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 Defendant Sanofi 	)
ORDER AND REASONS
Before the Court is Sanofi’s Motion for Summary Judgment Based on
Label Adequacy (Doc. 447). For the reasons set forth herein, the 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.1 Among these companies
are 	Defendants 	sanofi-aventis 	U.S. 	LLC 	and 	Sanofi 	U.S. 	Services 	Inc.
(collectively, “Sanofi”). Plaintiffs allege that Taxotere caused them to sustain
injuries 	to 	their 	lacrimal 	systems, 	including 	punctal, 	canalicular, 	and/or
nasolacrimal duct stenosis, which resulted in excessive tearing, otherwise
known as epiphora. Plaintiffs bring claims based on strict products liability
(failure to warn) and negligence.
1 Taxotere is the brand name for the drug docetaxel.
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In its prior Order and Reasons addressing Sanofi’s motion for summary
judgment on preemption, this Court provided extensive background on the
injury 	at 	issue 	and 	the 	history 	of 	the 	Taxotere 	label, 	which 	the 	Court
incorporates by reference here.2 To summarize, in 2002, Sanofi submitted a
changes-being-effected 	(“CBE”) 	change 	to 	include 	an 	“Ophthalmologic”
category 	in 	the 	Postmarketing 	Experiences 	subsection 	of 	the 	Adverse
Reactions section of the label.3 After communicating with the FDA, the label
was ultimately changed in 2002 to include the following warning:
Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or
without 	conjunctivitis. 	Excessive 	tearing 	which 	may 	be
attributable to lacrimal duct obstruction has been reported.4
Between 2003 and 2020, the label underwent various revisions, although
the label’s language regarding “[e]xcessive tearing which may be attributable
to lacrimal duct obstruction” remained the same. The current Taxotere label
continues 	to 	include 	that 	language 	in 	the 	Postmarketing 	Experiences
subsection.5
Generally, Plaintiffs contend the label was at all times inadequate
because it failed to warn that Taxotere could cause progressive and potentially
permanent stenosis of the nasolacrimal drainage system resulting in excessive
tearing, which may require surgical intervention. Plaintiffs further allege that
2 See Doc. 583. As this Court previously explained in its Order and Reasons addressing
Sanofi’s motion for summary judgment on preemption, since 2003, the regulations regarding
prescription drug labeling have been amended in certain respects, including those addressing
the categorization and hierarchy of a drug’s label. See Doc. 583 at 7 & n.15, 25.
3 See Doc. 481-1 at 7.
4 Doc. 486-1 at 7.
5 See Doc. 486-1 at 8.
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the label failed to warn about the need for prompt ophthalmologic referral upon
signs of excessive tearing.
