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 	)
ORDER AND REASONS
Before the Court are two Motions: (1) Accord’s Motion for Summary
Judgment on Preemption Grounds (Doc. 439) and (2) Sandoz’s Motion for
Summary Judgment on Preemption Grounds (Doc. 458). For the reasons set
forth herein, the Motions are 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 and/or scarring), which resulted in
excessive tearing, otherwise known as epiphora. On February 27 and 28, 2025,
1 Taxotere is the brand name for the drug docetaxel.
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Accord 	and 	Sandoz 	filed 	Motions 	for 	Summary 	Judgment, 	respectively.2
Defendants 	argue 	that 	Plaintiffs’ 	state-law 	failure-to-warn 	claims 	are
preempted under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its
corresponding regulations under the theory of “impossibility preemption.”
Plaintiffs oppose.3
I. 	Statutory Background
The Court begins by addressing the complex statutory framework under
the FDCA. Under the FDCA, a drug manufacturer must obtain approval from
the Food and Drug Administration (“FDA”) before selling its drug in the United
States.4 “Meeting those requirements involves costly and lengthy clinical
testing.”5 Originally, the same rules applied to all drugs.6 The Drug Price
Competition and Patent Term Restoration Act of 1984, or “Hatch-Waxman
Amendments,” however, were enacted to allow for certain “manufacturers to
develop generic drugs inexpensively, without duplicating the clinical trials
already performed on the equivalent brand-name drug.”7
Under those amendments, “there are three primary routes through
which a manufacturer can obtain approval of drugs.”8 Pursuant to § 505(b)(1)
of the FDCA, a manufacturer seeking approval of the first drug of a specific
kind, or reference listed drug (“RLD”), must submit a New Drug Application
(“NDA”) containing, “inter alia, ‘full reports of investigations which have been
2 Doc. 439; Doc. 458. The Court held oral argument on August 19, 2025.
3 Doc. 485.
4 Hickey v. Hospira, 102 F.4th 748, 750 (5th Cir. 2024) (citing 21 U.S.C. § 355(a)).
5 Id.
6 Id. (citing PLIVA v. Mensing, 564 U.S. 604, 612 (2011)).
7 Id. (citing Mensing, 564 U.S. at 612).
8 See id. at 751.
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made to show whether such drug is safe for use and whether such drug is
effective in use.’”9
Thereafter, manufacturers who prepare drugs that are either the same
or similar enough to the RLD “may use two abbreviated pathways to obtain
FDA approval with less burden and expense.”10 Pursuant to § 505(j), “ the
manufacturer of a generic drug” may “submit an Abbreviated New Drug
Application,” or “ANDA.”11 On the other hand, pursuant to § 505(b)(2), a
manufacturer seeking approval of drugs that “differ in ways that are slight
enough for the manufacturer to still rely on the RLD’s safety and efficacy data”
must submit an NDA,12 which “need contain only that information needed to
support the modification(s) of the listed drug.”13 “Unlike § 505(j) drugs, §
505(b)(2) drugs are not required to use the exact same labeling as the RLD.”14
9 Id. at 750–51 (quoting 21 U.S.C. § 355(b)(1)(A)). The Fifth Circuit 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.” Id. at 760 n.1.
10 Id. at 751.
11 Id. (citing 21 U.S.C. § 355(j)).
12 Id. (citing 21 U.S.C. § 355(b)(2)).
13 Id. (quoting 21 C.F.R. § 314.54).
14 Id. (citing 21 C.F.R. § 314.54 (a)(2)). Plaintiffs’ proposed regulatory expert, Dr. Ross,
explains that a drug approved through a 505(b)(2) NDA usually has a label that differs from
the innovator drug used to support approval. Doc. 493-101 at 44. He also notes that for a
505(b)(2) NDA that relies on full reports of safety and effectiveness from a 505(b)(1) NDA,
similarities between the labels of the two drugs are due “entirely to the similarity between
the scientific evidence underlying approval of both NDAs. In other words, the drug labels are
similar because they both make use of the same ‘full reports,’ not because of statutory and/or
regulatory dictates.” Id. at 45.
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A. 	Labeling requirements
“The FDA regulates the safety information that appears on the labels of
prescription drugs that are marketed in the United States.”15 “FDA regulations
set out requirements for the content, the format, and the order of the safety
information on the drug label.”16 Pursuant to these regulations, “[l]abels must
include various types of information, organized in a specific manner, by
sections.”17 “As those requirements make clear, the category in which 	a
particular risk appears on a drug label is an indicator of the likelihood and
severity of the risk.”18 “The hierarchy of label information is designed to
‘prevent overwarning’ so that less important information does not ‘overshadow’
more important information.”19
Two 	sections 	of 	the 	label 	are 	relevant 	here: 	the 	“Warnings 	and
Precautions” section, described in 21 C.F.R. § 201.57(c)(6), and the “Adverse
Reactions” 	section, 	discussed 	in 	§ 	201.57(c)(7). 	“In 	the 	Warnings 	and
Precautions section, a drug manufacturer ‘must describe clinically significant
adverse reactions[,] including any that are potentially fatal, are serious even if
infrequent, or can be prevented or mitigated through appropriate use of the
drug[.]’”20 “That section must be revised to include a warning about a clinically
significant 	hazard 	as 	soon 	as 	there 	is 	reasonable 	evidence 	of 	a 	causal
15 Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 304 (2019) (citing 21 U.S.C.
§ 355(b)(1)(F); 21 C.F.R § 201.57).
16 Id. at 304 (citing 21 C.F.R. § 201.57).
17 In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 118 F.4th 322, 329 (3rd
Cir. 2024) (citing 21 C.F.R. § 201.57).
18 Albrecht, 587 U.S. at 304.
19 Id. (quoting 73 Fed. Reg. 49605–49606 (2008)).
20 In re Fosamax, 118 F.4th at 329 (quoting 21 C.F.R. § 201.57(c)(6)(i)).
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association with a drug,” but “a causal relationship need not have been
definitely established before making such a revision.”21
“In the Adverse Reactions section of a label, the drug manufacturer must
describe the overall adverse reaction profile of the drug.”22 An “‘adverse
reaction’ is ‘an undesirable effect, reasonably associated with use of a drug,
that may occur as part of the pharmacological action of the drug or may be
unpredictable in its occurrence.’”23 But “this definition does not include all
adverse events observed during use of a drug, only those adverse events for
which there is some basis to believe there is a causal relationship between the
drug and the occurrence of the adverse event.”24
“To summarize, risks described in the Warnings and Precautions section
of a label (i.e., risks of clinically significant adverse reactions) are presumably
more serious than those that appear only in the Adverse Reactions section.”25
B. 	Changes-being-effected (“CBE”) regulation
“When the FDA approves a new drug, it also approves the exact text that
will be included on the drug’s labeling.”26 A drug manufacturer, however,
“bears responsibility for the content of its label at all times.”27 Even so,
generally, a manufacturer cannot change a drug’s label after approval until the
FDA approves a supplemental application.28 “But in some circumstances, the
21 Id. (citation modified).
22 Id. (citation modified).
23 Id. (citation modified).
24 21 C.F.R. § 201.57(c)(7) (emphasis added).
