Carl F. Cranor, Regulating Toxic Substances (Oxford University Press 1993) Acknowledgments, appendices, bibliography, figures, foreword by The Honorable George E. Brown, Jr., index, notes, tables. LC 91-47046; ISBN 0-19-507436-X. [272 pp. Cloth $45.00. 200 Madison Avenue, New York NY 10016.]
Cranor focuses on the different burdens of proof required in science versus those required in courts of law. Perhaps for simplicity, science and regulatory science (i.e., risk assessment) are treated as one. By co-mingling science, risk assessment and risk management concepts, he effectively undermines the reader's trust in the ability of science to protect us from unknown hazards because of the limitations of risk assessment. Cranor's arguments center on several major areas: (1) while science endeavors to minimize false positives (e.g., concluding a substance is carcinogenic when it in fact is not), science has been less concerned with minimizing false negatives (e.g., finding that a substance is not a concern when it in fact should be); (2) the slowness of risk assessments and rule-making tend to favor the status quo and may protect harmful chemicals better than public health; (3) science is not concerned with distributional justice issues; and (4) tort law serves as an important backup to administrative law in compensating victims and deterring the marketing of harmful products.
Cranor calls for greater attention to minimizing false negatives. He repeatedly states that the costs of under-regulation may be greater than those of over-regulation, but little empirical evidence is offered to support this assertion. As an additional justification for avoiding false negatives, he relies on philosophical considerations of distributional justice, in effect arguing for a rights-based approach to protecting individual health. More fundamentally, Cranor apparently attributes false negatives to science, rather than to risk management. Technically, as he acknowledges, science will not claim "negative" results, but only reveal no effect above a certain detection limit.
With regard to risk assessment and regulation, we agree wholeheartedly with Cranor's recommendation that regulatory scientists carefully display the limitations of their data, models and conclusions. Scientists can provide a statement of knowledge of risks in timely manner and with caveats as to uncertainty ranges, assumptions and detection limits. Risk managers can then do the difficult job of balancing this information with other factors. The explicit characterization of uncertainty in data and models provides insights not only into the limitations of scientific evidence but also into setting research priorities which will bolster future risk management.
Cranor argues strenuously for the use of expedited approximation procedures for conducting risk assessments.4 He also suggests that uncertainties may be "reduced" through risk management decisions.5 In our view, uncertainty can be reduced only by developing better data and models. A wide range of uncertainty opens the door for other considerations (e.g., risk avoidance to protect public health, comparison to other risks, and economic, social and political effects) to have key roles in risk management. Such considerations should not enter into regulatory science itself, such as through the use of compound conservative assumptions.
Cranor asserts that the evidentiary standards of science should not apply to risk assessment for regulatory purposes, arguing instead for use of a "preponderance of evidence" standard of proof as applied in civil litigation. Nonetheless, even though he argues for consistency in risk assessment procedures, he appears less concerned with consistency of the standards of evidence employed therein. As Cranor recognizes, it is not clear how the choice of standards, on a necessarily ad hoc, case-by-case basis, should be guided.
We view Cranor's approach to be highly risk averse, and the full effect of his proposal on economic behavior is unknown. As a blanket rule for risk regulation, we fear his approach would lead to less predictable regulations.6 He exacerbates this problem by calling for "universal" use of his proposed less comprehensive risk assessments, which could lead to false categorization of regulated products and, perhaps more dangerously, false reliance thereon.
Finally, with regard to civil litigation, Cranor's thesis has a certain appeal: Actors who introduce risky goods into the market should do so at their own economic peril: they should bear the burden of analyzing their products and activities and ensuring that they are not too hazardous. To illustrate his arguments, Cranor relies heavily on one case, Ferebee v. Chevron Chemical Co.7 The Ferebee court distinguished the scientific uses of evidence from the uses of such evidence in the courts. Ferebee itself does not express a majority rule, and judicial events in the last two years have further undermined the precedential value of the case.8 Nonetheless, from Cranor's discussion of this case and the role of the courts in regulating risky behavior, we came away with the distinct impression that he views the imposition of risk on any member of society as immoral.
Our system of tort law is not a system of absolute nor even "true" strict liability. The law requires a balancing of risks and benefits before holding a defendant liable for injuries caused to others.9 Unfortunately, we typically will be uncertain about the probability of bad outcomes and the causal link between exposures and injuries. To prevent paralysis, we must have some stopping rules enabling us to take action -- such as the marketing of a new drug or chemical -- before all risks are "known" and well characterized. If we adequately prioritize efforts to find the greatest risks and concentrate our resources on discovering and minimizing them, then the remaining risks should be reasonable. Given the unavoidable but reduceable uncertainty and constrained resources, what is the best way for society to manage risks?10
Our concern with the ability of the tort law to coherently manage risks is that the signals are blurred by varying fact patterns between cases, the workings of the trial courts are often obscured by lack of publication and post-trial settlements, and decisions are post-hoc and narrowly focused on injuries at hand.11 Benefits are downplayed, and the context in which society trades off quality of life with acceptance of some risks is hopelessly lost. The courts obviously have a role to play in controlling risky technology, but the specific competencies and limitations of administrative and judicial mechanisms need to be balanced in determining what their respective roles should be.
Regulating Toxic Substances challenges the reader to think about the potentially differing standards of evidence as used today in science, regulatory science, policy making and civil litigation. It is also useful for fleshing out the moral and legal issues involved in risk creation and management. We found Cranor's analysis stimulating and well worth reading.
Jon F. Merz & H. Christopher Frey*
2 Daubert definitely requires greater judicial scrutiny of the empirical basis underlying a witness' testimony, which may reduce the incidence of "junk science" in the courts. See Peter W. Huber, Galileo's Revenge: Junk Science in the Courtroom (1991); see also, Phantom Risk: Scientific Inference and the Law (Kenneth R. Foster, David E. Bernstein & Peter W. Huber eds. 1993).
