Overview
This session will review and discuss enforcement trends surrounding actions brought against FDA-regulated companies for fraudulent practices in late 2022 and early 2023, specifically related to the Foreign Corrupt Practices Act (FCPA) and False Claims Act (FCA), and address FDA, DOJ, and SEC enforcement activities and priorities in these areas. Last fiscal year settlements and judgements in FCA cases exceeded $2 billion, owed in part to health care fraud, unlawful kickbacks, and the rise of the Civil Cyber-Fraud Initiative. Panelists will discuss best practices to identify, avoid, and mitigate potentially fraudulent practices within an organization.
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Speakers
Luke Cadigan, Partner, Cooley LLP
Susan Cooke Anderson, Trial Counsel, SEC
Fritz Scanlon, Assistant Chief, Health Care Fraud Unit, DOJ
Moderated by Frederick R. Ball, Partner, Duane Morris LLP, Treasurer, FDLI Board of Directors
LUKE CADIGAN is a partner at Cooley LLP. He is head of business litigation for the east coast and an experienced trial attorney. He concentrates his practice on securities enforcement matters, shareholder disputes and actions, complex commercial litigation, internal investigations, and advice on regulatory compliance. Luke is a former assistant director in the U.S. Securities and Exchange Commission’s (SEC) Enforcement Division, serving in both the Boston regional office and in the SEC’s Foreign Corrupt Practices Act (FCPA) unit. He managed investigations conducted by staff attorneys and accountants including matters related to accounting fraud, offering fraud, insider trading, whistleblower complaints, investment advisers and broker dealers. Luke also oversaw investigations into potential FCPA violations and, serving as a member of the agency’s Cross Border Working Group, he supervised investigations into the accounting practices of Chinese and other foreign companies trading on US markets. Luke has been recognized by Chambers USA where a client stated that Luke is a “fantastic lawyer who is very familiar with the law and the SEC’s enforcement practices.” Prior to becoming an assistant director, Luke spent 7+ years as SEC senior trial counsel, in which role he investigated and litigated dozens of high-profile matters. As lead counsel, he also successfully tried several complex matters, both in federal court and in the SEC’s administrative forum. These matters include allegations of insider trading by a hedge fund employee, accounting fraud, insider trading by a director, a pay-to-play scheme by a former state senate majority leader, fraud by an investment adviser, and fraud by a broker-dealer (resulting in then the largest penalty awarded in a SEC administrative proceeding). He was a recipient of the Chairman’s Award for Excellence in 2002 and 2007, and the Division of Enforcement Director’s Award in 2007 and 2008. Luke served as law clerk for the Honorable Edward F. Harrington of the United States District Court for the District of Massachusetts and as a special assistant district attorney in Middlesex County.
SUSAN COOKE ANDERSON is a Senior Trial Attorney with the Securities and Exchange Commission, where she investigates and litigates a wide range of securities law violations, including pharmaceutical company disclosure cases and insider trading. Susan is the co-founder of the SEC’s FDA Task Force and was a member of the SEC’s Market Abuse Unit. Before joining the SEC in 2010, Susan worked in private practice for several years in the white collar and securities litigation and mass torts groups at Dechert LLP in Washington, D.C. She earned her J.D. from Georgetown University Law Center and her B.A. in Political Science from Yale University.
JOHN (FRITZ) SCANLON is an Assistant Chief in the Health Care Fraud Unit of the Criminal Fraud Section of the U.S. Department of Justice. In that capacity, Fritz oversees all Fraud Section prosecutors in the Miami, Tampa, and Orlando Health Care Fraud Strike Forces. The Strike Forces comprise teams from DOJ, FBI, and HHS-OIG, among other agencies, and prosecute dozens of health care fraud cases each year, involving hundreds of millions of dollars in fraud on Medicare, Medicaid, and private insurance companies and plans. In his time with the DOJ, Fritz has brought charges against a wide variety of defendants, including former professional football players who defrauded a health care plan of millions of dollars, the owner of a major cattle ranch who defrauded a publicly traded company of nearly $250 million, and the owners and operators of a financial advisory firm based in Key Biscayne that defrauded banks and investors of over $150 million. Fritz has also overseen a corporate criminal resolution with a publicly traded health care company, and he is lead counsel in the prosecution of former executives of a publicly traded hospital company accused of paying kickbacks and bribes to steer patients to the company’s hospitals. Prior to joining the Fraud Section, Fritz was a principal at Kobre & Kim LLP and an associate at Covington & Burling LLP. Fritz received a Law Degree from Harvard Law School and a B.A. from Columbia University.
FREDERICK (RICK) R. BALL is in the Boston office of Duane Morris LLP. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences/Biotech industry group. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. He assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. He emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.Virtual Learning FAQ
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