Profil
Carolyn Fitzhugh McNiven is a 5th generation Californian with deep local roots and a national government enforcement defense practice. Clients rely on Carolyn to handle their most challenging government enforcement problems because she is a strong client advocate, whether the matter is criminal, civil or both. Her understanding of government decision-making is grounded in her 14-year experience as a federal criminal prosecutor. As a federal prosecutor, Carolyn handled several high-profile corruption prosecutions of federal and state government officials (including a sitting governor and U.S. State Department official) and spearheaded taskforces in the areas of health care fraud, financial fraud, and bankruptcy fraud. She served as a criminal health care fraud coordinator for over 6 years and handled numerous parallel investigations.
As a trial attorney, Carolyn is not afraid to take a case to trial where appropriate. Although Carolyn enjoys trying cases, she is particularly skilled at negotiating with enforcement authorities before charging decisions are made. None of Carolyn’s individual clients who received target letters from federal law enforcement authorities has ever ended up being prosecuted. In several other cases where charges were brought before she was retained, Carolyn has been able to convince prosecutors to drop all charges with prejudice. In one year, Carolyn convinced federal prosecutors to dismiss three separate indictments and was later awarded the California State Bar Wiley W. Manuel Certificate for that work.
In light of her multidisciplinary health care enforcement background, Carolyn is routinely called upon to represent individuals and companies operating in the health sector (including all types of providers and manufacturers). This representation has included preparing executives to testify before Congress, defending False Claims Act complaints (intervened and non-intervened; federal and state), resolving actual or suspected regulatory violations, self-reporting overpayments, conducting internal investigations, and defending individuals and companies in criminal investigations and prosecutions. Carolyn is known in the False Claims Act defense bar for working well in joint defense teams and employing novel legal arguments. She prides herself on providing clients cost effective representation and, in particular, on developing strategies to seek favorable outcomes while at the same time minimizing legal fees.
In addition to her health sector work, Carolyn counsels companies faced with sensitive legal and practical problems relating to anti-corruption matters, suspected cybercrime, cybersecurity breaches, economic espionage, and more routine financial crimes. Carolyn has experience in designing and operating corporate compliance programs, particularly those operating in challenging international environments, such as India, where she has spent significant time supervising compliance matters for a Fortune 50 company.
Carolyn is active in many professional associations and community organizations and is a sought-after speaker. She currently serves as co-chair of the Rankings Initiative for the Women’s White Collar Defense Association (WWCDA) and as a board member of the Bay Area Council (BAC), the Head-Royce School Alumni Board, and the Berkeley Architectural Heritage Association (BAHA).
Concentrations
- White collar criminal defense
- Health care enforcement defense
- Foreign Corrupt Practices Act and anti-bribery and corruption enforcement defense
- False Claims Act defense
- Cybersecurity, cybercrime, and economic espionage
- Financial crimes
- Complex litigation
Expertise
Erfahrung
- Obtained dismissal with prejudice of a state criminal complaint against medical provider.
- Decimated qui tam whistleblower at their deposition and then settled health care fraud qui tam matter for corporate provider for an amount less than the costs of taking the case to trial in a matter where government was seeking an over $150 million award.
- Represented medical device company in unlawful kickback investigation.
- Representing physician on appeal in federal health care fraud prosecution involving the Travel Act (ITAR).
- Develop regulatory compliance program for substance use disorder facilities, including Part 2 compliance controls.
- Represented health care facility in state regulatory investigation concerning death of patient at one of their facilities.
- Convinced federal prosecutors not to indict target of $185 million federal health care fraud investigation.
- Obtained non-target letters for numerous individuals and companies in federal health care fraud investigations, including large national hospital system that allegedly submitted fraudulent Medicare claims.
- Obtained dismissal of three federal criminal indictments for three different defendants in one year based on little-known health care law.
- Resolved federal and state criminal and civil matters for medical transportation company executive who faced criminal charges and permanent exclusion.
- Represent large retail pharmacy chain in multiple drug discount pricing investigations.
- Obtained dismissal of California False Claims Act matter for regional pharmacy.
- Settled multiple state and federal False Claims Act matters for clients, including matters concerning non-emergency transportation, prescription drug pricing, and unnecessary services.
- Represented a prominent national health care compliance firm in connection with U.S. Department of Justice (Fraud Section) health care fraud investigation.
- Provided health care compliance, claims reimbursement, Anti-Kickback, Food, Drug, and Cosmetic Act (FDCA) and self-disclosure advice for a variety of health sector clients, including hospital systems, pharmaceutical, and medical device clients.
- Work with in-house team to develop legislative and regulatory strategy for large pharmaceutical manufacturer concerning discounts for high-cost drugs.°
- Advised multiple public companies under U.S. Department of Justice and SEC investigation on global anti-bribery and corruption compliance.
- Performed broad rewrite of global anti-bribery and corruption policies and procedures for pharmaceutical company.°
- Conducted assessment of FCPA compliance unit for major multinational public medical device corporation.°
- Represented individual targeted in international cybercrime investigation.
- Represented former bank board member targeted in bank fraud investigation.
- Represented a foreign executive under indictment in the United States for fraud.
- Led team investigating public corruption allegations against sitting governor.°
°The above representations were handled by Ms. McNiven prior to her joining Greenberg Traurig, LLP.
Anerkennung durch den Markt
- Listed, Chambers USA Guide, Litigation: White-Collar Crime & Government Investigations, 2023
- Listed, Euromoney's Expert Guides: Women in Business Law, "Guide to the World's Leading Women in Business Law," 2014-2017 and 2021-2022
- Team Member, a Law360 “Product Liability Practice Group of the Year,” 2021-2022
- Listed, Acritas Stars™ Independently Rated Lawyers, “Star Lawyers,” 2019-2021
- Law360, White Collar Editorial Board 2016
- Recipient, State Bar of California, Wiley W. Manuel Certificate for Pro Bono Legal Services, 2013
- Recipient, Federal Bureau of Investigation, Award in Recognition of Work on Operation Board Games (a/k/a U.S. v. Blagojevich et al), 2010
- Executive Committee Member, Women’s White Collar Defense Association (WWCDA)
- Board Member, Bay Area Council
- Member, National Association of Criminal Defense Lawyers (NACDL)
- Member, American Bar Association, Criminal Justice and Health Law Sections
- Member, American Health Lawyers Association
- Member, Health Care Compliance Association (HCCA)
- Member, California Bar Association
- Member, Federal Bar Association
- Member, Illinois Bar Association
Ausbildung
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J.D., University of California at Berkeley School of Law (Boalt Hall)
- Senior Executive Editor, California Law Review
- B.A., Fine Arts, cum laude, Amherst College
- U.S. District Court for the Northern District of Illinois, 1991-1993
- California
- Illinois
- U.S. Court of Appeals for the Ninth Circuit
- U.S. Court of Appeals for the Seventh Circuit
- U.S. District Court for the Northern District of California
- U.S. District Court for the Northern District of Illinois
- U.S. District Court for the Central District of California
- U.S. District Court for the Central District of Illinois