## Facts

- An eight-month-old child received Xylocaine (lidocaine) during a minor medical procedure and suffered cardiac and respiratory arrest, causing severe, irreversible brain damage.
- The child, through her mother, sued the drug manufacturer in diversity, asserting:
  - negligence based on failure to submit required FDA adverse-reaction reports for Xylocaine; and
  - strict products liability under Restatement (Second) of Torts § 402A, alleging the reporting failure rendered the drug defective.
- Plaintiffs alleged the manufacturer failed to forward to the FDA approximately 202 adverse-reaction reports received between 1964 and 1970 and that this omission was a substantial factor in the injury.
- The manufacturer argued Xylocaine was not subject to the “new drug” adverse-reaction reporting regime during the relevant period, relying on earlier FDA communications and advice of counsel.
- Evidence showed the manufacturer maintained adverse-reaction information and provided it in inspection materials to FDA personnel.
- Regulatory developments included an FDA Federal Register notice in 1968 revoking prior “not a new drug/no longer a new drug” opinions.

## Issues

1. Whether FDA adverse-reaction reporting statutes and regulations applied to Xylocaine during the relevant period such that nonreporting could supply the duty/standard of care in a state negligence claim.
2. Whether the evidence was sufficient for a jury to find that the reporting failure and resulting informational deficiency were substantial factors causing the child’s injury.
3. Whether the trial court erred by resubmitting inconsistent special interrogatories to the jury for clarification rather than treating the verdict as irreconcilable.
4. Whether the trial court abused its discretion by ordering a new trial limited to compensatory damages after an intervening change in Pennsylvania damages law.
5. Whether denial of the manufacturer’s mistrial motion was reversible error.

## Decision

- The Third Circuit affirmed the judgment for plaintiffs.
- The court upheld the jury’s liability findings on negligence and § 402A strict liability theories premised on failure to submit required adverse-reaction reports.
- The court held the evidence permitted a reasonable finding of causation, including that reporting could have prompted stronger warnings or restrictions that might have prevented the harm.
- The court approved the trial judge’s resubmission of special interrogatories to reconcile inconsistencies.
- The court held the damages-only retrial was within the district court’s discretion because damages were separable from liability and the liability trial was fully litigated.
- The court found no abuse of discretion in denying a mistrial.

## Legal Principles

- Federal drug-reporting regulations may be used in state tort litigation as evidence of the applicable standard of care; doing so does not require recognizing a private federal cause of action.
- A manufacturer’s failure to provide required safety information to regulators can support:
  - negligence (breach of a safety-related duty/standard of care), and
  - strict products liability under Restatement (Second) of Torts § 402A when the informational deficiency renders the product unreasonably dangerous.
- Causation may be established by evidence that compliance would likely have led to regulatory or warning changes that would have reduced the risk of the injury.
- When jury answers to special interrogatories conflict with the damages award, a trial court may resubmit the questions with instructions to permit clarification and reconciliation.
- A partial new trial limited to damages is permissible when liability and damages are distinct and separable and limiting retrial will not cause injustice.

## Conclusion

The court affirmed a plaintiff’s verdict against a drug manufacturer where failure to submit required FDA adverse-reaction reports supported both negligence and § 402A defect theories, and it upheld verdict-management procedures and a damages-only retrial ordered to reflect a change in state damages law.


Stanton v. Astra Pharm. Prods., Inc., 718 F.2d 553 (3d Cir. 1983)