Sleep apnea device recall drags on, stoking frustration

WASHINGTON — A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year. “What happened is the company just said, ‘Talk to your doctor.’ But doctors can’t manufacture new machines out of the blue,” said Dr. John Saito, a respiratory specialist near Los Angeles. Philips said its initial communication about the dangers posed by the foam was “a worst-case scenario for the possible health risks.” The deterioration appears to worsen with unauthorized cleaning methods, the company noted. Philips still hasn’t provided “all information we requested to evaluate the risks from the chemicals released from the foam.” Philips disclosed earlier this year that it received a Department of Justice subpoena over the recall. But an FDA inspection of Philips’ Pennsylvania offices uncovered a spate of red flags last fall, including emails suggesting the company was warned of the problem six years before the recall.