Andrew E. Kantra is a partner in the Health Sciences Department of Pepper Hamilton LLP, resident in the Philadelphia office. He focuses his practice on representation of pharmaceutical clients in multi-district litigation, state coordinated proceedings and individual cases, regulatory counseling and mediations of matters involving marketed products and clinical trials.
Mr. Kantra has defended wrongful death and personal injury actions involving marketed and investigational products, involving extensive expert witness work, analysis of medical literature, dispositive motion practice, and deposition preparation of company witnesses. Mr. Kantra also conducts internal corporate investigations.
Mr. Kantra counsels pharmaceutical and device companies on research and development procedures, adverse event reporting and analysis, compliance with FDA regulations and consistency with ICH and CIOMS guidance and conducts risk assessments of investigational and marketed pharmaceuticals. He has led Daubert challenges to experts in varied litigations and conducted Science Day programs for federal and state courts. He provides prophylactic counseling to clients with respect to FDA regulatory requirements regarding Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, clinical trials, labeling, risk management plans, private payor communications, and advertising and other promotional activities. He also drafts responses to inquiries and notices from FDA (including warning letters and label change requests) and foreign regulatory agencies; identifies potential litigation risks in proposed protocols, informed consent documents, regulatory submissions, scientific disclosures, medical letters, press releases, stand-by statements, website content, social media, and investor relations presentations; and conducts due diligence analysis of contract research organizations and biotechnology companies. He also evaluates potential litigation risks associated with clinical trials conducted outside the United States.
Mr. Kantra 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 and Temple University on epidemiology and admissibility of evidence from expert witnesses.