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American University Law Review
June, 1999


Dolly M. Trompeter*


Before the tort reform movement swept through the American political agenda, if a medical product harmed a consumer, recourse would likely come through a tort claim against the drug manufacturer under the Restatement (Second) of Torts. In most instances, this consumer could establish liability by proving either that the manufacturer lacked due care in designing the drug under a negligence theory, or that the product was in a defective condition unreasonably dangerous under the theory of strict liability. Therefore, under the Restatement (Second) of Torts, section 402A, a consumer could find protection in a tort system more concerned with "caring about others' safety" and being "responsive to others' needs or hurts" than insulating corporations from liability.

A "questionable" breed of tort law has emerged, however, focusing more on addressing corporate "needs" and "hurts" than considering those of the consumer. In 1997, the American Law Institute approved the Restatement (Third) of Torts: Products Liability. One of the most controversial aspects of this new Restatement is section 6(c). Section 6(c) governs design defect liability for medical products. To establish liability under section 6(c), a consumer must prove not only that a medical product caused her harm, but also that a reasonable health care provider would not have prescribed the product for any class of patients. In other words, if every user suffered harm, and no one derived benefit from a medical product, only then could a victim bring a successful claim for design defect. This new standard reduces company liability and responsibility and increases both corporate profits and public harm.

Section 6(c) will disproportionately affect women for two reasons: (1) women consume a greater share of medical products than men; and (2) the regulatory system has not adequately tested and monitored products for women. Section 6(c), however, is not the Restatement (Third)'s only product design defect provision. Section 2 establishes a separate standard of liability for general product design defect apart from medical or prescription products. As compared to Section 6, Section 2 provides an aggrieved consumer more opportunity to establish design defect liability. The Restatement (Third)'s authors (the "Reporters") acknowledge that the requirements to establish design liability for general product defect are less stringent than for medical products. Section 2 permits the plaintiff to present a reasonable alternative design to establish a design claim for general product defect, rather than requiring proof that the product was ineffective for all users.

In addition, section 2 provides for an exception to the liability standard for general product design defect claims. Under the comment e exception, if the product's design renders its social utility low in relation to its potential to cause harm, liability attaches regardless of the existence of a reasonable alternative design. The rationale behind comment e is that rigid liability standards should not apply to products with low social utility. Section 6(c), however, does not provide any such exception for medical product design defect claims.

The importance of comment e's general product defect exception is realized when one views the new theories of liability through the eyes of the aggrieved female consumer. Analyzing the Restatement (Third) from a gender perspective reveals its potential to minimize the obstacles women face when asserting medical product design defect claims. This Comment's approach to analyzing the Restatement (Third) is not unlike that taken by scholars who examine the law in gendered terms. For example, the "Woman Question" is one method of inquiry "designed to identify the gender implications of rules and practices which might otherwise appear to be neutral or objective." Many scholars have asked the Woman Question as it relates to tort law.

In keeping with this body of thought, this Comment poses the Woman Question to the Restatement (Third). The response is troubling as this inquiry reveals that section 6(c)'s liability standard for medical product defect claims will disproportionately harm women.

Unsettled by the Restatement (Third)'s response to the Woman Question, this Comment offers a more favorable answer: Comment e. That is, the tort system should recognize an exception for "manifestly unreasonably designed" medical products failing to meet the difficult standard of section 6(c).

By extending comment e to section 6(c), the tort system would embrace the idea that women's safety demands a more reasonable standard of liability for medical product defect claims. Absent such an exception, women will continue to suffer harm at the hands of the tort system as companies lack incentive to design safer products and to recall harmful products from the market. Furthermore, products genuinely helpful to a subset of users will remain on the market, as comment e's risk-benefit test will factor in the critical need for the product when determining whether to impose liability.

Part I of this Comment provides background on the relevant provisions of the Restatement (Second) and Restatement (Third). With regard to the Restatement (Second), Part I addresses the theories behind strict liability, unavoidably unsafe products, and the res ipsa loquitur standard. With regard to the Restatement (Third), Part I discusses general product design defect, "circumstantial evidence supporting the inference of product defect" (res ipsa loquitur), the concept of manifestly unreasonable design, and the design defect standard for medical products.

Part II of this Comment analyzes the case law offered in support of the section 6(c) standard in the Restatement (Third). This Part focuses on two primary issues. First, Part II argues that the one case cited by the Reporters of the Restatement (Third) for direct support of section 6(c) creates a "super" res ipsa loquitur standard like that in section 3 of the Restatement (Third). Additionally, the two cases relied upon by the Reporters for supplemental support for section 6(c) fail to reflect the section 6(c) standard. Second, Part II analyzes the feminist application of tort law by asking the Woman Question and focusing on the relationship between women and medical products. Part II argues that the special classification of medical products apart from other products in the Restatement (Third) is a tenuous distinction, that the regulatory system has many general flaws which prevent it from adequately monitoring and testing medical products, and that women's exclusion from drug testing renders the Food and Drug Administration (FDA) unable to regulate harmful products for women.

Part III advocates the adoption of the comment e exception for general product design defects in section 2 to the liability standard under section 6(c) for medical product design defects. Part III determines that although the Reporters did not intend comment e to apply to section 6(c), case law, the prior application of comment k of the Restatement (Second), and the theory behind the comment e exception suggest that comment e should apply to section 6(c).

* Dolly M. Trompeter, J.D. Candidate, 2000, American University, Washington College of Law; B.A. 1996, College of William & Mary. I am indebted to the following for their contributions to this Comment in substance and spirit: My parents, Maxyne and Steven Trompeter, for unapologetically raising a feminist amidst the often unforgiving hills of Southwest Virginia. My mentor, Professor Andrew Popper, for sharing his thoughtful passion for the law and his sincere compassion for those most vulnerable to it, inspiring me to want to achieve his marvelous aesthetic for myself. Finally, my muse, Star Trompeter, for singing me her beautiful song which led me to believe in the power of my own voice.