California Justices Will Consider Medical Device Warning Case

The California Supreme court on Wednesday agreed to decide what standard should be applied to failure-to-warn claims filed against the maker of a shock-therapy device.

The justices will consider whether plaintiffs who sue over insufficient risk warnings must prove that stronger warnings would have caused their doctor to change their mind about whether to prescribe a certain procedure.

Michelle Himes alleged in federal court that Somatics LLC failed to adequately warn her doctor that its Thymatron electroconvulsive therapy machine can cause brain damage, permanent memory loss, and the inability to form new memories. A stronger warning on the device would ...