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FDA not satisfied with Philips recall management, requests more testing

por John R. Fischer, Senior Reporter | October 09, 2023
Business Affairs
The FDA has requested that Philips perform more testing on its respiratory devices to rule out any risks.
According to the FDA, Philips has still not met the mark in terms of how it should handle the recall of its respiratory devices, prompting the agency to request that the company perform more risk testing.

In June 2021, the company recalled 5.5 million bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines after discovering that the polyester-based polyurethane (PE-PUR) sound abatement foam within them could break down and release particles that could enter a device’s air pathway and become toxic, possibly causing cancer.

Since then, the company has faced a barrage of legal claims brought against it, including 100,000 complaint reports and 385 deaths, reported Reuters. Just last month, it agreed to pay $479 million to resolve one category of legal claims for “economic damages” against it.

"We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices," said the FDA in its update on the matter.

The agency’s poor outlook on the company’s ability to efficiently rule out risks sent its shares down 9.6% on Friday, October 6. The recall previously cost it more than two-thirds of its market value in the 2021-2022 fiscal year, but the company has recovered some of this over the past year, according to Reuters.

In a statement, Philips said it has conducted testing with five independent, certified testing laboratories, that have said that its sleep therapy devices are not likely to pose harm to patients. Nevertheless, the company has agreed to perform additional testing on certain sleep and respiratory care devices.

“The FDA stated that the testing is extensive and conducted with independent parties, and expressed no concerns with the validity or objectivity of the testing. Philips Respironics is still in discussions with the FDA on the details of further testing,” said the company, adding that its first priority is the “health and well-being of patients.”

The agency told Philips in March 2022 to communicate more with the public about the recall, including issuing monthly updates. In May of that year, it proposed a repair/replace/refund order.

Philips continues to face personal injury claims and is being investigated by the U.S. Department of Justice in relation to the recall. It also is discussing a "consent decree" or settlement with the FDA.

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