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R. Jeffrey Layne

Head of Business Readiness and Development, United States

R. Jeffrey  Layne

Austin

T:+1 512 536 4593

Industry-leading health care and life sciences companies turn to Jeff not only to mitigate compliance and legal risks but also to achieve key business objectives. As each company defines success differently, Jeff applies his industry knowledge and legal background to support his client's goals, both inside and outside of the courtroom. Jeff is known for synthesizing his legal advice and strategy to fit the current issue at hand, while also balancing his client's business needs.

Jeff is a seasoned litigator, representing clients in complex government and internal investigations and related litigation. He is well-respected by governmental investigators and accustomed to managing complex disputes. Equally important, outside of the courtroom he and his team help companies build compliance and monitoring programs to mitigate risks inherent to their business operations.

Jeff and his Austin-based team (co-led by Ben Koplin) have developed industry-leading risk mitigation services and tools, including the firm's proprietary information analysis platform, NSight. NSight, along with other tools, analyzes clients' business and compliance systems, providing a detailed view into compliance and business risks, case defenses, and opportunities for improvement and future success. This process often includes turning the lessons learned in investigations and litigation into real, actionable business solutions to avoid litigation in the future.

Jeff and his team have successfully defended health care and life sciences companies in criminal, False Claims Act, commercial, and administrative litigation related to a wide variety of fraud and abuse, bribery, billing, marketing, and other regulatory allegations.  Their clients cover the spectrum of the healthcare industry, including pharmaceutical and medical device manufacturers, hospital systems, universities, retail and specialty pharmacies, distributors, suppliers, and managed care organizations.

Apart from his practice, Jeff is recognized as an industry leader in the innovation of legal services. He co-leads the firm's global R&D center, as well as the US Business Readiness and Development change leadership initiative, focusing on the generation and adoption of new legal solutions and services, including adoption of the firm's global SAP practice management system.  Jeff also serves as a member of Norton Rose Fulbright's Global Supervisory Board and Audit Committee.

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  • Education

    1998 - MPH., Harvard University
    1994 - JD, Duke University Law School
    1990 - BBA., magna cum laude, Finance, Texas Christian University

    Jeff was admitted to practice law in Texas in 1994 and in the District of Columbia in 1999.

