Zuchowicz v. United States

CALABRESI, J.

The defendant, the United States of America, appeals from a judgment of the United States District Court for the District of Connecticut. This suit under the Federal Tort Claims Act was originally filed by Patricia Zuchowicz, who claimed to have developed primary pulmonary hypertension, a fatal lung condition, as a result of the defendant's negligence in prescribing an overdose of the drug Danocrine. Following Mrs. Zuchowicz's death in 1991, her husband, Steven, continued the case on behalf of his wife's estate, claiming that the defendant was responsible for her death. After a bench trial, the district court awarded the plaintiff $ 1,034,236.02 in damages.

The case statement recited above goes to the heart of the law of torts. A plaintiff claims to have developed a fatal condition as a result of a defendant's negligence in prescribing an excessive amount of a drug -- a tragic injury allegedly caused by defendant's wrong. There is no doubt in the case before us either as to the injury or as to the defendant's wrong; both are conceded. The only issue is causation.

Did the action for which the defendant is responsible cause, in a legal sense, the harm which the plaintiff suffered? -- a question easily put and often very hard to answer. There is, moreover, no older requirement in this area of law than the need to show such a link between the defendant's actions and the plaintiff's loss. It long precedes the obligation to show that the defendant was at fault. Along with the showing of injury, causation constituted an essential part of what the plaintiff had to demonstrate for the early common law action in trespass to lie.

Over the centuries the courts have struggled to give meaning to this requirement -in the simplest of situations, who hit whom, and in the most complex ones, which polluter's emissions, if any, hurt which plaintiff. It is the question that we must seek to answer today in the context of modern medicine and a very rare disease.

I. Background

A. Drug, Illness, and Death

1. The Overdose

The facts, as determined by the district court, are as follows. On February 18, 1989, Mrs. Zuchowicz filled a prescription for the drug Danocrine at the Naval Hospital pharmacy in Groton, Connecticut. The prescription erroneously instructed her to take 1600 milligrams of Danocrine per day, or twice the maximum recommended dosage. The defendant has stipulated that its doctors and/or pharmacists were negligent and violated the prevailing standard of medical care by prescribing this wrong dosage.

Mrs. Zuchowicz took the 1600 milligrams of Danocrine each day for the next month. Thereafter, from March 24 until May 30, she took 800 milligrams per day. While taking Danocrine she experienced abnormal weight gain, bloating, edema, hot flashes, night sweats, a racing heart, chest pains, dizziness, headaches, acne, and fatigue. On May 30, she was examined by an obstetrician/gynecologist in private practice who told her to stop taking the Danocrine. During the summer, she continued to experience severe fatigue and chest tightness and pain, and began having shortness of breath. In October 1989, she was diagnosed with primary pulmonary hypertension ("PPH"), a rare and fatal disease in which increased pressure in an individual's pulmonary artery causes severe strain on the right side of the heart. At the time she was diagnosed with the disease, the median life expectancy for PPH sufferers was 2.5 years. Treatments included calcium channel blockers and heart and lung transplantation.

Mrs. Zuchowicz was on the waiting list for a lung transplant when she became pregnant. Pregnant women are not eligible for transplants, and pregnancy exacerbates PPH. Mrs. Zuchowicz gave birth to a son on November 21, 1991. She died one month later, on December 31, 1991.

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B. The Expert Testimony

The rarity of PPH, combined with the fact that so few human beings have ever received such a high dose of Danocrine, obviously impacted on the manner in which the plaintiff could prove causation. The number of persons who received this type of overdose was simply too small for the plaintiff to be able to provide epidemiological, or even anecdotal, evidence linking PPH to Danocrine overdoses. The plaintiff (Mrs. Zuchowicz's husband and executor), therefore, based his case primarily on the testimony of two expert witnesses, Dr. Richard Matthay, a physician and expert in pulmonary diseases, and Dr. Randall Tackett, a professor of pharmacology who has published widely in the field of the effects of drugs on vascular tissues. In rendering a judgment for the plaintiff, the district court relied heavily on the evidence submitted by these two experts. The defendant challenges both the admissibility and the sufficiency of their testimony.

