SIDE EFFECTS: NJ Court Says Drugmakers Must Give Warning
In a decision that has far reaching implications for drug manufacturers, the New Jersey Supreme Court ruled 5-2 yesterday that Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. and the makers of Norplant, could be sued for failing to disclose the drug's potential side effects to consumers as part of its direct marketing campaign. The court stated that a "pharmaceutical manufacturer that makes direct claims to the consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings," the AP/Philadelphia Inquirer reports. The ruling stems from issues surrounding the pending class-action lawsuit filed by 50,000 women who allege that Wyeth-Ayerst "failed to warn Norplant users adequately" of a number of side effects, including headaches, weight gain, depression and ovarian cysts, as part of its early 1990s ad campaign in women's magazines (Martello/Shaw, AP/Philadelphia Inquirer, 8/10). The company maintained that since Norplant must be inserted by a doctor, the doctor was responsible for relaying that message to patients. However, the Bergen Record reports that the ruling "reverses a widely held legal doctrine that placed the burden of informing patients largely on physicians" (Shook, Bergen Record, 8/10). The court asserted that the "new landscape of health care -- in which doctors working for managed care companies often spend little time with patients, and manufacturers advertise their drugs directly to consumers on radio, television and the Internet -- requires a new legal approach" (Yaffe, East Brunswick Home News Tribune, 8/10).
Consider Yourself Looped
"Up until today, it used to be the law in the majority of jurisdictions, including New Jersey, that if the drug manufacturer provided information to the doctor, they were pretty much out of the loop in terms of ultimate liability," said Richard Galex, an attorney for five New Jersey women in the suit. He added, "Today, the drug companies are spending billions to advertise directly to the public. ... It's created a shift in the relationship between drug companies and the patient." Jay Spievack, a product liability lawyer in New York, said, "This is a shocking departure from a well-established doctrine. This opinion says, if you, the manufacturer, advertise drugs that go to the consumer, you can be liable if the consumer watches your ads but doesn't really understand the warnings." In a statement yesterday, Wyeth-Ayerst said that the ruling "addresses an abstract issue unrelated to the Norplant system or the Norplant litigation," and said it would push for a dismissal of the suit (Bergen Record, 8/10).