United States Court of Appeals

for the Fifth Circuit

No. 20-30184

In re: Taxotere (Docetaxel) Products Liability 

Litigation

_______________________________

Barbara Earnest, 

Plaintiff—Appellant,

versus

Sanofi U.S. Services, Incorporated, formerly known as

Sanofi-Aventis U.S., Incorporated; Sanofi-Aventis, 

U.S., L.L.C., 

Defendants—Appellees.

Appeal from the United States District Court

for the Eastern District of Louisiana

USDC No. 2:16-MD-2740

USDC No. 2:16-CV-17144

Before Ho, Oldham, and Wilson, Circuit Judges.

Cory T. Wilson, Circuit Judge:

United States Court of Appeals

Fifth Circuit

FILED

February 10, 2022

Lyle W. Cayce

Clerk

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Barbara Earnest sued drug makers Sanofi U.S. Services Inc. and 

Sanofi-Aventis U.S., L.L.C. (collectively, Sanofi) in the Eastern District of 

Louisiana. Earnest’s suit is part of the multidistrict litigation (MDL) over 

several pharmaceutical companies’ alleged failure to warn users of Taxotere 

(generically docetaxel), a chemotherapy drug, of the risk of permanent 

alopecia or hair loss. See In re Taxotere (Docetaxel) Prod. Liab. Litig., 220 F. 

Supp. 3d 1360 (J.P.M.L. 2016). At trial, Sanofi elicited testimony from two 

medical doctors. One, Dr. John Glaspy, was accepted as an expert witness 

under Federal Rule of Evidence 702. The other, Dr. Michael Kopreski, was 

offered as Sanofi’s designated corporate representative under Federal Rule 

of Civil Procedure 30(b)(6). As a general matter, both testified that little 

medical evidence linked Taxotere to permanent hair loss. 

Earnest now challenges the admission of Dr. Kopreski’s testimony, 

arguing it was actually expert testimony admitted in contravention of Rule 

702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). By 

extension, she argues that because Dr. Glaspy’s testimony relied in relevant 

parts on Dr. Kopreski’s testimony, it also should not have been admitted.

Sanofi’s maneuvers in cloaking Dr. Kopreski’s quasi-expert 

testimony as “lay witness” opinion testimony under Federal Rule of 

Evidence 701, and then using Dr. Glaspy to repeat it as expert analysis, 

effected a concerning end run around Rule 702. Because this strategy

allowed Sanofi to shoehorn inadmissible opinion testimony into evidence—

and then emphasize those “expert” conclusions in closing arguments to the 

jury—it significantly prejudiced Earnest’s case. We REVERSE the district 

court’s judgment and REMAND the claims appealed here for a new trial.

I.

We start with a brief overview of TAX316, the Taxotere clinical study 

on which the parties heavily relied for the issue of medical causation. Then,

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we sketch the background of Earnest’s case. After laying that groundwork, 

we consider the issues Earnest raises on appeal.

A.

A drug must obtain approval from the Food & Drug Administration

before it is marketed and sold to the public. 21 U.S.C. § 355(a).1

 As with 

most new drugs, Taxotere was subjected to lengthy clinical testing divided 

into distinct trial phases. Phase I began in 1990 and determined the drug’s 

proper dosage. Phase II started two years later. It assessed the safety of the 

drug using larger test groups. By 1996, after successful clinical testing, 

Taxotere gained FDA approval for treatment of patients with metastatic 

breast cancer. 

After the initial FDA approval, Sanofi sought approval to use 

Taxotere as an adjuvant chemotherapy treatment. This would allow the use 

of Taxotere alongside other chemotherapy drugs to boost their efficacy. To 

that end, Sanofi sponsored a ten-year multi-center Phase III randomized 

clinical trial—the TAX316 study. TAX316 consisted of roughly 1,400 

participants and ran from June 11, 1997, to January 25, 2010. Its primary 

objective was to determine the efficacy of Taxotere as an adjuvant 

chemotherapy treatment in breast cancer patients with positive axillary 

lymph nodes, like Earnest. The study had a secondary objective to compare 

the participants’ overall survival rate, toxicity of the drug, and quality of life. 

The clinical trial compared participants in two treatment arms. The 

first arm (or the “TAC” arm) treated 744 patients with Taxotere in 

1 See Eckhardt v. Qualitest Pharms., Inc., 751 F.3d 674, 676 (5th Cir. 2014) (“Before 

a manufacturer can market a new drug, the FDA must approve ‘that it is safe and effective 

and that the proposed label is accurate and adequate.’” (quoting PLIVA, Inc. v. Mensing, 

564 U.S. 604, 612 (2011))).

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combination with two other chemotherapy drugs, Adriamycin and Cytoxan.2 

The second arm (or the “FAC” arm) treated 736 patients with 5-

fluorouracil, another chemotherapy drug, in combination with Adriamycin 

and Cytoxan.

