CPAP Lawsuits: A Decade of Silence Before the Recall

A recent CPAP cancer lawsuit filed April 12, 2024) alleges a Kentucky man's use of a Philips DreamStation for six years led to his breast and bone cancer diagnosis in February 2023. This lawsuit highlights ongoing concerns about Philips' handling of the massive CPAP recall initiated in 2021.

The allegations

The lawsuit centers on Philips' alleged knowledge of risks associated with the polyester-based polyurethane foam in their machines. This foam, according to the complaint, can degrade and release toxic particles users inhale, potentially causing severe health problems. The plaintiff claims significant physical and emotional distress due to these defects, including invasive cancer treatments and aftereffects.

Court-ordered correction in wake of troubled recall history

This lawsuit coincides with a recent federal court ruling on April 9th that highlights significant issues with Philips' handling of the 2021 CPAP recall. The judge not only banned Philips from distributing and manufacturing BiPAP and CPAP machines in the United States until they meet specific FDA requirements, but also imposed a series of corrective actions.

These court-ordered actions underscore the seriousness of the situation:

• Halt Production and Address Manufacturing Issues: Philips must stop production at specific facilities until they meet FDA requirements. This signifies potential problems with their manufacturing processes.

• External Oversight and Material Review: The company is required to hire independent experts to inspect additional facilities and review alternative foam materials. This suggests a need for a comprehensive review of their manufacturing practices and materials selection.

• Ongoing FDA Scrutiny: Philips must submit to ongoing oversight measures by the FDA. This indicates a potential loss of trust and the need for close monitoring by regulatory authorities.

The consent decree further restricts Philips, prohibiting them from selling new CPAP, BiPAP, or other respiratory care devices in the US until they meet specific safety and regulatory standards. This sales ban signifies a major blow to the company and emphasizes the severity of the situation.

Early warnings ignored and delayed action

An in-depth ProPublica investigation sheds light on a troubling pattern of behavior by Philips leading up to the recall:

• Missed Red Flags: Complaints regarding "black particles" and "contamination" within the machines surfaced as early as 2010. By 2015, these warnings reportedly numbered in the thousands. However, Philips allegedly withheld this critical information from the FDA.

• Profit Before Patients: Despite these mounting complaints, Philips reportedly continued aggressive marketing campaigns, promoting new models that still contained the hazardous foam. This prioritization of profit over patient safety is particularly concerning, especially considering the wide range of users potentially exposed, including infants, veterans, and critically ill patients.

• Slow Response to Risks: The investigation revealed a significant delay in Philips' response. They only launched a formal investigation into the foam degradation in 2019, a full nine years after the first complaints emerged. The recall itself wasn't announced until June 2021. This slow reaction raises serious questions about Philips' commitment to user safety.

Lawsuits and the road ahead

Multiple lawsuits are ongoing, including personal injury claims and class actions seeking medical monitoring and research into the devices' health risks. While Philips settled some cases in September 2023 for $479 million, they maintain the machines haven't been proven to cause injuries.

The full extent of the health crisis may take years to determine. With ongoing litigation and investigations, the fight for accountability and compensation for those potentially affected by Philips' CPAP machines continues.