N.J. court finds exception to learned intermediary doctrine.

In a victory for plaintiffs, the New Jersey Supreme Court has found that manufacturers of the Norplant contraceptive implant system must make warnings of potentially dangerous side effects clear to consumers, not just to doctors.

In a 5-2 ruling, the high court barred defendant Wyeth Laboratories from invoking the learned intermediary doctrine in lawsuits brought by 50 Norplant users in New Jersey. The plaintiffs claimed the manufacturer failed to adequately warn them of side effects, such as nausea, weight gain, headaches, dizziness, irregular menstruation, mood swings and depression, high blood pressure, and complications associated with removing the device. (Perez v. Wyeth Laboratories, Inc., No. A-16-98, 1999 WL 591438 (N.J. Aug. 9, 1999).)

The learned intermediary doctrine holds that when a drug maker properly warns a prescribing physician of the dangerous risks of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the consumer.

But the court found that modern marketing methods have diluted the physician's intermediary role. "Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines," wrote Justice Daniel O'Hern. "A pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product."

The New Jersey decision is especially significant because it is the first high-level court opinion in the country to create an exception to the learned intermediary doctrine as it relates to so-called direct-to-consumer advertising of prescription drugs, said Richard Galex, an East Brunswick, New Jersey, lawyer who represented the Perez plaintiffs.

Although the decision resolved the learned intermediary issue, the high court remanded the case, leaving it to the trial court to decide the question of liability. The women still must prove they relied on Wyeth's massive advertising campaign in deciding whether to use the long-term birth control system.

The learned intermediary portion of the holding is binding only in New Jersey, but it may have a significant impact on warnings for other types of drugs because many pharmaceutical companies are based in the state, Galex said.

"New Jersey is a major capital for the drug industry," he said, adding the decision will also have a tremendous effect nationwide "if other courts accept the New Jersey court's reasoning."

Mark Hutton, a Wichita, Kansas, plaintiff attorney who has handled several Norplant cases, characterized the decision as "probably the beginning of the break in the dam" that until now has blocked plaintiffs from holding Wyeth liable for failure to adequately warn users in its massive advertising campaign for Norplant.

The ruling is at odds with a Fifth Circuit decision issued earlier this year that allowed Wyeth to use the doctrine to turn back similar failure-to-warn claims by five Norplant users in Texas. (In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374 (5th Cir. 1999);Norplant Maker Has No Duty to Warn About Side Effects, TRIAL, May 1999, at 97.)

The New Jersey Supreme Court majority offered a concise history of the drug industry's shift toward marketing and advertising its products directly to consumers rather than to doctors, noting that current "medical-legal jurisprudence is based on images of health care that no longer exist."

Hutton said, "Twenty years ago, you never saw [direct-to-consumer] advertisements [from drug manufacturers]. The New Jersey court is changing with the times. It will probably take more and more state supreme court rulings before all courts catch up."