Drug Safety and Epidemiology
Drug safety is one of the most pressing public health issues of our time. Our work draws on expertise in epidemiology, outcomes, data analysis, and litigations involving mass torts, products liability, and off-label promotion investigations.
Our epidemiology research is grounded in data from controlled clinical trials and observational naturalistic settings. We have undertaken descriptive prevalence and incidence studies, and analytical comparative studies that evaluate temporal relationships and etiological associations.
The Science in Drug Safety Litigation
Epidemiologic expertise can play a critical role in assessing liability and estimating damages in drug safety matters.
We have also examined patient-reported outcomes such as quality of life, function status, and treatment satisfaction, and clinical effectiveness such as mortality, morbidity, response to treatment, risk factors analysis, disease recurrence, drug adjuncts and switches, medication compliance, and medical persistence.
We have also provided epidemiologic literature reviews related to risk management planning for new drug indications. In the context of litigation, we have been retained to conduct pharmacoepidemiologic/drug safety analysis and meta analysis of clinical trials to assess allegations of excess risk.