George B. Breen, Erica Sibley Bahnsen, and Daniel C. Fundakowski, Members of the Firm in the Health Care & Life Sciences practice, co-authored an article in Law360, titled “FCA Enforcement and Litigation Trends to Watch.” (Read the full version – subscription required.)

Following is an excerpt (see below to download the full version in PDF format):

This article addresses select False Claims Act enforcement efforts and notable court activity from 2022, and trends and cases to watch in 2023.

DOJ 2022 FCA Recoveries

In fiscal year 2022, the U.S. Department of Justice filed 296 new FCA matters — the highest number of new cases brought by the government in reported history — but overall recoveries were the lowest in 14 years. Of the 296 new FCA matters, 93 related to the health care and life sciences industries, which was consistent with filings in fiscal year 2021.

Total FCA recoveries exceeded $2.2 billion, a drop of more than 50% from the $5.7 billion recovered in fiscal year 2021.

However, even in a down year likely due largely to the lack of major settlements with prescription opioid manufacturers, including a $2.8 billion resolution with Purdue Pharma LP in fiscal year 2021, health care and life sciences entities continue to be the primary focus of the enforcement effort by DOJ and relators.

More than $1.7 billion — over 80% of all recoveries — related to matters involving the health care and life sciences industries. Of the $1.7 billion recovered, $1.2 billion came from qui tam cases in which the government declined to intervene.

By contrast, $777 million was recovered in cases where the government intervened or otherwise pursued. This marks the first time since the statistics have been maintained that more monies were recovered from cases in which the U.S. declined than in cases in which the U.S. intervened.

Although total recoveries declined, it is notable that over 80% of recoveries were still from the health care and life sciences industries.

Health care and life sciences entities should expect continued focus from DOJ and relators, particularly following the pandemic, a time when investigations and litigations stalled. However, given the aggressive posture DOJ has taken with respect to enforcement and the increasing number of cases pursued by relators post-declination, we do not expect fiscal year 2023 to show a similar decline.

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