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Sample of What's to Come: Extrapolation in FCA Cases

Client Alert | less than 1 min read | 01.20.16

On September 29, 2015, the Fourth Circuit agreed to hear an interlocutory appeal in U.S. ex rel. Michaels. v. Agape Senior Community, Inc., to address whether the statistical method of extrapolation may be used to prove liability and damages under the FCA. In a "Feature Comment" published in The Government Contractor, C&M attorneys outline the origins of extrapolation, examine the divergent district court rulings on whether it may be used to prove damages, explain the significance of it to contractors facing FCA liability, and provide practice tips for litigating cases with statistical sampling.

Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....