The TAX316 study was designed to track the short-term and longterm effects of each combination therapy, starting from thirty days after the 

last administration of the study drugs. Interim analyses were conducted 

during the study. After reviewing the fifty-five-month interim data, the FDA 

approved the administration of Taxotere as an adjuvant chemotherapy 

medication in combination with Adriamycin and Cytoxan in August 2004. 

The FDA later agreed to the submission of TAX316’s ten-year final study 

report.

Study investigators completed the final report in August 2010. It 

consisted of ten-year follow-up data from the 1480 patients treated with 

either TAC or FAC.3

 The study’s results demonstrated similar findings to 

those from the interim study data: the TAC-regimen generated statistically 

better results, in terms of cancer deterrence and survival rate, than its FAC 

counterpart. The results indicated that Taxotere, given in combination with 

Adriamycin and Cytoxan, was “an appropriate adjuvant chemotherapy 

option for women.” 

Apart from these findings, the final study reported on sixty-nine 

adverse events of the drug regime, including alopecia, or hair loss. The 

adverse effects were categorized as “persisting into follow-up,” “resolved,” 

2 The generic name for Adriamycin is doxorubicin; Cytoxan’s is 

cyclophosphadmide.

3 Among the 1480 patients, eighty-two patients were reported as lost to follow-up, 

such that no new data were available for them. 

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and “ongoing.” Of note, the study found that 4.2 percent of the population 

within the TAC arm, or twenty-nine of 744 participants, experienced 

“ongoing” hair loss. 

B.

Earnest was diagnosed with early-stage breast cancer in February

2011. She underwent a lumpectomy to remove the cancerous tumor. That 

surgery was followed with several rounds of adjuvant chemotherapy. 

At first, Earnest received four treatment cycles of dose-dense 

Adriamycin and Cytoxan, administered bi-weekly. Earnest lost her hair after

the second treatment cycle. Later in 2011, Earnest’s oncologist, Dr. James 

Carinder, treated her with Taxotere. In due course, the combination 

chemotherapy treatments proved successful, and Earnest was declared 

cancer free. Following chemotherapy, Dr. Carinder prescribed her

Arimidex, a cancer reoccurrence preventive drug. Earnest was still taking 

Arimidex when she filed suit. 

Although cancer free, Earnest’s hair has never grown back. She 

alleges that her hair loss is permanent and that Sanofi knew that Taxotere 

caused permanent hair loss and yet failed to warn her of that side effect.

C.

Shortly before Earnest filed her original complaint in the Eastern 

District of Louisiana on December 12, 2016, the Judicial Panel on 

Multidistrict Litigation ordered the transfer of thirty-three pending 

Taxotere-related cases to that district court for management under MDL 

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procedures. In re Taxotere (Docetaxel) Prod. Liab. Litig., 220 F. Supp. 3d at 

1361; see 28 U.S.C. § 1407. Many more claims followed.4

In February 2017, the district court ordered the plaintiffs collectively 

to file a master complaint and individually to file particularized short form 

complaints. Pursuant to that order, Earnest filed an amended short form 

complaint on December 12, 2017, alleging “[d]isfiguring permanent [hair 

loss] beginning after treatment with Taxotere (docetaxel) and continuing to 

present.” She asserted failure-to-warn and redhibition claims under 

Louisiana law.5

 

Discovery ensued. Pursuant to Federal Rule of Civil Procedure 

30(b)(6), Sanofi produced Dr. Kopreski as its corporate designee for 

depositions. Earnest deposed Dr. Kopreski three times. One of those rounds 

of depositions focused on the TAX316 study. In response to Earnest’s 

deposition notice regarding the study, Sanofi produced the identification 

numbers of the twenty-nine patients who were administered Taxotere in 

combination with Adriamycin and Cytoxan during the clinical trial and who 

4 By January 2022, more than 12,000 individual cases were pending in this MDL. 

See Pending MDLs By Actions Pending as of January 19, 2021,

https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_

Pending-January-19-2022.pdf.

5 To prove a failure to warn under Louisiana law, “the claimant bears the burden 

of establishing that ‘at the time the product left the manufacturer’s control, the product 

possessed a characteristic that may cause damage and the manufacturer failed to use 

reasonable care to provide an adequate warning of such characteristic and its danger to 

users and handlers of the product.’” Hutto v. McNeil-PPC, Inc., 2011-606, p.12 (La. App. 

