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

1
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 Adam Brufsky, M.D.,
Ph.D. (Doc. 440). 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
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 1 of 10

2
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 Adam Brufsky, M.D., Ph.D.
(“Dr. Brufsky”). On February 28, 2025, Plaintiffs filed the instant Motion to
Exclude Dr. Brufsky.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. 440.
4 Doc. 489.
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 2 of 10

3
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 an 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 admissible if the reasoning
or methodology underlying the expert’s testimony is scientifically valid and can
be properly applied to the facts in issue.”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
5 509 U.S. 579 (1993).
6 526 U.S. 137 (1999).
7 Wagoner v. Exxon Mobil Corp., 813 F. Supp. 2d 771, 799 (E.D. La. 2011); see also
Wilson v. Woods, 163 F.3d 935, 937 (5th Cir. 1999) (“A district court should refuse to allow
an expert witness to testify if it finds that the witness is not qualified to testify in a particular
field or on a given subject.”).
8 See United States v. Valencia, 600 F.3d 389, 424 (5th Cir. 2010).
9 Ruffin v. BP Expl. & Prod., Inc., 137 F.4th 276, 280 (5th Cir. 2025) (citation modified).
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. 2022).
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 3 of 10

4
“Second, the Court must determine whether the expert’s reasoning or
methodology ‘fits’ the facts of the case, and whether it will thereby assist the
trier of fact to understand evidence. In other words, it must determine whether
it is relevant.”12
In 	undertaking 	this 	tripartite 	analysis, 	courts 	must 	give 	proper
deference to the traditional adversary system and the role of the jury within
that system.13 “Vigorous cross-examination, presentation of contrary evidence,
and 	careful 	instruction 	on 	the 	burden 	of 	proof 	are 	the 	traditional 	and
appropriate means of attacking shaky but admissible evidence.”14 As the
“gatekeeper” of expert testimony, the trial court enjoys broad discretion in
determining admissibility.15
LAW AND ANALYSIS
Sanofi’s expert oncologist, Dr. Brufsky, is a Professor at the University
of Pittsburgh School of Medicine in the Division of Hematology-Oncology,
Department of Medicine. For the past twenty-five years, he was Co-Director of
the Comprehensive Breast Cancer Center of the UPMC Hillman Cancer
Center at Magee-Women’s Hospital in Pittsburgh, Pennsylvania, and Medical
Director of the Women’s Cancer Center at Magee-Women’s Hospital. He has
published over 300 peer-reviewed papers, presented abstracts at major medical
meetings, and has been invited to speak on topics related to breast cancer and
its management. He was involved in the development of docetaxel regimens in
12 Id. at 583 (citing Daubert, 509 U.S. at 591).
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).
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 4 of 10

5
current common use in breast oncology and has used these regimens in his
clinical practice.
Plaintiffs 	seek 	to 	exclude 	Dr. 	Brufsky’s 	opinions 	regarding 	(1) 	the
warnings oncologists allegedly provide their patients and (2) what oncologists
or other physicians knew or should have known about risks associated with
Taxotere. Plaintiffs argue that Dr. Brufsky lacks sufficient foundation for,
and/or is unqualified to offer, these opinions. The Court addresses each opinion
in turn.
I. 	Opinions Regarding Warnings Oncologists Allegedly Provided
Their Patients
First, Plaintiffs seek to exclude Dr. Brufsky’s opinions regarding the
warnings oncologists allegedly gave their patients. Specifically, Dr. Brufsky
opines that “it is not common practice for oncologists to warn patients receiving
Taxotere every three weeks of excessive tearing or lacrimal duct obstruction in
the initial patient teaching because it is an uncommon potential risk with this
dosing schedule.”16 He further opines that “many oncologists include this
warning 	in 	written 	materials 	provided 	to 	patients 	undergoing 	Taxotere
chemotherapy,” and that “[i]n the early decades after the development of
Taxotere, weekly Taxotere use was more common, the frequency of excessive
tearing from . . . patients receiving weekly Taxotere was recognized, and
patients were warned of this potential complication.”17
Plaintiffs 	seek 	to 	exclude 	these 	opinions, 	arguing 	that 	they 	are
unreliable and speculative—and therefore not helpful to a jury. They further
16 Doc. 440-2 at 14–15.
17 Id. at 15.
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 5 of 10

