Gebhardt

MEMORANDUM **

I.

In 1987, the Angelchik Anti-Reflux prosthesis device was implanted in Donald Hawkes’ upper abdomen by Dr. Chanour K Adrian to correct gastroesophageal reflux, the backward flow of stomach contents into the esophagus. The Angelchik controlled Hawkes’ reflux for approximately seven years with some side effects. During exploratory surgery in June 1994, doctors discovered that the Angelchik had apparently eroded into Hawkes’ stomach and pericardium. The device was subsequently removed from Hawkes’ upper abdomen. When Dr. Adrian chose to use the Angelchik device on Hawkes, he was familiar with the risks and benefits of the device based on personal experience, review of medical literature, and his interview with the device’s inventor. Dr. Adrian was also aware of an alternative surgical procedure, but he chose surgery with the Angelchik device because it was simpler and required less time under anesthesia.

After the device was removed from Hawkes’ abdomen, Hawkes brought an action against Mentor Corporation, who owned the rights to the Angelchik device, and Baxter Healthcare Corporation, who had previously owned the rights through a merger with American Hospital…