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Quimby Video

The Quimby video on this case - https://www.quimbee.com/cases/zuchowicz-v-united-states - very nicely summarizes the facts.

BUT it is VERY brief on the legal point. It shorthands everything as "self-proving causation" and... well... there's more there. It is best to read the fuller excerpt of the opinion below.

Introduction

As you read this case, consider these questions:

What was the DUTY?
What was the BREACH?
What must the fact-finder decide to satisfy the requirement that the BREACH specifically have caused the plaintiff's injury?
How does the court address it?

Fun side note: The author of this opinion, Guido Calabresi, taught at my law school while still serving as a Second Circuit justice. Professor Calabresi was known for his incredible compassion and for his subtle humor. (The subtle humor in this opinion is that he cited his own scholarly publication, using the third person.)

Zuchowicz v. United States

Court of Appeals for the Second Circuit (1998) (140 F.3d 381)

This suit under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671–2680, 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.

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.

Background

[PB: Here comes a lengthy recitation of facts! Remember, you don't need 99% of them. You can literally SKIP the whole Background section and proceed to the Discussion. The essential facts are necessarily repeated within the Discussion. I really could have edited the Background section out altogether... I left it in JUST to make this point. Take the shortcut and save ten minutes!]

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. [***]

According to the testimony of plaintiff’s expert Dr. W. Paul D’Mowski, who personally performed much of the initial research on the drug, Danocrine is safe and effective when administered properly. Based on studies by Dr. D’Mowski and others, Danocrine was approved by the Food and Drug Administration (“FDA”) for use in dosages not to exceed 800 mg/day.

Mrs. Zuchowicz was accidentally given a prescription instructing her to take twice this amount—1600 mg/day. According to Dr. D’Mowski no formal studies of the effects of Danocrine at such high doses have been performed, and very, very few women have received doses this high in any setting.

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.

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 *386 and course to the development of Mrs. Zuchowicz’s illness.

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.

Discussion

[PB Note: If you skipped straight to here, good job!]

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.

The liability of the federal government under the Federal Tort Claims Act is determined according to the law of the state in which the injury occurred. See 28 U.S.C. § 1346(b); Connecticut law, therefore, provides the applicable standards in this case.

A plaintiff alleging medical malpractice in Connecticut must first prove that the defendant negligently deviated from the customary standard of care. Since the defendant has stipulated that its agents were negligent in prescribing an overdose of the drug Danocrine, there is no question that this requirement is satisfied.

In addition, “the plaintiff must establish a causal relationship between the physician’s negligent actions or failure to act and the resulting injury by showing that the action or omission constituted a substantial factor in *388 producing the injury.”

This “substantial factor” causation requirement is the crux of the case before us. To meet the requirement that defendant’s behavior was a substantial factor in bringing about the plaintiff’s injury, the plaintiff must generally show:

(a) that the defendant’s negligent act or omission was a but for cause of the injury

(b) that the negligence was causally linked to the harm, and

(c) that the defendant’s negligent act or omission was proximate to the resulting injury. *389

In the case before us, as we shall see, neither the requirement of proximity nor that of causal link gives rise to any problems (though the presence of a strong causal link will prove to be highly significant).

The case turns only on the difficulty of showing a but for cause.

On whether, in other words, the plaintiff has sufficiently demonstrated:

(a) that defendant’s act in giving Mrs. Zuchowicz Danocrine was the source of her illness and death, and

(b) that it was not just the Danocrine, but its negligent overdose that led to Mrs. Zuchowicz’s demise.

We hold that, on the basis of Dr. Matthay’s testimony alone, the finder of fact *390 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, [***] 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, 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.

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?

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, 227 A.D. 281, 282 (1929) (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 *391 that in the actual case the wrongful conduct had not been a substantial factor.

Thus, in a case involving a nighttime collision between vehicles, one of which did not have the required lights, Judge Cardozo stated that lights were mandated precisely to reduce the risk of such accidents occurring and that this fact sufficed to show causation unless the negligent party demonstrated, for example, that in the particular instance the presence of very bright street lights or of a full moon rendered the lack of lights on the vehicle an unlikely cause. See Martin v. Herzog,228 N.Y. 164 (1920); see also Clark v. Gibbons, 66 Cal.2d 399 (1967) (Traynor, C.J.,concurring in part and dissenting in part on other grounds).

The general acceptance of this view is both signaled and explained by Prosser, which states categorically:

And whether the defendant’s negligence consists of the violation of some statutory safety regulation, or the breach of a plain common law duty of care, the court can scarcely overlook the fact that the injury which has in fact occurred is precisely the sort of thing that proper care on the part of the defendant would be intended to prevent, and accordingly allow a certain liberality to the jury in drawing its conclusion.

Prosser, supra note 6, § 41, at 270; see also Calabresi, supra note 6, at 71–73.

It is clear that Connecticut accepts this approach. 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.

Check Your Understanding

What was the BREACH?
Did you spot the "per se negligence" issue there?
What does it mean for (in)action A to be the "but-for cause" of injury B?
Does the plaintiff's estate have to prove that Danocrine caused the plaintiff's death? Or that the overdose caused her death? Why?
Why is it difficult, in this case, to be certain that the overdose was the "but-for" cause of the patient's death in this case?
What rule did the court invoke to justify greater liberality for the jury's conclusion in a case like this one?
This opinion is an example of a case that teaches both an "old rule" and a 'new rule." Summarize both in your own words.
Would the case have come out differently under the old rule? Why or why not? Why do you think the old rule didn't stick over time?
Why did Cardozo and other judges think it was important to overrule the older precedent and embrace the new rule?

The questions in bold font are the ones I view as most important for your outline!