## Facts

- Carter-Wallace manufactured and marketed Felbatol (felbamate), a prescription anti-epileptic drug, beginning in August 1993 without special warnings of serious side effects.
- By early-to-mid 1994, the manufacturer received reports of aplastic anemia associated with Felbatol and, in August 1994, sent warning letters to physicians.
- By September 1994, the manufacturer received reports of liver failure associated with Felbatol and sent additional warning letters to physicians.
- Plaintiffs sought to represent a nationwide class of Felbatol users and asserted state-law products liability theories, including strict liability, negligence, failure to warn, and breach of warranty, plus punitive-damages-related claims.
- The district court conditionally certified (1) a nationwide “Felbatol user” class (users beginning before August 1, 1994) and (2) a “serious injury” subclass (those who developed or would develop aplastic anemia or liver failure).
- The district court limited certification to certain “common issues” (including strict liability, negligence, failure to warn, breach of warranty, causation in fact, and punitive liability), excluding proximate causation, compensatory damages, and the amount of punitive damages.
- The certification order was accepted for interlocutory review, and the appeal concerned only whether class certification was proper.

## Issues

1. Whether the plaintiffs satisfied Rule 23(b)(3)’s predominance requirement in a nationwide prescription-drug personal-injury action involving individualized causation, warnings, and damages, and variations in state law.
2. Whether the district court adequately found that a class action was superior to other available methods of adjudication, including coordinated proceedings and consolidated discovery.

## Decision

- The Ninth Circuit vacated the class-certification order and remanded.
- The court held the district court abused its discretion by certifying the class without a sufficiently detailed, case-specific analysis of Rule 23(b)(3) predominance and superiority.
- The court emphasized that identifying “common issues” under Rule 23(c)(4) did not, by itself, establish predominance where individualized issues and state-law differences could overwhelm common questions.
- The court held the superiority analysis was inadequate because the certification order did not meaningfully address realistic alternatives to a nationwide class action, including coordinated litigation mechanisms.

## Legal Principles

- The party seeking class certification bears the burden to prove compliance with all Rule 23 requirements.
- Rule 23(b)(3) requires a rigorous analysis and specific findings that common questions predominate over individual questions and that class treatment is superior to other methods.
- In multi-state personal-injury products-liability cases, differences in state substantive law and individualized proof (including causation, warning adequacy and timing, and damages) can defeat predominance unless addressed with a workable, supported trial plan.
- A superiority finding must consider practical alternatives to class treatment; conclusory recitation of Rule 23(b)(3) language is insufficient.

## Conclusion

The Ninth Circuit vacated conditional certification of a nationwide Felbatol class because the record and order did not support Rule 23(b)(3) predominance and did not explain why a class action was superior to alternative coordinated litigation methods, requiring remand for a more detailed certification analysis.


Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. 1996)