3 Cir. 12/7/11); 79 So. 3d 1199, 1210–11 (quoting La. Stat. Ann. § 9:2800.57). 

 “Redhibition is the avoidance of a sale on account of some vice or defect in the 

thing sold which renders it either absolutely useless, or its use so inconvenient and 

imperfect, that it must be supposed that the buyer would not have purchased it, had [she] 

known of the vice.” Hoffmann v. B & G, Inc., 2016-1001, p.5 (La. App. 1 Cir. 2/21/17); 215 

So. 3d 273, 277.

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were documented as experiencing “ongoing” alopecia at the end of the tenyear follow-up period. Sanofi additionally produced a spreadsheet that 

contained Dr. Kopreski’s review of the TAX316 study. In the spreadsheet, 

Dr. Kopreski stated that only six of the twenty-nine patients sustained 

permanent hair loss, as defined by Earnest. 

In February 2019, Earnest moved to exclude expert witnesses that 

Sanofi had designated including Dr. John Glaspy, a medical oncologist and 

professor of medicine at UCLA Jonsson Comprehensive Cancer Center.

Earnest argued that the experts’ proffered testimony improperly relied on 

Dr. Kopreski’s review of the TAX316 study. Earnest argued that Dr. 

Kopreski had gone beyond testimony related to the corporate operations of 

Sanofi and had essentially offered expert medical testimony opining on the 

TAX316 study and its participants. Earnest further asserted that Dr. 

Kopreski’s analysis was litigation-driven and therefore in the nature of 

improper expert opinion evidence. Earnest maintained that Dr. Kopreski’s 

review was based on incomplete patient data because it encompassed only 

the twenty-nine patients identified in the final TAX316 clinical study report 

as experiencing “ongoing” hair loss, and his review relied solely on the fiftyfive-month interim data as opposed to the final results. Specifically as to Dr. 

Glaspy, Earnest argued that he failed “independently [to] verif[y]” the data 

in Dr. Kopreski’s review. 

The district court denied Earnest’s motion to exclude the expert 

testimony. Citing Federal Rule of Evidence 703 and case law, the court ruled 

that Dr. Glaspy was permitted to rely on Dr. Kopreski’s review of the 

TAX316 study, “provided such reliance [was] reasonable.” 

The same month, Sanofi moved for summary judgment based on 

Louisiana’s one-year statute of limitations. Sanofi asserted that Earnest was 

time-barred from asserting her failure-to-warn and redhibition claims. 

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Earnest responded in opposition. In July 2019, the district court granted 

Sanofi’s summary judgment motion in part and dismissed Earnest’s 

redhibition claim with prejudice.6 

Earnest’s failure-to-warn claim went to trial on September 16, 2019. 

In her case-in-chief, Earnest presented seventeen witnesses via video 

deposition and live testimony. That included testimony from eleven fact 

witnesses, one being Dr. Kopreski, and six expert witnesses. When Earnest 

rested on September 24, Sanofi moved for judgment as a matter of law, 

asserting preemption and Earnest’s failure to prove her failure-to-warn 

claim.7

 The district court deferred ruling on Sanofi’s motion.

Sanofi presented only two witnesses in its case-in-chief: Dr. Kopreski, 

as a Rule 30(b)(6) fact witness, and Dr. Glaspy, as an expert witness. Before 

Sanofi presented a segment of Dr. Kopreski’s video deposition, Earnest 

renewed her objections to his testimony, but the court overruled her 

objections and allowed the testimony into evidence. 

Dr. Kopreski testified regarding the procedure and theory behind 

clinical trials; specifically he spoke about the data adduced from TAX316’s 

trial participants. Using that data, Dr. Kopreski generated a table of all study 

participants who experienced hair loss more than six months after concluding 

the drug regimen. After applying a methodology to exclude some of these 

participants, Dr. Kopreski testified that his analysis showed a vanishingly 

small number of TAC participants—six—who experienced permanent hair 

loss. In turn, Dr. Glaspy testified at length regarding his own experience as a 

6 Earnest does not challenge the dismissal of her redhibition claim on appeal. 

Therefore, this opinion does not address or apply to that claim.

7 Both defendants moved for judgment as a matter of law; for the sake of simplicity, 

we refer to the motions, which were substantively the same, as a single motion in this 

discussion. 

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clinical oncologist and as a director of various clinical studies. Dr. Glaspy

testified specifically about the TAX316 study and hair loss in participants. 

