Torts - Cases, Principles, and Institutions Fifth Edition, 2016a

Witt & Tani, TCPI 6. Causation
basis on the testing that has been performed for supposing that the drug’s benefits outweigh these
increased risks. 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.
Notes
1. Self-proving causation? Professor Kenneth Abraham at the University of Virginia calls
Zuchowicz the most notorious example of a category of causation cases he calls “self-proving
causation cases,” by which he means cases where the fact of the negligence alone is the only
evidence of causation available. Abraham observes that “many torts scholars are skeptical of the
decision in Zuchowicz.” But in Abraham’s view, the case is best understood as an especially
salient example of a problem that is more widespread than it might otherwise seem. See Kenneth
Abraham, Self-Proving Causation, 99 VA. L. REV. 1811 (2013).
Note that there is some scientific justification for Judge Calabresi’s approach in the FDA’s
basic methodology. FDA approval of a particular dosage is based on a “dose-response curve,”
which measures that sensitivity of the patient’s reaction to a particular dosage. Is Judge
Calabresi’s ruling justified by the science, or by the uncertainty, of causation? What evidence
could a defendant offer to counter the plaintiff’s evidence of causation? Will this move over-deter
or under-deter negligence in dosing?
2. Bendectin: A case study. The story of Bendectin, a morning sickness pill, reveals some of
the pitfalls of using the tort system to manage drug safety. Bendectin was widely used in the
1960s and 1970s. However, some scientific studies showed an association between Bendectin
and various types of birth defects, including musculoskeletal deformities, brain damage, and
cancer. On the basis of these studies, hundreds of plaintiffs sued Merrell Dow, the maker of
Bendectin, and many of them won large awards. In 1983, after years of these suits, Merrell Dow
pulled Bendectin from the market, saying that the high cost of liability insurance made the drug
no longer profitable. The American College of Obstetricians and Gynecologists objected, saying
that morning sickness was severe enough in some women to pose a serious health risk and the
withdrawal of Bendectin would leave a “significant therapeutic gap.” Jane E. Brody, Shadow of
Doubt Wipes Out Bendectin, N.Y. TIMES, Jun. 19, 1983. Hospitalization rates of pregnant women
for nausea and vomiting (symptoms Bendectin treats) doubled after the drug was removed from
the market. Melanie Ornstein, Adrianne Einarson & Gideon Koren, Bendectin/Diclectin for
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