Liability doctrines

The plaintiffs are not claiming that the patent is invalid. Rather, relying on theories implicit in Moore, they seek to use informed consent liability doctrines to ensure low-cost genetic screening and testing for Canavan disease. The lawsuit is based on what I will call a breach of covenant, not a breach of promise. The term breach of covenant is appropriate, despite the contractual view in some of the literature (Schuck, 1994), because the relationship between the parties was not contractual. Breach of promise implies that their agreement was contractual in nature, which creates doctrinal problems (Palmer, 1989). 

A recently filed case in Pennsylvania illustrates a possible new face for liability (Cassidy v. SmithKline Beecham, 1999). The plaintiff claims that the manufacturer of a vaccine for Lyme disease should have warned physicians and patients in its advertisements that 30% of the population ran the risk of developing "treatment-resistant Lyme arthritis" because their particular genotype interacted adversely with the vaccine. This duty to warn is based not in product liability doctrine, but on negligence. 

At first blush, the increased risk of harm suit against a drug manufacturer on a negligence theory that pharmacogenomics could have been used to determine the increased risks to a portion of the population appears to be a logical extension of the doctrinal shifts in liability law signaled by Moore. The likelihood of success of this particular lawsuit is in fact small because of the nature of existing medical liability doctrine in Pennsylvania. 

Although drug manufacturer liability under a theory of design defect products tort was relatively easy to prove, especially in courts adopting the Barker risks benefits test, some DES plaintiffs were barred from recovery by limitations placed on the unborn plaintiff liability doctrine that originated with the thalidomide cases. While thalidomide s teratogenicity affected only fetuses exposed... 

The business community s efforts to roll back Public Interest Era products liability doctrines had a noticeable impact on the substance of tort law. The notion that the primary function of tort law was to increase the efficiency of product markets was foreign to legal scholars prior to the advent of the law... 

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