NJ ruling increases liability

The New Jersey Supreme Court ruling in Saray Perez, et al, versus Wyeth Laboratories, Inc. et al, was a central topic at the February 29 Drug Information Association workshop Marketing Pharmaceuticals in the New Millenium. The new judgment sends a strong warning to pharmaceutical marketers who are tempted to downplay a medicine's side effects in mass marketing.

The court justices reversed an Appellate Division judgment with a 5-2 vote. They ruled that consumers could sue the Norplant manufacturer for failure to adequately communicate side effects in its mass marketing campaign. The decision hinged on the "learned intermediary" concept and the role of direct-toconsumer advertising.

The court explained that the role of a physician as "learned intermediary" doesn't grant pharma companies a license to mislead or deceive consumers in advertisements. It is insufficient for a pharmaceutical company to simply provide a doctor with information about side effects if the company televises commercials that fail to warn of product dangers.

"Our medical-legal jurisprudence is based on images of health care that no longer exist," writes Justice Daniel O'Hern, author of the court's decision. The decision describes a world changed by managed care and DTC advertising-a world in which a physician's opinion no longer dominates.

The dissenting opinion, written by Justice Stewart Pollack, says "on the facts, moreover, Norplant is a poor vehicle to import so momentous a change." Norplant is not available in supermarkets or over the Internet. It is not promoted by health maintenance organizations and can only be obtained by prescription and is surgically implanted. Therefore, it requires significant involvement of the health care provider.

Due to the ruling; more than 50 cases against Wyeth-Ayerst Laboratories will return to Middlesex County Superior Court, where New Jersey Norplant cases are consolidated. Company attorneys had previously argued for dismissal in the lower courts under the Products Liability Act.

Companies may seek more FDA preclearance to reduce their liability for ITC campaigns. However, the FDA doesn't generally approve DTC ads, according to workshop speaker Lou Morris. Furthermore, consulting with the FDA is not a guarantee-the NJ Supreme Court is in the process of deciding whether such preclearance exempts manufacturers from tort liability.