On May 2, 2023, this Court issued Case Management Order No. 16
(“CMO 16”).6 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. On
February 28, 2025, Sanofi filed the instant Motion for Summary Judgment
Based on Label Adequacy.7 Plaintiffs oppose.8
LEGAL STANDARD
Summary 	judgment 	is 	appropriate 	“if 	the 	pleadings, 	depositions,
answers to interrogatories, and admissions on file, together with affidavits, if
any, show that there is no genuine issue as to any material fact and that the
moving party is entitled to a judgment as a matter of law.”9
In determining whether the movant is entitled to summary judgment,
the Court views facts in the light most favorable to the non-movant and draws
all reasonable inferences in his favor.10 “If the moving party meets the initial
burden of showing that there is no genuine issue of material fact, the burden
shifts to the non-moving party to produce evidence or designate specific facts
showing the existence of a genuine issue for trial.”11 Summary judgment is
appropriate if the non-movant “fails to make a showing sufficient to establish
6 Doc. 115.
7 Doc. 447.
8 Doc. 486.
9 Sherman v. Hallbauer, 455 F.2d 1236, 1241 (5th Cir. 1972).
10 Coleman v. Houston Indep. Sch. Dist., 113 F.3d 528, 532 (5th Cir. 1997).
11 Engstrom v. First Nat’l Bank of Eagle Lake, 47 F.3d 1459, 1462 (5th Cir. 1995).
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the existence of an element essential to that party’s case.”12 “In response to a
properly supported motion for summary judgment, the non-movant must
identify specific evidence in the record and articulate the manner in which that
evidence supports that party’s claim, and such evidence must be sufficient to
sustain a finding in favor of the non-movant on all issues as to which the
non-movant would bear the burden of proof at trial.”13 “We do not . . . in the
absence of any proof, assume that the nonmoving party could or would prove
the necessary facts.”14 Additionally, “[t]he mere argued existence of a factual
dispute will not defeat an otherwise properly supported motion.”15
LAW AND ANALYSIS
Sanofi moves for summary judgment on two grounds. First, Sanofi
argues that Plaintiffs lack admissible expert evidence on the adequacy of the
Taxotere label. Second, Sanofi contends that even considering Plaintiffs’ expert
evidence, no genuine dispute of material fact exists because Taxotere’s warning
is “adequate as a matter of law.”16
I. 	Expert Evidence
Sanofi argues that Plaintiffs lack expert testimony on label adequacy,
relying on arguments raised in its motions to exclude Drs. Kevin Knopf, David
12 Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986).
13 Johnson v. Deep E. Tex. Reg. Narcotics Trafficking Task Force, 379 F.3d 293, 301
(5th Cir. 2004) (internal citations omitted).
14 Badon v. R J R Nabisco, Inc., 224 F.3d 382, 394 (5th Cir. 2000) (Berrigan, J.)
(quoting Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (5th Cir. 1994)).
15 Boudreaux v. Banctec, Inc., 366 F. Supp. 2d 425, 430 (E.D. La. 2005).
16 Doc. 447-1 at 9.
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Ross, and Vikram Durairaj.17 Sanofi contends that without expert testimony,
Plaintiffs’ claims fail as a matter of law.
Here, Plaintiffs assert claims under the products liability laws of their
respective states. Because this Court exercises diversity jurisdiction, it applies
state substantive law.18 Where, as here, a transferee court presides over
multiple diversity actions consolidated in multidistrict litigation, it must apply
the substantive law of each transferor forum.19 Most, if not all, jurisdictions
generally require expert testimony on label adequacy.20 The Court need not
17 Sanofi further refers to the arguments raised in its motions to exclude Dr. McGwin,
Plaintiffs’ epidemiology expert, and Dr. Thundiyil, Plaintiffs’ toxicology expert. As to Dr.
McGwin, Plaintiffs conceded that he was not offering any opinions regarding the adequacy of
the label. See Doc. 487 at 27. As to Dr. Thundiyil, although Sanofi argues in the instant
Motion that he admitted he is not an expert in labeling, Sanofi’s motion to exclude did not
challenge any labeling-related opinions, instead seeking exclusion only of his general
causation opinions. See Doc. 446. Thus, neither expert appears to offer opinions regarding
label adequacy.
18 See Newsome v. Int’l Paper Co., 123 F.4th 754, 761 (5th Cir. 2024) (finding that
Texas substantive law applied to the inquiry of whether expert evidence was required to
establish causation); see also Smith v. Christus Saint Michaels Health Sys., 496 F. App’x 468,
470 (5th Cir. 2012); Ruffin v. BP Expl. & Prod., Inc., --- F.4th ----, 2026 WL 1478150, at *2
n.1 (5th Cir. May 27, 2026).
19 In re Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2740, 2022 WL 110494,
at *2 (E.D. La. Jan. 12, 2022) (Milazzo, J.) (quoting In re Air Disaster at Ramstein Air Base,
Germany on 8/29/90, 81 F.3d 570, 576 (5th Cir. 1996)); In re: Zicam Cold Remedy Mktg., Sales
Pracs., & Prods. Liab. Litig., 797 F. Supp. 2d 940, 942 (D. Ariz. 2011) (“As an MDL transferee
court, we apply the substantive law of each transferor forum.”).
