The True Test: Alternative Safer Designs for Drugs and Medical Devices in a Patent-Constrained Market

55 Pages Posted: 13 Dec 2005


In section 6(c) of the Products Liability Restatement, Professors James Henderson and Aaron Twerski, the American Law Institute (ALI) reporters, rejected the ordinary test of product design defect (the section 2(b) reasonable alternative design test) for prescription drugs and medical devices. For such medical products the ALI rule enunciates a manufacturer-protective standard, declaring that under it liability would only rarely be imposed. A product is defective under section 6(c) only if it provides no net benefit for any foreseeable class of patients. The rule was challenged in an earlier article by Professor Conk. The first state court of last resort to confront the issue, the Nebraska Supreme Court, overturned precedent and rejected the Restatement rule. This Article discusses the issue of the character of the proofs of design defect, which the Nebraska court indicated it will address in the future.

In a rebuttal the Reporters have embraced an alternative safer design test for drugs. But they would limit the test to comparison with FDA-approved products actually available on the market at the time of sale of the challenged product. The Reporters' saving construction is welcomed. But Conk finds the Reporters' new reading to be an unconvincing exegesis, if nonetheless a small step forward.

The Reporters assert that courts are incompetent to judge drug product design defect claims because they would have to replicate at trial the complex FDA approval process in order to pass upon a plaintiff's alternative safer design. This is a much greater burden than that for all other classes of products - for which no prototype need be produced, nor an alternative be shown to be on the market.

The new reading of section 6(c) is still inadequate. The problem of showing the existence of an alternative safer design in a patent-monopolized market is discussed. Conk argues that in patent-monopolized markets the burden on the plain-tiff to produce an alternative design should be lighter than in robust markets open to competition. In more open markets the absence of a safer product on the market may carry greater evidentiary weight on the issues of the feasibility and practicality of the plaintiff's proposed alternative design.

Three drugs for which liability could be found under the alternative safer design test of section 2(b), but would be excused under the manufacturer-protective test of section 6(c), are discussed - the anti-acne drug Accutane, unpasteurized Anti-hemophilic Factor concentrate (AHF), and Sabin live-virus oral polio vaccine.

Finally, pointing to medical devices like IUD's and tampons, and the fact that mechanical devices are more amenable to alternative safer design analysis than are drugs, the Article discusses the final fatal flaw of section 6(c) - its treatment of both drugs and devices by the same manufacturer - deferential standard of liability.

Keywords: drug product liability, prescription drugs, vaccines, medical devices, design defect, product liability, compensation, restatement

Suggested Citation

Conk, George W., The True Test: Alternative Safer Designs for Drugs and Medical Devices in a Patent-Constrained Market. UCLA Law Review, Vol. 49, p. 737, 2002, Fordham Law Legal Studies Research Paper No. 101, Available at SSRN:

George W. Conk (Contact Author)

Fordham Law School ( email )

150 West 62nd Street
New York, NY 10023
United States
212-636-7446 (Phone)


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