Medical Device Makers May Risk Liability Following FDA Effort

A Food and Drug Administration push to bring more artificial intelligence-based medical devices to market could open the door for product liability lawsuits if the technology changes the device after initial approval, attorneys say.

If medical devices change significantly as they learn, they could technically become a different product than the FDA originally approved. Some manufacturers could then lose immunity from liability that they had with the approved device, giving consumers more leeway to sue if the altered product becomes defective.

“There’s a gray area as to what would be preempted,” Lawrence J. Centola, a products liability attorney and principal ...