Product liability hovers over pharmaceuticals

Re “Whose Vioxx is gored?” Opinion, Aug. 28

Michael Kinsley’s article about Vioxx, while clever, misstates the laws governing negligence and product liability. If a person, as Kinsley suggests, cuts up and eats a beach ball, the resulting “dire consequences” are not, nor should they be, compensable under existing law because eating a beach ball is not the intended use for the product, and the manufacturer has no duty to warn against such an unanticipated event. Except for cigarettes, which cause injury and death when used in the manner intended by the manufacturer, most products, when so used, are required to be relatively safe.

Pharmaceutical manufacturers are required to include warnings in their labeling, informing the physician, the pharmacist and the patient about potential side effects. The physician and pharmacist have a commensurate duty to communicate the most serious side effects to the patient. The patient may then make an informed decision as to whether the benefit of using the drug outweighs the potential burden.

But when a manufacturer fails to make full disclosure about potential serious side effects, even when discovered after Food and Drug Administration approval, it has breached its duty to warn. Only time will tell whether Merck has breached its duty and whether its advertised policy of placing the patient first is just an empty slogan.

HERBERT WEINBERG

Pharmacist and attorney

Marina del Rey

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Kinsley’s article makes for provocative copy and fuels the tort reform debate. However, the piece makes no constructive contribution to a critical question: How can the United States best facilitate the marketing of prescription drugs that save lives and remedy pain economically and with minimal risk?

CARL TOBIAS

Professor of law

University of Richmond, Va.