Philips, a renowned multinational conglomerate with a long-standing presence in the electronics industry, has faced a challenging legal situation concerning their Respironics’ CPAP machines. CPAP machines are designed to assist individuals with sleep issues, particularly obstructive sleep apnea. However, a massive voluntary recall has been initiated due to allegations that the foam used in Philips CPAP machines is not only toxic but also carcinogenic. Troublingly, recent reports indicate that Philips may have been aware of these risks all along.
Understanding CPAP Machines:
CPAP machines are utilized to treat obstructive sleep apnea, a condition characterized by the intermittent cessation of breathing during sleep caused by relaxed throat muscles. These machines are connected to a face mask via a hose, delivering pressurized air to ensure the airways remain open during sleep. To reduce noise levels, Philips incorporated polyester-based polyurethane (PE-PUR) sound abatement foam into their machines. However, it has been reported that this foam can degrade over time and release particles and toxins that are carcinogenic to humans.
The Philips CPAP Recall:
In June 2021, Philips issued a voluntary recall of over 15 million CPAP and BiPAP ventilators that employed the PE-PUR foam. The company acknowledged the “life-threatening” risk associated with the foam’s potential degradation and the release of harmful chemicals into users’ airways. The recall focused on ventilators manufactured prior to April 26, 2021. The U.S. Food and Drug Administration (FDA) classified this recall as a Class I recall, indicating the most severe category reserved for products that can cause serious injury or death.
Health Risks and FDA Commentary:
The FDA expressed concerns over the foam’s impact, reporting instances of headache, upper airway irritation, cough, chest pressure, and sinus infections potentially attributed to the foam. The FDA further cautioned about the possibility of other complications such as asthma, nausea, inflammation, and the exposure of the liver and kidney to carcinogens.
Philips’ Response and Complications:
In September 2021, in an attempt to address the CPAP ventilator situation, Philips offered to replace or repair affected units. They established a website for CPAP users to determine if their device was subject to the recall and request the replacement of the sound abatement foam with a non-toxic alternative. However, this initiative raised questions about Philips’ commitment to consumer safety and its reputation in the health electronics sector.
Investigations and Withheld Information:
The voluntary recall triggered an FDA investigation into Philips’ records and its manufacturing plant in Pennsylvania. During this investigation, previously withheld data on a new silicone-based foam used in the 12-month replacement program came under scrutiny. Unfortunately, the FDA determined that the new foam also failed safety tests, this time concerning the release of volatile organic compounds (VOCs).
Additionally, the FDA’s investigation uncovered evidence that Philips was aware of foam degradation issues as early as 2016. Internal test reports from 2018 to 2020 indicated a link between foam degradation and high humidity and heat environments, yet this information was not disclosed to the public.
The Pursuit of Justice: CPAP Philips Lawsuit
In September 2021, the US Judicial Panel on Multidistrict Litigation consolidated all individual lawsuits into MDL Number 3014 in Pennsylvania’s Eastern District. The panel acknowledged the similarity of factual questions surrounding the recalled devices and the conduct of the recall in all personal-injury claims. No cases have been settled thus far, allowing affected individuals to take action. If you have used a CPAP or BiPAP machine and have experienced symptoms consistent with inhalation and intoxication as communicated by the FDA, you may be entitled to compensation.
At Oppenheim Law, we understand the emotional toll these impairments can have on individuals and their lives. Our dedicated team of professionals is committed to providing vigorous representation to our clients.
To learn more about your legal rights and pursue the compensation you deserve, please contact us at (954) 384-6114, reach out via email at contactus@oppenheimlaw.com, or visit our website at www.oppenheimlaw.com. Time is of the essence, and we are ready to assist you.