In Re: Taxotere (Docetaxel) Eye Injury Products Liability Litigation

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UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
IN RE: TAXOTERE (DOCETAXEL) 	) 	MDL NO. 3023
EYE INJURY 	)
PRODUCTS LIABILITY LITIGATION 	)
)
This document relates to: 	) 	SECTION: “H” (5)
All cases naming Sanofi as a Defendant 	)
ORDER AND REASONS
Before the Court is Plaintiffs’ Motion to Exclude Joohee Sul, M.D. (Doc.
460). For the reasons set forth herein, the Motion is GRANTED IN PART and
DENIED IN PART.
BACKGROUND
Plaintiffs 	in 	this 	multidistrict 	litigation 	(“MDL”) 	are 	suing 	several
pharmaceutical 	companies 	that 	manufactured 	and/or 	distributed 	a
chemotherapy drug, Taxotere or docetaxel, that Plaintiffs were administered
for the treatment of cancer, primarily breast cancer. Among these companies
are 	Defendants 	sanofi-aventis 	U.S. 	LLC 	and 	Sanofi 	U.S. 	Services 	Inc.
(collectively, “Sanofi”). Sanofi manufactures Taxotere, the brand name for the
drug docetaxel. Plaintiffs allege that the drug caused them to sustain injuries
to their lacrimal systems, including punctal, canalicular, and/or nasolacrimal
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duct 	stenosis, 	which 	resulted 	in 	excessive 	tearing, 	otherwise 	known 	as
epiphora.1
On May 2, 2023, this Court issued Case Management Order No. 16
(“CMO 16”).2 Among other things, CMO 16 set deadlines for discovery and
motion practice and bifurcated general dispositive issues, including but not
limited to preemption, adequacy of the label, and general causation. Pursuant
to CMO 16, Sanofi provided the expert report of their proposed regulatory
expert, Joohee Sul, M.D. (“Dr. Sul”). On February 28, 2025, Plaintiffs filed the
instant Motion to Exclude Dr. Sul.3 Sanofi opposes.4
LEGAL STANDARD
The admissibility of expert testimony is governed by Federal Rule of
Evidence 702, which provides as follows:
A witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of an
opinion or otherwise if: (a) the expert’s scientific, technical, or
other 	specialized 	knowledge 	will 	help 	the 	trier 	of 	fact 	to
understand the evidence or to determine a fact in issue; (b) the
testimony is based on sufficient facts or data; (c) the testimony is
the product of reliable principles and methods; and (d) the expert
has reliably applied the principles and methods to the facts of the
case.
1 For reference, this Court provided extensive background on the injury at issue and
facts giving rise to this case in its prior Order and Reasons addressing preemption. Doc. 583;
Doc. 591.
2 Doc. 115.
3 Doc. 460.
4 Doc. 491.
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The current version of Rule 702 reflects the Supreme Court’s decisions
in Daubert v. Merrell Dow Pharmaceuticals, Inc.,5 and Kumho Tire Co. v.
Carmichael.6 The 	threshold 	inquiry 	is 	whether 	the 	expert 	possesses 	the
requisite qualifications to render opinion on a particular subject matter.7
Having defined the permissible scope of the expert’s testimony, a court next
inquires whether the opinions are reliable and relevant.8 “Under Federal Rule
of Evidence 702 and Daubert,” expert testimony is reliable if “the reasoning or
methodology underlying the [expert’s] testimony is scientifically valid.”9
First, 	in 	assessing 	reliability, 	the 	Court 	may 	consider 	several
nonexclusive factors, such as “whether the expert’s theory or technique: (1) can
be or has been tested; (2) has been subjected to peer review and publication;
(3) has a known or potential rate of error or standards controlling its operation;
and (4) is generally accepted in the relevant scientific community.”10 “The
reliability 	analysis 	applies 	to 	all 	aspects 	of 	an 	expert’s 	testimony: 	the
methodology, the facts underlying the expert’s opinion, the link between the
facts and the conclusion, et alia.”11
“Second, the Court must determine whether the expert’s reasoning or
methodology ‘fits’ the facts of case, and whether it will thereby assist trier of
5 509 U.S. 579 (1993).
