Ilene Albala

Ilene Albala is a partner in Goodwin’s Complex Litigation and Dispute Resolution and Healthcare practices based in Washington, DC. She is a member of the firm’s Healthcare Government Enforcement and False Claims Act Defense group. Previously, she served as an Assistant US Attorney in the Eastern District of Virginia, where she was lead counsel for the federal government in False Claims Act (FCA) qui tam litigation. Ilene’s FCA investigations at the US Attorney’s Office focused exclusively on the healthcare and life sciences sectors, including medical device manufacturers, hospital systems, compounding pharmacies, clinical laboratories, diagnostic testing facilities, skilled nursing homes, behavioral health providers, hospice providers, physician practices, home health providers, and private equity investors in healthcare companies. She specializes in False Claims Act defense, complex litigation involving the Anti-Kickback Statute and Stark Law, and internal investigations involving healthcare.

Given her strong science background, Ilene was tasked as an AUSA with investigating alleged healthcare fraud and opioid-related matters. She supervised large teams of agents from federal agencies including the FBI, HHS-OIG, DEA, NSF, OPM, DHA, and FDA. She has significant experience handling parallel civil, criminal, and administrative cases. Prior to joining the US Attorney’s Office, Ilene was a Trial Attorney at DOJ’s Civil Division, where she represented HHS in suits brought under the National Childhood Vaccine Act. She was the sole attorney responsible for handling over 80 active cases and had frequent first-chair appearances. Ilene began her legal career at an international law firm, where she represented Fortune 500 companies in complex life sciences litigation and arbitration disputes.

Ilene is a member of the American Health Law Association (AHLA) and the Health Care Compliance Association (HCCA). She previously served as an Adjunct Professor at the NYU School of Global Public Health where she taught courses on the intersection of law, bioethics, and public health policy. Ilene is a member of the NYU Grossman School of Medicine’s working group exploring the ethics of big data and artificial intelligence (AI) in health research and healthcare.

Ilene is listed in the Legal 500 US 2024 for her work in Corporate Investigations and White-Collar Criminal Defense. Ilene is also listed in the Legal 500 US 2025 for her work in Healthcare Service Providers.

Ilene has published and presented on topics involving the intersection of health and law. Selected publications below:

• Co-Author, “DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities,” Goodwin Client Alert, July 21, 2025
• Co-Author, “Changes to Birthright Citizenship and the Impact on Fertility and Assisted Reproduction Clinics,” Goodwin Client Alert, July 3, 2025
• Speaker, “Top Ten 2025: Fraud and Abuse Issues to Watch,” Podcast, The American Health Law Association (AHLA), February 07, 2025
• Moderator, “Women’s Health and Wellness: Updates on the 2024 Regulatory Landscape and Key Considerations for 2025 and Beyond,” Webinar, Goodwin CLE Week 2025, January 17, 2025
• Co-Author, “Florida District Court Concludes FCA’s Qui Tam Provision Is Unconstitutional,” Goodwin Client Alert, October 8, 2024
• Co-Author, “How SuperValu Is Changing False Claims Act Litigation and Compliance,” American Health Law Association, September 1, 2024
• Speaker, “Anatomy of the False Claims Act”, HCCA Compliance Institute, April 14, 2024
• Co-Author, “DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement”, Goodwin Client Alert, February 26, 2024
• Speaker, “Civil Investigative Demands”, Health Ethics Trust, February 22, 2024
• Moderator on panel “Update on FDA-Related Qui Tams and the False Claims Act (FCA)”, FDLI, December 7, 2023 
• Co-Author, “A Practical Look at OIG’s New Compliance Guidance,” Goodwin Client Alert, November 22, 2023
• Co-Author, “The Supreme Court Holds that the False Claims Act’s Scienter Element Turns on Defendant’s Subjective Beliefs, Rejecting Seventh Circuit’s Objective Standard,” Goodwin Client Alert, June 5, 2023
• Co-Author, “DOJ Revises Corporate Compliance Guidance to Take on Compensation Incentives and Communications Preservation — With a Continued Emphasis on Individual Accountability,” Goodwin Client Alert, March 8, 2023
• Co-Author, “Supreme Court Holds DOJ Has Broad, But Not Unlimited, Discretion to Dismiss False Claims Act Qui Tam Litigation Brought by Private Whistleblowers,” Goodwin Client Alert, 2023
• Co-Author, “OIG Alert and DOJ Enforcement Action Summary: Telemedicine Arrangements,” Goodwin Client Alert, July 28, 2022
• Co-Author, “The Ethics of Off-Label Use of FDA-Approved Products,” in Off-Label Communications: A Guide to Sales & Marketing Compliance, 3rd and 4th editions, Food and Drug Law Institute, 2012, 2014
• Co-Author, “The evolution of informed consent forms for research: An evaluation of changes over a quarter century,” IRB: Ethics and Human Research 32(3):7-11, 2010
• Author, “Mandatory HPV vaccination: Is there a happy medium?” University of Pennsylvania Journal of Law and Social Change, 12(2): 221-246, 2008-2009
• Co-Author, “Disclosure of Information to Potential Subjects on Research Recruitment Web Sites,” IRB: Ethics and Human Research, Jan-Feb 2008
• Co-Author, “The reporting of monetary compensation in research articles,” Journal of Human Research Ethics, 2;4 2007