The defendant in the Taxotere litigation, Sanofi, produced Dr. Kopreski as its corporate designee for depositions. The plaintiffs deposed Dr. Kopreski three times. One of those rounds of depositions focused on the TAX316 study. 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. In advance of trial, the plaintiff moved to exclude Sanofi witness, Dr. John Glaspy, a medical oncologist, arguing that his proffered testimony improperly relied on Dr. Kopreski’s review of the TAX316 study. The plaintiff 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. The plaintiff further asserted that Dr. Kopreski’s analysis was litigation-driven and therefore in the nature of improper expert opinion evidence. The plaintiff maintained that Dr. Kopreski’s review was based on incomplete patient data and his review relied solely on the fifty-five-month interim data as opposed to the final results. Specifically as to Dr. Glaspy, the plaintiff argued that he failed to independently verify the data in Dr. Kopreski’s review. The District Court denied the motion to exclude. At trial, Sanofi presented only two witnesses: 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, the plaintiff renewed her objections to his testimony, but the court overruled her objections and allowed the testimony into evidence. Dr. Kopreski testified about the data adduced from TAX316’s trial participants, and 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 participants who experienced permanent hair loss. In turn, Dr. Glaspy testified at length regarding his own experience as a 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. During its closing argument to the jury, Sanofi asserted that the plaintiff’s whole case fails because Dr. Kopreski’s testimony regarding TAX316 established that hair loss affected only a small number of patients. “If 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.”

Vacating the defense verdict and remanding for a new trial, the U.S. Fifth Circuit found that the district court erred by admitting Dr. Kopreski’s testimony under Rule 701, and the error was not harmless because the plaintiffs was 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.”

The Court notes that a corporate designee has the authority to speak on behalf of the corporation with respect to the areas inquiry, which authority extends to facts, subjective beliefs, and opinions. “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.

“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, 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.”

With respect to Dr. Glaspy, the Court found that his reliance on much of the evidence was entirely proper under Rule 702 and Rule 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.’ 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.”

In sum: “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.”

 

In re Taxotere, 26 F.4th 256 (5th Cir. 2022).