2013 was another banner year for False Claims Act (FCA) enforcement. The Department of Justice (DOJ) brought in $3.8 billion between October 1, 2012 and September 30, 2013, and the number of new FCA matters brought by self-proclaimed whistleblowers reached an all-time high of 753, an increase of more than 100 over 2012. DOJ recovered fully $2.6 billion from healthcare, pharmaceutical, and medical device companies, relying on a wide array of theories of liability, including misbranding, kickbacks, current good manufacturing practices and best comparable pricing commitments. DOJ’s November announcement that Johnson & Johnson and its subsidiaries had agreed to a global resolution of $2.2 billion was one reflection of the magnitude of the government’s enforcement goals, but equally telling as to what we can expect by way of major FCA settlements across the industry in fiscal year 2014.
This CLE program will not only focus on the “FCA Basics,” including why every pharmaceutical and medical device company lawyer should care about the FCA, but also on significant recent decisions affecting FCA liability, current enforcement trends, and best practices for managing the risk of FCA liability.
WilmerHale Partners Jonathan Cedarbaum and Karen Green are featured speakers at this event.