Philips suing U.S. lab over sleep apnea machine recall; Says lab exaggerated the risks

Philips is suing an American research laboratory for the massive recall of its sleep apnea devices. According to the Dutch medical technology concern, PSN Labs made mistakes in its research that exaggerated the risks posed by the devices. Without those mistakes, the massive recall may never have happened, Eindhovens Dagblad reports based on the summons.

Philips says it largely based its June 2021 recall of 5.5 million sleep apnea devices worldwide on incorrect research results from the Pensylvania-based lab. The recall has already cost the company around 5 billion euros, including write-offs and settlements of damage claims. Philips is now claiming part of that money back from PSN Labs.

According to Philips, PSN Labs “made numerous serious errors in the testing and analysis” of the sleep apnea and respirator devices that were later recalled, and Philips suffered “significant damage” as a result. The company accuses the lab of “reckless and grossly negligent behavior.” According to Philips, it would have carried out “a different and more targeted recall” if the lab had not “overexaggerated the potential dangers to patients.”

Philips called the lab in March 2021 because small particles of insulating foam in the devices were coming loose. The company asked the lab to map out the health risks to users. PSN’s results were alarming. It found two types of gases released by the crumbling foam, including a carcinogenic one, and a hazardous substance. But later, other labs did not find the two dangerous gases at all, and the other hazardous substance remained well within the accepted limits. PSN was the only outlier in the studies, Philips said.

“With this lawsuit, we hold PSN responsible for the mistakes that were made, and in particular, the reprehensible actions of keeping their mistakes quiet after they had discovered them,” a spokesperson for Philips told Eindhovens Dagblad. Philips is holding PSN liable for the costs of the recall and the damage to its reputation.

“Philips regrets the concern that has arisen for patients and has continuously worked to map out the facts and learn from what happened,” the spokesperson said. “A key step in this process was that five independent, certified laboratories concluded that it is unlikely that the foam in these devices leads to health damage in patients.”

It is not clear whether PSN was the only lab on which Philips made the decision to recall millions of devices. However, the summons show that Philips had considered giving patients modified instructions instead of a recall. It wanted to advise users not to use certain devices for more than eight hours at a time to limit the ingestion of potentially harmful substances. The health tech company abandoned that plan because PSN found azomethane - a colorless, odorless, carcinogenic gas - in the sleep apnea devices. It later turned out to be acetone, which can cause irritation but not cancer.

It is not yet known when the case will appear in the Pennsylvania court.