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Changing times for the learned intermediary defense.

Article Excerpt
For the past nine years I have devoted the bulk of my time to litigating wrongful death cases against pharmaceutical companies. My typical case involves a suicide induced by Prozac, Zoloft, Paxil, or one of their cousin selective serotonin reuptake inhibitor(SSRI) drugs. One of the most common defenses that manufacturers invoke is the "learned intermediary" doctrine.

The courts have produced voluminous case law on the doctrine, including a few plaintiff-friendly decisions that have either recognized exceptions to the rule or limited when and how it is applied. But several questions remain unanswered, and lawyers who represent people injured by defective drugs must seek opportunities to confine this defense to its proper role.

Although the learned intermediary rule appears in neither the text nor the comments of the Restatement (Second) of Torts, almost every state has adopted a version of it--usually as a matter of common law--while interpreting and applying [section] 402A. (1)

When the American Law Institute promulgated the Restatement (Third) of Torts: Products Liability in 1997, the doctrine was elevated to "black letter" status in [section] 6, which provides that "a prescription drug or medical device is not reasonably safe ... if risks of harm are not provided to ... prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." In June, the Kentucky Supreme Court, in Larkin v. Pfizer Inc., became the country's first court of last resort to adopt this version of the learned intermediary doctrine. (2)

As the Larkin court acknowledged, the principal rationale supporting this defense is that because these products are available to the consumer only by prescription from a "learned intermediary," the manufacturer's common law duty to warn should extend only to the intermediary, who is responsible for weighing the risks and benefits of the drug as declared in the manufacturer's package insert.

Although this understanding of the doctrine has some surface appeal, it...

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