6
assert that Plaintiffs’ prescribing physicians will be deposed in the respective
bellwether cases and will be asked about their prescribing practices and what
warnings they specifically gave Plaintiffs.18
An expert may be qualified to testify based on the expert’s “knowledge,
skill, experience, training, or education.”19 Generally, “qualification is viewed
liberally and is determined by comparing the area in which the witness has
superior knowledge, skill, experience, or education with the subject matter of
the witness’s testimony.”20 An expert who is qualified may “draw a conclusion
from a set of observations based on extensive and specialized experience.”21 If,
however, “the witness is relying solely or primarily on experience,” he or she
“must explain how that experience leads to the conclusion reached, why that
experience is a sufficient basis for the opinion, and how that experience is
reliably applied to the facts.”22
Following 	this 	reasoning, 	courts 	have 	recognized 	that 	“a 	doctor’s
experience alone renders him a reliable witness to testify about a reasonable
18 In another MDL, this Court previously explained that “[t]o determine causation, the
jury will need to decide whether ‘a proper warning would have changed the decision of the
treating physician.’” In re Taxotere (Docetaxel) Prods. Liab. Litig., MDL No. 16-2740,
16-17039, 2021 WL 321661, at *3 (E.D. La. Feb. 1, 2021) (Milazzo, J.) (quoting Willett v.
Baxter Int’l, Inc., 929 F.2d 1094, 1098–99 (5th Cir. 1991)). “This Court, therefore, has ruled
that testimony from a treating physician, not a third-party physician, is appropriate to assist
the jury.” Id.
19 FED. R. EVID. 702.
20 In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 190 (S.D.N.Y. 2009) (citing
In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., No. 1:00-1898, MDL No.
1358, 2008 WL 1971538, at *6 (S.D.N.Y. May 7, 2008)).
21 Id. (citing In re MTBE, 2008 WL 1971538, at *6).
22 Andrews v. Rosewood Hotels & Resorts, LLC, 575 F. Supp. 3d 728, 734 (N.D. Tex.
2021) (alterations in original) (quoting FED. R. EVID. 702 advisory committee’s note to 2000
amendments).
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 6 of 10

7
standard of care or what a reasonable physician would do.”23 Most courts,
however, “have prohibited experts from testifying about what all doctors
generally consider in making prescription decisions or about what doctors
generally think, unless the testimony is based on something more reliable than
simply the expert’s own experience as a doctor.”24
Here, the Court finds that Dr. Brufsky may testify about his experience
informing patients through the decision-making process. He may also testify
to what his colleagues or others with whom he has personal experience have
done.25 Further, he may testify as to what a reasonable oncologist would have
done. He may not, however, testify that (1) all “patients were warned of this
complication” or that (2) “many oncologists include this warning in written
materials,” as such testimony is impermissibly speculative.26
II. 	Opinions Regarding What Oncologists or Other Physicians Knew
Second, Plaintiffs seek to exclude Dr. Brufsky’s opinions related to what
oncologists (or other physicians) knew or should have known about the risks
associated with Taxotere. Specifically, Plaintiffs seek to exclude Dr. Brufsky’s
opinion that “[f]rom the early 2000s onward, oncologists knew or should have
known from the Taxotere label,” the “published literature, and international
23 In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litig., No.
13-MD-2445, 16-5073, 2020 WL 6887885, at *26 (E.D. Pa. Nov. 24, 2020) (collecting cases).
24 See In re Suboxone, 2020 WL 6887885, at *27 (citation modified).
25 See id. (citing In re Loestrin 24 Fe Antitrust Litig., 433 F. Supp. 3d 274, 302–03
(D.R.I. 2019)).
26 See In re Taxotere, 2021 WL 321661, at *5 (noting that “Dr. Bosserman provides no
analysis that would support her opinions about the knowledge that Sanofi or the writers of
the informed consent document had”).
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 7 of 10

