Brian T. Guthrie’s primary practice involves preparing the defense of pharmaceutical and medical device manufacturers in complex product liability matters. He defends product liability claims arising out of the use of prescription drugs, implantable medical devices and consumer products in state and federal courts throughout the country.
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 also an instructor at the University of Florida College of Pharmacy, where he has taught graduate courses on health care regulation and federal food and drug law. Brian received his Pharm.D. 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.
- Pharm.D., University of Florida College of Pharmacy, 2011
- J.D., magna cum laude, Florida State University College of Law, 2010
- Order of the Coif
- Book Awards (Contracts I, Property, Gratuitous Transfers)
- B.S., summa cum laude, Midwestern University – Chicago College of Pharmacy, 2000
- Rho Chi Pharmaceutical Honor Society, President
- Merck Award (Outstanding Scholastic Achievement)
- B.A., cum laude, North Central College, 1998 (Chemistry)
- U.S. District Court, Middle District of Florida
- U.S. District Court, Northern District of Florida
- U.S. District Court, Southern District of Florida
- American Bar Association
- American Pharmacists Association
- American Society for Pharmacy Law, Board of Directors (2012-Present); Education and Scholarship Committee, Chair
- Florida Pharmacy Association, Educational Affairs Council (2012-2014)
- Hillsborough County Bar Association
- Federal Bar Association
Rate : $$$