designed to identify documents and data relating
to their dealings with foreign regulatory agencies.
Plaintiffs’ counsel regularly point to differences in
labeling and product design resulting from a phar-
maceutical companies’ compliance with foreign
regulations as evidence of ‘defectiveness’ in simi-
lar or identical products marketed in the United
States (Moore and Cullen, 1999). Thus, in over-
view, the global marketing of pharmaceuticals has
had significant product liability implications
resulting from jurisdictional issues, maintaining
records for different regulatory agencies and com-
pliance or noncompliance with regulatory require-
ments in different marketing venues.
47.5 Landmark cases
In contrast to the ostensibly uniform framework of
product liability law that defines drug-induced tort,
the history of high-profile pharmaceutical injury
litigation shows that the practical prosecution of
drug-related injury claims is broadly varied as it
reflects the many possible types of drug-induced
injuries. Although the breadth of potential harms
from the use of pharmaceuticals is, in theory, limit-
less, adverse drug effects generally fall into one of
seven groups: (a) toxic effects, where the drug
causes an undesired pharmacologic effect on the
body; (b) allergic effects, where the drug has an
unpredictably severe or harmful effect on hyper-
sensitive individuals; (c) dependence, where users
of the drug develop a psychological or physiologic
need for the drug; (d) indirect injury, where the
drug interferes with mental or physical functions,
resulting in collateral injuries; (e) interactions,
where ingesting the drug in the context of other
drugs or foods causes injury; (f) inefficacy, where
the drug fails to perform its intended function; and
(g) socially adverse effects, where a drug (usually
an antibiotic) is overused by a population of
patients, resulting in the rise and spread of resistant
microorganisms (Dukeset al., 1998). The follow-
ing discussion of several high-profile product lia-
bility cases shows how plaintiffs, corporations,
attorneys and courts have applied product liability
jurisprudence to varied types of pharmacological
injury.
Thalidomide
The drug thalidomide caused one of the most vivid
and widely publicized tragedies in the history of
medicine (Bernstein, 1997).^1 Thalidomide is a
piperidinedione hypnotic derived from a naturally
occurring amino acid, glutamic acid. Thalidomide
was first synthesized in West Germany in 1953 by
Ciba A.G., but it was initially abandoned after tests
in laboratory animals revealed neither a beneficial
nor a toxic effect. A few years later, chemists at
another West German pharmaceutical company,
Chemie Grunenthal A.G., deduced from thalido-
mide’s piperidinedione structure that it might have
an anticonvulsant effect, and they experimented
with giving thalidomide to epileptics. The ensuing-
studies revealed that thalidomidewas ineffective as
an anticonvulsant, butshowed thatit acted as a mild
hypnotic or sedative. On the basis of these data,
Chemie Grunenthal A.G. brought thalidomide to
market under the trade name Contergan in October
1957 (Robertson, 1972). Thalidomide was an early
success because it acted quickly to cause deep,
natural-feeling sleep, and the drug soon became a
favorite sleeping tablet for over-the-counter con-
sumers and for institutions. Promoted as a safe
tranquilizer, suggested uses of thalidomide
included mild depression, flu, stomach disorders,
menstrual tensio, and even stage fright (Allen,
1997). Also an antiemetic, Contergan was com-
monly prescribed for the nausea of pregnancy
(Sherman, 1986; cf. Burley, 1986).^2
Although thalidomide showed no toxicity to
laboratory animals when tested by Ciba and Chemie
Grunenthal A.G., potentially irreversible peripheral
polyneuritis was soon identified in patients follow-
ing long-term use of thalidomide. Symptoms(^1) Bernstein notes that thalidomide quickly entered the lexicon
as metaphor for poison and evil. ‘For years I have heard the
word Wait!’, wrote Martin Luther King Jr in his famous Letter
from Birmingham City Jail (1963). ‘It rings in the ear of every
Negro with a piercing familiarity. This ‘‘Wait’’ has almost
always meant ‘‘Never.’’ It has been a tranquilizingthalido-
mide, relieving the emotional stress for a moment, only to give
birth to an ill-formed infant of frustration.’
(^2) Burley argues that there is no evidence that thalidomide was
neither useful nor prescribed as an antiemetic, and thus it had
no place in the management of the nausea of pregnancy.
610 CH47 PHARMACEUTICAL PRODUCT LIABILITY