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 Plaintiffs’ Motion to Exclude Dr. Bita Esmaeli (Doc.
441). 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”). Sanofi manufactures Taxotere, the brand name for the
drug docetaxel. Plaintiffs allege that the drug caused them to sustain injuries
to their lacrimal systems, including punctal, canalicular, and/or nasolacrimal
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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, Sanofi provided the expert report of Dr. Bita Esmaeli. On February
28, 2025, Plaintiffs filed the instant Motion to Exclude Dr. Esmaeli.3 Sanofi
opposes.4
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.
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. 441
4 Doc. 490.
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The current version of Rule 702 reflects the Supreme Court’s decisions
in Daubert v. Merrell Dow Pharmaceuticals, Inc.,5 and Kumho Tire Co. v.
Carmichael.6 	The threshold inquiry is whether the expert possesses the
requisite qualifications to render opinion on a particular subject matter.7
Having defined the permissible scope of the expert’s testimony, a court next
inquires whether the opinions are reliable and relevant.8 “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.”9 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.”10 “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.”11
5 509 U.S. 579 (1993).
6 526 U.S. 137 (1999).
7 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.”).
8 See United States v. Valencia, 600 F.3d 389, 424 (5th Cir. 2010).
9 Ruffin v. BP Expl. & Prod., Inc., 137 F.4th 276, 280 (5th Cir. 2025) (alterations in
original) (citation modified).
10 Burleson v. Tex. Dept. of Crim. Just., 393 F.3d 577, 584 (5th Cir. 2004) (citing
Daubert, 509 U.S. at 593–94).
11 Nestle v. BP Expl. & Prod., Inc., 627 F. Supp. 3d 577, 583 (E.D. La. 2022)
(alterations in original) (quoting Knight v. Kirby Inland Marine Inc., 482 F.3d 347, 355 (5th
Cir. 2007)).
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In turn, “[i]n determining admissibility of expert testimony, the court
must determine whether the expert’s reasoning or methodology fits the facts
of case, and whether it will thereby assist the trier of fact to understand
evidence; in other words, it must determine whether it is relevant.”12
In 	undertaking 	this 	tripartite 	analysis, 	courts 	must 	give 	proper
deference to the traditional adversary system and the role of the jury within
that system.13 “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.”14 As the
“gatekeeper” of expert testimony, the trial court enjoys broad discretion in
determining admissibility.15
LAW AND ANALYSIS
Dr. 	Esmaeli 	is 	board-certified 	in 	ophthalmology 	and 	specializes 	in
ophthalmic plastic and orbital surgery. Her area of practice specifically focuses
on ophthalmic oncology, ophthalmic plastic surgery, and lacrimal surgery in
cancer patients. Before transitioning to private practice, she was a Professor
of Ophthalmology in the Department of Plastic Surgery, Division of Surgery at
MD Anderson Cancer Center for twenty-six years. As Sanofi explains, Dr.
Esmaeli is the “preeminent authority” on the various regimens of Taxotere use
and epiphora (excessive tearing) and stenosis of the nasolacrimal drainage
12 Id.
13 See Daubert, 509 U.S. at 596.
14 Id.
15 Wellogix, Inc. v. Accenture, L.L.P., 716 F.3d 867, 881 (5th Cir. 2013).
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system, and she has published numerous articles on the topic.16 Sanofi proffers
Dr. Esmaeli to offer opinions related to, among other things: (1) the nature and
treatment of the injury at issue; (2) her own publications, as well as additional
scientific literature; and (3) the Taxotere label.
Plaintiffs seek exclusion of Dr. Esmaeli’s opinions related to the Taxotere
label, which may be summarized as follows. After briefly explaining the history
and contents of the label, Dr. Esmaeli offers rebuttal opinions as to some of
Plaintiffs’ 	experts, 	who 	opine 	that 	the 	label 	did 	not 	reflect 	the 	risk 	of
permanent stenosis resulting in tearing and/or permanent damage to the
nasolacrimal drainage system or convey the need for prompt referral to an eye
specialist to prevent further progression of the disease. Dr. Esmaeli also offers
further opinions related to the purpose of the label and whether oncologists
were aware of the risk of stenosis related to Taxotere.
