Foreword to the Third Edition

Over the past few decades, the entire subject of risk assessment and risk management has undergone a profound and important evolution. Improvements in how to conduct objective scientific analyses have occurred, transparent regulatory procedures are more commonplace, promulgation of better risk standards has evolved, improved communication so as to secure buy-in from companies and their experts, as well as the general public, has become quite evident - these critical changes have had a positive impact. Perhaps even more importantly, there is a better understanding as to what risk assessment means - what science can (and cannot) do in providing the public with the type of objective answers it seeks. Today, we know better what we do not know about the benefits and limitations of scientific and regulatory methodologies in fashioning standards of safety. This third edition of "Human and Ecological Risk Assessment" continues to play an ongoing important role in educating experts and the public alike about the ever-changing subjects of risk assessment and management.

In dealing with the subject of risk, important administrative law changes have occurred in recent years when it comes to the process of evaluating risk and providing a blueprint that regulatory agencies may follow in setting standards and establishing rules. As a general matter, the risk assessment and management process have traditionally focused on those agencies that compile necessary data from the scientific and related communities, and fashion rules that help guide all interested parties and the public in better understanding risk. It is our federal and state agencies that are relied upon in the first instance for setting standards of use and safety in subjects as diverse as workplace safety, environmental hazards, pharmaceutical products, medical devices, vehicle safety, etc. In these and other similar areas of regulation, it is agency procedures and processes that are trusted to compile pertinent scientific, medical, and environmental evidence from scientists and other experts. Evaluating such evidence and promulgating appropriate criteria for identifying the level of risk that is acceptable have become the official guidebook to be implemented in guiding commercial, social, and related conduct.

But, in recent years, there has been renewed interest in this process, especially in light of the Supreme Court's Daubert decision.1 Risk assessment and management have increasingly become the province of our federal and state courts. Our trial courts - lawyers, judges, juries, verdicts, damages, etc. - have added another layer of review and comment in establishing new definitions regarding the magnitude of risk that society wishes to tolerate. Mass tort litigation aimed at deterring alleged negligent conduct by domestic and international corporations has become an important, expanding avenue of controversy in determining what is acceptable risk and how it can best be managed. Litigation supplements - and in some cases replaces - more conventional risk assessment methodologies. The courtroom rather than the regulatory agency has assumed new authority in determining what exactly is acceptable risk, often failing to provide due deference to standards of care promulgated by agencies relying upon credible, well-documented scientific and medical evidence. In an increasing number of cases, the trial court may decide to substitute its judgment for such agency findings and determinations. Recent litigation involving talc is a striking example of this pattern.

This trend away from judicial reliance on administrative agency scientific and other expert testimony is compounded by the growing likelihood that the current Supreme Court will recognize even less judicial deference to such agency determinations. The current Court may very well replace Chevron deference to agency statutory interpretations in favor of a fresh de novo review by the courts.2

As a result, individual citizens, and companies engaged in commercial activity that are subject to conventional regulatory procedures, increasingly evaluate risk based upon courtroom considerations: the ambiguity and limitations of statutory and regulatory agency language, the uncertainty of lawsuit and verdict outcomes, the cost of litigating in the courtroom, the impact of adverse judgments on company balance sheets, etc. Regulatory agency standards, once considered the best and most effective guide in defining acceptable corporate conduct, no longer can be relied upon without also considering the likelihood of trial outcomes. Courts and juries, rather than regulatory agencies, are in large measure redefining the limitations of acceptable risk in twenty-first century America.

This new reliance on courts rather than administrative agencies does not guarantee uniform favorable outcomes either for plaintiffs claiming injury or defendant businesses denying liability. In reviewing agency determinations, courts may either overstate or understate the risk. For example, courts may conclude that a higher risk exists than that determined by the agency, with talc and the Roundup herbicide being the best examples in recent years. But the alternative result is also a possibility - courts may in some cases see a lower risk than did the agency or block the agency from addressing an emerging risk.3 Professor Jonathan Wiener makes the effective argument that public perception of risk can both overstate and understate differing risks in differing contexts, compared to expert risk assessments; these perceptions may potentially foster inconsistent and diverse judicial decision-making.4

Once the courts become the new venue for determining acceptable risk, lawyer advertising (often citing successful verdicts) offers additional new client opportunities to sue and recover large damage awards. Meanwhile, companies, worried about unlimited legal exposure and costs, counter the new wave of complex litigation with prominent disclaimers warning the consumer about the product's limitations and the rare possibility of adverse medical reactions. But such public label warnings, based upon promulgated regulatory standards, often are deemed insufficient. Prominent companies such as Monsanto (the herbicide Roundup) and Johnson & Johnson (talc) may feel compelled to remove products from store shelves in response to ongoing litigation in the courtroom. When that occurs, it is often portrayed by trial lawyers as an admission of guilt rather than a necessary business decision.

But, as already indicated, judicial review is not a one-way street. Courts may understate risk when compared to administrative agencies. Climate change and Covid-19 may be such cases. In some cases, agency higher risk estimates (and associated expert testimony) may be rejected by the courts.5

What are the consequences? First, one has to consider the growing public skepticism concerning the accuracy of regulatory agency determinations. One need only think of the seriously polarized views of the public on Covid vaccinations and the use of masks. Objective scientific and medical findings and conclusions - critical important components of the regulatory process - are undercut when lawyers in the courtroom successfully challenge more protective agency rules, e.g. the OSHA rule requiring employers to vaccinate or test.6 Absent the legal doctrine of preemption and displacement (by which agency standards preclude such court determinations), which is rarely successful,7 the debate over standards of care, and the impact of such standards on the individual plaintiff or class of plaintiffs, becomes a function of judge and jury in the assessment of blame.

The result - even as risk assessment and management become more objective among our regulatory agencies - is subjectivity and jury empathy, undercutting reliance on sound science. The courtroom replaces the regulatory agency in fashioning definitions and limitations when it comes to risk assessment and management. This has been well described in many legal journals over the past twenty years.8

Second, this courtroom process, and its reliance upon judges and juries, undercuts the value of expertise and consistency in determining relative degrees of uncertainty. Instead of relying upon administrative agency procedures, including careful evaluation of objective scientific evidence resulting in credible findings regarding acceptable risk, the litigation lottery promotes uncertainty - inconsistent verdicts, lack of reliance on objective methodologies, and a new emphasis on jury sympathy and empathy often untethered from credible scientific inquiry. Defendant company culpability is often considered by the jury, rather than expert scientific testimony, in reaching verdicts. Inconsistent verdicts and occasional huge damage awards rendered by juries can change the legal landscape and make it increasingly difficult to predict awards, thus undermining the deterrence function of tort law and regulation. Lay juries become the vehicle for establishing findings of legal risk. It was originally believed that the Supreme Court's Daubert decision would keep "junk science" out of the courtroom, but most judges lack the willingness to make these decisions. Instead, many say "let the jury decide" even though it is not possible to expect lay jurors to assess topics which often require years of education and experience in order to understand the reasonableness of expert opinions.

Some courts attempt to deal with this problem by...