Clinical ColLABorative - Legal Insights in Laboratory Compliance

What To Do When The Government Knocks On Your Lab’s Door -

The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press release from the United States Department of Justice (DOJ) trumpeting a conviction of, or multimillion-dollar settlement with, a lab, lab owners, or lab personnel. In late April, for example, the DOJ announced a nationwide coordinated effort aimed at COVID-19 testing fraud, which encompassed target labs in California, New York, Florida, Maryland, and other states, and resulted in criminal charges against 21 defendants across nine federal districts. While the government certainly has invested significant resources in pursuing pandemic-related issues, the scope of enforcement in the lab space is far broader in regard to COVID-19 issues.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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