Ricky C. Benjamin Email & Phone Number

Atlanta, Georgia, United States

I advise companies on U.S. Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues, as well as clinical trials, studies, and FDA-regulated product development programs, 510(k), De Novo and Premarket Approval (PMA) submissions, and pre-submission meetings and FDA interactions. I also counsel clients on safety, labeling, and reporting requirements for consumer products under the laws enforced by the Consumer Product Safety Commission (CPSC), unfair and deceptive trade practices involving the Federal Trade Commission (FTC), including algorithm biases, and related state enforcement agencies. My clients include pharmaceutical, medical device, biologic, cosmetics and personal care products manufacturers, and clinical laboratories.

Atlanta, Georgia, United States

Life Sciences and Healthcare Shareholder - advises companies on US Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues, as well as clinical trials and FDA-related product development programs. Counsel clients on the safety, labeling, and reporting requirements for consumer products under the laws enforced by the US Consumer Product Safety Commission (CPSC), unfair and/or deceptive trade practices involving the Federal Trade Commission (FTC), and related state enforcement agencies. Clients include pharmaceutical, medical device, biologic, cosmetic and personal care products manufacturers, and clinical laboratories. As a Fraud, Waste & Abuse Attorney, frequently assists clients with identifying, quantifying and mitigating litigation and regulatory risks, including responding to FDA, OIG and DOJ Investigations and enforcement actions, including Stark and Anti-kickback laws (state and federal), Corporate Practice of Medicine guidelines, fee splitting issues, Merger & Acquisition deal structuring advice representation and warranties, and specialized due diligence. Routinely advises clients on the regulation of medical software (including the FDA's regulation of AI/ML relating to SaMD and biased algorithms), SaaS and other cloud-based transactions, premarket approval and clearance strategies, regulatory exclusivity strategies, advertising, labeling and promotional review matters, slaes and marketing guidelines, supply chain integrity requirements, and CGMP complianc

Atlanta, Georgia, United States

Substantial white collar litigation experience and demonstrated ability to identify and mitigate compliance risk involving fraud, waste & abuse, specifically related to AKS, FCA, FCPA and CMP while defending internal government investigations, implementing and recommending best practices, including various auditing, monitoring and oversight processes to ensure mitigation of such risks.Practice focused on advising pharmaceutical, biotechnology, medical device and diagnostic companies on a range of regulatory, compliance, transactional and litigation matters involving the FDA, FDCA, FTC, DOJ, OIG, CMS, HIPAA and the FCPA. Routinely advises clients on the regulation of medical device software (including the FDA's regulation of AI/ML), software as a service (SaaS), software as a medical device (SaMD), premarket approval and clearance strategies, regulatory exclusivity strategies, advertising and promotional review matters, sales & marketing guidelines, supply chain requirements, and cGMP compliance.Frequently assists clients with responding to FDA and Department of Justice investigations and enforcement actions, including Stark and AKS laws (state and federal) and M&A deal structuring, specialized Due Diligence and Representations & Warranties.Extensive experience in representing hospitals, health systems, medical device manufacturers, pharmaceuticals, biologicals, academic medical centers, nursing homes and physician group practices in qui tam litigation, healthcare regulatory counseling, and healthcare transactions, including Mergers & Acquisitions, Joint Ventures, Joint Operating Agreements, Co-Management Agreements, Clinical Affiliations, state Corporate Practice of Medicine and Fee-Splitting issues.Represents clients by leading internal FTC, FDA, CMS, OIG and DOJ investigations, as well as audits to prevent, detect and mitigate enterprise and compliance risks, including drafting Compliance Plans and implementing Compliance Programs.

Greater Atlanta Area

Seasoned litigator and advised C-Level executives on various compliance issues including Sarbanes Oxley, Wage & Hour issues, Title VII, Title IX, ADA, ADEA, FMLA, HIPAA, OFCCP regulations, whistleblower retaliation claims, collective bargaining and union organization process, grievance resolution matters.Firm leader in Healthcare Regulatory, Transactional and Risk Management issues as counsel to Health Systems, Hospitals, Physician Practice Groups, Ambulatory Surgical Centers, Nurses, Medical Device Manufacturers, Compounding Pharmacies, and Academic Medical Centers.Subject matter expert in Stark laws and Anti-kickback statutes, HIPAA, Qui Tam Whistleblower & False Claims Act Litigation.Trusted Counsel on Hospital & Health System Acquisition Transactions (FQHCs & RHCs), and CHOW Transactions.Counsel on Physician/Hospital Employment Agreements and wRVUs.Counsel on Section 330 Grant-Related Requirements and Policies Regarding Affiliations.Counsel on Private Inurement/Beneficiary Inducement Exemption Advice.Counsel on FTC/Unfair Trade Practice Investigatory Actions.Healthcare & Commercial Litigation (EPLI, D&O, E&O, CGL - on behalf of insurance companies)

