant 	Sanofi’s 	Motion 	to 	Exclude 	Certain
Testimony of Dr. David Ross (Doc. 456). For the reasons set forth herein,
Sanofi’s Motion is DENIED.
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”). Sanofi manufactures Taxotere, the brand name for the
drug docetaxel. Plaintiffs allege that Taxotere or docetaxel caused them to
sustain injuries to their lacrimal systems, including punctal, canalicular,
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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 their regulatory expert, Dr.
David Ross.
On February 28, 2025, Sanofi filed a Motion for Summary Judgment
arguing that Plaintiffs’ claims were preempted under the Federal Food, Drug,
and Cosmetic Act (“FDCA”) and its corresponding regulations because there
existed no “newly acquired information”—as defined in the regulations—such
that Sanofi could have changed its label pursuant to the changes-being-effected
(“CBE”) regulation.3 On December 1, 2025, this Court denied Sanofi’s Motion
for Summary Judgment, finding that Plaintiffs’ claims were not preempted
because 	there 	existed 	“newly 	acquired 	information” 	as 	early 	as 	2003.4
Specifically, the Court found that two articles, which summarized the findings
of studies done by Dr. Bita Esmaeli and others, constituted “newly acquired
information.” The first article, titled “Blockage of the Lacrimal Drainage
Apparatus as a Side Effect of Docetaxel Therapy,” was published in 2003 by
Dr. 	Esmaeli 	and 	others 	in 	Cancer 	(“2003 	Esmaeli 	Study”). 	The 	second,
1 For reference, this Court provided extensive background on the injury at issue and
the facts giving rise to this case in its prior Orders and Reasons addressing preemption. Doc.
583; Doc. 591.
2 Doc. 115.
3 Doc. 445.
4 Doc. 583 at 30.
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“Prospective Study of Incidence and Severity of Epiphora and Canalicular
Stenosis in Patients with Metastatic Breast Cancer Receiving Docetaxel,” was
published by Dr. Esmaeli and others in the Journal of Clinical Oncology in
2006 (“2006 Esmaeli Study”). 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.5
On February 28, 2025, Sanofi filed the instant Motion to Exclude Certain
Testimony of Dr. Ross.6 Plaintiffs Oppose.7
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.,8 and Kumho Tire Co. v.
5 Id. This Court granted similar Motions for Summary Judgment filed by Defendants
Accord Healthcare, Inc. (“Accord”); Sandoz Inc. (“Sandoz”); Hospira Worldwide, LLC f/k/a
Hospira Worldwide, Inc., Hospira, Inc. (collectively, “Hospira”), and Pfizer, Inc. (“Pfizer”), and
dismissed Plaintiffs’ claims against Defendants with prejudice. Doc. 591, Doc. 606, Doc. 609.
6 Doc. 456.
7 Doc. 484.
8 509 U.S. 579 (1993).
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Carmichael.9 The 	threshold 	inquiry 	is 	whether 	the 	expert 	possesses 	the
requisite qualifications to render an opinion on a particular subject matter.10
Having defined the permissible scope of the expert’s testimony, a court next
inquires whether the opinions are reliable and relevant.11 “Under Federal Rule
of Evidence 702 and Daubert,” expert testimony is reliable if “the reasoning or
methodology underlying the expert’s testimony is scientifically valid.”12 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.”13 “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.”14
In turn, in determining the admissibility of expert testimony, the Court
must also “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
9 526 U.S. 137 (1999).
10 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.”).
11 See United States v. Valencia, 600 F.3d 389, 424 (5th Cir. 2010).
12 Ruffin v. BP Expl. & Prod., Inc., 137 F.4th 276, 280 (5th Cir. 2025) (citation
modified).
13 Burleson v. Tex. Dept. of Crim. Just., 393 F.3d 577, 584 (5th Cir. 2004) (citing
Daubert, 509 U.S. at 593–94).
14 Nestle v. BP Expl. & Prod., Inc., 627 F. Supp. 3d 577, 583 (E.D. La. Sept. 12, 2022)
(alterations in original) (quoting Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 355 (5th
Cir. 2007)).
