The company at the center of a worldwide recall of sleep aids that left many sleep apnea patients unsettled is now under scrutiny by federal investigators on several fronts.
The Food and Drug Administration (FDA) announced that it has received more than 100 reports on deaths related to popular medical sleep aids trusted by many around the world.
This latest revelation comes after the company behind the recalled product – Philips Respironics, a subsidiary of the Royal Philips company – recently informed shareholders that it had received subpoenas from the US Department of Justice, as part of a research.
WHY IS PHILIPS RESPIRONICS RECALLING THE DEVICES?
Philips’ worldwide voluntary recall of CPAP, BiPAP devices and ventilators was first announced almost a year ago, in June 2021, after the company said there was a carcinogenic noise reduction foam in inside the device that could break and be inhaled by its user without knowing it.
The FDA was quick to label the recall Class One: a designation reserved for the most serious type of recall.
The researchers of the FDA reported after the recall affected more than 15 million devices worldwide.
So many sleep apnea patients around the world were relying on the devices covered by the recall that Philips said it didn’t have enough parts to immediately repair or replace the devices, leaving some patients without much choice.
Patients like Edward Coleman, a 73-year-old Vietnam veteran from Michigan City, Indiana, said his doctors at the VA prescribed a Philips DreamStation for his sleep apnea, regulating his breathing while he sleeps.
“My sleep is interrupted, you know, two to three times a night,” Edward explained. “So it’s hard to get a good night’s rest.”
Coleman said he’s still waiting for a replacement device, and since hearing about the recall, he’s now sleeping without any sleep aids after weighing the risks, but he worries about other veterans who may not know about the problem.
“I want to reach out to other veterans so they can get the information they need to get their appliances repaired or replaced,” Coleman told NBC 5 Responds. “That’s my biggest concern right now.”
Coleman’s frustration, like that of many Americans, has not been lessened by the latest revelations from regulators.
HOW MANY REPORTS HAS THE FDA RECEIVED ON MEDICAL DEVICES?
Since April 2021, the FDA has said it has received “more than 21,000 medical device reports (MDRs)” related to breakage of anti-noise foam from Philips Respironics CPAP, BiPAP and ventilation devices.
These reports include 124 deaths related to the recalled Philips devices, according to the FDA.
MDRs are a post-market surveillance tool used by the FDA to monitor medical devices, including reports of device-related malfunctions, injuries, or deaths.
These MDRs to the FDA include both mandatory reporting by Philips and voluntary reporting by healthcare professionals, consumers and patients, an FDA spokesperson said.
The FDA told NBC 5 Responds that it is studying each of the reports, but felt it was important to share the preliminary results with the public.
“We are evaluating each report and communicating this preliminary information to the public. Based solely on the reports, there is no immediate causal relationship between the deaths and foam rupture,” an FDA spokesperson said. “The 124 deaths have not been verified beyond medical device reports submitted to the FDA.”
In response to the FDA’s findings, Philips told NBC 5 Responds that while the company “investigates all allegations of device malfunction, death, or serious injury…the cause of an event typically cannot be determined from the reports [de la FDA] MDR.”
“Philips Respironics received a sharp increase in complaints allegedly associated with potential foam degradation” after the company announced the recall in June 2021, a spokesperson told NBC 5 Responds.
The company said: “Philips regrets any inconvenience caused by this issue and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions.”
The company also pointed to a study published by the American Journal of Respiratory and Critical Care Medicine (AJRCCM) last December which found that patients using its devices did not have an increased risk of cancer.
The company said: “Separate from Philips Respironics, in December 2021, an analysis was published in the [AJRCCM] which found no increased risk of incident cancer among obstructive sleep apnea (OSA) patients who used a Philips Respironics PAP device compared with OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment “.
NBC 5 Responds contacted the AJRCCM to verify details of the study, but did not receive a response by the deadline.
COURT SUMMONS AND DOJ LAWSUITS
Philips is starting to feel the pressure of the recall.
In a call to shareholders last month, Royal Philips CEO Frans van Houten said that on April 8 the US Department of Justice sent a subpoena to the company and its affiliates in connection with an investigation. ongoing product recall.
The Justice Department subpoena was “to provide information related to the events leading up to Respironics’ withdrawal,” van Houten said. “The relevant affiliates are cooperating with the agency.”
The CEO added that the summons did not raise any specific allegations, but was merely a general request for information on the recall.
Pressure is also mounting in courts across the country.
In that same call, the company acknowledged that it currently faces 185 personal injury lawsuits and more than 100 class action lawsuits related to the recall of the device. Those class action lawsuits are expected to be combined into two lawsuits this summer, the company said.
NBC 5 Responde reported in December that according to an FDA inspection, nearly a decade ago the company received more than a hundred complaints related to defects in the sleep aid device, but did not act immediately.
In an earlier statement, the company downplayed those FDA findings, saying that of the “limited complaints” it received, each one was “evaluated and addressed” on a case-by-case basis.
From the time it announced the recall, Philips said it plans to repair or replace all affected devices, but this will take time.
To date, of more than 15 million devices worldwide, the company has shipped 1.1 million replacement devices and repair kits to patients across the US.
In the April earnings call, CEO van Houten said he expects to have 90% of replacement devices shipped to customers by 2022.
THE FULL LIST OF PHILIPS RESPIRONICS MACHINES THAT ARE AFFECTED, ACCORDING TO THE FDA:
CPAP and BiPAP devices
|device type||Model name and number (all serial numbers)|
|Continuous ventilator, minimal respiratory support, use in facilities||E30 (Emergency Use Authorization)|
|Continuous ventilator, without life support||DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T y AVAPS, OmniLab Advanced+|
|non-continuous fan||SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
To register your affected device with Philips, and for more information on picking up and receiving a replacement device, click here.
|device type||Model name and number (all serial numbers)|
|continuous fan||Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent|
|Continuous ventilator, minimal respiratory support, use in facilities||A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto|
|Continuous ventilator, without life support||A-Series BiPAP A40, A-Series BiPAP A30|