Opinion ID: 1897541
Heading Depth: 2
Heading Rank: 1

Heading: The new Restatement (Third) of Torts has left the issue to developing case law.

Text: Parallel to the developments in drug marketing, the American Law Institute was in the process of adopting the Restatement (Third) of Torts: Products Liability (1997). The comment to Section 6 explains that subsection (d)(1) sets forth the traditional rule of the learned intermediary that drug and medical device manufacturers are liable for failing to warn of a drug's risks only when the manufacturer fails to warn the health-care provider of risks attendant to a specific drug. Restatement, supra, § 6(d) comment a. That same comment also notes that subsection (d)(2) reflects decisional law and provides limited exceptions to the traditional rule by requiring manufacturers to warn patients in certain circumstances. Ibid. Because situations may exist when the health-care provider assumes a much-diminished role as an evaluator or decisionmaker, it is appropriate to impose a duty on the manufacturer to warn the patient directly. Id. at § 6d comment b. Despite the early effort to provide an exception to the doctrine in the case of direct marketing of pharmaceuticals to consumers, the drafters left the resolution of that issue to developing case law. Id. at § 6d comment e. One commentator described the Restatement's approach as a tepid endorsement of the learned intermediary doctrine. Charles J. Walsh et al., The Learned Intermediary Doctrine: The Correct Prescription for Drug Labeling, 48 Rutgers L.Rev. 821, 869 (1994). Thus, under the new Restatement, warnings may have to be provided to a health-care provider or even to the patient, depending on the circumstances. William A. Dreier, The Restatement (Third) of Torts: Products Liability and the New Jersey LawNot Quite Perfect Together, 50 Rutgers L.J. 2059, 2097 (1998). This is an entirely appropriate resolution. Judge Cardozo, a shaper of both the common law and of the Restatements of law drafted by the American Law Institute, saw each role as complementary: Cardozo saw the Institute as continuing his own work as a common law judge: to show that new decisions that modernized law had their roots in ancient notions of the purpose of law to accomplish justice through an ongoing reformulation of the governing rules. [Andrew L. Kaufman, Cardozo 174 (1998).]