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understand 	evidence. 	In 	other 	words, 	it 	must 	determine 	whether 	it 	is
relevant.”15
In 	undertaking 	this 	tripartite 	analysis, 	courts 	must 	give 	proper
deference to the traditional adversary system and the role of the jury within
that system.16 “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.”17 As the
“gatekeeper” of expert testimony, the trial court enjoys broad discretion in
determining admissibility.18
LAW AND ANALYSIS
Dr. Ross is a board-certified physician who worked at the United States
Food 	and 	Drug 	Administration 	(“FDA”) 	from 	1996 	to 	2006, 	with
responsibilities for regulating approved, marketed drug products as well as
reviewing New Drug Applications (NDAs) and supplemental NDAs (sNDAs).
Plaintiffs proffer Dr. Ross as an expert on the regulation of prescription drugs
by the FDA. Sanofi seeks to exclude three aspects of Dr. Ross’s ultimate opinion
that Sanofi failed to comply with its regulatory obligations by failing to update
the Taxotere label.19 First, it seeks to preclude Dr. Ross from opining on
whether any information or data, including the 2003 Esmaeli Study, is “newly
acquired information” under federal law. Second, it seeks to exclude Dr. Ross’s
15 Id. at 583.
16 See Daubert, 509 U.S. at 596.
17 Id.
18 Wellogix, Inc. v. Accenture, L.L.P., 716 F.3d 867, 881 (5th Cir. 2013).
19 Dr. Ross also offers opinions as to other § 505(b)(2) Defendants in this case, who
have since been dismissed.
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opinions related to the Taxotere label. Third, it seeks to preclude Dr. Ross’s
opinions 	that 	Sanofi 	violated 	several 	provisions 	of 	the 	Code 	of 	Federal
Regulations 	by 	failing 	to 	update 	the 	Taxotere 	labeling. 	Sanofi 	does 	not
challenge 	Dr. 	Ross’s 	qualifications, 	but 	rather, 	argues 	that 	exclusion 	is
warranted because Dr. Ross did not reliably apply his stated methodology. It
further avers that Dr. Ross’s opinions are not based on sufficient facts or data,
or alternatively, constitute impermissible legal conclusions. This Court will
consider each argument in turn.
I. 	“Newly Acquired Information”
In his Report, Dr. Ross first outlines the FDA’s complex regulatory
scheme, 	including 	the 	requirements 	for 	a 	label 	change 	under 	the 	CBE
regulation, which “allows manufacturers to file a supplemental application
with 	the 	FDA 	and 	simultaneously 	implement 	a 	labeling 	change 	before
obtaining FDA approval.”20 The CBE regulation is available 	“to add or
strengthen a . . . warning” where there is “newly acquired information”
providing “evidence of a causal association between the drug and a risk of
harm.”21 	The 	regulation 	defines 	“newly 	acquired 	information” 	as 	“data
analyses, 	or 	other 	information 	not 	previously 	submitted 	to 	the 	Agency,”
including, but not limited to, “data derived from new clinical studies, reports
of adverse events, or new analyses of previously submitted data (e.g., meta-
analyses) if the studies, events or analyses reveal risks of a different type or
20 Hickey v. Hospira, 102 F.4th 748, 751 (5th Cir. 2024) (citing 21 C.F.R. §
314.70(c)(6)).
21 Id. (citation modified) (quoting Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S.
299, 304–05 (2019)).
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greater severity or frequency 	than previously included in submissions to
FDA.”22
Sanofi challenges Dr. Ross’s opinion that “Sanofi should have submitted
a CBE-0 label change as early as 2003” based on the 2003 Esmaeli Study.23
Sanofi argues that in doing so, Dr. Ross is improperly opining on whether that
study constitutes “newly acquired information.” Sanofi contends that Dr. Ross
“did not consider what information was previously submitted by Sanofi to FDA
before 2003”—information that, according to Sanofi, is necessary to determine
whether later information is “newly acquired.”24 In support, Sanofi points to
Dr. Ross’s testimony that he was “not completely clear on the universe of
information that was submitted.”25 Sanofi therefore argues that Dr. Ross failed
to apply the regulatory definition and did not rely on sufficient facts or data.
Finally, Sanofi argues that whether information qualifies as “newly acquired
information” is a legal question.
