Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. This timeline lays out the events of the ongoing saga.
ProPublica and the Post-Gazette previously released a scathing investigation outlining the alleged withholding of information around the issues with the devices even as they became more alarming.
The latest from the news outlets says the company decided to stop shipping defective devices in April 2021 after tests showed exposure to potentially dangerous particles. Philips alerted the FDA to the potential issue and considered a recall, the report says. However, the company instructed distributors to keep selling the devices, according to ProPublica and the Post-Gazette.
The directive came from Roy Jakobs — who now serves as CEO of Philips — the report says.
Philips selected Jakobs to succeed Frans van Houten as president and CEO about a year ago as the company grappled with the recall. Not long after he took the top job, he issued an apology for the recall on behalf of the company.
Lawyers claimed that top executives at Philips were aware of the issues for years. Jakobs became chief business leader of Philips’ Connected Care unit in 2020, overseeing respiratory devices. He served there until his appointment to CEO in October 2022. The report says that van Houten also “took on a key role” in the U.S. operations when the safety issues came to the fore.
According to the report, federal court testimony revealed that Jakobs told employees that distributors could keep selling devices in their inventory. A hearing in Pittsburgh last week offered more insight into the management of the recall. Caleb Seeley, a lawyer whose firm represents thousands of plaintiffs in claims against the company, alleged that the company is “still telling customers who have these devices that they can keep using them,” the report says.
The report said Philips argued that the parent company should be shielded from claims. The Dutch medtech giant says responsibility lies with its U.S.-based Respironics subsidiary. However, the report says attorneys argue that decisions came down from “the highest levels” of the company.
Philips told the outlet that Jakobs approved the sale of the remaining devices as Philips still assessed the risks and its “understanding of the issue was still evolving.”
Philips offers a statement
A Philips spokesperson issued the following statement to MassDevice via email:
Philips does not agree with the characterizations made in the most recent ProPublica article related to the Respironics recall.
Philips’ first priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them and how they improve their lives every day and night. We regret the distress and concern that the June 2021 recall notification/field safety notice has caused for patients and care providers. We deeply apologize for that and continue to work hard to resolve this for our patients and customers.
We would like to emphasize that in April 2021, Philips’ understanding of the component quality issue and the potential mitigating actions was still progressing. As part of the technical investigation, Philips Respironics took precautionary measures, including stopping the manufacturing and selling of sleep therapy devices to its distributors and customers.
At that time and pending the conclusion of the technical investigation, Philips Respironics’ ship hold decision would not extend to devices already in the possession and control of distributors and customers. In the absence of an authorized recall, Philips Respironics was not in a position to communicate to its distributors and customers to halt distributing devices.
A ship hold is a common industry process used by manufacturers to halt shipments of products with a potential issue to distributors and customers. This allows the company time to do a thorough technical investigation of the potential issue and to determine if further actions are necessary, including the potential for a recall.
When additional data and further analyses became available and after alignment with the relevant regulators and competent authorities, including the FDA, Philips Respironics initiated the recall in June 2021. The recall involved the global repair and replacement of the sleep therapy and ventilator devices under the recall.
Completing this recall remains our highest priority, with the remediation of the sleep therapy devices almost complete and remediation of the ventilators ongoing. Globally, over 99% of the sleep therapy device registrations that are complete and actionable have been remediated.”
