Drug Safety Litigation
Our experts in epidemiology and biostatistics apply analytical tools to assess claims related to drug safety and medical device safety and help counsel address issues of causation assessment, temporality of association, roles of differential diagnoses, commonality, and potential damages. We have worked extensively with data sources from clinical trials; insurance claims; electronic medical records; and spontaneous reporting systems, such as MedWatch, the FDA’s adverse event reporting system.
Our product liability and drug safety litigation work includes:
- Assessing spontaneous adverse event reports to assess signals of potential safety risks and how the quality of the data may affect the claims of causal relationships.
- Conducting and critiquing meta-analysis of clinical trial data to assess the impact on the timing of when efficacy and safety endpoints reached statistical significance within relevant subpopulations, as well as to assess the appropriateness of the methodology and/or potential biases introduced in a meta-analysis performed by others.
- Conducting analyses using observational data from real-world clinical practices, including health insurance claims data, electronic medical records data, prospective cohort epidemiology studies, patient registries, and patient and physician surveys.
- Supporting expert analysis to assess relevant case facts and drug safety publications, interpret complex technical data in court documents, investigate the methodology or theory of opposing causation, statistical and epidemiologic experts, and create medical merit indexes to assist with settlement negotiations.
- Identifying and critiquing relevant literature to critically assess biases and methodological approaches used to analyze and interpret data, and to support counsel in the development of strategies to address the existing body of literature.
- Health Care Bulletin Monitoring Online Signals: Implications of Internet Data in Pharmacovigilance
Assessing Potential Drug Safety Issues for a Major Pharmaceutical Company
- Featured Expert Lee-Jen Wei Professor of Biostatistics, Harvard School of Public Health
- Featured Expert Mei Sheng Duh Managing Principal, Boston
- AG Feature Anti-Obesity Drug Development Risks and Expectations
- Featured Expert Daniel O. Scharfstein Affiliate