As explained in its prior Order and Reasons denying Sanofi’s Motion for
Summary Judgment, this Court determined that the 2003 Esmaeli Study
constituted “newly acquired information.”26 This Court further explained that
whether information is “newly acquired” is ultimately a legal question for the
Court, not the jury, to determine, though that question may require resolution
of subsidiary factual disputes. The Court therefore declined to consider expert
testimony purporting to resolve that ultimate issue, finding such testimony
22 Id. (emphasis added) (quoting 21 C.F.R. § 314.3(b)).
23 Doc. 484-1 at 61.
24 See Doc. 456-1 at 7. Sanofi reasserts this argument in its Motion for Summary
Judgment on Label Adequacy.
25 Doc. 456-1 at 6.
26 Doc. 583.
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unhelpful. Accordingly, because the Court found that there existed “newly
acquired information,” and therefore has already resolved that issue, Sanofi’s
argument on this point must be denied as moot. Dr. Ross, however, may discuss
the existence of “newly acquired information” to the extent it relates to his
other opinions.
II. 	Label-Related Opinions
For the same reasons, Sanofi also seeks to exclude two related regulatory
opinions offered by Dr. Ross concerning the content of the Taxotere label. First,
Dr. Ross opines that the CBE label change “to the Adverse Reactions section”
should 	have 	included 	additional 	language 	describing 	“excessive 	tearing
attributable to potentially permanent stenosis of the nasolacrimal drainage
system requiring surgical intervention.”27 Second, he opines that a warning
should have been added to the “Warnings and Precautions” section to include
similar 	language, 	and 	also 	advise 	that 	patients 	undergo 	prompt
ophthalmological evaluation to prevent progression to permanent stenosis.28
Sanofi argues that these opinions are unreliable because they rest on Dr.
Ross’s view that Sanofi could have implemented a CBE change in 2003—an
action that, under federal law, requires the existence of “newly acquired
information.” According to Sanofi, because Dr. Ross did not adequately analyze
what information Sanofi had previously submitted to the FDA, his opinions
are not based on sufficient facts or data.
This 	argument 	conflates 	two 	distinct 	concepts: 	(1) 	whether 	“newly
acquired information” existed such that the CBE regulation was available, and
27 Doc. 456-2 at 62.
28 Id.
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(2) whether the Taxotere label was substantively adequate in light of the
available risk information. The former is a legal and regulatory threshold
question that turns on a comparison between post-approval information and
the information previously submitted to the FDA. The latter, by contrast,
concerns the adequacy of the warnings themselves and does not require the
same regulatory comparison.
Accordingly, 	Dr. 	Ross 	is 	not 	required 	to 	independently 	determine
whether “newly acquired information” existed. That issue has been resolved.
His task, instead, was to assess whether the label adequately conveyed the
relevant risks, considering the information available at the time. In doing so,
Dr. Ross relied on his experience working at the FDA, as well as, among other
things: (1) Sanofi’s initial NDA approval package; (2) draft and final labels for
Taxotere; (3) scientific literature cited by Plaintiffs’ expert Dr. McGwin; and
(4) clinical information described in Plaintiffs’ expert Dr. Durairaj’s report. 29
In any event, the record reflects that Dr. Ross did in fact consider Sanofi’s
prior submissions to the FDA. Although certain submissions—dated June 1,
2001; January 9, 2002; February 1, 2002; and May 28, 2002—are not cited in
the body of his report, a review of Dr. Ross’s reliance materials and deposition
testimony demonstrates that he considered them. For example, he identifies
materials from several of these submissions as exhibits to the Sima Desai
(Patel) deposition and cites a draft version of Sanofi’s May 28, 2002 letter to
the FDA. In his deposition, Dr. Ross also specifically referenced Sanofi’s Eighth
29 See, e.g., In re Taxotere Docetaxel Prods. Liab. Litig., Nos. 16-2740, 16-17039, 2021
WL 2982991 at *3 (E.D. La. July 14, 2021) (Milazzo, J.) (“Rule 703 of the Federal Rules of
Evidence allows an expert to reasonably rely on the work of another expert, and the Court
finds that Dr. Ross’s reliance on Dr. Madigan’s analysis appears reasonable.”).
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and Ninth Periodic Safety Update Reports (“PSURs”), which were submitted
on February 1, 2002 and which summarized adverse event reports involving
lacrimal disorders, including cases requiring surgical intervention and cases
that persisted after cessation of therapy.
