From the wrong end of the telescope: a response to professor David Bernstein.

• Author: Berger, Margaret A.
• Position: Response to article in this issue, p. 1961

TABLE OF CONTENTS INTRODUCTION I. FROM THE WRONG END OF THE TELESCOPE A. A Different Perspective on Bendectin B. The Parlodel Saga II. BERNSTEIN'S SLIPPERY SLOPE ARGUMENTS A. Informed Choice Warnings Are Not Worthless B. Bypassing Daubert Will Not Lead to Unreliable Expert Testimony III. ADMINISTRATIVE CONTROLS WILL NOT WORK CONCLUSION INTRODUCTION

On the pages of this law review, in an article entitled Uncertainty and Informed Choice: Unmasking Daubert, the authors argued for the recognition of a new product liability cause of action when drug companies fail to warn about uncertain risks attendant to the use of non-therapeutic drugs whose purpose is to enhance lifestyle. (1) We noted that in the post-Daubert era, plaintiffs have faced increasing difficulty in proving that a given toxic agent was causally responsible for the injuries suffered after ingesting a drug. (2) That plaintiffs cannot overcome the barriers to proving injury causation does not mean that defendants have met their obligation to warn about the dangers associated with taking the drug. In many instances it is clear that drug companies failed to warn about known dangers or negligently failed to adequately test drugs for dangerous side effects. (3) Even if plaintiffs cannot meet the high burden of proving injury-causation, we contend that plaintiffs should be able to establish a cause of action for the failure of drug companies to provide the requisite information so that plaintiffs could make informed choices as to whether they wanted to expose themselves to the uncertain risk associated with the drug. (4)

We acknowledge that when plaintiffs cannot establish injury-causation, recovery for physical harm is inappropriate. (5) However, a plaintiff deprived of informed choice has a legitimate claim for mental distress resulting from having lost the opportunity to refuse to subject herself to uncertain risk. (6) In our article we set forth the template for this causation-free cause of action for the deprivation of choice. (7)

In a sharply worded rebuttal, Professor David Bernstein takes issue with our thesis. (8) He considers our proposal to be "ill-conceived and dangerous." (9) Bernstein argues that Bendectin, the drug we use to exemplify the need for a causation-free informed choice cause of action, has proven to be safe. (10) From 1957 to 1983 Bendectin was a popular drug taken by women in the first trimester of pregnancy to reduce symptoms of nausea. (11) Though at first there was reason to believe that it might cause birth defects, two decades later, research has proven its safety. (12) Merrell-Dow, the manufacturer of Bendectin, withdrew the drug from the market because of the onslaught of litigation brought by parents who claimed that the drug was responsible for children born with limb reduction. (13) Bernstein bemoans the withdrawal of this useful drug from the market because of a bogus scare created by avaricious plaintiff's lawyers. (14) Bernstein argues that our proposal would deliver a new cause of action to an irresponsible plaintiff's bar based on a vague standard as to what qualifies to be a "material risk" deserving of an informed choice warning. (15) Absent Daubert screening for reliability, Bernstein argues, juries will fall prey to plaintiffs' attorneys who are "masters at appealing to juries' emotions." (16) Furthermore, he claims that informed choice drug litigation will deter doctors from prescribing safe drugs and patients from taking them even when necessary. (17) And if all this were not enough, adding this new drug cause of action will burden the scientific community with endless discovery requests that amount to harassment. (18) Bernstein concludes that our regime will deter innovation and ultimately result in a surfeit of useless warnings. (19)

1. FROM THE WRONG END OF THE TELESCOPE

   1. A Different Perspective on Bendectin

      Well over half of Professor Bernstein's rebuttal concerns Bendectin. Despite his suggestions to the contrary, we do not dispute his conclusion that by the 1980s Bendectin was shown not to pose actionable harm to the children of women who had taken the morning-sickness remedy. His discussion and conclusion are, however, totally irrelevant to our thesis. For us, the significant date is not the moment when a scientific consensus was reached that Bendectin was, at most, a mild teratogen with undetectable effects. For us the significant date is 1974, when Betty Mekdeci took Bendectin to counter the nausea she experienced while pregnant with her son David. (20) Professor Bernstein does concede, albeit in footnotes, that "[t]o the extent that physicians reportedly told patients that Bendectin was proven 'totally safe' before the 1980s, this information was inaccurate." (21)

      In text, Professor Bernstein tries to move the significant date back to 1977--the year Mekdeci instituted suit (22)--a date that is equally irrelevant to our hypothesis that plaintiff is entitled to a meaningful informed choice before taking a lifestyle drug. Professor Bernstein argues that fourteen epidemiological studies had been performed by 1977 finding no association and that "no serious doubts" had been raised about "[Bendectin's] safety in the scientific or medical community." (23) This statement is somewhat disingenuous. We are most fortunate that two excellent books exist about the Bendectin litigation written by two eminent law professors, Michael Green and Joseph Sanders. (24) Both books document that there were "signals" pointing to possible adverse outcomes and that there was no basis in 1974 for concluding that the drug was safe.

      Professor Sanders could find no indication that any research had been conducted on Bendectin before it was marketed in 1956. (25) He found nine epidemiological studies that were conducted prior to 1974, and although none found an association between Bendectin and birth defects, Professor Sanders critiques them as having little scientific value--most contained no statistical analyses, failed to focus on Bendectin, and had a limited ability to detect small defects. (26) One of the studies was done so badly that plaintiffs later...