FDA Regulation (Food Drug Administration) Expert Witnesses: 3

John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices. 

Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 30 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony. 

Areas of Expertise:

• Submissions (510(k), IDE, PMA, De Novo)
• Medical Device Quality Systems
• FDA Inspections

View Mr. Stevens' Consulting Profile.

Dr. Ewen Todd is a Food Safety Expert with over 45 years of knowledge and experience in general food safety and Food Microbiology Issues. Specifically, he has extensive experience in the reporting and surveillance of Foodborne Disease, as well as development of analytical methods for identifying foodborne pathogens. As a result of his work with the industry and his knowledge of foodborne disease, Dr. Todd has influenced research programs and regulatory approaches taken by the Health Protection Branch of Health Canada. In the US, he held the position of Director of the National Food Safety and Toxicology Center and the Food Safety Policy Center at Michigan State University. 

A leader in microbial research, foodborne disease surveillance, costing of outbreaks, food safety policy, seafood toxins, standard-setting, risk assessment, risk management, and risk communication. He has worked in numerous countries educating and training, and collaborating to set up surveillance systems, food safety policies, regulations, and HACCP and other control strategies, including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, and Europe, as well as Canada and the USA. He is also familiar with food defense and food fraud issues, and waterborne disease. He is familiar with the US and Canadian food industry, both foodservice and food processing, HACCP, disease investigation, food, and equipment contamination.

Since leaving the Canadian government and entering academia and as a consultant, he has been an expert witness in 25 cases in both the U.S. and Canada where foodborne illnesses have occurred. He has testified on the behalf of plaintiffs who suffered from E. coli O157:H7, Campylobacter, Salmonella, ciguatoxin fish poisoning, yeast, and unknown agents. He has also represented defendants in two illness cases. Therefore, his litigation services are available for both Plaintiff and Defense.

Areas of Expertise

• General Food Safety and Spoilage Issues
• HACCP and GHP Systems
• Standards for Poultry
• Listeria Monocytogenes in Soft Cheeses
• Standards for Poultry
• Seafood Toxins
• Food Workers
• Investigation of Foodborne and Waterborne Illnesses
• Foodborne Disease Surveillance Systems
• Risk Assessment, Risk Management and Risk Governance
• Safety of Aquaculture Systems
• Norovirus in Elder Care and Other Facilities
• Salmonella and Shigella in Schools and Child Care Centers
• Salmonella in Tahini and Other Oil-based Foods
• Escherichia coli O157:H7 in Leafy Greens
• Staphylococcus aureus in Cheese, Clostridium botulinum in Canned or Preserved Food and Native American / Inuit Fermented Food
• Listeria monocytogenes in Deli Meats and Soft Cheeses
• Controlling Listeria monocytogenes in Ready-to-eat Foods
• Hydrophobic Grid Membrane Filter Systems

View Consulting Profile.