Court Injunction Stops Distribution of Adulterated and Misbranded Products
The U.S. District Court for the District of New Hampshire entered a consent decree of permanent injunction against Atrium Medical Corporation (Atrium), Maquet Holding B.V. & Co. KG (Maquet), Maquet Cardiovascular LLC (Maquet CV), Maquet Cardiopulmonary AG (Maquet CP), Heinz Jacqui and Gail Christie to prevent the distribution of adulterated and misbranded medical devices, the Department of Justice announced today.
The department filed a complaint on Feb. 3 in the U.S. District Court for the District of New Hampshire, at the request of the U.S. Food and Drug Administration (FDA), alleging that defendants introduced adulterated and misbranded medical devices into interstate commerce. According to the complaint, Atrium manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems.
The FDA’s Quality System (QS) regulation sets forth current good manufacturing practice requirements for medical devices. The QS regulation governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of all finished devices intended for human use. The regulation is intended to ensure that finished devices will be safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act (FDCA). A medical device that has been manufactured, packed, stored or installed in violation of the QS regulation is deemed to be adulterated.
“The American public needs to have the confidence that medical devices on the market are safe and effective,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. “The failure to comply with the quality system regulation for medical devices can pose a serious risk to the public health.”
According to the complaint, Atrium manufactures its medical devices at a facility in Hudson, New Hampshire. As set forth in the complaint, Maquet CV has a manufacturing facility in Wayne, New Jersey; Maquet CP has manufacturing facilities in Hechingen and Rastatt, Germany; and Maquet manages quality operations for the corporate defendants: Heinz Jacqui has been Maquet’s Chief Executive Officer and Managing Director since April 2012 and Gail Christie has been Maquet’s Corporate Chief Quality Assurance/Regulatory Affairs and Compliance Officer since October 2013.
According to the complaint, FDA inspections of Atrium’s New Hampshire facility revealed deviations from current good manufacturing practice requirements for medical devices. Specifically, the complaint alleges that during a 2013 inspection, FDA observed numerous deviations from regulations for medical devices, including a failure of the company to establish and maintain procedures for implementing corrective and preventive action. As alleged in the complaint, the violations of the QS regulation observed in 2013 were similar to observations FDA made in separate inspections in September 2012, March 2010, and March 2009.
In addition, according to the complaint, as part of the 2013 inspection of Atrium’s manufacturing facility, FDA documented a violation of the Medical Device Reporting regulation given the company’s failure to submit a medical device report within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a death or serious injury.
The complaint also alleges that FDA performed inspections at the Maquet CV’s and Maquet CP’s manufacturing facilities, and documented numerous violations of the QS regulation for medical devices.
In conjunction with the filing of the complaint, all of the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction, which requires the defendants to come into compliance with the FDCA and remedy past deficiencies in their current good manufacturing practices. The consent decree requires that Atrium’s manufacturing facility in Hudson, New Hampshire, be shut down (with limited exceptions) until corrective actions described in the consent decree are completed. Corrective actions include addressing the deficiencies previously identified by FDA.
Under the consent decree, Atrium is permitted to continue to manufacture and distribute certain medical devices deemed to be medically necessary. In order to do so, the defendants must comply with specific notification and other provisions in the consent decree. The consent decree also provides that the corporate defendants shall pay the United States $6 million in equitable disgorgement within 28 days after the entry of the consent decree.
“Patients must be assured that medical devices are safe, effective and high quality,” said Jan Welch, Acting Director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance.”
The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch, with the assistance from Assistant U.S. Attorney Michael McCormack of the District of New Hampshire and Assistant Chief Counsel Shannon Singleton of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.