Every once in a while, we encounter a decision that is so obviously wrong that we have to pause and go back to the basics to make sure we did not miss something in our initial read.  This dynamic is something like reading the troubleshooting instructions that you might get when you buy a new electronic gizmo and cannot get it to work.

  • Check to make sure it is plugged in.
  • Check to make sure you have electricity in your home.
  • Check to make sure you are using a functioning outlet.
  • Check to make sure you pressed the power button.
  • Check again to make sure you pressed the power button firmly.
  • Are you sure you did not push the power button twice and turn it off?
  • If you got this far, then you can try our on-line help. When the on-line help has proved useless and you are ready to punch a hole in your wall, then we will get on the phone with you to try to help.

The mental checklist for identification of a bad decision has to be a little more fluid, but the goal is the same:  determining if the problem rests with us or the decision/gizmo.  We have run through our checklist and we are pretty sure that it is the Fifth Circuit’s decision in In re Taxotere (Docetaxel) Prods. Liab. Litig., No. 20-30184, 2022 WL 405298 (5th Cir. Feb. 10, 2022) (“Earnest”), that is the problem.  Part of its problem is that it missed some things we think are really basic.  Getting such a sloppy decision from the Fifth Circuit on an appeal of a case from the Taxotere MDL is surprising.  After all, a pair of affirmances last year hit #7 on our annual top ten list and the MDL has cranked out a number of blogworthy decisions over the last few years.  Like here, here, here, and here.  We will deviate from our general rule of not talking about the panel, but this one was quite unusual in its composition.  Although there are 26 judges on this court, all three of the judges on the panel were appointed by a recent one-term president.  Only one had any prior judicial experience—a short stint on a state intermediate appellate court—and the other two were political appointees under a particular governor.  Rather than speculate about the panel’s mastery of the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and Louisiana product liability law, we will just speculate that just about any other panel of the Fifth Circuit would have a different perspective.

Earnest involved the appeal of a defense verdict at trial on a single failure to warn count based on the highly questionable proposition that a change to the alopecia warnings for a life-saving cancer drug would have altered the decision of plaintiff’s oncologist to prescribe her the drug that helped save her life.  The crux of her argument on appeal was that deposition testimony from a physician who used to work for the defendant should not have been introduced at trial because he was not named as an expert, and that defendant’s designated expert should not have been allowed to rely on that deposition testimony when he testified live at trial.  The district court rejected these arguments before, during, and after trial, but the panel, while purporting to apply an abuse of discretion standard, reversed.  The panel characterized the “cloaking [of] Dr. Kopreski’s quasi-expert testimony as ‘lay witness’ opinion testimony” as “a concerning end run around Rule 702.”  2022 WL 405298, *1.  Dr. Kopreski was the former employee, once associate vice president of pharmacovigilance and epidemiology, a title appropriate for someone designated to be deposed as defendant’s representative on the cases and findings related to alopecia in the ten-year clinical study at the center of plaintiff’s case.  In the three depositions of Dr. Kopreski, plaintiff discovered Dr. Kopreski’s view of the findings from that study, the documents about alopecia in that study, and why the findings were what they were.  In short, he testified that less than 1% of study participants reported “permanent” hair loss—what plaintiff claimed and argued should have been in the label when she was prescribed the drug—and not 4.2% designated as “on-going” at the time of termination of the study.  He also gave apparently uncontradicted testimony that the study showed impressive efficacy in minimizing cancer and mortality from cancer.  We are getting ahead of ourselves, but it should already be obvious that the defense verdict was because of weak plaintiff evidence not an end-run on admitting expert testimony.  (We do not have a precise tally, but it looks like defendants in the MDL have won a bunch of summary judgments and two jury verdicts, while the plaintiffs have won zero jury verdicts.)

One further comment before we dive back into the decision.  As the quote above showed, the court used plenty of loaded language in characterizing the testimony at issue and the defendant’s intent in offering it.  We use language like “end run” and “cloaking” in our posts, but we do not expect to see their ilk peppered throughout a federal appellate decision.  As we quote more of the decision below and any language seems over the top, ask yourself why such language would be used.

Back to the meat of the decision.  As part of her long case, plaintiff presented deposition testimony from Dr. Kopreski.  Once she offered seventeen witnesses and rested, the defendant moved for directed verdict on “preemption and [plaintiff’s] failure to prove her failure-to-warn claim” and the court took it under advisement.  Id. at *4.  Either because they could not do full counter designations or wanted it presented separately, the defendant presented other deposition testimony from Dr. Kopreski in its case, along with testimony from an expert oncologist who relied in part on Dr. Kopreski’s deposition testimony and materials produced in connection with his deposition.  The defendant rested after two witnesses, closing arguments were delivered, and then the jury rendered a verdict for the defendant.  Recall that plaintiff only had the warnings claim and note that the defendant did not present additional evidence on the impact on the prescriber of theoretical additional warnings concerning alopecia.  Although the Earnest court’s recounting of the elements of a Louisiana warnings claim omitted it, id. at n.5, plaintiff did have to prove proximate cause.  See, e.g., In re Taxotere (Docetaxel) Prod. Liab. Litig., 994 F.3d 704, 708 (5th Cir. 2021) (“To prove causation in this context, a plaintiff must show that a proper warning would have changed the decision of the prescribing physician, i.e. that but for the inadequate warning, the prescribing physician would not have used or prescribed the product.”) (citation and quotation marks omitted).

