In a significant legal move, Philips has initiated a lawsuit against PSN Labs, holding them accountable for what it considers critical errors in the risk analysis of soundproofing foam used in its sleep apnea devices. Filed in the U.S. District Court for the Western District of Pennsylvania, Philips contends that the inaccurate conclusions drawn by PSN Labs led it to implement an extensive and costly recall of its sleep and respiratory devices that could have been handled differently.
The complaint highlights Philips’ stance that PSN Labs made “numerous egregious errors” during their testing and analysis phases. Furthermore, Philips criticized PSN for not sharing the raw data from testing, which they argue could have potentially aided in assessing the validity and reliability of the results presented. PSN Labs, meanwhile, declined to comment on the allegations when approached.
The backstory of this lawsuit dates to June 2021, when Philips initiated a recall of over 15 million devices, including continuous positive airway pressure (CPAP) devices, bilevel positive airway pressure (BiPAP) machines, and ventilators. The recall was prompted by concerns that the PE-PUR (polyester-based polyurethane) foam used in these devices could disintegrate, potentially causing users to inhale harmful particles or chemicals. These contaminants were thought to pose health risks, including headaches, irritation, and possibly more severe toxic or carcinogenic effects, as suggested by the Food and Drug Administration (FDA).
In its defense, Philips has contested claims regarding the foam’s toxicity, even stating last year that it is unlikely the devices pose a health hazard. However, the FDA has maintained a cautious stance, requiring Philips to undertake additional testing due to inadequacies in the initial analyses aimed at fully understanding the risks involved.
According to Philips’ complaint, the contractual relationship with PSN Labs began in 2020 following customer complaints about foam degradation in their devices. This was one of the reasons Philips engaged multiple independent labs, including PSN, to evaluate the risks associated with the foam, particularly under conditions of heat, humidity, and potential reactions from using ozone for device cleaning.
The lawsuit accuses PSN Labs of significant missteps, including incorrectly reporting the presence of the hazardous compound dimethyl diazene, which Philips asserts is not emitted by the foam. Moreover, Philips alleges that PSN used an inappropriate ozone detector, leading to a false detection of ozone in the devices — a byproduct not linked to foam degradation. Another claim is that PSN exaggerated the risks associated with a volatile organic compound known as phenol, 2,6-bis.
Before the recall decision was made, Philips had considered less extreme measures, such as installing filters to trap degrading foam particles or limiting device usage to reduce exposure risks. However, these were dismissed in favor of a broader recall action based on the data and risk assessment primarily influenced by the testing outcomes provided by firms like PSN.
Philips is now seeking to recover the significant financial expenditures and reputational damages it has suffered due to the recall through this lawsuit, citing breach of contract and negligence by PSN. The stakes are high, with Philips already committing substantial sums—over $479 million towards economic loss claims and $1.1 billion to settle personal injury claims related to the recalled devices.
This legal battle underscores not just a conflict over scientific analysis and corporate responsibility, but also the profound health implications for potentially millions of device users globally.
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