John is a member of the Life Sciences Health Industry Group. He represents clients in numerous highly regulated industries including the health care, medical device (including Software as a Medical Device), pharmacy (compounding, nuclear, specialty and retail), and drug industries (manufacturers, 3PLs, wholesalers, and distributors).
John provides strategic legal advice to businesses and individuals for compliance, transactional, and litigation matters. These types of matters include FDA, DEA, state and federal compliance, fraud and abuse (e.g., Anti-Kickback Statute and False Claims Act) compliance, mergers and acquisitions, and clinical trial issues. John has extensive experience representing clients throughout settlement and consent order negotiations, contract reviews, acquisitions, government investigations, inspections and audits, FDA Form 483’s, FDA Warning Letters, drug and product recalls, hearings before state and federal regulators, import and export issues, supply chain security issues, and advertising and promotion issues.
John is also a Certified Information Privacy Professional (CIPP/US), and counsels clients with respect to privacy matters related to FDA regulated products, including HIPAA privacy matters and when FDA-regulated devices capture patient data.
John has an active pro bono practice focusing on assisting clients affected by sexual exploitation and domestic violence.
