Margaret Erin Rodgers Schmidt represents pharmaceutical and medical device clients in complex civil and criminal government investigations, internal investigations, and civil litigation. Erin also advises clients on the negotiation, implementation, and monitoring of corporate integrity agreements involving healthcare entities, the US Department of Justice, and the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS). She also counsels clients on voluntary compliance agreements between healthcare entities and state regulators. Erin co-leads the healthcare industry initiative.
Clients rely on Erin to represent them in internal investigations, government investigations, and litigation arising under the False Claims Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, the Medicaid Rebate Statute, the Federal Food, Drug, and Cosmetic Act, and various US federal and state civil and criminal fraud statutes. Erin also regularly counsels clients on the development and oversight of compliance programs, as well as the preparation of compliance-related reporting to the government.
Erin maintains an active pro bono practice. As a child advocate, she represents young clients in dependency proceedings before the Family Division of the Philadelphia Court of Common Pleas.
Prior to attending law school, Erin was a researcher on art and cultural property issues for the Presidential Advisory Commission on Holocaust Assets in the United States and a contributor to the report “Plunder and Restitution: The US and Holocaust Victims’ Assets.”
Recently, Erin’s representations have included:
Representing a major pharmaceutical company in qui tam litigation involving allegations of scientific/laboratory improprieties.
Representing a multinational medical device manufacturer in multiple federal investigations.
Representation of an international medical device company in connection with alleged FCPA violations related to sales and marketing practices in India.
Representing a major pharmaceutical company in a criminal and civil federal investigation related to alleged off-label promotion.
Conducting internal investigations for a major pharmaceutical company including investigations related to alleged kick-backs, off-label promotion, and reimbursement guidance.
Representation of a startup pharmaceutical company in a full week arbitration involving breach of contract claims related to the conduct of a clinical trial.
Representation of a Fortune 50 computer manufacturer in a government investigation.
Representation of a major pharmaceutical company in federal and state government investigations involving the marketing and pricing of products.
Georgetown University Law Center, 2005, J.D., Cum Laude
Loyola College in Maryland, 1999, B.A., Summa Cum Laude, Phi Beta Kappa
U.S. District Court for the Eastern District of Pennsylvania
Awards and Affiliations
Co-Chair, Philadelphia Young Lawyers Division of the White Collar Crime Committee
Member, Pennsylvania Bar Association
Staff Editor, Georgetown Journal on Poverty Law & Policy