Federal officials have ramped up the pressure on a Dutch conglomerate over its expanding but slow recall of sleep apnea breathing devices relied on by millions of increasingly angry U.S. patients.

The Justice Department has issued a subpoena to Royal Philips NV in preparation for an undetermined investigation of the company’s CPAP machines and their recall, a problematic process about which the Food and Drug Administration recently also gave the company a kick, the Wall Street Journal reported:

“Philips said its Respironics division, and some other subsidiaries received the subpoena on April 8 to ‘provide information relating to events leading to the Respironics recall.’ It said it was cooperating with the agency. Philips Chief Executive Frans van Houten told investors … that the company wasn’t aware of any specific allegations. ‘They are preparing an investigation and we just have to accept that,’ he said.”

The newspaper also noted that:

“Philips initially expected to repair or replace three to four million devices world-wide — around half of which are in the U.S. — but has twice raised that estimate as more customers come forward. Now it anticipates the program will cover around 5.5 million devices. The recall, first announced in June, mainly affects CPAP and BiPAP machines, devices that regulate breathing by gently pushing air into the lungs through a mask. They are mainly used to treat sleep apnea, a condition that causes a person to stop breathing for brief periods while asleep. It also affects some ventilators. Mr. van Houten said … that the latest increase in devices covered came after a push to raise awareness of the recall, which led to a bump in registrations. The company had already earlier widened the scope of the program to include older devices, after receiving requests from customers for replacements or repairs. In the U.S., insurers typically replace such devices every five years, but some patients continue to use devices that are older than that.”

Philips’ assertion that it has pushed to help more of its customers, leading to a larger recall, does not square with FDA notices issued in March. The agency then jabbed the company with a public, official warning that it needed to do more about notifying consumers of the recall and the FDA added more information about Philips devices:

“On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate. Since issuing this updated safety communication in November 2021, the FDA also added information about the recall of certain Trilogy Evo ventilators with specific serial numbers.”

The agency also reported this:

“On March 14, 2022, the FDA added information about Philips Respironics prioritized replacement devices to the FDA Actions section below.”

The Wall Street Journal reported why regulators have expressed rising worries about the sleep apnea devices, which now are the focus of class-action and personal injury lawsuits:

“Concerns center on a sound-damping foam made of polyester-based polyurethane, or PE-PUR, found inside the affected devices that Philips said can degrade and be inhaled by the user. The company was also worried that the foam could emit harmful gases. Testing on potential harm from foam particles, and of emissions from other models containing PE-PUR foam, is still under way. The recall has placed sleep-apnea patients in a difficult position, forcing them to choose between continuing to use a device that could be causing them harm and ceasing a treatment that helps prevent serious long-term conditions such as strokes and heart problems.”

The FDA has cautioned patients against hasty action, advising them, instead, to consult in detail with their doctors about the best course with care for their sleep disorder. Patients have complained loudly that they are angry that Philips has put them in a tough spot — not wanting to harm their health due to the products’ prospective flaws but also reluctant to stop a treatment that doctors say can be lifesaving.

The situation has worsened because consumers say that Philips has dragged its feet in communicating about fixing or replacing devices. The company says it is doing the best it can, especially because it is struggling with coronavirus pandemic-related, global supply chain nightmares that have plagued businesses around the world.

Philips recently increased the money it is stashing aside to deal with what could become a $ 1-billion mess that also could lead it to lose major market share to competitors.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous devices, notably of the medical variety.

While it is good to see federal agencies prodding a medical device manufacturer to step up to its responsibilities to its customers in need, this situation is a painful reminder about patients’ vulnerability when dealing with big companies that make crucial products.

In this case, for example, their struggles have included determining who might help them best — their doctors, insurers, or health care middlemen. Doctors, in many cases, prescribe breathing devices for patients but orders for the machines are fulfilled by “durable medical equipment suppliers,” or DMEs, the Wall Street Journal has reported earlier. This can add yet another layer of bureaucracy, besides insurers, for patients to deal with as they try to get devices fixed or replaced, especially with urgency.

Critics long have assailed the oversight of medical devices as lacking and creating an area of health care more akin to the “wild, wild West.” Is it any surprise that consumer anger boils over — and that patients find that the civil justice system can provide them with a real option to remedy their problems and to hold difficult parties to account? We have much work to do to ensure the safety, effectiveness, and supply of vital medical devices.