In the more recent book, the editors pull together chapters describing the state of scientific knowledge in each of the following areas: electromagnetic fields and video display terminals, spermicides, Bendectin, asbestos, environmental pollutants (including dioxin, polychlorinated biphenyls, trichloroethylene, and radionuclides), trauma-induced cancer, and clinical ecology. For each substantive area, a legal critique of how the issues have fared in court is presented. Each subject is one in which litigation has occurred under circumstances where the science tending to establish or disprove a causal connection is (or was) uncertain. The editors draw on these examples to criticize the judicial fact-finding process for its deviation from the fact-finding processes of science. The assessment of the quality of scientific reasoning and methodology obviously presents a challenge to the judiciary. See also, generally, The Carnegie Commission on Science, Technology and Government, Science and Technology in Judicial Decision Making: Creating Opportunities and Meeting Challenges (1993).
3 In doing so, Cranor generally criticizes commentary calling for judicial restraint in admitting scientific testimony. See, e.g., Regulating Toxic Substances, at 66.
4 See, e.g., id. at 137.
5 See, e.g., id. at 136.
6 This problem may also be exacerbated by publication bias, or the tendency on the part of editors and authors to only publish positive results. This may lead to a biased sampling system under which only those studies that suggest toxic qualities of chemicals will initially make it into the literature. Since there is no good way to identify negative results, especially before any suggestion of toxic qualities are raised, then one suggestive study (even if statistically significant) may be quite inadequate, under any burden of proof, to establish the hazardous nature of a chemical. See, generally, Colin B. Begg & Jesse A. Berlin, Publication Bias: A Problem in Interpreting Medical Data, 151 J. Royal Statist. Soc. 419 (1988); Robert Rosenthal, The "File Drawer Problem" and Tolerance for Null Results, 86 Psychol. Bull. 638 (1979).
7 736 F.2d 1529 (D.C. Cir. 1984).
8 It is possible that the proffer of causation evidence in Ferebee would have been inadmissible under Daubert. Further, the liability basis of Ferebee has been substantially overturned by a line of cases following Cipollone v. Liggett Group, 112 S.Ct. 2608 (1992) and holding that various federal statutes preempt state failure-to-warn doctrine. See Arkansas-Platte & Gulf Partnership v. Van Waters & Rogers Inc., 981 F.2d 1177 (10th Cir. 1993) (pesticide); Shaw v. Dow Brands Inc., 61 U.S.L.W. 2727 (7th Cir. No. 92-2323, 1993) (bathroom cleaning products); Moss v. Parks Corp., 985 F.2d 736 (4th Cir. 1993) (paint thinner); Papas v. Upjohn Co., 985 F.2d 516 (4th Cir. 1993) (pesticides); King v. E.I. DuPont de Nemours and Co., 996 F.2d 1346 (1st Cir. 1993) (herbicide).
Even in the D.C. Circuit, Ferebee has been limited to instances where the evidence "stands at the frontier of current medical and epidemiological inquiry" and thus not applied in cases where substantial scientific study, although inadequate to prove (or disprove) a particular risk, is extant. In re Joint Eastern and Southern District Asbestos Litigation, supra note 1.
9 See, e.g., Restatement (Second) of Torts § 520 (1977) (abnormally dangerous activities) and § 402A (abnormally dangerous condition of defective products). There are a few courts, like Ferebee, that impose strict liability under a guise of failure to warn of risks of which there was no reasonable obligation to discover. See Ayers v. Johnson & Johnson Baby Products Co., 818 P.2d 1337 (Wash. 1991) (defendant liable for brain damage caused by inhalation of baby oil). Courts holding that foreseeability is not required ignore § 402A cmt. j, which requires a seller to give warning of latent dangers "if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge" of the risk.
10 See Richard Wilson, Edmund Crouch & Lauren Zeise, Uncertainty in Risk Assessment (1985).
11 See also, Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation (1993). At 59, Breyer, who is Chief Judge of the U.S. Court of Appeals for the First Circuit, states:
Courts also administer a system of tort law which discourages the negligent production of risky substances by forcing producers… to compensate those whom they injure. That system, however, leaves the determination of "too much risk" in the hands of tens of thousands of different juries who are forced to answer the question not in terms of a statistical life, but in reference to a very real victim needing compensation in the courtroom before them. The result is a system much criticized for its random, lottery-like results and its high "transactions costs"…. Whatever its merits and problems, I do not believe the tort system can serve as a substitute for government regulation.* Dr. Merz received a B.S. (Nuclear Engineering) from Rensselaer Polytechnic Institute, an M.B.A. from the University of North Florida, a J.D. from Duquesne University and a Ph.D. (Engineering and Public Policy) from Carnegie Mellon University. He is an Associate Policy Analyst at the RAND Corporation.
Dr. Frey received a B.S. (Mechanical Engineering) from the University of Virginia, and an M.E. (Mechanical Engineering) and Ph.D. (Engineering and Public Policy) from Carnegie Mellon University. He is an Assistant Professor of Civil Engineering at North Carolina State University
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Cranor's Reply to the above review
Merz and Frey's review of Regulating Toxic Substances,1 while summarizing some of my main points correctly, suggests that they may have a different view of the legal/regulatory environment than was articulated there. This may lead to some differences between us. While some regulatory safety statutes require manufacturers to have government approval before their products are permitted into commerce, this may be less significant than seems presupposed in their review.2 Many, perhaps most, substances have come into commerce or the environment as products, byproducts, contaminants or pollutants without extensive required testing for effects on human health or the environment.3 Legislation of the 1970's sought to address this, but it is not clear how successful it has been.4 Since the Toxic Substance Control Act was enacted in 1976, it is not clear how carefully substances permitted into the environment have been screened under its premarket approval procedure.5 Moreover, under most regulatory statutes, substances cannot be withdrawn from commerce, or exposures to pollutants or contaminants regulated, without the government's bearing a burden of proof to establish harm at current exposure levels.6 Also, tort law remedies are not available to plaintiffs who fail to carry both a burden of production to the satisfaction of a judge and a burden of persuasion to the satisfaction of a jury, each of which presents barriers to tort deterrence of exposures to harmful substances.
In this legal setting, environmental scientists must provide evidence of harm before a substance can be regulated more stringently or before a tort suit is successful. Scientific standards of evidence tend to be much more demanding than legal burdens of proof.7 In recent years, widespread discussion has urged that scientific information should be required to document even more thoroughly that substances are harmful before regulatory or tort action is permitted. Given the current legal/tort environment and the much more stringent burdens of proof in science, such demands greatly increase the difficulty of regulating substances or of bringing successful tort suits. The coincidence of scientific and legal burdens of proof may have gone unnoticed, but together, these can have profound consequences for protecting human health. Merz and Frey may not fully appreciate this.
