Erin Lewis is a member of the firm's health and life sciences group, focusing on compliance and investigation matters. She counsels clients on compliance issues and represents health care providers in criminal fraud and abuse investigations and civil False Claims Act lawsuits, among other matters. Erin has counseled major medical device manufacturers on compliance related issues and advised on their internal policies and procedures. She has provided counsel to hospitals and health systems regarding documenting financial arrangements as being fair market value. She also has helped clients navigate through regulatory and compliance issues related to clinical trials and negotiates master and study specific clinical trial agreements. In addition, Erin has conducted internal investigations on behalf of corporations.

Before joining Faegre Baker Daniels, Erin was an Assistant U.S. Attorney for the U.S. Department of Justice in the U.S. Attorney's Office for the Southern District of Indiana. She served as the district's civil health care fraud coordinator where she investigated and prosecuted violations of civil and criminal fraud involving the False Claims Act, Anti-Kickback Statute, Stark Act, HIPAA, Controlled Substances Act and others. She worked directly with the Office of Inspector General, Office of Audit Services; the Office of Inspector General, Office of Investigation; and Office of Inspector General, Office of Counsel to the Inspector General during all phases of the investigation, trial, sentencing and appeal. Erin argued numerous cases on behalf of the Attorney General in front of the Seventh Circuit Court of Appeals. Before joining the U.S. Attorney's Office, she spent three years in the litigation practice at Foley & Lardner in Chicago in the firm's white collar defense and corporate compliance practice group.

Representative Experience

• Advised major medical device manufacturer regarding revision, training and implementation of corporate policies, including practices related to use of consultants, required by government Corporate Integrity and Deferred Prosecution Agreements
• Assisted major pharmaceutical company with implementation of Corporate Integrity Agreement across a variety of functional areas
• Assisted large medical device manufacturer with development of systems to comply with a corporate integrity agreement entered into between it and the HHS Office of Inspector General
• Created corporate compliance program for a life sciences biomarketing company
• Represented medical practice being investigated for allegedly defrauding government programs through unlawful billing and coding practices
• Counseled major medical device manufacturers on the entire range of interactions between sales representatives and providers, including promotional activities, off-label promotion, fraud and abuse issues, business entertainment, research grants and honoraria.

Honors

• Loyola University School of Law — National Mock Trial Team
• NITA — Certified Instructor

Memberships

• Indiana University Alumni Association
• Immaculate Heart of Mary Catholic Church, Indianapolis

Civic Activities

• Susan G. Komen for the Cure — Indianapolis Affiliate, Public Policy Board
• WFYI Public Television — IRIS Program, Volunteer Broadcast Reader

Faculty Positions

• Indiana University School of Law-Indianapolis — Adjunct Professor

Publications

• "FDA Enforcement Heating Up," co-author with Ralph F. Hall, Law360, November 20, 2009
• Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations, co-author with James T. O'Reilly, James Patrick Hanlon, Ralph F. Hall and Steven L. Jackson, Oxford University Press, August 2009
• "'Bounty Hunters' on the Prowl for Fraud, Overpayments," Indianapolis Business Journal, April 6, 2009
• "Issues to Consider in the Planning Stages of a Medical-Legal Partnership," co-author with Chad Priest and Jessica Barth, ABA Health eSource, Volume 5, Number 4, December 2008
• "Rethinking How to Respond to Government Investigations," co-author with J.P. Hanlon and Ralph Hall, Update Magazine, Food and Drug Law Institute, Issue 6, November/December 2008
• "Not Even Alice in Wonderland Would Believe This Interpretation of the FCRA," co-author with Rocco J. deGrasse, 3 Journal of Health Care Compliance 1, January-February 2001

Presentations

• "Words to the Wise: Recent OIG Settlements," MAGI's 2009 Clinical Research Conference, San Diego, California, October 4, 2009
• "Emerging Regulatory and Prosecutorial Focus on Physicians," Ninth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Washington, D.C., October 2008
• "Enforcement: Challenges, Changes and Updates," Indianapolis Association of Corporate Council, October 2008