A woman who received electroconvulsive therapy for depression sued Somatics, LLC, the manufacturer of an FDA-cleared device that delivers electroconvulsive therapy (ECT), aka electric shock treatment, to treat severe major depressive episodes. Before undergoing her treatment, the patient was only warned that ECT could cause short-term memory loss. Unfortunately, her post-treatment symptoms were much more severe. She sued Somatics, LLC, alleging the company failed to warn her physician that the device could also cause “permanent brain damage” and several additional serious brain-related conditions.

Plaintiff Michelle Himes sued Somatics in federal court for negligence, strict liability, and loss of consortium. District Court Judge R. Gary Klausner of the Central District of California granted summary judgment in favor of the defendant. Himes appealed to the Ninth Circuit, which asked the California Supreme Court a certified question about whether a plaintiff is required to “show that a stronger risk warning” would have altered the physician’s decision to prescribe ECT and whether a “prudent person in the patient’s position would have thereafter declined the treatment notwithstanding the physician’s continued recommendation.” In the Ninth Circuit, there was a genuine dispute of material fact as to whether Dr. Raymond Fidaleo would have been alerted to a stronger warning and whether he would have passed along the warning to Himes.”

Prior to receiving ECT, Himes had taken at least nine different antipsychotics and antidepressants for her depression and was hospitalized several times for suicidal ideation and severe depression, but her condition worsened. Fidaleo determined that ECT was “appropriate” and used it on her 26 times. Himes alleged that Fidaleo was never warned by Somatics about the possibilities of “permanent brain damage, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome.”

A unanimous 7-0 decision by the California Supreme Court on June 20 ruled that “A plaintiff may … establish causation by showing that the physician would have communicated a stronger warning...and an objectively prudent person in the patient's position would have declined the treatment notwithstanding the physician’s continued recommendation of the treatment.” The opinion was authored by Justice Joshua P. Groban who explained that the Supreme Court would clarify state law questions about the proper causation standard that must be applied.

Groban’s opinion began with an explanation of the manufacturers’ “duty to warn end users about the hazards inherent in their products.” However, in drug and medical device cases, it is not the end-user patient, but the physician who has that duty. This rule, called the “learned intermediary doctrine,” from the Restatement (Third) of Torts, Products Liability, was created because lawmakers believe that physicians, not patients, are best positioned to understand the risks and benefits of medical devices as well as prescription drugs. In the lower courts, Somatics agreed that Himes could show the ECT caused her injuries and that the company “inadequately informed” Fidaleo about the risk of injury.

Next, the learned intermediary doctrine was further clarified. Groban explained that the doctrine requires manufacturers to warn physicians of any non-negligible risks that are generally unknown to the medical community. He explained that Somatics fulfills its duty by providing adequate warning to the physician. If this does not occur, as Himes argues, she may then sue Somatics asserting negligence for breach of their general duty of care of strict liability for marketing a defective product. The Supreme Court also noted that the “absence of an adequate warning about a prescription drug to a physician” does not “result in a duty to provide a warning to the patient.”

The Justices further clarified Himes’ case, explaining that it would not be decided on the basis of duty, but on causation. The opinion stated, “If a prescription drug or medical device manufacturer has breached its duty under the learned intermediary doctrine to provide an adequate warning (or any warning at all) to the physician, how must the plaintiff prove that the failure to warn caused his or her injury?”

The opinion provided answers. First, it stated that Himes “may establish causation by showing that the doctor would have communicated a stronger warning” to her, and an “objectively prudent person” in her position would have declined the treatment. The “causation analysis” also must consider whether the physician would still have recommended the ECT notwithstanding the stronger warning and whether the patient would have declined treatment regardless of the physician’s that the benefits would still outweigh the risks. It is not to be determined by the “plaintiff’s subjective belief as to what he or she might have done with the benefit of hindsight.” During his deposition, Fidaleo testified that additional warnings “would not have changed his mind.”

Groban then turned to the primary issue in the case: causation. He began with current causation law that is based on the “but-for test.” This test holds that “but for the alleged negligence, the harm would not have happened. Then it asks and answers how Himes could prove that, which could require a jury finding. He also stressed that patients, too, have a role in deciding their treatments.

The Supreme Court concluded that the Ninth Circuit properly adopted the “objectively prudent person in the patient’s position” test. The opinion said that a plaintiff is not required to show that a stronger warning would have altered the doctor’s decision to prescribe ECT, but the plaintiff may instead establish causation by showing Fidaleo could have communicated the stronger warning and an objectively prudent person would thus have declined the treatment regardless of the doctor’s “continued recommendation of the treatment.”