The science of risk assessment is both different from core areas of science and substantially permeated by uncertainties that carry unnoticed normative and other consequences.8 For example, if data and theories that would answer the question of whether X is a human carcinogen have a number of uncertainties, but one is not permitted to judge that it is a human carcinogen until all uncertainties have been removed, as typical scientific practice would have it, then the scientific position per force favors one side of the debate. Demands for more and better data, better mechanistic understanding and removing all or most uncertainties exacerbate this problem. Moreover, while stringent evidentiary demands are appropriate for the progress of science because they prevent mistakenly adding to the stock of scientific information, they are inconsistent with good environmental and public health policy -- namely preventing false negatives and providing early warning of potential harms. (If the burdens of proof in the tort and regulatory law were reversed so that the safety of substances had to be established before human exposure was permitted, would parties currently arguing for more stringent science change their views?) Further, for statistically-based scientific information, the more scientists try to reduce false positives mathematically, the higher false negative rates are, other things being equal.9
There is an interaction between the substantive scientific standards of evidence and substantive legal standards of evidence. With the Daubert court, I argued that the Frye test for the admissibility of scientific evidence should be abandoned in the tort law.10 I argued, also similar to that Court, that only some scintilla of probative value should be sufficient to introduce evidence (even if it is insufficient to carry the burden of persuasion).11 Should the threshold burden of production incorporate the demanding scientific standards of evidence and make this threshold similar to the "beyond a reasonable doubt" burden of proof in criminal laws?12 I think not, but this will result if we deliberately or inadvertently incorporate scientific burdens of proof into legally required burdens. When low false positive rates are required, scientific skepticism and the mathematics of statistical studies work for defendants. Would Merz and Frey endorse this result? The tort law typically does (and should) strike a somewhat different balance between false positives and false negatives than the balance in research science, as well as a different balance than some courts and commentators are recommending. Further, when we assess risk for regulatory purposes, we should realize that the rate of assessment is important. If substances in commerce are harmful, and agencies are slow in assessing them, the harm continues. Thus, slowness is itself harmful. Yet, many recent recommendations would slow regulatory risk assessments beyond their present snail's pace.13
Finally, because of the uncertainties and the complexity of risk assessment, mistakes will result from our environmental science and regulatory activities. Mistakes will result because of evidentiary problems or because we have evaluated toxic substances too slowly -- or, if we adopt expedited procedures, too quickly14 I agree with Merz and Frey that it is difficult to find evidence of these kinds of mistakes and their rate.15 Epidemiological and other scientific studies can be negative even when substances are harmful.16 Thus, we are frequently surprised by the toxicity of products in our midst; this suggests that false negatives are a problem.17
The issue is not: Will mistakes be made, but which ones? How shall we err? How do we design assessment procedures and legal institutions to prevent which mistakes? As I assess some approaches, the coincidence of legal and scientific burdens of proof strongly tends to predispose legal decisions to more false negatives than seems desirable. Of course, there are now false positives as well. Yet, one political difference between false positives and negatives is that the former tend to have a built in constituency (firms whose products may cause harm), but false negatives do not (because isolated individuals who suffer harm are unlikely to discover their common cause). For both political and scientific reasons, false negatives are not easily identified. Thus, "I… suggested… modifications in complex existing or recommended procedures in institutions to try to achieve a more appropriate balance of these kinds of mistakes."18
I argued that regulatory agencies should adopt faster risk assessment procedures and rely on consistent default positions and policy judgments to address uncertainties in the science.19 (Risk assessments relying on default procedures need not be inconsistent as Merz and Frey suggest -- agencies currently follow such procedures, often as a matter of administrative procedure.) Also, appellate courts should recognize the need for agencies to rely on such approximations and expedited scientific methods.20 Such modifications in practices and procedures could give somewhat greater weight to avoiding false negatives than at present without a major overhaul of either regulation or tort law.
Finally, it is important to recognize the complex relationship between the tort and the regulatory law. I agree with Merz and Frey that regulatory agencies in theory are better situated to judge complex risk tradeoffs and that tort law is not and should not be seen as a substitute for many reasons. However, agencies are subject to powerful political pressures that can undermine a fair consideration of issues. Given these and other problems, tort law, despite its "blurred signals to firms," should backup regulatory law, and it should not be so hamstrung by implicit scientific burdens of proof, restrictive admissibility rules or unwise preemption rules as to preclude this vital function.21
As noted by Merz and Frey, a moral view underlies these recommendations. Many in the regulatory arena implicitly adopt a utilitarian approach to evaluating institutions and public policy. But this paradigm tends to underprotect individual welfare because its main focus is overall social efficiency (cost-benefit analysis is a bastardized version of it). Thus, severe harms to a few can be outweighed (in principle) by minor benefits to many, and the distribution of benefits and burdens of a social policy are not necessarily a part of the theory.22 Utilitarian theories must be augmented or rejected because of these concerns. Theories of justice would give greater, but not necessarily decisive, weight to protecting individuals from the harms of toxic substances. However, I stopped short of suggesting a full rights-based alternative, and I stopped substantially short of claiming that "the imposition of risk on any member of society is immoral,"23 a view to which I do not subscribe.
Thus, I argue for a change in paradigms regarding the amount of scientific information to be legally required both to regulate and to recover in tort -- as well as for a change in how we think about such issues morally. Together, such paradigm changes will shift environmental health protections to fewer false negatives, albeit with the possibility of more false positives. Such institutional changes would improve current procedures and correct present trends.
Carl F. Cranor*
2 See Merz & Frey review supra (hereafter M&F).
Sections of the Food, Drug and Cosmetic Act and the Federal Insecticide, Fungicide and Rodenticide Act require premarket approval of pesticides and the Toxic Substances Control Act requires premanufacture notifications for substances (including minimal testing) to be filed with the EPA, and then the EPA ordinarily has 90 days to identify substances that need further testing. Under these three laws, however, premarket review applies only to "new" chemicals. Office of Technology Assessment, Identifying and Regulating Carcinogens, 199 (1987) (hereafter OTA).
3 For pesticides, in 1987 there were about 600 that had been in the market prior to 1970 that had not been adequately tested at all. Even many registered since 1970 lack full toxicity testing; OTA, supra note 2, at 118-126.
4 Id., at 3-20, esp. 18.
5 Id., at 14 and 126-134.
6 Id., at 199-200.
7 RTS, at 55, 77 and 156.
8 Id., at 13-38.
9 Id., at 31-40.
10 Id., at 60-71.
11 Id., at 77.
Daubert v. Merrell Dow Pharmaceuticals, Inc., 113 S.Ct. 2786, 2798 (1993): "[I]n the event that the trial court concludes that the scintilla of evidence presented supporting a position is insufficient to allow a reasonable juror to conclude that the position more likely than not is true the court remains free to direct a judgment...."
12 RTS, at 76-78.
13 Id., at 115-126.
14 Merz and Frey appear to suggest a sharp distinction between the presumed policy -- or moral -- neutrality of risk assessment and risk management. Yet if the arguments of RTS are correct, this separation is not easy; RTS, at 23-28.
15 Whether the costs of underregulation are greater than the costs of overregulation is difficult to answer; M&F, at 76. Partly this is a monetary question; partly it is a non-monetary social question -- how we view costs of more expensive products (or their loss) versus how we view any social or human costs of increased exposures to toxic substances. Thus, it will be difficult to obtain adequate empirical data on this issue.
16 RTS, at 31-39 & 136.
17 E. W. Lawless, Technology and Social Shock (1977).
18 RTS , at 134. Merz and Frey's comment about preventing "paralysis . . . [so that we can] take action such as the marketing of a new drug or chemical before all risks are known or well-characterized" is puzzling; M&F, at 79. It suggests that I have urged more stringent premarket regulations (which I have not). Identifying and controlling potentially harmful substances already in commerce or the environment seem the more immediate issues.
19 RTS, at 137. Merz and Frey note that uncertainties can only be "reduced" by data and information. I tried to use the phrase "addressing uncertainties," but occasionally used "reduced;" RTS, at 136. Nonetheless, there are different kinds of uncertainties. Some can be addressed in the short run by choices -- choosing different models consistent with complex regulatory aims -- while others are addressed by measuring more carefully, by better data, etc.
20 RTS, at 147-151.
21 Merz and Frey call attention to recent cases which permit regulatory law and proceedings to preempt state tort actions. For reasons indicated here and in the book, this does not seem to be a desirable trend. Id., at 63-66.
22 Id., at 163-168.
23 M&F, at 79.
* Dr. Cranor is Professor of Philosophy and Interim Dean, College of Humanities and Social Sciences, University of California, Riverside. He received a B.A. (Mathematics) from the University of Colorado, a Ph.D. (Philosophy) from the University of California, Los Angeles and a M.S.L. from Yale Law School.
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The Ethics of Reproductive Technology (Kenneth D. Alpern ed., Oxford University Press 1992) Additional readings, glossary, introduction, notes, preface. LC 92-8252; ISBN 0-19-507435-1. [370 pp. Paper $19.95. 200 Madison Avenue, New York NY 10016.]
Beyond a broad overview, the book is divided into eight parts, each beginning with a brief introduction followed by at least two papers. Alpern begins by laying a framework for addressing topics later raised. These include not only ethical considerations, but also the physical, emotional and legal obstacles that infertile couples face, particularly when using RTs in an attempt to procreate.
The first section provides an important foundation. It outlines biological structures and processes required for unaided reproduction, common causes of infertility, major available RTs, and common emotional reactions of infertile couples.
The second and longest section, is entitled Conflicting Perspectives: Issues, Positions, and Arguments. Its papers present and debate current positions on RTs of particular note and consider the child's perspective. Next, three essays examine the meaning and significance of having children, with a list of common reasons,1 and focus on reasons for wanting children to whom one is genetically related.
Making and Selling Babies: Production and Commerce contains an abridged version of a law review article and a paper with a theological slant. The fifth set of essays highlights the impact of RTs on women, individually and collectively.
A sixth set of papers focuses particularly on legal issues raised by RTs, initially centering on Constitutional law; later, on "surrogate motherhood" agreements. Insofar as Alpern implies in his initial overview that the term, "surrogate motherhood," is unfortunate and "may affect the meaning and implications of traditional concepts without our realizing it,"2 it is somewhat surprising to find the term used here and throughout the book.
In a section entitled Professional Responsibilities, one essay urges that hospitals not admit surrogate mothers except, parenthetically, "those who arrive in labor or require services which only that hospital can provide."3
In the eighth and last section of his book, Alpern succinctly describes "just a small sampling of the troubling, often bizarre, disputes and conundrums"4 leading to litigation and lucidly discusses their resolution. From their placement, it appears that he wishes readers to have an informed perspective before reading them. Two, involving parenting through contract, are treated in some detail: one where everyone wanted the child; one where no one did. A final paper briefly describes four controversies over the legal status of in vitro embryos.
Throughout, Alpern neutrally synthesizes arguments and counter-arguments, but he offers no conclusion as such. This would have been helpful even if readers must ultimately fashion their own. Nevertheless, he has assembled a single volume that presents widely differing aspects of and positions on a host of RT issues and has begun to establish a framework for treating them. Lawmakers, lawyers or anyone concerned with reproductive technologies should find this work highly useful.
Rochelle S. Ferber*
2 At 7-8.
3 At 312.
4 At 325.
* Ms. Ferber received her B.L.S.(Molecular Biology) from Yale University and J.D. from Franklin Pierce Law Center. She has training in gene mapping, has been a Reproductive Health Educator and has served as a Board member of the NH Chapter of the March of Dimes. She practices law in Concord, NH.
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M. Stuart Madden, Toxic Torts Deskbook (Lewis Publishers 1992) Acknowledgements, case index, general index, notes, preface. LC 91-48238; ISBN 0-87371-508-X. [230 pp. Cloth $69.95 domestic, $84.00 elsewhere. 2000 Corporate Boulevard, NW, Boca Raton FL 33431.]
