Why We Need a No-Fault Compensation System for Drug Injuries

The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.

When the federal regulatory system was initially developed in the early 20th century, these two systems played important roles in protecting the public health. Today, however, while the FDA comprehensively and effectively manages the unavoidable risks of prescription drugs, it is becoming increasingly clear that the tort liability system may not do the same. In fact, the tort liability regime may actually undermine the FDA's risk-management scheme, to the detriment of the public. The development of an alternative means for compensating those injured by prescription drugs is therefore appropriate.