Accordingly, the Court finds that Dr. Ross’s opinions regarding label
adequacy are based on sufficient facts and data and are the product of a reliable
methodology. Sanofi’s request to exclude these opinions is therefore denied.
III. 	Regulatory And/or Statutory Compliance
Next, asserting similar arguments, Sanofi seeks to preclude Dr. Ross’s
opinion that, as to Taxotere’s labeling, “Sanofi failed to meet its regulatory
obligations with regard to epiphora (excessive tearing) from stenosis in the
nasolacrimal drainage system in patients receiving Taxotere . . . .”30 Dr. Ross
opines 	that 	although 	the 	CBE-0 	regulation 	requires 	“newly 	acquired
information,” the general labeling regulations independently require that “the
labeling must be updated when new information becomes available that causes
the labeling to become inaccurate, false, or misleading.”31 He further explains
that an NDA holder “can analyze all safety information it knows of,” and that
the 	results 	of 	such 	analyses 	may 	themselves 	constitute 	“newly 	acquired
information” if they reveal risks of a different type or greater severity or
frequency.32 Based on this regulatory framework, Dr. Ross opines that Sanofi
failed to meet its labeling obligations in several respects. Specifically, he
concludes that:
30 Doc. 456-2 at 60.
31 Id. (citing 21 C.F.R. § 201.56(a)(1)).
32 Id.
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1. Sanofi failed to comply with the statutory requirement that
the Taxotere labeling not be false or misleading. 21 U.S.C. §
352(a)(1).
2. Sanofi failed to comply with the regulatory requirement that
the Taxotere labeling contain “a summary of the essential
scientific information needed for the safe and effective use of
the drug.” 21 C.F.R. § 201.56(a)(1).
3. Sanofi failed to comply with the regulatory requirement that
the Taxotere labeling “must be informative and accurate and
neither promotional in tone nor false or misleading in any
particular.” 21 C.F.R. § 201.56(a)(2).
4. Sanofi failed to comply with the regulatory requirement that
the 	Taxotere 	labeling 	“must 	be 	updated 	when 	new
information becomes available that causes the labeling to
become 	inaccurate, 	false, 	or 	misleading.” 	21 	C.F.R. 	§
201.56(a)(2).33
Dr. Ross further opines that Sanofi’s alleged noncompliance stems from its
failure to submit a CBE supplement to update the Adverse Reactions and
Warnings and Precautions sections of the label. In essence, Dr. Ross concludes
that once sufficient information existed to support a causal association, Sanofi
could have—and therefore should have—used the CBE process to update the
label, and its failure to do so rendered the labeling noncompliant with federal
requirements.
Sanofi 	argues 	that 	these 	opinions 	constitute 	impermissible 	legal
conclusions and should therefore be excluded. Sanofi further contends that
such opinions would carry undue weight and risk confusing the jury. Federal
33 Id. at 60-61.
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Rule of Evidence 704 provides that “[a]n opinion is not objectionable just
because it embraces an ultimate issue.” As the Fifth Circuit has explained,
however, Rule 704 “does not open the door to all opinions.”34 Rather, testimony
that merely tells the jury what result to reach is not permitted; nor does the
Rule allow a witness to offer legal conclusions.35 Consistent with this principle,
courts in this Circuit have excluded expert testimony that a drug’s labeling
was 	“adulterated, 	misbranded, 	or 	false 	and 	misleading 	under 	the 	FDA
regulations,” reasoning that such statements embrace “legal terms of art” and
cross the line into an impermissible legal opinion.36
Even 	so, 	district 	courts 	presiding 	over 	pharmaceutical 	MDLs 	have
permitted expert testimony regarding FDA regulatory requirements and a
defendant-manufacturer’s conduct in relation to those requirements.37 Indeed,
“[n]umerous courts have found that the testimony of regulatory experts on the
reasonableness of a pharmaceutical company’s conduct in light of the complex
34 Owen v. Kerr-McGee Corp., 698 F.2d 236, 240 (5th Cir. 1983); see also Kelley v.
Smitty’s Supply, Inc., No. 17-4711, 2019 WL 296819, at *1 (E.D. La. Jan. 23, 2019);
Snap-Drape, Inc. v. C.I.R., 98 F.3d 194, 198 (5th Cir. 1996)).
