JurisdictionUnited States

When a person has been injured by a vaccine (and not merely by errors in needle administration), that person may expect to have a claim based on one or more theories of product liability law. If there were not the exclusive remedy of the federal vaccine compensation system, discussed in later chapters, the pursuit of a vaccine case would be framed within state product liability law boundaries.

Unfortunately, the various theories of product liability (e.g., negligence, strict liability, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, breach of express warranty, and/or misrepresentation) are not uniformly observed from state to state. For example, in Oregon, by statute there is only one product liability cause of action.1 In Indiana, breach of implied warranty in tort was subsumed by that state's adoption of Section 402A of the Restatement (Second) of Torts.2 New York, on the other hand, recognizes the theories of strict product liability, negligence, breach of express warranty, and breach of implied warranty.3

Further complicating the issue is that states have varying statutes of limitations, statutes of repose, and/or may provide immunity for certain defendants. Such dramatic variances make generalizations about products liability law difficult, which is why there are multiple books dedicated to the subject.4 The following, therefore, is a general overview of product liability claims for the purpose of understanding the differences between the tort system and the vaccine statutory compensation program.

As with all product liability law, there has been significant variation in the adoption of the Restatement across the states. For example, Kansas has adopted the rule of strict liability as set forth in Section 402A of the Restatement (Second) of Torts.5 California, on the other hand, rejects Section 402A's requirement that plaintiff prove that a product's defect was "unreasonably dangerous."6 Further, some states do not recognize strict liability in some or all circumstances.7

In states that recognize some form of strict liability, the plaintiff must prove that the product was "defective."8 Although what constitutes a "defective" product varies by state, three types of defects are typically recognized: design defect, manufacturing defect, and failure to warn.

A design defect claim alleges that there is something wrong with how the product was designed, such that all products of that design are defective. In contrast, in defective manufacturing claims, the design of the product is not the problem, but rather something occurred during the product's manufacture that rendered a particular product defective. In failure to warn cases, the allegation is that the product came with inadequate warnings of its danger, rendering it defective.

Negligence claims can also be raised. In jurisdictions whose product liability statutes have not subsumed other product liability theories, negligence may be a viable cause of action. Negligence in the products liability setting is comprised of the same familiar elements (duty, breach, causation, and harm). However, they are typically classified by the type of defect the negligence allegedly caused: design defect, manufacturing defect, and failure to warn. Although these types of defects are conceptually the same as in the...

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