Zuchowicz v. United States

Facts

On February 18, 1989, Patricia Zuchowicz filled a prescription for Danocrine at the Naval Hospital pharmacy in Groton, Connecticut. The prescription wrongly told her to take 1600 milligrams a day, twice the FDA-approved maximum of 800. The United States stipulated that its doctors and/or pharmacists were negligent in prescribing that dosage. She took 1600 milligrams a day for a month, then 800 milligrams a day from March 24 until May 30. While on the drug she had weight gain, bloating, chest pains and fatigue. In October 1989 she was diagnosed with primary pulmonary hypertension (PPH), a rare, fatal disease in which high pressure in the lung artery strains the right side of the heart. She died on December 31, 1991. Dr. D'Mowski, who did much of the drug's initial research, testified that Danocrine is safe and effective when properly given, and that no formal studies of such high doses had been done. Too few people had received this overdose for epidemiological evidence, so the plaintiff relied mainly on two experts. Dr. Matthay, a pulmonary specialist who examined and treated her, excluded all causes of secondary pulmonary hypertension and all previously known drug-related causes of PPH, though not every possible cause. He testified that she was healthy before the overdose and had symptoms shortly after it, and that the timing pointed to the overdose, not merely the drug. Dr. Tackett, a pharmacology professor, testified that the overdose more likely than not caused PPH through hormonal changes.

Issues

1. Did the district court abuse its discretion in admitting the causation testimony of Dr. Matthay and Dr. Tackett?
2. Could the fact finder find that Danocrine caused Mrs. Zuchowicz's PPH, though the government argued that the drug had never before been linked to PPH and there was no epidemiological evidence?
3. Is it enough to show that Danocrine caused the illness, or must the plaintiff show that the overdose, the negligent part of the prescription, caused it?
4. When a side effect is shown to result from a drug that was wrongly prescribed in an unapproved, excessive dose, may the fact finder conclude that the overdose was a substantial factor in the harm?

Holding

The experts' testimony was properly admitted. On Dr. Matthay's testimony alone, the fact finder could find that Danocrine caused Mrs. Zuchowicz's PPH. The finding that the negligent overdose, not merely the drug, caused her PPH and death was not clearly erroneous: her PPH was shown to result from a drug wrongly prescribed in an unapproved, excessive dose, a strong causal link that permitted the finding, and Dr. Matthay's timing testimony gave direct support. The damages challenges also failed.