25 In re Fosamax, 118 F.4th at 329.
26 Hickey, 102 F.4th at 750 (citing Wyeth v. Levine, 555 U.S. 555, 568 (2009)).
27 Wyeth, 555 U.S. at 570–71.
28 Hickey, 102 F.4th at 750 (citing Wyeth, 555 U.S. at 568).
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changes-being-effected 	(“CBE”) 	regulation 	allows 	manufacturers 	to 	file 	a
supplemental application with the FDA and simultaneously implement a
labeling change before obtaining FDA approval.”29 The FDA, however, may
still reject labeling changes made pursuant to the CBE regulation in its review
of the supplemental application.30
Pursuant to 21 C.F.R. § 314.70(c)(6)(iii), a CBE change can be invoked
for “[c]hanges in the labeling to reflect newly acquired information” to, among
other things, “add or strengthen a contraindication, warning, precaution, or
adverse reaction for which the evidence of a causal association satisfies the
standard for inclusion in the labeling under § 201.57(c) of this chapter . . . .”
Thus, the CBE regulation allows a manufacturer to change a label to reflect
(1) “newly acquired information” if the changes add or strengthen a warning
for which there is (2) evidence of a causal association.31
In turn, 21 C.F.R. § 314.3(b) 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
greater 	severity 	or 	frequency 	than 	previously 	included 	in 	submissions 	to
FDA.”32
29 Id. (citing 21 C.F.R. § 314.70(c)(6)).
30 Wyeth, 555 U.S. at 571. “If the FDA later disapproves the CBE application, ‘it may
order the manufacturer to cease distribution of the drug product(s)’ with the new labeling.”
Albrecht, 587 U.S. at 321 (Thomas, J., concurring) (alterations in original) (quoting 21 C.F.R.
§ 314.70 (c)(7)).
31 21 C.F.R. § 314.70(c)(6)(iii)(A).
32 (emphasis added).
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II. 	Factual Background
A. 	Alleged injury
With this background in mind, the Court turns to the events that gave
rise to the present suit. Taxotere is a chemotherapy drug manufactured by
Sanofi. Defendants Accord and Sandoz, who filed the instant Motions, each
manufacture versions of docetaxel, which were approved for use by the FDA
based on the RLD Taxotere. Here, Plaintiffs allege that Taxotere/docetaxel
caused 	punctal, 	canalicular, 	and/or 	nasolacrimal 	duct 	stenosis 	(i.e.,
narrowing), resulting in excessive tearing (otherwise known as epiphora) and
leading to disabling and irreversible, or potentially irreversible, damage.
Understanding the injuries at issue requires some background on the
eye’s complex tearing production and drainage systems.33 Epiphora can occur
due to overproduction of tears or, in the case of stenosis, impairment of the
eye’s ability to drain tears. Tears are produced by the lacrimal glands, which
are located just above the eye, and are spread across the surface of the eye
when a person blinks. The nasolacrimal excretory system apparatus—which is
comprised of the puncta, canaliculi, lacrimal sac, and nasolacrimal duct—is
responsible for the drainage of tears from the ocular surface to the nasal cavity,
where the tears are ultimately absorbed by the body. Tears first enter the
nasolacrimal system via the puncta, which are small openings on the surface
of the upper and lower eyelid margin. The tears then flow from the puncta to
the lacrimal sac via narrow drainage canals (called the canaliculi). The tears
33 For reference, this Court previously provided an illustration of the pertinent
anatomy in its Order and Reasons denying Sanofi’s Motion for Summary Judgment on
Preemption. Doc. 583.
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are then drained from the lacrimal sac into the attached nasolacrimal sac,
which opens into the nasal cavity.
The published scientific literature indicates that the mechanism by
which Taxotere/docetaxel causes stenosis may be through secretion of the drug
in the tears, causing inflammation, scarring, and/or fibrosis of the nasolacrimal
drainage system.34 This scarring/fibrosis may progress until pathways are
closed and predominately affects the punctal and canalicular systems, and
sometimes the nasolacrimal duct.
There 	are 	a 	few 	examinations 	used 	to 	diagnose 	stenosis 	of 	the
nasolacrimal drainage system, including (1) administering dye to the eye to
monitor drainage, (2) probing and irrigation, and (3) imaging. Probing and
irrigation, which are typically done together, test for the patency of the
punctum and canalicular system and sometimes may provide for relief of
symptoms. 	A 	probe 	is 	passed 	through 	the 	punctum, 	then 	through 	the
canaliculi, and into the lacrimal sac. Irrigation involves injecting saline into
the nasolacrimal drainage system.
Treatment of epiphora resulting from stenosis depends on the severity of
symptoms, as well as the degree to which stenosis has progressed and its
anatomical location. Treatments may include antibiotics/steroid drops or more
serious interventions. For stenosis of the punctum, a surgical treatment called
a punctoplasty may be used to widen or open the puncta to restore proper
drainage. A temporary stent may be inserted to allow the punctum to remain
34 For example, in a 2002 study published in the Annals of Oncology, Dr. Esmaeli and
others stated that “[c]analicular stenosis associated with weekly docetaxel is most likely
caused by secretion of docetaxel in the tear film and resultant chronic inflammation of the
canaliculi due to direct contact with the drug.” Doc. 493-108.
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open during healing. Mild stenosis of the canaliculi and/or nasolacrimal duct
is often treated with probing and irrigation, artificial tears, and/or topical
steroids. Moderate stenosis of canaliculi/nasolacrimal duct is often treated
with bicanalicular silicone intubation, which involves surgical placement of a
silicone 	stent. 	For 	more 	severe 	cases, 	there 	are 	a 	number 	of 	surgical
procedures. 	One 	is 	dacryocystorhinostomy 	(“DCR”), 	a 	surgical 	procedure
intended to create a new tear drainage pathway to allow tears to drain directly
into the nasal cavity, after which temporary silicone stents are inserted to keep
the new passage open during healing. Complete and/or severe closure of the
canaliculi may require a “total bypass procedure” involving placement of a
permanent Pyrex glass tube, or “Jones tube,” through an opening inside the
corner of the eye and into the nasal cavity to drain tears in the nose.
