Dive Brief:
- Philips said on Tuesday it reached a $4.2 million settlement with the U.S. Department of Justice under the False Claims Act over its IntelliVue MP2 Mobile Patient Monitor.
- The DOJ alleged that Philips sold the device to military customers after substituting key components of the device, without re-certifying it to ensure it was safe to use in aircraft.
- Philips is in the final stages of discussions on two other settlements with the DOJ, the company said in a statement. The discussions are related to its Connected Care portfolio, but are separate from the ongoing recall of sleep apnea devices and ventilators. Philips said in July it was in consent decree talks with the DOJ related to the sleep apnea recall.
Dive Insight:
From January 2012 through November 2018, Philips sold the MP2 patient monitors to the U.S. Air Force, Army, and Navy and to the Defense Logistics Agency, according to the lawsuit. The devices, which are now discontinued, provided patient vital signs and were designed to be used in transport or low-acuity settings.
According to the settlement, Philips received initial airworthiness and safe-to-fly certifications for the monitors from the Army in 2008 and the Air Force in 2011. Later, Philips made modifications to the devices, but did not notify military testing facilities. As a result, the DOJ alleged that the sales resulted in false claims.
In an emailed statement late Tuesday, Philips acknowledged that it didn’t adequately notify the relevant military certifying facilities to determine whether the device modifications would or would not require retesting to maintain airworthiness and safe-to-fly certifications.
The company said it had already recorded a provision in connection with the settlement. Philips didn’t disclose what other two settlements had reached the final stages of discussions, but said it has also recorded provisions related to those settlements.
