statutes that allow regulatory compliance as a valid
defense in pharmaceutical product liability actions
(N.J Code Section 2A:58C-4). A handful of other
states have also adopted modified versions of a
regulatory compliance defense which, for exam-
ple, bar punitive damages for drugs approved by
the FDA or create a rebuttable presumption of non-
liability in light of FDA approval (Lifton and
Bufano, 2004). Similarly, in the United Kingdom,
Section 4(1) of the Consumer Protection Act of
1987 provides a valid defense if the defect is attri-
butable tocompliance either withadomestic enact-
ment or with European Community law (Heuston
and Buckley, 1992).
Disclaimers
With regard to product liability actions brought
under the principles of warranty, a defendant may
assert a defense based on a disclaimer from a
warranty associated with the purchase or use of
the product in question. For example, in the United
States under UCC Section 2-316(2), a seller of a
product may make a written disclaimer of the
warranty of merchantability if it is conspicuous.
However, it should also be noted that the Magnu-
son–Moss Federal Trade Commission Improve-
ment Act of 1974, 15 USC Section 2301,et seq.,
provides that, if a written warranty is given to a
consumer, there cannot be any disclaimer of any
implied warranty.
Contributory negligence
A defense of contributory negligence asserts that a
plaintiff who is him/herself negligent in that he/she
does not take reasonable care to protect him/herself
from damage, and whose negligence contributes
proximately to his/her injuries, is either entitled
only to reduced recovery from his/her damages,
or in some countries, is totally barred from recov-
ery (Heuston and Buckley, 1992). In these cases,
the plaintiff is held to the same standard of care as
the defendant, which is that of a similar reasonable
party under similar circumstances. Although a
plaintiff’s contributory negligence will be a
defense in product liability actions brought under
the principles of negligence, virtually all courts
have agreed that in most actions brought under
the principles of warranty or strict liability, con-
tributory negligence may not be a viable defense.
For example, if a plaintiff’s contributory negli-
gence lies in a failure to inspect the product or a
failure to become aware of the danger from that
product, virtually all courts agree that this is not a
defense. However, if the plaintiff learns of the risk
and voluntarily assumes the risk in purchasing and
using the product, contributory negligence may be
a defense to strict liability. Similarly, if the plain-
tiff’s contributory negligence consists of his/her
abnormal use or misuse of the product in question,
this may be a defense to strict liability, depending
on the degree of foreseeability of the abnormal use
or misuse.47.4 International issues
In recent years, pharmaceutical companies have
faced increased litigation from overseas claimants
because of the international differences in product
liability laws that make them easier targets. Such
differences include the absence of discovery
mechanisms, jury trials, legal contingency fees
and variations in the learned intermediary doc-
trines in many foreign jurisdictions. Lawsuits are
also being filed in the United States because for-
eign parties are not able to get justice in their own
country. This represents a marked reversal in the
‘foreign non-convenience rule’, which was origin-
ally adopted to protect defendant companies from
being sued in some distant location where it had a
small operation. Now, the very rules that used to
help multistate or multinational corporations are
being turned against them, on the theory that it is
not convenient for these foreigners to sue in their
own country because they do not have a claim
there or they are not able to have their case heard
for many years. Similarly, the plaintiffs’ bar has
become increasingly sophisticated in using global
regulatory inconsistencies to their clients’ advan-
tage during discovery and at trial. During the
course of litigation, pharmaceutical companies
are now routinely faced with discovery requests,47.4 INTERNATIONAL ISSUES 609