One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.
Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it's not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.
. . .
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.
Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.
His wife represented Theranos, as well as a breast implant manufacturer whose products were linked to a "rare form of lymphoma."