Mei Sheng Duh

Dr. Duh is a pharmacoepidemiologist specializing in drug and medical device safety issues associated with mass tort product liability, patent infringement, securities fraud, and antitrust litigations. Her practice involves supporting law firms and in-house counsel with assessing general causation between drug and side effect, conducting rigorous critiques of literature, interpreting complex biostatistical and epidemiological data in court documents, conducting meta-analysis of clinical trials and observational data, analyzing spontaneous adverse event data, assessing the strength of safety signals, creating clinical metrics to assist with settlement negotiations, and assessing the typicality of patient and physician characteristics in evaluating class certification. Dr. Duh also conducts pharmacoepidemiology and pharmacovigilance studies for pharmaceutical companies to address drug safety issues raised by regulatory agencies, such as the FDA and EMA, and provides strategic advice to address drug safety issues in the context of black box warnings, product withdrawals, limited access programs, and NDA applications. She has published over 200 articles in peer-reviewed journals in the areas of drug safety, clinical trial data analysis, health economics and outcomes research (HEOR), and utilized data from clinical trials, literature, large health insurance claims data, FAERS and MAUDE spontaneous report data, medical records review, and patient surveys.

Dr. Duh has been appointed to several positions in academia and professional societies. She is a visiting scholar in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health, and she serves on an expert panel convened by the Foundation for the National Institutes of Health’s Observational Medical Outcomes Partnership (OMOP) to develop methodologies for studying drug-induced adverse events on a national scale. She is a peer reviewer for several journals, including Pharmacoepidemiology and Drug Safety, Drug Safety, Chest, British Journal of Cancer, PharmacoEconomics, American Journal of Hospital-System Pharmacists, Critical Care, American Journal of Kidney Diseases, and The American Journal of Managed Care. Dr. Duh is an elected member of the American Society of Hematology, and a member of the International Society of Pharmacoepidemiology, and the International Society of Pharmacoeconomics and Outcomes Research.

Dr. Duh is a graduate of the Harvard School of Public Health, where she received a Doctor of Science degree with a concentration in pharmacoepidemiology, biostatistics, and health policy and management. She received an M.P.H. in chronic disease epidemiology from Yale School of Medicine, and a B.S. in pharmacy from Kaohsiung Medical College (Taiwan).