Having read some other decisions from this litigation and been around the block a few times, this recounting strongly suggests that the jury did not believe the plaintiff carried her burden to prove the prescriber would have done anything different, meaning she lost on proximate cause, not because the jury concluded there was no duty to warn or that she did not have permanent hair loss from her use of the medication.  We could be wrong—specific answers to jury interrogatories are not discussed—but this does seem like something to discuss in assessing whether any error in admitting testimony that did not relate to proximate cause was so material as to merit a new trial.

Another gap in the court’s analysis is that the argument that Dr. Kopreski was a hidden expert and plaintiff was somehow surprised by the introduction of some of his deposition testimony implicates Fed. R. Civ. P. 26(a)(2).  No part of this rule is discussed in Earnest, though.  Under 26(a)(2)(A), “a party must disclose to the other parties the identity of any witness it may use at trial to present evidence under Federal Rule of Evidence 702, 703, or 705.”  Rule 26(a)(2)(B) provides the familiar standard for expert reports, unless altered by order or agreement:  a report is required “if the witness is one retained or specially employed to provide expert testimony in the case or one whose duties as the party’s employee regularly involve giving expert testimony.”  Was the defendant required to identify Dr. Kopreski as an expert under these provisions?  Did it do so in a timely and appropriate fashion?  Was he required to serve an expert report?  Did plaintiff raise these arguments below or waive them?  These all seem like critical questions to ask when evaluating plaintiff’s primary argument on appeal.  It does not make sense to jump to the issue of whether Rule 701 or 702 should have applied to his challenged testimony, but that is what the Earnest court did.

Another fundamental misunderstanding in its analysis was the repeated reference to defendant presenting Dr. Kopreski at trial as a “designated representative under Federal Rule of Civil Procedure 30(b)(6).”  There is a reason that Rule 30 is grouped with “Disclosure and Discovery” rather than “Trials” within the Federal Rules of Civil Procedure.  When a deposition notice is issued to an organization and the deposition happens, some actual person needs to be sworn in to testify.  That person is the designated representative of the organization only for purposes of the deposition and only on the specified matters.  There is no equivalent rule for trials.  Several other rules govern the use of deposition testimony at trial.  In Earnest, plaintiff’s specified matters in the notice led to Dr. Kopreski being designated to offer testimony on the precise subjects that plaintiff later introduced in her case and complained that defendant got to use in its case.  Consider how this works in the real world of litigation.  If Dr. Kopreski showed up and was not able to testify on the designated matters, then plaintiff would have moved to compel further deposition.  Same thing if he lacked personal knowledge on some part of the matter and did not do sufficient preparation to try to be able to testify about it (e.g., a time period after he left the company).  This dynamic may be why he ended up getting deposed three times.  If Dr. Kopreski had offered “opinions” or testimony based on technical knowledge that plaintiff liked, then she would surely try to offer them at trial as admissions of a speaking agent regardless of designations, reports, Rule 701, or Rule 702.  This suggests that the issue for plaintiff was not that the testimony was a surprise or expert, but that it was bad for her.  Given that the matters for which he was designated inherently related to the interpretation of data from a clinical study, it is not hard to imagine that just about all of Dr. Kopreski testimony could be considered expert and/or opinion, regardless of who asked the question and whether it used words like “opinion” or “conclusion” in the title.  Given that the study’s final report was issued in August 2010, many years before the litigation began or the depositions occurred, it is also not hard to imagine that Dr. Kopreski had to review materials and prepare to be deposed consistent with the requirements of Rule 30(b)(6).  Again, the Earnest decision is devoid of these considerations.

The panel concluded that:

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—reflect a calculated and troubling end-run around Rule 702 and Daubert.

Id. at *5.  While we are firm proponents of vigorous gatekeeping by trial judges, we would expect a detailed analysis to back up this conclusion along the way to finding the deposition testimony was admitted in error.  We do not see it here.  The plaintiff alleged that the testimony “was riddled with unqualified and unreliable expert opinion,” but no details are given to support the allegations or find that they were correct.  Id. at *6.  Instead, Earnest finds that the trial court applied the correct law—defendant’s from the Fifth Circuit rather than plaintiff’s from the Third Circuit—in finding that Dr. Kopreski’s testimony “reflected his personal knowledge and experience” at the defendant and that he had personal knowledge of the study at issue.  Id. at *7.  It also noted Fifth Circuit authority that a 30(b)(6) designee may give deposition testimony on “subjective beliefs and opinions.”  Id. (citation omitted).

