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Mention the Third Restatement of Torts and the learned
intermediary rule in the same sentence, and our response would be
to cite §6(d) of the product liability part of the
Restatement. But the Third Restatement also confirms that this
widely followed (perhaps the most widely followed)
legal rule also applies to negligence causes of action. We
discovered this fact totally by accident recently while researching
duty in a non-drug/device context. Specifically, Comment i to
Restatement (Third) of Torts, Physical & Emotional Harm §7
(I)n the field of products liability, courts have declared that
the warning obligation of prescription-drug manufacturers
ordinarily is limited to the prescribing physician and does not
extend to warning the patient directly. They reason that the
physician can best assess the relevant risk information and
determine the appropriate course of treatment. When appropriate,
the physician can inform the patient of means by which the patient
may minimize the risk of adverse side effects. . . . Courts have,
through this duty limitation, made a categorical determination that
having manufacturers provide safety information to physicians,
rather than to patients, is the appropriate manner for minimizing
the costs of adverse side effects. Such a categorical determination
also has the benefit of providing clearer rules of behavior for
actors who may be subject to tort liability and who structure their
behavior in response to that potential liability.
We were not expecting to find further Third Restatement support
for the learned intermediary rule in a non-product liability
section. Having stumbled across it, we decided to review the
entirety of §7 – entitled simply “Duty”
− for other possible nuggets. First, that section’s black
(a) An actor ordinarily has a duty to exercise reasonable care
when the actor’s conduct creates a risk of physical harm.
(b) In exceptional cases, when an articulated countervailing
principle or policy warrants denying or limiting liability in a
particular class of cases, a court may decide that the defendant
has no duty or that the ordinary duty of reasonable care requires
That’s far better and more nuanced than the absolutist
language in the Second Restatement that “anyone who does an
affirmative act is under a duty to others to exercise the care of a
reasonable man to protect them against an unreasonable risk of harm
to them arising out of the act.” Restatement (Second) of Torts
§302, comment a (1965).
As exemplified by the already-discussed comment i concerning the
learned intermediary rule, other nuggets are available in
Restatement Third §7’s wide-ranging comments. For example
there is additional support for the non-existence of a “duty to recall” a
(C)ourts generally impose on sellers of products that are not
defective at the time of sale the limited duty to warn of newly
discovered risks, rather than the more general duty of reasonable
care, which a jury might find includes a duty to recall and
retrofit the product so as to eliminate the risk.
Restatement (Third) §7, comment a. Further, while
“stop selling” claims involving prescription medical
products were held preempted in Mutual Pharmaceutical Co. v.
Bartlett, 570 U.S. 472 (2013), the Third Restatement’s duty
considerations urges that such claims should not exist, ab
initio under state law:
(W)hen a plaintiff claims that it is negligent merely to engage
in the activity of manufacturing a product, the competing social
concerns and affected groups would be appropriate considerations
for a court in deciding to adopt a no-duty rule.
Restatement (Third) §7, comment f. State courts don’t
have the “institutional competence” to make such
Comment j recognizes that – contrary to those few courts
allowing innovator liability – that foreseeability is not
properly the primary (or, indeed, any) consideration for the
establishment of a duty:
Despite widespread use of foreseeability in no-duty
determinations, this Restatement disapproves that practice and
limits no-duty rulings to articulated policy or principle in order
to facilitate more transparent explanations of the reasons for a
no-duty ruling and to protect the traditional function of the jury
“Just as foreseeability is unhelpful in determining whether
there is no duty, foreseeability is unhelpful for expanding the
scope of tort law, such as in the area of affirmative duties.”
Id. (Reporter’s Notes). The Third Restatement thus
recognizes that “foreseeability” is simply a dodge courts
use to disguise result-oriented decisions, and instead urges courts
to be “more transparent” in their reasoning.
Finally, the economic loss rule also receives some favorable
treatment in the comments to §7, here:
(O)ne reason the general duty of reasonable care stated in
§6 is limited to physical harm is that liability for purely
economic harm in commercial cases often raises issues better
addressed by contract law or by the tort of misrepresentation.
Id., comment d.
In sum, we were surprised by the amount of useful material that
we found in Restatement (Third) §7. Feeling our readers might
be equally unaware of the wide-ranging discussion in this section,
we went through it thoroughly. We note that similarly useful
support for defense arguments might exist in other, adjacent
sections of this part of the Third Restatement that we have yet to
have occasion to review.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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