Here, Plaintiffs contend that they sustained disfiguring and sometimes
permanent damage to their nasolacrimal systems due to docetaxel, with many
plaintiffs undergoing the various surgical procedures just described. They also
contend that stenosis is a progressive but preventable injury and that prompt
referral to an ophthalmologist and/or early intervention is critical to prevent
the progression of stenosis.
B. 	Regulatory background
In May 1996, the FDA approved a New Drug Application (“NDA”)
submitted by Sanofi for Taxotere, the brand name and Reference Listed Drug
for docetaxel. At this time, Taxotere was approved for the treatment of patients
with locally advanced or metastatic breast cancer whose disease progressed
during anthracycline-based therapy, or whose disease has relapsed during
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anthracycline-based adjuvant therapy.35 In 2004, the FDA also approved
Taxotere 	as 	an 	adjuvant 	chemotherapy 	treatment 	for 	early-stage 	breast
cancer. All FDA approved indications for Taxotere involve infusions every
three weeks.36 Although there are no indications for Taxotere involving weekly
infusions, it is often prescribed off-label for such use.
The 	Taxotere 	and 	docetaxel 	labels 	have 	never 	included 	a 	warning
explicitly using the term “stenosis.” Rather, Taxotere’s label, which was first
changed in 2002 and remains largely the same today, includes a warning that
“[e]xcessive tearing which may be attributable to lacrimal duct obstruction has
been reported.”37 This label change was prompted in mid-2000 when Sanofi
received a group of cases of “canalicular fibrosis and lacrimation disorders”
from a non-Sanofi sponsored clinical trial involving docetaxel and another
drug.38 Afterwards, the European Agency for the Evaluation of Medicinal
Products 	(“EMA”) 	requested 	that 	Sanofi 	further 	investigate 	and 	submit
information on this adverse reaction.39 Ultimately, the EMA requested that
Sanofi add a warning about excessive tearing and “lacrimal duct obstruction”
to the European label.40
On July 9, 2002, Sanofi submitted a CBE change to update the label to
include 	similar 	language 	under 	the 	Adverse 	Reactions 	section 	(in 	the
35 Generally, patients treated in the metastatic setting have late-stage cancer that
cannot be cured. Neoadjuvant (pre-surgery) and adjuvant (post-surgery) therapies are given
in earlier stages. Docetaxel is usually used every three weeks and for a shorter duration when
used in the adjuvant setting compared with when used in the metastatic setting.
36 Doc. 485-11 at 1; Doc. 527 at 4–5.
37 Doc. 583 at 19.
38 Id.
39 Id.
40 Doc. 527 at 7, 9.
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Postmarketing Experiences subsection) of the Taxotere United States Package
Insert (“USPI”).41 In September 2002, the label was updated to include the
following language:
Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or
without 	conjunctivitis. 	Excessive 	tearing 	which 	may 	be
attributable to lacrimal duct obstruction has been reported.42
In February 2003, the Taxotere label was again revised as follows:
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.43
This language remained until 2013, after which this section of the label was
revised to include as a final sentence the warning that “Cases of cystoid
macular edema (CME) have been reported in patients treated with Taxotere.”44
In 2020, the “reversible upon discontinuation” language was revised.
With Sanofi’s patent for Taxotere set to expire in 2010, Accord and
Sandoz sought FDA approval under § 505(b)(2) to sell docetaxel. Accord and
Sandoz submitted their NDAs on December 21, 2009 and September 16, 2010,
41 Id. at 14. Although a drug’s label is commonly understood to refer to the sticker
affixed to the bottle, “in this context the term refers more broadly to the written material that
is sent to the physician who prescribes the drug and the written material that comes with
the prescription bottle when the drug is handed to the patient at the pharmacy.” Albrecht,
587 U.S. at 303–04 (citation modified). These inserts are often lengthy and contain detailed
information about the drug’s medical uses and health risks. Id.
42 Doc. 458-7; Doc. 439-6.
43 Doc. 493-44 at 28 (emphasis added).
44 Doc. 527 at 27–28.
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respectively. Accord’s docetaxel differed from Taxotere in the inclusion of two
inactive ingredients: citric acid and polyethylene glycol.45 Sandoz’s differed in
the addition and concentrations of certain excipients and in that it was a one
vial, ready-to-use formulation, in contrast to the two vial Taxotere (which had
a diluent vial).46
Defendants’ applications relied on the RLD Taxotere’s clinical studies
supporting the pharmaceutical product and the FDA’s findings of safety and
effectiveness from Taxotere’s NDA.47 The FDA approved Accord’s application
on June 8, 2011, and Sandoz’s on June 29, 2011. Accord’s approved label
matched the 2003 Taxotere label. Sandoz’s label was nearly the same as the
Taxotere 	label, 	although 	it 	contained 	certain 	differences 	with 	respect 	to
information on dosage forms and strengths. Sandoz and Accord subsequently
revised their labels to essentially match the updates to the Taxotere label
described above.
45 Doc. 485-1 at 7.
46 See Doc. 458-3 at 2.
47 Doc. 485-1 at 7 (“Accord fully relied on the RLD Taxotere’s clinical studies
supporting the pharmaceutical product and the FDA’s finding of safety and efficacy as well
as its approved warnings for its NDA.”); Doc. 485-7 at 2 (“The NDA [submitted by Sandoz]
contained no new non-clinical information other than the concentration of the formulations .
. . .”). Additionally, the Court takes judicial notice of the documents in the FDA’s “Approval
Package” regarding Sandoz’s NDA No. 201525. See Drugs@FDA: FDA-Approved Drugs,
located at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (last accessed Dec. 5,
2025). The Clinical Pharmacology Biopharmaceutics Review, located at the Review Tab,
states that “[s]ince the Sandoz drug product is pharmaceutically equivalent to the listed drug,
the current 505(b)(2) application did not include clinical studies and relies on the FDA’s
findings of safety and effectiveness for Taxotere® for Injection.” CENTER FOR DRUG
EVALUATION AND RESEARCH, Clinical Pharmacology and Biopharmaceutics Review(s),
p.3, 	located 	at
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000ClinPharmR.pd
f (last accessed December 5, 2025).
