Learning the Wrong Lessons from “An American Tragedy”: A Critique of the Berger-Twerski Informed Choice Proposal

Margaret Berger and Aaron Twerski are among the leading scholars in their respective fields of Evidence and Products Liability. I have benefited from their work on many occasions. Precisely because of the deserved respect and esteem in which Berger and Twerski are held-not to mention the prominence of their forum, the Michigan Law Review-their proposal to create a new “informed choice” cause of action in pharmaceutical litigation is likely to receive sympathetic attention. Because I believe that their proposal is ill-conceived and dangerous, I feel compelled (with some trepidation) to write this response. Berger and Twerski propose that courts recognize an informed choice cause of action that would allow plaintiffs claiming injury from pharmaceutical products to recover damages for deprivation of informed choice when (1) the causal relationship between the toxic agent and plaintiff’s harm is unresolved at the time of litigation and will likely remain unresolved; (2) the drug is not therapeutic but rather its purpose is to avoid discomfort or to improve lifestyle; (3) it is almost certain that a patient made aware of the risk that is alleged to be associated with consumption of the drug would have refused to take it; and (4) defendant drug company was aware of the potential risk or should have undertaken reasonable testing to discover the risk and failed to provide the requisite information to the physician or patient. These guidelines, however, are rather vague. Whether they are meant to apply broadly or narrowly means the difference between a cause of action that would open a Pandora’s Box of litigation and one that would be available only in limited, perhaps even extraordinary, circumstances. Apparently, Berger and Twerski intend the scope of the informed choice action to be broad indeed. So broad, in fact, that if adopted it could lead to an unprecedented wave of litigation against pharmaceutical manufacturers, including lawsuits involving products that are completely safe and effective.