Supreme Court Denies Cert. in Rule 9(b) Pleading Requirements Case
Client Alert | 1 min read | 04.03.14
The Supreme Court has followed the government's recommendation (discussed in a previous bullet point and blog post) not to hear an appeal challenging the dismissal of relator's complaint in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, 707 F.3d 451 (4th Cir. 2013), for failure to allege specific false claims instead of a false scheme – an issue over which the government admits there is "at least some continuing uncertainty." The Court has invited the government's views on granting cert. in another prominent FCA case, KBR, Inc. v. U.S. ex rel. Carter (addressing the scope of the FCA's first-to-file bar and the Wartime Suspension of Limitations Act) (discussed here), but the Solicitor General has not yet weighed in.
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Client Alert | 14 min read | 12.22.25
European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU
On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.
Client Alert | 11 min read | 12.22.25
European Commission Proposes Simplifying the Rules on EU Medical and In-Vitro Diagnostic Devices
Client Alert | 3 min read | 12.22.25
Second Circuit Expands District Court Review of Magistrate Judge Report and Recommendations
Client Alert | 2 min read | 12.19.25