Madden's book is a comprehensive review of toxic tort law. It serves as a guide to policy, describes the parties involved, summarizes the many causes of action and defenses that may be raised, reviews the practical requirements involved in bringing or defending a toxic tort claim, and discusses damages that may be awarded. Additional topics include potential statutory limitations, jurisdictional disputes, conflicts of law, indemnity and contribution, products that have been the focus of toxic tort suits, and insurance coverage under comprehensive general liability policies.
Madden describes the crucial components of toxic tort law succinctly, and an enormous amount of information is summarized in fewer than 225 pages. Each chapter begins with an overview of the topic to be covered and is followed by a concise, but more detailed, description. Reading a six page chapter on "Causation" makes one wonder why weeks of law school had to be spent on it.
Nonlawyers, however, may not find this book quick or easy reading. They may be overwhelmed by an eight page introduction which rushes through definitions of torts and toxic torts, types of harm, pertinence of state and federal statutes, goals of tort law, damages, citizen suits, and special characteristics of toxic tort law, such as the use of multiple theories of recovery in one case, the typically long latency period from the time of injurious exposure to the onset of disease, and the difficulty this creates for the plaintiff in proving that defendant's product or activity was a direct cause of the injury.
Yet, nonlawyers should keep reading. Topics are repeatedly revisited and are likely to be understood in the end. Also, despite Madden's attempt to make the book useful for nonlawyers, "compensatory damages," for example, is repeatedly used but not defined until page 172. A glossary would have been helpful.
Although they are not discussed in detail, Madden makes good use of cases to illustrate key concepts. Also, a great deal of valuable information is provided in endnotes.
Regardless of the situation with readers wholly unfamiliar with the law, those having at least passing familiarity with tort law will find a wealth of information within Toxic Torts Deskbook -- and the more they already know, the more they are apt to find. This book is ideal for law students and a good starting point for attorneys interested in toxic torts. It would be a valuable addition to many libraries.
Laura Marron*
* Ms. Marron received her B.S. (Human Resources) from the University of Delaware. After experience as a paralegal in asbestos litigation, she received her J.D. from Franklin Pierce Law Center. She is the Coordinator for the Lowell Tobacco Control Coalition at the University of Massachusetts-Lowell.
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National Research Council, Issues in Risk Assessment (National Academy Press) Appendices, executive summary, figures, preface, references, tables. LC 92-61838; ISBN 0-309-04786-2. [374 pp. Paper $37.50 -- S&H, $4 for first and $0.50 for each additional copy. 2101 Constitution Avenue, NW, Washington DC 20418.]
Thus, the Committee on Risk Assessment Methodology (CRAM), consisting of experts drawn from several disciplines, was established within the NRC Board on Environmental Studies and Toxicology of the Commission on Life Sciences "to assess the scientific basis, inference assumptions, and regulatory uses of and research need in risk assessment.2 This book contains the first three in a series of reports addressing such issues.
Aside from a twelve page executive summary, the body of Issues in Risk Assessment is organized into three parts that address respectively the use of maximum tolerated dose (MTD) in animal carcinogenicity bioassays, the two-stage model of carcinogenesis, and an ecological risk assessment paradigm. Each part contains a report with extensive supporting documentation. Indeed, of 344 pages containing these parts, approximately two-thirds are given to commissioned papers in their entirety, lists of workshop attendees and workshop agendas. Since one of CRAM's goals is to recommend methodologies for consistent use by scientists, this documentation should be helpful.
In a preface, Bernard Goldstein, the CRAM chair, notes that an important objective was "to help scientists in regulatory agencies, academe, and industry to find common ground...."3 Yet, while CRAM was able to make unanimous recommendations in the second and third parts of the book, ironically, it could not itself achieve consensus on MTD use. Thus, that report contains both "majority" and "minority" opinions and "reflects differing judgments on which approach to carcinogenicity testing would be most effective in providing information to assist risk managers."4
One has the impression that some of the detail in appendices, most notably in the first part, could easily have been omitted. Perhaps it was included because the committee could not find "common ground." If so, CRAM is to be commended for fully setting forth support for recommendations in areas of potential disagreement.
CRAM expects next to examine exposure assessment and developmental toxicity. If reports on those topics follow the same format as ones addressed in Issues in Risk Assessment, scientists will have as much guidance as possible in making consistent risk assessments. Where uncontroverted guidance is impossible, this will frustrate scientists seeking bright line rules, but others involved in risk assessment and management will want to pay close attention. Such circumstances highlight issues that cannot, at least for the moment, be characterized as primarily "technical."5
Diane M. Albert*
2 Id.
3 Id. at .xi.
4 Id. at 8; see also at 19 and 64.
5 See, e.g., Academy Splits on Risk, 259 Science 759 (1993) -- quoting CRAM staff project director, Gail Charnley: "It's an ideological argument. But we just don't know which [MTD group] is right."
* Ms. Albert received a B.A. (Biology and German) from Colby College. After seven years as an environmental regulator and consultant, she is a candidate for the J.D. at Franklin Pierce Law Center and the M.S.L. (environmental) at Vermont Law School.
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Eleanor Singer & Phyllis M. Endreny, Reporting on Risk (Russell Sage Foundation 1993) Acknowledgments, index, notes, preface, references, tables. LC 92-40130; ISBN 0-87154-801-1. [256 pp. Cloth $24.95. 112 East 64th Street, New York NY 10021.]
Mass media's influence on observers' perceptions of risk and their behavior is easily seen. For example, a 1986 terrorist attack on a TWA jet caused a substantial decline in U.S. tourists traveling in Europe and the Middle East, although more U.S. citizens drowned in bathtubs than were killed by terrorists that year.2 Media consumers need objective, helpful information about risk related issues, and media producers should try to provide it. But do they? That is an important question. To address this and other related issues, the authors examined how selected mass media -- both print and electronic -- reported on risk from September 1 to December 31, 1984 and during September 4-10 and 18-24 and December 11-17 and 25-31, 1960.3
The book divides risks into seven categories:4 natural hazards, energy hazards, material hazards (e.g., chemicals, nuclear reactors and alcohol), activities involving benefits and costs (e.g., various dangerous recreational activities), chronic and acute illnesses, complex technologies and, a bit inaccurately, activities with costs only (terrorism and crime). It thoroughly examines the quality and quantity of media coverage of the first six, but, because coverage has been extensively analyzed by others, the last is not dealt with.5
In discussing their research, Singer -- a senior research scholar at the Center for the Social Sciences, Columbia University and analyst with the U.S. Bureau of the Census -- and Endreny -- a Chicago consultant and former assistant professor of communication and media at the University of Illinois -- provide many tables and much statistical analysis of media reports on risk and how this changed between the two periods they studied. They also analyze media sources, report accuracy, who is blamed for harm and the role of geographical location on media coverage.
So, how does the mass media report on risk? To that question Singer and Endreny answer in part:6
Our analysis suggests that media coverage of hazards is similar to the coverage of other news. It focuses on individuals and events rather than on social and economic forces, on drama and conflict rather than on long-term conditions. Thus, [as found in a 1988 study] it presents "a superficial and fragmented view of reality." It is, in addition, a view biased by journalists' dependence on institutional sources, as well as by their assumptions about the media audience and its interests.Although sometimes overburdened with the statistics, their book provides very interesting and critical analysis about media coverage of risks. It is a study recommendable to all who are interested in risk-related issues.
Mladen Singer*
2 At 1-2.
3 See at 16-17.
4 Detailed listings of risks classified in each particular category can be found in Appendix A, at 183.
5 At 9.
6 At 64.
* Mr. Singer received an LL.B. from the University of Zagreb Law School (Zagreb, Croatia) and the Masters of Intellectual Property from the Franklin Pierce Law Center. He is a Research Fellow at FPLC.
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Elizabeth M. Whelan, Toxic Terror: The Truth Behind the Cancer Scares (Prometheus Books 1993) Acknowledgements, appendix, figures, foreword by Norman F. Borlaug, index, notes tables. LC 92-34154; ISBN 0-87975-788-4. [476 pp. Cloth $26.95. 59 John Glenn Drive, Buffalo NY 14228-2197.]
Toxic Terror revises a book written ten years ago. Its thesis is straightforward: The bad news about health and the environment is not scientifically correct. For example, in the introduction, concern with the growth regulator alar, used to hold apples on trees until they redden, is described as "alarmania"; concern with ethylene dibromide is labeled as "hysterical"; and environmental stories are dismissed as the fantasy of "left-wing environmental groups." Dr. Whelan lays blame for this on media described as coopted by faulty environmental analysis.
The book, then, might be good news if it provided scientific basis to refute environmental concerns. But its approach is much like what it criticizes. For example, Whelan criticizes scientists who speak negatively about technologies such as pesticides or nuclear power. She is sensitive enough to ask where scientists are who might refute the research papers by environmentalists. After all, if scientists cited by environmentalists are all wrong or even just exaggerating, one might expect more legitimate scientists, as Whelan sees them, to enter the debate and set the public record straight. The answer offered is that legitimate scientists "shun the spotlight" because they don't want to communicate with the public at large, they don't want to give the media information about public health, they are afraid of debate and they are afraid that their integrity will be questioned if they or their universities receive research dollars from those they defend. This analysis is likely correct; but it is inadequate to refute research that environmentalists cite. If other scientists are afraid to defend their work and integrity in public arenas, why reject those who aren't? Whelan's book does not provide much by way of answer.
Nor does Toxic Terror provide the data one needs to accept its central thesis of good news. Again, for example, when Whelan examines criticisms of pesticides for their environmental persistence, she finds persistence to be a virtue, because "fewer applications are needed." The more persistent organochlorine insecticides are praised as "generally less toxic than many other[s]." Yet, she does not distinguish between short-term or acute toxicity and chronic toxicity, crucial distinctions for meaningful analysis. Also, her conclusion is totally unsupported by any footnote or documentation. Instead, she quotes an unattributed source that the low cost and stability derived from the persistence of the organochlorines are the reason for their usefulness.1
This lack of support also appears in an appendix entitled, "Myth of the Cancer Epidemic." As is true elsewhere, the appendix accuses the media of misrepresenting the incidence of cancer and provides a series of graphs showing a decrease in cancer mortality. Yet, the section on breast cancer is telling. Here Whelan shows increased cancer incidence. Rather than consider that this might be cause for legitimate concern, she strongly implies that, because "One report has suggested that there may be two distinct forms of breast tumors... malignant and benign,"2 the statistics are but the results of increased self-examination and identification of benign tumors. The report is not cited, and her conclusion is itself as unsupported as many she faults.
Most would like to believe Toxic Terror, but it lacks the necessary supporting data and rigorous analysis.3
Sarah Redfield*
2 At 450.
3 See, The ASCH: Forefront of Science or Just a Front?m Consumer Reports, May 1994, at 319 (Dr. Whelan is president of ASCH, the American Council on Science and Health). See also, Public-Interest Pretenders, op. cit., at 316. [Editor]
* Professor Redfield teaches environmental law at Franklin Pierce Law Center. She received her B.A. from Mount Holyoke College, her J.D. from Northeastern University and her LL.M. from Harvard Law School.
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Ann Rappaport, Development and Transfer of Pollution Prevention Technology (Quorum Books 1993) Appendices, bibliographical references, figures, index, preface, tables. LC 93-292; ISBN 0-89930-816-3 [203 pp. Cloth $55.00. 88 Post Road West, Westport CT 06881.]
How do companies develop such technology without sacrificing products or profits? Rappaport, a Professor of Civil and Environmental Engineering at Tufts University, answers in a well-written, comprehensive examination of technology development and transfer in a multinational corporation. She does an excellent job of tackling the seemingly difficult task of integrating the goals of relevant international treaties, codes, organizations and conferences with U.S. laws and provides an in-depth discussion of the technical, legal and political dynamics.3 For example, her discussion of the relationship between U.S. regulation of plant emissions and multinational corporate responses is clear and concise. She also addresses the corporate response to customers, stockholders, stakeholders and employees growing awareness of the environmental effects of corporate activity.4
Chapters 5-7 are devoted to case studies of three different product groups; Controls, Medical, and Motors.5 These outline environmental challenges faced by each group, the staff designated to address them, the goals of each group and current programs being used (as well as group strategies for encouraging new program ideas and innovations). The case studies also include examples of pollution prevention that have been implemented and methods used to transfer technology among plants. These include changing packaging, substituting raw materials and encouraging customers to accept more environmentally-sound products, and she uses examples of such changes effectively throughout her book. This should facilitate other firms' mixing and matching different techniques, strategies and managerial structures to fit their specific needs, rather than trying to fit a common mold -- as long as they adopt managerial structures to encourage effective intracorporate communication6 and innovation,7 two propositions she strongly advocates. A third is somewhat more provocative:8
The more specific and restrictive government regulations are, the more likely it is that pollution prevention technology will be developed and transferred.Overall, Rappaport's book is well organized and clearly written. Although covering a broad area, she chooses examples that those without extensive technical background can understand. Finally, the utility of her book is enhanced by a concise concluding chapter that integrates many of her concepts and provides general advice on ways to improve corporate environmental practices.
Kristina M. Jahns*
2 See, e.g., at 12 and 48.
3 At 40-50.
4 At 51.
5 At 85-122.
6 See, e.g., at 128.
7 See, e.g., at 138.
8 At 144 (emphasis in original).
* Ms. Jahns received her B.S. (Chemical Engineering) from the University of Washington. She is a candidate for the J.D. and Master of Intellectual Property (M.I.P.) at Franklin Pierce Law Center (FPLC).
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The Genetic Frontier: Ethics, Law, and Policy (Mark S. Frankel & Albert Teich eds., American Association for the Advancement of Science 1994) Acknowledgments, appendix, contributors, figures, index, introduction, notes, references, tables. LC 93-37230, ISBN 0-87168-526-4. [260 pp. Paper $22.95. 1333 H St., NW, Washington DC 20005.]
If we enable the weak and the deformed to live and to propagate their kind, we face the prospect of a genetic twilight. But if we let them die or suffer when we can save or help them, we face the certainty of a moral twilight.Since we can now detect "flawed" genes and soon will be able to treat their effects or even eliminate them, the risk seems no longer the perpetuation of faulty genes but going too far with genetic information and intervention. The Human Genome Project2 and other research is reshaping the most personal aspects of our lives, e.g., courtship, marriage, reproductive choices, medical diagnosis and treatment, and control of private information. As the number and impact of genetic options increase, novel ethical issues proliferate. The twilight we fear is the unprincipled use of new technologies, the shades of eugenics and of discrimination based on immutable characteristics.
The Genetic Frontier is a useful resource for those interested in legal and ethical issues raised by genetic research. It is a collection of articles by highly respected authors based on presentations at a June 1992 conference organized by the American Association for the Advancement of Science (AAAS)-American Bar Association, National Conference of Lawyers and Scientists and the AAAS Committee on Scientific Freedom and Responsibility.3 Although much of the guidance for this meeting came from the AAAS Project on Ethical and Legal Implications of Genetic Testing,4 its scope extended beyond genetic testing to encompass other current and complex issues. Thus the book has four sections: the effects of genetic research and testing on the family and social policy; privacy and confidentiality issues; the relationship between genes, behavior and responsibility; and intellectual property rights. Most articles include extensive references; those who read particular articles will probably find useful sources in related contributions.
A book with objectives of "rais[ing] intriguing ethical and legal questions, as well as important policy issues"5 is apt to be longer on questions than answers. Still, it presents helpful suggestions and frames of reference for use in the search for answers. The authors generally express the hope that as scientists and policy makers cope with the effects of genetic research, they will use "an ethical imagination,"6 "refer[ring] to what it is to be human, to live in responsible relations to others, to posterity, and to the natural and cosmic sources of life."7
Participants in the conference leading to The Genetic Frontier were deeply involved with many aspects of the effects of genetic research and testing: doctors, biomedical researchers, sociologists, theological ethicists and government officials.8 This diversity produces a fairly balanced treatment of each topic. Yet, given a select and sophisticated original audience, the authors assume that readers have at least a general knowledge of genetics. Terms of art such as "genetic load" and "ultimacy" are used without definition. This is a barrier to readers who would have benefitted from a brief glossary.
Suzanne A. Sprunger*
2 See e.g., 5 Risk 95-175 (1994) (papers from a 1993 conference on intellectual property and technology transfer issues raised by the Human Genome Project).
3 Acknowledgments, at xi.
4 Id.
5 Introduction at xv.
6 At 21.
7 At 19.
8 Appendix at 225.
* Dr. Sprunger received her B.S. (Biology) from Cornell University and, after several years of research in molecular biology and genetics, she received a Ph.D. (Genetics) from the University of Wisconsin-Madison. She is a candidate for the J.D. and M.I.P. at FPLC.
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Richard O. Gamble II, How to Reduce Professional Liability for Engineers and Architects (Noyes Data Corporation 1987) Foreword, references, index, table of cases. LC: 87-12256; ISBN: 0-8155-1128-0. [102 pp. Cloth $36.00. Mill Road, Park Ridge NJ 07656.]
Gamble's discussion is written for the non-legal audience and begins by overviewing types of litigation most relevant to design professionals, including design ethics (governed by various trade-adopted codes), contract-based obligations and general public safety requirements. According to Gamble, when faced with expanding liability, the best way to avoid trouble is simply to improve the quality of one's work,4 and he briefly treats the legal concept of negligence as related to designers.
However, his book is generally organized around three key phases of the design process -- contract negotiation, product design and construction. He explores the risks associated with each phase, providing specific recommendations where appropriate. This arrangement is incredibly easy to follow.
As indicated by a title promising to reduce, not eliminate, liability, Gamble shows awareness that careful planning cannot eliminate a threat of liability, much less litigation. Thus, the last third of his book addresses various forms of dispute resolution and compares and contrasts traditional litigation, arbitration and mediation. Here, Gamble identifies relative advantages and disadvantages without using legal jargon. Always grounded in reality, he also examines professional liability insurance as a means for surviving disputes that are resolved unfavorably.