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As 	part 	of 	its 	pharmacovigilance 	obligations, 	Sandoz 	subsequently
submitted to the FDA three periodic “Postmarketing 15-day ‘Alert reports.’”48
Such reports cover “each adverse drug experience that is both serious and
unexpected.”49 An adverse drug experience is “unexpected” if it is “not listed in
the current labeling for the drug product.”50 The first report, which covered the
period from September 2012 to November 2012, contained two cases of “ocular
drainage system stenosis/bilateral blockage at the lower canaliculus.”51 The
second, which covered a period between June 2014 and May 2015, described
one case of “[m]ild stenosis of lower lacrimal puncta.”52 The third report, which
covered the period from June 2019 to May 2020, included one case of “punctal
stenosis.”53 In all three reports, Sandoz listed these events as “serious unlisted”
events. Sandoz advised the FDA that “[t]he nature and frequency of the cases
reported during this period provide no reasonable evidence for any change in
the established safety profile.” Sandoz further noted that “[g]iven the data
available to Sandoz at this time, the current prescribing information for this
48 The parties do not present evidence of any adverse events reported and/or received
by Accord.
49 21 C.F.R. § 314.80(c)(1)(i). An “adverse drug experience” is “[a]ny adverse event
associated with the use of a drug in humans, whether or not considered drug related . . . .” 21
C.F.R. § 314.80(a). The regulations further define a “serious adverse drug experience” as
“[a]ny adverse drug experience occurring at any dose that results in,” among other things,
death, a life-threatening adverse drug experience, persistent/significant disability, or
prolonged hospitalization. See id. This definition also includes adverse drug experiences that
“may require medical or surgical intervention to prevent” one of the listed outcomes. Id.
50 21 C.F.R. § 314.80(a). This definition “includes events that may be symptomatically
and pathophysiologically related to an event listed in the labeling but differ from the event
because of greater severity or specificity.” Id.
51 Doc. 493-95.
52 Doc. 493-96.
53 Doc. 493-97.
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product continues to accurately reflect the benefit-risk balance and requires no
modification for safety reasons.”
LEGAL STANDARD
I. 	Summary Judgment
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.”54
II. 	Law on Preemption
The 	doctrine 	of 	preemption 	derives 	from 	the 	U.S. 	Constitution’s
Supremacy Clause, which provides that “federal law ‘shall be the supreme Law
of the Land . . . any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.’”55 A preemption analysis must be guided by the
two cornerstones of preemption jurisprudence.56 First, a court should consider
“the purpose of Congress.”57 Second, in all preemption cases, a court must
assume “that the historic police powers of the States were not to be superseded
by 	the 	Federal 	Act 	unless 	that 	was 	the 	clear 	and 	manifest 	purpose 	of
Congress.”58
54 Sherman v. Hallbauer, 455 F.2d 1236, 1241 (5th Cir. 1972).
55 PLIVA v. Mensing, 564 U.S. 604, 617 (2011) (quoting U.S. CONST. art. VI, cl. 2))
(alterations in original).
56 Wyeth, 555 U.S. at 565.
57 Id.
58 Id. (quoting Medtronic. v. Lohr, 518 U.S. 470, 485 (1996)).
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Congress 	may 	preempt 	state 	law 	expressly 	(via 	language 	directly
defining the existence or scope of preemption), or implicitly.59 One way in
which Congress may implicitly preempt state law is via federal law that
“directly conflicts” with state law.60 “Where state and federal law ‘directly
conflict,’ state law must give way.”61 “Conflict preemption” applies, among
other 	things, 	“where 	complying 	with 	both 	federal 	law 	and 	state 	law 	is
impossible.”62 “Impossibility preemption” is a “demanding defense.”63
In 	the 	failure-to-warn 	context, 	“[t]he 	question 	for 	‘impossibility’ 	is
whether the private party could independently do under federal law what state
law requires of it.”64 A party cannot act “independently” under federal law if it
“cannot satisfy its state duties without the Federal Government’s special
permission and assistance, which is dependent on the exercise of judgment by
a federal agency.”65 “The underlying question . . . is whether federal law
(including appropriate FDA actions) prohibited the drug manufacturer from
adding any and all warnings to the drug label that would satisfy state law.”66
“A state law challenge to FDA-approved warnings, including a tort action
under state law, can thus proceed only when the defendant had the unilateral
ability to change that labeling; otherwise, the claim is preempted.”67
59 Crystal Clear Special Util. Dist. v. Jackson, 142 F.4th 351, 363–64 (5th Cir. 2025).
60 Id.
61 Mensing, 564 U.S. at 617 (quoting U.S. CONST. art. VI, cl. 2) (alterations in original).
62 Crystal Clear Special Util. Dist., 142 F.4th at 364 (quoting Barrosse v. Huntington
Ingalls, Inc., 70 F. 4th 315, 320 (5th Cir. 2023)).
63 Wyeth, 555 U.S. at 573.
64 Hickey, 102 F.4th at 753 (quoting Mensing, 564 U.S. at 620) (alterations in original).
65 Mensing, 564 U.S. at 624.
66 Knight v. Boehringer Ingelheim Pharms., Inc., 984 F.3d 329, 337 (4th Cir. 2021)
(quoting Albrecht, 587 U.S. at 313–314) (alterations in original).
67 Id. (emphasis added).
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The CBE regulation allows a unilateral label change (that is, a change
without prior FDA approval) where there is (1) newly acquired information for
which there is (2) evidence of a causal association between the drug and the
harm.68 In Hickey v. Hospira, the Fifth Circuit established that, in this
preemption context, “the availability of the CBE regulation is a threshold
issue” to the preemption analysis.69 “[A]ll requirements of the CBE regulation
must be met before a manufacturer can unilaterally change its label.”70 If the
CBE regulation is not available, a plaintiff’s claims are preempted.
If the CBE regulation is available, 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.”71 In Merck Sharp & Dohme Corp. v.
Albrecht, the Supreme Court clarified that “clear evidence” is “evidence that
shows the court that the drug manufacturer fully informed the FDA of the
justifications for the warning required by state law 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.”72
LAW AND ANALYSIS
Defendants argue that under the theory of impossibility preemption,
Plaintiffs’ state-law failure-to-warn claims are preempted under the FDCA
68 “[I]n practice, manufacturers typically consult with [the] FDA prior to adding risk
information to labeling.” In re Fosamax, 118 F.4th at 330 (alterations in original).
69 Hickey, 102 F.4th at 754.
70 Id. at 756 (citing Supplemental Applications Proposing Labeling Changes for
Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49603, 49606 (Aug. 22, 2008)).
