Mass Torts and Product Liability
Chronic, long-term use of drugs is increasing as an aging population with complex medical profiles consumes drugs in combinations not studied in clinical trials.
As a result, unexpected adverse events may lead to more product liability and product fraud litigations, especially involving pharmaceutical, biotechnology, and medical device manufacturers.
The "Missing Data" Challenge
In this Q&A, Professor Daniel Scharfstein explains the challenges of using clinical trials data in litigation.
Our work in these areas includes the following types of analyses:
- Determining the appropriateness of class certification
- Assessing drug-specific causation and damages
- Development of plaintiff medical databases
- Projecting the likely number of plaintiffs
- Estimating the magnitude of drug-related injury.
In matters involving a drug or device alleged to be associated with negative outcomes, we have applied biostatistical analysis to clinical trial data to assess the rates of adverse events.
We have worked extensively with data from MedWatch, the FDA’s adverse-event reporting system, and have used it in mass tort litigations as well as drug safety work for manufacturers.