Defective Complaint Can Still Have Preclusive Effect Under FCA's First-to-File Bar
Client Alert | 1 min read | 06.12.13
In U.S. ex rel. Heineman-Guta v. Guidant Corp. (May 31, 2013), the First Circuit weighed in on a jurisprudential split over the FCA's first-to-file bar between courts that hold that the earlier-filed complaint must meet Rule 9(b)'s particularity requirement for pleading fraud in order to have preclusive effect and those that do not. Affirming the dismissal of the relator's claims, the First Circuit joined the D.C. Circuit and other district courts in rejecting the application of Rule 9(b) to the first-to-file bar and holding that dismissal is appropriate so long as the earlier complaint put the government on sufficient notice to initiate an investigation into the alleged fraud.
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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
Client Alert | 3 min read | 04.07.26
Answering the Top Seven Questions About Pending Section 301 Deadlines
