FDA Approval Expert Witnesses in Tennessee

This highly credentialed biomedical engineer has significant experience in the design and development of cardiothoracic medical devices. He earned his Master's degree from Georgia Tech and the Emory University School of Medicine; After six years of industry experience he returned to academia and obtained the PhD from the University of Aarhus in Denmark. Then at the Aarhus University Hospital he achieved the Doctor Medicinae (DrMed) degree, which denotes medical research expertise above and beyond a PhD. He is an active member of several scholarly societies in the biomedical field and is a regular reviewer of the Annals of Biomedical Engineering, the Journal of Surgical Research, and Cardiovascular Engineering and Technology. He currently serves on the biomedical engineering faculty of a major Southern university.

This highly qualified expert has over a decade's experience in orthopedic trauma medical device sales in both a field capacity as well as executive, following a career in law enforcement in special operations. Extensive experience, has been in thousands of surgical procedures; and has previously conducted hundreds of criminal investigations. At DePuy Synthes, Companies of Johnson & Johnson, he managed a large territory in Orthopedic Trauma devices, providing clinical expertise and training to surgeons and hospitals regarding the proper use of the company's trauma line. He is currently the Vice President at another orthopedics device company specializing in carbon fiber trauma and oncology products. In summary, this expert has sales, compliance and sales training experience, with a Law Enforcement, Collegiate Athletics, and a military academy background.

This expert is highly fluent in environmental compliance strategies that take into account state and federal environmental regulations and guidances, and the principles of sound engineering practices. His regulatory expertise includes the regulation and enforcement of hazardous waste, superfund and toxic substance laws and UIC regulations. This expert worked in the U.S. Environmental Protection Agency for 31 years and was EPA's RCRA national hazardous waste expert and one of a few who was also a RCRA and Superfund Remedial Project Manager (RPM). Because of his extensive knowledge, he testified as a government witness in federal court proceedings and inspected and evaluated the largest, most difficult hazardous waste sites involving complicated toxicology and environmental site conditions. He directed the Regional RCRA inspection team and personally evaluated industrial sites, including refineries, oil and gas production and treatment facilities, metal refiners, power plants, and waste disposal sites across the Region to determine their compliance with environmental laws. A registered PE and board-certified environmental engineer, this expert helped the EPA develop policies and rules regarding regulatory compliance, risk assessment, site remediation, and worker health issues at waste disposal sites, hospitals, refineries, oil and gas production and power plants. Since retiring from EPA, this expert has had numerous expert witness engagements where he has written several expert reports and participated in various court proceedings.

This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.

This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the average consumer will understand, integration of behavior modification and design, working with medical teams to provide documentation required for FDA approval process, and developing health professional’s tools for patient counseling to ensure that the patient education materials are used correctly. She also has expertise in working with medical device companies and packaging companies to ensure that it will be easy for patients to understand the “how to use” instructions and use the products correctly. She received her BSP degree and completed her residency training in hospital pharmacy at the University of Saskatchewan before receiving her Pharm.D. degree from the University of Cincinnati. She is a founding member of the American College of Clinical Pharmacy, a former member of the Board of Directors and Chairperson of the Business Council at the National Council on Patient Information and Education, and is active in many professional and consumer organizations, including the American Association of Colleges of Pharmacy and the Alliance for Safe Online Pharmacies. She has published 150+ peer-reviewed journal articles on patient education and adherence and serves as a reviewer for the American Pharmacists Association. She is the author of 23 books on how to use medications safety for health professionals and consumers. She has appeared on many radio and television shows to help consumers learn how to take their medications correctly. She is also the former director of clinical affairs at the American Pharmacists Association, which honored her with its Foundation Pinnacle Award for her outstanding leadership. Additionally, she is the former coordinator of the ambulatory patient pharmacy at Sunnybrook Medical Center and a former associate professor of clinical pharmacy at the University of Toronto. Currently, she is the CEO of a major patient education company that develops information to help patients understand how to manage their medications, medical devices and therapies correctly, consults with pharmaceutical companies on how to promote patient understanding and patient safety, develops multi-component patient education programs requiring FDA approval, and develops patient education programs for world-wide clinical trials to increase patient adherence so that the approved FDA dosage is more accurate and thus safer.

This highly-qualified expert has over 25 years of experience in work zone safety, with demonstrated experience in health and safety management, regulatory compliance, safety auditing and reviews, and accident and incident investigations in areas of construction and mine safety. He earned his AS in electronics systems technology at Community College of the Air Force and his BS in occupational safety and health at Columbia Southern University. This expert holds several certifications in his field, including as a certified safety professional (CSP), a certified construction manager of environment safety and health (C-MESH), an OSHA and MSHA Part 48 metal/non-metal instructor, and a miner. He is also certified in fall protection and electrical safety, holding a NFPA 70E certification. He is active in his field as a member of the American Traffic Safety Services Association. He began his career as an antenna systems technician for the United States Air Force before transitioning to work as a loan officer for Freedom Mortgage Services and a senior financial officer for Carteret Mortgage Corporation. He also served as a lead instructor for the American Red Cross, a traffic control supervisor for Moore & Son, and a health and safety manager for Rogers Group Inc. Currently, this expert is the health and safety director of a safety industrial firm in North Carolina.

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.

This medical device sales professional has been in the industry since 1999. He earned his B.A. in Economics from Emory University and eventually went to work for Boston Scientific as a Territory Sales Manager in Men's and Women's Health. After 10 years with Boston Scientific, the expert joined St. Jude Medical's Neuromodulation device team as a Territory Manager in the Gulf Coast region. He was involved in 800+ implants and worked on device servicing for an additional 200+ patients. The expert left St. Jude at the end of 2015 and is now a Business Development and Sales Manger for a different device company in a separate product category.