20 See, e.g., In re Taxotere (Docetaxel) Prods. Liab. Litig., 462 F. Supp. 3d 650, 653 &
n.14 (E.D. La. 2020) (Milazzo, J.) (collecting cases holding that “[t]o defeat summary
judgment, Plaintiffs would need to show expert evidence creating an issue of fact on the
adequacy of Taxotere’s warning”); Eghnayem v. Boston Sci. Corp., 873 F.3d 1304, 1321 (11th
Cir. 2017) (noting that “the adequacy or inadequacy of the warning to inform a physician
must, except in the more obvious situations, be proved by expert testimony” (citation
modified)); Chandler v. Janssen Pharms., Inc., 322 F. Supp. 3d 314, 325 (E.D.N.Y. 2018)
(“Even though a jury does not need expert testimony to find a label inadequate, courts
routinely have held that conclusory opinions from counsel or experts are not enough to create
a genuine issue of material fact in a failure to warn claim.” (citation modified)).
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resolve whether expert testimony is required, however, because the Court has
previously determined that Plaintiffs’ experts may offer opinions related to the
Taxotere label.21
Specifically, this Court found that Dr. Ross, Plaintiffs’ regulatory expert,
could opine on the FDA regulatory scheme and the regulatory adequacy of the
Taxotere label, including whether Sanofi complied with certain regulations.22
The Court determined that Plaintiffs’ oncology expert Dr. Knopf may offer
testimony—subject to certain limitations—regarding the Taxotere warning
from the perspective of an oncologist, including testimony concerning the risks
identified on the label and how those warnings compare to the risks allegedly
associated with the drug.23 Finally, the Court determined that Dr. Durairaj,
Plaintiffs’ ophthalmology expert, may also testify regarding the injury at issue,
the risks associated with Taxotere, and compare those risks to the risks
warned about on the label.24 Accordingly, because Plaintiffs have produced
admissible expert testimony related to the Taxotere label, Sanofi is not entitled
to summary judgment on the ground that Plaintiffs lack expert evidence.
II. 	“Adequate as a Matter of Law”
Sanofi 	further 	argues 	that 	even 	considering 	Plaintiffs’ 	experts’
testimony, Plaintiffs have failed to create a genuine dispute of material fact
because the Taxotere label is “adequate as a matter of law.” Generally, the
adequacy of a prescription-drug warning is assessed under the applicable state
21 Plaintiffs also appear to agree that expert testimony is generally required to survive
a motion for summary judgment on label adequacy.
22 See Doc. 628.
23 See Doc. 631.
24 See Doc. 619.
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substantive law.25 Nevertheless, courts recognize that “[i]t is axiomatic that an
essential 	element 	of 	a 	failure 	to 	warn 	claim 	is 	a 	defendant’s 	failure 	to
adequately warn about the alleged risks associated with its product.”26 “In
prescription 	drug 	cases 	like 	this 	one, 	the 	learned 	intermediary 	doctrine
modifies 	the 	adequacy 	analysis.”27 	Under 	this 	doctrine—which 	no 	party
disputes applies here28—“adequacy in the context of prescription drugs is a
function of whether the doctor, rather than the patient, would reasonably
understand the risks.”29 “Physicians become learned intermediaries only when
they have received adequate warnings from the drug manufacturer.”30
“Ordinarily, the adequacy of a warning is a factual matter that will be
determined by the trier of fact.”31 It may, however, “become a question of law
25 See H.B. v. Abbott Laboratories, Inc. (In re Depakote) (hereinafter “In re Depakote”),
No. 3:15-cv-00702, 2017 U.S. Dist. LEXIS 174218, at *7–8 (S.D. Ill. Oct. 20, 2017) (holding
that Maryland law applied to the adequacy analysis); see also In re Bard IVC Filters Prod.
Liab. Litig., 969 F.3d 1067, 1076–77 (9th Cir. 2020) (applying Georgia law in concluding that
the adequacy of the defendant-manufacturer’s warnings regarding its G2 Filter was a
question properly posed to the jury).
26 In re Taxotere, 462 F. Supp. 3d at 652 (quoting In re Fosamax (Alendronate Sodium)
Prods. Liab. Litig., No. 12-cv-492, 2014 WL 2738224, at *8 (D.N.J. June 17, 2014)).
27 Id.
28 See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 813 (E.D.
Tex. 2002) (recognizing that although each state’s laws “may permit different exceptions to
the doctrine,” most jurisdictions “excuse a drug manufacturer from warning patients who
receive its product when the manufacturer properly warns the prescribing healthcare
provider of the product’s dangers”).
