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 	)
ORDER AND REASONS
Before the Court is Defendant Sanofi’s Motion to Certify Order for
Interlocutory Appeal Under 28 U.S.C. § 1292(b) (Doc. 595). Plaintiffs do not
oppose. For the following reasons, the Motion is GRANTED.
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”), Accord Healthcare, Inc. (“Accord”), and Sandoz Inc.
(“Sandoz”). Plaintiffs allege that Taxotere or docetaxel caused them to sustain
injuries 	to 	their 	lacrimal 	systems, 	including 	punctal, 	canalicular, 	and/or
nasolacrimal duct stenosis (narrowing), which resulted in excessive tearing,
otherwise 	known 	as 	epiphora. Plaintiffs 	bring 	state-law 	claims 	for 	strict
products liability (failure to warn) and negligence.
1 Taxotere is the brand name for the drug docetaxel.
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Sanofi manufactures Taxotere, the brand name and Reference Listed
Drug (“RLD”) for docetaxel. In 1996, Sanofi sought approval via the method for
a “brand new drug” as “laid out in § 505(b)(1) of the FDCA,” or 21 U.S.C. §
355(b)(1).2 	This 	method 	“requires 	manufacturers 	to 	file 	a 	New 	Drug
Application (“NDA”), which includes, inter alia, ‘full reports of investigations
which have been made to show whether such drug is safe for use and whether
such drug is effective in use.’”3 Thus, the RLD is the first drug of a specific kind
to be approved under § 505(b)(1).4
“Thereafter, other manufacturers who want to prepare the same drug or
a drug that is similar enough may use two abbreviated pathways to obtain
FDA approval with less burden and expense.”5 One of these pathways—laid
out in § 505(j), or 21 U.S.C. § 355(j) —is available to manufacturers of what is
generally considered a “true generic” drug.6 In seeking approval with the FDA,
§ 355(j) allows such manufacturers to submit an “Abbreviated New Drug
Application” that relies on the safety and efficacy data submitted in the RLD’s
NDA.7
In 2011, Sandoz and Accord each sought approval for their docetaxel
drugs pursuant to a third pathway set forth in § 505(b)(2) of the FDCA, or 21
U.S.C. 	§ 	355(b)(2). 	In 	simple 	terms, 	this 	pathway 	is 	available 	for
2 See Hickey v. Hospira, 102 F.4th 748, 750–51 (5th Cir. 2024) (explaining the various
pathways for approval under the FDCA). The Court and the parties “refer to this provision
and its counterparts—§§ 505(b)(2) and (j)—by their location in the FDCA rather than their
location in the United States Code,” because “doing so is common practice.” See id. at 750 n.1.
3 Id. at 751 (quoting 21 U.S.C. § 355(b)(1)(A)(i)).
4 See id.
5 Id.
6 See id. (citing 21 U.S.C. § 355(j)).
7 See id. (citing 21 U.S.C. § 355(j)(2)(A)).
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manufacturers whose drugs fall somewhere in the middle of the two types of
drugs just described. More specifically, these drugs “differ from the RLD in
ways that are slight enough for the manufacturer to still rely on the RLD’s
safety and efficacy data.”8 A § 505(b)(2) manufacturer must submit an NDA
that contains only “that information needed to support the modification(s) of
the listed drug.”9 “ Unlike § 505(j) drugs, § 505(b)(2) drugs are not required to
use the exact same labeling as the RLD.”10
In 2002, Sanofi’s Taxotere label was updated to include the following
warning as an “adverse event” in the “Post-marketing Experiences” subsection
of the label:
Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or
without 	conjunctivitis. 	Excessive 	tearing 	which 	may 	be
attributable to lacrimal duct obstruction has been reported.11
In 2003, this section was again 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. Rare
cases of 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 the infusion.12
When Accord’s and Sandoz’s docetaxel drugs were approved in 2011, the labels
essentially matched the 2003 warning on the Taxotere label.
