The Maker of CPAP Machines Knew Its Product Could Infect or Kill and Hid the Fact.
An Estimated 700,000 Veterans Given the Defective CPAP through the VA.
Since 2010, Philips Repironics has known of patients reporting serious illness and problems due to the foam liner it used in its machines. Worse, they knew these machines were specifically for use by people who were already ill and had trouble breathing and were therefore more vulnerable. CPAP devices help people suffering from sleep apnea, which causes breathing to stop suddenly at night, and the DreamStation CPAP was one of the more popular models.
However, over a few years the complaints went from a few to hundreds and then to thousands. The company not only ignored these complaints - they buried the reports and hid them from the FDA and regulators. Then the reports began to show worse and worse illness and adverse effects. Nonetheless, the company continued to hide the reports while enjoying its growing profits.
The fact that the industrial foam padding that Philips used on their breathing machines decayed and fell apart to be inhaled into the lungs of users has been known for quite a while. But a report by ProPublica and the Pittsburgh Post-Gazette has revealed what so many suspected- that despite an almost unbelievable slate of patient reports of the “oily ooze” and “black particles” coming off of the foam, the company hid the complaints and evidence that it was threatening the health of the very people who relied on these devices to stay alive (Philips Kept Complaints About Dangerous CPAP Machines Secret While Company Profits Soared — ProPublica).
The report shows that for 11 years Philips withheld more than 3,700 complaints from the FDA - complaints including those for deaths, injuries or malfunctions which federal law required that they turn in within 30 days. Instead, the company marketed the devices harder- trying to sell more to the unsuspecting public without even trying to remove the defect. Later, the company found that formaldehyde was among the dangerous chemicals also released by the foam, but they kept secret a series of meetings of engineers to discuss the problem. Meanwhile, people continued to get sick and die for reasons no one outside of the company was certain about.
Almost every medical device manufacturer, or drug distributor, or hospital, when finally confronted with facts like these will publicly state that “patient safety is our top priority.” And almost every company, when caught with the evidence, will claim they fixed things as soon as they found out. As ProPublica reports, the company’s own former compliance supervisor put it “It was a catastrophic series of errors [....] There were people who knew and knew for a long time.” And today, the company is backpedaling yet again and claiming there is no problem with its products at all.
On top of all this, we now know that the VA, apparently unaware of the hidden foam defect, distributed several hundred thousand of the Philips CPAP machines to veterans who were already at risk for having trouble breathing. Overall, reports have documented thousands of cases of cancer; hundreds of liver and kidney illnesses; and 17,000 respiratory illnesses, all traced to the foam that the company knew was bad but sold as good. Not one word of this would have gotten out if not for regulation, litigation, and investigation. No one in the health care business puts “patient safety as a top priority,” unless someone makes them do so.