## Facts

- Carol Lynn Wooderson, with no history of hypertension or kidney disease, sought contraception from her physician in 1972.
- Her physician prescribed Ortho‑Novum 1/80, a high‑estrogen oral contraceptive available only by prescription and manufactured by Ortho Pharmaceutical Corp.
- Wooderson used the drug continuously from 1972 to June 1976 (with a brief interruption in early 1974).
- During use, her blood pressure rose over time, culminating in hospitalization in June 1976.
- She was diagnosed with malignant hypertension, hemolytic uremic syndrome, and renal failure, resulting in permanent kidney damage requiring dialysis and later a kidney transplant.
- Wooderson alleged the drug caused or contributed to her conditions and that Ortho failed to provide timely and adequate warnings to prescribing physicians in its labeling materials.
- A jury found for Wooderson and awarded $2,000,000 in compensatory damages and $2,750,000 in punitive damages; the trial court entered judgment on the verdict.
- Ortho appealed, challenging evidentiary sufficiency (including causation and warning adequacy), submission of punitive damages, and certain instructions and evidentiary rulings.

## Issues

1. What duty does a prescription-drug manufacturer owe to warn the medical profession of known or reasonably knowable dangers, and was Ortho’s warning inadequate during the period of plaintiff’s use?
2. Whether Kansas recognizes a presumption that an adequate warning would have been heeded, and how that affects causation proof in a failure-to-warn claim involving a prescribing physician.
3. Whether the manufacturer’s constructive knowledge for warning purposes is limited to the state of scientific knowledge during the plaintiff’s period of product use, and what standard applies to that knowledge.
4. Whether the evidence supported submitting punitive damages to the jury for willful, wanton, or reckless disregard for safety.

## Decision

- The Kansas Supreme Court affirmed the judgment for Wooderson, including compensatory and punitive damages.
- The court held there was competent substantial evidence supporting the jury’s findings that Ortho’s warnings to physicians were not timely or adequate, given the seriousness of the alleged risks and the information available during 1972–1976.
- The court held the evidence supported causation, applying a presumption that an adequate warning would have been heeded when a warning is shown to be inadequate.
- The court held there was sufficient evidence of willful or wanton disregard to justify submitting punitive damages to the jury and declined to disturb the punitive award.
- In reviewing sufficiency challenges, the court applied a deferential standard: it would not reweigh evidence or credibility and would view the record in the light most favorable to the prevailing party.

## Legal Principles

- A prescription-drug manufacturer must provide timely and adequate warnings to the medical profession about dangerous side effects it knows or has reason to know.
- The duty to warn is proportionate to the seriousness of the danger; greater danger requires stronger warnings.
- Although the warning duty ordinarily runs to the prescribing physician (learned intermediary), the manufacturer may be directly liable to the patient for breach of that duty.
- Constructive knowledge for drug manufacturers is measured by the standard of an expert in the field, and the duty to warn is continuous, requiring attention to research, adverse reaction reports, and scientific literature.
- The manufacturer’s chargeable knowledge is limited to what was known or reasonably knowable during the plaintiff’s period of product use; there is no duty to warn of risks unknown to science at that time.
- An adequate warning is one reasonable under the circumstances; a manufacturer may not disregard scientific or medical evidence suggestive of danger solely because it finds the evidence unconvincing.
- In failure-to-warn cases, an adequate warning is presumed to be heeded; when warnings are inadequate, the presumption operates as a presumption of causation, and the plaintiff need not prove what the prescribing physician would have done with an adequate warning.
- Punitive damages may be submitted when evidence permits a finding of willful, wanton, or reckless disregard for the rights and safety of others.

## Conclusion

The Kansas Supreme Court upheld a substantial verdict against a prescription-drug manufacturer, holding that the manufacturer had an ongoing, expert-level duty to warn physicians commensurate with the gravity of known or reasonably knowable risks during the plaintiff’s use, and that inadequate warnings trigger a heeding presumption that supports causation and may, when paired with evidence of reckless disregard, support punitive damages.


Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038 (Kan. 1984)