A Medtech Insight article reports on a False Claims Act panel including attorneys from the U.S. Department of Justice, Food and Drug Administration and private practice, moderated by life sciences regulatory & compliance counsel Beth Weinman (Washington, D.C.) at the Food & Drug Law Institute's 2021 Enforcement, Litigation and Compliance Conference.
The panelists reviewed recent trends in cases, predicted a continuing focus on anti-kickback violations and violations of FDA regulations, and suggested that the DOJ might soon be busy with allegations focused on pandemic-related fraud and abuse by life sciences and medical technology companies.
Beth noted that with unprecedented amounts of government funding flowing to medical products critical to the pandemic response, whistleblowers and DOJ might focus on “fraud in the inducement" theories, potentially including allegations that a company made key misrepresentations to obtain grants, loans, or other federal contracts. Other possible theories underlying FCA cases might include express contract violations, fraud on the FDA in order to obtain marketing authorization, misleading promotion, and billing for defective or deficient products.
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