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.