Plaintiffs seek exclusion of Dr. Esmaeli’s opinions on two bases. First,
they argue that by her own admission, Dr. Esmaeli is not qualified to opine on
the sufficiency of the Taxotere label. Second, they argue that Dr. Esmaeli’s
further opinions related to the label are not adequately supported.
I. 	Whether Dr. Esmaeli is Qualified to Offer Opinions Related to the
Label
First, Plaintiffs argue that by her own admission, Dr. Esmaeli is not
qualified 	to 	opine 	on 	the 	“adequacy 	of 	Taxotere’s 	label,” 	identifying 	the
following opinion from her report:
Although I am not a label expert, in my opinion, the Taxotere label
seems to be sufficient to warn oncologists of stenosis/obstruction,
16 Doc. 490 at 3.
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that the obstruction could be permanent, and put them on notice
that symptomatic patients should be referred to an eye doctor.
Once a patient is referred to the eye doctor, the eye doctor can
determine the cause of the tearing and evaluate the patient for
proper treatment.17
Sanofi responds that although she is not an oncologist or an expert in
FDA labeling, Dr. Esmaeli is qualified to offer her opinions based on her (1)
research on the injury at issue; (2) extensive clinical experience in the field of
oncology; and (3) experience evaluating and treating the injury at issue. Sanofi
points out that Plaintiffs’ expert Dr. Durairaj also stated that he was not a
labeling expert, yet he offers similar opinions. Sanofi further notes that
Plaintiffs did not depose Dr. Esmaeli and argues that courts have denied
motions to exclude under similar circumstances.18
At the outset, the Court rejects Sanofi’s argument that Plaintiffs must
depose Dr. Esmaeli in order to lodge their objections. The caselaw does not
require this.19 Likewise, the Court disagrees with Plaintiffs that Dr. Esmaeli
“admitted” that she is not qualified to offer opinions related to the Taxotere
label.
As 	to 	whether 	Dr. 	Esmaeli 	is 	qualified, 	as 	this 	Court 	previously
explained, 	an 	expert 	may 	be 	qualified 	to 	testify 	based 	on 	the 	expert’s
17 Doc. 441-2 at 33.
18 Doc. 490 at 6 (first citing Compton v. Moncla Cos., LLC, No. CV 17-2258, 2020 WL
1638287, at *3 (E.D. La. Apr. 2, 2020); then citing In re M/V Ram XVII, No. 6:22-CV-0998,
2024 WL 5246869, at *4 (W.D. La. Dec. 30, 2024).
19 See, e.g., Shaum v. Cunningham Grain Inc., No. 12-0495, 2013 WL 8812524, at *1
(W.D. Okla. May 7, 2013) (“There may be tactical reasons to take a deposition, but deposing
the expert is in no sense a prerequisite to a Daubert challenge.”).
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“knowledge, 	skill, 	experience, 	training, 	or 	education.”20 	Generally,
“qualification is viewed liberally and is determined by comparing the area in
which the witness has superior knowledge, skill, experience, or education with
the subject matter of the witness’s testimony.”21 An expert who is qualified may
“draw 	a 	conclusion 	from 	a 	set 	of 	observations 	based 	on 	extensive 	and
specialized 	experience.”22 	If, 	however, 	“the 	witness 	is 	relying 	solely 	or
primarily on experience,” 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 experience is reliably applied to the facts.”23
Following this reasoning, courts have held that a physician may testify
“about whether generally recognized medical risks associated” with a drug “are
in fact warned about” on the label.24 “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.”25 Indeed, courts have found medical
experts “qualified to render an opinion regarding the completeness or accuracy
20 FED. R. EVID. 702.
21 In re Fosamax, 645 F. Supp. 2d 164, 190 (S.D. N.Y. 2009) (citing In re Methyl
Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., No. 1:00-1898, M21-88, MDL No. 1358,
2008 WL 1971538, at *6 (S.D.N.Y. May 7, 2008)).
22 Id. (citing In re MTBE, 2008 WL 1971538, at *6).
23 Andrews v. Rosewood Hotels & Resorts, LLC, 575 F. Supp. 3d 728, 734 (N.D. Tex.
2021) (citing FED. R. EVID. 702 advisory committee’s note to 2000 amendment).