6 526 U.S. 137 (1999).
7 Wagoner v. Exxon Mobil Corp., 813 F. Supp. 2d 771, 799 (E.D. La. 2011); see also
Wilson v. Woods, 163 F.3d 935, 937 (5th Cir. 1999).
8 See United States v. Valencia, 600 F.3d 389, 424 (5th Cir. 2010).
9 Ruffin v. BP Expl. & Prod., Inc., 137 F.4th 276, 280 (5th Cir. 2025) (alterations in
original).
10 Burleson v. Tex. Dep’t of Crim. Just., 393 F.3d 577, 584 (5th Cir. 2004) (citing
Daubert, 509 U.S. at 593–94).
11 Nestle v. BP Expl. & Prod., Inc., 627 F. Supp. 3d 577, 583 (E.D. La. Sept. 12, 2022).
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fact to understand evidence. In other words, it must determine whether it is
relevant.”12
In 	undertaking 	this 	tripartite 	analysis, 	courts 	must 	give 	proper
deference to the traditional adversary system and the role of the jury within
that system.13 “Vigorous cross-examination, presentation of contrary evidence,
and 	careful 	instruction 	on 	the 	burden 	of 	proof 	are 	the 	traditional 	and
appropriate means of attacking shaky but admissible evidence.”14 As the
“gatekeeper” of expert testimony, the trial court enjoys broad discretion in
determining admissibility.15
LAW AND ANALYSIS
Sanofi’s 	proposed 	regulatory 	expert, 	Dr. 	Sul, 	is 	a 	board-certified
neurologist with fellowship training in neuro-oncology. She has practiced
clinical medicine, conducted academic research, and is a former employee of
the United States Food and Drug Administration (“FDA”). Her experience at
the FDA includes providing scientific, clinical, and regulatory oversight for
investigational and approved drugs within the Center for Drug Evaluation and
Research 	(“CDER”), 	the 	Center 	for 	Biologics 	Evaluation 	and 	Research
(“CBER”), and the Center for Devices and Radiological Health (“CDRH”).
Citing specific paragraphs of Dr. Sul’s report, Plaintiffs seek to exclude
three categories of Dr. Sul’s opinions, First, according to Plaintiffs, Dr. Sul
offers unreliable and speculative opinions about the FDA’s oversight with
12 Id. at 583.
13 See Daubert, 509 U.S. at 596.
14 Id.
15 Wellogix, Inc. v. Accenture, L.L.P., 716 F.3d 867, 881 (5th Cir. 2013).
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respect 	to 	labeling 	changes 	done 	pursuant 	to 	the 	changes-being-effected
(“CBE”) regulation.16 	Second, Plaintiffs argue that Dr. Sul is not qualified to
offer medical opinions on oculoplastic and/or ophthalmological issues. Third,
Plaintiffs raise various objections as to Dr. Sul’s label adequacy opinion,
specifically seeking to exclude her opinions related to (1) her review of a
centralized database for medical terminology and (2) foreign regulatory bodies.
The Court addresses the admissibility of each opinion in turn.
