Two recent cases suggest that the Department of Justice (DOJ) may be more open to deferred prosecution agreements (DPAs) as a vehicle to resolve False Claims Act (FCA) suits. Just recently on January 4, the U.S. Attorney’s Office for the Southern District of Illinois announced that a Pennsylvania medical device company simultaneously agreed to settle an FCA case against it, while entering into a DPA that included monetary penalties and an admission of guilt. The government deployed a similar strategy in July 2022 when a specialty pharmacy agreed to settle an FCA case brought in the District of Massachusetts in exchange for, among other things, a DPA. These two recent cases suggest a willingness on behalf of the government to consider DPAs in return for a corporate admission of liability to charges filed via criminal information as a means of resolving allegations of fraud typically addressed through civil False Claims Act cases.
The most recent case involved Jet Medical, Inc. (Jet), the manufacturer and distributor of Allevio, a device intended to treat migraine headaches. Jet was charged in a one-count information with introduction of misbranded devices into interstate commerce under the Food, Drug, and Cosmetic Act. The information alleged that Jet never sought the proper clearances to market Allevio, and instead, listed it as exempt from FDA approval under a regulation designed for ”[e]ar, nose, and throat drug administration device[s].”
Concurrently with the filing of...
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