Relying wholly on Dr. Kopreski’s analysis, Dr. Glaspy concluded that the 

study demonstrated that permanent hair loss was an outlier risk of the drug 

regimen. 

At the close of evidence, Sanofi renewed its motion for judgment as a 

matter of law, which the district court again deferred. During its closing 

argument to the jury, Sanofi asserted that Earnest’s “whole case fails” 

because Dr. Kopreski’s testimony regarding TAX316 established that hair

loss affected only a small number of patients. Sanofi’s reliance on Dr. 

Kopreski’s analysis was emphatic: “[I]f you want to know what really 

happened with TAX316, just like a book, you have to read the book to know 

how the story ends. And the only person in this case that did that was Dr. 

Kopreski.” 

Following deliberation, the jury rendered a unanimous verdict in favor 

of Sanofi, and the court entered judgment in accordance with that verdict. 

Earnest thereafter filed a motion for new trial pursuant to Federal Rule of 

Civil Procedure 59(a), asserting that the district court erroneously admitted 

improper opinion testimony from Dr. Kopreski and Dr. Glaspy. The district 

court concluded that Dr. Glaspy’s reliance on Dr. Kopreski’s analysis was 

reasonable under Rule 703 and denied Earnest’s motion. The court reasoned 

that the testimony was proper because (1) Dr. Glaspy was heavily involved in 

the TAX316 study; (2) Dr. Glaspy was personally aware that “ongoing” and 

“permanent” were not synonymous within the meaning of the TAX316 data

regarding side effects; (3) Earnest was permitted to cross-examine Dr. 

Glaspy on why such reliance was warranted; and (4) the jury was shown all 

the evidence, such that it could decide for itself whether to rely on Dr. 

Glaspy’s expert testimony. 

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This appeal followed.

II.

We review the district court’s evidentiary rulings for abuse of 

discretion. Hewlett-Packard Co. v. Quanta Storage, Inc., 961 F.3d 731, 736 (5th 

Cir. 2020). “A district court abuses its discretion when its ruling is based on 

an erroneous view of the law or a clearly erroneous assessment of the 

evidence.” Heinsohn v. Carabin & Shaw, P.C., 832 F.3d 224, 233 (5th Cir. 

2016) (quoting Nunez v. Allstate Ins. Co., 604 F.3d 840, 844 (5th Cir. 2010)). 

“The harmless error doctrine applies to the review of evidentiary rulings, so 

even if a district court has abused its discretion, [this court] will not reverse 

unless the error affected ‘the substantial rights of the parties.’” Id.

We afford the district court “broad discretion” in its rulings regarding 

the admission of expert testimony. Sandifer v. Hoyt Archery, Inc., 907 F.3d 

802, 807 (5th Cir. 2018). We reverse such a ruling only if it is “manifestly 

erroneous.” Guy v. Crown Equip. Corp., 394 F.3d 320, 325 (5th Cir. 2004) 

(emphasis omitted) (citing Gen. Elec. Co. v. Joiner, 552 U.S. 136, 141–42 

(1997)). “We reverse the trial court only in unusual and exceptional cases.” 

Sandifer, 907 F.3d at 807 (cleaned up).

Likewise, we review the denial of a motion for new trial for abuse of 

discretion. Williams v. Manitowoc Cranes, L.L.C., 898 F.3d 607, 614 (5th Cir. 

2018) (citation omitted). We reverse the district court only if “there is an 

absolute absence of evidence to support the jury’s verdict.” Id. (citation 

omitted).

III.

Earnest raises two interrelated issues on appeal: the district court’s 

evidentiary rulings during trial and the court’s denial of her post-judgment 

motion for a new trial. Both challenges rest on Earnest’s assertion that the 

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district court erred by admitting testimony grounded on Dr. Kopreski’s post

hoc review of the TAX316 clinical study.

A.

Earnest first contends that the district court improperly admitted 

what she terms Dr. Kopreski’s “re-analysis” of the TAX316 data. She 

asserts that, as a lay witness, Dr. Kopreski could not offer expert opinions 

and his testimony was neither relevant nor reliable under Federal Rule of 

Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 

(1993).

8 Sanofi counters that Dr. Kopreski’s testimony was admissible for 

two reasons. First, Sanofi contends that, as the district court concluded, Dr. 

Kopreski’s testimony was properly admissible “opinion testimony by a lay 

witness” under Federal Rule of Evidence 701. Alternatively, Sanofi asserts 

that Earnest opened the door to Dr. Kopreski’s testimony, noting that 

Earnest first introduced Dr. Kopreski’s testimony in her own case-in-chief. 