8 Id. (citing 21 U.S.C. § 355(b)(2)).
9 Id. (first citing 21 U.S.C. § 355(b)(2); then citing 21 C.F.R. § 314.54(a)).
10 Id. (citing 21 C.F.R. § 314.54(a)(2)).
11 Doc. 583 at 21; Doc. 493-13.
12 Doc. 493-44.
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I. 	Sanofi’s Motion for Summary Judgment on Preemption
On February 28, 2025, Sanofi filed a Motion for Summary Judgment
arguing that under the theory of “impossibility preemption,” Plaintiffs’ claims
were preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”) and
its corresponding regulations.13 Briefly, federal law impliedly preempts state
law when state and federal law “conflict,” in other words, when “it is impossible
for a private party to comply with both state and federal law.”14 In this
failure-to-warn-context, “impossibility” means that the drug manufacturer
could 	not 	have 	added 	and/or 	updated 	the 	warnings 	on 	its 	drug’s 	label
independently—i.e., without preapproval from FDA—in order to satisfy any
alleged state law duties to warn.15
In the Fifth Circuit, the threshold question in a case such as this one is
whether a manufacturer could have unilaterally changed the label on its drug
via the changes-being-effected (“CBE”) regulation.16 Relevant here, the CBE
regulation “permits drug manufacturers to change a label without prior FDA
approval if the change is designed to ‘add or strengthen a . . . warning’ where
there 	is 	‘newly 	acquired 	information’ 	about 	the 	‘evidence 	of 	a 	causal
association’ between the drug and a risk of harm.”17 If these requirements are
not satisfied, a plaintiff’s claims are preempted. If they are satisfied, however,
13 Doc. 445.
14 Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372–373 (2000).
15 See Hickey, 102 F.4th at 753 (quoting PLIVA v. Mensing, 564 U.S. 604, 620 (2011)).
16 Id. at 751, 754 (citing 21 C.F.R. § 314.70(c)(6)).
17 Merck Sharp & Dohme Corp. v. Albrecht, 586 U.S. 299, 305 (2019) (alterations in
original) (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A)).
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a plaintiff’s claims are nevertheless preempted if a manufacturer can show
“‘clear evidence’ that the FDA would not have approved a change to the label.”18
Sanofi moved for summary judgment only on the threshold question, arguing
that there existed no “newly acquired information” as required to invoke the
CBE process.
Pursuant to 21 C.F.R. § 314.3(b), “newly acquired information” must
“reveal risks of a different type or greater severity or frequency than previously
included in submissions to FDA.”19 On summary judgment, Sanofi provided
evidence that it submitted three “groups” of evidence. First, consistent with its
pharmacovigilance 	obligations, 	it 	submitted 	to 	the 	FDA 	a 	“15-day 	ADE
Report,” which included cases from two publications. The first was an abstract
titled “Early Recognition of Taxane-Associated Canaliculitis Important in
Preserving Lacrimal Duct Function,” which was published in 2000 by R.
Kneuper Hall and others in Breast Cancer Research and Treatment (“2000
Kneuper 	Hall 	Abstract”). 	The 	second 	publication, 	“Canalicular 	Stenosis
Secondary to Docetaxel (Taxotere): A Newly Recognized Side Effect,” was
published in 2001 in Ophthalmology by Dr. Bita Esmaeli and others (“2001
Esmaeli Ophthalmology Article”).
Second, in conjunction with the 2002 label change, Sanofi submitted to
the FDA Supplement 17, which included as attachments case line listings.
Finally, in February 2002, Sanofi submitted a Supplemental NDA (“sNDA”),
which included the Eighth Periodic Safety Update Report for Taxotere (“PSUR
8”), as well the Ninth Periodic Safety Update Report for Taxotere (“PSUR 9”).
18 Id. at 300 (quoting Wyeth v. Levine, 555 U.S. 555, 571 (2009)).
19 (emphasis added).
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PSURs 8 and 9 were previously prepared and submitted to the European
Agency for the Evaluation of Medicinal Products (“EMA”). In PSUR 8, Sanofi
concluded that “[t]o date, there is no clear mechanism of action for docetaxel to
cause canalicular fibrosis.”20 PSUR 9’s summary included cases from the 2000
Kneuper Hall Abstract and 2001 Esmaeli Ophthalmology Article. In PSUR 9,
Sanofi estimated that “tearing abnormality requiring intervention,” as well as
those possibly involving tear duct obstruction or blockage, were at “rates less
than or equal to 1/10,000 patients,” or .01%, and noted that “patient exposure
data is not available based on dosing schedule.”21
In 	their 	Opposition, 	Plaintiffs 	first 	argued 	that 	prior 	to 	the 	2008
amendments to the regulations, newly acquired information was not required
for a manufacturer to unilaterally change its label. They contended that
regardless, several pieces of scientific literature constituted newly acquired
information.
