Philips blames lab for breadth of recall 

PITTSBURGH – Philips says PSN Labs conducted “numerous egregious errors in its testing and analysis” related to the company’s recalled sleep and respiratory devices, causing it “significant damage.” 

In a lawsuit filed July 29 in U.S. District Court for the Western District of Pennsylvania, Philips says PSN’s work was a big reason it initiated a worldwide recall of more than 15 million sleep and respiratory devices in June 2021 and that the company would have pursued a “different and more focused recall” had PSN not “overestimated the potential threats to patients.”  

Philips alleges that PSN, which the company relied on to research and study the polyester-based polyurethane sound abatement foam used in certain sleep and respiratory devices, as well as any volatile organic compounds, made several errors, including: 

• Repeatedly insisting that it had identified in the foam a potentially mutagenic and genotoxic VOC called dimethyl diazene that is not present in – and is not emitted from – the foam at all. Philips alleges that the dimethyl diazene that PSN supposedly detected was actually acetone, a naturally occurring and routine compound that does not present anywhere near the potential risks. 

• Insisting it had discovered that certain of the CPAP and BiPAP devices it had tested emitted ozone, another potentially toxic chemical, but was again incorrect. The company alleges PSN had not used an appropriate ozone detector in testing. 

• Insisting that another VOC – phenol – posed such a risk to PAP users that the devices could not be safely used. Yet, PSN disregarded the safety thresholds for that chemical identified in pre-clinical toxicity studies cited by multiple public health agencies, resulting in PSN vastly overstating the risk presented by the level of phenol it had detected. 

Philips alleges that PSN’s “cover-up was extensive and the depths of it have only recently been fully understood,” following its ability to obtain raw data by subpoena. 

The company has since assembled an independent science panel to review the full scope of available data and found that PSN’s findings were the “only outlier.” It says the other independent labs reinforced the conclusion that the foam carried a negligible risk of harm after evaluating samples of the same foam PSN had analyzed and performed the same VOC testing on devices containing the foam. The company also says three other labs did not identify one of the potentially hazardous VOCs that PSN mistakenly reported at all, and further testing has shown that the other compounds of concern were well within accepted toxicological threshold levels – often 100 or more times below levels of actual potential harm for users. 

Philips seeks to recover from PSN the significant expenses it incurred and reputational harm it suffered in connection with the recall because of PSN’s errors. It also seeks to recover for the harm the company suffered from PSN’s efforts to cover up its own mistakes and undermine the conclusion about the toxicity of the foam.