Weighing the parties’ contentions, we are persuaded that the district 

court erred by admitting Dr. Kopreski’s testimony under Rule 701, and the 

error was not harmless because Earnest’s substantial rights were prejudiced 

by admission of the testimony. Sanofi’sstratagem of skating the line between 

Rules 701 and 702 with Dr. Kopreski’s testimony—borne out by the record 

and essentially confirmed at oral argument—reflects a calculated and 

troubling end-run around Rule 702 and Daubert. These evidentiary gates 

exist to keep out error that may impermissibly affect the jury, see Carlson v. 

8 The substantive aspects of this case are governed by Louisiana law, but the 

Federal Rules of Evidence control the admission of evidence. Roman v. Western Mfg., Inc., 

691 F.3d 686, 692 (5th Cir. 2012); see also Wackman v. Rubsamen, 602 F.3d 391, 400 n.2 

(5th Cir. 2010) (citations omitted).

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Bioremedi Therapeutic Sys., Inc., 822 F.3d 194, 202 (5th Cir. 2016), and the 

district court should not have left the gate ajar here.

Rule 701 governs the admissibility of opinion testimony by a lay 

witness:

If a witness is not testifying as an expert, the testimony in the 

form of an opinion is limited to one that is: 

(a) rationally based on the witness’s perception;

(b) helpful to clearly understanding the witness’s testimony or 

to determining a fact in issue; and 

(c) not based on scientific, technical, or other specialized 

knowledge within the scope of Rule 702.

Fed. R. Evid. 701. A lay opinion is thus admissible if it is “based on 

personal perception, . . . one that a normal person would form from those 

perceptions, and . . . helpful to the jury.” Miss. Chem. Corp. v. Dresser-Rand 

Co., 287 F.3d 359, 373 (5th Cir. 2002) (citations omitted). “In particular, the 

witness must have personalized knowledge of the facts underlying the 

opinion and the opinion must have a rational connection to those facts.” Id. 

“If these two requirements are met[,] ‘a layman can under certain 

circumstances express an opinion even on matters appropriate for expert 

testimony.’” Id. (quoting Soden v. Freightliner Corp., 714 F.2d 498, 511 (5th 

Cir. 1983)).

The thrust of Earnest’s argument on this issue is that Dr. Kopreski’s 

testimony was riddled with unqualified and unreliable expert opinions. In 

support of her contention, she relies on Montgomery County v. Microvote 

Corp., 320 F.3d 440 (3d Cir. 2003), and Crowley v. Chait, 322 F. Supp. 2d 530 

(D.N.J. 2004). In Microvote Corp., the district court excluded the testimony 

of Microvote’s expert witness as unreliable because the witness conceded 

that he did not review actual election use data in evaluating electronic voting 

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equipment that had malfunctioned. 320 F.3d at 448–49. Instead, the expert

relied on a document prepared by Microvote’s former sales director who

“guesstimate[d]” about the amount of time the equipment was down. Id. 

The district court also found that the sales director had not based his guess 

on primary data. Id. at 449. Applying Rule 702 and Daubert, the Third 

Circuit affirmed the district court. Id.

In Crowley, the receiver of an insolvent insurance company sued the 

company’s senior management for breach of fiduciary duty and also sued

PricewaterhouseCoopers (PwC) for alleged negligence in connection with 

audits of the insurance company’s parent company. 322 F. Supp. 2d at 534. 

PwC moved to exclude one of the receiver’s experts, contending that the 

expert prepared his reports solely based on highly selective deposition

testimony chosen by the receiver and the receiver’s attorney, who

disregarded contradictory testimony. Id. at 545–46. The district court found

that the expert’s conclusions were unreliable because they were reached 

through a “highly filtered version of the events.” Id. at 547.

Sanofi counters that neither Microvote nor Crowley should inform our 

analysis here. Instead, Sanofi offers United States v. Valencia, 600 F.3d 389 

(5th Cir. 2010) (per curiam), as instructive. In Valencia, the defendant 

argued that one of the Government’s witnesses, Glenn Labhart, was in reality 

an expert witness who consequently implicated Rule 702’s reliability 

requirements. 600 F.3d at 413. Rejecting that argument, the district court 

ruled that Labhart was a lay witness because his testimony, while analytical,

“related to his former job duties.” Id. at 416. On review, this court agreed

that “Labhart was a lay witness, not an expert witness.” Id. “Because 

Labhart’s knowledge and analysis were derived from duties he held at [his 

company], his opinions were admissible as testimony based upon personal 

knowledge and experience gained while employed . . . .” Id.; accord Fed. R. 

