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 (2010), provides:
[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 letter:
(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 modification.
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 product:
[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 decisions. Id.
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 as factfinder.
“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.