OLYMPIA, Wash. (Legal Newsline) - Washington state law is clear that drug companies need only provide clear warnings to doctors for prescription medicines, the state’s highest court ruled, rejecting a plaintiff’s argument the rise in direct-to-consumer advertising required a change in the rules.
The learned intermediary doctrine – meaning it is enough to warn physicians about the risks associated with prescription drugs – has been “a fixed part of Washington law” since 1978 and prevails in every other state, the Washington Supreme Court said in a June 2 decision.
David Dearinger and his wife sued Eli Lilly in federal court after he suffered a stroke he blamed on Cialis, an erectile dysfunction drug. Dearinger accused Lilly of failing to adequately inform him of the stroke risk, although the company disclosed the potential side effects in communications with doctors.
Since the lawsuit was based upon the Washington Product Liability Act, the federal court asked the state’s high court to answer whether that law superseded the learned intermediary doctrine and imposed an additional duty on drug companies to adequately warn consumers. The Washington Supreme Court answered with an emphatic no, rejecting several plaintiff arguments including that the WPLA’s statutory language abrogated the learned intermediary doctrine.
The WPLA was passed three years after the Washington Supreme Court decided Terhune v. A.H. Robins establishing the learned intermediary doctrine, the court noted, and it isn’t clear the legislature sought to abrogate that doctrine. The statute mentions warnings but doesn’t say who the warnings must be aimed at, the court continued.
“In short, nothing in the WPLA’s text detracts from our common law embrace of the learned intermediary doctrine,” the court concluded.
The court also rejected arguments public policy requires changes to the learned intermediary doctrine because drug companies increasingly market directly to consumers. Physicians still have an independent duty to prescribe correctly, however, the court said.
“A patient’s active role in managing their health care does not support the conclusion that a physician abdicates their duty to exercise independent judgment,” the court said, rejecting scholarly articles suggesting consumers pressure their doctors to prescribe drugs they saw in advertisements. Those studies were equivocal, the court said, and found that advertising may actually help consumers have a more informed discussion with their doctors.
The Washington State Association for Justice Foundation (WSAJF) filed a brief in support of Dearinger, while the Pharmaceutical Research and Manufacturers of America (PhRMA) and the
Washington Defense Trial Lawyers submitted briefs supporting Lilly. Lawyers for WSAJF and PhRMA also presented oral arguments before the court.