False Claims Act Risks and Enforcement Priorities for the Med Tech Industry
October 7, 2026
12:00 PM – 1:00 PM
Join Akin Gump as they provide actionable takeaways to minimize compliance risks and position organizations for effective and credible responses when FCA investigations arise.
Presented by Akin Gump Straus Hauer & Feld LLP
False Claims Act Risks and Enforcement Priorities for the Med Tech Industry
October 7, 2026
12:00 PM – 1:00 PM
False Claims Act Risks and Enforcement Priorities for the Med Tech Industry
October 7, 2026
12:00 PM – 1:00 PM
Join Akin Gump Straus Hauer & Feld LLP in this discussion: The volume of False Claims Act (FCA) whistleblower filings is on pace for a third-consecutive record-setting year, and the Department of Justice has signaled its intention to use the FCA as a key component of its health care enforcement efforts. Members of Akin’s health care and life sciences team will examine how DOJ and HHS are collaborating through the reinvigorated DOJ–HHS False Claims Act Working Group, including its stated focus on materially defective medical devices that impact patient safety, and what that means for internal investigations, disclosures, and documentation.
The team will also address emerging risk areas involving customs compliance and country of origin requirements as DOJ expands its interagency partnerships through its Trade Fraud Task Force. The program will provide an overview of noteworthy FCA matters affecting device companies, including its first cyber-fraud settlement involving medical devices. It will discuss how recent organizational changes within DOJ may affect enforcement activity in the future, and how your FDA engagement and regulatory strategy can affect (or reduce) your FCA exposure.
Attendees will hear from former DOJ senior leaders Sara McLean and Colin Huntley, who spent more than four decades combined supervising nationwide FCA enforcement at DOJ, including more than a decade supervising investigations and litigation relating to FDA-regulated products, as well as Nate Brown, who leads Akin’s FDA practice. Akin’s health care and life sciences team will provide actionable takeaways to minimize compliance risks and position organizations for effective and credible responses when FCA investigations arise.
What You’ll Cover
- FCA whistleblower cases are reaching record levels, with DOJ increasing healthcare enforcement efforts.
- Focus areas include defective medical devices, patient safety, and FCA compliance risks.
- Emerging enforcement risks include customs compliance, country-of-origin requirements, and cyber-fraud.
- Former DOJ and FDA leaders will share practical strategies to reduce FCA exposure and respond to investigations.
Date: Tuesday, October 7, 2026
Time: 12:00 PM – 1:00 PM ET
Location: Online
Meet the Speakers
Nate Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
- Focuses on food and drug law and health care reimbursement and regulatory issues.
- Served in prominent roles at the FDA and on the Senate Health, Education, Labor and Pensions (HELP) Committee.
- Advises manufacturers and developers of medical devices and diagnostics, drugs and biologics, and other industry participants regulated by the FDA, as well as hospitals and other providers.
Sara McLean, Partner, Akin Gump Strauss Hauer & Feld LLP
- Distinguished FCA lawyer and civil fraud litigator widely recognized as a leader in the FCA investigations and enforcement space.
- Represents clients facing FCA and civil fraud investigations and litigation, bringing to bear more than 25 years of DOJ enforcement experience.
- As Assistant Director in the DOJ’s Civil Division, Commercial Litigation Branch (Fraud Section), guided DOJ FCA enforcement efforts nationwide and supervised nearly five hundred civil fraud cases.
- As a Fraud Section Trial Attorney, handled dozens of FCA and other fraud investigations, settlements and litigations.
- Experience includes fraud claims involving health care and life sciences (especially Stark Law and Anti-Kickback Act compliance), cybersecurity and data privacy, government contracts and grants, energy, mortgage fraud, education and trade.
Colin Huntley, Partner, Akin Gump Strauss Hauer & Feld LLP
- Former Deputy Director in DOJ’s Civil Fraud Section and nationally recognized expert in FCA enforcement, drawing upon nearly two decades of DOJ experience.
- Represents clients in all phases of government investigations and civil enforcement proceedings relating to health care services, pharmaceutical and medical devices, payment of customs duties and tariffs, pandemic relief programs, government loan and grant programs, small business contracting and federal procurement.
- As a former senior career official with DOJ, spearheaded FCA enforcement efforts in hundreds of complex fraud investigations nationwide, working closely with all 93 U.S. Attorneys’ Offices, federal law enforcement agencies and State Attorneys General.
- Negotiated more than 100 FCA settlements across a wide range of federal agencies and programs, along with dozens of settlements relating to conflicts of interest, breach of contract, agency overpayments and common law claims.
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