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JUSTICE NEWS

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Tuesday, October 31, 2017
District Court Enters Permanent Injunction Against Philips North America and Two Executives to Limit Distribution of Adulterated External Defibrillators

A federal court enjoined Philips North America LLC (Philips) and two of the company’s executives from distributing certain medical devices, including some of the company’s external defibrillators, until the company takes remedial steps, the Department of Justice announced today.



The U.S. District Court for the District of Massachusetts entered a consent decree of permanent injunction against Philips, headquartered in Andover, Massachusetts, and two of the company’s executives, Carla Kriwet and Ojas Buch. Ms. Kriwet is the business group leader for the Patient Care and Monitoring Solutions (PCMS) business group within Philips. Mr. Buch is Vice President, Head of Quality and Regulatory for the PCMS business group. With limited exceptions, the consent decree permanently enjoins the defendants from distributing certain medical devices until remedial steps are undertaken.



“The Department of Justice is committed to protecting consumers and patients by ensuring that medical device manufacturers comply with the law,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “When a company fails to comply with legally required manufacturing standards, patients may be put at risk. The Department of Justice is committed to working with FDA to prevent these violations.”



The Department filed a complaint in the District of Massachusetts on Oct. 11, at the request of the U.S. Food and Drug Administration (FDA). As alleged in the complaint, FDA inspected Philips’ Bothell, Washington, facility in 2015. The inspection revealed that company had failed to establish and maintain adequate procedures for implementing corrective and preventive action as required by federal regulation. Specifically, the complaint alleged that while Philips initiated corrective and preventive action in response to complaints involving certain resistor failures during the use of the HeartStart HS1 and FRx defibrillators, Philips’ corrective actions did not fully address the problem with the devices in the field and Philips continued to receive complaints about the failure.



The complaint also alleged that another 2015 inspection by FDA at Philips’ Andover, Massachusetts, facility revealed the company’s failure to establish and maintain adequate procedures for implementing corrective and preventive action in connection with the company’s Q-CPR meter (a device that provides feedback on chest compressions during cardiopulmonary resuscitation), and for design verification in connection with a change to a battery used in the Heartstart MRx defibrillator.



The permanent injunction enjoins defendants, with limited exceptions, from manufacturing or distributing certain Emergency Care & Resuscitation devices until it can demonstrate that it has undertaken required remedial measures. The injunction also orders Philips to issue notifications with respect to its Q-CPR meters, and external defibrillators manufactured with a specific resistor. For the external defibrillators covered by the notice and still under warranty, Philips will provide a refurbished exchange unit at no cost; if the device is no longer under warranty, customers may be eligible for a trade-in rebate. Furthermore, the injunction requires Philips to take specific steps with respect to the company’s other PCMS business units at its Andover and Bothell facilities. Those steps include hiring an expert consultant to inspect these business units to ensure, among other things, that the methods and controls used to manufacture and distribute Philips’ PCMS devices comply with the federal Food, Drug, and Cosmetic Act and its implementing regulations.



“Manufacturing medical devices in violation of current good manufacturing practice is conduct that cannot be tolerated. This decree ensures that Philips will reform its practices and comply with the law,” said Acting U.S. Attorney William D. Weinreb, District of Massachusetts.



“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency,” said Melinda Plaisier, FDA Associate Commissioner for Regulatory Affairs. “People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk.”



The government is represented by Trial Attorney Alexander Sverdlov of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney George Henderson of the U.S. Attorney’s Office for the District of Massachusetts, with the assistance of Associate Chief Counsel Jennifer Kang of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.



Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/c...er-protection-branch. For more information about the U.S. Attorney’s Office for the District of Massachusetts, visit its website at https://www.justice.gov/usao-ma.

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Not knowing the full details and background story, I don't know whether this is about government red tape and the company simply not dotting all its I's and crossing its t's or whether there was definite management malfeasance or incomptence.

This is relevant to my interests. I have the HeartStart HS1, sold as the HeartStart Home and HeartStart OnSite.

It is difficult to find detailed information about the actual issue(s).

Working in the medical device manufacturing field this a huge issue.

FDA regulations require that we investigate all customer complaints and have a system in place to determine and apply any required corrective actions and preventive actions. Our quality department is possibly larger than our manufacturing department.

It is a lot of government red tape but in these cases you cannot depend on businesses to do the right thing without external oversight. The FDA showed up unannounced at our front door about 3 weeks ago for a site visit. We have one hour from when they identity themselves to have our audit team assembled and the audit started. This is the normal that we operate under.