September 28, 2022

Philips to pay $4.2 million in DOJ settlement for changes to patient monitoring device

[Image from Philips’ website]

Philips (NYSE: PHG) today agreed to pay approximately $4.2 million to resolve allegations of replacing key components of a monitoring device.

The company has settled with the US Department of Justice (DOJ) allegations that it replaced components of its Intellivue MP2 mobile patient monitoring device that it sold to military buyers without rectifying the device for military airworthiness. .

A spokesperson for Philips said that among the company’s discussions with the DOJ, it has reached the final stages of settlement discussions regarding three separate issues, all related to its connected care portfolio. This is the first of three regulations to have been announced.

Despite their relationship to the connected care portfolio, none of the three settlement discussions are related to Philips Respironics’ June 2021 recall, which the company is also in talks with the DOJ for.

According to a DOJ press release, from January 1, 2012 to November 27, 2018, Philips sold the MP2 devices to the US Air Force, US Army, US Navy and Defense Logistics Agency. Agencies require airworthiness and flight safety testing and certification of medical devices used in certain aircraft environments. Such testing by military agencies ensures that a device does not affect the operation of aircraft systems while conversely confirming that the aircraft does not affect the proper operation and effectiveness of equipment. medical.

In the settlement agreement, Philips admits that after receiving initial airworthiness and flight safety certifications for the MP2 from the US Army in 2008 and the US Air Force in 2011, the company made changes to MP2 but did not notify the appropriate military test facility sufficiently to determine whether the modifications required retesting for certification.

The result was civil claims from the United States alleging that Philips had submitted/caused the submission of false claims to the United States military.

“By agreeing to this settlement, Philips acknowledges that it has not adequately notified the applicable military certification facilities to determine whether or not the device modifications would require retesting to maintain military airworthiness and safety certifications. theft,” the Philips spokesperson wrote.