Kyle focuses his practice on FDA regulatory and health care fraud and abuse counseling, and works on litigation matters concerning similar issues. In his regulatory counseling practice, Kyle provides analysis, advice, and transactional support on FDA regulatory issues relating to prescription and OTC drugs, medical devices, biologics, and compounded products, including labeling, promotion, cGMP, and other issues. He also drafts and negotiates agreements between companies across the supply chain of FDA-regulated products. His health care regulatory counseling practice includes advising clients on the Anti-Kickback Statute, Stark Law, Physician Payment Sunshine Act, and False Claims Act.
As a litigator, he defends pharmaceutical, medical device, and health care industry clients in products liability actions, consumer, and third party payor class actions, contract disputes, and False Claims Act, and Foreign Corrupt Practices Act investigations and litigation.
Kyle also represents pro bono clients in prisoners' civil rights cases and in conjunction with Philadelphia VIP. In 2023, he tried a prisoner's civil rights claim in the U.S. District Court for the District of New Jersey and obtained a monetary settlement from defendants mid-trial. Previously, Kyle was a member of the team that served as pro bono co-counsel with the American Civil Liberties Union of Delaware (ACLU) and Community Legal Aid Society, Inc. (CLASI) in bringing claims on behalf of mentally ill inmates being held in solitary confinement by the Delaware Department of Correction. The case resulted in a successful settlement on behalf of the inmates, including improved conditions and mental health treatment services. In recognition of its efforts, the team received a number of awards in 2016-2017, including the ACLU's Clarence Darrow Award, CLASI's Founder's Award, the National Disability Rights Network (NDRN) Advocacy Award, and the Delaware State Bar Association's Christopher W. White Distinguished Access to Justice Leadership Award.
Articles + Publications
04.10.24
New FDA Guidance on AI and Medical Products
Articles + Publications
06.05.23
FDA Proposes New Rules for Prescription Drug Labeling
Speaking Engagements
10.26.22
Medmarc Webinar: Increasing Diversity in Clinical Trials: FDA Guidance and Industry Efforts
Articles + Publications
06.14.22
FDA Draft Guidance Instructs Sponsors on Content and Timing of Diversity Plans for Clinical Trials
Firm News
03.11.22
Troutman Pepper Counsels MVM Partners in Investment in Nalu Medical to Help Patients Battling Chronic Pain