Public Citizen v. Food and Drug Administration (Seprafilm)

Public Citizen sued the Food and Drug Administration (FDA) over its failure to respond to a Public Citizen citizen petition, submitted in 2015, asking the agency to ban the medical device Seprafilm. Seprafilm is a material used by surgeons during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissues that can block the intestine and cause other complications following surgery. As of July 2015, when Public Citizen filed its petition, the agency had received more than 500 reports of serious adverse events experienced by patients receiving Seprafilm, including at least 21 patient deaths following surgery.

The lawsuit seeks a declaration that the agency violated the Administrative Procedure Act by failing to act on Public Citizen’s petition and an order requiring the agency to respond.