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Indeed, FDA-mandated trials for most drugs are small, involving a few thousand patients, compared to the masses consuming a cheap-zyrtec after it has been approved. That means that some rare side effects will be discovered only after the drug has been taken by hundreds of thousands or millions of patients. Expanding the testing process to require more and larger clinical trials might uncover a few more side effects, but would also delay the introduction of valuable new therapies - as it is, drug development often takes more than a decade.

This confronts the agency with a speed-safety tradeoff: ensuring safer drugs entails a longer wait, and hence higher morbidity and mortality for patients in need of new treatments. The agency must thus balance speed of approval with safety. The FDA, although not perfect, at least has access to the right expertise to make science-based decisions on whether the existing speed-safety tradeoff is in the best interests of society. Courts and juries - who only see injured plaintiffs - are poorly positioned to second-guess those balanced decisions and will focus too much on liability rather than innovation.