## Facts

- Bryan Kelley was recovering from severe injuries suffered in an automobile accident and required airway management as part of his hospital care.
- During a procedure to insert a breathing tube (intubation), anesthesiologist Dr. John C. Burdon administered Anectine, a drip solution of succinylcholine muscle relaxant manufactured by Burroughs Wellcome Co. (Burroughs).
- Anectine was given to relax Kelley to permit intubation. After an initial attempt to place the tube failed, the Anectine drip was increased.
- Kelley was turned to a prone position, and he suffered cardiac arrest. During resuscitation efforts, the Anectine infusion was left running.
- Kelley survived but sustained severe impairment following the cardiac-arrest event.
- The Anectine package insert warned that the drug may induce severe hyperkalemia and cardiac arrest in patients recovering from severe trauma or in patients with extensive denervation of skeletal muscle.
- Dr. Burdon testified he was aware of the insert and its hyperkalemia/cardiac-arrest warning. He also testified that, when he chose to use Anectine, he believed Kelley was not “extensively denervated.”
- Kelley presented medical testimony that Anectine administration can cause hyperkalemia and cardiac arrest in extensively denervated patients and that Kelley was extensively denervated when Anectine was administered; Kelley’s experts also criticized the continuation of the drip during resuscitation.
- Kelley sued Dr. Burdon and the anesthesiology group for medical malpractice and sued Burroughs on a products-liability failure-to-warn theory, contending the insert should have gone further and affirmatively contraindicated Anectine for extensively denervated patients.
- The jury returned a verdict for Kelley and apportioned fault 90% to the anesthesiologist defendants and 10% to Burroughs. The trial court denied Burroughs’s post-trial motion for judgment notwithstanding the verdict (JNOV), and Burroughs appealed.

## Issues

1. Whether the trial court should have entered JNOV for Burroughs because the evidence did not support a finding that Anectine’s warning was unreasonably dangerous or that any alleged warning deficiency proximately caused Kelley’s injury.
2. Whether, given Dr. Burdon’s admitted knowledge of the risk identified in the package insert, Kelley proved that a stronger warning (such as a clear contraindication) would have changed the anesthesiologists’ conduct and prevented the injury.

## Decision

- The appellate court reversed the denial of Burroughs’s JNOV motion and vacated the judgment against Burroughs.
- The court concluded the evidence did not support imposing products-liability fault on Burroughs because Kelley failed to prove that the package insert was unreasonably dangerous and failed to prove proximate cause as to the claimed warning defect.
- The court set aside the 10% allocation of fault to Burroughs and assessed total liability for the verdict against the anesthesiologist defendants.

## Legal Principles

- A court may enter JNOV only when, viewing the evidence in the light most favorable to the verdict winner, the evidence so strongly favors the movant that no contrary verdict can stand.
- In prescription-drug failure-to-warn litigation, the plaintiff must prove both: (1) an unreasonably dangerous condition due to an inadequate warning, and (2) proximate cause linking the inadequate warning to the injury.
- Where the alleged defect is that the manufacturer should have used stronger warning language (including an affirmative contraindication), proximate cause requires evidence that the different warning would have altered the prescribing or administering physician’s decision or conduct in a way that would have avoided the harm.
- When the treating physician knew of the specific risk stated in the manufacturer’s warning and proceeded based on the physician’s judgment that the risk did not apply to the patient, the causal connection between the wording of the warning and the injury may fail as a matter of law.

## Conclusion

Kelley upheld a malpractice-based recovery against the anesthesiologist defendants but removed the drug manufacturer from the judgment: although the jury assigned 10% fault to Burroughs, the appellate court held that Kelley did not present evidence that any inadequacy in Anectine’s package insert—such as failing to state a positive contraindication—was unreasonably dangerous or caused the injury, particularly where the anesthesiologist testified he knew the warning and acted on his belief that Kelley was not within the warned-of category.


Kelley v. Associated Anesthesiologists, Inc., 589 N.E.2d 1050 (1992)