Life Science Compliance Update

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July

2018

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When “Free” Really Isn’t Free – A Look at the Abiomed Case

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Robert N. Wilkey, Esq.

In March, the United State Department of Justice (DOJ) and U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million-dollar settlement with Abiomed to resolve allegations that the company was actively using illicit marketing tactics with physicians to increase sales in a manner that violated the AKS and FCA.  Such settlement highlights that there is no such as a free lunch.


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    October

    2016

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    GSK & China – The Latest FCPA Settlement Isn’t the End

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

    GlaxoSmithKline(“GSK”) reached a settlement with the Chinese government in 2014 related to bribes and improper actions taken by company officials. Recently, GSK reached an agreement with the United States Securities and Exchange Commission for allegations that GSK violated the FCPA. While the SEC settlement is nowhere near the value of the 2014 Chinese settlement, they are both worth taking a look at.


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    August

    2017

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    This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options

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

    In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol-Myers Squibb in a jurisdictional argument at the nation’s Highest Court. This article outlines the background, the case decision, and the decision’s ramifications to companies.


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    July

    2018

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    LSCU Free Articles

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    January

    2015

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    Sample Issue of LSC Update: A Look Back On A Busy 2014

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    The sample issue of Life Science Compliance Update looks back on what was a busy 2014 for the pharmaceutical and device industry.

    On the enforcement front, the Department of Justice was very active negotiating settlements involving kickback allegations. We look at the government’s activity in this space. The Physician Payments Sunshine Act was also a priority for the life science industry in 2014—this issue examines the rocky roll-out, the Open Payments data, and CMS’s often confusing interpretation of the continuing medical education reporting requirement. In keeping with the increasingly global nature of transparency, we also provide a useful resource for compliance with the EFPIA Disclosure Code. Finally, this issue provides an overview of three central antitrust issues facing the pharmaceutical industry, including the latest cases and legislation affecting competition.

    August

    2016

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    Misleading Survival Data Leads to FCA Liability in Recent Genentech Case

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    Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
    The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful attempts. However, the recent Genentech settlement may illuminate a path to success for the DOJ utilizing the False Claims Act. This article outlines the Genentech case, why it is different from other off-label cases, and what compliance officers can do to prevent their company from experiencing the same fate.


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    April

    2016

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    The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability

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

    The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration (FDA) of medical devices for “single limited use” shields and otherwise immunizes manufacturers from product liability suits results from non-FDA approved uses.


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    July

    2018

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    October

    2016

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    EFPIA HCP Financial Disclosure Is Not Risk Free

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    Ulf H. Grundmann, Partner, King & Spalding LLP, Frankfurt a.M. (Germany) and Elisabeth Kohoutek, Associate, King & Spalding LLP, Frankfurt a.M. (Germany)

    A large number of pharmaceutical companies across Europe had until June 30, 2016 to disclose their financial interactions with health care professionals (HCPs) in order to comply with the guiding principles of the EFPIA disclosure code. There are several legal regulations complicating compliance with EFPIA disclosure requirements. This article explores those complications.


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    August

    2016

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    Transparency Across the Pond – A Look at Efforts in Germany and the UK

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

    On June 30, 2016, transparency efforts around the world released numbers on financial interactions between industry and physicians. This article goes through recent releases in Germany and the United Kingdom, including analysis on where the money is coming from, and who it is going to.


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    March

    2017

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    Do DPA’s Work? – The BioMet Case Study

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    Robert N. Wilkey, Esq., LSCU Staff Writer

    On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer BioMet) had agreed to pay a $17.4 million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act (FCPA) involving the company’s operations in Mexico and Brazil.” This is not the first time BioMet faced allegations involving its business practices in foreign countries, and in 2012 entered a deferred prosecution agreement (DPA). The BioMet settlement highlights the significant liability life health science companies face when failing to adhere to DPAs and how large-scale settlements are used by the government to ensure industry compliance.


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    March

    2018

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    Uncle Sam Wants His Money – First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate in FCA Liability

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

    In October 2017, First Coast Cardiovascular Institute, entered into an almost $450,000 settlement with the DOJ to resolve allegations that it violated the False Claims Act by knowingly delaying repayment of more than $175,000 in overpayments. This settlement involving First Coast is a substantive example of how failing to make timely repayment can bring substantial, additional liability under the FCA. Therefore, it is crucial to ensure timely repayment to and reconcile any overbalances with the U.S. Government.


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    February

    2015

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    February

    2015

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    August

    2015

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    August 2015: Life Science Compliance Update Volume 1.6

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    The August issue of Life Science Compliance Update provides an interesting look at the recently released 2014 Open Payments data. One article outlines the drastic decline in research payments from 2013. Another looks into what manufacturers are writing in Open Payments comment spaces—free-text boxes that allow manufacturers to offer context to their various transfers of value.

    Also in this month’s edition, Paul Silver, the Managing Director and Practice Leader at Huron Life Sciences, as well as other members of his team at Huron, contributed an article entitled “Open Payments Driving Adjustments in HCP Engagement Practices.” The article provides insight into how organizations may use Open Payments for compliance and commercial insights. The article includes specific examples from the Open Payments database, and offers best practices for how to analyze the information.

    The issue also features an article on the Open Payments “Review and Dispute” process by Abraham Gitterman, JD, an FDA/Healthcare Associate at the law firm Arnold and Porter. In it, Gitterman offers recommendations for manufacturers to consider when addressing physician disputes, not only to resolve inaccuracies to ensure compliance with the Sunshine Act, but also to identify and potentially mitigate additional compliance risks that may arise from or be attributed to disputes.

    This publication also includes an article titled “Ensuring Compliant MSL Interactions with Healthcare Providers.” As manufacturers continue to move away from a traditional sales rep model, the government has adjusted its spotlight onto how Medical Science Liaisons (MSLs) interact with healthcare providers. This article provides a look at risk areas and government guidance for compliance within the MSL role.

    To view the table of contents for this issue, click here.

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