Direct-to-consumer advertising modifies the "learned intermediary" doctrine, the New Jersey Supreme Court declared in an Aug. 9 ruling concerning Wyeth-Ayerst's promotion of its contraceptive Norplant.

"Direct advertising of drugs to consumers alters the calculus of the learned intermediary," the court said. The learned intermediary doctrine "does not apply to the direct marketing of drugs to consumers."

The doctrine, which generally relieves drug manufacturers of a duty to warn consumers about drug risks as long as physicians receive adequate information, "does not confer on pharmaceutical manufacturers a license to mislead or deceive consumers when those manufacturers elect to exercise their right to advertise their products directly to consumers," the court said.

The litigation stems from the allegations of five plaintiffs that Wyeth failed to adequately warn consumers about the side effects of Norplant (levonorgestrel implants) in a 1991 print ad campaign.

The Norplant case marks the first time that the learned intermediary doctrine, a common defense adopted by the pharmaceutical industry in liability cases, has been undermined as a direct result of DTC advertising.

"In the case of DTC marketing of drugs, patients deprived of reliable medication information [are allowed] to establish that the misinformation was a substantial factor contributing to their use of a defective pharmaceutical product," the court ruled.

Recognizing FDA's authority to regulate drug ads, the court provided that if DTC ads targeted in litigation complied with FDA's advertising requirements, a "rebuttable presumption" would apply. In that case, advertising that complied with FDA would be assumed to contain adequate warning and the burden of proof to demonstrate otherwise would fall to plaintiffs.

Regulatory letters from FDA's ad division reporting inadequate risk disclosure could serve as fodder in plaintiffs' cases to prove inadequate warning.

Although the decision by the state court applies only to New Jersey, FDA's ad division could see an influx of ads submitted for comment and pre-clearance.

Pre-clearance does not necessarily guarantee the agency will not find the ads problematic at a later date. Glaxo has reported that FDA "changed its mind" about DTC campaigns for two Glaxo products (¹ Also see "Broadcast Ad Preclearance Discussions Wanted By Networks -- Glaxo Exec" - Pink Sheet, 23 February, 1998.).

The implications of the decision depend to some extent on the readiness of other courts to dismiss the learned intermediary doctrine in similar cases. In related litigation, the Fifth Circuit Court in Texas recently held that under Texas law, the learned intermediary doctrine did apply in the context of Norplant.

The N.J. Supreme Court's 5-2 decision overturns trial and appellate court rulings: summary judgement requests from plaintiffs were initially dismissed based on the learned intermediary doctrine. While common-law in most states, the learned intermediary doctrine is a statutory rule in New Jersey.

"Although the statute provides a physician-based standard for determining the adequacy of the warning due to a physician," the decision argued, "the statute does not legislate the boundaries of the doctrine."

Pharmaceutical companies "may seek contribution, indemnity or exoneration because of the physician's deficient role in prescribing that drug," the court provided, finding that in the case of DTC marketing neither the physician nor the drug company should be entirely relieved of their respective duties to warn.

The Supreme Court returned the case to trial court for further proceedings. "The issue on remand will be whether, on a summary judgement motion, there is sufficient evidence for a reasonable jury to determine ...that the absence of information or presence of misinformation in Norplant advertising was in violation of FDA requirements and whether such violations, if any, were a substantial factor in bringing about the harm suffered," the court wrote.

The plaintiff's case could potentially stumble on the fact that none of the women in the suit claim to have been exposed to the Norplant DTC ads.

Wyeth "expects to move promptly for dismissal," maintaining that the Norplant ads "complied fully with FDA guidelines, they were submitted and cleared by the FDA, and they are accurate and fair."

DTC Ads Fall Outside "Learned Intermediary" Protections, N.J. Court Rules

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