71 Albrecht, 587 U.S. at 300 (quoting Wyeth, 555 U.S. at 571).
72 Id. at 303.
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because there is no evidence establishing that they had “newly acquired
information” 	that 	would 	have 	permitted 	them 	to 	unilaterally 	“add 	or
strengthen a contraindication, warning, precaution, or adverse reaction” via
the CBE process. Because Defendants only address this threshold issue, they
do not raise the “clear evidence” standard. Citing to several pieces of scientific
literature, Plaintiffs argue that Defendants had “newly acquired information”
as early as 2012.73
I. 	Standard for “Newly Acquired Information” in the § 505(b)(2)
Context
“Newly acquired information” is defined 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 greater severity or
frequency than previously included in submissions to FDA.”74 “Importantly,
‘newly acquired information is not limited to new data, but also encompasses
new analyses of previously submitted data.’”75 “This ‘rule accounts for the fact
that risk information accumulates over time and that the same data may take
on a different meaning in light of subsequent developments.’”76 “Still, the new
73 See Doc. 493. Plaintiffs’ Omnibus Opposition, which also addresses Sanofi’s Motion
for Summary Judgment on Preemption (previously denied by this Court), also cites literature
published before the § 505(b)(2) Defendants’ docetaxel was approved. To the extent that
Plaintiffs assert that any of this literature constitutes “newly acquired information,”
Plaintiffs’ argument must be rejected. See Hickey, 102 F.4th at 759 n.8 (citing In re Celexa &
Lexapro Mktg. & Sales Pracs. Litig., 779 F.3d 34, 41 (1st Cir. 2015)).
74 21 C.F.R. § 314.3(b) (emphasis added).
75 Knight, 984 F.3d at 338 (quoting Wyeth, 555 U.S. at 569).
76 Id. (quoting Wyeth, 555 U.S. at 569).
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analysis 	must 	reveal 	‘risks 	of 	a 	different 	type 	or 	of 	greater 	severity 	or
frequency’ to constitute ‘newly acquired information.’”77
In a case involving a name-brand manufacturer, courts assess whether
information is “newly acquired” by determining whether such information
shows a “risk of a different type, or greater severity or frequency” than that of
the information previously submitted to the FDA (presumably by the name-
brand manufacturer).78 The analysis, however, becomes more complicated
when assessing a plaintiff’s claims against a manufacturer whose drug was
approved under the hybrid § 	505(b)(2) pathway. Generally, although a §
505(b)(2) applicant may rely on the RLD’s safety and efficacy data to obtain
approval, it does not have a “right of reference” to at least some of that data. 79
Stated another way, without access to the RLD’s underlying submissions, a §
505(b)(2) manufacturer theoretically cannot know the entirety of what was
“previously submitted to the FDA” at the time of the RLD’s approval; thus, one
cannot say that any information reveals anything “new” from the § 505(b)(2)
manufacturer’s perspective because it has no prior submission data with which
to compare it.
Even so, a § 505(b)(2) manufacturer must still “submit its own safety and
efficacy data concerning the differences between its drug and the RLD”;
77 Id. (quoting Wyeth, 555 U.S. at 569).
78 Id.
79 A “505(b)(2) application is an NDA submitted under section 505(b)(1) of the Federal
Food, Drug, and Cosmetic Act for a drug for which at least some of the investigations
described in section 505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act and relied upon
by the applicant for approval of the NDA were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted.” 21 C.F.R. § 314.3.
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therefore, “it would be able to compare post-approval data related to such
differences against its own submissions to the FDA.”80 But where—as is the
case here—those differences are not alleged to have caused a plaintiff’s injury,
such data is not relevant.81
In Hickey v. Hospira, the Fifth Circuit addressed this issue, clarifying
that the “newly acquired information” inquiry centers on what happens after
the FDA approves a § 505(b)(2) drug.82 While the claims in Hickey were
different, 	the 	case 	involved 	the 	same 	drug 	at 	issue 	here.83 	The 	court
acknowledged 	that, 	at 	the 	time 	the 	§ 	505(b)(2) 	defendants’ 	drugs 	were
approved in 2011, they lacked a right of reference to the clinical-trial data and
adverse event reports submitted by Sanofi (the name-brand manufacturer)
when the RLD was approved.84 But this did not mean that information arising
after could never be “newly acquired.”
The court noted that after the FDA initially approved the RLD, Sanofi
was required—“as part of its pharmacovigilance duties”—to submit to the FDA
“publicly available scientific literature” concerning the drug.85 It explained
that 	“because 	there 	was 	publicly 	available 	scientific 	literature 	[prior 	to
approval] . . . on the drugs,” there was “something for these Defendants to
review and be aware of and responsive to.”86 Accordingly, that scientific
literature 	provided 	“a 	baseline 	comparator 	for 	determining 	whether”
80 Hickey, 102 F.4th at 756 (citing 21 C.F.R. § 314.54(a)).
81 See id.
82 Id. at 755.
83 Hospira and Accord moved for summary judgment in Hickey. Id. at 752.
84 Id.
85 Id. at 754 (citing 21 C.F.R. § 314.80(b)–(d); 21 C.F.R. § 314.81(b)).
86 Id. at 756.
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information arising after 2011, or “post-approval information,” revealed “risks
of a different type or greater severity or frequency than previously included in
submissions to FDA.”87
The Fifth Circuit did not determine whether this “baseline” information
was actually submitted to and/or considered by the FDA; rather, it assumed it
had been—or deemed it equally available to the FDA—for purposes of the
analysis. And it rejected the plaintiffs’ contention that any individual study
that 	Sanofi 	was 	required 	to 	submit 	before 	approval 	of 	the 	§ 	505(b)(2)
defendants’ 	drugs 	in 	2011 	“independently” 	constituted 	“newly 	acquired
information.”88 In short, the court declined to consider as “newly acquired
information” 	any 	publicly 	available 	information 	published 	before 	the 	§
505(b)(2) manufacturers’ drugs were approved.89
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.90 This conclusion is
consistent with the fact that, once its own drug is approved, a § 505(b)(2)
manufacturer has the same post-market pharmacovigilance obligations as the
RLD and therefore has access to relevant data after approval.
87 Id. at 756 n.5. The court noted that “Plaintiffs do not dispute that, before the FDA
approved Defendants’ drugs, Sanofi had an obligation to submit to the FDA” the scientific
literature at issue. Id.