Evid. 701 advisory committee’s note to 2000 amend. (“[Officer] opinion 

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testimony is admitted not because of experience, training or specialized 

knowledge within the realm of an expert, but because of the particularized 

knowledge that the witness has by virtue of his or her position in the 

business.”); Versai Mgmt. Corp. v. Clarendon Am. Ins. Co., 597 F.3d 729, 737 

(5th Cir. 2010) (per curiam) (company president was permitted “a broader 

range of testimony than a traditional lay witness . . . when testifying to 

matters concerning [the value of the] business”). 

Following similar reasoning, the district court treated Dr. Kopreski’s 

testimony as lay testimony, not expert testimony. And we agree that, as in

Valencia, much of Dr. Kopreski’stestimony reflected his personal knowledge 

and experience gained while employed as Sanofi’s associate vice president of 

global pharmacovigilance and epidemiology. He testified that in this role, he 

regularly reviewed scientific literature, abstracts, adverse event reports, and 

clinical trials and studies. Sanofi also designated Dr. Kopreski as its company 

designee, even though he was no longer a Sanofi employee, in response to 

Earnest’s Rule 30(b)(6) deposition notice, which expressly sought to 

examine Sanofi’s company designee about TAX316.9 A corporate designee 

9 Earnest’s second amended Rule 30(b)(6) notice stated in part that Sanofi was 

required “to designate and fully prepare” an officer with regard to:

1. Reports of any kind between 01/01/1992 and 12/31/2004 

regarding persisting alopecia being associated and/or related in any way 

with the use of TAXOTERE (alone or in combination) regardless of the 

source of such report(s)[.] 

. . . .

3. The identity of each patient, by reference number, who 

reportedly experienced persisting alopecia while enrolled as a participant 

in the TAX316 . . . so that it can be determined whether each such patient 

is included[.]

. . . .

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“has the authority to speak on behalf of the corporation with respect to the 

areas within the notice of deposition” and that authority extends “to 

facts, . . . subjective beliefs[,] and opinions.” Brazos River Auth. v. GE Ionics, 

Inc., 469 F.3d 416, 433 (5th Cir. 2006) (citation omitted). 

But even with that latitude, a Rule 30(b)(6) witness does not have 

license, without more, to opine as an expert. Assuming that Sanofi’s 

corporate designee could offer Rule 701 “lay witness” opinion testimony, 

Dr. Kopreski’s “testimony in the form of an opinion [remained] limited to 

[opinions] . . . not based on scientific, technical, or other specialized 

knowledge within the scope of Rule 702.” Fed. R. Evid. 701(c). The

TAX316 clinical trials were conducted during Dr. Kopreski’s tenure with 

Sanofi and he had personal knowledge of the study. Histestimony describing

the TAX316 study is thus the type of testimony generally admissible under 

Rule 30(b)(6) and Rule 701. Up to a point.

While parts of Dr. Kopreski’s testimony fall within the parameters of 

Rule 701, he also strayed beyond “facts, . . . subjective beliefs[,] and 

opinions,” GE Ionics, Inc., 469 F.3d at 433, within either his personal 

knowledge or his capacity as Sanofi’s corporate designee. He testified 

regarding highly specialized and technical information related to Taxotere, 

the TAX316 study, and drug studies in general. During its examination, 

Sanofi transparently sought Dr. Kopreski’s opinions about the TAX316 data 

“as a board certified oncologist,” as much as a former Sanofi employee. And 

Dr. Kopreski’stestimony is littered with his interpretation and analysis of the 

6. The findings regarding alopecia as [treatment-emergent 

adverse events] persisting into the follow-up period in TAX316 at the 

median follow-up of 55 months. 

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TAX316 study data, which he prepared during litigation in response to 

Earnest’s Rule 30(b)(6) deposition notice. 

When questioned about his review of TAX316, Dr. Kopreski 

explained his methodology: 

I looked at the patients from the 29 that were considered to be 

ongoing [i.e., with hair loss], and I asked of those if there was 

documentation that answered two questions, two simple 

questions: Number 1, did we have documentation, either from 

what was provided in the [case report forms] or what was 

provided in terms of . . . clinical trial datasets, that were 

produced from the [case reports forms] that showed 

documentation that the alopecia was still present six months 

after the last chemotherapy. So that was—that was the first 

criteri[on]: Was the alopecia still present six months after the 

last chemotherapy that was received.

