This case arose from Medtronic’s failure to inform physicians and patients about a known risk of a medical device, which caused severe injury to Richard Stengel. Although the Food and Drug Administration initiated enforcement action against Medtronic for failing to inform its customers about the risk, and although Medtronic then sent an “urgent” letter to physicians to notify them and, soon thereafter, changed the warnings provided with the product through a recall, Medtronic argued that the Stengels’ state-law claims based on failure to warn about the risk were expressly and impliedly preempted by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act. After the Ninth Circuit Court of Appeals rejected Medtronic’s preemption arguments, Medtronic petitioned the Supreme Court for review.
Public Citizen served as co-counsel at the petition-stage in the Supreme Court. The opposition to the petition argued that Medtronic’s petition should be denied because the appellate court’s decision was correct on the merits under this Court’s precedents and implicated no conflict among the circuits. After considering the petition at its first Conference of the 2013 Term, the Supreme Court on October 7, 2013, requested that the Solicitor General file a brief expressing his views about whether to grant or deny the petition. In May 2014, the Solicitor General filed a brief recommending that the Court deny the petition and explaining why the Stengels’ claims are not preempted. In June 2014, the Court denied the petition.