Philips is accused of concealing around 3,700 grievances about its sleep apnea devices from the U.S. regulatory body, FDA, a situation unearthed by NRC, ProPublica, and the Pittsburgh Post Gazette after an examination of above 100,000 public documents.
Research reveals that Philips initiated the use of a specific sound-abating foam in its respiratory aids in 2010, and the first of the grievances followed shortly. A mass recall in 2021 was initiated by Philips due to potential degradation of this foam upon interaction with some cleaning agents, potentially exposing users to carcinogenic particles.
American legal provisions require manufacturers to notify the government within a stipulated thirty-day period of receiving reports of any injuries, fatalities, or potential malfunctions that could be harmful, arising from their devices. Allegedly, Philips, over an eleven-year period, did not disclose at least 3,700 such incidences relating to this sound-abating foam to the FDA.
Among the unrevealed complaints, some report possible fatalities connected to the use of the ventilators. Additional complaints involved descriptions of contamination within the devices such as “black particles,” an “oily-like substance,” and “unknown sticky substance.”
Legislation also mandates immediate inquiry into any reported defects that could be detrimental. It wasn’t until 2019 that Philips initiated its first investigation, leading to the 2021 recall of 15 million DreamStation sleep apnea and other machines which incorporated the disputed foam.
Post-recall reviews by Philips revealed numerous unreported complaints of foam degradation to the FDA, a situation confirmed by the FDA itself. A representative of Philips conveyed that, in the interest of precaution, previous complaints that were deemed unnecessary to be reported were eventually forwarded to the FDA due to possible links to the deteriorating foam.
Philips contends its unawareness of the magnitude of the issue until 2021 as complaints were addressed individually by its subsidiary, Philips Respironics. Consequently, the regulatory intervention was delayed by eleven years, receiving only a handful of reports regarding the disintegrating foam until spring 2021.
This protracted concealment has resulted in significant financial ramifications for Philips, with its stock value plummeting, the resignation of CEO Frans van Houten, and incoming layoffs announced by successor Roy Jakobs. Massive claims, running into billions of euros, are being assembled against Philips in the U.S.
Philips has recently communicated a settlement concord in the U.S. to address numerous ongoing lawsuits and compensations related to the recall. Moreover, a substantial reserve of more than 600 million dollars has been allocated by Philips in anticipation of impending legal and settlement expenditures in the United States.
Filing Your Sleep Apnea Injury Claim
Victims and their families who have suffered due to the alleged malfunctions of Philips sleep apnea devices and respirators should speak with Parker Waichman LLP about seeking rightful compensation. The firm’s seasoned team of attorneys can assist in filing a lawsuit against the responsible entities, demanding accountability for the pain, suffering, and loss incurred by the injured device users. With their extensive experience in product liability cases, Parker Waichman LLP can meticulously guide victims through every step of the legal process, ensuring their rights are upheld and their voices are heard.
In a product liability lawsuit, victims can pursue various forms of damages, depending on the extent and nature of their sufferings and losses. Compensatory damages aim to financially recompense victims for their medical expenses, lost wages, and any future earnings that may be impacted due to the injury. Furthermore, plaintiffs can seek damages for pain and suffering, encompassing both physical pain and emotional distress encountered due to the defective product. In cases where the misconduct of the manufacturers is especially egregious, victims might also be awarded punitive damages, serving as a deterrent to other potential wrongdoers.
Choosing to partner with Parker Waichman LLP empowers victims and their families to fight for justice against corporations that have caused harm through their products. The firm’s dedication to upholding victims’ rights and its commitment to securing fair compensation make it a formidable ally in the legal battle against manufacturers of defective devices. If you or your loved ones have been adversely affected by Philips’ defective sleep apnea devices or respirators, consider reaching out to Parker Waichman LLP and take a step towards restoring your life and obtaining the justice you deserve.
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