The second criteri[on]: Was there any evidence of resolution 

of that alopecia? If there was any resolution, then it would not 

be considered persistent. So that—that, very simply, is—isthe 

process. It was a very straightforward process. It was looking 

to see if—if there was documentation for any of those two 

characteristics. 

Regardless of whether it was a “very straightforward process” to Dr. 

Kopreski, his refinement of the TAX316 data in the context of litigation was 

the product of “scientific, technical, or other specialized knowledge” and 

application of scientific “principles and methods” within the scope of Rule 

702, not simply lay opinion testimony based on his perceptions, as allowed by 

Rule 701. Therefore, it was erroneous for the district court to allow Dr. 

Kopreski to testify about his “re-analysis” of the TAX316 data without first 

enforcing its “basic gatekeeping obligation” under Rule 702 and Daubert. 

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999).

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Of course, “even if a district court has abused its discretion, [this 

court] will not reverse unless the error affected ‘the substantial rights of the 

parties.’” Heinsohn, 832 F.3d at 233 (quoting Nunez, 604 F.3d at 844). Here, 

the prejudice sustained by Earnest is evident. Sanofi effectively smuggled

inadmissible opinion testimony past the expert-disclosure and expertdiscovery obligations imposed by the discovery and evidentiary rules by 

offering Dr. Kopreski as a lay witness. Then Sanofi used that inadmissible 

testimony to bootstrap yet more expert testimony from Dr. Glaspy. Sanofi 

then relied on its only two witnesses’ testimony to argue during closing that 

the plaintiff’s “whole case fails.” Cf. Carlson, 822 F.3d at 202 (concluding 

that improper testimony “relied upon during the defendants’ closing 

arguments” was prejudicial). It is hard for us to see how Sanofi’s approach 

did not thus unfairly influence the jury and thereby “affect[] ‘the substantial 

rights of [Earnest].’” Heinsohn, 832 F.3d at 233 (quoting Nunez, 604 F.3d at 

844).

Moreover, we do not find Sanofi’s alternative argument, that Earnest 

first opened the door to Dr. Kopreski’s testimony by offering parts of his 

testimony herself, to be persuasive. For this proposition, Sanofi presents 

only United States v. Delk, 586 F.2d 513 (5th Cir. 1978). But that case is very 

different from this one. In Delk, we stated an uncontroversial proposition 

about rebuttal testimony: “[I]t is well settled that the purpose of rebuttal 

testimony is to explain, repel, counteract, or disprove the evidence of the 

adverse party and if [a party] opens the door to the line of testimony, [she]

cannot successfully object to the [other party] accepting the challenge and 

attempting to rebut the proposition asserted.” 586 F.2d at 516 (quotation

marks omitted). But the TAX316 “re-analysis” Dr. Kopreski presented in 

Sanofi’s case-in-chief was not in rebuttal to anything Earnest had offered. It 

was expert opinion, offered by Sanofi on offense, not on defense. As such, 

even to the extent Earnest opened the door for rebuttal evidence, that did not 

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allow Sanofi to jump the gate provided by Rule 702 and Daubert in presenting 

its case-in-chief. 

B.

Earnest next argues that the district court abused its discretion by 

admitting Dr. Glaspy’s expert testimony to the extent it was based on Dr. 

Kopreski’s review of the TAX316 study. Earnest does not challenge Dr. 

Glaspy’s qualifications as an expert witness. Instead, she takes issue with Dr. 

Glaspy’s failure to compare TAX316’s actual data with Dr. Kopreski’s “reanalysis” of TAX316. According to Earnest, Dr. Glaspy’s expert testimony 

violated Rule 702 and Daubert because he did not independently validate Dr. 

Kopreski’s review of the data. She points to Dr. Glaspy’s concession during 

his testimony that “if the data that Dr. Kopreski put in [his] table [aren’t]

accurate, then my analysis is flawed. If [they are] accurate, I will stand by it.” 

Building on our conclusion that parts of Dr. Kopreski’s testimony were 

improperly admitted, here too there was an abuse of discretion that 

prejudiced Earnest. 

The Supreme Court’s Daubert framework governing the admissibility

of expert testimony is effectively codified in Rule 702:

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.

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Fed. R. Evid. 702. The object of Rule 702 is to protect juries from 

unreliable and irrelevant expert testimony. E.g., Curtis v. M&S Petroleum, 

Inc., 174 F.3d 661, 668 (5th Cir. 1999). “To be reliable, expert testimony 

must ‘be grounded in the methods and procedures of science and . . . be more 

than unsupported speculation or subjective belief.’” Puga v. RCX Sols., Inc., 

922 F.3d 285, 293 (5th Cir. 2019) (quoting Johnson v. Arkema, Inc., 685 F.3d 

452, 459 (5th Cir. 2012) (per curiam)). “To be relevant, the expert’s 

‘reasoning or methodology [must] be properly applied to the facts in issue.’” 