I. 	FDA Oversight
Plaintiffs first seek to exclude Dr. Sul’s opinions regarding the FDA’s
alleged “mindset” and “preferences” in overseeing labeling changes.17 In her
report, Dr. Sul describes the CBE regulatory framework, which allows for a
drug manufacturer, in certain circumstances, to unilaterally change its drug’s
label prior to FDA approval.18 Dr. Sul opines that the FDA “prefers to maintain
input and regulatory authority over labeling,” and that “the most conservative
approach,” which affords the FDA “the most oversight,” should be applied to
labeling changes. In support, Dr. Sul cites a 2004 FDA guidance document
(“FDA Guidance”).19 From this, she concludes that a unilateral CBE change
(i.e., a “CBE-0” change) should be “reserved for safety issues of the most urgent
nature.”20 She further asserts that, although a CBE-0 can be enacted without
FDA approval, in practice, the FDA will respond promptly with feedback for
16 See 21 C.F.R. § 314.70(c).
17 Doc. 460-2 at 33–34.
18 See 21 C.F.R. § 314.70(c).
19 Doc. 460-2 at 33 (citing U.S. D EP’ T OF H EALTH & H UM . S ERV., FOOD & D RUG ADMIN.,
CTR. FOR D RUG EVALUATION & RSCH . (CDER), G UIDANCE FOR I NDUSTRY : CHANGES TO AN
APPROVED NDA OR ANDA (April 2004) (“FDA Guidance”)).
20 Id.
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urgent safety updates and that, in many cases, the FDA may have already
discussed a CBE-0 with the sponsor prior to submission.21 Finally, Dr. Sul
explains how the FDA reviews a proposed label update and lists examples of
CBE label changes submitted for other drugs.
Courts routinely permit regulatory experts to testify regarding the
FDA’s regulatory requirements and procedures, as such testimony may assist
the jury in understanding a complex regulatory scheme.22 Accordingly, the
Court finds that Dr. Sul is qualified to testify that, based on her personal
experience, “in practice,” the FDA often engages with sponsors during the CBE
process. She may also explain how the FDA reviews labeling changes and give
examples of CBE changes.
Dr. Sul’s further opinions, however, must be excluded. First, Dr. Sul may
not offer her opinion about what the FDA “prefers.” Courts consistently
preclude regulatory experts from opining “on the intent, motives or states of
mind of corporations, regulatory agencies and others,” as such opinions “have
no basis in any relevant body of knowledge or expertise.”23
Second, Dr. Sul’s broader conclusion that FDA Guidance “specifies that
the most conservative approach where FDA is afforded the most oversight
21 Id.
22 See Robinson v. Ethicon, 588 F. Supp. 3d 726, 736 (S.D. Tex. 2022) (collecting cases);
see also In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 191 (S.D.N.Y. 2009) (allowing
regulatory expert to testify about “FDA regulatory requirements and procedures” and to offer
an opinion as to the defendant-manufacturer’s compliance therewith, reasoning that “[a] lay
jury cannot be expected to understand the complex regulatory framework that informs the
standard of care in the pharmaceutical industry”).
23 In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 547 (S.D.N.Y. 2004); see also
In re Fosamax, 645 F. Supp. 2d at 192 (granting defendant-manufacturer’s motion to the
extent it “seeks to preclude Dr. Parisian from testifying as to the knowledge, motivations,
intent, state of mind, or purposes of Merck, its employees, the FDA, or FDA officials”).
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should be applied to labeling change”—and therefore CBE-0 changes “should
be reserved for safety issues of the most urgent nature”—are not supported by
the FDA Guidance upon which she relies.24 Indeed, Dr. Sul cites the section of
the 	FDA 	Guidance 	which 	addresses 	“general 	requirements” 	for 	all
“post-approval changes,” which provides only that the FDA must be notified of
most changes.25 Moreover, her opinion is arguably contradicted by the CBE
regulation itself—or, at the very least, may confuse or mislead a jury. As Dr.
Sul herself explains, while a CBE-0 change allows a sponsor to submit changes
to the FDA and concurrently update the label without awaiting FDA review,
other changes require further review before a change can be published.26
Accordingly, Dr. Sul cannot offer her testimony on this issue. Dr. Sul, however,
may discuss the FDA Guidance as supportive of her other opinions, provided
such testimony is otherwise admissible.27
II. 	Oculoplastic and/or Ophthalmological Issues
Plaintiffs also seek to exclude Dr. Sul’s opinions discussing the “lacrimal
system” and the injury at issue.28 Plaintiffs argue that her experience as a
24 Doc. 460-2 at 33.
25 Sanofi counters that the FDA guidance directs drug manufacturers to utilize the
most restrictive category for “multiple related changes.” See Doc. 491 at 4. Dr. Sul’s broader
opinion about FDA oversight, however, does not appear to be limited to such a change.
