Brady Mickelsen is an associate in the Litigation practice of Paul Hastings and is based in the firm's Washington, D.C. office. Mr. Mickelsen's practice focuses on representing life sciences clients in a wide range of white collar and regulatory matters, including complex internal investigations, government enforcement actions, and compliance counseling. He has considerable experience in both clinical and management roles within industry allowing him to have a deep understanding of the unique legal, policy, and business issues faced by pharmaceutical, biological, and medical device companies.
University of Virginia School of Law, J.D.
Trinity Washington University, M.B.A.
Westminster College, B.A. (summa cum laude)
Co-Author, "The Progress and Potential for Medicare Coverage of Innovative Technology," American Health Law Association (November 2020)
Quoted in, "Device Experts Say FDA Is Too Heavily Invested In Pre-Cert Program," Inside Health Policy (September 2020)
Participates in speaking engagements and guest lecturing on topics related to FDA regulatory compliance and enforcement
Presenter, "Impact on MDSAP Model on Risk Based Product Safety Monitoring," 6th Annual Medical Device Postmarket Surveillance Conference (January 22, 2020)
Quoted in, "Device Lawyer: Pre-Cert Test Plan May Help FDA Get New Authority," Inside Health Policy (June 2019)
"Utah Court Should Find Medical Devices Merit Exception to Strict Product Liability," Washington Legal Foundation (November 2018)
Led a large associate and contract attorney team in major recall of multiple medical device products and related global internal investigation
Conducted an extensive data integrity investigation related to an import alert issued against a large API manufacturer
Advised multiple biotech manufacturers on issues related to gene therapy and regenerative medicine, including interactions with FDA related to a Complete Response Letter
Defended multiple False Claims Act qui tam cases filed against global pharmaceutical and biotech manufactures based on allegations of Food, Drug, and Cosmetic Act violations
Advised medical device manufacturer and telemedicine services company on FDA premarket strategy for bringing multiple devices to market
Represented major pharmaceutical company in a significant International Trade Commission inquiry and subsequent appeal alleging unfair competition against the Company's global competitors and served as second chair in a related National Advertising Board matter
Advocated on various life sciences issues before the U.S. Congress and advised on response to congressional inquiries