The Supreme Court's recent decision in Ford is sure to be framed by some as expanding—perhaps quite significantly—the availability of specific personal jurisdiction under the Due Process Clause. But the decision should not be...more
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 Background: In early December, the Supreme Court denied a whistleblower's request to review the Fifth Circuit's affirmance of the district court's dismissal of a False Claims Act ("FCA") case. This denial left the...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: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more
A case must be filed within either six years of the FCA violation or three years from when the government knew or should have known of the violation.
In Cochise Consultancy, Inc. v. U.S. ex rel. Hunt, the Supreme Court...more
5/16/2019
/ Appeals ,
Cause of Action Accrual ,
Cochise Consultancy Inc v United States ex rel Hunt ,
Dismissals ,
False Claims Act (FCA) ,
Intervenors ,
Limitation Periods ,
Qui Tam ,
Reaffirmation ,
Relators ,
Reversal ,
SCOTUS ,
Statute of Limitations
The Situation: The Sixth Circuit recently affirmed the certification of an issue class in a groundwater pollution case. The court endorsed a "broad" view of Rule 23(c)(4) under which common questions must predominate only...more
4/26/2019
/ Causation ,
Class Action ,
Class Certification ,
Contaminated Properties ,
Denial of Certiorari ,
FRCP 23(b)(3) ,
FRCP 23(c)(4) ,
Groundwater ,
Injury-in-Fact ,
Predominance Requirement ,
Property Damage ,
SCOTUS ,
Strict Product Liability
The Situation: Courts have disagreed over whether Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016), announced a mandatory test for implied certification liability under the False Claims Act ("FCA").
The...more
On June 18, 2018, the U.S. Supreme Court dismissed Leidos v. Indiana Public Retirement System, a securities case that raised important and unsettled issues about the scope of liability under Section 10(b) of the Securities...more
The Situation: A provision in the False Claims Act ("FCA") had clarified when Anti-Kickback Statute ("AKS") violations can make a claim false, but the provision's rule of per se falsity does not answer when a claim "result[s]...more
2/1/2018
/ Anti-Kickback Statute ,
Appeals ,
Charitable Donations ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Physicians ,
Relators ,
Stark Law ,
Summary Judgment
The Situation: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act.
The Result: Coyne v. Amgen is...more
1/15/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
Health Care Providers ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Prescription Drugs ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
11/28/2017
/ Acquiescence ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Statements ,
Government Knowledge Defense ,
Material Misstatements ,
Materiality ,
Medicare Part D ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar