Uncertainty and informed choice: unmasking Daubert.

• Author: Berger, Margaret A.

TABLE OF CONTENTS INTRODUCTION I. DAUBERT: THE DIFFICULTY OF ESTABLISHING CAUSATION IN TOXIC TORT CASES II. THE FORGOTTEN RIGHT OF INDIVIDUAL CHOICE AND PATIENT AUTONOMY A. Medical Malpractice: The Informed Consent Paradigm B. Products Liability: The Informed Choice Paradigm III. REDEFINING MATERIALITY FOR A CAUSATION-FREE INFORMED CHOICE ACTION IV. FORMULATING A REMEDY FOR THE DEPRIVATION OF CHOICE A. Dignitary Tort Damages B. Damages for the Anguish of Choice Deprivation CONCLUSION Here is a company [Merrell Dow--the manufacturer of Bendectin] who has been in thalidomide, involved with thalidomide, and they know that the only animal that had the identical deformity to man was one species of macaque monkey.... They never went to higher animals. Here's a company who knows all about thalidomide, yet they haven't got the money to go to higher animals.... I feel like there were certainly enough [adverse reactions of limb reduction in children born after their mothers had taken Bendectin to alleviate symptoms of nausea] reported, given our bad reporting system ... to have warranted some kind of acknowledgment of this on the labeling and to physicians. I think I should have had the choice to make up my mind whether I wanted to take this drug based on the fact of what you had in your files and what the FDA had. Then if I wanted to go ahead and take it and take my chances, we wouldn't be sitting across from each other. But, it's not fair to you to have this knowledge, whether or not you have established in your minds this causal relationship, and not share it with the medical community and with the public who is going to be consuming this stuff. (1) I. INTRODUCTION

In toxic tort litigation, causation is the rub. Plaintiffs have, in large part, been stymied by their inability to establish that toxic agents, no matter how potentially dangerous, were actually responsible for the harms they have suffered. Their difficulties in this regard have increased exponentially since the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc. (2) With great frequency, plaintiffs have been unable to convince courts to admit expert testimony that a given agent was causally responsible for the plaintiff's injury. (3) Courts and scholars are in sharp disagreement as to the wisdom of Daubert and whether it has been fairly applied. (4) The authors of this Article are not of one mind on either of the above issues. (5) This Article is agnostic as to the controversy swirling around Daubert and its progeny. We proceed on the premise that significant changes in the doctrine are not in the offing. Plaintiffs will continue to lose toxic tort cases because they will be unable to establish causation. This phenomenon would not be troubling if there were not a recurring pattern of drug cases in which: (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) the 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.

We shall argue that the time has come for courts to recognize the right of patients to informed choice about risks associated with the use of a drug, a right that does not require plaintiffs to prove that the toxic agent was the cause of the plaintiff's harm. (6) To do so we shall suggest a new paradigm for this informed choice cause of action that protects the right of patient autonomy, yet does not impose liability for the full extent of damages as would be the case when a plaintiff is able to prove causation. Absent recognition of a right predicated on informed choice, plaintiffs will be deprived of vital information necessary to make critical decisions regarding lifestyle drugs and pharmaceutical manufacturers will have little incentive to discover and warn about uncertain risks. With causation standing as a barrier to recovery, defendants will sit back confident that liability is highly unlikely to attach to conduct that is admittedly negligent.

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation--medical malpractice and products liability--and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for defining materiality of risk in informed choice where the goal is to protect patient autonomy, and having established the substantive right to recovery, the Article will then suggest a measure of damages for depriving the patient of her right to autonomous decisionmaking.

1. DAUBERT: THE DIFFICULTY OF ESTABLISHING CAUSATION IN TOXIC TORT CASES

   A plaintiff who brings an action for the failure of a pharmaceutical company to warn about a material risk that allegedly caused her injury faces significant obstacles to recovery. A trilogy of cases decided by the U.S. Supreme Court dealing with the admissibility of expert testimony in the federal courts has made it very difficult for a plaintiff to successfully prosecute a toxic tort case. (7) The three opinions--starting in 1993 with Daubert v. Merrell Dow Pharmaceuticals, Inc., (8) and continuing with General Electric Co. v. Joiner (9) in 1997 and Kumho Tire Co. v. Carmichael (10) in 1999--do not purport to deal with tort law. Ostensibly, they deal solely with the evidentiary test a trial judge must use in determining whether an expert will be allowed to state an opinion. But the Daubert trilogy speaks very directly to the issue of what it takes to establish the causal nexus between wrongful defendant conduct and the harm suffered by the plaintiff--the crucial issue in each of the Supreme Court cases and in virtually all toxic tort litigation. (11)

   Before looking at what the courts have done post-Daubert and the consequences therefrom, we need to consider briefly how much evidence relevant to foreseeable risks and their causal consequences there is likely to be when a drag first appears on the market. The safety and efficacy studies done by manufacturers to obtain Food and Drug Administration ("FDA") approval will often provide inadequate data to prove the causal relationship between a toxic agent and the harm suffered by a plaintiff. The time frame for pre-marketing studies means that latent effects will not have had a chance to appear, the size of the studies is not sufficiently large to detect rare toxicities, the studies are conducted on a different population than the persons to whom the product will be marketed, the consumers who use the product once it is marketed may well be taking other medications that interact with the new drug, and we as yet know little about the role genetic susceptibilities play. (12) Once the product is approved, the FDA lacks authority to require the drug manufacturer to undertake further research, and physicians may prescribe off-label uses that have never been tested. (13) Because of escalating budget cuts and a statutory shift to requiring swifter new drug approvals, the FDA's system of post-market surveillance has been drastically curtailed since 1993. Although the manufacturer is required to gather Adverse Reaction Reports from a variety of sources that recount unusual or unanticipated toxicities in patients who are using the drug, (14) busy health providers infrequently make these reports which are crucial to identifying a problem. A former Acting Commissioner of the Food and Drug Administration stated, "It is popularly believed that less than 10% of the true adverse events are reported." (15) At some point in time evidence may surface that a drug is causing one or more adverse reactions. But even if the evidence is sufficient for the FDA to remove the drug from the market or to warrant a warning about the drug's possible toxic effect, proving an actual causal connection has been an uphill battle for plaintiffs post-Daubert.

   In Daubert, the chief controverted issue was whether Bendectin, an anti-morning sickness pill taken by millions of pregnant women, could cause birth defects in their offspring, and had caused limb reduction in the plaintiffs. (16) The difficulty in establishing causation arose from the fact that there is a significant background risk of birth defects. The mere fact that a child was born with a limb reduction to a mother who had ingested Bendectin did not necessarily point to Bendectin as the cause of the birth defect. The court below, like many others that had granted judgments n.o.v. or summary judgments in Bendectin cases, found plaintiffs' expert testimony insufficient to prove a causal connection, and granted summary judgment. (17) The Supreme Court first held that the Frey or "general acceptance" test--used by some federal courts in determining when expert proof was admissible--had not survived the enactment of the Federal Rules of Evidence. Instead, the Court told trial judges that they must screen all "purportedly scientific evidence" on which an expert plans to rely to ensure that it is "not only relevant, but reliable." (18) By reliability, the Court meant that the trial court had to ascertain whether the proffered expert's opinion was "ground[ed] in the methods and procedures of science." (19) The Court then examined...