35 See Tsao v. Ferring Pharms., Inc., No. 4:16-cv-01724, 2018 WL 3649714, at *14 (S.D.
Tex. Apr. 19, 2018) (“The Federal Rules of Evidence do not permit an expert to render
conclusions of law, because such testimony cannot properly assist the jury in understanding
the evidence or determining a fact in issue. Rather, expert testimony couched as legal
conclusion merely tells the jury which result to reach” (citation modified)).
36 See Robinson v. Ethicon, Inc., 588 F. Supp. 3d 726, 736 (S.D. Tex. 2022). In
Robinson, the court held that a regulatory expert could not “make the final legal conclusions
in her testimony,” including that the drug was “adulterated” or “misbranded,” but allowed
the expert to “use the terms ‘adulterated’ and ‘misbranded’ to demonstrate to the jury what
the regulations require.” Id. See also Tsao, 2018 WL 3649714, at *14 (“Finally, Dr. Plunkett’s
opinions 	that 	the 	Bravelle 	was 	‘misbranded’ 	or 	‘adulterated’ 	are 	inadmissible 	legal
conclusions.”).
37 See In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 467 (S.D. N.Y. 2016)
(collecting cases).
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nature of the FDA framework is helpful to a jury.”38 “Although experts cannot
supplant the role of counsel in making argument at trial, and the role of the
jury in interpreting the evidence, and while generally an expert’s testimony on
issues 	of 	law 	is 	inadmissible, 	courts 	admit 	expert 	testimony 	regarding
companies’ compliance with FDA regulations.”39 As one court explained,
[t]he cases in this MDL are not governed by federal regulations but
by state law theories of negligence and strict liability. Expert
testimony 	on 	regulatory 	compliance 	will 	assist 	the 	jury 	in
determining 	whether 	[the 	defendant] 	acted 	as 	a 	reasonably
prudent pharmaceutical manufacturer. The Court will instruct the
jury that it must take the law from the Court and not from any
witness.40
Courts following this reasoning have further explained that in addition to
proper jury instruction, cross-examination and the presentation of contrary
evidence sufficiently mitigate any risk that the jury places undue weight on
such testimony.41 The Court finds this reasoning persuasive. As such, here, Dr.
Ross may testify about the FDA regulatory framework, “what the regulations
38 Robinson, 588 F. Supp. 3d 	at 	736 (citing In re Suboxone (Buprenorphine
Hydrochloride and Naloxone) Antitrust Litig., MDL No. 2445, Civ. A. No. 16-5073, 2020 WL
6887885 (E.D. Penn. Nov. 24, 2020)); see also In re Mirena, 169 F. Supp. 3d at 467 (citing In
re Fosamax Prods. Liab. Litig., 924 F. Supp. 2d 477, 493 (S.D.N.Y. 2013)).
39 In re Mirena, 169 F. Supp. 3d at 467 (citation modified).
40 In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 191 n.16 (S.D.N.Y. 2009).
41 See id. at 191; see also In re Yasmin & YAZ (Drospirenone) Mktg., Sales Pracs. &
Prods. Liab. Litig., No. 09–MD–2100, 2011 WL 6302287, at *25 (S.D. Ill. Dec. 16, 2011)
(finding that “[t]o the extent [the expert] does offer legal conclusions, the Court finds that
[the expert’s] testimony is permissible because of the complex nature of the process and
procedures . . . [The expert’s] testimony will assist the trier of fact in understanding the
federal regulations, and the jury will be instructed that that the Court, not [the expert] nor
any other witness, will instruct the jury on the law in this case”).
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require,” and Sanofi’s “conduct with regard to the regulations,”42 including
Sanofi’s “compliance therewith.”43
CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Sanofi’s Motion to Exclude Certain Testimony of
Dr. Ross (Doc. 456) is DENIED.
New Orleans, Louisiana this 24th day of April, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
42 See Robinson, 588 F. Supp. 3d at 736 (citing In re Suboxone, 2020 WL 6887885).
43 See In re Fosamax, 645 F. Supp. 2d at 191. To the extent Sanofi argues that Dr.
Ross’s opinions on this issue are not supported by sufficient facts or data, the Court rejects
that argument for the reasons stated above. See supra Section II.
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