David Tolley, Chair of the Boston Litigation & Trial Department, represents healthcare and life sciences companies in high-stakes government investigations and litigation.
Mr. Tolley represents clients in a variety of investigative, litigation, regulatory, and compliance matters. He represents a full spectrum of industry clients, including:
- Hospital systems
- Medical device and pharmaceutical companies
- Pharmacy benefit managers
- Pharmaceutical distributors
He helps clients navigate their highest-stakes issues involving the False Claims Act, the Anti-Kickback Statute, and their state analogs. He draws on extensive experience with government regulators and prosecutors including those from the:
- Department of Justice
- Department of Health and Human Services (HHS) - Office of Inspector General
- Centers for Medicare & Medicaid Services
- HHS - Office for Civil Rights
- State Attorneys General
Mr. Tolley helps clients frame complex issues and advocates on their behalf using accessible narratives, drawing on his background in medical ethics and health policy, a sophisticated understanding of both the law and the industry, and his ability to deescalate and navigate strategically through high-pressure situations.
Industry Leadership and Pro Bono
Mr. Tolley has served as a Chapter President for the Healthcare Financial Management Association and is a member of the American Health Lawyers Association. He works regularly with the Center for Health Law Policy Innovation at Harvard Law School, pursuing pro bono litigation against state Medicaid agencies on behalf of people with Hepatitis C denied access to curative therapies.
Mr. Tolley is recognized for Healthcare: Advice to Health Issuers by The Legal 500 US 2020.
Mr. Tolley’s experience includes representing:
- A large multi-hospital system in multiple internal investigations
- Several organizations in criminal and civil investigations related to opioid products
- A diagnostic laboratory in multiple state enforcement matters, including suspension proceedings
- A large academic medical center in state and federal inquiries regarding the medical necessity of inpatient hospital admissions
- A pharmacy chain in a multi-state investigation
- Organizations in privacy law enforcement matters
- A large health insurer in a national False Claims Act matter
- A large university medical school in a False Claims Act case; the case was ultimately dismissed
- A healthcare organization facing staggering recoupment demands in affirmative litigation against CMS
- A large hospital chain in various litigation matters
Regulatory & Compliance
- Several large healthcare organizations as primary counsel with respect to privacy issues
- Multiple healthcare organizations on breach assessment and response matters
- A large health system to develop and structure risk-sharing and accountable care arrangements with multiple private health plans