On December 1, 2025, this Court issued an Order and Reasons denying
Sanofi’s 	Motion 	(the 	“Sanofi 	Order”), 	wherein 	it 	first 	acknowledged 	that
neither the Fifth Circuit nor the Supreme Court had addressed the issue of
whether the 2008 amendments were consistent with previous regulations. The
Court declined to decide the issue, however, because two pieces of published
scientific literature satisfied the definition of newly acquired information. That
is, as compared to Sanofi’s previous submissions, they revealed “risks of a
different type, or greater severity or frequency.” The first was an article
published in 2003 in Cancer by Dr. Esmaeli and others titled “Blockage of the
20 Doc. 583 at 13.
21 Id. at 15.
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Lacrimal Drainage Apparatus as a Side Effect of Docetaxel Therapy” (“2003
Esmaeli Study”). The 2003 Esmaeli Study was a retrospective study that
evaluated the records of 148 patients with epiphora associated with docetaxel
therapy. The purpose of the study was “to report the severity and management
of canalicular and nasolacrimal duct stenosis as a side effect of docetaxel
therapy 	and 	to 	report 	the 	outcomes 	of 	surgical 	intervention 	for 	this
condition.”22
The second was a study titled “Prospective Study of Incidence and
Severity of Epiphora and Canalicular Stenosis in Patients with Metastatic
Breast Cancer Receiving Docetaxel” that was published in the Journal of
Clinical Oncology (“2006 Esmaeli Study”). The purpose of the 2006 Esmaeli
Study was to “determine the incidence and severity of epiphora and canalicular
stenosis in patients receiving docetaxel weekly or every 3 weeks.” The authors
reported that among the 28 patients who received weekly docetaxel, 9 patients
(32%) developed stenosis. Among patients taking docetaxel every three weeks,
2 out of 28 patients (7%) developed stenosis.23
II. 	Sandoz’s 	and 	Accord’s 	Motions 	for 	Summary 	Judgment 	on
Preemption
On 	February 	27 	and 	28, 	2025, 	Defendants 	Accord 	and 	Sandoz
respectively filed similar Motions for Summary Judgment, arguing that there
existed on the record no newly acquired information published after approval
of their drugs in 2011.24 On January 28, 2026, this Court issued an Order and
22 Doc. 493-111.
23 Doc. 493-120.
24 Doc. 439 (Accord’s Motion for Summary Judgment); Doc. 458 (Sandoz’s Motion for
Summary Judgment).
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Reasons granting both Motions (“505(b)(2) Order”), finding that there existed
no newly acquired information such that Accord and Sandoz could have
unilaterally changed their labels.25
In so holding, this Court followed the Fifth Circuit’s decision in Hickey v.
Hospira, which set the standard for the newly acquired information analysis
as applied to § 505(b)(2) manufacturers.26 Although Hickey involved different
claims than those alleged by Plaintiffs here (the plaintiffs there alleged
permanent chemotherapy-induced alopecia, or “PCIA”), it involved the same
drug and defendant-manufacturers.27
In Hickey, the Fifth Circuit explained that a § 505(b)(2) manufacturer
may submit an NDA that relies, at least in part, on the RLD’s safety and
efficacy data when seeking approval.28 But generally, those manufacturers do
not have access, or “right of reference,” to that information during the relevant
time.29 Nor did the § 505(b)(2) defendants have access to the RLD’s adverse
event reports at that time.30 With respect to newly acquired information, this
creates a knowledge gap: a § 505(b)(2) manufacturer theoretically could not
know if information was “new” without knowing what was already submitted
to the FDA.
25 Doc. 591.
26 Hickey, 102 F.4th 748.
27 Id. In Hickey, the court addressed motions for summary judgment filed by the
defendant-manufacturer Accord, as well as Hospira (another § 505(b)(2) manufacturer). Id.
at 752.28 Id. at 751.