  • Representative experience
    • Representation of medical device company ArthroCare in federal criminal investigation of alleged $750 million healthcare and securities fraud that ultimately lead to the felony conviction of the company's former CEO and CFO.  Through strong advocacy and meaningful cooperation, we secured a favorable outcome for the company, including a substantial fine reduction and a two year deferred prosecution agreement with no monitor.
    • Representation of Xerox Business Services in investigation by the Texas Attorney General of alleged $900 million healthcare fraud case related to the company's administration of the state's Medicaid program. Strong advocacy at the investigation stage established key defenses to the alleged misconduct.
    • Representation of The Scooter Store in federal criminal investigation of health care fraud, which began with a raid of company headquarters by 150 federal agents.  The heavily-publicized raid caused catastrophic economic damage to the company. We robustly defended the company, ultimately working with DOJ and Medicare to keep the company in business during the ongoing investigation of the company and its executives. Although the economic damage to the company was too great to overcome, the case ended with no charges filed.
    • Representation of one of the nation's largest post-acute provider chains in federal False Claims Act investigation of alleged billing fraud spanning dozens of facilities and alleging hundreds of millions of dollars in damages. Our defense of the company was built on industry-leading understanding of the relevant regulations and rules, and use of analytical tools such as NSight to build a defense base on the company's own systems and data demonstrating compliance.
    • Representation of leading global medical device manufacturer in federal False Claims Act lawsuit alleging bribery scheme built around surgeon consumer preference surveys. The Department of Justice declined the case after we marshaled evidence from across the company and its business systems to prove the legitimacy of the program.
    • Representation of leading global pharmaceutical company in federal False Claims Act case alleging off-label marketing and physician kick-backs. We obtained a dismissal of the case on Rule 9(b) grounds, and that dismissal was confirmed on appeal.
    • Internal investigations of alleged violations of federal anti-bribery statutes, including Foreign Corrupt Practices Act for global medical device company.
    • Representation of multiple acute care hospitals in federal False Claims Act investigations regarding Medicare bills for "one-day stays." While similar cases around the country were settling for tens of millions of dollars, we advocated for successful declinations by proving up the reasonableness of the our clients' compliance efforts. 
    • Assessment and development of industry-leading global compliance plans and infrastructures.
  • Admissions
    • District of Columbia Bar
    • Texas State Bar
  • Rankings and recognitions
    • The National Law Journal, Litigation Trailblazer, ALM Media Properties LLC, 2015
    • Client Choice Award, Texas: health care and life sciences, International Law Office, 2013
    • Best Lawyers in America, Best Lawyers, 2018
    • Texas Super Lawyer, health care, Thomson Reuters, 2017
  • Publications
    • Co-author, "Changes Proposed to Sunshine Act Reporting: Would Remove CME Exclusions May Broaden Availability of 'Indirect-Payment' Exclusions," Compliance Commoner, July 2014
    • Co-author, "CMS Delays Data Submission at Least 30 Days," Health Law Update, February 19, 2014
    • Co-author, "CMS Offers New Resources and Guidance on Two-Phase Approach to Sunshine Act Reporting," Sunshine Act forecast, February 2014
    • Co-author, "New Data Submission Resources Available for Sunshine Act Reporting," Norton Rose Fulbright - Sunshine Act forecast, November 4, 2013
    • "Principally in charge of Sunshine Act Task Force publications"
    • Co-author, "Industry user guide released," Norton Rose Fulbright - Sunshine Act forecast, August, 19, 2013
    • Co-author, "CMS publishes new Sunshine Act resources", Norton Rose Fulbright - Sunshine Act forecast, August, 8, 2013
    • Co-author, "The Sunshine Act's international reach," Norton Rose Fulbright - Sunshine Act forecast, July 3, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Hosts a National Provider Call Relating to the Open Payments Program." Sunshine Alert, May 22, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Request for Comments; Data Templates and Teaching Hospital List Available," Fulbright's Sunshine Act Task Force, May 3, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "FAQs Released for Sunshine Act," Sunshine Forecast, April 12, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "The Other Side of the Sunshine Act: Reporting Ownership & Investment Interests," Sunshine Forecast, March 21, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Reporting 'Indirect Payments' Under the Sunshine Act: A Closer Look," Sunshine Act Forecast, March 4, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Tracking Payments: How Should Manufacturers Allocate Food and Beverages?," Sunshine Act Forecast, February 13, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Highlights of the Sunshine Act's Final Rule Part 1: Key Changes and Clarifications," Sunshine Act Forecast, February 4, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Still No Sunshine," Sunshine Forecast, January 11, 2013
    • Co-author with Benjamin Koplin and Selina Coleman, "Department Of Health And Human Services Submits Sunshine Act Rules to OMB for Review," "Sunshine" Alert, November 30, 2012
    • Co-author with Rod Lambert and Frederick Robinson, "Comment Period Opens for EU Proposed Framework on Medical Device Regulation," Fulbright Briefing, November 29, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Massachusetts Posts Final Rules on 'Modest Meals' and Reporting Requirements," "Sunshine" Forecast, November 29, 2012
    • Co-author with Selina Coleman and Benjamin Koplin, "Reporting Under The Sunshine Act: Still In The Dark," Law360.com, Oct. 4, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "How Will Physicians/Teaching Hospitals Review the Collected Data and Resolve Disputes?," Fulbright's Sunshine Act Task Force, August 29, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Challenges to Reporting Physician Ownership and Investment Interests," Fulbright's Sunshine Act Task Force, May 7, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Delays Final Rulemaking Until Later This Year; Will Not Require Data Collection or Reporting Until 2013," Fulbright Alert, May 4, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Who Reports Transfers of Value?," Fulbright's Sunshine Act Task Force, April 30, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "Industry Continues to Await Sunshine Act's Final Rules," Fulbright's Sunshine Act Task Force, April 23, 2012
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Publishes Long-Awaited Proposed Regulations to the Sunshine Act," Fulbright Alert, December 15, 2011
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Responds to Letters on Missed Deadline for Sunshine Act; Avoids Promising Release Date for Overdue Regulations," Fulbright & Jaworski L.L.P. Briefing, November 3, 2011
    • Co-author with Benjamin Koplin and Selina Coleman, "CMS Misses Sunshine Act Deadline; Industry Awaits CMS Comment, Regulations," Fulbright & Jaworski L.L.P. Briefing, October 5, 2011
  • Speaking engagements
    • Presenter, "Collecting, Controlling and Certifying Indirect Payments from CROs and Third Party Vendors," ACI Forum on Sunshine Act Compliance & Aggregate Spend Reporting, New York, NY, October 7, 2013
    • Presenter, "A View from the FCPA Defense Bar on Enforcement Activities in Healthcare and Life Sciences," American Health Lawyers Association, October 3, 2013
    • Presenter, "Operationalize Your Compliance Program," MDMA 6th Annual Medical Technology Executive Forum, Palo Alto, CA, September 19, 2013
    • Presenter, "Regulatory Challenges and Current Trends," IBA World Life Sciences Conference, Dallas, TX, May 3, 2013
    • Presenter, "Compliance Complexities and the Pitfalls to Avoid for Emerging Life Sciences Companies," MDMA 2013 Annual Meeting, Washington DC, April 17, 2013
    • Presenter, "Effective Compliance Programs: Mitigating Risk in Latin America," AdvaMed 2013 Latin America Compliance Conference, Miami, FL, January 17, 2013
    • "Cost Efficient Compliance Programs for Small and Medium Enterprises," 2012 International Medical Device Industry Compliance Conference, Stockholm, Sweden, May 10, 2012. 
    • Co-presenter, "Back to School with Stark," Dallas-Fort Worth Hospital Council, August 29, 2012
    • Panelist, "Compliance: Current Investigative Initiatives," Fulbright & Jaworski L.L.P. Eighth Annual Health Law Symposium, February 2-3, 2012
    • Co-presenter "Compliance Investigations," "Overpayments Part 1: Billing Issues," and "Overpayments Part 2: Stark Issues," Legal Issues Boot Camp for Compliance Professionals, June 7-8, 2011
    • "Compliance--Voluntary Refunds and Disclosures: Not So 'Voluntary' Anymore," Fulbright & Jaworski L.L.P. Seventh Annual Health Law Symposium, February 3-4, 2011
  • Memberships and activities
    • American Bar Association - Health Law Section, former Vice Chair for Programming
    • District of Columbia Bar Association - Health Law Section
    • State Bar of Texas - Health Law Section