The False Claims Act's ("FCA") use of qui tam relators (private individuals bringing suit on behalf of the government) has long raised both procedural and substantive challenges....more
In July 2021, a bipartisan group of senators introduced a bill, S. 2428, entitled the False Claims Amendments Act of 2021 ("S. 2428"), which proposed substantive and procedural amendments to the False Claims Act ("FCA")....more
11/2/2021
/ Burden of Proof ,
Burden-Shifting ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Authority ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Materiality ,
Proposed Legislation ,
Qui Tam ,
Regulatory Reform ,
Relators ,
Whistleblower Protection Policies
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
The Situation: A new line of qui tam cases predicated on alleged human trafficking violations has begun to emerge.
The Result: Potential exposure to qui tam claims heightens the risk of allegations of human trafficking...more
The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more
3/4/2020
/ Defense Strategies ,
Deficit Reduction ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
False-Certification of Conformance ,
Materiality ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Relators ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
The Situation: False Claims Act ("FCA") cases are high-risk matters, given their potential to result in "company-busting judgments."
The Strategy: The high stakes require defendants and their counsel to treat the budget...more
The Situation: Despite recently acknowledging the significant burden imposed by frivolous False Claims Act claims and affirming its statutory grant of power to dismiss meritless claims brought by relators, DOJ has maintained...more