Vaccines and the Law

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required under the program in the initial legislation, assuming that better science would be developed on vaccine causation. The science has not developed as anticipated, mostly because vaccine side effects are so low that they are hard to study. The Department of Health & Human Services, intimately involved in the program, takes the position that causal proof must be backed by “hard science” under the program. The Federal Circuit, the federal court charged with overseeing the program, has gradually relaxed the sufficiency standard for causal proof This Article argues that the Federal Circuit, while implementing a program with different policy goals and not constrained by toxic tort law, has gone too far under the Act as written, but that the logic of its decisions should cause Congress to amend the Act to conform to the more relaxed causation standard. Reprinted by permission of the publisher