88 Id. at 759 n.8.
89 Id. (explaining that “the line so drawn lets the FDA be the exclusive judge of safety
and efficacy based on information available at the commencement of marketing, while
allowing the states to reach contrary conclusions when new information not considered by
the FDA develops” (quoting In re Celexa & Lexapro, 779 F.3d 34, 41 (1st Cir. 2015)).
90 Id. at 756.
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To summarize, the Fifth Circuit established the following framework for
addressing “newly acquired information” in the § 505(b)(2) context. First, the
court determined that the publicly available literature that existed prior to the
§ 505(b)(2) manufacturer’s approval was the baseline for the analysis. Second,
the court compared the pre-approval literature (baseline) to the information
available to the § 505(b)(2) manufacturer after the approval of its drug, which
included publicly available literature and any adverse event reports that the §
505(b)(2) manufacturers received. The court made clear that to constitute
“newly acquired information,” this post-approval information had to reveal a
“risks of a different type, or greater severity or frequency” than the pre-
approval literature.91
II. 	Whether 	There 	Was 	“Newly 	Acquired 	Information” 	After
Approval of Defendants’ Docetaxel
To determine if there existed “newly acquired information” such that
Defendants 	could 	have 	changed 	their 	labels, 	the 	Court 	must 	determine
whether any information that was publicly available (or otherwise available to
Defendants) after approval of their drugs in 2011 reveals risks of permanent
stenosis that differed in type, severity, or frequency than the publicly available
literature published before that date.
A. 	Risks of a greater frequency
1. 	Pre-approval literature
In 2006, Dr. Bita Esmaeli and others published an article summarizing
the results of a prospective clinical trial, which aimed “[t]o determine the
91 21 C.F.R. § 314.3.
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incidence 	and 	severity 	of 	epiphora 	and 	canalicular 	stenosis 	in 	patients
receiving docetaxel weekly or every 3 weeks” (“2006 Esmaeli Study”).92 The
study, 	which 	was 	sponsored 	by 	Sanofi, 	included 	fifty-six 	patients 	with
metastatic breast cancer: twenty-eight patients received docetaxel weekly, and
twenty-eight patients received it every three weeks. Patients underwent a
comprehensive ophthalmologic exam, including probing and irrigation before
and during treatment, and patients with “preexisting epiphora or canalicular
or nasolacrimal duct blockage on probing and irrigation” were excluded.93 If a
patient developed epiphora, antibiotic and steroid drops were administered to
the eyes. If epiphora worsened or did not improve with drops, or if findings on
probing and irrigation suggested further narrowing of the canaliculi, the
patient was advised to consider a range of surgical procedures based on the
severity of stenosis.
Of the 	patients 	who received 	weekly 	docetaxel, 	eighteen developed
epiphora. Nine patients (32%) had worsened canalicular stenosis, and surgery
92 Doc. 458-22. Sandoz also cites incidence rates of stenosis from literature published
by Dr. Esmaeli and others between 2001 and 2003, contending that these show a greater
frequency of permanent stenosis than the post-approval literature. See Doc. 458-23 at 20–21.
In the 2006 Esmaeli Study, the authors noted that “[d]espite substantial literature
documenting canalicular stenosis as an adverse effect of docetaxel, the exact incidence of this
important adverse effect is unknown.” Doc. 458-19. Citing to the same publications cited by
Sandoz, the authors reasoned that “[a]ll previous publications were based on retrospective
studies at tertiary ophthalmology practices, and only patients who had symptoms of epiphora
were evaluated.” Id. Further, the only study published prior to 2002 that focused on
determining an incidence rate appears to be a study published in 2002 by Dr. Esmaeli and
others 	in 	Ophthalmology 	(“2002 	Ophthalmology 	Study”). 	Doc. 	458-19. 	The 	2002
Ophthalmology Study, which was 	a retrospective, 	non-randomized 	comparative trial,
reported stenosis requiring surgery in 50% of patients taking weekly docetaxel and 0% in
patients taking docetaxel every three weeks. Doc. 458-19.
93 Doc. 458-22.
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was recommended in all nine. Six patients agreed to undergo surgery, and
while 	no 	patient 	required 	Pyrex 	Jones 	tubes, 	these 	surgeries 	included
temporary silicone tube placement and DCR with temporary and permanent
silicone tubes. Of the patients receiving docetaxel every three weeks, eleven
developed epiphora, with nine patients seeing resolution of symptoms. The two
patients (7%) who did not improve had grade 1 (mild) canalicular stenosis and
underwent DCR with placement of silicone tubes. Thus, the authors concluded
that moderate or severe canalicular stenosis was seen in about one-third of
patients in the weekly group and in none of the patients in the every-three-
weeks group.94
2. 	Post-approval literature
In 2013, Arlene Chan and others published “Prevalence of Excessive
Tearing 	in 	Women 	with 	Early 	Breast 	Cancer 	Receiving 	Adjuvant
Docetaxel-Based Chemotherapy” in the Journal of Clinical Oncology, reporting
the 	results 	of 	a 	prospective 	study 	of 	early-stage 	breast 	cancer 	patients
receiving adjuvant docetaxel every three weeks. The study—described by its
authors as the first to evaluate potential lacrimal duct obstruction in the
adjuvant setting—aimed to “define the incidence and impact of tearing in
patients receiving adjuvant docetaxel-based chemotherapy and assess for
lacrimal duct obstruction (LDO) as a causative factor.”95
94 Two additional prospective studies were published prior to 2011, but both studies
focused only on patients taking weekly docetaxel. See Doc. 493-116; Doc. 493-121. Plaintiffs
do not produce or cite to any post-approval literature reporting incidence rates in patients
taking weekly docetaxel. See Doc. 485; Doc. 493.
95 Doc. 493-129.
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At 	the 	beginning 	of 	and 	throughout 	treatment, 	patients 	completed
questionnaires regarding tearing symptoms and underwent serial ophthalmic
examinations that included slit-lamp evaluation, probing, and irrigation—the
same methods used in the 2006 Esmaeli Study. Patients also underwent an
imaging test, computed tomographic dacryocystography (“CT-DCG”), before
and 	after 	chemotherapy. 	Among 	patients 	who 	returned 	for 	follow-up
evaluations, the authors reported that 30% demonstrated LDO on CT-DCG
and 22% demonstrated LDO on ophthalmic examination.96 Overall, the study
reported that the majority of patients experienced tearing—but concluded that
tearing occurred at similar rates in patients with and without LDO and that
“docetaxel-related tearing is not caused by LDO.”97
Although these reported rates of “LDO” are numerically higher than the
rates of stenosis reported in the 2006 Esmaeli Study, they do not establish
“risks of a greater frequency” for several reasons.98 First, Chan reported that
at baseline, “some degree of lacrimal duct obstruction” was present in 17
patients on ophthalmic examination and 18 patients on CT-DCG. The authors
did not, however, stratify post-treatment findings by baseline LDO status. As
96 	Rather 	than 	give 	a 	specific 	denominator, 	the 	Chan 	authors 	noted 	that
“approximately 25% of patients” failed to attend follow-up evaluations. Id. at 4. The
agreement table presented in the article shows that 22 of 73 patients (30%) who underwent
both assessments had LDO on CT-DCG, while only 13 of those 73 (18%) had LDO on
ophthalmic examination, implying that 4 additional patients returned for ophthalmic
examination alone. Thus, 17/77 (22%) of patients who returned for ophthalmic exam were
found to have LDO. Id.
