In a landmark decision, California’s highest court ruled that patients may sue medical device makers for insufficient risk warnings, even if their doctors would have still recommended the device. The unanimous ruling came from the California Supreme Court on Thursday, reviving Michelle Himes’ lawsuit against Somatics, the manufacturer of an electroshock therapy device that she claims caused her brain damage while treating her severe depression.
Previously, U.S. District Judge R. Gary Klausner dismissed Himes’ lawsuit under the “learned intermediary” doctrine. This legal principle, adopted by nearly all states, states that drug and device makers must warn doctors about their products’ risks, who then inform their patients. Klausner ruled that since Himes’ doctor would have recommended the device regardless of a stronger warning, the lack of warning didn’t cause her injury.
Himes contended that she would have refused the treatment if a more explicit warning had been provided, prompting the 9th U.S. Circuit Court of Appeals to seek clarification from the California Supreme Court. Justice Joshua Groban, writing for the court, stated that the learned intermediary doctrine also acknowledges “patient autonomy,” emphasizing the importance of informed consent in medical decisions.
Groban argued that if a physician’s recommendation were the sole determinant, disregarding the patient’s informed decision, the principle of informed consent would be undermined. He clarified that patients must demonstrate that a “reasonably prudent person in the patient’s position” would have refused the treatment despite the doctor’s advice.
Bijan Esfandiari, representing Himes, hailed the ruling as a significant victory for consumer rights and patient autonomy. However, a representative for Somatics did not comment immediately.
The decision has significant implications for the pharmaceutical industry. The Pharmaceutical Research and Manufacturers of America (PhRMA) warned in an amicus brief that this ruling might prompt manufacturers to overwhelm patients with extensive, detailed warnings, potentially deterring them from the best treatments.
The case, Himes v. Somatics LLC, Supreme Court of California, No. S273887, will be closely watched as it progresses, potentially reshaping the landscape of patient consent and manufacturer liability.