1. Dr. Matthay

Dr. Richard Matthay is a full professor of medicine at Yale and Associate Director and Training Director of Yale's Pulmonary and Critical Care Section. He is a nationally recognized expert in the field of pulmonary medicine, with extensive experience in the area of drug-induced pulmonary diseases. Dr. Matthay examined and treated Mrs. Zuchowicz. His examination included taking a detailed history of the progression of her disease, her medical history, and the timing of her Danocrine overdose and the onset of her symptoms.

Dr. Matthay testified that he was confident to a reasonable medical certainty that the Danocrine caused Mrs. Zuchowicz's PPH. When pressed, he added that he believed the overdose of Danocrine to have been responsible for the disease. His conclusion was based on the temporal relationship between the overdose and the start of the disease and the differential etiology method of excluding other possible causes. While Dr. Matthay did not rule out all other possible causes of pulmonary hypertension, he did exclude all the causes of secondary pulmonary hypertension. On the basis of Mrs. Zuchowicz's history, he also ruled out all previously known drug-related causes of primary pulmonary hypertension.

Dr. Matthay further testified that the progression and timing of Mrs. Zuchowicz's disease in relation to her overdose supported a finding of drug-induced PPH. Dr. Matthay emphasized that, prior to the overdose, Mrs. Zuchowicz was a healthy, active young woman with no history of cardiovascular problems, and that, shortly after the overdose, she began experiencing symptoms of PPH such as weight gain, swelling of hands and feet, fatigue, and shortness of breath. He described the similarities between the course of Mrs. Zuchowicz's illness and that of accepted cases of drug-induced PPH, and he went on to discuss cases involving classes of drugs that are known to cause other pulmonary diseases (mainly anti-cancer drugs). He noted that the onset of these diseases, which are recognized to be caused by the particular drugs, was very similar in timing and course to the development of Mrs. Zuchowicz's illness.

2. Dr. Tackett

Dr. Randall Tackett is a tenured, full professor of pharmacology and former department chair from the University of Georgia. He has published widely in the field of the effects of drugs on vascular tissues. Dr. Tackett testified that, to a reasonable degree of scientific certainty, he believed that the overdose of Danocrine, more likely than not, caused PPH in the plaintiff by producing: 1) a decrease in estrogen; 2) hyperinsulinemia, in which abnormally high levels of insulin circulate in the body; and 3) increases in free testosterone and progesterone. Dr. Tackett testified that these hormonal factors, taken together, likely caused a dysfunction of the endothelium leading to PPH. Dr. Tackett relied on a variety of published and unpublished studies that indicated that these hormones could cause endothelial dysfunction and an imbalance of vasoconstrictor effects.

II. Discussion

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B. Were the District Court's Factual Findings with Respect to Causation Clearly Erroneous?

We review the district court's factual findings for clear error. The defendant argues that, even assuming that the testimony of the plaintiff's experts was admissible, the district court's finding that the Danocrine overdose more likely than not caused Mrs. Zuchowicz's illness was clearly erroneous. The defendant contends that, since Danocrine has never been previously linked to PPH, the district court's conclusion that the drug caused Mrs. Zuchowicz's illness was impermissible. For the reasons stated below, we reject the defendant's arguments.

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4. Was Danocrine a But For Cause of Mrs. Zuchowicz's Illness and Death?

We hold that, on the basis of Dr. Matthay's testimony alone, the finder of fact could have concluded -- under Connecticut law -- that Mrs. Zuchowicz's PPH was, more likely than not, caused by Danocrine. While it was not possible to eliminate all other possible causes of pulmonary hypertension, the evidence presented showed that the experts had not only excluded all causes of secondary pulmonary hypertension, but had also ruled out all the previously known drug-related causes of PPH. In addition, Dr. Matthay testified, based on his expertise in pulmonary diseases, that the progression and timing of Mrs. Zuchowicz's illness in relationship to the timing of her overdose supported a finding of drug-induced PPH to a reasonable medical certainty. In this respect, we note that in the case before us, unlike many toxic torts situations, there was not a long latency period between the onset of symptoms and the patient's exposure to the drug that was alleged to have caused the illness. Rather, as Dr. Matthay testified, the plaintiff began exhibiting symptoms typical of drug-induced PPH shortly after she started taking the Danocrine. Under the circumstances, we cannot say that the fact finder was clearly erroneous in determining that, more probably than not, the Danocrine caused Mrs. Zuchowicz's illness.

