Carolyn Fitzhugh McNiven

Carolyn is not afraid to take a case to trial where appropriate. Although she enjoys trying cases, she is particularly skilled at negotiating with enforcement authorities before charging decisions are made. None of Carolyn’s past individual clients who received target letters from U.S. DoJ prosecutors 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 criminal indictments, based on a little-known health care law, and was later awarded the California State Bar’s Wiley W. Manuel Certificate for this work.

Carolyn has a reputation for impeccable integrity and is a go-to defense attorney for clients in the health care sector. Client feedback elicited by Chambers USA includes: “Carolyn is a tremendous resource for complicated healthcare questions.” and “She’s my go-to person in healthcare fraud. She knows the space inside out… . She’s also very easy to work with and collegial.” Carolyn also prides herself on providing clients cost-effective representation and on developing strategies seeking favorable outcomes while at the same time minimizing legal fees.

U.S. Department of Justice Experience

Carolyn’s understanding of government decision-making is grounded in her 14-year experience as a federal criminal prosecutor. She handled several high-profile corruption prosecutions of federal and state government officials (including a sitting governor and a 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 more than six years and handled numerous parallel investigations. Carolyn first-chaired multiple trials to verdict, and gained extensive experience in the use of informants, covert taping and obtaining cooperation from criminal defendants.

Health Care Fraud & Compliance

Given her multidisciplinary health care enforcement background, Carolyn is routinely called upon to represent individuals and companies operating in the health sector, including hospital systems, retail pharmacies and clinics, as well as pharmaceutical and medical device manufacturers. This representation has included preparing executives to testify before Congress, resolving actual or suspected regulatory violations, self-reporting overpayments, conducting internal investigations, and defending individuals and companies in criminal investigations and prosecutions.

She has settled multiple state and federal, intervened and non-intervened False Claims Act matters for clients, including cases concerning nonemergency medical transportation, prescription drug pricing, anti-kickback violations and unnecessary services. Carolyn is known in the False Claims Act defense bar for working well in joint defense teams and employing novel legal arguments. 

Health Care Fraud & Compliance Experience

• Obtained nontarget letters for a large national hospital system that allegedly submitted fraudulent Medicare claims.
• Obtained a dismissal with prejudice of a state criminal complaint against a medical provider.
• Decimated a qui tam whistleblower at their deposition, and then settled the health care fraud qui tam matter for a corporate provider for an amount less than the costs of taking the case to trial, in a matter where the government was seeking more than a $150 million award.
• Represented a medical device company in an unlawful-kickback investigation.
• Represented a physician on appeal in a federal health care fraud prosecution involving the Travel Act (ITAR).
• Developed a regulatory compliance program for substance-use disorder facilities, including Part 2 compliance controls.
• Represented a health care facility in a local (Maricopa County) investigation concerning the death of a patient at one of their facilities.
• Successfully represented a behavioral health care chain in a case brought by the California Department of Insurance. 
• Represented the CEO of a large health care provider in testimony before the United States Congress. 
• Acted as pool counsel for health care provider company executives in multiple matters.
• Represented multiple former executives of rehabilitation providers in several different federal parallel investigations; no clients were indicted despite target letters.
• Convinced federal prosecutors not to indict the target of a $185 million federal health care fraud investigation.
• Resolved federal and state criminal and civil matters for a medical transportation company executive who faced criminal charges and permanent exclusion.
• Represented a large retail pharmacy chain in multiple drug discount-pricing investigations, including reaching settlement with state authorities in multiple state False Claims Act actions.
• Obtained a dismissal of a California False Claims Act matter for a regional pharmacy.
• Represented a prominent national health care compliance firm in connection with a U.S. DOJ Fraud Section health care fraud investigation.
• Worked with an in-house team to develop legislative and regulatory strategy for a large pharmaceutical manufacturer concerning discounts for high-cost drugs.
• Obtained dismissal of a pending criminal complaint against a licensed health care professional for fraud.

Fraud, Anticorruption & Other White Collar Defense

In addition to her health sector work, Carolyn routinely advises companies and individuals in many industries faced with sensitive legal and practical problems relating to anticorruption matters, suspected cybercrime, cybersecurity breaches, economic espionage and more routine financial crimes. She is a persuasive writer and client advocate in court filings and communications with law enforcement authorities. 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.

Fraud, Anticorruption & Other White Collar Experience

• Led a team of over 25 outside counsel and in-house compliance professionals handling anticorruption compliance in India for a Fortune 50 company.
• Handled multiple sensitive internal investigations for companies involving allegations of corruption, bribe-paying, fraud and other criminal conduct.
• Obtained dismissal of a federal False Claims Act matter and subsequently successfully defended that matter on appeal to the Ninth Circuit for a national telecommunications company.
• Represented multiple individuals and companies that were victimized by fraud and other crimes in presentations to law enforcement authorities.
• Represented a company in a U.S.DoJ investigation of antitrust violations in the liquor industry. 
• Represented an intervening insurance company in a state court matter involving attempted fraud by the insured.
• Developed compliance training materials for a U.S.-based pharmaceutical manufacturer that was under investigation for FCPA violations.
• Successfully represented a former bank board member targeted in a bank fraud investigation.
• Successfully defended an attorney in a criminal bankruptcy fraud investigation and related bar investigation.
• For a major pharmaceutical company, performed a broad rewrite of global antibribery and corruption policies and procedures.
• Represented a non-U.S.-based company under investigation by U.S. authorities for paying bribes to local U.S. officials.
• Represented multiple private equity firms in responding to grand jury subpoenas and other investigative matters.
• Represented a foreign executive under indictment in the United States for fraud.
• As a federal prosecutor, led an investigation of public corruption allegations against a sitting U.S. governor.
• For a major, multinational, public medical-device manufacturer, conducted an assessment of a FCPA compliance unit.
• Represented a former corporate executive in a federal criminal matter involving allegations of bribing public officials.
• Represented an individual targeted in an international cybercrime investigation.

Personal Interests

In her free time, Carolyn enjoys gardening, reading, traveling with her family, and interacting with her numerous dogs and cats.