At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.
He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pa.
There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.
Federal regulators acknowledge they were aware of infections tied to a heart-surgery device used in Karst’s operation by the summer of 2014. But they waited 14 months before issuing a public alert about the risks, and it wasn’t until last month — more than two years later — that they issued detailed recommendations to hospitals and patients on what to do.
Critics say a swifter response could have saved thousands of patients like Karst from being exposed to potentially deadly bacteria. Some patients fell ill or died without knowing the real cause, doctors say.