APA Amicus Cites Safety, Effectiveness of ECT in California Supreme Court Case
Abstract
The amicus was filed in the case Michelle Himes v. Somatics LLC to provide accurate information about the use of electroconvulsive therapy and refute inaccuracies in the plaintiff’s complaint against the manufacturer.
A large body of scientific evidence demonstrates that electroconvulsive therapy (ECT) is a safe and effective treatment for certain serious mental illnesses and can be lifesaving, according to an amicus curiae brief filed by APA with the California State Supreme Court.
The amicus was filed in the case Michelle Himes v. Somatics LLC in support of neither party but to provide accurate information about the use of electroconvulsive therapy. Somatics LLC, a manufacturer of ECT devices, is being sued by the plaintiff for injuries allegedly sustained from ECT treatment, including an allegation that Somatics failed to provide adequate warning.
A Supreme Court ruling is expected early this year.
The 9th Circuit Court of Appeals sent the following question to the California Supreme Court: Is a plaintiff required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product? Or can a plaintiff establish causation by showing that the physician would have communicated the stronger risk warning to the plaintiff and a prudent person in the patient’s position would have declined the treatment?
“We want the court to understand that ECT is an effective and even life-saving treatment for people with severe depression, mania, and/or psychosis that doesn’t respond to other treatments,” says Reena Kapoor, M.D.
Reena Kapoor, M.D., chair of the APA Committee on Judicial Action, said APA’s interest in the case is ensuring that the court makes its decision on the basis of accurate information about the risks and benefits of ECT. “The plaintiffs, in their filing, had asserted things about ECT that we consider to be inaccurate and fear mongering. We want the court to understand that ECT is an effective and even lifesaving treatment for people with severe depression, mania, and/or psychosis that doesn’t respond to other treatments.”
The brief outlined four key arguments in support of the validity of ECT as a treatment:
Scientific evidence demonstrates that ECT can be an effective treatment, particularly when other treatments fail. The efficacy of ECT has been documented in a substantial body of research going back to the 1940s. Notably, the Food and Drug Administration (FDA) has determined that there is sufficient evidence for the safety and effectiveness of ECT for treatment of major depressive episodes and catatonia for individuals aged 13 and older. ECT also shows particular efficacy in individuals with severe depression that is accompanied by psychosis. Additionally, ECT can be fast acting as compared with treatment with medication; it is common for symptoms of major depression to improve significantly after only a few ECT treatments.
Patients and physicians must weigh potential side effects of ECT—including cognitive side effects—against treatment benefits. A clinician’s decision to recommend ECT is always based on a risk/benefit analysis. As part of that calculus, the risks of ECT treatment are weighed against the benefits of ECT treatment not only relative to non-treatment but also relative to other available treatments, including medications.
In this regard, when ECT is prescribed, it is generally when a rapid response is needed due to severe symptoms or when other treatment options have failed, often repeatedly. Serious adverse events—including severe cardiovascular and pulmonary complications or death—are rare. Longitudinal studies have shown that mortality rates following hospitalization are lower among depressed patients treated with ECT than among patients who received other treatments, or who received no treatment at all.
Ethical and legal standards require obtaining patients’ informed consent before administering ECT. Clinicians are trained to respect patient autonomy and the principle of informed consent. As with any medical procedure (especially one that includes general anesthesia), informed consent is required before ECT is administered. Clinicians make a recommendation for ECT based on an overall assessment of risks and benefits, informed by education, training, and clinical expertise. Ultimately, however, the judgment about whether to undergo ECT is made by the patient or the patient’s authorized legal representative.
Portrayal of ECT as cruel or inhumane is inconsistent with modern ECT practice. Early, now-outdated ECT techniques and practices, along with media portrayals, contribute to a stigma around ECT despite modern advances in its application. ECT as practiced in the 1930s to the 1950s bears little resemblance to modern practice. For example, while ECT was frequently administered without anesthesia when it was first introduced, the use of anesthesia has now been common for decades. Today, ECT is administered using general anesthesia, precisely controlled electrical stimulation, and physiological monitoring (including monitoring of seizure, blood pressure, electrocardiograms, and oxygenation) to achieve the greatest benefits with the least possible risk. Major technical advances have also occurred in instrumentation, with the present generation of ECT devices incorporating decades of research and refinements.
The amicus brief concludes: “Overall, improvements and innovations in ECT techniques have contributed to a growing acceptance of ECT by both practitioners and patients. … Epidemiological evidence of favorable patient outcomes supports the use of ECT, with informed consent, in the treatment of serious psychiatric disorders.” ■
