Case law update

✍ Scribed by John C. West

• Book ID: 102894480
• Publisher: Wiley (John Wiley & Sons)
• Year: 1996
• Tongue: English
• Weight: 875 KB
• Volume: 16
• Category: Article
• ISSN: 1074-4797
• DOI: 10.1002/jhrm.5600160107

✦ Synopsis

Facts: Eunice Beavers died on December 28, 1988, while undergoing coronary angioplasty. Her death was allegedly due to the failure of the catheter to deflate. The catheter used in this procedure was the Mini Profile triple lumen catheter distributed by Bard. Her family did not know of any of the problems associated with the use of the catheter until they were contacted by a newspaper reporter in November 1993 for their comment on the criminal case against Bard.

This particular catheter is a Class 111 device (a device that is designed for "use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health") under the FDA's classification scheme and, as such, it was subject to FDA regulations on pre-market approval and post-approval notification. Plaintiff alleged that certain employees at Bard began to willfully ignore the FDA's approval and notification requirements as early as 1987. Plaintiff further