Prescription drug maker Eli Lilly did not err when it didn’t directly warn a patient of a drug’s risks because it had adequately informed the physician, the Washington state supreme court announced this week.
The case involved the question of where responsibility lies when drug manufacturers advertise directly to consumers. Patient David Dearinger and his wife argued that Eli Lilly should be held responsible after he suffered a hemorrhage that led to a stroke that caused him permanent disabilities two hours after taking erectile dysfunction drug Cialis. But the court disagreed.
“We hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects,” Justice Susan Owens wrote in the opinion on behalf of the Washington state supreme court.
The case brings up the issue of the learned intermediary doctrine, which states that a drug or device manufacturer has a duty to warn the physician rather than the patient and was put in place in 1978. The Western District of Washington Court asked the state supreme court via certified question whether the court recognizes an exception to this doctrine when the drug manufacturer directly advertises to consumers.
Renowned product liability attorney Andrew Tauber of Winston & Strawn has written on the topic of the learned intermediary doctrine and said he would have been surprised if the court had ruled the other way because every state has adopted the learned intermediary doctrine in some iteration. He said that only one state has ruled that there is an exception to the learned intermediary doctrine, and that was New Jersey in a case in 1999. Therefore, the court’s ruling in this case maintains the status quo.
“The drug manufacturers are not in a position to provide relevant warnings to a patient because relevant warnings have to be tailored to a patient’s current medical condition and history,” Tauber said. “The fact a drug manufacturer might advertise directly to patients doesn’t mean patients can go out to buy those products.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Dearinger brought the case against Eli Lilly under the Washington product’s liability act for negligent design, negligent failure to warn, and breach of warranty, according to the opinion.
The Washington State Association for Justice Foundation filed a brief in support of Dearinger, while the Pharmaceutical Research and Manufacturers of America and the Washington Defense Trial Lawyers submitted briefs supporting Lilly.
The court rejected an exception to the learned intermediary doctrine based on the grounds that “the policies underpinning the learned intermediary doctrine remain true today,” and “state law sufficiently regulates product warnings and prescription drug advertising,” according to the opinion.
One justice wrote a concurring opinion that included a rejection of part of the majority opinion. The majority had ruled that it takes a physician’s knowledge to understand a drug manufacturers’ warnings. But Justice Sheryl Gordon McCloud said the explosion of health websites for patients seeking information on prescription drugs shows that patients do not rely on a physician to understand the side effects.
“I cannot agree with the majority’s unsupported assumptions that all physicians ‘comprehend … complex information’ better than all patients. And I cannot agree with the consequence of that assumption, that is, that it is better to withhold complex information from patients about their own medical condition than to reveal it to them in a commonsense, understandable way,” Justice Gordon McCloud wrote.
A spokesperson for Eli Lilly said in an emailed statement, “Lilly strongly believes the Court arrived at the correct decision by rejecting the plaintiffs’ request to recognize an exception to the learned intermediary doctrine in Washington. Physicians and other prescribers will continue to play a crucial role in and are responsible for ensuring that patients understand the risks and benefits of medications.”
Despite this point, she supported the majority that there is no exception to the learned intermediary doctrine.
Dearinger, who represented himself, did not immediately respond to request for comment.
The case is 99956-2 in the Supreme Court of the state of Washington.
