## Facts

- A patient implanted with certain Medtronic pacemaker leads sued the manufacturer, alleging the leads were defective.
- The complaint asserted state-law claims including negligence, strict products liability, breach of warranty, and fraud based on alleged concealment of lead failure rates and safety problems.
- The proposed nationwide class included U.S. recipients of the identified leads; tens of thousands had been implanted and many remained active.
- Related litigation concerning the same leads was already pending in multiple jurisdictions.
- The plaintiff sought class certification for (1) damages under Rule 23(b)(3) and (2) injunctive relief, including medical monitoring, under Rule 23(b)(2), and also suggested narrower or partial certification.

## Issues

1. Whether the proposed nationwide class satisfied Rule 23(a)’s numerosity, commonality, typicality, and adequacy requirements.
2. Whether a Rule 23(b)(3) damages class was certifiable, including whether class treatment was superior to other methods given manageability, dispersion of evidence, and state-law variation.
3. Whether a Rule 23(b)(2) injunctive-relief/medical-monitoring class was appropriate despite individualized medical circumstances and multi-state legal differences.
4. Whether partial or issue-only certification could avoid the obstacles to certifying the case as a class action.

## Decision

- The court found Rule 23(a) satisfied: the class was sufficiently numerous, shared common questions about the product and alleged nondisclosure, the named plaintiff’s claims were typical, and representation was adequate.
- The court denied Rule 23(b)(3) certification, holding class treatment was not superior to other methods because a nationwide proceeding would be difficult to administer.
- The court emphasized the geographic dispersion of class members, witnesses, and medical records, creating substantial logistical burdens for coordinated adjudication.
- The court also relied on anticipated choice-of-law and manageability problems from applying the substantive law of many states to products-liability, warranty, and fraud claims, including variations affecting elements and defenses.
- The court denied Rule 23(b)(2) certification for injunctive relief and medical monitoring, concluding that individualized circumstances and the same manageability and state-law problems made mandatory injunctive-class treatment unsuitable.
- The court declined to certify a narrower, partial, or issue-only class because individualized and multi-state complications would remain.

## Legal Principles

- Satisfaction of Rule 23(a) does not justify certification unless a proposed class also meets an applicable Rule 23(b) category.
- Under Rule 23(b)(3), a nationwide state-law products-liability class may fail the superiority inquiry when geographic dispersion and trial administration concerns outweigh expected efficiency gains.
- The need to apply multiple states’ substantive laws can create choice-of-law and manageability barriers that defeat Rule 23(b)(3) certification.
- Rule 23(b)(2) is generally inappropriate where the requested relief (including medical monitoring) turns on individualized medical conditions and individualized determinations of entitlement and scope of relief.
- Courts may deny partial or issue-only certification when it does not materially reduce individualized inquiries or the complexity created by multi-state legal variation.

## Conclusion

The court denied certification of any nationwide class concerning allegedly defective pacemaker leads, holding that although Rule 23(a) was met, the proposed damages class failed Rule 23(b)(3) superiority due to dispersion and multi-state law problems, and the requested injunctive/medical-monitoring class under Rule 23(b)(2) was likewise unsuitable because individualized issues and manageability concerns persisted.


Haley v. Medtronic, Inc., 169 F.R.D. 643 (C.D. Cal. 1996)