97 This conclusion is puzzling given that the authors state that their study “was not
designed to evaluate specific causes of tearing.” Id. at 5.
98 Plaintiffs also argue that Chan’s reported rates of epiphora are higher than the pre-
approval literature. Here, however, those rates are irrelevant because (1) the label already
warned about “excessive tearing, which may be due to lacrimal duct obstruction,” and (2) the
2013 Chan Study found that tearing and LDO were not necessarily associated.
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a result, the study does not permit calculation of the incidence of new-onset
LDO. 	Put 	differently, 	without 	knowing 	which 	patients 	had 	baseline
obstruction, the number of new cases cannot be determined.
In fact, shortly after its publication, Dr. Esmaeli and others published
an editorial in the same journal responding to and critiquing the 2013 Chan
Study (“2013 Esmaeli Editorial”). The authors noted “nearly 20% of patients
had asymptomatic partial lacrimal duct obstruction at baseline” and that these
patients should have been excluded from the 2013 Chan Study, “given that
nasolacrimal duct obstruction was one of the primary study end points.”99
Even accepting Chan’s reported rates at face value—which Plaintiffs
themselves do not do—comparison to the 2006 Esmaeli Study is not an “apples
to apples” comparison.100 In the 2006 Study, stenosis was defined anatomically,
graded by severity, and explicitly linked to clinical outcomes, including the
need for surgical intervention. 101 Although Chan employed similar ophthalmic
99 Doc. 493-131 at 2. Further, based on the stated methodology, it seems these patients
should have been excluded from the 2013 Chan Study, but the results suggest otherwise.
100 Plaintiffs concede that the baseline LDO rates should not be included in the
incidence rate. They aver, however, that “[o]f those 73 patients, 30% and 22% of patients,
based on CT-DCG and ophthalmic review, respectively, had ‘LDO,’ compared with 17% and
18% before treatment, indicating between 13% and 4% of patients developed ‘LDO’ during
treatment with docetaxel, compared to baseline examinations.” Doc. 485 at 21. As explained
above, Plaintiffs’ calculations are incorrect. First, the 30% and 22% rates are based on
patients who returned, whereas the baseline percentages are based on all 100 patients. As
such, the baseline and post-chemo percentages share different denominators. Second, the
true incidence rate cannot be determined, because it is not clear which patients returned and
which did not.
101 In the 2006 Study, patients underwent probing of canaliculi and irrigation of the
nasolacrimal ducts. Canalicular stenosis was graded by the ophthalmologist as follows: 0, no
stenosis; 1, mild stenosis—puncta were small but could be probed after dilation, and the
probe came to a bony stop; 2, moderate stenosis—canaliculi could be only partially probed,
the probe did not come to a bony stop, and insertion of the probe was associated with pain; or
3, severe canalicular stenosis—canaliculi could not be probed, probing was associated with
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examination techniques, the study provides little detail regarding the location,
severity, or clinical significance of the “LDO” it reports. Specifically, the
authors generally classified LDO as present or absent.102 While the authors
reported that 27% of patients had punctal stenosis at baseline, they did not
report punctal stenosis rates at the end of chemotherapy. Nor did they conclude
that surgical intervention was required in any case or meaningfully link
obstruction 	findings 	to 	the 	severity 	or 	persistence 	of 	symptoms. 	To 	the
contrary, the authors concluded that tearing was “generally short lived” and
that “in the majority of cases, surgical intervention is not required.” Under
these 	circumstances, 	it 	is 	unclear 	that 	the 	injury 	reported 	in 	Chan 	is
comparable to the pre-approval literature.
Finally, Chan reported that six patients (6%) demonstrated worsening
obstruction 	on 	irrigation 	during 	the 	study, 	with 	one 	patient 	developing
complete obstruction, and that nine patients (9%) demonstrated worsening
obstruction 	on 	CT-DCG.103 	The 	2006 	Esmaeli 	Study 	reported 	that
approximately 7% of patients receiving docetaxel every three weeks developed
canalicular stenosis. Even assuming these figures are comparable—which
severe pain or bleeding, or the nasolacrimal duct was not patent to irrigation through the
upper or lower canaliculi. Doc. 458-22 at 3.
102 As to tearing, the authors reported that “[s]ix patients (6%) reported grade 3
tearing at some time during their chemotherapy, with complete resolution in four patients
and improvement to grade 1 in one patient at the post chemotherapy follow-up visit.” Id. at
3–4. Further, “[t]he remaining patient, who reported grade 3 tearing at the time of follow-up,
had patent lacrimal ducts on both post-chemotherapy CT-DCG and ophthalmic examination.”
Id. at 4.
103 The authors represent that this number reflects 8.8% of the patient population,
which would include 102, rather than 100, patients as the denominator. Only 100 patients,
however, were included in the study after 2 patients withdrew. Doc. 493-129 at 3.
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Chan does not establish—they do not demonstrate an increased frequency of
clinically relevant stenosis in the post-approval literature.104
In sum, the 2013 Chan Study does not provide the information necessary
to 	determine 	that 	permanent 	stenosis, 	stenosis 	requiring 	surgery, 	or
progressive stenosis occurred at a greater frequency than reported in the pre-
approval literature.105
B. 	Risks of a different type or greater severity
Plaintiffs also argue that the post-approval literature reveals risks of a
different type or greater severity because it reveals new information about the
mechanism 	of 	injury, 	surgical 	outcomes, 	prompt 	referral, 	and/or 	various
indications and treatment settings. The Court disagrees.
