Public Health Law Map - Beta 5 - Medical and Public Health Law Site

designed for an expert user who had the responsibility for ensuring that the device was
properly assembled. The anesthesiologist claimed that the machine should have been
designed to prevent misassembly. The manufacturer lost because the jury determined
that the manufacturer could not rely on the anesthesiologist to know how to properly
assemble the anesthesia machine. [Richards EP, Walter CW. How is an anesthesia
machine like a lawnmower?—the problem of the learned intermediary. IEEE Eng Med
Biol Mag. 1989;8:55.]
1. The Legal Risks of Safety Devices*
Paradoxically, medical instrumentation poses the greatest challenges in critical care
units (CCUs) but generates the most litigation in areas such as obstetrics and
anesthesia. CCUs are the subject of legal debate far in excess of the medical
malpractice cases they spawn. Most of the legal attention has been focused on the
right of patients to refuse life support rather than on medical malpractice issues. As
financial considerations reduce the availability of CCU care, it is expected that the
legal controversies will shift from refusal of care to denial of care and conventional
malpractice claims. Before discussing the expected increase in CCU- related
litigation, it is important to understand why a relatively simple problem such as
obstetric monitoring has generated much more litigation than the difficult problem of
CCU monitoring.
When physicians think of medical device litigation, it usually brings to mind
products liability claims against the device’s manufacturer. Such primary litigation is
a problem for device manufacturers but not a direct threat to physicians using the
devices. The problem for physicians is secondary litigation. Secondary litigation
arises from medical devices that perform properly but increase litigation against the
physicians who use them. Safety devices such as monitors have generated most
secondary litigation, although it can occur with life-supporting devices as well. The
best-documented example of secondary litigation is that due to obstetric fetal
monitors. The problems that arose from fetal monitors have implications for
selection of new technologies by physicians and hospitals.
Electronic fetal heart monitors and pulse oximeters illustrate a continuum from
devices that increase secondary litigation to those that decrease it. The widespread
use of fetal heart monitors was accompanied by a dramatic increase in obstetric
malpractice litigation. It is certain that factors other than fetal heart monitors were
primarily responsible for this increase. It is also certain, however, that the use of
these monitors did not decrease litigation and, in the cases where fetal heart monitor
records are available, these records increase the probability of litigation when an
infant is born damaged. Conversely, the widespread adoption of pulse oximetry in
the operating room was accompanied by a dramatic reduction in malpractice claims
against anesthesiologists. These monitors appear to be among the primary causes of
this reduction in claims. They clearly are not being used against anesthesiologists in
the way that fetal heart monitors have been used against obstetricians.
Secondary litigation does not imply a defectively designed product, at least not in the
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