Mr. Roberts

Mr. Roberts was admitted to the University Medical Center with heart failure. He was well known to the staff, having had quadruple bypass surgery 10 years prior when he was 55. He had been a frequent visitor to the cardiology and surgery service with various heart complications since then. After a long night of tests and consultations, the cardiology team diagnosed Mr. Roberts with end-stage heart failure. Due to his past medical history, he was deemed to be ineligible for a heart transplant. Visibly distressed by the news, Mr. Roberts, his hands tightly clasping his wife's, asked the attending physician about his prognosis. In his current condition, he was told, he probably had a month to live. "Come on doc, there must be something you can do." The attending physician told Mr. Roberts he would consult with his colleague, Dr. Jones, to see whether there were any treatment alternatives.

Dr. Jones, an eminent cardiac surgeon at the medical center, had been preoccupied with transplants and machines since his medical school days. Although he had performed numerous heart surgeries in his 25 years of practice, the goal of creating a cardiac device that would eliminate the problems of rejection or failure had long been in his dreams. For the past 20 years, he had been developing an artificial heart in collaboration with its manufacturer, Hipprotech. In the past year the FDA approved the device for a clinical trial with humans, and 10 months ago they implanted one in a patient to much fanfare.

Although the implant occurred without incident, the patient sustained several embolic strokes and died after two months. The autopsy had shown a thrombus within the artificial heart, a problem thought to have been resolved in developing the device. After deliberating, Dr. Jones's group had decided to press ahead with the trial and to collect more data from the next eligible patient to determine whether the clotting problem was device-based or due to the patient, as well as to gather more data about the implant.

They could not decide, however, whether to disclose the clotting problem to the next patient. It was not part of the informed consent protocol, but some of Dr. Jones's colleagues argued that the problem might be in the device. They adjourned the meeting without a consensus. At that point, the cardiology service paged Dr. Jones with the news of a new candidate for the trial. Driving in to the hospital, he was excited about continuing his research. On arrival, he found that the patient's file was already on his desk. Eager to familiarize himself with the profile before talking to the patient and family about joining the trial, he immediately flipped open the folder. To his surprise, the patient was one that he had operated on several times in the past decade: Mr. Roberts.