24 See Conn v. C.R. Bard, Inc., No. 4:14-CV-298, 2021 WL 2346036, at *3 (S.D. Tex.
June 8, 2021) (quoting Winebarger v. Boston Sci. Corp., No. 2:13-CV-28892, 2015 WL
1887222, at *15 (S.D. W. Va. Apr. 24, 2015)).
25 In re Yasmin and YAZ (Drospirenone) Mktg., Sales Pracs., & Prods. Liab. Litig., No.
3:09-md-02100, 2011 WL 6301625, at *11 (S.D. Ill. Dec. 16, 2011).
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of” drug labels.26 Courts have also held, however, that absent experience with
FDA compliance and/or the formation of warnings labels, such experts are not
qualified to offer testimony “about whether the label complied with the FDA
regulations,” or offer conclusions about “what should or should not have been
included” on a label.27
Here, as this Court held with respect to Dr. Durairaj, Dr. Esmaeli may
explain 	the 	relevant 	terminology, 	including 	the 	risks 	associated 	with
docetaxel, and opine as to whether those risks are in fact included on the
label.28 While she does not prescribe Taxotere, like Plaintiffs’ expert Dr.
Durairaj, Dr. Esmaeli’s extensive clinical and research experience renders her
qualified to address these issues.29 Nevertheless, Dr. Esmaeli may not offer an
ultimate 	opinion 	that 	the 	label 	was 	“adequate,” 	or 	“sufficient” 	to 	warn
oncologists of the risk at issue, as courts treat this a “regulatory” opinion that
requires further expertise.30 Alternatively, such a statement may constitute an
26 In re Baycol Prods. Liab. Litig., 532 F. Supp. 2d 1029, 1064 (D. Minn. 2007); In re:
Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine), No. MDL 1203, 2000 WL
876900, at *11 (E.D. Pa. June 20, 2000) (holding same 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”); but see In re Davol, Inc./C.R.
Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig., 546 F. Supp. 3d 679, 689 (S.D.
Ohio 2021) (stating that 	generally, “[e]xperts may not testify as to the legal or regulatory
adequacy of warnings,” but allowing medical experts to “offer opinions about whether the
warnings sufficiently apprised medical doctors of the risks of the” medical device at issue
“from the vantage point of the end-user”). Here, while Dr. Esmaeli and Dr. Durairaj are not
oncologists and have not prescribed Taxotere, both experts have experience with the injury
at issue and may at least discuss that injury and compare it to the risk described on the label.
27 See Conn, 2021 WL 2346036, at *3
28 See In re Diet Drugs, 2000 WL 876900, at *11.
29 See id.
30 See Conn, 2021 WL 2346036, at *3 (citing In re: Ethicon Inc. Pelvic Repair Sys. Prod.
Liab. Litig., No. MDL 2327, 2016 WL 4556807, at *4 (S.D. W. Va. Aug. 31, 2016)).
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impermissible 	legal 	conclusion31 	and/or 	improper 	speculation.32 	And, 	Dr.
Esmaeli is not an oncologist. Accordingly, as was the case with Dr. Durairaj,
Dr. Esmaeli will be limited in this respect.
II. 	Additional, Purportedly “Unsupported” Opinions
Next, Plaintiffs argue that Dr. Esmaeli’s “further opinions” related to the
Taxotere label are not adequately supported.33 Plaintiffs do not specifically
identify 	any 	of 	these 	“further 	opinions” 	other 	than 	those 	related 	to 	(1)
additional opinions about “how oncologists interpret the label” and (2) “the
purpose of the label.”34 The Court addresses each in turn.
A. 	Opinions Related to Oncologists
Plaintiffs argue that Dr. Esmaeli’s “clinical expertise does not extend to
opining as to how oncologists interpret the label and should therefore be
excluded.”35 Relevant to that issue, Dr. Esmaeli explains in her report that she
also reviewed the label of another chemotherapy drug, 5-Fluorouracil (“5-FU”).
She states that “the 5-FU label . . . lists a potential side effect of ‘lacrimal duct
stenosis.’ As such, a warning of ‘lacrimal duct’ obstruction is the industry
standard and an adequate label to put oncologists on notice of the side effect.”36
31 See Robinson v. Ethicon, 588 F. Supp. 3d 726, 735–36 (S.D. Tex. 2022) (noting that
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,” and is not
“permitted to merely tell the jury what result to reach.” (citation modified)).
