## Facts

- St. Jude Medical, Inc. (SJM) manufactured the Silzone prosthetic heart valve, which included an antimicrobial silver coating on the sewing cuff.
- After FDA approval, SJM sponsored a randomized controlled study comparing Silzone-coated valves to non-Silzone valves.
- Study data showed a statistically significant increase in paravalvular leaks requiring explantation for Silzone recipients.
- SJM recalled all unimplanted Silzone valves.
- Numerous suits were filed nationwide and consolidated for pretrial proceedings in an MDL in the District of Minnesota.
- Five named plaintiffs filed a consolidated amended putative class action on behalf of more than 11,000 valve recipients.
- Plaintiffs asserted common-law theories (including strict liability, negligence, warranty, and medical monitoring) and statutory claims under Minnesota consumer-protection laws.
- Plaintiffs sought damages and equitable relief, including medical monitoring and related injunctions.
- The district court unconditionally certified a Rule 23(b)(3) consumer-protection class under Minnesota statutes and also certified an injunctive subclass; it applied Minnesota law to all class members after a limited choice-of-law discussion.
- SJM appealed the interlocutory class certification orders.

## Issues

1. Whether the district court erred by applying Minnesota law to nationwide consumer-protection claims without a rigorous choice-of-law analysis.
2. Whether Rule 23(b)(3) predominance and superiority were satisfied given potential material variations among states’ laws.
3. Whether certification of an injunctive/medical-monitoring subclass could stand where the governing legal standards likely varied by state.

## Decision

- The Eighth Circuit reversed the class certification orders and remanded.
- The court held the district court abused its discretion by certifying the consumer-protection class without an adequate choice-of-law analysis.
- The court further concluded the district court failed to account for how differences in state law could defeat Rule 23(b)(3) predominance and superiority.
- Because the same deficiencies infected the injunctive consumer-protection certification, that certification also could not stand and required reconsideration on remand.

## Legal Principles

- Class certification requires a rigorous analysis of Rule 23, including a substantive choice-of-law inquiry when claims arise from multistate conduct and injuries.
- A forum state’s interest in regulating an in-state defendant, standing alone, does not justify applying forum law to nonresident class members’ claims.
- For Rule 23(b)(3), material variations in state law may defeat predominance and undermine superiority by making the class unmanageable or requiring individualized legal determinations.
- A court acts unreasonably when it treats state-law differences as unmanageable for one set of claims but disregards similar differences for closely related claims without a coherent explanation.

## Conclusion

The Eighth Circuit vacated nationwide consumer-protection and related injunctive class certifications because the district court did not conduct a sufficiently rigorous choice-of-law analysis and did not confront how state-law variations affect Rule 23(b)(3) predominance and superiority, requiring remand for reconsideration under proper standards.


In re St. Jude Med., Inc., 425 F.3d 1116 (8th Cir. 2005)