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Ilene Albala

Ilene Albala

Partner
Washington, DC
+1 202 346 4413
Ilene Albala
Washington, DC
+1 202 346 4413

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.

Areas of Practice

Professional Experience

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.

Professional Activities

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.

Credentials

Education

JD2010

University of Pennsylvania Law School

Master of Bioethics2010

University of Pennsylvania Perelman School of Medicine

BA2007

University of Chicago

(with Honors)

Admissions

Bars

  • District of Columbia
  • New York

Publications

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

  • 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. 

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