Nathan Brown Quoted by Bloomberg on Possible Risks for Medical Device Makers

May 14, 2019

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Bloomberg has quoted Akin Gump health care and life sciences partner Nathan Brown in the article “Medical Device Makers May Risk Liability Following FDA Effort.” A move by the Food and Drug Administration to bring more artificial intelligence-based medical devices to market, the article reports, could pave the way for product liability lawsuits if the technology changes the device after initial approval.

According to the article, if medical devices were to change significantly as they learn, they could technically become a different product than the FDA originally approved. That would lead some manufacturers to lose immunity from the liability they had with the approved device, giving consumers more leeway to sue if the altered product becomes defective.

The FDA must approve any medical device before it hits the market, the article notes, and federal law generally preempts personal-injury suits at the state level against medical devices that have gone through the FDA’s most rigorous review, premarket approval. The article adds that the FDA currently requires a premarket review of certain devices each time the device’s algorithm undergoes a major change—which could mean a lot of red tape for makers of devices that continuously learn and evolve.

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. The FDA would be approving the methodology of the device as much as the device itself, he said.

“New medical technologies are becoming more of a process than a static thing,” Brown said.

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