The finer points of when exactly the US government can collect from a device company for selling it a bill of goods are under reconsideration, even as the fast pace of False Claims Act suits continues, attorneys with law firm Gibson Dunn concluded during a series of recent webinars.
Can a manufacturer be held liable for violating the US False Claims Act if it never directly lied to the government? Some recent court cases suggest it’s possible, attorneys say.
The question was raised by the US Supreme Court’s 2016 Escobar decision, which held that a company could be held...
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
