Unanimous Supreme Court Holds that Implied Certification Can be Basis for FCA Liability
Client Alert | 1 min read | 06.16.16
On June 16, 2016, the Supreme Court handed down Universal Health Services v. United States ex rel. Escobar, holding unanimously that the “implied certification” theory can be a basis for False Claims Act (FCA) liability when a defendant submitting a claim makes specific representations about the goods or services provided, and fails to disclose noncompliance with material statutory, regulatory, or contractual requirements, thereby making those representations misleading. Although the Court rejected the First Circuit’s broad materiality standard (that any legal noncompliance is material so long as the defendant knows that the government would be entitled to refuse payment were it aware of the violation), it made clear that the underlying statutory, regulatory, or contractual requirement need not be an explicit condition of payment to trigger liability under the implied certification theory; rather, the test is whether the representation would likely influence government payment, a determination that may be made using both objective and subjective standards.
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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


