Third Restatement: new prescription for makers of drugs and medical devices.

Author:Kaplan, Harvey L.
Position:Third Restatement of Torts (Draft

SECTION 402A of the Restatement (Second) of Torts is a useful but aging item in need of repair. Recognizing this, the American Law Institute in 1991 undertook the momentous process of drafting what will evolve into the Restatement (Third) of Torts: Products Liability. James A. Henderson, who is Frank B. Ingersoll Professor of Law at Cornell Law School, and Aaron D. Twerski, professor of law at Brooklyn Law School, have been selected by the ALI as reporters for the project.

These able scholars crafted a preliminary draft, which was released in April 1993. They later revised that draft in the light of discussions held with the Advisory Committee, the Members Consultative Group and various liaison groups that were asked to comment. The liaison groups include the American Bar Association, the Defense Research Institute, the Association of Trial Lawyers of America and the Product Liability Advisory Council.

In September 1993 another draft, entitled Council Draft No. 1, was released. It was submitted to the ALI Council in October 1993. Based on substantive suggestions aired then, the council decided that it would prefer to see another version before approving a "Tentative Draft." Council Draft No. 1 is not officially citable. Under ALI procedures, the document will be citable only after it is approved as a Tentative Draft.

Because of the status attained by Section 402A of the Restatement (Second), the significance of its proposed successor cannot be overstated. The document, when completed, will command attention in both classroom and courtroom. Therefore, it behooves defense counsel to know something about the draft in its present form. After a cursory overview of six of the sections now contained in the Council Draft, this article explores in more detail Section 103, which addresses the liability of manufacturers of prescription drugs and medical devices, and then looks at what lies ahead. For purposes of this article, Council Draft No. 1 will be referred to by section numbers and comment designations.


The heir apparent to Section 402A of the Restatement (Second) is proposed Section 101--an omnibus provision that sets forth standards of liability for manufacturing defects, design defects, and defects attributable to inadequate warnings. Subsection 101 (b)(2) adopts a risk-utility test as the standard for design defects, under which a plaintiff must prove that the manufacturer failed to adopt a "reasonable alternative design" that would have reduced the product's foreseeable risks of harm. The proposed standard contains two constraints. First, the alternative--no matter how safe--must be reasonable in terms of cost and usefulness to consumers. An ultra-safe product that is too pricey or of scant value to consumers is not a reasonable alternative. Second, the alternative will be deemed reasonable only if the product's overall safety is enhanced. A new design that would have spared the plaintiff, yet imperiled others, is not reasonable.

The comments set forth the factors that may be considered in determining the reasonableness of a design. These factors include the magnitude of the foreseeable risks, consumer expectations, the effects on production costs, the effects of the alternative design on product function, the pros and cons of the proposed safety features, product longevity, maintenance and repair, esthetics, and marketability. Explicitly rejected is the consumer expectations test as an independent standard for determining design defect.

Section 102 addresses the situation where a product that malfunctions is destroyed in the ensuing accident. It provides that when a manufacturing defect was the likely cause of the malfunction, the trier of fact can infer that the manufacturing defect caused the harm. The plaintiff need not specify the nature of the defect.

Section 104 states that the principles that govern causation in tort are equally applicable when the issue is whether a product defect caused the harm.

In Section 105, the draft deals with harms that are said to have been enhanced because of a product defect. A typical situation is an automobile accident not caused by a product defect and in which the plaintiff would have sustained some harm even had the car been perfectly safe. The claim is that a defect aggravated the injuries. Under Section 105(b), when the plaintiff proves that a defect increased the harm, the manufacturer is liable for all of the harm unless it is able to prove the extent of the enhanced harm.

Section 106 provides that the rules governing apportionment of responsibility will apply when a harm is caused both by the plaintiff's negligence and the product's defect.

Last, Section 107 covers contract-based defenses. It states that disclaimers or limitations by manufacturers, as well as waivers by consumers, will not bar an otherwise valid products claim, essentially constructing an irrebuttable presumption that the plaintiff lacked sufficient information or bargaining power to execute a fair limitation on the right to recover.


