US High Court Punts On ‘Objective Falsity’ FCA Standard
Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.
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A report from the law firm Gibson Dunn found that the US government brought more new cases under the False Claims Act last year than ever before, which they partially attribute to COVID-19 enforcement actions.
The Illinois senator pointed to an apparent mismatch between ongoing reports of equipment shortages, and alleged stockpiles of unsold masks.
Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.