Bloomberg BNA reports that “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 were to “change significantly as they learn, they could technically become a different product than the FDA originally approved,” and “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.” The piece adds that the US Supreme Court “has held that the Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act preempt state-law tort claims against makers of medical devices that go through the FDA’s stringent premarket approval process.” FDA Attorney Nathan A. Brown “said preemption should apply to continuously learning devices requiring premarket approval, as long as any changes fall within the scope of the FDA’s approval.”

From the news release of the American Association for Justice.