Product Liability Litigation & Mass Torts

Analysis Group provides rigorous epidemiological, biostatistical, clinical, and economic expertise to support clients in complex product liability and mass tort litigations. Our diverse roster of subject-matter experts and expertise in both general and specific causation assessment enable us to deliver comprehensive consulting support and expert testimony across a wide range of topics related to matters involving drug safety, medical device safety, environmental and chemical exposures, and food and nutrition.

Our experience spans pharmaceutical, biotech, and medical device companies, insurers, food manufacturers, chemical producers, and consumer product companies involved in mass torts in high-stakes litigation related to product safety, product defects, false advertising, and regulatory compliance, among others.

Our product liability and mass tort work is further strengthened by Analysis Group’s extensive scientific research work in epidemiology, pharmacovigilance, biostatistics, and clinical regulatory evidence generation for life sciences companies, allowing us to integrate scientific rigor with practical deep insights for expert testimony.


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 biostatical analyses on 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 & 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 & Signal Detection – Analyzing spontaneous adverse event report data collected through pharmacovigilance systems, such as company’s own adverse event database and FDA’s FAERS and MAUDE, 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
Our Capabilities

 

Epidemiology & Biostatistics Experts

Providing in-depth epidemiological and statistical analysis of spontaneous reports safety data, clinical trials, and real-world observational data to assess claims of general causation and signal detection

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Clinical and Medical Experts

Analyzing and interpreting scientific evidence regarding potential associations between exposures and health outcomes and evaluate patient medical records and established risk factors to assess claims of specific causation

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Disease Area Scientific Experts

Providing insights into disease etiology and evaluate biologic plausibility of claimed causal associations

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Regulatory Experts

Offering insights into the regulatory approval process, compliance issues, and the implications of adverse event reporting and post-market surveillance

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Pharmaceutical and Biotech Industry Experts

Evaluating industry standards, safety protocols, and product development processes

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Economic and Damages Experts

Analyzing the potential short- and long-term health care needs and costs of treatment associated with adverse health outcomes allegedly caused by at-issue exposures

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