Id. (alteration in original).

To support her position, Earnest cites numerous cases from our 

circuit and others, as well as from several district courts, that illustrate the 

general principle that Rule 702 and Daubert require an expert witness 

independently to validate or assess the basis for his or her assumptions. We 

do not disagree with this proposition, as this court has previously stated: 

[T]he party seeking to have the district court admit expert 

testimony must demonstrate that the expert’s findings and 

conclusions are based on the scientific method, and, therefore, 

are reliable. This requires some objective, independent 

validation of the expert’s methodology. The expert’s 

assurances that he has utilized generally accepted scientific 

methodology is insufficient . . . . The proponent need not 

prove to the judge that the expert’s testimony is correct, but 

she must prove by a preponderance of the evidence that the 

testimony is reliable.

Moore v. Ashland Chem., Inc., 151 F.3d 269, 276 (5th Cir. 1998) (en banc)

(citations omitted); but see Fed. R. Evid. 703 (permitting an expert witness 

to base his opinion on “facts or data . . . that the expert has been made aware 

of or personally observed” and to opine on inadmissible evidence if “experts 

in the particular field would reasonably rely on those kinds of facts or data in 

forming an opinion on the subject”).

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At trial, Sanofi offered Dr. Glaspy as an expert in oncology, breast 

cancer care and treatment, labeling, risk information for chemotherapy, 

clinical trials, and informed consent regarding side effects of chemotherapy. 

Following voir dire, the district court accepted Dr. Glaspy as an expert in 

those areas. Dr. Glaspy then testified about causation in this case. 

Ultimately, he opined that it is “impossible” reliably to conclude that 

Taxotere caused Earnest’s hair loss. Dr. Glaspy based his opinion on his 

review of Earnest’s medical records, the other experts’ depositions, Dr. 

Kopreski’s TAX316 review, and an array of scientific literature. His reliance 

on much of this evidence was entirely proper under Rules 702 and 703. But 

for his linchpin conclusion about causation, Dr. Glaspy specifically 

acknowledged his dependence on Dr. Kopreski’s “re-analysis” of the 

TAX316 data, going so far as to say that “if the data that’s in [Dr. Kopreski’s] 

table is incorrect, then none of my opinions are valid.” (Emphasis added.) 

Because Dr. Kopreski’s “re-analysis” data amounted to improper expert 

opinion, Dr. Glaspy’s opinion as to causation based on Dr. Kopreski’s 

analysis was likewise tainted.10 And for the same reasons that the admission 

of Dr. Kopreski’s opinion testimony prejudiced Earnest, the admission of Dr. 

10 To be clear, we obviously do not conclude that an expert may never rely on 

inadmissible evidence. We reiterate that Rule 703 expressly permits an expert to base 

opinions on “facts or data . . . that the expert has been made aware of or personally 

observed,” including inadmissible evidence if “experts in the particular field would 

reasonably rely on those kinds of facts or data in forming an opinion on the subject.” And 

we likewise do not conclude that an expert may not rely on another expert’s (or a lay 

witness’s) admissible testimony. See Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 

F.3d 1283, 1303 (Fed. Cir. 2015). Rather, we determine that in these particular 

circumstances—where the inadmissible evidence (1) is from a witness testifying at the 

same trial, (2) is critical to the expert’s testimony, and (3) is not independently verified by 

the expert—the expert’s testimony relying on that inadmissible evidence does not pass 

muster under Rules 702 and 703. We leave to the district court to decide in the first 

instance how best to move forward on retrial.

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Glaspy’s testimony derived from it affected Earnest’s substantial rights as 

well.

C.

Even mindful of the “wide latitude” afforded to district courts in 

deciding the admissibility of expert testimony, Roman v. Western Mfg., Inc., 

691 F.3d 686, 692 (5th Cir. 2012), we conclude that the district court 

reversibly erred in its evidentiary rulings regarding Sanofi’s two witnesses at 

trial. In turn, the admission of those witnesses’ improper expert testimony, 

featured prominently in Sanofi’s closing argument to the jury, prejudiced 

Earnest’s substantial rights during trial. As a result, we reverse the judgment 

of the district court and remand the appealed claims for a new trial.

REVERSED and REMANDED.

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