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.

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

• 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