29 See id. at 755 (citing 21 U.S.C. § 355(b)(2)).
30 See id.
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Thus, the question was how to interpret the requirement that newly
acquired information “reveal risks of a different type or greater severity or
frequency than previously included in submissions to FDA.”31 The record
indicated that prior to approval of the defendants’ drugs in 2011, numerous
scientific studies and articles were published describing the “risk of docetaxel-
induced PCIA.”32 Because this literature was available to the public, there was
something for the defendants to “be aware of” and “responsive to.”33 The court
also noted that Sanofi (the RLD manufacturer) was presumably required to
submit those studies in the years before the defendants’ drugs were approved.
This publicly available literature formed the baseline for the analysis—that is,
“prior submissions to the FDA.”34
The court concluded that “for post-approval information to meet the
requirements of ‘newly acquired information,’ it must at least ‘reveal risks of a
different type or greater severity or frequency’ than the risks revealed in the
scientific literature available to” the 505(b)(2) defendants.35 Stated another
way, the “baseline comparator” was the publicly available scientific literature
that existed prior to approval of the § 505(b)(2) manufacturers’ drugs in 2011.36
Turning back to this Court’s analysis, in its 505(b)(2) Order, the Court
concluded that the post-approval (i.e., post-2011) information available to
Defendants Accord and Sandoz did not reveal “risks of a different type, or
31 See id. (emphasis added) (quoting 21 C.F.R. § 314.3(b)).
32 See id. at 757.
33 Id. at 756.
34 Id. at 757.
35 Id. As to post-approval information, this included scientific literature published
after 2011, as well as any adverse event reports the defendants may have received. Id.
36 Id.
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greater severity or frequency” than the publicly available scientific literature
published 	prior 	to 	2011. 	As 	was 	the 	case 	in 	Hickey, 	the 	post-approval
information did not reveal any new or more severe risks; nor did it reveal a
“frequency” that was any higher than the established frequency in the publicly
available pre-approval literature, namely, the 2006 Esmaeli Study.
III. 	Instant Motion to Certify
On January 27, 2026, Sanofi filed the instant Motion for Certificate of
Appealability requesting that the Court certify for interlocutory appeal its
December 1, 2025 Order and Reasons denying Sanofi’s Motion for Summary
Judgment. Plaintiffs do not oppose.37
LEGAL STANDARD
Pursuant to 28 U.S.C. § 1292, a court can allow for interlocutory appeal
of orders without directing entry of a final judgment on the order. For an
interlocutory order to be appealable pursuant to § 1292(b), the Court must
certify in writing that: (1) the order involves a controlling question of law, (2)
there exists a substantial ground for difference of opinion on that question of
law, and (3) an immediate appeal from the order may “materially advance the
ultimate termination of [the] litigation.”38 The moving party carries the burden
of showing the necessity of interlocutory appeal.39 An interlocutory appeal is
37 On February 12, 2026, Plaintiffs informed the Court via email that they did not
intend to oppose Defendants’ Motion to Certify.
38 28 U.S.C. § 1292; see also Rico v. Flores, 481 F.3d 234, 238 (5th Cir. 2007).
39 Chauvin v. State Farm Mut. Auto. Ins. Co., Nos. 06-7145, 06-8769, 2007 WL
4365387, at *2 (E.D. La. Dec. 11, 2007) (citing Complaint of L.L.P. & D. Marine, Inc., Nos.
Civ. A. 97-1668, 97-2992, 97-3349, 1998 WL 66100, at *1 (E.D. La. Feb. 13, 1998)).
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“exceptional,” and “assuredly does not lie simply to determine the correctness
of a judgment of liability.” 40
LAW AND ANALYSIS
Sanofi argues that this Court’s Sanofi Order presents a controlling
question 	of 	law 	that, 	if 	appealed, 	may 	materially 	advance 	the 	ultimate
termination of the litigation. Sanofi further contends that there is a substantial
ground 	for 	difference 	in 	opinion 	because 	this 	Court’s 	Sanofi 	Order 	is
“inconsistent” with its 505(b)(2) Order. Sanofi also argues that, in holding that
the 2003 and 2006 Esmaeli Studies constituted “newly acquired information,”
the Court “expanded” the regulatory definition. The Court will consider each
argument in turn.
