1. Home
  2. |Insights
  3. |Earlier Complaint Fails 9(b), But Bars FCA Suit

Earlier Complaint Fails 9(b), But Bars FCA Suit

Client Alert | 1 min read | 11.08.11

Addressing a question of first impression for it, the D.C. Circuit in U.S. ex rel Batiste v. SLM Corp. held that the FCA’s “first-to-file” rule deprives the district courts of subject matter jurisdiction when a complaint filed earlier alleges “the same material elements of a fraudulent scheme,” even if the earlier complaint did not meet the heightened standard of Rule 9(b).  In so holding, the D.C. Circuit disagreed with the Sixth Circuit in Walburn v. Lockheed Martin Corp., noting that nothing in the FCA incorporates Rule 9(b)’s particularity requirement into the first-to-file rule and that the earlier complaint was sufficient to allow the government to investigate the fraudulent scheme.

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....