Court Opinion

ID: 6220258
Source: CourtListenerOpinion
Date Created: 2022-02-10 19:00:27.725227+00
Date Added: 2024-06-11T08:57:17.569687
License: Public Domain

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:
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                                    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,

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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 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.

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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 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.

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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’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).

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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’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[.]
                  ....

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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. 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.

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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—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).

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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 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

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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 “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.

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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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