San Jose, Ca

Litigation Manager overseeing and supervising outside counsel.Counseled on Section 330 Grant-related requirements and policies regarding affiliations relating to hospitals, FQHCs and RHCs.Draft Intellectual Property licenses and Supply Chain Management contracts.Draft Medical Director Agreements, Operating Agreements, Lease/Subleases, Physician and Technology Services Agreements ancillary to hospice and home healthcare.Defended actions and investigations by CMS the FTC, DOJ & OIG in matters ranging from Unfair Trade Practice actions amid allegations of inadequate data security protocols to Qui Tam actions involving Fraud, Waste & Abuse.Conducted audits, investigations, and gap analyzes to assess compliance and intellectual property asset risks, and provided training & monitoring after identifying and prioritizing such risks. Defended organization in wrongful death malpractice lawsuit, where one patient killed another patient, leading to fraud allegations associated with the facility practice and protocols, including claims of inadequate staffing ratios, negligent hiring, negligent supervision, and negligent retention, allegedly leading to the wrongful death.Advised organization on laws that impacted healthcare compliance risks, including: affiliation guidelines, physician compensation agreements, complaints of retaliation, excluded individual/entity monitoring regimen, billing & coding protocols, accuracy of documentation to establish medical necessity, prevention and mitigation of medical identity theft, and billing for non-covered services. HIPAA Privacy & Security Officer for the facility.Managed & supervised outside counsel litigation.Developed training programs on Fraud, Waste & Abuse, anti-retaliation, and identification of excluded individuals/entities from enterprise activity. Conducted internal audits, monitored compliance program, and created compliance metrics to assess adequacy and effectiveness of compliance training and program.

Milwaukee, Wi

Lead counsel on labor & employment law counseling, litigation and class action litigation matters representing: software technology manufacturers, medical device manufacturers, food & drug retailers, municipal governments & quasi-governmental entities, educational institutions, professors, hospitals, physicians, insurance companies and insurance company insureds on EPLI claims. Drafted and negotiated Intellectual Property licenses, Biotechnology and Agri-Biotechnology licensing agreements, Supply Chain Management contracts, technology vendor agreements (including PBM contracts), EHR software agreements, and counseled on maximizing client intellectual property assets.Lead counsel on healthcare law counseling, compliance audits and investigations involving Section 330 Grant-related requirements and policies regarding affiliations, Medicare/Medicaid regulatory issues, Healthcare Fraud, Waste & Abuse laws and regulations, STARK law and Anti-Kickback statute, Federal Anti-trust law, Federal tax considerations relating to beneficiary inducement and private inurement, Privacy & Data Security legislation/regulation.Advised hospitals, physicians, community health centers, and rural health clinics on strategies relating to affiliations, discovery of overpayments from federal and state governments, licensing and certification issues, and HIPAA laws, in addition to advice on EMTALA risks associated with patient transfers.Litigated Whistleblower Qui Tam actions under False Claims Act. Drafted, implemented, audited Compliance Plans/Programs. Advised hospitals, physicians, FQHCs, and RHCs on STARK and Anti-Kickback risks arising from ownership, investment and physician compensation arrangements. Conducted training, audits and investigations to identify, prevent and mitigate Fraud, Waste & Abuse in billing, coding, informed consent issues, medical documentation to support medical necessity, medical identity theft and billing for non-covered services or items.

Denver, Co

Litigation Manager, oversaw and supervised outside counsel litigation. Drafted and negotiated Intellectual Property licensing agreements and technology vendor services agreements, including EHR software agreement.Drafted and negotiated Supply Chain Management contracts, including PBM contracts.Defended practice in Qui Tam Whistle-blower action under the federal False Claims Act.Drafted ownership, investment and physician compensation arrangements involving: Joint Ventures, Joint Operating, Clinical Affiliation, Co-Management, Employment & Professional Services Agreements, Risk-Sharing Arrangements, and Managed Care Agreements.Drafted Compliance Plan & Implemented Compliance Program. Counseled surgeon practice on Healthcare Fraud & Abuse laws and regulations including Medicare & Medicaid compliance issues, including: unbundling, upcoding, overpayments, the STARK law, the Anti-Kickback statute, Clinical Laboratory Improvements Act (CLIA), HIPAA compliance, and workplace expectations of Privacy & Security involving PHI.Managed outside counsel and audited files for compliance with Fraud and Abuse laws. Counseled on voluntary disclosure strategies relating to overpayments and risks of false certification exposure where contract requirements were potentially involuntarily violated.Drafted and negotiated executive compensation agreements, employee benefit contracts, restrictive covenants, and performance management policies.Drafted and Counseled on negotiation of strategic alliance agreements, asset/stock purchase agreements and the purchase of additional surgical practices and properties, highlighting the risks of STARK law exposure involving such arrangements.

Denver, Co

Managed the Enterprise Compliance function and Staff Legal Office overseeing litigation in Colorado, New Mexico, and Wyoming, including management of outside counsel in all 3 states, and oversaw in-house litigation docket, caseloads and staff of 20+ Attorneys and support staff.Defended labor & employment law lawsuits, including Title VII, Title IX, ADA, ADEA, FMLA, FTC and whistleblower retaliation lawsuits including defense and/or prosecution of breach of non-compete agreements and other restrictive covenants. Defended Whistle-blower Qui Tam Fraud & Abuse actions in federal and state courts.Regularly advised hospitals, surgical groups, physicians, academic medical centers, dialysis care service providers, clinical laboratories, and nursing homes on Fraud and Abuse litigation under federal and state False Claims Acts. Dotted-line supervision of 60 employees with responsibility for compliance, risk management, auditing, monitoring, Qui Tam litigation, compliance training, payor contract compliance and selection of healthcare plan partners.Drafted litigation budgets and developed strategies for early lawsuit resolution or government investigations (including responding to Civil Investigative Demands) involving progress of litigation and propriety of settlements involving lawsuits against clients, which included: hospitals, surgical groups, physicians, dialysis care service providers, academic medical centers, clinical laboratories, and nursing homes.First chair jury trials, bench trials and administrative hearings, involving over 200 litigated claims/complaints or government investigations by private plaintiffs, the DOJ, FTC or OIG. Audited legal bills/invoices of outside counsel.Evaluated the impact of a change in regulatory requirements that impacted the risks of litigation against healthcare organizations and the level of proof necessary to determine liability or affirmative defenses.

Juris Doctor, Law

Bachelor Of Science, Computer Science