Product Liability Litigation & Mass Torts

Our Capabilities

• General Causation Assessment – Applying epidemiological principles to evaluate whether exposures to products (e.g., drugs, devices, chemicals, food) are causally associated with alleged adverse health outcomes
• Clinical Trial Data Analyses – Conducting biostatistical analyses of clinical trial data to evaluate whether the findings may vary by select patient groups, evaluating the quality of clinical trial publications to perform meta-analysis to assess safety and efficacy endpoints, and examining the quality of methodologies and potential biases in existing studies
• Real-World Data and Observational Data Analyses – Conducting and assessing analyses of real-world data, including registries, electronic health records, and claims databases, to evaluate safety and efficacy outcomes
• Adverse Event Reporting and Signal Detection – Analyzing spontaneous adverse event report data collected through pharmacovigilance systems, such as a company’s own adverse event database and the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) and Manufacturer and User Facility Device Experience (MAUDE) database, to evaluate data quality, signal detection, and claims of causal relationships
• Literature Assessment – Identifying, evaluating, and interpreting relevant scientific literature to assess methodological approaches used to analyze data by applying established scientific frameworks for causal assessment
• Specific Causation Assessment – Supporting clinical expert analysis to assess case facts, medical literature, and expert testimony to determine likely causes of individual plaintiffs’ health outcomes