FDA Bans Two Heart-Lung Bypasses for Use in Philadelphia and Across the US
Last week, the U.S. Food and Drug Administration has announced that Terumo Cardiovascular Systems Corporation (TCVS) has just signed a consent decree of permanent injunction. Two of the company's officers, Mark A. Sutter, president and CEO Mark Lincoln Vice President of Quality Assurance and Operations have had to personally sign the decree.
According to reports, the consent decree is being filed in the U.S. District Court for the Eastern District of Michigan and the Department of Justice, Office of Consumer Litigation, and the United Sates Attorney's Office. The consent decree will prohibit the manufacturing, sale, and distributing of two heart-lung bypass systems and other cardiovascular devices to new customers.
During an FDA inspection that spanned from January through March 2010, numerous cGMP and MDR violations at the company's Ann Arbor manufacturing facility were revealed. These violations could cause serious injuries to patients in the Philadelphia area and across the country. Violations included deficiencies in processes for corrective and preventive action, nonconforming product, complaints, purchasing, process validation, design controls, and adverse event reporting.
The company that made the devices, TCVS has previously profited $35 million for the sales of the devices. This amount will now be paid to the federal government as part of the legal action taken by the FDA. Additional disgorgement amounts will be charged should it fail to comply with the provisions of the consent decree in a timely manner.
This decree is meant to protect residents of Philadelphia and hospital patients across the country. If you or a loved one has suffered injury due to a faulty medical device or has been the victim of medical malpractice, contact a Philadelphia injury lawyer or a Philadelphia law firm today.