I. 	(1) Controlling Question of Law and (3) Material Advancement
“A controlling question of law is one ‘that would require reversal on
appeal from a final judgment or would materially affect the outcome of the
case.’”41 Resolution of a controlling question of law need not terminate the
litigation entirely so long as it “would have some significant impact on the
advancement of the litigation.”42 “To this extent, the ‘controlling question’
inquiry is inherently related to the requirement that resolution of the issue
40 Clark-Dietz and Associates-Engineers, Inc. v. Basic Const. Co., 702 F.2d 67, 68, 69
(5th Cir. 1983).
41 D.H. Griffin Wrecking Co. v. 1031 Canal Dev., LLC, No. 20-1051, 2020 WL 7626817,
at *3 (E.D. La. July 14, 2020) (quoting Jesclard v. Babcock & Wilcox, Civ. A. No. 82-1570,
1990 WL 182315, at *1 (E.D. La. Nov. 21, 1990)).
42 Id. (citing Ryan v. Flowserve Corp., 444 F. Supp. 2d 718, 723 (N.D. Tex. 2006)).
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materially advance the litigation.”43 “Additionally, controlling questions of law
generally must be purely legal in nature.”44
The Fifth Circuit has held that federal preemption “certainly falls within
the ambit of 28 U.S.C. § 1292(b).”45 Although this Court noted in its Sanofi
Order that both steps of the preemption question may require resolution of
subsidiary factual disputes, it also recognized that preemption is ultimately a
question of law for a judge to determine.46 And as Sanofi points out, an
immediate appeal would advance the litigation because a Fifth Circuit ruling
in Sanofi’s favor would require dismissal of claims against Sanofi. Sanofi also
argues, and Plaintiffs do not dispute, that Plaintiffs would not be prejudiced if
Sanofi’s 	interlocutory 	request 	were 	granted. 	Thus, 	the 	first 	and 	third
requirements are satisfied.
II. 	(2) Substantial Ground for Difference in Opinion
The more difficult question here is whether the second requirement is
satisfied. Courts often find that a substantial ground for difference of opinion
exists if “novel and difficult questions of first impression are presented.”47
First, Sanofi argues that this Court’s Sanofi Order is inconsistent with its
43 Id.
44 Id. (citing Williams v. Taylor, No. CIV.A. 15-321, 2015 WL 4755162, at *2 (E.D. La.
Aug. 11, 2015)).
45 Spong v. Fidelity Nat’l Prop. & Cas. Ins. Co., 787 F.3d 296, 304 (5th Cir. 2015).
46 See Doc. 583 at 27–30; In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 118
F.4th 322, 344 (3d Cir. 2024) (holding that, although the ultimate question is a question of
law that is reviewed de novo, when a district court resolves subsidiary factual matters in the
course of deciding that ultimate legal question, it would review those findings under a “clearly
erroneous” standard).
47 Mitchell v. Hood, No. 13-5875, 2014 WL 1764779, at *5 (E.D. La. May 2, 2014)
(quoting Couch v. Telescope, Inc., 611 F.3d 629, 633 (9th Cir. 2010)).
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505(b)(2) Order. From that premise, Sanofi sets out in its Motion two separate
issues that raise a substantial ground for difference in opinion:
1. Whether FDA’s approval of later-in-time (i.e. 2011) 505(b)(2) drugs
with identical warning language to the RLD holder on the alleged
risk provides evidence that intervening publicly available medical
literature does not constitute “newly acquired information”; and
2. In 	light 	of 	the 	Court’s 	505(b)(2) 	Order, 	whether 	the 	publicly
available literature available to Sanofi before 2011 and considered
by the Court satisfies the plain text definition of newly acquired
information.
a. Whether this Court’s Orders conflict
Contrary to what Sanofi suggests, this Court’s application of Hickey’s
reasoning in the 505(b)(2) Order does not render it “irreconcilable” with the
Sanofi Order. Hickey created a rule that applies to § 505(b)(2) defendants. The
plain terms of the regulation require the Court to assesses if information
reveals 	different, 	more 	severe, 	or 	more 	frequent 	risks 	than 	previous
submissions to the FDA. 48 As to Sanofi, the Court must necessarily evaluate
Sanofi’s previous submissions as the baseline comparator. In Sanofi’s case,
Plaintiffs argued that studies that were published after 2002 constituted newly
acquired information. The Court therefore compared those post-2002 studies
to the evidence in the record that Sanofi contended it submitted to the FDA
prior to (and in) 2002. Under the plain terms of the regulation, this is all that
is required.
