Andy focuses his practice on the representation of pharmaceutical clients in multidistrict litigation, state-coordinated proceedings and individual cases involving investigational products in clinical trials and marketed products.
In defending wrongful death and personal injury actions, he draws on his experience with expert witnesses and his ability to understand and explain complex medical concepts to lead the science component of litigation. He has successfully challenged and defended experts in varied litigations and conducted Science Day programs for federal and state courts. His work crosses multiple therapeutic areas, including endocrinology, epidemiology, gastroenterology, infectious diseases, immunology, neurology, oncology, psychiatry, teratology, and toxicology.
Andy’s litigation insights help clients identify and manage risk associated with clinical trials, prophylactically or in real time with ongoing litigation or government investigations. He advises on research and development policies and procedures, adverse event reporting and analysis, study protocols, informed consent documents, clinical holds, clinical study reports, scientific disclosures of data, compliance with FDA regulations and consistency with ICH and CIOMS guidance (e.g., Good Clinical Practices; Good Laboratory Practices; Good Manufacturing Practices), and FDA warning letters. For marketed products, he counsels clients on FDA regulatory requirements regarding payor communications and promotional activities. He also conducts internal corporate investigations.
Andy applies his litigation experience to other related matters, such as business disputes between clinical trial sponsors and clinical research organizations and securities fraud matters involving investigational products.
Andy has spoken on legal risks in the clinical trial setting at the Biotechnology Industry Association’s annual convention, and on risk evaluation of contract research organizations at the Practising Law Institute and to the Tort and Insurance Practice Section of the American Bar Association. Additionally, he is a contributing author to the “Drug and Medical Device Product Liability Desk Book.” He has been a guest lecturer at the University of Pennsylvania on epidemiology and admissibility of evidence from expert witnesses.
