Working Paper No. 05-15:
Learning the Wrong Lessons from 'An American Tragedy': A Critique of the Berger-Twerski Informed Choice Proposal

Author(s):

David Bernstein

Date Posted: 2005

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Abstract:

This paper is a critique of Margaret Berger and Aaron Twerski, 'Uncertainty and Informed Choice: Unmasking Daubert', forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects.

Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears that a pharmaceutical manufacturer could be held liable for failure to provide informed choice: (a) even when there was never any sound scientific evidence suggesting that the product caused the harm at issue, and there was an unbroken consensus among leading experts in the field that the product did not cause such harm; (b) when the product prevented serious harm to a significant number of patients, and prevented substantial discomfort to a much greater number, even when there were no available alternative products; (c) when a plaintiff claims that she would not have taken the product had she been informed of an incredibly remote and completely unproven risk; and (d) when the defendant is unable to prove "a negative" - that the product in question definitely did not cause the claimed injury.

No rational legal system would allow such a tort. Putting the Bendectin example aside, the informed choice proposal has the following additional weaknesses: (1) it invites reliance on unreliable "junk science" testimony; (2) it ignores the fact that juries are not competent to resolve subtle risk assessment issues; (3) it reflects an unwarranted belief in the ability of juries to both follow limiting instructions and ignore their emotions; (4) it ignores the problems inherent to multiple trials---even if defendants were to win most "informed choice" cases, safe products could still be driven off the market by a minority of contrary verdicts; (5) it ignores the inevitable costs to medical innovation as pharmaceutical companies scale back on researching product categories that would be particularly prone to litigation; (6) to preempt litigation, pharmaceutical companies would "overwarn," rendering more significant warnings less useful; and (7) FDA labeling requirements would arguably preempt the proposed cause of action.