192 Cal. App. 4th 757
Cal. Ct. App.2011Background
- Trejo, 15, allegedly suffered SJS/TEN from Motrin ibuprofen in 2005; McNeil/J&J are manufacturers; Trejo sues in 2008 for negligence, strict liability, warranty; punitive damages sought under Civ. Code §3294(c)(1); trial court denied summary adjudication on punitive damages; appellate court granted writ and then denied, concluding triable issues exist regarding malice; FDA labeling history and regulatory framework are central to the dispute; labeling changes and OEM duties are contested facts; court focuses on whether McNeil’s conduct showed despicable conduct or conscious disregard; issues involve whether withholding information or delaying labeling changes evidences malice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether failure to warn supports punitive damages | Trejo argues McNeil’s failure to warn shows malice | McNeil contends labeling complied with FDA standards and changes required approval | Triable issue of material fact remains |
| Whether FDA labeling regime affects punitive-damages viability | Plaintiff asserts FDA regulatory framework does not extinguish punitive claims | Defendants rely on Wyeth v. Levine to limit state-law punishments | Triable issue of material fact remains |
| Whether withholding information from the FDA supports malice | Petitioners allegedly buried relevant safety data; FDA response cited but not conclusively favorable | Information was provided in citizen petition; no withholding proven | Triable issue of material fact remains |
| Whether labeling changes showing symptoms rather than SJS/TEN name affect liability | Specific symptom warning could have triggered earlier action demonstrating malice | Labeling debates and FDA discretion may render changes non-malice | Triable issue of material fact remains |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. Supreme Court 2009) (FDA labeling changes and state-law remedies interplay; limits on preemption and duty to warn)
- Arnall v. Superior Court, 190 Cal.App.4th 360 (Cal. Ct. App. 2010) (de novo review of summary adjudication; higher proof standard for punitive issues)
- American Airlines, Inc. v. Sheppard, Mullin, Richter & Hampton, 96 Cal.App.4th 1017 (Cal. Ct. App. 2002) (punitive-damages standard and summary-judgment standard)
- Hoch v. Allied-Signal, Inc., 24 Cal.App.4th 48 (Cal. Ct. App. 1994) (summary judgment on punitive damages proper only if no clear-and-convincing evidence of malice)
- Spinks v. Equity Residential Briarwood Apartments, 171 Cal.App.4th 1004 (Cal. Ct. App. 2009) (guidance on punitive damages standard and appellate review)
- Aguilar v. Atlantic Richfield Co., 25 Cal.4th 826 (Cal. 2001) (reaffirmed standard for triable issues and punitive damages burden)