Indeed, Dr. Sul separately opines on “multiple related changes” in her report. See Doc. 460-2
at 32. Further, Plaintiffs contend that regardless, multiple changes are not the issue here.
Plaintiffs, however, have not moved to exclude these opinions in Dr. Sul’s report.
26 For example, Dr. Sul explains that a sponsor submitting a “CBE-30” change may
not publish an updated change until thirty days after submission of that change. If the FDA
has no objection to the updates, the sponsor can publish the changes. If FDA has comments
or edits, the sponsor and FDA will negotiate these in the usual fashion. Doc. 460-2 at 31.
27 Dr. Sul also offers similar opinions comparing the CBE-0 and CBE-30 processes,
which Plaintiffs have not moved to exclude. See Doc. 460-2 at 30.
28 Id. at 37–39.
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neurologist does not qualify her to render opinions on oculoplastic matters.
Sanofi counters that Dr. Sul is qualified, based on her medical training and
work at the FDA, to opine on these issues, and that her opinion is supported
by her review of medical literature.
In her report, Dr. Sul provides a brief overview of “lacrimation and the
lacrimal system more broadly” in order to “put into context the description of
this condition in the Taxotere label.”29 In that overview, she explains the
“lacrimal duct system,” provides an illustration of the relevant anatomy, and
describes how the narrowing of what she calls the “lacrimal ducts” can lead to
“various symptoms such as excessing tearing.”30 Plaintiffs take issue with this
opinion, as well as Dr. Sul’s statement that “lacrimal duct obstruction”—which
is contained on the Taxotere label—is “a condition where one or more ducts
become narrowed, preventing tears from draining to the nasal cavity and
leading to excessive tearing.”31 Plaintiffs argue that this definition “is found in
no medical textbook” and that Dr. Sul does not cite anything to support her
assertion.32 They further argue that her definition is “contrary to definitions
offered by Sanofi itself,” pointing to deposition testimony from Sanofi’s former
employees.33 Sanofi responds that Plaintiffs’ own expert, Dr. Ross (a prior FDA
employee who is board-certified in internal medicine) similarly discusses the
injury at issue in his report.
29 Id. at 38–39.
30 Id. at 39.
31 Id.
32 Doc. 522 at 5.
33 Id.
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“A district court should refuse to allow an expert witness to testify if it
finds that the witness is not qualified to testify in a particular field or on a
given subject.”34 Even so, “Rule 702 does not mandate that an expert be highly
qualified in order to testify about a given issue. Differences in expertise bear
chiefly on the weight to be assigned to the testimony by the trier of fact, not its
admissibility.”35 	Here, 	the 	Court 	concludes 	that 	Dr. 	Sul, 	as 	a 	licensed
physician, is qualified to offer her limited background testimony, including the
basic structure and function of the lacrimal system. Such testimony requires
no subspeciality training. 36 Dr. Sul may also explain her understanding of the
injury at issue, the definition of which the parties have contested throughout
this litigation. That Plaintiffs disagree with Dr. Sul’s definition of the injury
goes to the weight of her testimony, not its admissibility.37 Notably, Dr. Sul
indicates that as a Medical Officer at the FDA, she was required to review,
among other things, safety information related to investigational and approved
drugs as well as proposed and existing labeling. The Court therefore denies
Plaintiffs’ request to exclude Dr. Sul’s opinions related to the nasolacrimal
system.
