Academic journal article Defense Counsel Journal

Third Restatement: New Prescription for Makers of Drugs and Medical Devices

Academic journal article Defense Counsel Journal

Third Restatement: New Prescription for Makers of Drugs and Medical Devices

Article excerpt

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. …

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