32 See In re Suboxone, MDL NO. 2445, No. 13-MD-2445, 2020 WL 6887885, at *27
(E.D. Penn. Nov. 24, 2020) (collecting cases holding that testimony as to “the asserted
perceptions of other doctors, or whether doctors generally understand the contents of the
label” is impermissibly speculative).
33 Doc. 441-1 at 3.
34 Id.
35 Doc. 514 at 2.
36 Doc. 441-2 at 33 (emphasis added).
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She further states that, based on her experience serving on her hospital’s
Institutional Review Board (“IRB”) and conducting “clinical trials, I know that
the preferred language for drug side effects and potential toxicity is simple
terminology, often referred to as ‘8th grade level’ that is understandable by the
general 	public, 	and 	in 	this 	case 	by 	the 	average 	oncologist 	and 	average
ophthalmologist.”37
Next, 	Dr. 	Esmaeli 	opines 	that 	based 	on 	her 	experience, 	“medical
oncologists are aware of the potential for permanent stenosis/obstruction when
patients present with tearing when receiving Taxotere-containing regimens.”38
She apparently reaches this conclusion based on (1) the number of patients
referred to her with this side effect and (2) her perceived decrease in the
number of procedures related to this condition that she has performed over the
years.
Again, while she may opine on the terms used in the label and the risks
associated with the drug, Dr. Esmaeli is not qualified to opine on FDA
regulations or requirements for warnings labels. Thus, her opinion that the
label language is “industry standard” is inadmissible. Further, as was the case
with Dr. Durairaj, Dr. Esmaeli may discuss her personal experience treating
patients with this condition. Assuming such testimony is otherwise admissible,
she may also discuss her experience with her hospital’s IRB. She may not,
however, 	offer 	her 	broader 	opinions 	about 	“preferred 	language,” 	what
oncologists knew or understood about the risk at issue, how any oncologist
37 Id. (emphasis added).
38 Id.
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would interpret the label. She also may not opine that the label was “adequate”
to put oncologists on notice.
Finally, Dr. Esmaeli opines that “if a medical oncologist was confused
about what lacrimal duct meant and the oncologist googled the term lacrimal
duct, all of the top results discuss the tear system and even include headings
such as: ‘blocked tear duct—symptoms & causes’ with a link to the Mayo
Clinic.”39 	Courts have held that medical testimony about what a third-party
physician would do or would think generally “must be based on something
more reliable than simply the expert’s own experience as a doctor.”40 Here, Dr.
Esmaili may not offer speculative opinions about what oncologists would do if
confused. But provided such testimony is otherwise admissible, Dr. Esmaeli
may testify as to the contents of the Mayo Clinic’s website generally.
B. 	Opinions Related to the Purpose of the Label
Finally, Plaintiffs 	argue that Dr. Esmaeli’s opinions related to the
purpose of the label are unsupported, irrelevant, do not fit the facts of the case,
and would be unhelpful to the jury. In her report, Dr. Esmaeli opines that
“labels are not used to tell doctors how to manage a side effect,” and that
“[p]utting highly specialized anatomically precise language in the label, in my
opinion, would in fact defeat the purpose of informing the oncologists of what
the side effect is and what to look for and when to make the appropriate
referrals.”41 The Court finds that Dr. Esmaeli is not qualified to offer her
39 Doc. 441-2 at 33.
40 See In re Suboxone, 2020 WL 6887885, at *27 (quoting Bartlett v. Mut. Pharm. Co.,
742 F. Supp. 2d 182, 196 (D.N.H. 2010)). Notably, both parties have proffered experts in the
fields of oncology and regulatory matters to offer opinions related to the label.
41 Id.
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opinions about the use and purpose of labels, as she is not—by own her
admission—a label expert and/or an expert in regulatory matters.
CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Plaintiffs’ Motion to Exclude Dr. Esmaeli (Doc.
441) is GRANTED IN PART and DENIED IN PART, as detailed herein.
New Orleans, Louisiana this 24th day of April, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
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