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An editorial, written by three physicians and published in today’s New England Journal of Medicine, argues that the Supreme Court should reject the preemption defense.
To our eyes, of course, the doctors miss the point.
The question is not whether drug and device manufacturers should be “shielded from liability.” The question is who is best situated to judge the safety and efficacy of complex medicines and medical devices — an expert federal agency that devotes its existence to that task, or a random jury of twelve lay people?
The FDA should be funded adequately and do its job correctly. If a drug is ineffective or unsafe, the FDA shouldn’t let it be sold. If post-marketing experience shows that a drug is unsafe or ineffective or requires additional warnings, the FDA should do what’s needed to protect the public health.
But lay juries, sitting in a courtroom in the presence of an injured plaintiff, should not have the power to second-guess the FDA’s decisions.
That’s the issue; the Supreme Court will tell us shortly who’s right as a matter of law.