Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?
Conk, George W., The Yale Law Journal
In the Restatement (Third) of Tons: Products Liability, the American Law Institute (ALI) announced a general role to resolve the problem of the meaning of the word "defect," a problem that has haunted the law of torts since section 402A of the ALI's 1965 Restatement (Second) ushered in the era of strict liability for defective products. The new role rejects consumer expectations as a reliable measure of defect and proposes that the key question is whether there existed a feasible alternative safer design, the omission of which was unreasonable.(1) The Restatement (Third) thus heralds the end of strict liability for product sellers, grounding products-liability law's key concept--the defective product--in the law of negligence.
Courts had long grappled with the problem of defining "defect," drawing on concepts such as warranty and the consumer's reasonable expectations. But they drew most successfully on risk-utility analysis, a negligence-based approach championed by John Wade,(2) the successor to William Prosser as Reporter for the Restatement of Torts. The "alternative-safer-design" rule enshrined in section 2 of the Restatement (Third) is the vindication of Wade's view that design-defect litigation should turn on whether the product could have and should have been made safer before it was sold. Section 2 articulates a functional standard(3) that does not depend on the common-law categories that have persisted since the announcement of the Restatement (Second)'s section 402A.(4) In adopting the alternative-safer-design standard, the ALI thus resolved the doctrinal wars of the past thirty-five years over strict-liability, negligence, and warranty theories of liability.
But a design defect lurks in the heart of the Restatement (Third). In section 6(c), the ALI, virtually without debate, adopted a rule that exempts sellers of prescription drugs(5) and medical devices(6) from the alternative-safer-design standard applied to all other products.(7) Under the ALI's new rule, designers and manufacturers of drugs and medical devices will not be held liable even if their products reasonably could have been made safer. The manufacturer need persuade the factfinder only that, on balance, the product does more good than harm for at least one class of users, so that a reasonable physician would prescribe it. The alternative-safer-design standard is rejected not only for drugs, but also for vaccines and mechanical devices such as cardiac pacemakers. Blood products, although regulated as drugs by the Food and Drug Administration (FDA), are excluded entirely from the Restatement, which acquiesces in the wide legislative ban on strict or warranty liability for blood products. The Restatement (Third) thus carves out a special, protective standard for a uniquely favored industry.
The two-tiered system that section 6(c) inscribes in black letter demands less than reasonable care from manufacturers of drugs and medical devices. Its declaration that manufacturers of medical products need not make a safer product if the existing product does more good than harm reverses thirty-five years of safety-advancing products-liability law. If adopted by the courts, the rule will create a dangerous chasm in the tort law and ultimately will undermine the credibility of the ALI.
Citing the experience of hemophiliacs,(8) who became infected with hepatitis and HIV through the use of contaminated blood products, this Essay argues that drugs, vaccines, biological products, and medical devices can and should be tested for defect by the same measures as all other products. The unsafe-design problems that section 6(c) seeks to solve can be addressed effectively by the mature and reliable functional rules of section 2--the rules applicable to all other products. Applying the alternative-safer-design standard to prescription drugs, vaccines, blood products, and medical devices would accomplish a major objective of the ALI's Restatement process: culling a coherent rule from the cacophony of common-law decisions. …