Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. Court of Appeals for the Eleventh Circuit
Ranbaxy Labs. Inc. v. First Databank, Inc.
Ranbaxy, a pharmaceutical company, seeks money damages and injunctive relief for alleged misrepresentations made by FDB, a company that publishes a drug information database for use by pharmacies across the United States. Ranbaxy alleges that FDB’s database, MedKnowledge, falsely represents that Ranbaxy’s acne drug Absorica is non-unique. The district court granted summary judgment to FDB. The court affirmed the order and judgment, concluding that Ranbaxy has not raised a genuine issue of material fact with regard to falsity. The court concluded that, because FDB provides ample explanation of the information and terms in its database, no reasonable reader would conclude that Absorica was therapeutically equivalent to or substitutable for other drugs. View "Ranbaxy Labs. Inc. v. First Databank, Inc." on Justia Law
Vitreo Retinal Consultants v. U.S. Dep’t of Health & Human Servs.
VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law