The US Department of Justice’s recent announcement of a $350m settlement by Shire PLC resolving allegations that the company illegally enticed physicians to prescribe the company’s Dermagraft artificial skin product brought fresh attention to the ongoing issue of False Claims Act enforcement. The settlement, DOJ said, was the largest ever paid in a device enforcement action. (Also see "Shire To Pay Record-Setting Device FCA Settlement" - Medtech Insight, 12 January, 2017.)
However, attorneys urged caution in making too much of the settlement. While $350m is a large amount for a device...