Life Science Compliance Update

August

2017

COMMENTS

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA

Written by , Posted in False Claims

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

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court decision in Universal Health Care v. Escobar, which effectively raised the legal burden by whistleblowers to demonstrate claims under the FCA.

July

2017

COMMENTS

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Punting on the Issue of FCA and Statistical Sampling

Written by , Posted in False Claims

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

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases.

July

2017

COMMENTS

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Pharmaceutical and Device Manufacturers: Buyer Seller Beware

Written by , Posted in False Claims

John Kelly, Matt Curley and Rob Platt

Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.

June

2017

COMMENTS

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June

2017

COMMENTS

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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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