False Claims Act Liability: Defendant’s Belief Claims Were False Matters, Supreme Court Finds
In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.
You may also be interested in...
Justices cite changing circumstances, constitutional concerns in preventing government from seeking dismissal of a case in which it initially declined to intervene. They also question whether government should intervene before moving to dismiss.
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.