Philips blames lab for wide range of recalls

PITTSBURGH – Philips says PSN Labs made “numerous egregious errors in its testing and analysis” related to recalled sleep and breathing devices that caused “significant harm.”

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

Philips alleges that PSN, which the company relied on to test and analyze the polyester-based polyurethane foam used in some of its sleep and breathing devices, as well as any volatile organic compounds, made a number of errors, including:

• Having repeatedly insisted that it had identified a potentially mutagenic and genotoxic volatile organic compound called dimethyldiazene in the foam, which is not present in the foam and is not emitted from it at all, Philips claims that the dimethyldiazene that PSN supposedly detected was in fact acetone, a naturally occurring and routine compound that poses nowhere near the potential hazards.

• In claiming it had discovered that some of the CPAP and BiPAP devices it tested emitted ozone, another potentially toxic chemical, the company was wrong again. The company said PSN failed to use an appropriate ozone detector during testing.

• Insisting that another VOC—phenol—posed such a high risk to PAP users that the devices could not be used safely, PSN nevertheless ignored safety thresholds for that chemical identified in preclinical toxicity studies cited by multiple public health agencies, causing PSN to significantly overstate the risk from the levels of phenol detected.

Philips claims PSN “engaged in a massive cover-up, the scale of which was only recently understood” after the network was able to obtain the raw data via subpoenas.

The company has since organized an independent scientific panel to review the full range of available data and concluded that PSN’s findings were “the only outlier.” It claims that other independent labs have confirmed its conclusion that the foam carries a negligible risk of harm after evaluating samples of the same foam that PSN analyzed and conducting the same VOC tests on devices containing the foam. The company also claims that three other labs failed to identify any of the potentially hazardous VOCs that PSN falsely reported, and that further testing showed that other compounds of concern were within acceptable toxicological thresholds — often 100 times or more below levels of actual potential harm to users.

Philips is seeking to recover from PSN the significant costs and reputational damage it suffered as a result of the recall due to PSN’s errors. It is also seeking to recover damages it suffered as a result of PSN’s efforts to conceal its errors and undermine its conclusion that the foam was toxic.