Court concluded that company’s failure to fully disclose risks of electroshock to a physician meant that the patient also did not know the risks before undergoing the procedure, which resulted in brain damage. Citizens Commission on Human Rights warns device has never been proven safe.
by CCHR National Affairs Office
The California Supreme Court has issued a decision in a product liability case involving an electroshock machine which establishes that patients must receive adequate disclosure of the risks of the device prior to treatment. Citizens Commission on Human Rights (CCHR) says electroshock has never been proven safe and has known risks that include brain damage and permanent memory loss.
The lawsuit at issue concerned Somatics LLC, manufacturer of a device used by psychiatrists to deliver electroconvulsive therapy (ECT, or electroshock) to patients who may be experiencing deep depression. The electroshock machine sends a strong electrical current through brain tissue that causes convulsions, a procedure used as treatment even though it is not known how electroshock is supposed to work. Somatics was sued by a woman who had sustained brain damage from ECT treatment.
According to Wisner Baum, the law firm representing the plaintiff, Somatics “did not dispute in the lower court that its electroshock therapy (ECT) device can cause brain damage and permanent memory loss; did not dispute it failed to warn doctors of the risk of brain damage and permanent memory loss; and did not dispute that plaintiff…sustained brain injury.”
Somatics relied for its defense on legal precedent which had established that device manufacturers have a duty to warn physicians of the risks associated with their products but need not warn the patient of those risks. The company presented testimony that even if it had given the physician a stronger warning, the physician still would have recommended electroshock to his patient.
However, in its ruling, California’s highest court wrote that a patient’s expectations about the effects of a medical device are based on what their physicians tell them, and without adequate disclosure of risks to the physician, the physician could not give adequate disclosure to the patient. The court concluded that patients could prevail in establishing product liability “by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment,” even if the doctor continued to recommend the treatment.
“This California ruling is a win for patients who have a right to know the full extent of the potential damage from electroshock,” said Anne Goedeke, president of the CCHR National Affairs Office. “Patients should be informed that electroshock has never been proven safe or effective.”
Patients undergoing electroshock – mostly women and the elderly, but even young children – are often not being given enough information about the serious risks and lack of effectiveness of the procedure, according to professor of psychology John Read, Ph.D., who conducted an audit of patient information pamphlets.
He found that pertinent information about risks was omitted, such as the cardiovascular risks, the risk of death, the lack of evidence of long-term benefits, and the fact that it is not known how ECT is supposed to work. “The minimisation of risks is not uncommon in ECT practice and research,” Read said.
Read disputes claims that electroshock is highly effective, writing that no proof of that exists. “There have…been no placebo-controlled studies of ECT for depression since 1985, and all 11 studies prior to that date were very small, severely flawed and conducted on adults,” he wrote, adding, “There have been no placebo-controlled studies on children or adolescents.”
The U.S. Food and Drug Administration (FDA) requires ECT machines to have signs next to them stating, “The long-term safety and effectiveness of ECT treatment has not been demonstrated,” Read observed.
The Citizens Commission on Human Rights advocates a total ban of electroshock. More than 135,000 people have signed CCHR’s online petition to ban ECT.