Earnest v. Sanofi US Services ( 2022 )

Case: 20-30184 Document: 00516197805 Page: 1 Date Filed: 02/10/2022
United States Court of Appeals
for the Fifth Circuit United States Court of Appeals
Fifth Circuit
FILED
February 10, 2022
No. 20-30184
Lyle W. Cayce
Clerk
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:
Case: 20-30184 Document: 00516197805 Page: 2 Date Filed: 02/10/2022
No. 20-30184
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,
2
Case: 20-30184 Document: 00516197805 Page: 3 Date Filed: 02/10/2022
No. 20-30184
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))).
3
Case: 20-30184 Document: 00516197805 Page: 4 Date Filed: 02/10/2022
No. 20-30184
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 long-
term 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.
4
Case: 20-30184 Document: 00516197805 Page: 5 Date Filed: 02/10/2022
No. 20-30184
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
5
Case: 20-30184 Document: 00516197805 Page: 6 Date Filed: 02/10/2022
No. 20-30184
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.
6
Case: 20-30184 Document: 00516197805 Page: 7 Date Filed: 02/10/2022
No. 20-30184
were documented as experiencing “ongoing” alopecia at the end of the ten-
year 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 fifty-
five-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.
7
Case: 20-30184 Document: 00516197805 Page: 8 Date Filed: 02/10/2022
No. 20-30184
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.
8
Case: 20-30184 Document: 00516197805 Page: 9 Date Filed: 02/10/2022
No. 20-30184
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.
9
Case: 20-30184 Document: 00516197805 Page: 10 Date Filed: 02/10/2022
No. 20-30184
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
10
Case: 20-30184 Document: 00516197805 Page: 11 Date Filed: 02/10/2022
No. 20-30184
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’s stratagem 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).
11
Case: 20-30184 Document: 00516197805 Page: 12 Date Filed: 02/10/2022
No. 20-30184
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
12
Case: 20-30184 Document: 00516197805 Page: 13 Date Filed: 02/10/2022
No. 20-30184
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
13
Case: 20-30184 Document: 00516197805 Page: 14 Date Filed: 02/10/2022
No. 20-30184
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’s testimony 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[.]
....
14
Case: 20-30184 Document: 00516197805 Page: 15 Date Filed: 02/10/2022
No. 20-30184
“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. His testimony 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’s testimony 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.
15
Case: 20-30184 Document: 00516197805 Page: 16 Date Filed: 02/10/2022
No. 20-30184
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—is the
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).
16
Case: 20-30184 Document: 00516197805 Page: 17 Date Filed: 02/10/2022
No. 20-30184
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 expert-
discovery 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
17
Case: 20-30184 Document: 00516197805 Page: 18 Date Filed: 02/10/2022
No. 20-30184
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 “re-
analysis” 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.
18
Case: 20-30184 Document: 00516197805 Page: 19 Date Filed: 02/10/2022
No. 20-30184
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”).
19
Case: 20-30184 Document: 00516197805 Page: 20 Date Filed: 02/10/2022
No. 20-30184
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.
20
Case: 20-30184 Document: 00516197805 Page: 21 Date Filed: 02/10/2022
No. 20-30184
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.
21