Academic journal article Defense Counsel Journal

Conning the IADC Newsletters

Academic journal article Defense Counsel Journal

Conning the IADC Newsletters

Article excerpt

Recognizing that a wide range of practical and helpful material appears in the newsletters prepared by committees of the International Association of Defense Counsel, this department highlights interesting topics covered in recent newsletters and presents excerpts from them.

New Restatement and the Learned Intermediary Doctrine

Writing in the January newsletter of the Drug, Device and Biotech Committee, Janet H. Smith of Arter & Hadden, Cleveland, looks at the future of the learned intermediary doctrine:

The learned intermediary doctrine relieves drug and medical device manufacturers of the duty to warn a patient when the manufacturer has provided an adequate warning to the patient's physician. What will be impact of the newly promulgated Restatement (Third) of Torts on the learned intermediary doctrine--now and in the future?

Persuasive authority

Although the new Restatement is not approved by any legislature and is not binding on any court, it is undisputed that the persuasive authority of the Restatement (Second) of Torts greatly influenced--if not created--the present state of product liability law based on strict liability/defect. Section 402A of Restatement (Second), adopted in 1965, states that a plaintiff may recover if injured by a "unreasonably dangerous" product.

Comment k to Section 402A laid the groundwork for the learned intermediary doctrine when it stated that:

      Such a product properly prepared, and accompanied by proper directions
   and warnings, is not defective, nor is it unreasonably dangerous.... The
   seller of such products, again with the qualification that they are
   properly prepared and marketed, and proper warning is given, when the
   situation calls for it, is not to be held to strict liability for
   unfortunate consequences attending their use.

While only alluded to in Comment k, the learned intermediary doctrine, based on proper and adequate warnings to physicians, developed on a parallel course with the growing acceptance of Section 402A. Since 1966, when the term "learned intermediary" was first coined in Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966), courts have acknowledged the common sense reasoning behind this bright line no duty rule.

The oft-cited case of Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), explains the rationale:

      Prescription drugs are likely to be complex medicines, esoteric in
   formula and varied in effect. As a medical expert, the prescribing
   physician can take into account the propensities of the drug as well as the
   susceptibilities of his patient. His is the task of weighing the benefits
   of any medication against its potential dangers. The choice he makes is an
   informed one, an individualized medical judgment bottomed on a knowledge of
   both patient and palliative. [498 F.2d at 1276]

A review of case law reveals that in the vast majority of product liability actions brought against manufacturers of drugs and medical devices, courts have rightfully continued to uphold the learned intermediary doctrine.

Enter: New Restatement

Since the overwhelming majority of cases involving prescription drugs and medical devices are "inadequate warning" cases, the new Restatement (Third) of Torts has attempted to bring some order to the now well-established concepts of product defect and the learned intermediary doctrine. Section 6(d) of the new Restatement provides:

      (d) A prescription drug or medical device is not reasonably safe because
   of inadequate instructions or warnings if reasonable instructions or
   warnings regarding foreseeable risks of harm are not provided to:

      (1) prescribing and other health care providers who are in a position to
   reduce the risks of harm in accordance with the instructions or warnings;
   or

      (2) the patient when the manufacturer knows or has reason to know that
   healthcare providers will not be in a position to reduce the risks of harm
   in accordance with the instructions or warnings. … 
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