III. 	Opinions Related to the Label
Next, Plaintiffs seek to partially exclude Dr. Sul’s opinions related to the
adequacy of the Taxotere label. Dr. Sul states in her report that based on her
34 Huss v. Gayden, 571 F.3d 442, 452 (5th Cir. 2009).
35 Id. (citing Daubert, 509 U.S. at 596).
36 See id.
37 See In re Avandia Mktg., Sales Pracs., & Prods. Liab. Litig., MDL No. 1871,
2007-MD-1871, 2011 WL 13576, at *5 (E.D. Penn. Jan. 4, 2011) (declining to exclude the
plaintiffs’ experts where the defendant-manufacturer argued that they defined ‘adverse
event’ too broadly”).
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review of the materials, background in oncology, and work at the FDA, her
opinion is that “lacrimal duct obstruction,” as described in the Taxotere label,
“adequately describes the potential adverse reaction at issue in this lawsuit.”38
Dr. Sul lists four separate bodies of evidence supporting her conclusions: (1)
foreign regulatory actions and foreign labels, including regulatory actions by
the European Agency for the Evaluation of Medicinal Products (“EMA”)39 and
Taxotere’s European label; (2) medical literature discussing this condition; (3)
her review of the Medical Dictionary for Regulatory Activities (“MedDRA”);
and (4) FDA-approved labels of other drugs.
Plaintiffs 	seek 	to 	exclude 	Dr. 	Sul’s 	opinions 	related 	to 	MedDRA
terminology, foreign regulatory bodies, and foreign labels. Plaintiffs also argue
that Dr. Sul’s opinions constitute impermissible legal conclusions.
A. 	MedDRA Terminology
Dr. Sul explains that MedDRA is a standardized, internationally used
medical 	terminology 	system 	designed 	to 	ensure 	consistent 	coding 	and
classification of adverse events in clinical trials, postmarketing reports, and
regulatory 	submissions. 	It 	organizes 	related 	medical 	concepts 	into 	a
hierarchical 	structure, 	allowing 	different 	clinical 	descriptions 	of 	similar
conditions to be grouped under broader categories for regulatory purposes. Dr.
Sul further explains that while not specifically mandated, the FDA typically
uses 	MedDRA 	to 	characterize 	adverse 	event 	terms 	and 	that 	MedDRA
38 Doc. 460-2 at 57–58.
39 In Dr. Sul’s report, “EMA” refers to the European Agency for the Evaluation of
Medicinal Products, which changed its name to the European Medicines Agency in 2004. Doc.
460-1 at 10 n.5.
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endeavors to capture multiple terms describing the same adverse reaction so
that these events can be captured, coded, and described consistently.
Dr. Sul explains that she reviewed the various MedDRA terms under the
“Lacrimal Disorders Standardised MedDRA Query (“SMQ”).”40 SMQs allow for
“retrieval of MedDRA-coded data,” and “are validated, pre-determined sets of
MedDRA terms grouped together.”41 She further states that she focused on the
MedDRA term “Dacryostenosis acquired,” and that terms related to this term
included “lacrimal duct obstruction” and “stenosis.”42 Building on this, Dr. Sul
concludes that because “lacrimal duct obstruction” is a defined MedDRA term,
and since the Taxotere label uses this term, the Taxotere label adequately
captures the adverse event. She states that, as it relates to the Taxotere label,
“what is important in my opinion is that ‘lacrimal duct obstruction’ is a defined
MedDRA term.”43
Plaintiffs argue that Dr. Sul is not qualified to offer these opinions
because she lacks ophthalmologic specialization and that her reasoning is
unreliable. Here, the Court finds that Dr. Sul is qualified to testify regarding
MedDRA generally, including its role as a standardized medical terminology
dictionary used by FDA and other regulatory agencies in pharmacovigilance
and drug labeling. Dr. Sul may also testify that “lacrimal duct obstruction” is
a recognized MedDRA term and that the FDA commonly uses MedDRA. Dr.
