Abiomed and the Abiocor Clinical Trials (a)

To protect patient confidentiality, Abiomed, makers of the AbioCor artificial heart, adopt a 30-day "quiet period" surrounding implantations, which is construed by mainstream media as a "news blackout." In late 2002, James Quinn, the fifth transplant recipient, dies after 289 days. A month later, in a New York Times article describing Quinn's pain and suffering, Quinn's widow claims that her husband had not been adequately informed of the likely ordeal. This case raises issues about transparency and communication with stakeholders. The A-case may lead some students to focus on the public sensationalism surrounding the Quinn story, but a closer examination of the case reveals that the more urgent issue for AbioMed is getting the stalled clinical trial back on track and raising a slumping stock price. The B-case provides a detailed epilogue, including reactions to the Quinn's informed consent lawsuit and AbioMed's handling of the on-going clinical trial and investor relations. Excerpt UVA-BC-0204 January 25, 2010 ABIOMED AND THE ABIOCOR CLINICAL TRIALS (A) On November 5, 2001, James Quinn became the fifth recipient of the AbioCor implantable replacement heart; he lived for 289 days. About a month after his death, the New York Times ran an article chronicling Quinn's experience. According to Irene Quinn, the patient's wife, the Quinns had not been prepared for the pain and suffering they would endure. Irene faulted the experimental procedure for James' poor quality of life in his remaining days. While the Quinns adored their surgeon, they came to regret their participation in the AbioCor clinical trial, fired a patient advocate who was to assist them with ethical decisions, and hired a malpractice attorney. Long before the clinical trials began, Abiomed, maker of the artificial heart, had carefully considered how to ethically manage their many stakeholders' information needs. Before enrolling a patient in a clinical trial, the company counseled the patient about what to expect, formalizing these conversations with an “informed consent” agreement. Regarding transparency during the clinical trial, the company had to weigh the “good” of protecting patient confidentiality against the “good” of disclosing news and keeping investors and the public informed about experimental results. To avoid the kind of sensational media reporting that had besieged previous artificial heart recipients, the company went to great lengths to manage the expectations of a public eager for a medical breakthrough. Reasoning that putting patients first had to be the highest priority, Abiomed adopted a 30-day “quiet period” before reporting any news related to a new implantation. Although some had questioned Abiomed's communication policies prior to the Times article, the company had managed initially to attract favorable media attention. But circumstances had begun to sour. General economic conditions stagnated following the terrorist attacks of September 11, 2001. Then, when Abiomed researchers were unable to find volunteers healthy enough to survive the procedure, the trials stalled. Consequently, investor confidence diminished, lowering the company's stock price throughout 2002. . . .