48 See, e.g., Wyeth, 555 U.S. at 569–70.
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By contrast, in Hickey, the court considered how to apply the regulation
to the § 505(b)(2) defendants, whose drugs were approved after the RLD
manufacturer via a different process. The Hickey court concluded that the
relevant “pre-approval” publicly available literature created the baseline for
the analysis. This Court applied that rule to Sandoz and Accord. In short, the
Sanofi Order does not conflict with the 505(b)(2) Order. Rather, the Orders are
chronological.
b. Whether FDA approval of Accord’s and Sandoz’s labels in 2011
affects the “newly acquired information” inquiry as to Sanofi
In any event, Sanofi’s argument is not about conflicting orders, though
Sanofi frames it as such. Rather, Sanofi argues that information cannot be
newly acquired as to Sanofi if the FDA had it when it approved Accord’s and
Sandoz’s labels in 2011. Indeed, Sanofi posits that this Court assumed in its
505(b)(2) Order that prior to 2011, Sanofi had submitted the 2003 Esmaeli
Study and the 2006 Esmaeli Study to the FDA. Sanofi contends that this
implies that the FDA considered both studies prior to approving Accord’s and
Sandoz’s labels in 2011, both of which were identical to Taxotere’s label in
2003. According to Sanofi, this creates an “untenable result” vis-à-vis the
Sanofi Order. This is so because if the 2003 and 2006 Studies did “in fact
present additional risk information that was not adequately captured” by the
2003 	labeling, 	then 	the 	“FDA 	could 	not 	have 	approved 	the 	505(b)(2)
applications without requiring revised warnings.”49 Stated another way, if the
2003 and 2006 studies were “newly acquired information” allowing Sanofi to
49 Doc. 595-1 at 7.
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change its 2003 label, Accord’s and Sandoz’s labels could not have been
approved in 2011 without also changing.
The Fifth Circuit in Hickey bolstered its reasoning that the “publicly
available literature” served as the baseline by adding, in a footnote, that Sanofi
was 	required 	to 	submit 	publicly 	available 	literature 	as 	part 	of 	its
“postmarketing” pharmacovigilance obligations, but the court made no explicit
finding that Sanofi had done so.50 As Hickey noted, requiring the § 505(b)(2)
defendants to look back in time and sift through pre-approval information
would put “the highest standard on secondary manufacturers rather than
original ones, which does not comply with the overall framework.”51
Sanofi seeks to impose a rule that the FDA’s 2011 label approval as to
Accord and Sandoz cannot be “second guessed” by Sanofi. But in their Motion
for Summary Judgment, Sanofi failed to raise any of the issues it attempts to
raise here—namely, that the 2011 label approvals are relevant. Sanofi further
failed to point to any evidence as to what it submitted between 2002 and 2011.
Ordinarily, Sanofi’s failure to present these issues would be fatal to raising
them now.52 Even so, given Plaintiffs’ failure to oppose, the Court will address
Sanofi’s argument.
50 See Hickey, 102 F.4th at 756 n.5 (citing 21 C.F.R. § 314.80(b)–(d) and 21 C.F.R. §
314.81(b)). Plaintiffs do not dispute that issue here. Plaintiffs did note in their Opposition,
however, that there was no evidence that certain studies were ever submitted, including the
2003 Study.
51 See id. at 755.
52 See Morrow v. Jones, 140 F.4th 257, 261 (5th Cir. 2025); see also Rollins v. Home
Depot USA, Inc., 8 F.4th 393, 397 (5th Cir. 2021) (discussing forfeiture and waiver); In re
Zicam Cold Remedy Mktg., Sales Pracs., & Prods. Liab. Litig., No. 09–md–2096–PHX–FJM,
2011 WL 2784803, at *2 (D. Ariz. July 15, 2011) (denying motion for interlocutory appeal, in
part because the defendants’ “[f]ailure to argue the issue on summary judgment is fatal to
raising it now”).
