Kristen Schwendinger, Senior Counsel

Biography

Kristen Schwendinger is an attorney in the firm's Health Law Practice Group. She focuses her practice on compliance matters, including Federal laws effecting university health and research operations, and broad corporate compliance with the Stark Law, Anti-Kickback Statute, HIPAA, and data privacy. Kristen also assists clients in fulfilling their obligations under the Controlled Substances Act (CSA) and the DEA's implementing regulations. Kristen also provides advisory services to university and research institution clients related to the Federal grant and contract requirements, research compliance broadly, and Title IX investigations involving STEM areas of faculty and graduate students.

Prior to joining Quarles & Brady, Kristen worked with the U.S. Department of Health and Human Services for nearly eight years as a Senior Counsel to the Office of Counsel to the Inspector General, as well as for Indiana University, Washington University, and Massachusetts General Hospital. While working for the OIG, she supported the Department of Justice in False Claims Act investigations, negotiations, and litigation. In doing so, she managed cases through evaluating the merits of case theories and damages on behalf of the OIG.

Representative Experience:

  • Conducted reviews of conduct to determine the need for Corporate Integrity Agreements (CIA); imposing penalties related to conduct under CIAs, while monitoring 10 companies under CIAs.
  • Served as a resident expert on fraud related research compliance, federal grants, and contracts while collaborating with Special Investigations Units at private health plans.
  • Worked with forensic data experts to prove the fabrication and falsification of data in research fraud cases on behalf of HHS.
  • Defended the Inspector General’s exclusion determinations before Administrative Law Judges while leading affirmative investigations of companies and individuals alleged to have committed fraud.
  • Served as OIG's key opinion leader on grant and contract fraud.
  • Provided expert witness and consulting witness services to clients regarding employee discrimination internal investigations and complaints.
  • Provided start-ups with advice about Federal grant and contract requirements.
  • Provided counsel to clients regarding GDPR, IRB, and clinical trial compliance - including Federal and Corporate funded research.

Legal Services

Education and Honors

  • Washington University (J.D., 2010)
    • Public Service Law Student of the Year 2010
  • Indiana University (M.P.A., 2007)
    • Concentrations in Social Entrepreneurship and Nonprofit Management
  • Washington University (B.A., cum laude, 2002)

Bar Admissions

  • Washington D.C.
  • Missouri

Certifications

  • Certification in Title IX Investigation and Coordination (ATIXA)
  • Certified Corporate Compliance and Ethics Professional (SCCE)
  • Certified Fraud Examiner (ACFE)