claim, too, was questionable, however, in light of
the contemporaneous Hamilton v. Fife Health
Board(1993) decision, holding that a child could
not suffer ‘personal injuries’ while still a fetus.
Reasoning that unborn children are not ‘legal per-
sons’, Lord Prosser ruled that antenatal personal
injuries did not give rise to a cause of action for
damages. Although the Hamilton case was subse-
quently overruled by the legislature in the Conge-
nital Disabilities (Civil Liability) Act of 1976,
additional uncertainty would certainly have arisen
from the empirical difficulty in proving that thali-
domide was the teratogenic cause for each plaintiff
given the spontaneous risk of abnormality inherent
in human embryonic development (see Ferguson,
1992). Indeed, proof of causation would most
likely have rested on equivocal statistical analysis
of epidemiological data.
In light of the clear hurdles to establishing a
successful strict liability or negligence claim, the
thalidomide plaintiffs’ lead counsel advised that
the plaintiffs’ chance of success at trial was
‘slightly less than even’ (The Sunday Times,
1973). Upon this advice, the thalidomide plaintiffs
initially agreed to a £3.5 million settlement. Over
the next decade, public pressure forced Distillers
Co. to increase the settlement amount to £20 mil-
lion, but it is estimated that this fund will be
exhausted by 2012 (Waterhouse, 1995). Although
the settlement agreement provided some timely
compensation to the thalidomide plaintiffs, the
fact that the case was settled out of court made it
impossible to determine which, if any, of the plain-
tiffs’ claims would have been successful at trial.
The legacy of the thalidomide tragedy thus was not
a clarification of drug product liability law. Instead,
thalidomide focused the attention of lawmakers
and scientists on the potential risks of all medica-
tions. This legislative mandate ultimately led to
stronger and more effective drug regulations
worldwide, including in the United States.^11
Bernstein (1997) quotes various sources stating
that the German Pharmaceutical Law of 1976 and
the Japanese Drug Side-Effect Injury Relief Fund
Act of 1979 were indirect products of the thalido-
mide experience. Drug manufacturers in Sweden
adopted voluntary regulations, and drug legislation
in Canada was tightened in sympathy with the new
laws in the United States (which set up the frame-
work for current FDA regulations regarding new
drugs).Diethylstilbestrol (DES)
DES is a synthetic analogue of estrogen, first man-
ufactured in the United Kingdom in 1937. The
inventor’s altruistic decision not to patent DES
led to the drug’s manufacture by more than 300
companies (Ferguson, 1996). Arguments in favor
of the use of DES at the time of its introduction
were largely theoretical, but although few rigorous
clinical trials were performed to evaluate its effi-
cacy, physicians began to promote the use of DES
in pregnancy to treat threatened abortion or to
prevent habitual abortion. The FDA licensed DES
in 1947 for the prevention of early miscarriage.
Due to vigorous support by physicians, acceptance
by the FDA, and low cost, between 3 and 4 million
women in the United States ingested DES; and
between 20 000 and 100 000 fetuses were exposed
to DESin utero, each year, for 20 years (Dutton,
1988).
In retrospect, it is questionable whether DES had
any meaningful therapeutic effect. Beginning
approximately 15 years after the peak of DES use,
doctors found that female children of mothers who
had taken DES during their gestation tended to
develop preneoplastic vaginal and cervical changes
in adolescence or adulthood. Male and female DES
children also showed an increased incidence of
fertility disturbances after puberty (Dukeset al.,
1998). In 1984, the World Health Organization esti-
mated that hundreds of thousands of pregnancies,
especially in the United States and The Netherlands,
were potentially affected (Buitendijk, 1984).
Since the early 1980s, thousands of pharmaceu-
tical product liability cases have been brought
against the manufacturers of DES. These plaintiffs
had a stronger strict liability design defect claim
than those for thalidomide because DES, marketed
to prevent miscarriages, had no demonstrable(^11) Public outcry over thalidomide is credited for the 1962
amendments to the Federal Food, Drug, and Cosmetic Act
(FFDCA).
612 CH47 PHARMACEUTICAL PRODUCT LIABILITY