8
conference presentations that [lacrimal duct obstruction]27 and tearing were
potentially 	irreversible 	complications 	of 	Taxotere 	therapy.”28 Dr. 	Brufsky
further opines that he “was personally aware of this uncommon but possibly
significant complication in the early 2000s.”29 Finally, he opines that “[i]t is
well known that conjunctivitis and lacrimation do not end upon the completion
of any one chemotherapy infusion.”30
Plaintiffs argue that while Dr. Brufsky is qualified to offer opinions as to
side effects that are well known to him personally, he has no basis to proffer
testimony regarding what oncologists know about other side effects, or to guess
at what literature and conferences other oncologists throughout the country
have seen and attended to ascertain when each of them allegedly became
aware of a particular side effect.
Courts 	have 	held 	that 	a 	doctor 	may 	testify 	as 	to 	his 	or 	her 	own
knowledge, as well as that of colleagues or other physicians with whom he or
she has personal experience.31 In Bartlett v. Mutual Pharmaceutical Co., the
District Court for the District of New Hampshire precluded similar testimony
from the defendant-manufacturer’s medical expert (“Dr. Stern”).32 In Bartlett,
the plaintiff sued the manufacturer of Sulindac, a generic, nonsteroidal anti-
inflammatory drug (“NSAID”), alleging that the drug caused severe side
27 Though it has undergone numerous changes, from 2003 on, the Taxotere label has
warned about the risk of “excessive tearing, which may be attributable to lacrimal duct
obstruction . . . .” See Doc. 440-2 at 24–25.
28 Id. at 23.
29 Id.
30 Id. at 24.
31 See In re Suboxone, 2020 WL 6887885, at *27 (citing In re Loestrin, 433 F. Supp. 3d
at 302–03).
32 742 F. Supp. 2d 182 (D.N.H. 2010).
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 8 of 10

9
effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis
(“SJS/TEN”).33 The plaintiff sought to preclude Dr. Stern “from testifying about
what doctors generally know about SJS/TEN and their link to NSAIDs,”
arguing that such testimony was speculative.34 The court agreed, reasoning
that Dr. Stern had not identified a more reliable basis (other than his own
experience as a doctor) for his testimony.35 The court, however, allowed Dr.
Stern to “testify about what a reasonable doctor should know about the link
between NSAIDs and SJS/TEN and how a reasonable doctor would interpret
Sulindac’s safety warning,” reasoning that such testimony was “properly based
on his experience as a professor of dermatology at Harvard Medical School, the
chief of dermatology at a major Boston hospital, and the author of frequently
cited articles on SJS/TEN and its link to NSAIDs.”36
Here too, the Court finds that Dr. Brufsky may offer testimony about
what he personally knew regarding the risks associated with Taxotere and may
discuss this knowledge in relation to the relevant published literature and
conferences. 	He 	may 	also 	testify 	about 	what 	(1) 	that 	literature 	reveals,
including, for example, whether it indicates that conjunctivitis and lacrimation
do not end upon the completion of any one chemotherapy infusion and (2) what
a reasonable oncologist should know about such risks. Dr. Brufsky may not,
however, offer speculative opinions about what all oncologists generally knew
about the risks associated with Taxotere.
33 Id.
34 Id. at 195.
35 Id. at 195–96.
36 Id. at 196.
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 9 of 10

10
CONCLUSION
For the foregoing reasons,
IT IS ORDERED that Plaintiffs’ Motion to Exclude Adam Brufsky,
M.D., Ph.D. (Doc. 440) is GRANTED IN PART and DENIED IN PART, as
detailed in this opinion.
New Orleans, Louisiana this 29th day of April, 2026.
____________________________________
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
Case 2:22-md-03023-JTM-MBN Document 630 Filed 04/29/26 Page 10 of 10