In 2001, Dr. Esmaeli and others first reported on docetaxel-related
stenosis in the weekly setting, publishing a case series describing this “newly
recognized 	side 	effect” 	in 	Ophthalmology.106 	The 	article 	described 	three
patients who developed punctal and/or canalicular stenosis and epiphora after
being administered weekly docetaxel (in combination with other drugs). Then,
in 2003, Dr. Esmaeli published an article summarizing a retrospective report,
wherein she found that this adverse event occurred much more frequently in
104 The only other study published after approval of Defendants’ drugs from which an
incidence rate may be determined appears to be a retrospective study published by Blake H.
Fortes and others in the European Journal of Ophthalmology. Doc. 439-10. That study,
however, showed an incidence rate of <1.1%, which is lower than the incidence rates in the
pre-approval literature.
105 The 2013 Chan Study also does not show risk of a different type or greater severity.
The authors conclude that “patients receiving docetaxel-based treatment . . . should be
reassured that tearing is generally mild and transient in the majority of cases, and surgical
intervention is not required.” Doc. 493-129 at 6.
106 Doc. 458-17.
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patients taking weekly docetaxel and that the severity of canalicular stenosis
resulting from weekly docetaxel increased with higher cumulative doses of this
drug and longer duration of therapy. From 2001 to 2011, numerous studies,
case reports, and scientific articles—including Sanofi-sponsored studies—were
published addressing the risk of permanent stenosis, with the majority of these
including Dr. Esmaeli as an author.
The post-approval literature identified by the parties does not show new
or different risks. Rather, it restates or emphasizes points that were present
in the pre-approval literature. For example, Plaintiffs argue that a 2017 article
published in the British Journal of Ophthalmology (“Kang Article”) shows new
information about the level of obstruction and treatment outcomes. The 2017
Kang 	Article 	found 	that, 	in 	patients 	taking 	docetaxel, 	the 	punctum 	or
canaliculus was the most common obstruction site and that in all cases,
stenosis could be managed with less invasive surgical treatment. The pre-
approval literature, however, revealed the risk of stenosis occurring at these
levels and reported on surgical outcomes. Likewise, although Plaintiffs spend
little time addressing them in their Opposition, articles produced by Plaintiffs
that (1) focus exclusively on epiphora, rather than stenosis and/or (2) merely
summarize 	the 	pre-approval 	literature 	do 	not 	reveal 	new 	information.107
107 See Doc. 493 at 55–64 (citing articles published by Sorbe, Ho, Kang, Mansur, and
Sodhi). Although not mentioned in their Opposition, Plaintiffs produce a study authored by
their expert, Gerald McGwin, and published in 2023 in Current Eye Research (“2023 McGwin
Study”). The 2023 McGwin Study, which was a “disproportionality analysis” conducted using
the FDA Adverse Event Reporting Systems (FAERS), sought to “investigate the association
between lacrimal and retinal disorders and the use of docetaxel and paclitaxel.” Doc. 493-137.
The 2023 McGwin Study, however, is not “newly acquired information” because it does not
show any new or different risks. But even if it did, the 2023 Study (though published outside
of this litigation) likely constitutes an expert report and/or report prepared with the benefit
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Although “newly acquired information is not limited to new data,” it must still
reveal “risks of a different type or of greater severity or frequency’ to constitute
‘newly acquired information.”108 Here, the literature does not.
Nor does the literature reveal risks that are more severe. Plaintiffs cite
to a case report published by Tomoko Yamagishi and others in 2014 (“2014
Yamagishi Article”), arguing that it shows “irreversible stenosis” occurring in
patients taking docetaxel every three weeks in the small cell lung cancer
setting. The 2014 Yamagishi Article reported one patient who developed
epiphora that continued after cessation of docetaxel. This patient was found to
have mild stenosis of the lower lacrimal puncta, and epiphora resolved after
probing and irrigation. Because Dr. Esmaeli had previously reported cases of
permanent stenosis and/or stenosis requiring surgery, including in patients
taking docetaxel every three weeks, the 2014 Yamagishi Article cannot be
“newly acquired information.”109
of hindsight, which courts outside of this jurisdiction have held cannot constitute “newly
acquired information.” See Bueno v. Merck & Co., Inc., 746 F. Supp. 3d 853, 877–78 (S.D. Cal.
2024) (noting that “[w]hile ‘new analyses of previously submitted data’ can constitute ‘newly
acquired information’ in certain circumstances, 21 C.F.R. § 314.3(b), new analyses do not
comprise ‘newly acquired information’ when ‘conducted by an expert in preparation for
litigation with the benefit of hindsight.’” (quoting R.S.B. v. Merck & Co., No. 20-C-1402, 2021
WL 6128161, at *4 (E.D. Wis. Dec. 28, 2021))).
108 Knight, 984 F.3d at 338 (quoting Wyeth, 555 U.S. at 569).
109 See Doc. 439-9 (article published by Dr. Esmaeli and others in 2003). And the fact
that patients in the 2014 Yamagishi Article had lung cancer, rather than breast cancer, is of
no moment because the article does not purport to associate the risk with cancer type. See In
re Zofran, 57 F.4th at 339 (finding that certain animal studies that differed in dose from
animal studies previously submitted to the FDA were not “newly acquired information”
because, among other things, the studies indicated that the observed anomalies in the animal
subjects were “not dose related” and/or “had no dose-dependency”).
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Finally, Plaintiffs contend that Defendants interpret “risks of a different
type, 	or 	greater 	severity” 	too 	narrowly, 	arguing 	that 	newly 	acquired
information need only alter the risk–benefit profile known to the FDA at the
time of approval. To the extent these formulations are not merely two ways of
expressing 	the 	same 	standard, 	Plaintiffs’ 	argument 	still 	fails: 	the
post-approval literature does not reflect any change as 	compared to the
publicly available information.110
The Court finds that Defendants had no “newly acquired information”
rendering the CBE process available them, and Defendants could not have
unilaterally changed their labels. Plaintiffs’ state-law claims are therefore
preempted by federal law.
CONCLUSION
For the foregoing reasons, Defendants’ Motions for Summary Judgment
are GRANTED.
New Orleans, Louisiana this 16th day of January, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
110 To the extent Plaintiffs argue that Sandoz’s Adverse Event reports are “newly
acquired information,” the Court rejects that argument. The reports, which described cases
of “ocular drainage system stenosis/bilateral blockage at the lower canaliculus,” “[m]ild
stenosis of lower lacrimal puncta,” and “punctal stenosis,” do not show a different or more
severe risk than the pre-approval literature. Further, they do not report on or otherwise
estimate a patient population from which these patients were drawn, so it is not possible to
calculate an incidence rate.
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