## Facts

- Recipients of the Accufix Atrial “J” Lead pacemaker component sued the manufacturer and affiliates, alleging the lead’s retention wire could fracture and cause serious injury or death.
- Plaintiffs asserted products-liability theories, including defective design/manufacture and failure to warn, and sought a court-supervised medical-monitoring program for recipients who had not yet suffered physical injury.
- Federal cases concerning the device were centralized in a multidistrict litigation in the Southern District of Ohio, involving thousands of recipients (commonly estimated at over 25,000 in the United States).
- After an earlier nationwide class certification was reconsidered and decertified due to state-law variation and manageability concerns, plaintiffs filed a renewed motion proposing narrowed subclasses.
- The renewed motion sought certification of subclasses for medical monitoring, negligence, strict products liability, and punitive damages under Federal Rule of Civil Procedure 23.

## Issues

1. Whether the proposed class and subclasses satisfied Rule 23(a)’s numerosity, commonality, typicality, and adequacy requirements.
2. Whether a medical-monitoring subclass could be certified under Rule 23(b)(1)(A) and/or Rule 23(b)(3) given risks of inconsistent adjudications and the predominance/superiority requirements.
3. Whether negligence and strict-liability claims could be certified under Rule 23(b)(3) despite differences in state substantive law.
4. Whether punitive-damages claims were suitable for class treatment under Rule 23(b)(3) in light of state-law variation and individualized determinations.

## Decision

- The court granted the renewed motion in part and denied it in part.
- Rule 23(a) was satisfied because the class was large, core liability questions were shared, the representatives’ claims arose from the same alleged defect and conduct, and representation was adequate.
- A medical-monitoring subclass was certified under Rule 23(b)(1)(A) to avoid inconsistent adjudications creating incompatible standards for any monitoring program, and also under Rule 23(b)(3) because common issues predominated and a class proceeding was superior.
- Negligence and strict-liability subclasses were certified only to the extent they could be organized into manageable groupings of states with sufficiently similar legal standards such that common issues predominated.
- Class certification was denied for punitive damages because punitive-damages law varies materially by state and the inquiry is highly individualized, defeating predominance and manageability.

## Legal Principles

- Rule 23(a) commonality and typicality may be satisfied in products-liability litigation where common questions about an alleged defect, defendant knowledge, and warnings predominate over variations in individual medical histories and injury severity.
- Rule 23(b)(1)(A) may support certification where individual suits risk inconsistent adjudications that would impose incompatible standards of conduct on a defendant, particularly for prospective, programmatic relief such as medical monitoring.
- Rule 23(b)(3) predominance is not met when differences in applicable state law or individualized issues overwhelm common proof; however, subclassing by clusters of similar state laws can support certification for liability issues.
- Punitive-damages claims are generally ill-suited to class treatment when state standards materially differ and individualized considerations drive entitlement and amount.

## Conclusion

The court partially certified an MDL class by approving a medical-monitoring subclass and limited liability subclasses organized around similarities in state law, while rejecting class treatment for punitive damages due to legal variation and individualized proof.


In re Telectronics Pacing Sys., Inc., 172 F.R.D. 271 (S.D. Ohio 1997)