Left turn

Sleep Apnea Machine Recall

In June 2021, Philips issued a sweeping sleep apnea machine recall of up to 15 million breathing and ventilator machines used to treat sleep apnea and other respiratory conditions. This massive recall stemmed from a dangerous defect – degraded sound abatement foam breaking down inside the devices. When inhaled, the foam particles and chemical emissions put users at risk of serious lung, organ, and even cancer hazards. Examining how this defect emerged and the extensive fallout provides a sobering case study in product liability.

Understanding the Philips Sleep Apnea Machine Recall 

Philips manufactures several models of continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines commonly used to treat sleep apnea. They also produce life-sustaining mechanical ventilators.

In 2021, Philips disclosed that the polyester-based polyurethane (PE-PUR) sound-dampening foam in these devices can degrade into particles over time. When air passes through the machine, users inhale these potentially toxic fragments. The company acknowledged the foam may also off-gas volatile compounds.

The scope of the recall encompassed millions of affected devices across the US and worldwide. The FDA designated it a Class I recall – the most serious category reserved for situations with the potential for severe injury or death.

Consequences of the Defective Machines  

The recalled Philips machines subjected users to multiple risks:

  • Respiratory damage from inhaling foam and chemical particles
  • Possible toxic and carcinogenic effects to organs
  • Headaches, irritation, inflammation, respiratory issues 
  • Long-term lung, kidney, and cancer risks

In the two years since the recall began, over 100,000 medical device reports have been filed describing sleep apnea brain injury and health problems tied to the defective machines. Several hundred deaths have also been reported, though causation is difficult to confirm.

For those relying on these devices for potentially life-saving respiratory therapy, the recall created incredible hardship. Faced with unavailable or extremely limited replacement options, many had no choice but to continue using the defective machines, gambling with their health.  

Results of the Recall and Litigation

The Philips foam debacle has spawned extensive legal action to hold the company accountable for injuries and damages. In September 2022, Philips agreed to a $479 million settlement to compensate affected users – though litigation continues over personal injuries.

sleep apnea recall

Additional key results and ongoing issues include:

  • Widespread mistrust in Philips and the medical device industry
  • Disrupted access to critical respiratory therapy 
  • Limited replacement supplies leaving patients untreated
  • Questionable testing and claims minimizing risks 
  • Calls for increased oversight and regulations 

Though Philips has claimed updated testing shows low risk from the foam, many experts dispute these findings. The full effects may remain unknown for years given the potential for long-term harm.

Keeping Accountable

When product defects irresponsibly jeopardize consumer health, companies should be held fully liable. Patients placed trust in Philips, and the company betrayed that trust. By cutting corners on safety, they subjected millions to unconscionable hazards. 

Cases like the Philips sleep apnea recall illustrate the critical need for accountability when profit-driven negligence results in preventable injury and loss. Strict regulations and vigorous legal remedies empower consumers and act as deterrents against similar disregard for public wellbeing. Companies that fall short must bear the consequences.

The Defective Products Attorneys You Can Rely On

Crossen Law Firm has an extensive record of success in handling product liability claims and fighting for maximum compensation. As a consumer, you put your trust in the manufacturers and distributors of the products you use daily. If something goes wrong, the right parties need to be held accountable. Don’t go up against a large corporation on your own. Contact us today or call us at 317-401-8626 for a free consultation – you pay nothing unless we obtain damages for you.