Seasoned compliance and regulatory enforcement attorney, leader and results driven professional. Expert in compliance, with proven experience developing local, state and federal compliance programs. Over 20 years’ experience in compliance and regulatory matters, including OSHA, FTC, FDA, ABC, Healthcare, zoning and land use. Litigated multimillion-dollar cases against individuals and companies for fraud, compliance and regulatory matters. Crafted compliance settlements which have industry standard. Drafted policies, injunctions, subpoenas; extensive trial experience, both civil and criminal.
Catherine Borsetto is a member of the California Bar and served as Deputy District Attorney and as a Prosecutor in several California counties, where she was responsible for litigation and enforcement relating to healthcare and other industry practices. Her current focus is advising clients on navigating the significant legal and enforcement hazards in the healthcare industry.
Catherine’s healthcare expertise combines deep experience in healthcare litigation, healthcare regulatory and compliance counsel, enforcement of white-collar, healthcare crimes, and healthcare corporate and transactional work.
As a Prosecutor, Catherine represented the People of the State of California in a variety of matters, including Medical Board disciplinary and licensing matters, Cannabis sales, zoning and other state regulatory violations, and many state and federal, healthcare regulatory violations. As a member of the Food, Drug and Medical Device Task Force, Catherine joined nine other California counties in prosecuting business owners and major corporations for claims including Unfair Business Practices, False Advertising, Public Health law and Unlawful Business Practices. Over dozens of trials and many more enforcement actions, Catherine’s work resulted in tens of millions of dollars in settlements.
Her extensive government experience includes the review, analysis, and case determination of Healthcare and Insurance Fraud, Unlawful and Unfair Business Practices, and False and Misleading Advertising. As a prosecutor, Catherine worked closely with Medical Board investigators, the Department of Health and Human Services (HHS), California Department of Health Care Services (DHCS), the Office of the Attorney General, the U. S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and other law enforcement agencies.
Catherine has substantial trial experience, handling both criminal and civil prosecutions, during her 20-year career as a Deputy District Attorney. She has served as lead counsel on over 60 jury trials and hundreds of hearings and bench trials. Most notably, she served as trial counsel on the multi-jurisdiction prosecution, People v. Overstock 12 Cal.App.5th 426 (2017), for unfair business practices and false and misleading statements, securing over 8 million dollars in penalties.
Catherine also managed a division of compliance for one of California’s largest Health Plans, developing and implementing policies and procedures, preparing and presenting audits for federal and state agencies, and conducting company-wide training. In this capacity, Catherine also drafted and implemented procedures for HIPAA and state privacy and security law, and Medicare Final Rule implementation compliance documents.
Catherine counsels physicians, healthcare entrepreneurs, established companies, and executives accused of fraud, health care fraud, false advertising, misbranding of drugs and medical devices, and other offenses. She also develops business strategies, including creating compliance plans for a wide variety of businesses entities.
Clients seeking effective business strategies to guard against government investigations, FDA or FTC warning letters, professional board complaints, and other regulatory agencies, appreciate how Catherine draws on her vast government experience and unique understanding of healthcare law, to provide invaluable representation.
Catherine’s practice areas include:
- Government Investigations
- Professional Board Compliance and Complaints
- FDA & FTC Advertising and Marketing Claims
- OTC Drugs, Medical Devices, Cosmetics
- Cannabis Business Formation, Compliance, SOPs. Licensing
- Healthcare Compliance & Audits
- Healthcare Fraud
- Telehealth & Telemedicine Law
- HIPAA, Security and Privacy
- Medicare Compliance
- Healthcare Mediation and Dispute Resolution
- University of California, Berkeley, Mediation Certificate 2017
- Western State University School of Law, J.D., 1994
- University of California, Irvine, Social Ecology, B.S. 1991