Drug and Device Enforcement Trends to Watch

Since the inception of the Health Care Fraud and Abuse Control (‘‘HCFAC’’) Program in 1997, the Medicare Trust Funds have received $25.9 billion in recoveries. A substantial portion of this sum has stemmed from allegations against pharmaceutical manufacturers relating to off-label promotion and the Anti-Kickback Statute (‘‘AKS’’). While prosecutors have continued to rely on these theories of liability, 2014 bucked the recent trend of billion dollar settlements resolving such allegations and also marked the lowest annual total of dollars received by the government under the False Claims Act (‘‘FCA’’) in five years. The evolution of the government’s enforcement priorities and focus of the qui tam relators’ bar cannot be predicted with certainty. However, what is certain is that government and private enforcement targeted at the industry will not soon abate and that both prosecutors and whistleblowers will continue to pursue new potential theories of liability.