## Facts

- Patricia Zuchowicz filled a Danocrine (danazol) prescription at a Naval Hospital pharmacy in Groton, Connecticut.
- Navy-employed medical personnel negligently prescribed and dispensed Danocrine at 1600 mg/day, twice the recommended maximum dosage.
- Zuchowicz took 1600 mg/day for about a month, then reduced to half that amount (still above the recommended maximum) until the prescription ended.
- During the high-dose exposure, she developed serious symptoms, including rapid weight gain, cardiovascular complaints, and fatigue.
- She was later diagnosed with primary pulmonary hypertension (PPH), a rare and often fatal condition with frequently unknown cause.
- At the time, medical literature had not established an association between Danocrine and PPH.
- Zuchowicz’s condition worsened; she became ineligible for a heart-lung transplant after becoming pregnant and died in 1991.
- Plaintiff’s experts testified, to a reasonable medical certainty, that the overdose caused her PPH, relying on timing, clinical course, and exclusion of other likely causes through differential diagnosis.
- The United States did not dispute negligence and primarily contested causation, arguing the claim was speculative without epidemiological proof and because PPH can be idiopathic.

## Issues

1. Whether the evidence was sufficient to prove, more likely than not, that the negligent Danocrine overdose was a substantial factor in causing Zuchowicz’s PPH and death.
2. Whether the factfinder could infer causation from proof that the negligent overdose increased the risk of serious systemic harm and the plaintiff suffered that type of harm.
3. Whether the district court permissibly credited and relied on expert causation testimony despite limited published scientific support and the inability to exclude every conceivable alternative cause.

## Decision

- The Second Circuit affirmed the district court’s judgment for the plaintiff under the Federal Tort Claims Act.
- The court held that the district court had a sufficient evidentiary basis to find that the overdose caused Zuchowicz’s PPH and subsequent death.
- The court accepted that causation could be inferred where the negligent conduct increased the risk of the kind of harm that occurred and expert testimony supported that link.
- The court upheld the district court’s reliance on expert testimony, concluding the methodology was acceptable and the ultimate causation opinion was not required to be supported by epidemiological studies.

## Legal Principles

- A plaintiff must prove causation by showing that the defendant’s negligence was, more likely than not, a substantial factor in producing the injury.
- When negligence is defined by the creation of a particular type of risk, and the plaintiff suffers harm of that general type, the factfinder may infer causation from the risk increase, supported by the surrounding circumstances.
- Proof of causation in medically complex cases may rest on a combination of expert testimony and circumstantial evidence, including temporal relationship and differential diagnosis.
- Expert testimony on causation need not eliminate every possible alternative cause; it is sufficient if the expert reasonably excludes likely alternatives and concludes, to a reasonable medical certainty, that the negligent exposure caused the injury.
- The absence of epidemiological or published evidence does not categorically bar causation findings where expert reasoning and case-specific facts support a more-likely-than-not conclusion.

## Conclusion

The Second Circuit sustained liability where an undisputed negligent overdose created a heightened risk of serious harm and the plaintiff developed a rare fatal condition consistent with that risk; supported by medically grounded expert testimony, the factfinder could conclude that the overdose was a substantial factor in causing the injury and death.


Zuchowicz v. United States, 140 F.3d 381 (2d Cir. 1998)