Drug designs are different.

• Author: Henderson, James A., Jr.
• Position: Essay

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. (1) In doing so, he joins other commentators who have been critical of this aspect of the new Restatement, (2) 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. (3) 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. (4) 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. (5) 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. (6)

Our critics have misread the prescription drug design provision of the new Restatement. (7) 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 crossconsumer 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.

1. CONKS CRITIQUE OF THE NEW RESTATEMENT AND HIS SUGGESTED APPROACH TO JUDGING PRESCRIPTION DRUG DESIGN

   Conk focuses his critique of the Restatement on section 6(c), which sets out the standard to be applied for defective drug design. Section 6(c) provides:

   A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. (8)

   Conk asserts that, under section 6(c), "if the medical product does more harm than good for at least one class of users, it will not be considered defective. This is true even if the product unnecessarily causes harm, in the sense that there is a feasible safer alternative design." (9) By his account, section 6(c) prevents a plaintiff from proving not only that a drug manufacturer was negligent in failing to develop an alternative safer drug and achieve timely FDA approval for its marketing, but also that an FDA-approved drug already on the market is a reasonable, safer alternative to the FDA-approved drug that harmed the plaintiff. Thus, Conk reads the Restatement language in section 6(c) to mean that, as long as a prescription drug standing alone provides a net benefit to a class of users, the drug cannot be found to be defectively designed.

   The new Restatement deals with nonprescription product designs in section 2(b), which provides that a product is defective in design "when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design ... and the omission of the alternative design renders the product not reasonably safe." (10) In establishing that the defendant's product design was not reasonably safe when distributed, the plaintiff proves that a reasonable alternative design (RAD) could have been conceived, developed, and marketed that would, at acceptable cost, have helped the plaintiff. (11) Conk argues that this RAD-based standard, generally applicable to nonprescription products, should also apply to prescription drugs and medical devices. (12) Were that general design standard applied to prescription products, a plaintiff would be free to prove that a drug manufacturer was negligent for failing to develop and market a drug that would have provided the same or greater benefits with less risk of harm. (13) In the event that no RAD can be established, Conk urges application of a "manifestly unreasonable design" standard. When the sum of the product's known risks at the time of sale outweighs its aggregate utility such that no reasonable manufacturer would have marketed the drug, he insists that liability for defective drug design should attach. (14)

   Conk supports his argument that prescription drug designs are the same as other product designs, and thus should be measured by the general RAD-based standard, with what he views to be the unfortunate results of the litigation arising from use of hepatitis-infected blood during the late 1970s and early 1980s. (15) In that time frame, hemophiliacs who required blood plasma ran the risk of being transfused with blood contaminated with the hepatitis C virus. Later, when it became clear that AIDS is a blood-borne disease and public pressure mounted, manufacturers developed a heat-treatment process that eradicated HIV and hepatitis viruses from blood. If the same methods had been implemented earlier, Conk insists, the hepatitis epidemic among hemophiliacs could have been avoided. In his view, hemophiliacs were barred from recovering for their injuries because the courts failed to adopt a RAD-based design standard such as that contained in section 2(b). (16) Conk concludes that the test for design defect embodied in section 6(c) will replicate such unfortunate results in the future, and courts should, for that reason, reject it. (17)

2. CONK'S CRITIQUE CONTAINS SIGNIFICANT ERRORS

   Before proceeding to show the errors of Conk's ways, we must clear the air. As what follows makes clear, some of the relevant language in both the blackletter of, and comments for, section 6(c) is ambiguous, and the authors, as retired Reporters, have no more standing than anyone else--including George Conk--to opine regarding the Restatement's meaning. Conk's reading of section 6(c) is rational and deserves a considered response. We submit that, when one objectively considers the relevant data relating to the new Restatement's meaning, Conk has read it wrong. We are as much to blame as he for the confusion; we should have been clearer in the relevant phraseology. In any event, even if we succeed in showing that our interpretation is correct, significant substantive differences between the true meaning of section 6(c) and Conk's preferred approach to drug design liability will remain to be considered in subsequent discussions.

   1. Contrary to Conk's Reading, the New Restatement Does Allow Courts To Consider Already-Marketed Alternatives in Assessing a Drug Design's Defectiveness

      Conk reads the prescription drug design provision in section 6(c) to prevent plaintiffs from establishing defect by showing that a safer alternative to a defendant's drug was available. We emphatically disagree with Conk's insistence that section 6(c) does not allow any alleged RAD to be considered by the court in determining whether a prescription product's design is defective...