In order to succeed in a claim of negligence, a
plaintiff must prove all three elements. It is not
enough to show that the defendant had a duty of
care and was in breach of it. There must be proof
that the breach caused the plaintiff’s alleged injury,
which is often the most difficult task for a plaintiff,
especially in claims concerning pharmaceutical
products, where there may be other possible causes
of the plaintiff’s condition.
In the law of tort, including negligence, liability
is fault based. It must be proved that the defendant
was at fault in that he/she acted wrongfully and as a
result violated a right of the plaintiff, causing harm
to him/her. The requirement offault differentiates a
genuine accident from a negligent act for which the
injured person can be compensated.
Liability can result under other laws in the
United States, such as the False Claims Act,
which provides for civil proceedings to punish
healthcare fraud when a person knowingly causes
a false claim to be made to a government agency. A
lawsuit can be filed by the government or by a
citizen, who then receives a portion of the mone-
tary recovery.
To complicate matters in some countries, liabi-
lity may also arise in tort without proof of fault.
This is known as strict liability. An important
example of strict liability for pharmaceutical com-
panies is what is commonly referred to as the
‘European Products Liability Directive’, which
introduced a Europe-wide scheme of strict liability
for defective products. (see Chapter 52 on ‘Phar-
maceutical Product Liability’). As liability is strict,
the defences that are available in the legislation are
most important. The UK legislation, for example,
includes a ‘development risk defence.’ This essen-
tially means that, if the state of scientific knowl-
edge was such that the producer could not have
discovered the defect, this will provide a defence to
the claim.
The United States has also adopted a theory of
strict liability. This theory imposes liability on the
seller of a product that is unreasonably dangerous
because of a defect in its design, manufacture or
warnings. There are special provisions carved out
for pharmaceutical products because of their value
tosocietyandthefacttheyare‘unavoidablyunsafe’.
Such products need to be accompanied by an
adequate warning. Under strict liability, a pharma-
ceutical company is unquestionably subject to strict
liability as a ‘seller’ of a pharmaceutical product. A
pharmaceutical physician, however, is generally not
subject to this type of liability.46.6 The legal framework for
regulating pharmaceutical
productsAs any pharmaceutical physician is well aware, the
development, manufacture, marketing and safety
of pharmaceutical products are subject to close
governmental control in most countries through
specific regulations on the sale of medicines and
medical devices. Pharmaceutical physicians play a
key role in ensuring that, at each stage in the life of
a pharmaceutical product, the regulatory require-
ments have been met. As discussed above, there
may be criminal implications if certain require-
ments are not fulfilled. Also, in a negligence action
against the pharmaceutical company, the failure by
the company or by one or more individual employ-
ees to comply with the regulations may be relevant
to the question of whether or not a company has
acted reasonably. Indeed, in the United States,
some courts have held that a company failing to
comply with government regulations may be pre-
sumed to be negligent; known as ‘negligence-
per-se’, it essentially lessens the plaintiff’s burden
regarding the standard of care owed by the
defendant. Negligence-per-se focuses on the
defendant’s actions, whereas in strict liability,
the focus is on the product and whether it was
defective.
In the United Kingdom, regulation is derived
from the Medicines Act of 1968, which provides
a comprehensive system of licensing affecting
most aspects of the sale of medicinal products. It
also contains provisions on related matters, such as
pharmacovigilance and the requirements for the
reporting of adverse events (AEs). The Medicines
Act encompasses measures contained in European
Community Directives, including the first on
the control of medicines, introduced in 1965. The
Medicines Act led to the creation of various598 CH46 PHARMACEUTICAL MEDICINE AND THE LAW