## Facts

- Sulzer Orthopedics, Inc. manufactured the Inter-Op acetabular shell, a component used in hip replacement surgery.
- A manufacturing problem allegedly left a residual oily film on certain shells, impairing bone bonding and causing post-operative loosening and potential need for revision surgery.
- Sulzer issued a voluntary recall of affected Inter-Op shells after discovering the problem.
- More than 26,000 U.S. patients were potential claimants, with injuries and risks ranging from revision surgery already performed to future revision surgery concerns.
- Numerous actions were filed nationwide and consolidated in multidistrict litigation in the Northern District of Ohio (MDL No. 1401).
- The parties negotiated a proposed nationwide class settlement with subclasses generally distinguishing patients who already had revision surgery from those who might require it later.
- Plaintiffs moved for settlement-class certification under Rule 23 and for preliminary approval of the settlement and notice plan.

## Issues

1. Whether a proposed nationwide settlement class satisfied Rule 23(a) (numerosity, commonality, typicality, and adequacy of representation).
2. Whether the class satisfied Rule 23(b)(3) by showing predominance of common issues and superiority of class treatment in the settlement posture.
3. Whether the proposed settlement was sufficiently fair, reasonable, and adequate to warrant preliminary approval, class notice, and a final fairness hearing.

## Decision

- The court conditionally certified the proposed nationwide settlement class and related subclasses under Rule 23(b)(3).
- The court found Rule 23(a) satisfied based on the size and dispersion of the class, shared liability questions concerning the alleged defect and defendants’ conduct, typicality of representative claims, and adequacy of representatives and counsel (including subclass representation to address differing interests).
- The court found predominance satisfied because the core liability questions about defectiveness and defendants’ conduct were common, and individualized issues did not defeat certification in the settlement context.
- The court found superiority satisfied given the number of claimants, the costs and complexity of medical-device litigation, efficiency gains, and reduced risk of inconsistent outcomes.
- The court granted preliminary approval of the settlement as within a reasonable range of fairness and ordered dissemination of class notice and scheduling of a final fairness hearing.

## Legal Principles

- A settlement class must meet the requirements of Rule 23(a) and one provision of Rule 23(b), even when certification is sought solely for settlement.
- Numerosity is met where the proposed class is large and geographically dispersed such that joinder is impracticable.
- Commonality and typicality may be satisfied where claims arise from a single alleged product defect and a common course of conduct, even if damages and medical circumstances vary among class members.
- Adequacy requires aligned interests between representatives and absent class members and competent counsel; potential intra-class conflicts may be addressed through subclasses and separate representation.
- For Rule 23(b)(3), predominance focuses on whether common liability issues outweigh individualized issues; in the settlement posture, trial-manageability concerns carry less weight than they would for a litigation class.
- Preliminary settlement approval is appropriate when the proposal appears fair, reasonable, and adequate enough to justify notice and a final fairness hearing, considering litigation risks, expected costs, relief offered, and the stage of the proceedings and investigation.

## Conclusion

The court allowed a nationwide settlement to proceed by conditionally certifying a Rule 23(b)(3) settlement class and granting preliminary approval, concluding that common defect-related liability issues and the benefits of a coordinated resolution justified class treatment and warranted notice and a final fairness hearing.


In re Inter-Op Hip Prosthesis Liability Litigation, 204 F.R.D. 330 (N.D. Ohio 2001)