Metropolitan News-Enterprise


Monday, April 4, 2022


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Ninth Circuit Queries State High Court About Duty to Warn in Medical Products Cases


By a MetNews Staff Writer


The Ninth U.S. Circuit Court of Appeals declared Friday that needs help from the California Supreme Court in deciding whether a woman who underwent psychiatric treatment entailing electrical shocks to the brain, and allegedly suffered harms, has a viable claim against the maker of the device that was used in the treatments for failing to provide adequate warnings as to dangers.

A three-judge panel—comprised of Circuit Judges Sandra S. Ikuta, Kenneth K. Lee, and Danielle J. Forrest— said in a memorandum opinion that while summary judgment was properly granted by U.S. District Court Judge R. Gary Klausner in favor of defendant Somatics, LLC, a Florida company, in an action by plaintiffs Marcia Benjamin, and Daniel Benjamin, it’s unclear whether plaintiff Michelle Himes should have a day in court.

 Marcia Benjamin’s doctor, Michael Frankel, had admitted that he customarily did not “pay terribly much attention “to literature from manufacturers with safety warnings, the judges noted, while Himes’s doctor said he does read such material. Stronger warnings from Somatics could not have made a difference with respect to the Benjamins, the panel said, affirming the judgment as to them.

Evidence in Record

“For Himes’s claims, we conclude that evidence in the record shows that Himes’s treating physician. Dr. Raymond Fidaleo, would have learned about stronger warnings and passed them along to Himes, but there is no evidence that these warnings would have altered his prescribing conduct.”

The opinion explains:

“The resolution of this appeal turns on the proper causation standard applied to Himes’s claim. If the district court and Somatics are correct that in failure-to-warn claims, a plaintiff must show that stronger manufacturer warnings would have altered the physician’s prescribing conduct, Himes’s claims fail. If, on the other hand, a plaintiff can establish causation by showing that a physician would have communicated the stronger warning to the patient and that a prudent person in the patient’s position would have declined the treatment after receiving the stronger warning, Himes’s claims survive summary judgment.”

But, the judges noted, there is no California precedent on the burden of proof.

Ninth Circuit’s Question

In its certification order, the panel queried:

“Under California law, in a claim against a manufacturer of a medical product for a failure to warn of a risk, is the plaintiff required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger risk warnings to the plaintiff, either in their patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning?”

Himes was among the plaintiffs who brought a putative class action against Somatics based on various alleged ill effects from electroconvulsive therapy (“ECT”) using the defendant’s devices. The harms were said to include “skin burns, permanent brain damage, severe permanent cognitive and memory impairment, broken teeth, prolonged seizures, myocardial infarction, ruptured bowels, acute and/or chronic organic brain syndrome, complete neurological collapse, and sometimes death.”

With respect to Himes, it was alleged that she received “over twenty rounds of ECT shock treatment between about April 2011 and about July 2012 at Sharp Mesa Vista Hospital in San Diego, California” and that, as a result, she “suffers severe physiological, psychological, and emotional injury.”

The case is Himes v. Somatics, 21-55517.


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