29 In re Taxotere, 462 F. Supp. 3d at 652 (quoting In re Meridia Prods. Liab. Litig., 328
F. Supp. 2d 791 (N.D. Ohio 2004), aff’d sub nom, Meridia Prods. Liab. Litig. v. Abbott
Laboratories, 447 F. 3d 861, 867 (6th Cir. 2006)).
30 Meridia, 447 F.3d at 867 (quoting Thom v. Bristol–Myers Squibb Co., 353 F.3d 848,
853 (10th Cir. 2003)).
31 Nelson v. C.R. Bard, Inc., 44 F.4th 277, 282 (5th Cir. 2022) (applying Mississippi
law).
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where the warning is accurate, clear and unambiguous.” 32 “A warning may be
held adequate as a matter of law where the adverse effect was one that the
manufacturer specifically warned against.”33 Courts have found a drug’s label
adequate 	where 	it 	is 	“reasonable 	under 	the 	circumstances.”34 	“[T]o 	be
reasonable, the warning should neither understate nor overstate the known
risks associated with the use of a particular product.”35
Further, 	courts 	presiding 	over 	multidistrict 	litigation 	have, 	in
appropriate circumstances, resolved warning-adequacy issues on summary
judgment. For example, in In re Fosamax, the court held that a warning was
adequate as a matter of law where the label was “accurate, clear, consistent,
and, 	read 	as 	a 	whole, 	conveyed 	‘an 	unmistakable 	meaning 	as 	to 	the
consequences of ingesting the drug.’” 36
Here, 	Plaintiffs 	do 	not 	argue 	that 	this 	Court 	must 	engage 	in 	an
individualized choice-of-law analysis in order to resolve Sanofi’s Motion for
Summary Judgment.37 Rather, Plaintiffs dispute that the Taxotere label is
32 Meridia, 447 F.3d at 867 (quoting Thom, 353 F.3d at 853); see also Saraney v. TAP
Pharm. Products Inc., No. 1:04 CV 02026, 2007 WL 148845, at *5 (N.D. Ohio Jan. 16, 2007)).
33 Nelson, 44 F.4th at 282; see also 12 BUS. & COM . LITIG. FED. CTS. § 131:7 n.4 (5th
ed.) (collecting cases deeming warnings adequate as a matter of law “where the adverse effect
ultimately visited upon the plaintiff was one the manufacturer specifically warned against”).
34 Nelson, 44 F.4th at 282; see also Meridia, 447 F.3d at 876; In re Chantix (Varencline)
Prods. Liab. Litig., 881 F. Supp. 2d 1333, 1343 (N.D. Ala. 2012).
35 Nelson, 44 F.4th at 282. Again, the Court recognizes that state substantive laws
may vary. Nevertheless, the Court will apply the general principals
36 In re Taxotere, 462 F. Supp. 3d at 652 (quoting In re Fosamax, 2014 WL 2738224,
at *11).37 See, e.g., In re Depakote, 2017 U.S. Dist. LEXIS 174218, at *11 (determining
Maryland substantive law governed the adequacy analysis); c.f. In re Chantix, 881 F. Supp.
2d at 1342–43 (finding that, irrespective of any differences among varying states’ laws, the
black box warning for a smoking-cessation medication was adequate as matter of law where
the plaintiffs sought to pursue a theory based on the warning’s failure to “tell physicians
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“adequate as a matter of law” under the general standards set forth by Sanofi.
Even 	setting 	aside 	any 	choice-of-law 	issues, 	however, 	this 	Court 	cannot
conclude as a matter of law that Taxotere’s label, read as a whole, conveyed an
unmistakable warning regarding the relevant risk. Plaintiffs have provided
evidence sufficient to show a genuine dispute as to whether the label, in
warning about “lacrimal duct obstruction,” adequately warned of the specific
condition Plaintiffs identify—namely, “stenosis of the nasolacrimal drainage
system.” Moreover, Plaintiffs argue that the label did not convey the severity
of that risk, that is, that stenosis could be permanent.
