Life Science Compliance Update

Search Results for: The Escobar Hurdle – False Claims, Materiality, and Dismissal

April

2018

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The Escobar Hurdle – False Claims, Materiality, and Dismissal

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Robert N. Wilkey, Esq.

U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court opted to vacate a nearly $350 Million FCA verdict involving a nursing home operator. The case is significant because it demonstrates the ongoing impact of a party’s failure to meet the Escobar materiality standard.


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June

2017

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Genentech & Escobar: Using Materiality to Escape False Claims Liability

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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.


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September

2017

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False Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up

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John Kelly, Julia Tamulis, and Robert Platt

Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in the eighth year of over $3 billion in FCA recoveries. Additionally, recent judicial decisions in FCA suits have further refined the test outlined in the Supreme Court’s 2016 Escobar decision, statistical sampling has resulted in significant FCA liability.


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March

2018

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Establishing the Link – The False Claims Act and Temporal Proximity

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Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board

Under the Patient Protection and Affordable Care Act of 2010, a provision was added to significantly strengthen the Federal Anti-Kickback Statute by making a violation of the AKS also a violation of the Federal False Claims Act. Thus, if a relator or government can prove that Anti-Kickback Statute was violated, then it would constitute a false or fraudulent claim under the False Claims Act. But, what type of evidence is needed to connect a kickback to a false or fraudulent claim? A recent United States Court of Appeals for the Third Circuit case, United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89 (3d Cir. 2018), answered this question. This article discusses that case and its implications.


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  • August

    2016

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    A Mixed Bag – Implied Certification in False Claim Act Cases after the Escobar Decision

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

    The United States Supreme Court, in its Court recent decision in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) reaffirmed that the government and realtors via qui tam suits can pursue False Claim Act (“Act”) liability against life science and healthcare companies. In doing so, the Court recognized such claims can proceed on an implied false certification theory. The Court also added a requirement that such parties must also demonstrate any misrepresentations were “material” on statutory, regulatory, or contractual requirements that make such representations misleading on those goods and services. Given that this heightened materiality standard is new, and the Court has remanded some cases for application of such new standard, the impact of Escobar on FCA liability will require a wait and see approach.


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    February

    2016

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    Through the Looking Glass – Exploring Transparency, False Claims Act, and Promotional Claims

    Written by , Posted in Enforcement

    By: Charles Sullivan, Professor of Law, Seton Hall University School of Law

    This article discusses the new white paper issued by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, analyzes the role of federal and state agencies, and their relationship with private “relators,” in direct and indirect enforcement of the Food and Drug Administration’s (FDA) off-label promotion rules.


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    September

    2017

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    Taking Center Stage – Washington State’s Medicaid Fraud Control Unit, the False Claims Act and Celegene

    Written by , Posted in False claims

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

    On July 26, 2017, the Washington State Attorney General Bob Ferguson announced one of the State’s largest recoveries against the pharmaceutical company Celgene for allegations involving violations of the Medicaid False Claims Act, in particular claims related to the company’s off-label marketing, fraudulent billing and providing kickbacks to doctors. The Washington State AG recovery represents a pivotal point in life science compliance, where State AGs, are actively seeking recoveries against companies that violate state and federal Medicare programs.


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    March

    2016

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

    Written by , Posted in 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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    August

    2017

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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.


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    March

    2018

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    Soldiering On – The False Claims Act Cases Continue to Significantly Impact Life Science Companies in FY 2017

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    Gwen Ball, Staff Writer, Life Science Compliance Update

    For FY 2017, the Federal False Claim Act continued to be a potent weapon for combating health care fraud by life sciences companies. However, while overall the settlements appeared to hold steady, there were more defendants and smaller settlements. This article explores the FY 2017 data for what it may reveal about the future of FCA cases against life sciences companies.


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    March

    2017

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    Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    We have seen many large False Claims and Anti-kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.


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    April

    2017

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    Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations

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    Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This article explores the most recent case involving Baxter Healthcare Corporation and some of its troubling implications.


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    February

    2018

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    Has the Shine Worn Off False Claims QUI TAM Actions

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    Gwendolyn Ball, Staff Writer, Life Science Compliance Update

    At the recent HCCA Annual Conference, the Deputy Director of DOJ’s Civil Fraud Section may have signaled a change in policy relative to handling qui tam cases. This article explores the issue and what it might mean for life science companies going forward.


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    May

    2016

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    Breathing Life into Privilege – Internal Corporate Investigations, Attorney-Client Privilege, and the False Claims Act

    Written by , Posted in Compliance operations

    Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
    Recent legal cases have highlighted the important issue of whether or not attorney-client privilege attaches to internal corporate investigations particularly if the investigations involve serious civil or criminal allegations relating to a breach of the public trust, including bribery, corruption, and violations of the False Claims Act (FCA).


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    July

    2016

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    Dentsply v. Bates: Taking a “Bite” Out of False Claim Act (FCA) Violations for Lack of Evidence

    Written by , Posted in Enforcement

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

    Recently the U.S. District Court for the Eastern District of Pennsylvania dismissed Plaintiffs’ qui tam False Claim Act (FCA) claims, finding that the plaintiffs had failed to produce any evidence that Defendants “influenced” any health care provider to submit a false claim for reimbursement to the federal government.


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