Webcast: False Claims Act – 2021 Update for Drug and Device Manufacturers

October 19, 2021

Third of four industry-specific programs

The False Claims Act (FCA) is one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse involving public funds. After several years of statements and guidance that the Department of Justice (DOJ) may change its approach to FCA enforcement, the Biden administration appears to be taking a different and more aggressive approach. Meanwhile, newly filed FCA cases remain at all-time highs, and the government has recouped nearly $ 3 billion or more a year from FCA for a decade. The government also continues to pursue new and significant spending plans in COVID-related stimulus and infrastructure, which could lead to even stronger efforts by the Justice Department to prosecute fraud, waste and abuses in government spending. More than ever, any business that receives government funding, especially in the drug and medical device industry, needs to understand how government and private whistleblowers are using FCA and how they can defend themselves.

Please join us to discuss developments within the FCA, including:

  • The latest trends in FCA enforcement actions and related litigation affecting drug and medical device manufacturers;
  • Updates on the Biden administration’s approach to FCA enforcement, including developments impacting the DOJ’s use of its statutory revocation power;
  • New proposed amendments to the CFL presented by Senator Grassley; and
  • The latest trends in FCA case law, including developments in particular FCA legal theories affecting your industry and the continuing evolution of how lower courts interpret Supreme Court decisions Escobar decision.

View slides (PDF)



PANELISTS:

Winston Y. Chan is a former federal prosecutor and litigation partner in the San Francisco office, and co-chair of the firm’s False Claims Act practice group. He has particular experience in managing business for healthcare and life sciences companies involving government enforcement advocacy, internal investigations and compliance advice. From 2003 to 2011, Mr. Chan served as the Assistant United States Attorney in the Eastern District of New York, where he held several supervisory positions and investigated a wide range of issues, including violations of the False Claims Act. and healthcare fraud.

Marian J. Lee is a partner in the Washington, DC office and co-chair of the firm’s FDA and Healthcare Practice Group. She has significant experience advising clients on FDA regulatory strategy, risk management and enforcement actions. His practice covers the product life cycle, including the conduct of preclinical and clinical studies, good manufacturing practices and quality systems, pre-market approvals and authorizations, scientific communications, labeling and advertising. products, and post-market compliance.

John DW partridge is a partner in the Denver office where he focuses on white collar defense, internal investigations, regulatory investigations, corporate compliance programs and complex business litigation. He has particular experience with the FCA and the Foreign Corrupt Practices Act (“FCPA”), including advising large companies on their compliance programs.

Brendan stewart is a lawyer in the New York office and a former federal prosecutor. Previously, he was Deputy Chief of the Fraud Section of the Criminal Division of the United States Department of Justice, where he oversaw a unit of health care fraud attorneys in the Eastern District of New York. from 2017 to 2021. As a prosecutor since 2012, he has led many complex investigations – in coordination with the United States Attorney’s Office, the FBI, the Office of the Inspector General of the Department of Health and Human Services social, state attorneys general – focused on potential violations of federal laws prohibiting healthcare fraud and medical misrepresentation and other crimes.


MCLE CREDIT INFORMATION:

This program has been approved for credit in accordance with the requirements of the New York State Council on Continuing Legal Education for a maximum of 1.5 credit hours, of which 1.5 credit hours may be applied to the requirement areas of professional practice.

This course is approved for transitional / non-transitional credit. Lawyers seeking credit in New York should obtain an Affirmation Form before viewing the archived version of this webcast. Please contact [email protected] to request the MCLE form.

Gibson, Dunn & Crutcher LLP certifies that this activity has been approved for MCLE credit by the State Bar of California for an amount of 1.5 hours.

California lawyers can claim “self-study” credit for viewing the archived version of this webcast. No certificate of attendance is required for the California Self-Study Credit.


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