|
Drug Designs are Different |
|
|
|
|
James A. Henderson Jr. and Aaron D. Twerski [View as PDF]
|
111 Yale L.J. 151 (2001)
In an essay published in this Journal entitled Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?, George Conk criticizes the American Law Institute and the Reporters of the new Restatement for immunizing prescription drug manufacturers from liability for defective design. In doing so, he joins other commentators who have been critical of this aspect of the new Restatement, upon which we served as Reporters. Because Conk claims to have history on his side, and because this most recent criticism may prove to be disproportionately influential, we offer a response both to him and to other critics.
Conk praises the general product-design standard adopted by the Restatement, which predicates liability for almost all nonprescription products upon proof that a reasonable alternative design could have been adopted that would have avoided or reduced harm to the plaintiff. However, he criticizes the Restatement's provisions relating to defective drug design for not applying the same "reasonable alternative" standard. (The Restatement deems a drug defective in design only if it would not be prescribed for any class of patients.) In his view, the Restatement test for defective drug design would protect prescription drug manufacturers from liability even if a plaintiff could show that an alternatively designed drug would have avoided unnecessary risk. Conk argues that during the late 1970s and early 1980s, the absence of a reasonable alternative design standard for prescription drugs allowed distributors of blood to escape liability for supplying blood products contaminated with the hepatitis C virus and that the Restatement test would condone such noxious results in the future. Claiming this regrettable history as support for his position, Conk urges that the defectiveness of prescription drug designs should be determined by the same standard as is generally applicable to nonprescription products.
Our critics have misread the prescription drug design provision of the new Restatement. It does not immunize prescription drug manufacturers for defective design. Plaintiffs may establish defectiveness by showing that safer alternative drugs were available on the market that reasonable health care providers would have prescribed in place of a defendant's drug for all classes of patients. Moreover, Conk's premise that the blood cases in the 1980s would have been decided differently if blood products had been subject to the reasonable alternative design rule of the new Restatement is false. Finally, the purportedly pro-plaintiff approach he advocates, which would require courts to deny classes of patients access to a particular drug that provides them unique benefits in order to protect other patients from the risks of misprescription by negligent physicians, is both unfair and inefficient. In short, the Restatement is quite correct in treating prescription drug designs differently from other product designs, although it does not treat them as differently as Conk supposes. Drug designs are different from other product designs, and they deserve different treatment under the new Restatement.
Part I of this Essay summarizes Conk's thesis, including his interpretation of the new Restatement. Part II identifies significant errors in Conk's critique: He has read the Restatement incorrectly, and his reliance on the blood cases is misplaced. Part III explains and justifies the substantive differences between the new Restatement's treatment of prescription drug design and its treatment of defective product design generally. These differences include the Restatement's refusal to allow courts to consider alternative, safer prescription products that have not yet received FDA approval (under the general design provisions, courts routinely consider not-yet-marketed alternative designs) and its refusal to sacrifice the welfare of one class of patients to enhance the welfare of another class of patients (under the general design provisions, such cross-consumer sacrifices of welfare are routinely condoned). Part III also explains why drug design litigation cannot legitimately be made more plaintiff-friendly by reducing its complexity and why the rule in the new Restatement should not significantly reduce manufacturers' incentives to discover new and safer prescription products.
|
