Hospira prevailed in a Florida lawsuit that alleged the Pfizer subsidiary falsely advertised its epinephrine products as being FDA approved.
Florida-based Belcher Pharmaceuticals claimed that Hospira knowingly marketed a 1 mg/mL ampule and a 0.1 mg/mL, 10 mL prefilled syringe, as having received the agency’s green light when in reality they were unapproved.
But Hospira argued that its previous owner, Abbott Laboratories, marketed and sold epinephrine prior to the Food, Drug and Cosmetic Act becoming law in 1938, meaning the products were grandfathered and did not require FDA approval.
U.S. District Court Judge James Moody, Jr. sided with Hospira, saying there was no evidence the company marketed the products as being agency approved. The company simply supplied the product at the FDA’s request during a time of significant shortage and ceased manufacturing when told to, he said in his summary judgment that ended the case.
“There is no evidence that Hospira explicitly marketed its epinephrine products as FDA-approved,” he said. The company “did everything the FDA requested to manage a severe shortage of a medically necessary drug.”