Consent Decrees and Permanent Injunction
Medical Device Manufacturers
2011 Consent Decree Between United States of America and Terumo Cardiovascular Systems, et al.
On March 22, 2011, the U.S. Food and Drug Administration announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.
The consent decree, to be filed in the U.S. District Court for the Eastern District of Michigan by the Department of Justice, Office of Consumer Litigation, and the United States Attorney’s Office, prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers.
The consent decree also restricts sale of these systems to existing customers until TCVS complies with the FDA’s current Good Manufacturing Practice (cGMP) and Medical Device Reporting (MDR) requirements.
TCVS also agreed to pay the federal government $35 million in disgorgement of profits derived from past sales and additional disgorgement amounts should it fail to comply with the provisions of the consent decree in an effective and timely manner.
“Medical device manufacturers must comply with the FDA’s current Good Manufacturing Practice and Medical Device Reporting requirements, as this action demonstrates,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “These requirements protect patients by assuring that medical devices are safe, effective, and high quality.”
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UNITED STATES OF AMERICA, Plaintiff,
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, a corporation; and MARK A. SUTTER and MARK LINCOLN, individuals, Defendants.
FDA enters consent decree with Medtronic, Inc.
April 27, 2015
The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.
The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use.
The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.
The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree. (read more)
UNITED STATES OF AMERICA, Plaintiff.
MEDTRONIC, INC .. a corporation, and S. OMAR ISHRAK and THOMAS M. TEFFT, individuals, Defendants.
2015 Consent Decree between United States of America and Atrium Medical Corp., et al.
On February 4, 2015, a federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium) in Hudson, New Hampshire; Maquet Cardiovascular, LLC (Maquet CV) in Wayne, New Jersey; and Maquet Cardiopulmonary AG (Maquet CP) in Rastatt and Hechingen, Germany.
Maquet and its related companies manufacture a wide variety of medical devices that are commonly used in hospital and health care settings, including oxygenators, tubing sets, catheters, life support systems, and surgical mesh.
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UNITED STATES OF AMERICA, Plaintiff,
ATRIUM MEDICAL CORP., MAQUET HOLDINGB.V. & CO. KG, MAQUET CARDIOVASCULAR, LLC, and MAQUETCARDIOPULMONARY AG, corporations, and HEINZJACQUI,and GAIL CHRISTIE, individuals. Defendants.
Dietary Supplement Manufacturers
UNITED STATES FILES COMPLAINT AGAINST THREE WISCONSIN DIETARY SUPPLEMENT MANUFACTURERS
The Department of Justice filed a complaint today alleging that three Wisconsin companies that manufacture dietary supplements were not complying with the U.S. Food and Drug Administration’s (FDA’s) current good manufacturing practices and were misbranding their products. The complaint was filed in the Eastern District of Wisconsin against Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and the owners of the three firms, James F. Sommers and Roberta A. Sommers. The companies, located in Wautoma, Wisconsin, sell dietary supplements to retail stores, healthcare professionals and directly to consumers via the Internet. (read more)
- Dr. David Lim with Regulatory Doctor provides regulatory consulting and training services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS)
Last Updated: 2015-08-06