Royal Philips (NYSE:PHG) is facing scrutiny and legal action amid a serious recall involving millions of its sleep therapy devices.
A number of plaintiffs across the U.S. and Canada have filed class-action lawsuits and personal injury claims in response to the recall, which FDA last month designated the as Class I — the most serious kind — noting that users of the Philips ventilator devices face a host of health problems and toxic carcinogenic effects. The agency said that there have been more than 1,200 complaints and more than 100 injuries.
Philips is no longer taking orders of sleep therapy systems as it handles the recall, which may knock it out of the sleep therapy market for a year. As a result of the recall, ResMed saw a dramatic surge in demand for its sleep and respiratory care products and is now facing supply chain issues.
A lawsuit filed in Massachusetts by plaintiff Nick Manna kicked off legal actions in June, while a letter sent by Connecticut Sen. Richard Blumenthal to Philips North America CEO Vitor Rocha requested explanations for a number of questions on the recall, including and not limited to:
- How many devices and patients were impacted?
- How has the company has reached out to affected patients to alert them?
- When does the company expect to repair or replace all impacted devices?
- When does the company expect to submit a mitigation plan to the FDA?
Blumenthal demanded answers to those questions and more by Sep. 7, 2021.
“The current situation is untenable, unacceptable, and must be immediately rectified,” Blumenthal wrote. “I look forward to reviewing your answers to these questions. In the meantime, I urge Philips to continue its outreach to impacted patients, immediately expedite its replacement and repair program, submit a mitigation plan with sufficient evidence to FDA for authorization, and work to ensure that such a mass recall does not occur again in the future.”