26 F.4th 256
5th Cir.2022Background
- Taxotere (docetaxel) was studied in a large Phase III trial (TAX316) comparing TAC (Taxotere+doxorubicin+cyclophosphamide) to FAC; final report showed 29 of 744 TAC patients with “ongoing” alopecia at 10‑year follow‑up.
- Barbara Earnest received multiple chemo regimens including Taxotere and alleges permanent hair loss caused by Taxotere; she sued Sanofi in the Taxotere MDL for failure to warn under Louisiana law.
- Sanofi designated Dr. Michael Kopreski as its Rule 30(b)(6) corporate witness; Kopreski prepared a litigation‑era re‑analysis of TAX316 and testified that only six TAC patients met Earnest’s definition of permanent hair loss.
- Sanofi’s expert Dr. John Glaspy relied substantially on Kopreski’s re‑analysis in opining that Taxotere was not shown to cause permanent alopecia in Earnest’s case.
- The district court admitted Kopreski’s testimony as permissible lay opinion under Rule 701 and accepted Glaspy as an expert under Rule 702; the jury found for Sanofi and the court denied Earnest’s new‑trial motion.
- The Fifth Circuit held the district court erred: Kopreski’s litigation re‑analysis was expert opinion requiring Daubert/Rule 702 scrutiny, Glaspy’s reliance on that unverified re‑analysis tainted his expert opinion, and the errors were prejudicial — reversed and remanded for new trial.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Kopreski’s testimony | Kopreski’s re‑analysis is expert opinion and should have met Rule 702/Daubert | Kopreski’s testimony was lay opinion under Rule 701 and 30(b)(6) corporate‑knowledge | Kopreski’s re‑analysis exceeded permissible lay testimony; admission without Daubert review was error |
| Reliance by Glaspy on Kopreski’s analysis | Glaspy failed to independently verify Kopreski’s data; his causation opinion is therefore unreliable | Glaspy was qualified and could rely on materials reasonably relied on by experts | Glaspy’s causation opinion was tainted because it depended on inadmissible, unverified analysis; admission was prejudicial |
| Opening the door defense | N/A — Earnest did not invite Sanofi’s use of Kopreski’s on‑offense re‑analysis | Earnest introduced parts of Kopreski’s deposition, so Sanofi could present his testimony | Court rejected Sanofi’s opening‑the‑door argument; Kopreski’s offensive use required Rule 702 compliance |
| Harmless‑error / new trial | Admission of Kopreski and Glaspy testimony was prejudicial and warranted new trial | Any error was harmless because jury could assess evidence; testimony was cross‑examined | Error was not harmless; testimony featured centrally in Sanofi’s closing and affected Earnest’s substantial rights; reversed and remanded |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S. 1993) (sets gatekeeping standard for expert admissibility)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (U.S. 1999) (Daubert gatekeeping applies to all expert testimony)
- Moore v. Ashland Chem., Inc., 151 F.3d 269 (5th Cir. 1998) (expert testimony must have objective, independent validation)
- United States v. Valencia, 600 F.3d 389 (5th Cir. 2010) (analytical testimony by former employees may be admissible as lay if drawn from job duties)
- Montgomery County v. Microvote Corp., 320 F.3d 440 (3d Cir. 2003) (excluding expert who relied on unverified secondary data)
- Crowley v. Chait, 322 F. Supp. 2d 530 (D.N.J. 2004) (expert unreliable when based on selectively filtered testimony)
- Carlson v. Bioremedi Therapeutic Sys., Inc., 822 F.3d 194 (5th Cir. 2016) (improper testimony relied on in closing can be prejudicial)