PSN Labs, a laboratory based in Erie, Pennsylvania, has countered allegations made by Philips in a legal filing, asserting that Philips misrepresented test results concerning the soundproofing foam in its sleep and respiratory devices. This dispute arises from Philips suing PSN Labs for purported errors in its analysis which Philips claims led them to mishandle a recall of over 15 million devices initiated in 2021. The recall was prompted by concerns that the polyester-based polyurethane (PE-PUR) foam used in the devices could degrade and potentially harm users, with risks including inhalation of toxic or carcinogenic effects.
Philips initiated investigations into the foam degradation issue as early as 2016, conducting in vitro assays by 2018 which confirmed the foam’s potential to cause genetic mutations through three identified substances: formaldehyde, Phenol, 2,6-bis, and benzoic acid-ethoxy-,ethyl ester. Despite these findings, Philips hired PSN Labs in 2021 to conduct further tests. According to PSN Labs, their testing found two of the three substances Philips had previously identified, leading to an acknowledgement that additional analysis was necessary to properly assess the risks, which Philips allegedly declined.
The laboratory defended its methodologies and findings in its response, challenging Philips’ claims that PSN Labs inaccurately reported the presence of a mutagenic and genotoxic compound, dimethyl diazene. PSN Labs clarified that this identification was tentative and called for further testing, which Philips then refused. PSN Labs also expressed concern over Philips’ repeated requests for raw data, fearing that compliance might compromise their independence. They argued that providing raw data was not usual industry practice and suspected Philips might misuse it to coerce a modification of the lab’s report.
PSN Labs’ defense paints a picture of prior knowledge by Philips of the problems related to the foam well before the recall and before contracting the lab for testing. They accused Philips of using the lab’s results to deflect blame from its own mishandling of the foam degradation issue, even though previous testings already suggested clear genotoxicity and volatile organic compound failures, substantive enough to trigger a product recall.
Amidst these legal disputes, Philips defended their actions in a statement, insisting the lawsuit was necessary to hold PSN Labs accountable for alleged errors and cover-ups in their conduct. Philips argued that the risk was overestimated by PSN, leading to a broad recall strategy that could have been more focused.
Adding to Philips troubles, the FDA found the company’s initial testing and analysis inadequate for a full evaluation of the risks posed by the degrading foam. As a result, Philips had to strike a consent decree with the Department of Justice in April, ceasing sales of many of its sleep and respiratory products in the US until it proved yearslong compliance with FDA quality standards. The agreement also requires Philips to repair, replace, or refund the affected devices as per the remediation plan.
This ongoing legal and regulatory saga underlines significant challenges in the medical device industry related to product safety, responsibility, and the integrity of corporate risk assessments. It poses serious questions about corporate governance and public trust, especially in products that are critical to consumer health.
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