Brian’s primary practice involves preparing the defense of pharmaceutical and medical device manufacturers in complex product liability matters and commercial litigation. He frequently defends claims arising from the use of prescription drugs, implantable medical devices, and consumer products in state and federal courts throughout the country. In addition, Brian has represented manufacturers in the automotive and telecommunication industries against claims stemming from product design and contract disputes.
Brian also counsels Food and Drug Administration-regulated companies on regulatory and compliance issues involving the federal Food, Drug and Cosmetic Act and other health care laws and regulations regarding prescription and over-the-counter medications and medical devices. Recent examples of Brian’s regulatory practice include:
- Counseling 503(b) outsourcing facilities on compliance with the Drug Quality and Security Act.
- Providing advertising and promotion review to ensure compliance with FDA and FTC guidance.
- Counseling on compliance with the Anti-Kickback Statute and the False Claims Act.
- Advising on requirements of the Drug Supply Chain Security Act.
Brian is a former instructor at the University of Florida College of Pharmacy, where he taught graduate courses on health care regulation and federal food and drug law. Brian received his Doctor of Pharmacy degree and practiced for several years as a registered pharmacist in community, hospital and long-term care settings before attending law school. This training and experience has benefited both his litigation and regulatory practices by enabling him to understand and appreciate the complexity of the medications and medical devices he encounters as well as how these products fit into the FDA’s regulatory framework.
Debra Dunne & Brian Guthrie, Crafting Changes for the Future: The Use of Technology to Expand Access to Medications, Update (Food and Drug Law Institute), May/Jun. 2014, at 31.
Debra Dunne & Brian Guthrie, Crafting Changes for the Future: Increasing the Availability of Nonprescription Drugs, Update (Food and Drug Law Institute), Mar./Apr. 2014, at 27.