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8 January 20242 minute read

Learned intermediary doctrine: California Supreme Court case may impact failure-to-warn lawsuits within the state

A significant aspect of the learned intermediary doctrine currently being considered in the California Supreme Court in Himes v. Somatics, LLC may impact future lawsuits filed in California which are premised on a failure-to-warn theory.
In Himes, plaintiffs alleged that Somatics’s failure to warn of certain risks of its electroconvulsive therapy device caused their injuries. The district court granted summary judgment in favor of Somatics, holding that plaintiffs failed to establish causation due to an absence of evidence that stronger warnings would have affected their physicians’ decision to prescribe the treatment. 

Plaintiffs appealed, and the Ninth Circuit Court of Appeals certified the following question involving causation in a failure-to-warn case:

Can a plaintiff meet the causation requirement by showing that the physician (if informed of the potential dangers in using the product) would have relayed stronger warnings to the patient such that a prudent person would have declined using the medical product? Or does the plaintiff have to prove that a manufacturer's stronger risk warning would have altered the physician's decision to prescribe the product?

Although the matter has been fully briefed, as of this writing, no oral argument has been scheduled.
In California failure-to-warn cases, the learned intermediary doctrine provides that a manufacturer’s duty to warn of risks runs to the physician, and not the patient. In the context of a doctor-patient relationship, if there is no evidence that additional warnings would have impacted a physician’s prescribing conduct, then a failure-to-warn plaintiff cannot prove that a deficiency of warnings caused her injury. 

In Himes, the California Supreme Court will consider whether “a plaintiff can establish causation by showing that a physician would have communicated the stronger warning and that the patient would have declined the treatment after receiving the stronger warning…” 

Depending on the Court’s decision, it is possible that a plaintiff could establish causation by simply claiming that she would not have given consent had her physician communicated stronger warnings. 

We will continue to monitor developments in this case.  For more information, please contact the authors.