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State Higher Ed Entities Face Arm-of-the-State Test

Client Alert | less than 1 min read | 06.25.12

In US ex rel. Oberg v. Ky. Higher Educ., the Fourth Circuit considered whether corporate entities created by several states to provide higher education financing (and accused of making false claims to DOE) are "persons" subject to FCA liability. The court stated that "the critical inquiry is whether [the entities] are truly subject to sufficient state control to render them a part of the state, and not a 'person,'" and instructed that Eleventh Amendment "arm-of-the-state" analysis applies to determine if they are subject to liability.


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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....