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An unfortunate aspect of our legal system is that many important legal issues are not resolved by the courts because a controversy is not only too big to try, but also too big to be filed. A good example is federal-government-threatened civil and criminal claims against pharmaceutical manufacturers for “off-label” promotion, i.e., promotion of pharmaceutical products for uses other than those described on their FDA-approved labeling. Pre-litigation settlements in these cases are negotiated in the shadow of the law and, lacking a robust set of court decisions on the scope of liability, potential defendants are bludgeoned into settlements because of substantial uncertainty over the scope of legitimate claims that could result in, effectively, near death sentences. Not surprisingly, in this environment, manufacturers facing threatened off-label marketing prosecution have agreed to enormous settlement payments, recently as large as $3 billion.

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