Reverse False Claim Requires "Established" Obligation to Pay
Client Alert | less than 1 min read | 12.15.16
On December 13, 2016, the Fifth Circuit, reversing the district court, held in U.S. ex rel. Simoneaux v. E.I. DuPont De Nemours & Co that the 2009 amendments to the FCA did not abrogate its prior precedent holding that reverse false claims liability did not extend to potential or contingent obligations to pay unassessed government fines or penalties. Agreeing with both the defendant and, notably, the United States, the court concluded that, while the 2009 amendments clarified that the amount of the obligation need not be “fixed,” the duty to pay had to be “established” before liability could attach.
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Client Alert | 4 min read | 04.08.26
Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marked the most significant expansion of FDA’s authority over cosmetics in 80 years — and the agency is putting that authority to work. From the launch of a new adverse event reporting tool to forthcoming rules on fragrance allergens and good manufacturing practices (GMP), FDA is reshaping the regulatory landscape for manufacturers, packers, and distributors of cosmetic and personal care products.
Client Alert | 11 min read | 04.08.26
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Answering the Top Seven Questions About Pending Section 301 Deadlines