Sul’s 	experience 	as 	a 	former 	FDA 	Medical 	Officer 	involved 	reviewing
adverse-event terminology and drug labeling, thereby qualifying her to explain
40 Doc. 460-2 at 64.
41 Id.
42 Id.
43 Id. at 65.
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how FDA utilizes MedDRA terminology in practice. Although Plaintiffs argue
that Dr. Sul’s “circular reasoning” renders her conclusion unreliable, Plaintiffs’
objection goes to the weight of her testimony, not its admissibility.
Even so, Plaintiffs further assert that Dr. Sul lacks the specialized
ophthalmological 	expertise 	to 	reliably 	assess 	the 	clinical 	suitability 	of
MedDRA terms for this specific injury, which Plaintiffs contend is the basis of
her label adequacy opinion. Courts have allowed regulatory experts to opine
on the adequacy of a drug’s label from “a regulatory perspective,” so long as
they do not opine on the label from a “clinical perspective,” that is, “stray from
[their] expertise in the regulatory arena into the area of how other physicians
might interpret the label.”44
Here, as this Court found with respect to Dr. Ross, Dr. Sul may testify
as to the adequacy of the label from a “regulatory perspective,” including offer
testimony 	about 	the 	FDA 	regulatory 	framework, 	“what 	the 	regulations
require,” and Sanofi’s “conduct with regard to the regulations,”45 including
Sanofi’s “compliance therewith.”46 To the extent such regulatory opinions
constitute 	legal 	conclusions, 	this 	Court 	has 	found 	such 	testimony
permissible.47 Dr. Sul may not, however, opine about the label from a “clinical
perspective,” as she is not qualified to do so (and regardless, Sanofi’s other
experts will address this issue).
44 In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 464, 465 (S.D.N.Y. 2016).
45 See Robinson, 588 F. Supp. 3d at 736 (citing In re Suboxone (Buprenorphine
Hydrochloride and Naloxone) Antitrust Litig., MDL NO. 2445, Civ. A. No. 16-5073, 2020 WL
6887885 (E.D. Penn. Nov. 24, 2020)).
46 See In re Fosamax, 645 F. Supp. 2d at 191.
47 See Doc. 628 at 13–14.
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B. 	Foreign Regulatory Bodies
Finally, Plaintiffs seek to exclude Dr. Sul’s opinions related to foreign
regulatory bodies. Dr. Sul opines that “lacrimal duct obstruction,” as described
in the Taxotere label approved by the FDA, “adequately describes the potential
adverse reaction at issue in this lawsuit” because “‘lacrimal duct obstruction’
was the specific medical term initially selected by” the EMA following its
receipt of materials from Sanofi.48 She also discusses the Taxotere labels
reviewed and approved by the relevant regulatory authorities in Canada and
Australia. Plaintiffs argue that her opinions are irrelevant and risk confusing
the jury.
“Courts 	have 	found 	that 	evidence 	of 	foreign 	regulatory 	actions 	in
products 	liability 	litigation 	is 	properly 	excluded 	as 	irrelevant 	and/or
confusing.”49 In In re Mirena, the court precluded the plaintiffs’ regulatory
expert from testifying on foreign regulatory issues, except to the extent that
she intended “refer to the fact of a particular foreign regulatory action as
evidence of information available to” the manufacturer defendants “on the
basis of which a regulatory obligation in the U.S. was triggered.”50 The court
found that (1) the expert was not an expert in the laws of foreign jurisdictions,