5. Was the Overdose a But For Cause of Mrs. Zuchowicz's Illness and Death?

To say that Danocrine caused Mrs. Zuchowicz's injuries is only half the story, however. In order for the causation requirement to be met, a trier of fact must be able to determine, by a preponderance of the evidence, that the defendant's negligence was responsible for the injury. In this case, defendant's negligence consisted in prescribing an overdose of Danocrine to Mrs. Zuchowicz. . . . For liability to exist, therefore, it is necessary that the fact finder be able to conclude, more probably than not, that the overdose was the cause of Mrs. Zuchowicz's illness and ultimate death. The mere fact that the exposure to Danocrine was likely responsible for the disease does not suffice.

The problem of linking defendant's negligence to the harm that occurred is one that many courts have addressed in the past. A car is speeding and an accident occurs. That the car was involved and was a cause of the crash is readily shown. The accident, moreover, is of the sort that rules prohibiting speeding are designed to prevent. But is this enough to support a finding of fact, in the individual case, that speeding was, in fact, more probably than not, the cause of the accident? The same question can be asked when a car that was driving in violation of a minimum speed requirement on a super-highway is rear-ended. Again, it is clear that the car and its driver were causes of the accident. And the accident is of the sort that minimum speeding rules are designed to prevent. But can a fact finder conclude, without more, that the driver's negligence in driving too slowly led to the crash? To put it more precisely -- the defendant's negligence was strongly causally linked to the accident, and the defendant was undoubtedly a but for cause of the harm, but does this suffice to allow a fact finder to say that the defendant's negligence was a but for cause?

At one time, courts were reluctant to say in such circumstances that the wrong could be deemed to be the cause. They emphasized the logical fallacy of post hoc, ergo propter hoc, and demanded some direct evidence connecting the defendant's wrongdoing to the harm. See, e.g., Wolf v. Kaufmann (denying recovery for death of plaintiff's decedent, who was found unconscious at foot of stairway which, in violation of a statute, was unlighted, because the plaintiff had offered no proof of "any causal connection between the accident and the absence of light").

All that has changed, however. And, as is so frequently the case in tort law, Chief Judge Cardozo in New York and Chief Justice Traynor in California led the way. In various opinions, they stated that: if (a) a negligent act was deemed wrongful because that act increased the chances that a particular type of accident would occur, and (b) a mishap of that very sort did happen, this was enough to support a finding by the trier of fact that the negligent behavior caused the harm. Where such a strong causal link exists, it is up to the negligent party to bring in evidence denying but for cause and suggesting that in the actual case the wrongful conduct had not been a substantial factor.

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The case before us is a good example of the above-mentioned principles in their classic form. The reason the FDA does not approve the prescription of new drugs at above the dosages as to which extensive tests have been performed is because all drugs involve risks of untoward side effects in those who take them. Moreover, it is often true that the higher the dosage the greater is the likelihood of such negative effects. At the approved dosages, the benefits of the particular drug have presumably been deemed worth the risks it entails. At greater than approved dosages, not only do the risks of tragic side effects (known and unknown) increase, but there is no basis on the testing that has been performed for supposing that the drug's benefits outweigh these increased risks. See generally 21 U.S.C. § 355(d) (indicating that the FDA should refuse to approve a new drug unless the clinical tests show that the drug is safe and effective for use under the conditions "prescribed, recommended, or suggested in the proposed labeling"). It follows that when a negative side effect is demonstrated to be the result of a drug, and the drug was wrongly prescribed in an unapproved and excessive dosage (i.e. a strong causal link has been shown), the plaintiff who is injured has generally shown enough to permit the finder of fact to conclude that the excessive dosage was a substantial factor in producing the harm.

In fact, plaintiff's showing in the case before us, while relying on the above stated principles, is stronger. For plaintiff introduced some direct evidence of causation as well. On the basis of his long experience with drug-induced pulmonary diseases, one of plaintiff's experts, Dr. Matthay, testified that the timing of Mrs. Zuchowicz's illness led him to conclude that the overdose (and not merely Danocrine) was responsible for her catastrophic reaction.

Under the circumstances, we hold that defendant's attack on the district court's finding of causation is meritless.

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[J]udgment of the district court is affirmed.