pharmaceutical product liability law, review
recent developents and emerging trends among
pharmaceutical companies and product liability
lawyers, and discuss how they might impact the
industry as a whole in the future.
47.1 Principles of product
liability lawThe origins of product liability law can be traced to
cases brought before British courts shortly after the
onset of the Industrial Revolution in the first half of
the nineteenth century. Since then, an ever-increas-
ing volume of product liability cases have been
brought before the courts in industrialized coun-
tries. In the United States alone, product liability
lawsuits have increased from over 2000 cases in
1975, which marked the first crisis in the product
liability insurance market, to over 13 000 cases in
the late 1980s (Epstein, 1995). Although approxi-
mately 60% of this increase resulted from cases
involving exposure to asbestos, a large fraction of
the remainder have been brought against pharma-
ceutical companies.
In general terms, ‘product liability’ refers to the
liability of a seller of a product which, because of a
defect, causes damage to its purchaser, user, or
sometimes a bystander. Responsibility for a product
defect that causes damage lies with all sellers of the
product who are in the distribution chain including
the product manufacturer, manufacturers of compo-
nent parts, wholesalers and retail stores that sold the
producttotheconsumer.Laws inmostcountriesand
jurisdictionsrequirethataproductmeettheordinary
expectations of the consumer. When a product has
an unexpected defect or danger, that product cannot
be said to meet the ordinary expectations of the
consumer. Product liability law is primarily based
on precedent case law that varies among jurisidic-
tions. For example, in the United States, there is no
federal product liability lawper se.Typically, pro-
duct liability claims are based on state laws and
relevant commercial statutes, modeled on the Uni-
form Commercial Code (UCC), that pertain to war-
ranty rules that govern manufacturers and their
products. Classically, for product liability to arise,
atsomepoint,theproductmusthavebeensoldinthe
marketplace resulting in a contractual relationship,
known as ‘privity of contract’, between the person
injured by a product and the supplier of the product.
However, in most countries and jurisdictions today,
the privity requirement no longer exists, and the
injured person does not have to be the purchaser
of the product in order to recover. Any person who
foreseeably could have been injured by a defective
product can recover for his or her injuries, as long as
the product was sold to someone.
Pharmaceutical companies are increasingly
being named as defendants in product liability
suits. Pharmaceutical manufacturers have a duty to
appropriately test their products before releasing
them into the market, based on criteria from regu-
latory bodies such as the US Food and Drug Admin-
istration (FDA) and the European Medicines
Evaluation Agency (EMEA). These criteria are
regarded as industry standards, but the fact that a
drug was properly licensed by the FDA or EMEA
has no effect on the manufacturer’s liability to an
injured plaintiff, if the drug proves to be otherwise
defective. A drugmanufacturer hasadutytowarn of
side effects of a drug when such effects are under-
stood to occur, but is not expected to warn of
unknown dangers. Often the manufacturer dis-
charges this duty by providing the necessary infor-
mation to the patient’s prescribing physician or to
the pharmacist. There is no duty to warn of possible
reactions in unusually susceptible consumers, but
just because a reaction is rare does not mean the
manufacturer has no duty to warn about it. As with
almost all medical products, with the exception of
over-the-counter drugs, there will usually be a
‘learned intermediary’ between a drug’s manufac-
turer and the ultimate user. This can be the doctor
who prescribes a drug, a nurse who instructs the
patient on its proper use or the pharmacist who fills
the prescription. The key role of these health profes-
sionals in the use of pharmaceutical products gave
rise tothe ‘learnedintermediary doctrine’which has
been used by pharmaceutical companies as a pri-
mary defense in failure to warn claims. Under the
doctrine, a pharmaceutical company is relieved of
its duty to warn a patient of side effects associated
with a drug when the company has provided an
adequate warning to the patient’s physician. How-606 CH47 PHARMACEUTICAL PRODUCT LIABILITY