When choosing a partner to participate in your human clinical trial, does it matter if you select a state- or federally chartered clinical facility versus a privately operated clinic or hospital? David Shuey, North America life sciences practice leader for insurance brokerage firm Willis Group Holdings plc., believes it does. In fact, if you are not aware of the differences, it could cost you dearly should a problem arise. The issue is sovereign immunity, an ancient carryover from England that is designed to protect the government from lawsuits.
“Sovereign immunity is a remnant of medieval British law,” says Shuey. “When we were still the British colonies and embraced their laws, we adopted this concept. It held that the king could do no wrong, and therefore could not be sued for negligence. To this day, sovereign immunity gives the federal government and, in some cases, the state government, immunity against tort liability. If a patient can’t sue the state or federal government, this has severe implications for the sponsor.”