In support of its argument that “lacrimal duct obstruction” conveys the
risk 	of 	“stenosis,” 	Sanofi 	cites 	the 	1995 	edition 	of 	Stedman’s 	Medical
Dictionary, which defines obstruction as a “[b]lockage or clogging, e.g., by
occlusion or stenosis.”38 In response, however, Plaintiffs point to the 2006
edition of the same dictionary, which defines stenosis as “a stricture of any
canal or orifice,” or a “narrowing,” and cautions: “[d]o not confuse this word
with 	atresia 	or 	occlusion.”39 	Thus, 	the 	medical 	literature 	itself 	does 	not
(unequivocally) equate “stenosis” with “obstruction.”40
Sanofi further argues that Plaintiffs’ experts have conceded, at least
implicitly, that the term “lacrimal duct obstruction” sufficiently conveys the
risk “stenosis of the lacrimal drainage system,” as well as the possibility that
when to prescribe it,” the complaint “did not stretch far enough to include such a claim,” and
the plaintiffs’ experts offered no opinions supporting that theory).
38 Doc. 447-22 at 6.
39 Doc. 493-104 at 5.
40 In its prior Order and Reasons granting in part and denying in part Sanofi’s motion
to dismiss, this Court previously considered and rejected many of the same arguments that
Sanofi raises here. See Doc. 81.
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the obstruction and resulting tearing may become permanent, pointing to the
experts’ deposition testimony. Plaintiffs respond that Sanofi overstates and at
times 	mischaracterizes 	these 	purported 	concessions. 	After 	reviewing 	the
experts’ reports, as well as the relevant testimony, the Court finds that at most,
it creates competing factual inferences that are properly resolved by a jury,
rather than summary judgment.
Indeed, the experts appear to disagree on this issue. Sanofi relies on its
regulatory expert, Dr. Sul, who opines that there is no material distinction
between “nasolacrimal” and “lacrimal,” or between “potentially permanent
stenosis” and “obstruction,” because those terms do “not inherently change the
characterization 	of 	the 	condition 	or 	impart 	additional 	or 	more 	useful
information for the prescriber.”41 Dr. Ross, by contrast, opines that the Adverse
Reactions section should have warned of “[e]xcessive tearing attributable to
potentially permanent stenosis to the nasolacrimal drainage system requiring
surgical 	intervention.”42 	Dr. 	Durairaj 	further 	opines 	that 	“lacrimal 	duct
obstruction” is not terminology he uses in his practice. As such, Plaintiffs have
introduced evidence from which a reasonable jury could conclude that the
warning failed to clearly communicate the nature and severity of the condition.
Further, even assuming that the label’s warning about “lacrimal duct
obstruction” conveyed the risk at issue, there remains a genuine dispute of
material fact as to whether the warning was misleading between 2003 and
2020.43 Courts have recognized that “[m]erely mentioning a possible injury or
41 Doc. 447-9 at 9.
42 Doc. 447-20 at 62.
43 Plaintiffs argue that the warning was “worse than no warning at all.” Doc. 486 at 9.
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adverse effect is not necessarily adequate.”44 “Rather, ‘[t]he jury is to consider
all pertinent factors’ in determining the adequacy of a product warning,”
including, for example, the “seriousness of the consequences.”45 Here, between
2003 and 2014, the label stated, in relevant part:
Ophthalmologic: conjunctivitis, lacrimation, or lacrimation with or
without 	conjunctivitis. 	Excessive 	tearing, 	which 	may 	be
attributable 	to 	lacrimal 	duct 	obstruction 	has 	been 	reported.
Transient visual disturbances (flashes, flashing lights, scotomata)
typically occurring during drug infusion and in association with
hypersensitivity 	reactions 	have 	been 	reported. 	These 	were
reversible upon discontinuation of infusion.46
In 2014, this section was revised to state:
Ophthalmologic: conjunctivitis, lacrimation, or lacrimation with or
without 	conjunctivitis. 	Excessive 	tearing, 	which 	may 	be
attributable 	to 	lacrimal 	duct 	obstruction 	has 	been 	reported.
