Carol Ann Poindexter
Norton Rose Fulbright US LLP
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Carol practices in the firm's Washington, D.C. office.
Carol has extensive regulatory, investigatory and litigation expertise across a broad range of health care, life sciences, and other government-regulated industries. She represents entities involved in a variety of investigation and enforcement actions, including: federal, state, and global civil, criminal, and regulatory enforcement and compliance matters involving the Department of Justice, U.S. Attorney's Office, Food and Drug Administration, Securities and Exchange Commission, HHS Office of Inspector General, and State Attorneys General.
She has represented entities in: fraud investigations; False Claims Act litigation and internal investigations; Foreign Corrupt Practices Act and anti-bribery/corruption investigations, due diligence and compliance; FDA enforcement and compliance issues; clinical research compliance; NIH grant compliance and enforcement; and HIPAA Privacy issues. Carol also counsels, advises, and represents organizations on policy and governance issues, crisis management, emerging legal developments, and regulatory compliance issues.
Carol holds a number of leadership positions including serving as Vice-Chair of the ABA Health Law Section's Sponsorship Committee, and is Past Chair of the ABA Health Law Section Fraud and Abuse Interest Group and Past Vice-Chair of the American Health Lawyers Association Fraud & Abuse Practice Group.
Carol has authored numerous articles and frequently speaks at national and international conferences on fraud and abuse, Foreign Corrupt Practice Act and Anti-Corruption issues, the False Claims Act, clinical research compliance, NIH grant fraud and abuse issues, internal investigations and various other topics.
JD, served as Editor-in-Chief of the UMKC Law Review, University of Missouri - Kansas City School of Law, 1996
BLA, with distinction, University of Missouri-Kansas City, 1993
- District of Columbia Bar
- Kansas State Bar
- Missouri State Bar
Examples of recent representations include:
- Representing a global pharmaceutical company in connection with potential US FCPA and Chinese commercial bribery violations involving allegations of bribery and corruption with respect to multiple distributors' activities in its business operations in China, including conducting an intensive cross-border internal investigation and document review;
- Conducting internal investigations in connection with potential corruption and kickback issues for a multinational medical device manufacturer;
- Advising and defending a pharmaceutical manufacturer in connection with a False Claims Act case involving allegations of improper off-label promotion and improper payments to physicians;
- Defending a large academic medical center in a government investigation and declined qui tam False Claims Act action regarding allegations that certain researchers submitted falsified and/or fabricated research data to federal agencies in connection with grants funding scientific research;
- Representing a global pharmaceutical manufacturer on potential government enforcement risks associated with the manufacturer's savings offers, including electronic vouchers, coupons, and free product offers, and in responding to an OIG request for information about those programs;
- Representing a multinational pharmaceutical company in relation to various allegations of Anti-Kickback Statute violations, including alleged "white coat marketing."
- Advising multiple global pharmaceutical manufacturers in connection with various global legal and regulatory compliance issues, including clinical trials, sales and marketing, and FCPA-related issues;
- Representing a multinational medical device manufacturer in connection with a federal government investigation into alleged government contractor misconduct;
- Conducting an internal investigation and representing a multi-national medical device manufacturer concerning its multinational post-market clinical research;
- Representing a pharmaceutical manufacturer in connection with federal and state investigations, litigation and qui tam False Claims Act actions involving Average Wholesale Price, Medicaid Rebate arising out of pricing, and sales and marketing practices;
- Representing a major university in connection with a False Claims Act case based on allegations of billing for attending physician supervision of radiology residents that was not actually provided, including conducting an extensive internal investigation and successfully negotiating a settlement agreement and corporate integrity agreement;
- Representing an academic medical center in an FDA investigation regarding alleged improper drug promotion;
- Representing a pharmaceutical manufacturer in connection with a False Claims Act case involving allegations of off-label promotion and kickback issues;
- Representing a specialty pharmacy in conducting an internal investigation and review of billing practices, preparing a voluntary self-disclosure and successfully negotiating settlement of the issue;
- Representing a national long-term care entity, in connection with a qui tam False Claims Act action arising out of billing practices and vendor relationships, including securing a dismissal with prejudice;
- Representing a pharmaceutical manufacturer in connection with a federal criminal investigation into alleged kickbacks paid to a physician to influence drug formulary decisions;
- Designing and implementing a remediation plan for a multinational medical device manufacturer to address potential domestic and international fraud and anti-corruption compliance issues;
- Conducting an internal investigation and defending a multinational medical device manufacturer in a qui tam False Claims Act action arising out of sales and marketing practices;
- Representing a multinational medical device manufacturer in connection with a Federal government investigation into alleged improper training activities and relationships with physicians;
- Providing compliance training for a multinational medical device manufacturer on fraud and anti-corruption compliance issues for that company's marketing and sales force throughout the United States and Europe;
- Advising life science and health care organizations respecting domestic and global fraud and anti-corruption risks, compliance programs and best practices;
- Designing a new anti-corruption compliance program for a Fortune 200 U.S. company to meet the company's expanding business in Africa and the Middle East (program was recognized by Corporate Secretary Magazine as one of the five best compliance programs in 2010);
- Conducting internal investigations and representing a home health agency in connection with an OIG investigation into potential Stark Law and kickback violations;
- Representing a Fortune 500 hospital system in connection with an OIG and U.S. Attorney's investigation in the context of a national investigation into cost report, home health, and durable medical equipment reimbursement and kickback issues;
- Advising a multinational software vendor in connection with federal and state privacy issues regarding electronic medical records and personal health records;
- Advising a multinational software vendor in connection with regulatory compliance issues related to the establishment of on-site medical clinics;
- Representing an agriculture equipment manufacturer in a Department of Justice, Securities and Exchange Commission, and Serious Fraud Office investigation for violations of the FCPA resulting in a deferred prosecution agreement in the United States and a non-prosecution determination in the UK.
