Philips accuses lab which analysed apnea foam of major errors

Medical technology company Philips has filed a lawsuit against an American laboratory it claims made mistakes in its analysis of the foam used in sleep apnea devices, which led to a massive recall.

Philips said in the complaint, filed in Pennsylvania last week, it would have taken a different approach to the recall if it had not been for the results of the PSN tests, US media reported.

Philips alleges that PSN “committed numerous egregious errors” in its testing and analysis, and said PSN declined to share the raw testing data. “Philips RS has spent hundreds of millions of dollars toward this recall and would have pursued a different and more focused recall had PSN not made its serious mistakes and greatly overestimated the potential threat to patients,” the company said.

Philips began a recall of the sleep apnea devices in June 2021 after the US FDA said foam particles and chemicals released by the devices could cause headaches, irritation, hypersensitivity or nausea and have toxic or carcinogenic effects.

Philips is suing PSN for breach of contract and negligence and said it intends to recover expenses and reputational harm from the recall.

Philips has so far agreed to pay $1.1 billion to settle personal injury claims related to the devices in the US alone. Last year, Philips also settled a €575 million claim in the US to compensate patients for the cost of buying equipment which they said was not fit for purpose.

According to the Financieele Dagblad, the total cost of dealing with the sleep apnea affair has cost the company €5.2 billion so far.

Six of the 10 court cases are still being processed, of which the most important is the criminal case brought by the US department of justice. Two other cases have been brought by investors who want compensation for falling share prices.