California Supreme Court ruled that patients' autonomy in making treatment decisions must be respected

The following is a summary of the post Wisner Baum Prevails in Landmark Win for Patient Autonomy in CA Supreme Court Ruling the official ruling.

On June 20, 2024, the California Supreme Court made an important decision that changes how pharmaceutical and medical device companies can be held responsible for not warning about the risks of their products.

Here’s what happened:

Background: A company called Somatics LLC makes a device used for electroshock therapy (ECT). This device can cause brain damage and memory loss, and Somatics did not warn doctors about these risks. A patient named Michelle Himes suffered brain damage from the device. Somatics argued that they should not be held responsible because Himes’ doctor said he would have used the device even if he had known about the risks.
The Argument: Somatics relied on something called the “learned intermediary doctrine.” This legal idea says that manufacturers only need to warn doctors about risks, not patients. Somatics argued that Himes needed to prove that if her doctor had been properly warned, he would have changed his decision to use the device.
The Court’s Decision: The California Supreme Court disagreed with Somatics. The Court said that patients’ choices are important and can’t be ignored. Even if the doctor would still recommend the treatment, a stronger warning could have led the patient to refuse the treatment.
Impact: This ruling means that in future cases, patients can hold manufacturers liable if they can show that a better warning would have led them to refuse the treatment, even if their doctor still recommended it.
Significance: This decision stops companies from using the learned intermediary doctrine to avoid responsibility for not properly warning about risks. It emphasizes the importance of patients’ rights to make informed decisions about their own healthcare.

In summary, the California Supreme Court ruled that patients’ autonomy in making treatment decisions must be respected, and manufacturers can’t dodge responsibility by only warning doctors and ignoring the patients’ right to know.