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We Can Handle the Truth: Meet the Healthcare Law Enforcers

Recorded On: 10/07/2024

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Explore healthcare fraud litigation and investigations from the perspective of legal enforcers. This panel of healthcare law enforcers will share what enforcers focus on and what it means for in-house counsel. Gain valuable perspectives on government priorities and trends and discover the inner workings of an investigation from the government’s point of view. Stay up to date on civil, criminal, and administrative updates and get practical advice directly from the enforcers themselves.

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We Can Handle the Truth: Meet the Healthcare Law Enforcers
Recorded 10/07/2024  |  75 minutes
Recorded 10/07/2024  |  75 minutes
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Melissa Hoffman

VP, Regulatory Corporate Counsel

Edwards Lifesciences Corporation

Licensed California attorney with over 16 years of experience, including 9 years of in-house experience with three multinational MedTech companies as well as experience with large (AM Law 100) and mid-sized law firms.

Broad legal experience with a foundation of transactional corporate and securities law, evolving to include several additional areas of expertise, including contract team management, commercial support, product launches, advertising and promotion, healthcare regulatory compliance, dispute management, and strategic intellectual property issues.

Strong leadership experience as a current member of one of Edwards’ Business Unit leadership teams, its Legal Department leadership team, and a US Commercial and Sales leadership team.

Effective communicator and relationship builder who understands that legal leadership requires a deep understand of the business and a willingness to partner to identify creative solutions while effectively managing risk (and often a healthy sense of humor).

Core competencies include:
* Medical device regulatory
* Compliance
* Clinical trials
* Contract drafting and negotiation
* Securities
* M&A
* Financing transactions
* Fraud and abuse
* Advertising and promotion
* Corporate governance
* Dispute management
* Business and legal strategy

Ellen Bowden McIntyre

Deputy Chief, Affirmative Civil Enforcement

U.S. Attorney's Office

Attorney with high-level investigative, litigation, and negotiation experience in major plaintiff suits brought under the False Claims Act, the Controlled Substances Act, the Federal Trade Commission Act, the Food, Drug and Cosmetics Act, and civil rights laws. Recipient of DOJ's Director's Award and HHS' Inspector General awards in 2021 for outstanding work and monumental recoveries.

Lisa Noller

Partner

Foley & Lardner LLP

A trial lawyer and investigator in our Chicago office, Lisa is chair of the firm’s national Litigation Department and former chair of the firm’s Government Enforcement Defense & Investigations Practice Group and the firm’s Management Committee.

Named to the inaugural Forbes America’s Top 200 Lawyers list and recognized by Who’s Who Legal: Investigations in 2024, Lisa has spent over 25 years investigating, litigating, and trying complex criminal and civil cases, responding to government investigations, conducting corporate internal investigations, and persuading the government not to pursue clients. “Lisa has been lauded by clients and colleagues for her subject-matter expertise, investigative prowess, tenaciousness and integrity,” noted the Forbes editor, and “she is an expert in healthcare litigation and white-collar defense.” As a member of the prestigious American College of Trial Lawyers since 2015, Lisa has been recognized for her trial success in over 30 civil and criminal trials in state and federal courts. She represents companies and individuals in parallel civil and criminal proceedings initiated by government agencies, and proactively counsels clients in enforcement and other litigation matters. Lisa successfully has represented clients in many districts around the country, most often in Illinois, Arizona, Florida, Tennessee, Texas and Wisconsin.

Lisa is particularly renowned for her excellence in healthcare litigation: sources label her “an exceptional attorney in the area of healthcare.” She represents providers in helping them navigate the False Claims Act and criminal matters, including Anti-kickback Statute (AKS), PPP loans and Managed Care/Medicare Advantage issues. Lisa has served as a private mediator in an AKS dispute, and she was court-appointed as the special master for discovery in a complex tax shelter and fraud case.

“[Lisa] is very knowledgeable in the health care regulatory area,” according to Chambers and Partners USA. “Clients love her – she’s very personable, she’s bright and she knows this space incredibly well.”

