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Pharmaceutical and medical device manufacturers can’t shift liability for harm caused by their product to the doctor who recommended the product, even if the manufacturer warned the doctor of possible risks, the Supreme Court of California ruled.
The ruling stems from a lawsuit filed by Michelle Himes against Somatics LLC, the manufacturer of an electroshock therapy (ECT) device. Himes sustained a brain injury after her doctor recommended the use of the device.
ECT, also known as electroconvulsive therapy, involves the administration of electricity to the brain.
The ECT device is known to pose a risk of brain damage and permanent memory loss. Himes’ doctor prescribed ECT treatment — and testified that he would have done so even if the manufacturer had warned him of the risk.
Somatics used the “learned intermediary” doctrine to claim the company should be immune from liability for Himes’ injury, based on the doctor’s recommendation and testimony.
Under the doctrine, learned intermediaries, including doctors, are considered qualified to “assess the risks and benefits of treatment,” absolving product manufacturers of the responsibility to provide this information directly to patients.
In a win for patient autonomy, the Supreme Court of California on June 20 unanimously rejected the “learned intermediary” argument.
Bijan Esfandiari, a senior partner with the Wisner Baum law firm who argued the case in California, said in a statement:
“As a result of the California Supreme Court’s Himes decision, moving forward, pharmaceutical and device manufacturers who fail to warn of risks associated with their products can no longer avoid liability by misusing the learned intermediary doctrine.
“Today’s decision in Himes is not only a victory for consumers injured by defective pharmaceuticals and medical devices but is a victory for anyone who champions patient autonomy.”
Mary Holland, CEO of Children’s Health Defense, also welcomed the ruling. She told The Defender:
“I applaud the decision of the California Supreme Court upholding a patient’s right to medical autonomy. In this case, the court held that the device manufacturers could not hide behind the ‘learned intermediary doctrine’ to shield themselves from liability for the brain damage their device caused.
“Along with the Hippocratic oath, ‘First Do No Harm,’ the principle of patient autonomy must be at the foundation of ethical medicine.”
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Big Pharma ‘exploited’ legal loophole ‘for decades’
According to a statement by Wisner Baum, the law firm that represented Himes, Big Pharma “has exploited” this “gap in the law,” known as the learned intermediary doctrine, “for decades.”
Wisner Baum called Thursday’s decision a “landmark ruling.”
Pharmaceutical and device manufacturers have “successfully convinced some courts to dismiss meritorious claims brought by injured patients by arguing the doctor would have prescribed the medication or medical procedure and the autonomy of patients was irrelevant,” the statement noted.
Himes, along with several other plaintiffs who “sustained brain damage, permanent cognitive impairment, and permanent memory loss caused by electroshock therapy,” sued Somatics LLC in the U.S. District Court for the Central District of California in September 2017.
The District Court granted summary judgment for Somatics in May 2021. However, on appeal, the U.S. Court of Appeals for the 9th Circuit sent the case to the Supreme Court of California in April 2022, on the basis that state law, in this case, was unclear in determining legal causation.
In last month’s decision, the court ruled, “The patient’s role in deciding his or her own course of treatment does not disappear in the context of the learned intermediary doctrine. … The learned intermediary doctrine does not ‘allow health care professionals to substitute their judgment for that of their patients.’”
“No one should be able to substitute judgment for a patient,” Holland told The Defender.
“The Supreme Court’s ruling confirms that patient autonomy remains sacrosanct and must be considered in pharmaceutical product liability failure to warn cases,” Wisner Baum said in its statement.