Gamble's book packs a large amount of useful information into a small package. Aimed at design professionals (not lawyers), it is appropriately devoid of legalese. Most included suggestions are proactive, i.e., designed to reduce the threat of litigation. Further (and maybe most importantly), it provides simple, practical and honest approaches that do not feature the exploitation of such legal loopholes as may exist.
How to Reduce Professional Liability... ends with a summary that not only provides closure but also a helpful review. While not exhaustive, Gamble's book certainly lays a foundation for design professionals to identify (and minimize) potential litigation risks. It is highly recommended.
While a small thing, it warrants noting that readers for whom appearance and quality are inextricably linked may struggle with the way the book has been produced. Aside from a high-quality cover, the book is an inexpensive reproduction of a typed manuscript. Readers who can ignore this distraction will learn much of value.
Erik C. Swanson*
2 At 1.
3 Id.
4 At 101.
* Mr. Swanson received his B.S. (Mechanical Engineering) from the University of Miami. He is a candidate for the J.D. at FPLC, emphasizing intellectual property law.
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Making Decisions about Liability and Insurance (Colin Camerer & Howard Kunreuther eds., Kluwer Academic Publishers 1993) Figures, index, notes, tables. ISBN 0-7923-9393-7 [139 pp. Cloth $89.95. 101 Phillip Drive, Assinippi Park, Norwell MA 02061.]
With this as a foundation, the editors, in a separately published special issue of the Journal of Risk and Uncertainty, provide seven articles explaining the impact of the tort system upon individual decisions regarding liability and risk. The collection offers readers a variety of viewpoints, opinions and theories on why "we" collectively (or individually as consumers, firms or citizens), make certain decisions about insurance and deal generally with three subjects, "probability distortions,"2 "transaction analysis"3 and "ambiguity."4
Yet, surprisingly little attention is given to liability. Aside from general editorial observations,5 little space is devoted to "how" or "why" we make decisions about liability. For example, a well-drafted, first selection by Jonathan Boran and Ilana Ritiu discusses implications and intuitions relative to tort law but emphasizes how the tort system overvalues "deterrence" when determining victim compensation, rather than addressing liability.6 Throughout the book, consideration of liability is conspicuously absent. After full review, one wonders how the book's title was chosen.
Overall, the studies presented here pose interesting ideas about decisionmaking processes and offer some insights into how they are affected by uncertainty and ambiguity. Many are thought provoking. Yet, as a reader who has studied the tort system in law school and encountered it in the context of civil litigation, I was very unsatisfied overall. For example, at page 7, the editors present a "social decision model" "designed to serve as a guide for the articles in this issue."7 However, instead of guiding me, this figure seemed to model what I found to be the major failing of this book, i.e., it tended to simplify and label human reactions according to black and white response categories.
The editors and many of the authors offer neat, solid-lined patterns and explanations about the decisions made about insurance. Too often they burden readers with confusing statistics, indecipherable variables and circular explanations of how data was compiled and conclusions reached. Only in isolated instances8 do the authors consider alternative explanations or factors. In short, I was all too often unable to distinguish the authors' assumptions from documented or documentable facts, however limited they may be in such studies under the best of circumstances. Economists and social scientists may find this work of value, but it is unlikely to appeal to typical lawyers.
Joseph M. Carreiro, Jr.*
2 E.g., at 35-52 and 95-116.
3 E.g., at 53-70.
4 See at 71- 94.
5 At 5-15.
6 At 17-34.
7 At 6.
8 E.g., at 53-70 and 89-74.
* Mr. Carreiro received his B.A. (History) from the University of Massachusetts-Boston and worked for five years at a civil litigation firm in Boston. He is a J.D. candidate at FPLC.
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Gerald Holton, Science and Anti-Science (Harvard University Press 1993) Index, notes, preface, sources. LC 92-272; ISBN 0-674-79298-X. [176 pp. Cloth $24.95. 79 Garden St., Cambridge MA 02138.]
He begins with a lengthy introduction to Ernst Mach and his influence on later scientists, including Einstein and B. F. Skinner. In Chapter 4, he turns to Newton, Bacon and Jefferson. There, the "Newtonian" approach is characterized as the "basic" science or an "attempt to grasp the totality of empirical facts, leaving out not a datum of experience."1 The "Baconian" approach is described as "applied" science or "enlarging of the bounds of Human Empire, to the effecting of all things possible."2 Only here do we learn that Holton prefers a "Jeffersonian research program," the focus of the chapter.
Holton respects Jefferson as a scientist and says that his style "locates the center of research in an area of basic scientific ignorance that lies at the heart of a social problem."3 Jefferson's approach is portrayed as extending those of Newton and Bacon. Holton thinks that such an approach leads to both the fuller understanding of nature and the freedom and happiness of mankind, or to the search for truth and serving the interests of society -- and commends it as neither discipline- nor problem-oriented, but some combination and extension of each.4 Then Holton briefly explores alternative fates for science, decay or merger into one coherent body of understanding for all natural phenomena.
Finally, Holton turns to anti-science whether engaged in by animal rights activists, environmentalists, feminists or social-constructionists (including those who fear that science threatens to overwhelm the individual) or by Creationists, New Age healers and astrologers. Holton credits the anti-science movement to rampant U.S. scientific illiteracy, referring, e.g., to a Presidential Science Advisor's report that "half the adults questioned did not know that it took one year for the Earth to orbit the Sun."5 and notes that "we are currently losing thirteen mathematics and science teachers for each one entering the profession."6 He also notes that less than 7% of U.S. adults can be called scientifically literate at a time when the accomplishments of modern science and technology are more spectacular than ever.7
Holton sees the anti-science movement as a major cultural challenge and a possible threat to the modern world view.8 He believes that many of today's social and cultural problems result from widespread lack of science literacy and that they will increase. He argues that U.S. society must increase its scientific endeavors or fall pray to the decline of civilization as we know it. Even those who do not entirely share this view may find Science and Anti-Science of interest.
Russell W. Binns, Jr.*
2 At 115 (quoting Francis Bacon).
3 At 115.
4 Id.
5 At 147 (quoting D. Allan Bromley).
6 Id.
7 At 148.
8 At 184.
* Mr. Binns received his B.S. (Electrical and Computer Engineering) from Clarkson University. After several years as an engineer, he is a candidate for the J.D. at FPLC.