As the Massachusetts Supreme Judicial Court is set to answer a certified question regarding a drug manufacturer’s failure to report adverse events to the Food and Drug Administration, a woman’s claims of failure to warn through reports to the regulator are allowed to proceed against the manufacturer and distributor of Korlym.

Anna Pietrantoni filed the civil action against Corcept Therapeutics Inc., in U.S. District Court for the District of Massachusetts, for its manufacturing, marketing, and distributing Korlym, as well as Optime Care, Inc., for contracting with Corcept to serve as the “‘sole specialty pharmacy and exclusive distributor’” of Korlym to patients. Korlym is a prescription medication used to treat symptoms associated with Cushing’s Disease and its active ingredient is mifepristone.