Transient visual disturbances (flashes, flashing lights, scotomata)
typically occurring during drug infusion and in association with
hypersensitivity 	reactions 	have 	been 	reported. 	These 	were
reversible 	upon 	discontinuation 	of 	infusion. 	Cases 	of 	cystoid
44 In re Meridia, 328 F. Supp. 2d at 809–10 (citing Stahl v. Novartis Pharms. Corp.,
283 F.3d 254, 267 (5th Cir. 2002); see also Johnson v. C.R. Bard Inc., No. 19-cv-760, 2021 WL
1784661, at *8 (W.D. Wis. May 5, 2021) (finding that, under Wisconsin law, the fact that the
product generally warned of possible complications ultimately experienced by the plaintiff
did not render the warning adequate as a matter of law); In re Depakote, 2017 U.S. Dist.
LEXIS 174218, at *16 (applying Maryland law and holding that although there was no
dispute that the prescription drug Depakote’s label “included the 1-2% risk of spina bifida,”
the label was not adequate as a matter of law because, among other things, the label excluded
a “last resort instruction” and included a “statement that ‘all antiepileptic drugs carry a risk
of birth defects’”).
45 Johnson, 2021 WL 1784661, at *8 (alterations in original) (quoting Mohr v. St. Paul
Fire & Marine Ins. Co., 674 N.W.2d 576, 589 (Ct. App. Wis. 2003)); see also In re Bard IVC
Filters Prod. Liab. Litig., 969 F.3d 1067, 1076–77 (9th Cir. 2020) (applying Georgia law and
concluding that label adequacy was a question properly posed to the jury).
46 Doc. 486-15 at 24 (emphasis added).
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macular edema (CME) have been reported in patients treated with
TAXOTERE.47
This language remained until the label was revised in 2020.
Sanofi 	argues 	that 	the 	phrase 	“these 	were 	reversible 	upon
discontinuation of infusion” plainly refers only to the immediately preceding
sentence 	regarding 	“transient 	visual 	disturbances.” 	The 	Court 	disagrees.
Viewing the evidence in the light most favorable to Plaintiffs, a reasonable jury
could conclude that the label suggested that excessive tearing associated with
lacrimal duct obstruction was reversible when, according to Plaintiffs, the
condition could instead progress to permanent injury.48
Moreover, Plaintiffs allege through their expert Dr. Ross not only that
the label failed to warn about excessive tearing due to potentially permanent
stenosis, but also that it failed to warn physicians regarding (1) prompt referral
to an ophthalmologist upon signs of excessive tearing and (2) the potential need
for surgical intervention. Citing Dr. Sul’s testimony, Sanofi argues that it has
no duty to provide such a warning because treatment decisions may vary and
manufacturers are not required to instruct physicians how to manage disclosed
47 Doc. 486-17 at 35.
48 Sanofi further asserts that Plaintiffs have failed to produce expert testimony
supporting their contrary interpretation. Courts have recognized, however, that warning
adequacy ordinarily must be established through expert testimony “except in the more
obvious situations.” Eghnayem, 873 F.3d at 1323. But even assuming expert testimony is
required on this theory, Plaintiffs have produced it—Dr. Ross’s proposed warning omits the
“reversible” language entirely, and Dr. Knopf opines that the label implies that the injury is
reversible.
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side effects. In relying on competing expert testimony, however, Sanofi again
underscores the factual dispute presented here.49
Setting aside the fact that Plaintiffs’ expert disagrees, Dr. Sul’s opinions
do not conclusively establish that Sanofi had no duty to include Plaintiffs’
proposed warning. According to Dr. Sul, the FDA generally declines to include
“management instructions for adverse events” in labels in order to avoid
“dictating the 	practice of 	medicine.”50 As to 	Plaintiffs’ 	proposed 	warning
regarding referral to an ophthalmologist, such a warning is not necessarily a
“management instruction.” Further, while the parties do not argue that any
specific state’s law applies, courts in several jurisdictions have held that an
inadequate 	warning 	claim 	may 	be 	based 	on 	“alleged 	inadequacies 	in 	a
recommended medical monitoring or testing regime.”51 And as Plaintiffs point
out, the Taxotere label itself contains comparable language elsewhere in the
Warnings and Precautions section. For example, the warning regarding cystoid
macular edema states that “[p]atients with impaired vision should undergo a
prompt and comprehensive ophthalmologic examination.”52 As to Plaintiffs’
49 Sanofi argues that Plaintiffs’ experts have conceded that the term “lacrimal duct
obstruction” adequately warns of the risk of surgical intervention. As stated above, to the
extent any concessions were made, the Court finds that they are not dispositive.
