Juilette McKinney vs Koninklijke Philips N.V. et al Civil Action No.: 21-11500, filed in United States District Court, District of Massachusetts.
Parker Waichman LLP, a national law firm, filed a lawsuit on September 13, 2021, against Koninklijke Philips N.V., and subsidiaries, in United States District Court, District of Massachusetts. The lawsuit, claiming failure to warn, design defect and breach of warranty, was filed on behalf of Juilette McKinney, of Midway, West Virginia, alleges that Ms. McKinney developed lung cancer as a direct result of her daily use of Philips’ continuous positive airway pressure (“CPAP”) devices: a System One RemStar Auto CPAP and a DreamStation Auto CPAP.
Ms. McKinney’s physician prescribed the devices for obstructive sleep apnea (OSA), a breathing disorder that can result in snoring, fatigue, and cardiovascular conditions. CPAP devices deliver filtered, pressurized air through a mask, holding a patient’s airway open.
On June 14, 2021, Philips announced a recall of millions of CPAP devices, including the two devices used by Ms. McKinney for obstructive sleep apnea (OSA). On July 29, 2021, the FDA classified the recall as Class I, the most serious recall classification which involves the potential for the risk of serious injury or death. Since 2009, Philips has used a polyester-based polyurethane (“PE-PUR”) foam in the recalled devices.
In announcing the recall, Philips admitted that the PE-PUR foam potentially exposes users to critical safety risks, including “possible toxic and carcinogenic effects,” when the foam degrades. The lawsuit maintains that Philips knew or should have known about the risks from PE-PUR foam degradation long before it notified the public in 2021. An adverse event report in the FDA database shows a patient complaining of “black dust” as early as 2011 and OSA patients regularly reported the presence of black particles in the tubes of their devices on message boards.
The lawsuit seeks damages for Ms. McKinney’s severe injuries, as well as punitive damages.
Jerrold S. Parker, founding partner of Parker Waichman LLP, noted that “Philips chose to rush devices to market, without adequately investigating, and disregarded numerous warnings. Ms. McKinney now faces lung cancer. It’s time for Philips to answer for its actions.”
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