Then the logic train goes off the tracks.

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,” 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 TAX316 study data, which he prepared during litigation in response to Earnest’s Rule 30(b)(6) deposition notice.

Id. (internal citation omitted).  First, Rule of Civil Procedure 30(b)(6) does not concern admissibility.  Second, the deposition notice called for a representative to be prepared to testify on “highly specialized and technical information related to Taxotere, the TAX316 study, and drug studies in general” and the company’s “interpretation and analysis of the TAX316 study data.”  Third, preparation for a deposition as a representative is by nature “in response to [a party’s] Rule 30(b)(6) deposition notice.”  Fourth, and this is borne out by the example the court gives of Dr. Kopreski allegedly straying into expert matters, to answer the fundamental question of “why did the company think adverse events in the study were not a signal of a risk of permanent hair loss”—surely, the crux of the deposition—the representative would have discuss principles of oncology, clinical research, pharmacology, etc., that informed that thinking and process followed to evaluate the issues.  The court’s conclusion that some part of Dr. Kopreski’s deposition testimony—some or all of what the defendant played—should have been excluded was based on his use of “scientific ‘principles and methods’” to prepare to answer plaintiff’s questions on scientific issues.  Id. at *8.  This, of course, is what he was supposed to do as a 30(b)(6) witness on plaintiff’s selected matters.  The alternatives were presumably that he would have been unable to answer questions in deposition or that he would have answered them without any basis.

Consider the two examples of permissible lay opinions given in the advisory committee notes for Fed. R. Evid. 701:  the owner of a business testifying to the value or projected profits of the business and heavy amphetamine users testifying that a substance was amphetamine.  Clearly, such witnesses—like Dr. Kopreski—could testify to what they thought in the past even though this could be considered an opinion.  Better questioning, whether to buttress their “opinions” or required by the court as simple foundation, might involve recounting the witness’s experience with projecting profits, valuing businesses, or identifying amphetamines.  Perhaps with different words, it would be expected to inquire as to their methodology for projection, valuation, or identification and how they came to know this methodology.  Before she testified, the business owner, for instance, might go back and see if her business valuation accounted for the issue of goodwill raised in the course of the litigation.  We do not see much light between that and Dr. Kopreski’s testimony as we understand it.

We will not spend much time on the court’s conclusions, in this order, that plaintiff was prejudiced by the admission of the portion of Dr. Kopreski’s deposition testimony that defendant played in its case and that the defendant’s retained expert should not have been allowed to rely on some of Dr. Kopreski’s work.  On the former issue, before evaluating the latter issue, the court concluded:

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.” 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].’ ”

Id. (internal citation omitted).  Most of this does not sound like prejudice and it is not surprising that a defendant that called only two witnesses would point to them in its closing.  Nor is surprising, in warnings case where it would be implausible for an oncologist to change a decision to prescribe a life-saving cancer drug based on a change in the alopecia warnings, that the weakness of the plaintiff’s main evidence of a purported signal would be highlighted.

After all of this, it is also not surprising that the court rejected the argument that plaintiff opened the door to the testimony from Dr. Kopreski that she challenged.  It was, however, somewhat strange to see this addressed only in the context of prejudice and not on whether the trial judge abused his discretion in admitting some deposition testimony from Dr. Kopreski in defendant’s case after other deposition testimony had been admitted in plaintiff’s case.  It was stranger to conclude without ever discussing the substance of any evidence or argument from plaintiff that “the TAX316 ‘re-analysis’ Dr. Kopreski presented in Sanofi’s case-in-chief was not in rebuttal to anything Earnest had offered.”  Id.  The gist of plaintiff’s allegation, and presumably their designation from the defendant’s representative to talk about this study, was that it showed a risk of permanent hair loss that should have been incorporated in the label before plaintiff was prescribed the drug.  Testimony that the study did not show such a risk seems like prototypical rebuttal evidence.

Returning to our mental checklist, we did entertain the possibility that this was all procedural—that the panel was really complaining that the trial judge had not conducted a proper Daubert analysis.  The conclusion that the testimony should not have been admitted is punctuated by “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.”  Id.  However, there is scant information provided on the motions practice below and no Daubert analysis was required unless Dr. Kopreski had to be designated as an expert to testify to the “opinions” from his deposition.  (As we said, that is a Rule 26 issue, which the panel never touched.)  Perhaps more importantly, the remand after reversal was a new trial, not for the trial court to conduct a proper analysis of Dr. Kopreski’s qualifications and methodology.  So, we still feel pretty confident that Earnest is a bad decision, at odds with the inherently weak warnings case for plaintiffs that has resulted in a number of good results for the defendants and none, before this, for the plaintiffs.