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In support of the proposition that the FDA “could not have approved the
505(b)(2) applications without requiring revised warnings,” Sanofi cites 21
C.F.R. § 314.125(b), which provides that the “FDA may refuse to approve an
NDA” in a number of circumstances.53 Specifically, pursuant to 21 C.F.R. §
314.125(b)(6), the FDA may refuse approval where “[t]he proposed labeling is
false or misleading in any particular.” Pursuant to § 314.125(b)(8), the FDA
may also refuse approval where “[t]he drug product’s proposed labeling does
not comply with the requirements for labels and labeling in part 201.” Part 201
requires that the Warnings and Precautions section of the labeling “describe
clinically significant adverse reactions . . . as soon as there is reasonable
evidence of a causal association with the drug” and that the Adverse Reactions
section describes “undesirable effect[s], reasonably associated with use of a
drug[.]”54
First, Sanofi may overread the regulations, particularly in light of the
Supreme Court’s pronouncement that “it is a central premise of the [FDCA]
and the FDA’s regulations that the manufacturer bears responsibility for the
content of its label at all times.”55 Second, the FDA’s actions in 2011 (or
inaction) seem more pertinent to the “clear evidence” inquiry—the second step
of the preemption analysis—as first established in Wyeth v. Levine.56 In Merck
Sharpe and Dohme Corp. v. Albrecht, the Supreme Court clarified that to
establish “clear evidence,” a drug manufacturer must show that it “fully
informed the FDA of the justifications for the warning required by state law
53 (emphasis added).
54 21 C.F.R. §§ 201.57(c)(6)(i), (c)(7).
55 Wyeth, 555 U.S. at 570–71.
56 Id. at 572.
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and that the FDA, in turn, informed the drug manufacturer that the FDA
would not approve a change to the drug’s label to include that warning.”57
Assuming the issue had been raised, it is unclear that the present facts satisfy
that standard.58
Finally, Sanofi cites the First Circuit’s decision in In re Celexa for the
proposition that the FDA is “the exclusive judge of safety and efficacy based on
information available at the commencement of marketing[.]”59 In Celexa, the
court ultimately found that there existed no “newly acquired information” after
approval 	of 	the 	manufacturer’s 	Supplemental 	NDA 	(“sNDA”).60 	Notably,
Celexa did not involve a separate manufacturer’s label.61 Although Sanofi
began marketing well before 2011, Sanofi seeks to extend Celexa’s “pre-
marketing” rule here to have the Fifth Circuit hold that subsequent approval
of Accord’s and Sandoz’s drugs in 2011 means that nothing arising before it
can be newly acquired as to Sanofi. Sanofi leaves out, however, that Celexa
emphasized that drawing the line at the commencement of marketing also
allows “the states to reach contrary conclusions when new information not
considered by the FDA develops.”62 And there, unlike here, the plaintiffs “made
no claim” that the two relevant pieces of scientific literature were “based on
57 Albrecht, 587 U.S. at 303 (emphasis added).
58 Sanofi stated in its Motion for Summary Judgment that because it “moves for
summary judgment only on the threshold issue of newly acquired information, it does not
address the clear evidence standard.” Doc. 445-1 at 5 n.2.
59 Doc. 595-1 at 6 (citing In re Celexa & Lexapro Mktg. Sales Pracs. Litig., 779 F.3d
34, 41 (1st Cir. 2015)).
60 In re Celexa, 779 F.3d at 42–43.
61 See id. at 35 (noting that the defendant manufactured both Lexapro and Celexa).
62 Id. at 41.
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new data,” so the court ultimately found that there existed on the record no
“newly acquired information.”63
At bottom, while Sanofi did not raise on summary judgment the issues
of (1) approval of Accord’s and Sandoz’s docetaxel labels in 2011 or (2) what it
submitted between 2002 and 2011, the Fifth Circuit has not addressed the
question 	of 	how, 	if 	it 	all, 	the 	subsequent 	label 	approval 	of 	a 	different
manufacturer’s drug affects the preemption question. Considering this, and
the fact that (1) the first and third requirements are satisfied and (2) Plaintiffs
chose not to oppose Sanofi’s Motion, the Court will grant Sanofi’s request to
certify its Order for interlocutory appeal.64
CONCLUSION
For 	the 	foregoing 	reasons, 	Sanofi’s 	Motion 	to 	Certify 	Order 	for
Interlocutory Appeal is GRANTED.
New Orleans, Louisiana this 27th day of February, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
63 Id. at 42.
64 As such, the Court need not reach Sanofi’s second argument that this Court
“expanded” the regulatory definition of newly acquired information.
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