Life Science & Healthcare Compliance & Investigations

Overview

Our experienced attorneys help you navigate the challenges of the ever-changing healthcare regulatory landscape.

Prosecutors and regulators have made healthcare fraud one of their highest priorities. We help you navigate the complex maze of regulations covering day-to-day operations, building compliance programs, conflicts of interest policies, and training programs for employees and executives.

We counsel you on matters involving government investigations, pharmaceutical pricing and reimbursement, Medicare and Medicaid, and more. We also advise on violations of federal and state laws and regulations, including the Anti-Kickback Statute, False Claims Act, FCPA, Stark Law, and state gift ban statutes.

When litigation becomes unavoidable, our team of highly skilled trial lawyers achieves favorable results for entities and individuals in some of the nation’s largest and highest-profile civil and criminal proceedings.

No matter the issue, rely on us to navigate the ever-changing regulatory landscape.

Representative Experience

• Represent clients on matters involving off-label promotion, good manufacturing practices, average wholesale price, overpayments, payment suspensions, physician consulting agreements, misbranding, and adulteration
• Provide counsel around corporate integrity agreements, deferred prosecution agreements, and other monitorship agreements
• Pharmaceutical manufacturer in a novel FDA enforcement matter, and advised the client on navigating complex government, customer, and media concerns. This was a critical, time-sensitive move toward a successful resolution of the matter.
• Global medical device company in a False Claims Act investigation and subsequent litigation regarding manufacture and sale of medical devices. A U.S. Attorney’s Office declined to intervene in the matter and the relators have pursued ongoing qui tam litigation.
• Large medical device manufacturer in a complex multi-pronged DOJ/SEC investigation involving alleged FCPA violations, revenue recognition issues, and restructuring efforts. The matter was resolved with no charges or admission of wrongdoing.
• International medical device manufacturer in a multi-pronged DOJ/FBI/FDA investigation
• Medical device company in a multipronged SEC formal investigation regarding business practices in China
• National hospice company in a DOJ probe of a qui tam action
• Large hospital in complex civil litigation and a government investigation related to a Hepatitis C outbreak, with a complex privacy law and privilege overlay
• Global pharmaceutical company in a False Claims Act investigation conducted by a U.S. Attorney’s Office and the Civil Fraud Section of Main Justice relating to the manufacturer’s donations to patient assistance foundations
• Major pharmaceutical manufacturer in two separate government investigations involving alleged off-label promotion, anti-kickback violations, and improper “Best Price” reporting under the Medicaid Drug Rebate Program. These matters, along with a third investigation, were resolved as part of a global $3 billion criminal and civil settlement with the federal government and certain participating states, the largest healthcare fraud settlement in US history.