50 Doc. 447-9 at 9.
51 Stahl, 283 F.3d at 270 (noting that “many courts applying the law of other states
have implicitly assumed that medical monitoring recommendations contained in package
inserts are ‘warnings’ by evaluating such recommendations (or the absence of such
recommendations) in determining whether a drug manufacturer has fulfilled its duty to
warn”); but see Dye v. Covidien LP, 470 F. Supp. 3d 1329, 1341 (S.D. Fla. 2020) (holding that,
under Florida law, the defendant-manufacturer “need only warn of complications stemming
from the use of the [p]roduct—not the subsequent measures medical professionals may
employ to treat those complications”). Even assuming, however, that the rule outlined in Dye
applied here, it would not necessarily extend to Plaintiffs’ proposed warning about referral.
52 Doc. 486 at 18.
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proposed warning about surgical treatment, Sanofi’s communications with the
FDA indicate that the FDA itself initially proposed language to be added to the
label 	indicating 	that 	“silastic 	tube 	replacement”—a 	type 	of 	surgical
treatment—may be required in some cases.53 Accordingly, the Court cannot
conclude as a matter of law that Plaintiffs cannot proceed on their theory that
Taxotere’s label failed to warn about the need for prompt referral or surgical
intervention.
Finally, in addition to opining that the warning in the Adverse Events
section should have been revised, Dr. Ross opines that a warning should have
been added to the Warnings and Precautions section.54 Again citing Dr. Sul’s
opinion, Sanofi argues that Dr. Ross’s proposed warning could not properly
appear in the Warnings and Precautions section because that section is
reserved for risks that are sufficiently “serious or are otherwise clinically
significant” such that they have “implications for prescribing decisions or for
patient 	management.”55 	To 	the 	extent 	Sanofi 	argues 	that 	federal 	law
categorically prohibits inclusion of stronger warning language in the Warnings
and Precautions section, the Court is not persuaded. In his report, Dr. Ross
concluded that such a warning would be proper, citing the relevant guidelines
and 	regulations.56 	The 	remaining 	issue 	is 	therefore 	whether 	the 	label
53 Doc. 447-13 at 2.
54 Doc. 447-20 at 62.
55 Doc. 447-9 at 82.
56 This Court has found that analogous regulatory opinions, to the extent they
constitute legal conclusions, are nevertheless permissible. See Doc. 628. Moreover, courts,
including this Court, have found expert testimony pertinent to the issue of whether a warning
is properly placed on a prescription drug’s label. See, e.g., In re Taxotere, 462 F. Supp. 3d at
674–75 (Milazzo, J.) (holding Taxotere’s warning adequate as a matter of law where the label
expressly disclosed the relevant risk and the plaintiffs produced no expert evidence
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adequately conveyed the risk. In resolving that issue, the jury may consider
the parties’ competing expert testimony.
At bottom, this case does not present the type of clear and unambiguous
warning that may properly be deemed adequate as a matter of law. Significant
disputes remain regarding whether the Taxotere label adequately conveyed
the nature and severity of the condition, as well as whether aspects of the
warning 	were 	misleading. 	Those 	disputes 	are 	for 	the 	jury 	to 	resolve.
Accordingly, Sanofi’s Motion for Summary Judgment must be denied.
CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Sanofi’s Motion to for Summary Judgment Based
on Label Adequacy (Doc. 447) is DENIED.
New Orleans, Louisiana this 25th day of June, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
supporting their theory that the warning was inadequate because it did not appear in the
“Warnings and Precautions” section); In re Chantix, 881 F. Supp. 2d at 1340–43.
Case 2:22-md-03023-JTM-MBN Document 639 Filed 06/26/26 Page 15 of 15