Elizabeth J. McEvoy

Research-Related Investigations

• Conducted an external audit and investigation into the operations of an Institutional Review Board of a prominent New England health care system. Elizabeth performed a top-to-bottom review of regulatory compliance, operational effectiveness, and corporate governance after the system reported multiple instances of noncompliance with FDA and Office for Human Research Protections regulations governing investigator-initiated clinical trials.
• Advised the Research Integrity Officer of an academic medical center in addressing and responding to various matters involving allegations of potential data fabrication/falsification in connection with federally-regulated and federally-funded research conducted at the center.
• Counseled a university on addressing alleged violations of whistleblower protections under the False Claims Act based on an internal investigation of research misconduct claims and related matters. Elizabeth represented the university in subsequent litigation of legal claims filed against the university in federal court.
• Conducted an internal investigation for a health/lifestyle app addressing allegations of federal grant mismanagement, submission of false claims to NIH, and retaliation.

Research-Related Counseling

• Support the research operations of a large academic medical center, and advise on the review, audit, and regulatory compliance of its extensive portfolio of FDA-regulated clinical trials.
• Draft and review a variety of collaborative and/or clinical trial agreements on behalf of a large health system addressing a wide variety of topics, including data/material use, informed consent, import/export of biospecimens, and related aspects of inter-institutional collaborations.
• Serve as a member of a hospital/academic medical center’s internal Conflict of Interest Committee and provide legal advice on matters before the committee, including financial conflicts of interest, potential kickbacks, and other potential conflicts of interest and/or commitment.
• Serve as a non-scientific, non-affiliated member of a university’s Institutional Animal Care and Use Committee (IACUC). Elizabeth led an investigation into alleged diversion/noncompliance with controlled substance regulations on behalf of the IACUC’s subcommittee.
• Advised a nonprofit research foundation on potential conflicts of interest and concerns involving patient solicitation from affiliated organizations and providers. Elizabeth also revised the foundation’s internal conflict of interest policies and procedures.

 Research-Related Government Enforcement Matters

• Advised and responded to FDA Form 483 letter on behalf of a Sponsor-Investigator and academic medical center hosting an FDA-regulated trial involving an Investigational New Drug.
• Represented a prominent scientist accused of failing to disclose financial conflicts of interest to an academic institution and NASA relating to alleged participation in China’s Thousand Talents Program and other Chinese government-sponsored research.
• Secured a supervisory plan from ORI for a Research & Development (R&D) company pursuing therapy commercialization. The plan allowed the company’s principal—who had entered into a voluntary supervision agreement with ORI based on allegations of research misconduct brought by former academic institutions—to continue participating in the company’s federally-funded research.
• Advised a community health center on a series of cyberattack/phishing incidents and interfaced with the Office for Civil Rights and Massachusetts Attorney General's Office. Elizabeth successfully avoided sanctions and monetary penalties.

Health Care Litigation

• Obtained summary judgment in a multi-count lawsuit brought by a recently terminated physician alleging age discrimination under M.G.L. ch. 151B and related claims arising from adverse medical credentialing decisions by hospital medical staff.
• Successfully defeated a preliminary injunction and moved to dismiss legal claims brought by competing health care systems to halt the opening of a new cardiac catheterization laboratory in a Massachusetts hospital.
• Represented a prominent heart surgeon at a premiere Boston hospital in responding to a federal grand jury subpoena relating to alleged kickbacks with a large medical device company.

Non-Health Care-Related Investigations and Litigation

• Conducted an internal investigation of a pilot school requested by a Massachusetts public school district in response to parental complaints of widespread bullying, retaliation, sexual misconduct, academic performance, and other safety issues. Elizabeth led the comprehensive investigation of the school and district, resulting in a series of phased reports that provided the groundwork for the district to take timely action and implement changes.
• Second-chaired an 11-day jury trial in the U.S. District Court for the District of Massachusetts, defending a former investment advisor accused of conspiracy to commit mail and wire fraud and substantive mail and wire fraud offenses.
• Achieved the dismissal of all claims brought against a professional liability company in a comprehensive arbitration arising from a partnership dispute.