Research-Related Injuries in Clinical Trials: Who Pays?

Article excerpt

Pharmaceutical and medical device companies often reduce clinical trial liability costs by requiring test subjects to assume the burden of risk from the treatment. The key to this is using consent language such as: "Treatment for research-related injury will be made available. Costs associated with this treatment will be billed to your insurance company. Costs not covered by your insurance company will be your responsibility." And while they provide medical companies with some protection, the risk they transfer to their patients might defeat the purpose of the entire enterprise.

Medicare will pay for routine care in cancer clinical trials, and some states require their health plans to do the same. Such regulations are unclear, however, as to whether health plans will pay for research related injury treatments in addition to those routine costs. But health plans are unlikely to pay for research-related injury treatment costs.

And while the plans do not cover "investigative" treatment, they say nothing about whether they do cover research-related injuries that happen as a result of such treatment. This means that before signing up for a clinical trial, prospective subjects should contact their health plan provider to find out if research-related injuries are covered, or whether they will have to pay for such treatment costs out-of-pocket.

Some sponsors, however, do offer to pay lot research-related injury costs, as outlined in their consent forms. For example: "If you sustain a bodily injury as a direct result of taking drugs provided in this study, medical treatment will be provided. You will be reimbursed by the Sponsor for reasonable doctor's fees and medical expenses necessary for the diagnosis and treatment of injuries that are a direct result of taking the study medication and are not covered by your medical or hospital insurance coverage, provided you have followed all of the instructions of the study doctor and his/her staff." Or, "If you are physically injured by the study drug or properly performed study procedures and you have not caused the injury by failing to follow the directions of the study personnel, the Sponsor will cover the reasonable medical expenses necessary to treat the injury. No other compensation such as lost wages or payments for emotional distress is offered by the Sponsor, but you do not waive any legal rights by signing this consent form. …