California’s highest court ruled that a patient can pursue a claim against a drug or medical device maker for failing to warn of a product’s risks, even if the warning would not have stopped the patient’s doctor from recommending it. In a unanimous opinion by Justice Joshua Groban on Thursday, the California Supreme Court revived a lawsuit against Somatics, the maker of an electroshock therapy device, brought by a woman who claimed she suffered brain damage after using it to treat her severe depression.
U.S. District Judge R. Gary Klausner in Los Angeles had previously ruled against plaintiff Michelle Himes’ lawsuit under the “learned intermediary” doctrine. This doctrine, adopted by courts in almost all states, states that the duty of drug and device makers to warn about product risks is to doctors, not patients, who then pass on these warnings to their patients. Himes’ doctor testified that he would have recommended the device even with a stronger warning, leading Klausner to conclude that the lack of a warning could not have caused Himes’ injury.
Himes appealed to the 9th U.S. Circuit Court of Appeals, arguing that she would have refused the treatment if the device had a stronger warning, despite her doctor’s recommendation. The 9th Circuit asked the California Supreme Court to decide whether this argument could succeed under California law.
Justice Groban wrote that it could, acknowledging the “learned intermediary” doctrine’s recognition of “patient autonomy” and noting that medical decisions involve both a doctor’s recommendation and a patient’s informed consent. He argued that if the physician’s prescribing decision was the only factor, disregarding the patient’s informed consent, the informed consent rule would be unnecessary.
However, Groban stipulated that a patient cannot merely claim they would have refused treatment despite a doctor’s recommendation, as such a “subjective” standard would be “prone to hindsight bias.” Instead, he stated that a patient must prove that an “objectively prudent person in the patient’s position” would have refused the treatment despite the doctor’s recommendation.
Himes’ attorney, Bijan Esfandiari of Wisner Baum, hailed the ruling as a victory for consumers injured by defective pharmaceuticals and medical devices and for those championing patient autonomy. A lawyer for Somatics did not immediately respond to a request for comment.
The drug industry closely monitored the case, with Pharmaceutical Research and Manufacturers of America (PhRMA) arguing in an amicus brief that a ruling for Himes could prompt manufacturers to shield themselves from liability by directing physicians to inundate patients with exhaustive, untailored warnings about every conceivable risk, potentially discouraging patients from pursuing the best treatments.
