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The Gatekeeper Has a New Set of Keys

The Reference Manual on Scientific Evidence

The Gatekeeper Has a New Set of Keys



John A. