Philips Hid Breathing Machine Complaints: Report

In a study co-published with the Pittsburgh Post-Gazette, the investigative journalism newsroom ProPublica says Philips Respironics kept adverse event reports about their CPAP machines and ventilators from FDA for a decade while aggressively marketing the troubled machines. “Company insiders said the devices posed an ‘unacceptable risk,’” the report says.

On 9/7, Philips said it had allocated $615 million under an agreement to resolve all “economic loss claims” in the U.S. multidistrict litigation related to its voluntary recall of certain sleep and respiratory care devices.

ProPublica says the first complaints about the devices came into Philips Respironics in 2010, describing black particles from the foam used to quiet the machines. “Philips withheld the vast majority of the warnings from FDA, even as their numbers grew from dozens to hundreds to thousands and became more alarming each year,” the report says.

In 6/2021, more than a decade after the first reports, Philips announced a recall of millions of machines that had been delivered throughout the U.S. and in dozens of other countries. The company acknowledged that the foam it had chosen could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats, and lungs of users.

While a Philips statement said the company acted as soon as it learned of the potential significance of the problem, ProPublica says that in the 11 years between the first complaints and the recall the company sought to protect its marquee products as stock prices soared to the highest level in decades.

While federal law requires medical device manufacturers to turn over to the government all reports of patient injuries, deaths, and malfunction that have the potential to cause harm within 30 days and investigate the complaints, ProPublica found that Philips withheld over 3,700 complaints from FDA over 11 years.

ProPublica and the Post-Gazette say they interviewed over 200 former company supervisors, doctors, toxicologists, patients, and relatives of those who died, and obtained company records showing that officials knew about the dangers but continued to sell the machines that FDA later said were capable of causing severe illness or death. The reporters also reviewed thousands of complaints submitted to the company and the government describing device malfunction and injuries, including over 370 reports of deaths.

In a statement to the news organizations, Philips said its top priority is patient safety and that it regretted the “distress and concern” caused by the recall. “We deeply apologize for that and continue to work hard to resolve this,” it said.