The new drug and medical device discovery process necessarily requires human clinical trials.
The insurance industry has traditionally provided insurance coverage for trial patients who are injured during a trial based on theories of negligence and tort liability.
An emerging risk for American drug and device companies is that many international regulators require patient compensation for trial subject injuries regardless of the sponsor’s or clinic’s negligence.
If insurance won’t respond, the sponsor and/or clinic will be required to pay for these injuries as an operating expense.
The insurance industry is struggling to keep pace with this emerging risk.