Pamela Kuhn v. Wyeth, Inc.
686 F.3d 618
| 8th Cir. | 2012Background
- Kuhn and Davidson used Prempro (estrogen plus progestin) and allege increased breast cancer risk and inadequate warnings by Wyeth.
- Kuhn used Prempro just over three years; Davidson used it for about three years or less, and both filed lawsuits in Western District of Arkansas later consolidated in MDL in Eastern District of Arkansas.
- Wyeth moved to preclude Dr. Austin’s testimony alleging insufficient reliability to support short-term breast cancer risk from Prempro use of three years or less.
- A Daubert hearing was held; the magistrate judge excluded Dr. Austin’s testimony, and the district court later granted Wyeth summary judgment based on the preclusion.
- On appeal, Kuhn and Davidson challenge the Daubert ruling and judgment; Kuhn contends her duration was over three years, affecting short-term use status.
- The Eighth Circuit held the magistrate abused its discretion in precluding Dr. Austin’s testimony and reversed remanding for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Austin’s testimony was admissible under Daubert | Kuhn; Dr. Austin’s methods were reliable and data adequate. | Wyeth; testimony lacked reliability given WHI reliance and study gaps. | Yes; testimony admissible; magistrate abused discretion. |
| Whether preclusion of Dr. Austin’s testimony warranted summary judgment | Dr. Austin offered reliable epidemiological support for short-term risk. | Preclusion was proper due to analytic gaps and flawed studies. | Remanded; preclusion reversed; summary judgment inappropriate. |
| Whether Calle, Million Women, and Fournier studies reliably support short-term risk | Observational studies validate short-term cancer risk from Prempro. | Foreign studies have limitations and don’t reliably establish short-term risk for Prempro. | Admissible; collectively supportive though with limitations; credibility for cross-examination. |
| Whether Kuhn’s use duration qualifies as short-term use under the Daubert analysis | Short-term risk exists in brief exposure; duration analysis robust. | WHI evidence shows no short-term risk; duration precision lacking. | Remand to determine if Kuhn’s duration affects short-term status; not resolved on record. |
Key Cases Cited
- Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) (gatekeeping reliability of expert testimony; focus on methodology)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) (abuse-of-discretion review for admissibility; causal conclusions later)
- Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999) (extends Daubert gatekeeping to all expert testimony)
- In re Paoli R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir.1994) (scope and standards for scientific reliability; validation requirement)
- Bonner v. ISP Techs., Inc., 259 F.3d 924 (8th Cir.2001) (conflicting evidence; questions for jury when admissible)
- Norris v. Baxter Healthcare Corp., 397 F.3d 878 (10th Cir.2005) (problem of cherry-picking studies; admissibility and weight)
- Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986 (8th Cir.2001) (undervalued generic assumptions; need evidence-specific support)
- General Electric Co. v. Joiner, 522 U.S. 136 (1997) (see above (mirror of Daubert standard application))