At the modest home of Claude Moreau in Bordeaux, France, a small medical device sits unused on his bedside table. The 58-year-old teacher had relied on his Philips continuous positive airway pressure (CPAP) machine for years to manage his severe sleep apnea. Now, it gathers dust—a daily reminder of the health anxiety he’s endured since learning his breathing device might pose serious health risks.
“I would wake up gasping for air without my CPAP,” Moreau explains, his voice reflecting the weariness of countless disrupted nights. “But using a device that might cause cancer seemed like choosing between two terrible options.”
Moreau is one of millions worldwide caught in the fallout of Philips’ massive recall of sleep apnea devices—a crisis that recently escalated as French authorities launched a criminal investigation into the medical technology giant. The Paris Public Prosecutor’s Office confirmed the probe earlier this week, focusing on potential charges of “involuntary injuries,” “endangering the lives of others,” and “aggravated deception.”
The investigation marks a significant escalation in the legal challenges facing Philips, which first announced a global recall of approximately 5.5 million breathing devices in June 2021. The company disclosed that the polyurethane foam used to reduce sound and vibration in these machines could degrade, potentially allowing users to inhale toxic chemicals and particles during sleep.
For sleep medicine specialist Dr. Sophie Lambert at Bordeaux University Hospital, the health implications remain deeply concerning. “Many patients feel betrayed by a system that was supposed to protect them,” she notes. “We’re seeing increased anxiety, sleep disruption, and in some cases, worsening of underlying conditions as patients avoid using their prescribed therapy.”
The French investigation follows similar legal actions in other countries, including the United States, where Philips agreed to a preliminary $479 million settlement in April to resolve personal injury claims. However, the company continues to face additional class-action lawsuits and regulatory scrutiny globally.
In response to the French investigation, Philips stated it would “cooperate fully with the authorities” while emphasizing its commitment to patient safety. The company has previously disputed some of the more serious health allegations, citing independent testing that found the health risks to be “limited.”
However, for patient advocacy groups like the European Sleep Apnea Alliance, these assurances offer little comfort. “The true impact of this recall goes beyond physical health,” explains Jean-Pierre Vernet, the organization’s spokesperson. “Many patients face impossible choices—use potentially dangerous equipment or risk the serious consequences of untreated sleep apnea.”
Public health experts suggest the Philips case highlights critical gaps in medical device regulation. “There’s often insufficient long-term safety testing before devices reach patients,” explains Dr. Émilie Dubois, a public health researcher at Sorbonne University. “Unlike pharmaceuticals, medical devices frequently enter the market with less rigorous clinical evidence.”
For patients like Moreau, the criminal investigation offers a glimmer of hope for accountability, though little immediate relief. “I’ve since received a replacement device,” he says, “but the trust is broken. Each night, I wonder what I’m breathing in.”
As the French investigation unfolds, millions of patients worldwide continue navigating the uncertain aftermath of a recall that raises profound questions about medical device safety and regulatory oversight. The challenge now falls to health systems, manufacturers, and regulators to restore not just affected devices, but the shattered confidence of patients who placed their health—and their breath—in technology they once trusted without question.
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