Life Science Compliance Update

June

2017

COMMENTS

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June

2017

COMMENTS

0

Genentech & Escobar: Using Materiality to Escape False Claims Liability

Written by , Posted in False Claims

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc.(“Genentech”) of defrauding Medicare by way of concealing substantive health care analytics data involving purported side effects of the company’s cancer drug Avastin the Third Circuit of Appeals in a recent decision determined that the Plaintiff in this matter had failed to demonstrate that any noncompliance had an impact on government payments. Specifically, the Court applied the prevailing standard in Escobar that an FCA lawsuit must demonstrate that any misrepresentation is “material” to the government’s payment decision. In dismissing this suit and invoking this heightened standard of materiality, the Third Circuit not only reinforces Escobar but places the now clear burden on FCA Plaintiffs to demonstrate that any noncompliance was material to alleged fraudulent payments.

March

2016

COMMENTS

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Be Careful What You Sign Up For – Implied Certification and the False Claims Act (FCA)

Written by , Posted in Abstract, False Claims

By: Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court recently granted certiorari in the Escobar case from the 1st Circuit Court of Appeals that will significantly impact the way in which the False Claim Act (FCA) may impose civil liability. Given the overall purpose, scope, and intent of the FCA, we believe that the Court will seek to uphold rather than diminish the role of implied certification.

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