“[Lisa] really knows about government investigations. She is very knowledgeable and to-the-point with her advice,” according to Thomson Reuters.

“[Lisa] is one of the best lawyers in Chicago. She has impeccable judgment and is a tremendous trial lawyer.”

Lisa is widely known for her handling of False Claims Act litigation, public corruption charges, antitrust, and high-stakes fraud matters. Clients note:

“[Lisa] keeps us well informed, is pragmatic in her approach and keeps things moving along.” – Chambers and Partners USA 

Lisa utilizes her extensive experience as a former civil and criminal prosecutor to defend health care and life science clients against false claims allegations. Clients note:

“She’s a preeminent person in Chicago’s FCA space.”

Lisa is frequently sought nationally and locally to be an author, speaker, panelist, and conference organizer on topics related to False Claims Act defense, government investigations, and white-collar criminal defense, among other topics. She is a lecturer in law at the University of Chicago Law School, where she founded and teaches the Prosecution and Defense Clinic and is Chair of the Law School Council. She also is an adjunct professor at Northwestern Law School, where she teaches trial advocacy.

Prior to joining Foley, Lisa was an assistant U.S. attorney in Chicago, where she worked in both the civil and criminal divisions of the office. She was a member of the U.S. attorney’s team dedicated to the prosecution of healthcare fraud in Northern Illinois, and she has worked on numerous complex fraud cases as well as parallel investigations with other agencies, including HHS-OIG, NIH, and the SEC. Lisa served as a deputy chief in the U.S. Attorney’s Office, most recently in the Financial Crimes and Special Prosecutions Section, where she prosecuted complex federal criminal cases from investigation through appeal involving the AKS, Stark Law, public corruption, mortgage fraud, bank fraud, health care fraud, tax fraud, research grant fraud, racketeering, embezzlement, money laundering, obstruction of justice, and terrorism financing.

She earned a Director’s Award for Superior Performance for successfully trying a 100-count RICO case, and she also received the Mitch Mars Prosecutorial Excellence Award from the Chicago Crime Commission. Before joining the Criminal Division, she also worked for three years in the Civil Division, where she represented the United States in affirmative civil enforcement and health care fraud actions, including False Claims Act matters. In addition to her trial experience, Lisa also has successfully argued numerous appeals before the Seventh Circuit Court of Appeals. In 2014, Lisa earned a white belt certificate in Legal Lean Sigma® and project management from the Legal Lean Sigma Institute.

Kathryn Booth

Deputy Criminal Chief, White Collar Crime

United States Attorney’s Office, Middle District of Tennessee

Ms. Booth has served as the Deputy Chief of White Collar Crime since February 2023. Prior her appointment as a Deputy, Ms. Booth was an Assistant United States Attorney in the White Collar section from July 2011 through April 2015 and from June 2018 through February 2023. As an AUSA, Ms. Booth handled a wide variety of white collar cases, including multi-million dollar bank fraud cases, Ponzi schemes, criminal tax fraud, public corruption, health care fraud, embezzlement, and identity theft. Ms. Booth has served as first or second chair on multiple federal criminal jury trials and bench trials, and she has successfully briefed and argued appeals before the Sixth Circuit.

Between August 2015 and June 2018, Ms. Booth spent three years as a Legal Writing Instructor at Vanderbilt Law School. Prior to joining the USAO, Ms. Booth was a Trial Attorney in the Department of Justice Tax Division, where she entered the Department through the DOJ Honors program in September 2008. Before joining the Tax Division, Ms. Booth was a judicial law clerk for Judge Barbara Milano Keenan, who was then on the Supreme Court of Virginia.

Ms. Booth received her B.A. in Art History, cum laude, from Duke University in 2001, and her J.D., cum laude, from Georgetown University Law Center in 2006.

Tony Maffei

Special Agent

Health and Human Services, Office of Inspector General

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