Prescription drug maker Eli Lilly did not err by not directly warning patients about the risks of the drug because it had adequately informed doctors, Washington State Supreme Court announced this week.
The case deals with the question of where drug manufacturers are responsible for direct-to-consumer advertising. Patient David Dearinger and his wife argued that Eli Lilly should be held responsible for bleeding that caused a stroke and permanent disability two hours after taking the erectile dysfunction drug Cialis. But the court disagreed.
“We believe that whether or not prescription drug manufacturers advertise their products directly to consumers, manufacturers have fulfilled their duty to warn patients when they adequately warned prescribing physicians of the risks and side effects of the drug,” Judge Susan Owens said in a statement on behalf of the Washington State Supreme Court. court.
The case raises the question of the learned mediation doctrine, which Statement that it is the responsibility of the manufacturer of a drug or device to warn the doctor, not the patient, and was implemented in 1978. The U.S. District Court for the Western District of Washington asked the state Supreme Court through certified questions whether the court recognized an exception to the principle when drug manufacturers advertise directly to consumers.
Andrew Tauber, a renowned product liability attorney at Winston & Strawn who has written on the learned intermediary principle, said he would be surprised if the court ruled the other way, since every state has adopted the learned intermediary principle in some iterations. He said only one state has ruled an exception to the learned mediation doctrine, New Jersey in a 1999 case. Therefore, the court’s decision in this case maintains the status quo.
“Drug manufacturers cannot provide warnings to patients because the warnings must be adjusted based on the patient’s current medical condition and medical history,” Tauber said. “The fact that drug manufacturers may advertise directly to patients does not mean that patients can go out and buy these products.”
According to the opinion, Dearinger sued Eli Lilly under the Washington Product Liability Act for negligent design, negligent warning and breach of warranty.
The Washington State Judicial Association Foundation filed a brief in support of Dillinger, while U.S. Drug Research and Manufacturers and Washington Defense Trial Lawyers filed a brief in support of Eli Lilly.
The opinion said the court rejected the exception to the learned intermediary doctrine on the grounds that “policies supporting the learned intermediary doctrine still apply today” and that “state law adequately regulates product warnings and prescription drug advertising.”
A judge wrote a concurring opinion that included rejecting part of the majority opinion. Most ruled that a doctor’s knowledge was required to understand a drug manufacturer’s warning. But Judge Sheryl Gordon McCloud said the surge in health websites for patients seeking information on prescription drugs showed patients were not relying on doctors to learn about side effects.
“I cannot agree with the unsupported assumption that all physicians ‘understand…complex information’ better than all patients. I cannot agree with the consequences of this assumption, which is that it is better to hide it from patients Complex information about their own health is not disclosed to them in a common-sense, understandable way,” Justice Gordon MacLeod wrote.
An Eli Lilly spokesman said in an emailed statement: “Lilly strongly believes that by dismissing plaintiffs Washington. Physicians and other prescribers will continue to play a key role and be responsible for ensuring that patients understand the risks and benefits of medicines. “
Still, she supports the majority view that the learned mediation doctrine is no exception.
Dillinger, who represents himself, did not immediately respond to a request for comment.
the case is 99956-2 in the Washington State Supreme Court.
