As 2022 came to a close, the U.S. Department of Justice (the “Justice Department” or “DOJ”) demonstrated a continued and dogged pursuit of criminal prosecutions and civil actions under the federal Anti-Kickback Statute (“AKS”)[i] and the False Claims Act (“FCA”)[ii] against medical device companies. DOJ’s biggest enforcement priority in the medical device industry (at least as evidenced by the quantity and breadth of its investigations) remains commercial corruption (i.e., the use of kickbacks and/or inducements),[iii] which it targets through criminal and civil enforcement of the AKS.[iv]
Aggressive AKS investigations presuming that a company’s marketing efforts run afoul of the statute’s “one-purpose” test are thus apparently here to stay. But while corruption in federal programs remains at the forefront of enforcement activity, DOJ has increasingly targeted product safety and quality misdeeds through the FCA.[v]
This increased focus and use of the FCA to target product quality and
safety issues is unsurprising, as Principal Deputy Assistant Attorney General Brian M. Boynton (“Boynton”), head of the Justice Department’s Civil Division, has stated that the FCA “is one of the most important tools available to the department both to deter and to hold accountable those who seek to misuse public funds,”[vi] and that the government, through FCA enforcement, “will not permit companies to . . . put profits over patient safety.”[vii]
And, as can already be seen in the first few...
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