Legal 500 US, recommended lawyer, Healthcare: Life Sciences, The Legal 500, 2015 - 2016
The Best Lawyers in America, Best Lawyers, 2014 - 2020
BTI Client Service All-Star Team, 2008
Best of the Bar, Kansas City Business Journal, 2009 - 2011
Missouri and Kansas Super Lawyers, Healthcare, Thomson Reuters, 2007 - 2012
Washington DC Super Lawyers, Healthcare, Thomson Reuters, 2007 - 2012, 2017 - 2019
- Co-author, "6 Legal And Regulatory Risks Facing Specialty Pharmacies," Law360, March 9, 2017
- Author, "Criminal and civil liability for corporations officers and directors," Practical Law, Thomson Reuters, August 2016
- Author, "Trends in federal white collar prosecutions," Practical Law, Thomson Reuters, January 2016
- Co-author, "Risks Arise For Health Providers After FCA Overpayment Case," Law360, August 11, 2015
- Co-author, "Donor Risks With Charity Patient Assistant Programs," Law360, June 5, 2014
- Co-author, "Corporate Criminal and Civil Liability, Understanding and Minimizing Risk," Practical Law The Journal: Litigation, September 2013
- Contributing Author, "PHARMACEUTICAL LAW: REGULATION OF RESEARCH, DEVELOPMENT, AND MARKETING," 1st Edition (BNA Books, 2008, 2009, 2010, 2011, 2012 Supplements).
- Contributing Author, "HEALTH CARE FRAUD AND ABUSE: PRACTICE PERSPECTIVES," 2nd Edition (BNA Books, 2008, 2009, 2010, 2011, 2012 Supplements).
- Author, "Diabetes Test Strip Suppliers Should Expect Audits," Law360, November 2012
- Co-author, "Mandatory Disclosure: The Physician Payments Sunshine Act and Proposed Regulations and Perspectives on Compliance," BNA's Health Law Reporter, February 2012
- Author, "Parallel Proceedings: Internal Investigations and Waiver Issues," DRI's For the Defense, July 2011
- Author, "Corporate Internal Investigations and Potential Evidentiary Privilege Waiver Issues in Parallel Proceedings," DRI, June 2011
- Author, "Defining The Purpose and Scope of the Organization's Internal Investigation," ABA National Institute on Internal Corporate Investigations & Forum for In-House Counsel, May 2011.
- Author, "Recent Trends in Federal White Collar Prosecutions," PLC Law Department, January 2011.
- Contributing Author, "Institutional Review Boards: A Primer," 2nd Edition 2010 (AHLA Publications).
- "Addressing Risk Under the Clean Companies Act & Other Global Anti-Corruption Enforcement Efforts," Latin America Compliance Conference, February 11, 2014, Sao Paulo, Brazil.
- Regulation and dissemination of Off-Label Information, American Conference Institute FDA Boot Camp, March 19-20, 2014, Philadelphia, PA.
- Managing, Defending and Curtailing Whistleblower Allegations Under an Expanded False Claims Act, American Conference Institute 14th National Summit on Reducing Legal Risks in the Sales & Marketing of Medical Devices, April 9-10, 2014, Boston, MA.
- Regulation and dissemination of Off-Label Information, American Conference Institute FDA Boot Camp, September 18-19, 2014, Boston, MA.
- cGMPs: Drugs and Biologics, American Conference Institute FDA Boot Camp, September 30-October 1, 2015, Boston, MA.
- Gaining Practical Takeaways by Bridging the Ethics Gap Between Attorney-Client Privilege & Internal Investigations, American Conference Institute Women Leaders in Healthcare Law, September 28-29, 2015, Washington, D.C.
- False Claims Act Primer, AHLA Fraud & Compliance Forum, October 5-7, 2015, Baltimore, MD.
- False Claims Act Developments and Enforcement Trends, Minnesota Continuing Legal Education Foundation, November 3, 2015, Minneapolis, MN.
- Compliance Issues Involving Fabrication and/or Falsification of Research Data, American Bar Association Health Law Section Emerging Issues in Healthcare Law, March 2-5, 2016, San Diego, CA.
- The Federal Anti-Kickback Statute and the Sales & Marketing of Drugs in Today's Healthcare Environment, American Conference Institute 16th National Summit on Reducing Legal Risks in the Sales & Marketing of Medical Devices, March 9-10, 2016, Boston, MA.
- Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Trends that Impact FDA Practice, American Conference Institute FDA Boot Camp, September 21-23, 2016, Boston, MA.
- Anti-Kickback Stark, & False Claims – More Ways to Run Afoul of the Feds, MAGI Clinical Research Conference, October 25, 2016, Las Vegas, NV.
- Taking a Ride on the Fraud and Abuse Rollercoaster: A Master Class on the Anti-Kickback Statute, American Bar Association Health Law Section, June 16, 2017
- Third-Party Distributor Monitoring & Lessons Learned from Recent FCPA and Anti-Corruption Enforcement Actions, American Conference Institute 18th National Summit on Reducing Legal Risks in the Sales & Marketing of Medical Devices, March 5-7, 2018, Boston, MA.