Healthcare Enforcement & Litigation 2020

Healthcare Enforcement & Litigation 2020

Pages: 112

ISBN: 978-1-83862-159-9



  • £300.00

Providing a global overview of the regulation and investigation of the healthcare industry, Healthcare Enforcement & Litigation contains expert analysis across 14 jurisdictions. 

Published in September 2019, this edition features the following chapters:

Editorial chapters

  • Global Overview
    • Michael K Loucks, Jennifer L Bragg and Alexandra M Gorman, Skadden, Arps, Slate, Meagher & Flom LLP

Jurisdictions

  • Brazil
  • China
  • France
  • Ireland
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Switzerland
  • Turkey
  • United Arab Emirates
  • United Kingdom
  • United States
  • Michael K Loucks, Skadden, Arps, Slate, Meagher & Flom LLP

    Michael K Loucks is an experienced trial and appellate attorney whose practice focuses on internal investigations and government enforcement matters in the United States and abroad, and on false claims act litigation in federal and state courts. Prior to joining Skadden in 2010, Mr Loucks had most recently served as acting US attorney and first assistant US attorney for the District of Massachusetts.

    Since joining Skadden in 2010, Mr Loucks’ practice has focused on representing companies in government criminal investigations, in False Claims Act and other civil litigation, in regulatory matters with the Food and Drug Administration and the Office of Inspector General, and in Foreign Corrupt Practices Act investigations. He has represented companies and individuals around the world from a wide variety of industries, including healthcare, pharmaceutical and biotech, medical devices, energy and natural gas, transportation and shipping, private equity, publishing and insurance, among others.

    He has advised on corruption and prosecution matters in Latin America, Europe and Asia, and has represented clients under US federal and state investigations in numerous jurisdictions. His government investigations work has involved off-label promotion and anti-kickback issues; best price and average sales price reporting issues; numerous Medicare issues, including billing, secondary payer and Part C risk adjustment payment system matters; data submissions to the Center for Medicare and Medicaid Services; consumer fraud issues; HIPAA data breaches and violations; alleged violations of the Clean Air Act; and FCPA issues in a variety of industries.

    Jennifer L Bragg, Skadden, Arps, Slate, Meagher & Flom LLP

    An experienced regulatory and litigation attorney, Jennifer L Bragg advises FDA-regulated companies, as well as hospitals and healthcare systems, facing government investigations and US Food and Drug Administration (FDA) enforcement challenges. She frequently represents pharmaceutical, medical device and food companies in crisis management situations related to products that have manufacturing or quality issues, helping them navigate the myriad of matters that arise in the context of product recalls, and also counsels on compliance, advertising and promotion issues. Additionally, Ms Bragg conducts due diligence and related counseling in connection with transactions in the life sciences and healthcare industries.

    Her work often involves developing strategies to help companies resolve regulatory issues to minimise litigation and enforcement risks, as well as overcome transactional hurdles.

    From 1998 to 2003, Ms Bragg served in the FDA’s Office of Chief Counsel as associate chief counsel for enforcement, where she provided advice to the FDA’s Office of Criminal Investigations. During that time, she tried to verdict four criminal jury trials involving violations of the Federal Food, Drug and Cosmetic Act (FDCA) and other federal statutes. Her matters involved compounding pharmacies, unapproved pharmaceuticals, controlled substances, misbranded devices and food-related good manufacturing practices (GMP). She was also designated by the DOJ to serve as a special assistant US attorney in various districts throughout the country regarding ongoing criminal investigations under the FDCA. Additionally, Ms Bragg served as the FDA Office of Chief Counsel’s primary liaison with the Office of Criminal Investigations relating to policy issues.

    Alexandra M Gorman, Skadden, Arps, Slate, Meagher & Flom LLP

    Alexandra M Gorman represents pharmaceutical, medical device and biotech companies, and healthcare providers in connection with civil and criminal investigations, as well as in litigation, enforcement and regulatory matters.

    Ms Gorman has represented numerous pharmaceutical and medical device manufacturers, health maintenance organisations and corporations in False Claims Act and criminal or civil investigations and litigation by the US Department of Justice. She has significant experience conducting internal investigations relating to the federal and state anti-kickback statutes, off-label promotion, Stark law, Medicare and Medicaid reimbursement, and other allegations of healthcare fraud and abuse. Ms Gorman has counseled healthcare companies and individuals in connection with the Foreign Corrupt Practices Act, Food and Drug Administration, Office of Inspector General and other agency regulations. Ms Gorman regularly advises clients on regulatory compliance matters, including voluntary disclosure of potential statutory and regulatory violations to appropriate government agencies and compliance with federal regulations regarding sales, marketing and pricing practices, medical affairs and clinical research. She also has managed discovery, settlement and pretrial proceedings on behalf of pharmaceutical clients in products liability actions in Massachusetts.


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