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Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and devices including clinical investigators, sponsor/monitors, institutional review boards, Good Laboratory Practices, and pre-approval inspections. He served as a supervisory investigator supervising medical device and drug experts and specialists. Expert served as a compliance officer reviewing and evaluating evidence, recommending legal action, drafting complaints and assisting the United States Attorney in prosecution of legal actions. Other responsibilities included service as a criminal investigator assigned to the Department of Justice, and training of FDA investigators and foreign officials.

Expert taught food and drug law as an adjunct professor of law. He also served as the chair for the Chicago Bar Association FDA Law Committee. He has authored a chapter in an expert treatise, and has been requested and provided training to industry and academia.

For more than ten years he has provided litigation support services as a consultant and expert for plaintiff and defense clients. Cases have revolved around compliance with FDA requirements in pre-market development, testing, approval, manufacturing, use, and and post-approval reporting for medical devices and pharmaceuticals. Cases have included fraud and misrepresentation, personal injury, breach of contract, product liability, medical malpractice, libel, and Qui tam actions. Expert has also provided regulatory compliance consulting to industry including corrective action plan design and implementation.

Expert is currently serving as a compliance expert for the plaintiff in a libel suit. The defendants (corporate and individuals) published a series of newspaper articles of manufacturing and distributing unsafe pharmaceutical products. To date he has reviewed and evaluated production request (discovery) documents as well as FDA records he located on the FDA web site to evaluate the plaintiff's compliance with FDA law and regulations. Expert is currently serving as a compliance expert for the plaintiff in a fraud misrepresentation suit. He located, reviewed and evaluated FDA records relevant to defendant medical device manufacturer's compliance with FDA law and regulations relevant to the manufacturer's financial interest disclosure of clinical investigators. He wrote an expert opinion and was deposed. Expert served as a compliance expert for the relators in a Qui tam action. He reviewed and evaluated production request records as well as records he located on the FDA web site. He wrote an opinion letter on the state of compliance for the defendant medical device manufacturer, which was published to the United States Attorney. Expert was the litigation consultant for the plaintiff/defendant (cross complaints) in a breach of contract case. He inspected a pharmaceutical manufacturing and testing facility, conducted a GLP (Good Laboratory Practices) inspection, reviewed and evaluated bioavailability and bioequivalence testing programs, and reviewed and evaluated numerous ANDA (Abbreviated New Drug Application) approvals. Expert was the litigation consultant for the relator in a Qui tam action. He reviewed and evaluated clinical trial documents for evidence of violations of FDA law and regulations. He advised the attorney significance of violations as well as probable FDA response.