Ricky C. Benjamin

Ricky Benjamin leads our FDA & Life Sciences industry practice. Ricky advises companies on U.S. Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues, as well as clinical trials and FDA-regulated product development programs. He also counsels clients on the safety, labeling, and reporting requirements for consumer products under the laws enforced by the U.S. Consumer Product Safety Commission (CPSC), unfair and deceptive trade practices involving the Federal Trade Commission (FTC), and related state enforcement agencies. Ricky’s clients include pharmaceutical, medical device, biologic, cosmetics and personal care products manufacturers, and clinical laboratories.

As a Life Sciences & Health Care Regulatory Industry Leader, Ricky provides comprehensive guidance on navigating the complex web of federal and state laws and regulations, specifically surrounding potential fraud involved in aggregate spend transactions for a range of activities like speaking engagements, consulting on unmet medical needs, conducting clinical trials and serving on Advisory Boards. His regulatory guidance includes investigations and enforcement efforts regarding sales and promotion activities focused on off-label promotion of non-approved uses of a drug, interactions and transactions between healthcare professionals and Life Sciences institutions; disclosure and publication of clinical trial results; and treatment of benefits and risks information in promotional activities.  He represents companies with international and domestic presence before the Food and Drug Administration (FDA). He assists clients with the development, manufacture, marketing (premarket approvals, De Novo application grants and 510(k) clearances), and regulatory compliance, including labeling and recalls of medical devices, drugs, and cosmetics.

Ricky also represents manufacturers in supply chain matters related to these regulated products, including supply agreements and software licensing agreements (SaaS, SiMD, SaMD, and IoT). Ricky represents clients in all phases of the product life cycle, including formulation and marketing authorizations, post-market compliance, certification, and manufacturing best practices. He also advises on regulatory issues at the intersection of health services innovation, digital health, and emerging technologies, including bias in artificial intelligence and machine learning algorithms.

Ricky has extensive litigation experience in the areas of medical malpractice defense, qui tam litigation, mass tort, product liability, and risk management counseling involving the Foreign Corrupt Practices Act (FCPA), the Federal Food, Drug, and Cosmetic Act (FDCA), and the Federal Tort Claims Act (FTCA), as well as involving the Federal Trade Commission (FTC), the Department of Justice (DOJ), the Office of Inspector General (OIG), and the Centers for Medicare & Medicaid Services (CMS). His litigation experience makes him uniquely suited to anticipate, identify, and defend product liability actions in such a way as to marshal the facts to minimize later qui tam actions by private plaintiffs or regulatory enforcement actions by the government. With a robust litigation background, Ricky has litigated more than 200 cases, defended or responded to more than 50 government investigations, and conducted more than 75 internal audits as part of managing global privileged investigations under the FCPA amid allegations of fraud, waste, and abuse.

Ricky's transactional practice encompasses in-depth due diligence of Life Sciences transactions, including deal structuring, representations and warranties, and compliance with regulatory requirements associated with mergers and acquisitions. Ricky’s diverse background includes roles as general counsel for dental and surgical practices, in-house regional head of litigation for a global insurance company, lead national trial defense counsel for opioid litigation, and professor of health care law and ethics at Tulane University. In addition to his law degree, Ricky has a bachelor’s degree in computer science and worked as a software programmer before attending law school.

• The National Black Lawyers Top 100 (2020)

• Member & Board of Directors, Jaguar Foundation of Atlanta
• Chairman/President, Milwaukee Urban Debate League (Former)
• Member & Board of Directors, Juvenile Diabetes Research Foundation (Former)

• American Health Lawyers Association
• Member, State Bar of Georgia
• Member, State Bar of Colorado
• Member, State Bar of Wisconsin
• President, Sam Cary Bar Association (Former)
• Vice President, Denver Bar Association (Former)
• Member & Board of Trustees, Colorado Bar Association (Former)

Legal Practice Assistant

Nicole Golay
(404) 685-4286
ngolay@burr.com