Recent False Claims Act cases highlight key considerations for U.S. Food and Drug Administration-regulated life sciences defendants navigating FCA litigation and considering a request for a government-initiated dismissal. A cross-practice team examined the issue in a Law360 article published on Dec. 12.
The attorneys explain that if a drug or medical device company finds itself subject to a qui tam whistle-blower FCA action, it should highlight the considerations outlined in the Granston memo, in discussions with the DOJ as the government weighs whether to intervene in the case, or in requesting a government initiated dismissal of the case. They note that continued relator-driven civil litigation of meritless FCA cases in the drug and medical device fields, where the FDA has important policy interests and powerful regulatory tools and authority, could ultimately lead to a negative impact on the public health.
The article was authored by life sciences regulatory & compliance counsel Beth Weinman, appellate & Supreme Court partner Douglas Hallward-Driemeier (both of Washington, D.C.), and life sciences regulatory & compliance associate Joshua Oyster (Washington, D.C.).
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