  1. Different Treatment

    The "black-letter" language of Section 402A of the existing Restatement contains no explicit reference to prescription drugs or medical devices. The proposed Restatement appropriately places prescription drugs and medical devices in a separate section, Section 103, which is supported by eight comments and five illustrations. The products that fall within the scope of the section are those "drugs and medical devices that legally can be sold only pursuant to a medical provider's prescription." For convenience, this article will refer to such products as "prescription drugs and medical devices" or "drugs and devices."

    That prescription drugs and medical devices have been set aside--not for special treatment but rather for different treatment--is, if nothing else, a long ovverdue recognition that they are unlike other products. At the very least, pharmaceutical manufacturers should be pleased that prescription drugs and medical devices are not, under the proposed black-letter Restatement, adjudged under the same standards that govern snow blowers and blenders.(1)

  2. Unchanged Provisions

    Certain provisions of Section 103 constitute little or no change from the Restatement (Second) and present law.

    Subsection 103(a) establishes liability standards for prescription drugs and medical devices that are defectively manufactured, defectively designed or defective due to inadequate warnings. The standards are the same for both drugs and medical devices.

    Subsection 103(a)(1) provides that product defectiveness will be established if the plaintiff proves that the drug or device contained a manufacturing defect. A manufacturing defect, unlike a design defect, involves not an entire line of products but rather those products that mistakenly differ from others in the product line. In many cases, manufacturing defects are readily identifiable.(2) In addition, the number of products that will enter the marketplace with manufacturing defects has been said to be predictable.(3) Because of that, the imposition of liability is somewhat less objectionable insofar as manufacturing defects are something against which manufacturers might insure.

  3. Learned Intermediary Rule

    Subsection 103(a)(2) states that liability will attach when manufacturers fail to provide reasonable warnings to prescribing and "other" medical providers who were in a position to receive warnings and reduce risks. The subsection restates the traditional rule that manufacturers of drugs and medical devices discharge their warning duties by warning a "learned intermediary," but it does not identify who the "other" medical providers might be. Thus, it may be rather difficult to provide warnings to them.

    Manufacturers typically provide written warnings to prescribing physicians, but manufacturers have no control over physicians' decisions to delegate treatment duties to other medical providers. Manufacturers should not be required to warn unascertainable "others" who, because of independent decisions made by doctors, have been enlisted in the treatment of patients.

  4. Exceptions to Learned Intermediary Rule

    Subsection 103(a)(3) would establish serious inroads to the learned intermediary doctrine by providing that manufacturers of prescription drugs and medical devices would be liable if reasonable warnings were not given directly to the patient in three situations--when (1) the manufacturer knew or had reason to know that no medical provider would be in a position to recive the instructions and warnings and to reduce the risks of harm; (2) Food and Drug Administration regulations required that direct warnings be given; or (3) the manufacturer advertised or otherwise promoted the drug or medical device directly to users and consumers.

    1. Background of the Rule

      The learned intermediary rule--sometimes known as the "prescription drug rule"--has deep doctrinal roots. Makers of prescription drugs and medical devices discharge their duty of care to patients by warning physicians. The rule is sensible. Comprehending risks that are inherent in prescription drugs and medical devices is not an assignment for someone who lacks medical expertise. Only a person with proper medical training is in a position to appreciate such risks fully and relate them to patients.

      The Fifth Circuit has stated:

      Prescription drugs are likely to be complex

      medicines, esoteric in formula and varied in ef-

      fect. As a medical expert, the prescribing physi-

      cian can take into account the propensities of the

      drug, as well as the susceptibilities of his pa-

      tient. His is the task of weighing the benefits of

      any medication against its potential dangers. The

      choice he makes is an informed one, an indi-

      vidualized medical judgment bottomed on a

      knowledge of both patient and palliative. Phar-

      maceutical companies then, who must warn ulti-

      mate purchasers of dangers inherent...

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