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 | 5 min read | 03.22.26
EU Pharma Package: Regulatory Data Protection Compromise Proposal
In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.
Client Alert | 1 min read | 03.20.26
Client Alert | 6 min read | 03.20.26
Client Alert | 10 min read | 03.19.26
