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Washington High Court Refuses to Change Duty to Inform Manufacturers of Drug Risks

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A manufacturer of prescription drugs has fulfilled its legal duty by warning doctors who prescribe the risks of a drug under Washington law, even when the drugs are promoted directly to consumers, the state Supreme Court has ruled.

The ruling may have maintained the status quo, but it addresses a legal challenge that has sought to shift the obligation to inform consumers about side effects to drug manufacturers to keep up with changes in healthcare and increase direct advertising to consumers. .

The U.S. District Court for the Western District of Washington has asked the High Court to decide whether there is an exception for direct advertising to consumers in a learned intermediate case involving a man who suffered a stroke and permanent disabilities after taking medicine for erectile dysfunction Cialis.

“The policies underlying the learned intermediate doctrine remain intact even in the context of direct advertising to consumers,” the court ruling reads. “In addition, the existing state law sufficiently regulates product warnings and advertising for prescription drugs. Accordingly, we consider that, regardless of whether a manufacturer of prescription drugs advertises his products directly to consumers, the manufacturer fulfills his duty to warn a patient when he adequately warns the prescriber of the risks and side effects of the medicine. “

The case is Dearinger et al. v. Eli Lilly. Plaintiff David Dearinger claims in a lawsuit that two hours after taking the prescription drug made by Eli Lilly and Co. to treat hyperplasia, pulmonary arterial hypertension and erectile dysfunction, hemorrhage, which led to a stroke.

The lawsuit was filed in federal court under the Washington Negligence Liability Act and claims that Lilly knew or should have known that Cialis was at risk for a stroke and did not warn users about the risk.

Lilly decided to dismiss the complaint because it provided appropriate warnings to Dearninger’s prescriber in accordance with learned interim doctrine, a policy adopted by most states that places the responsibility for warning patients about the risks of prescription drugs on prescribers.

Dearinger replied that there is an exception to this doctrine for drug manufacturers who advertise to consumers. As no court in Washington has considered this exception, Dearinger has asked the U.S. District Court to certify a question to the high court asking whether state law recognizes such an exception.

The Washington State Association for Justice Foundation filed a amicus curiae document in support of Dearinger, and Pharmaceutical Research and Manufacturers of America and the Washington Defense Trial Lawyers presented documents in support of Lilly.

The case focuses on product liability, which is governed by the Washington Product Liability Act. In its ruling, the court cited two previous applicable decisions from 2017 and 1978 that support the learned intermediate doctrine.

The act makes the manufacturers liable for not providing warnings about a product in case it harms a user, but this obligation to provide warnings to patients in accordance with the learned intermediate doctrine is transferred to the doctor, “who is in a better position to then communicate to the patient “, according to the sentence.

“Courts applying the learned intermediate doctrine have done so without acknowledging an exception,” the ruling reads.

Dearninger was contacted for comments.

A spokesman for Lilly responded to a request for comment by e-mail with the following statement: “Lilly strongly believes that the Court has reached the right decision by rejecting the applicants’ request to recognize an exception to the Washington Intermediate Doctrine. Doctors and other prescribers will continue to play a crucial role and are responsible for ensuring that patients understand the risks and benefits of medicines. ”

Dearinger and other interested parties also argued that the changes to healthcare and the increase in direct advertising to consumers require an exception to the learned intermediate doctrine.

In examining this argument, the High Court referred to the reasoning in state law that physicians exercise independent judgment, patients rely primarily on that judgment, physicians decide what facts should be told to the patient, and it is difficult for drug manufacturers to communicate directly. with the consumer. .

“Through the bill, a doctor must exercise independent judgment in prescribing drugs, and a consumer must rely on this decision to obtain a prescription such as Cialis,” the ruling reads.

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