Daniel v. Wyeth Pharmaceuticals, Inc.
15 A.3d 909
Pa. Super. Ct.2011Background
- Daniel and Daniel, Sr. (the Daniels) sued Wyeth for negligence, breach of express warranty, and fraud over Prempro use and breast cancer diagnosis.
- Wyeth sought FDA approval for Prempro; WHI results later linked estrogen/progestin to breast cancer prompting a black box warning.
- Jury returned compensatory damages for Daniel and Daniel, Sr., and found punitive damages supported by the evidence.
- Wyeth moved for JNOV on punitive damages; the trial court granted it, and Wyeth conducted a post-trial mini-trial with the same jury.
- Wyeth later moved for new trial for after-discovered evidence (Layfield recantation); the trial court granted the new trial.
- The Daniels appealed the JNOV denial on punitive damages and Wyeth’s new-trial grant; Wyeth cross-appealed on multiple post-trial rulings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Punitive damages: whether the trial court erred by granting JNOV on punitive damages | Wyeth knew of risks for decades but failed to test; conduct warranted punitive damages | No basis for punitive damages given testing/compliance and lack of conscious disregard | Reversed; punitive damages reinstated |
| New trial based on after-discovered Layfield recantation | Layfield recanted; new trial justified | No true recantation; recantation evidence insufficient to compel different result | Reversed; no new trial |
| Admission of post-use labels as evidence of negligence | Post-WH1 labeling admissible to prove causation | Pretrial in limine preserved; use for negligence improper | Waived for appeal; limited use permissible for causation |
| Proximate causation under learned intermediary doctrine | Adequate warnings would have changed physician's behavior | Insufficient evidence of proximate causation | Denied; sufficient evidence supports proximate causation |
| Punitive damages: choice of law and constitutional limits | Pennsylvania law governs punitive damages; conduct in PA supports punishment | Out-of-state conduct and federal limits preclude punitive damages | Pennsylvania law applies; punitive damages allowed; cross-appeal denied |
Key Cases Cited
- BMW of N. Am., Inc. v. Gore, 517 U.S. 559 (U.S. 1996) (state may not punish lawful conduct in other states; limits on punitive awards)
- State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408 (U.S. 2003) (out-of-state conduct and nexus required for punitive damages; due process)
- Phillips v. Cricket Lighters, 584 Pa. 179 (Pa. 2005) (punitive damages require outrageous conduct; state-of-mind analysis)
- Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356 (Pa. Super. 2009) (proximate cause in failure-to-warn cases; WHI findings may influence causation)
- Dion v. Graduate Hospital of University of Pennsylvania, 360 Pa. Super. 416 (Pa. Super. 1987) (any expert with similar education can opine on warning adequacy)
- Taurino v. Ellen, 397 Pa. Super. 50 (Pa. Super. 1990) (learned intermediary doctrine; warnings directed to physician)
- Hutchison ex rel. Hutchison v. Luddy, 582 Pa. 114 (Pa. 2005) (standard for punitive damages involving reckless indifference)
- Jones v. Wyeth, 989 A.2d 356 (Pa. Super. 2009) (see Simon; proximate causation in drug failure-to-warn actions)
- Nelson v. Wyeth Pharmaceuticals, Inc., 4 A.3d 1054 (Pa. 2010) (post-trial procedural standards and record completeness notes)