Global Investigations Review - The law and practice of international investigations

Kathleen Meriwether

Kathleen Meriwether

kathleen.meriwether@ey.com

Kathleen Meriwether is a principal with the Health Sciences team of Ernst & Young LLP’s Fraud Investigation & Dispute Services practice. She has worked with legal and compliance issues for over 25 years. Prior to her tenure with EY, Kathleen was an Assistant United States Attorney (AUSA) in the U.S. Attorney’s Office for the Eastern District of Pennsylvania.

As an AUSA, Kathleen focused on health care fraud investigations, including alleged violations of the anti-kickback (fraud and abuse) and Medicaid best price statutes, fraudulent billing practices, alleged off-label marketing of pharmaceuticals and medical devices, “fraud on the FDA” claims and quality of care issues.

Before becoming an AUSA, Kathleen spent over 16 years with Bristol-Myers Squibb Company in a number of legal, regulatory affairs and compliance positions. Kathleen began her legal career as a litigation associate with the national law firm of Drinker Biddle & Reath.

Kathleen focuses on assisting health sciences companies with complex investigations, global risk and compliance assessments, and regulatory compliance analyses. She works closely with management teams and counsel to identify enforcement risks, determine potential vulnerabilities and recommend solutions from business and operational perspectives. Kathleen also assists counsel, both outside and in-house, in fraud investigations, compliance inquiries, and response strategy to governmental subpoenas and other inquiries.

Examples of Kathleen’s project experience include the following:

  • Investigation — Foreign Corrupt Practices Act: Kathleen led a global team assisting a pharmaceutical company’s outside counsel in performing an investigation of bribery and corruption issues in a number of the client’s high-risk markets around the world.
  • Investigation — fraud and abuse: Kathleen led a team assisting outside counsel investigating alleged sales force misconduct involving gifts and entertainment provided to physicians.
  • Compliance — Corporate Integrity Agreement (CIA) readiness: Kathleen led multiple engagements for global pharmaceutical companies to assess their readiness to comply with the expected requirements of a CIA with the Department of Health and Human Services; she made recommendations for compliance program enhancements to facilitate CIA implementation.

Compliance — sales and marketing: Kathleen led a team performing a compliance assessment for the commercial operations of a pharmaceutical manufacturer focused on off-label promotion and fraud and abuse risks.