so she was not qualified to opine on foreign regulatory issues; (2) there was no
reason to believe that the foreign regulatory framework was similar to the
FDA’s system; and (3) the expert’s “report and proposed testimony in this area
is a recitation of reports and regulatory actions, with little or no analysis,
48 Doc. 460-2 at 57–58.
49 In re Mirena, 169 F. Supp. 3d at 488 n.87 (collecting cases).
50 Id. at 477–78.
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which is not proper expert testimony because it is not helpful to the trier of
fact.”51 The court noted, however, that the plaintiffs could provide direct
evidence of interactions with foreign bodies as evidence of the manufacturer’s
knowledge, provided it was otherwise admissible.52
Here too, the Court concludes that Dr. Sul’s opinions related to foreign
regulatory bodies should be excluded, as Dr. Sul is not qualified to opine on
these issues. As other courts have found, “experts are not ‘appropriate vehicles’
for introduction of evidence related to foreign regulatory actions because [the]
subject of that testimony is a lay matter.”53 Further, her opinions on these
issues are likely of limited relevance and pose a substantial risk of confusion.54
As such, Dr. Sul may not discuss the contents of foreign labels or actions taken
by foreign regulatory bodies. 	Sanofi responds that Dr. Sul’s discussion of
Sanofi’s 	interactions 	with 	the 	EMA 	is 	relevant 	background 	information,
pointing out that Dr. Sul explains that the EMA’s identification of “nine cases
of canalicular fibrosis from a non-Sanofi sponsored clinical trial involving
trastuzumab” 	was 	the 	catalyst 	for 	conducting 	“a 	cumulative 	review 	of
canalicular 	fibrosis 	and 	lacrimation 	disorder” 	associated 	with 	the 	use 	of
Taxotere. Plaintiffs, however, do not seek to exclude these statements in her
report. Regardless, the Court finds that Dr. Sul may discuss this fact, as it is
relevant to Sanofi’s interactions with the FDA. Finally, to the extent the
51 Id. at 477.
52 See id. at 478, 488.
53 Id. (quoting In re Rezulin, 309 F. Supp. 2d at 553).
54 In re Xarelto (Rivaroxaban) Prods. Liab. Litig., MDL No. 2592, Case No. 2:14-md-
02592, Doc. No. 7194, at 5 (E.D. La. Aug. 1, 2017) (Fallon, J.). In In re Xarelto, the Court
noted that such evidence was likely excludable as “irrelevant, confusing, and misleading,”
but reserved ruling on the issue pending trial context. Id.
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parties seek to provide direct evidence of what information Sanofi provided to
the EMA as relevant to any other issues, such as its knowledge of the risk at
the time, they may do so, provided such evidence is otherwise admissible.
CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Plaintiffs’ Motion to Exclude Dr. Sul (Doc. 460)
is GRANTED IN PART and DENIED IN PART, as follows:
1. Plaintiffs’ request to exclude Dr. Sul’s opinions regarding the FDA’s
mindset and/or preferences (Doc. 460-2, ¶¶ 94–96) is GRANTED IN
PART and DENIED IN PART. Dr. Sul may offer the opinions in
paragraphs 95–96 	of her report, which address FDA practices and
procedures. Further, Dr. Sul may offer her testimony that “although a
CBE-0 can be enacted without FDA approval, in practice, FDA will
respond promptly with feedback for urgent safety updates and in many
cases may have already discussed a CBE-0 with the sponsor prior to
submission,” which is located at paragraph 94. The remainder of Dr.
Sul’s opinions in paragraph 94 will be excluded.
2. Plaintiffs’ request to exclude Dr. Sul’s opinions regarding the “lacrimal
system” (Doc. 460-2, ¶¶ 107–111) is DENIED.
3. Dr. Sul’s label adequacy opinions (Doc. 460-2, ¶¶ 72 and 177-7) is
GRANTED IN PART and DENIED IN PART. Dr. Sul may offer
testimony about the label from a “regulatory perspective.” She may not,
however, offer testimony about the adequacy of the label from a “clinical
perspective.”
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4. Plaintiffs’ 	request 	to 	exclude 	Dr. 	Sul’s 	opinions 	related 	to 	foreign
regulatory actions (Doc. 460-2, ¶¶ 162–167) is GRANTED.
New Orleans, Louisiana this 22nd day of May, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
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