Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?

Abstract

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 and medical devices from the alternative-safer-design standard applied to all other products. 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.