## Facts

- American Medical Systems (AMS), a Pfizer subsidiary, manufactured and sold multiple models of penile prostheses.
- Paul Vorhis and other implanted patients alleged device malfunctions and related injuries, asserting claims including strict liability, negligence, warranty, fraud, punitive damages, and medical monitoring.
- Vorhis sought to represent a nationwide class of all U.S. persons implanted with AMS prostheses and their spouses claiming damages from implantation.
- The record reflected substantial variation: AMS made roughly ten prosthesis models, and alleged failures occurred in different ways and for different reasons among proposed class members.
- AMS moved to stay or defer class certification and separately moved to dismiss for lack of personal jurisdiction or transfer for improper venue; the district court did not rule on those motions before addressing certification.
- After a hearing, the district court ordered amendment to add named plaintiffs and then conditionally certified a nationwide class on all issues without a detailed, factor-specific Rule 23 analysis.

## Issues

1. Whether mandamus was an appropriate vehicle to review and set aside the district court’s conditional nationwide class certification order.
2. Whether the district court abused its discretion under Federal Rule of Civil Procedure 23 by certifying a nationwide products-liability class despite variations in product models, alleged malfunctions, individualized causation and damages, and differing state laws.

## Decision

- The court granted the petitions for a writ of mandamus.
- The court held that the district court’s repeated procedural departures in managing and certifying the class justified extraordinary mandamus review.
- The court held the district court abused its discretion by conditionally certifying a nationwide class without the required Rule 23 analysis and despite predominance and manageability problems.
- The court directed the district court to vacate the conditional class certification orders.

## Legal Principles

- Class certification requires a rigorous analysis of Rule 23; compliance with Rule 23(a) must be demonstrated, not presumed, and is not satisfied by conclusory recitation of the rule.
- In products-liability and mass-tort litigation, individualized issues of defect, causation, injury, and damages often defeat Rule 23(a) commonality/typicality and Rule 23(b)(3) predominance/superiority.
- Material differences among product models and alleged failure modes can prevent named plaintiffs’ claims from being typical of the proposed class and can weaken any shared factual or legal questions.
- Nationwide classes raise choice-of-law and manageability concerns when liability and remedies depend on the differing substantive laws of multiple states, undermining predominance and superiority.
- “Conditional” certification does not relieve a court of the duty to satisfy Rule 23 requirements at the time of certification.
- Mandamus, though extraordinary, may issue to correct a clear abuse of discretion where procedural errors are severe and recurrent and ordinary appellate review is not an adequate remedy.

## Conclusion

The Sixth Circuit used mandamus to overturn a broad, conditionally certified nationwide class, holding that Rule 23 demands a rigorous, demonstrated fit and that individualized product, medical, and state-law issues made the mass-tort class improper.


In re Am. Med. Sys., Inc., 75 F.3d 1069 (6th Cir. 1996)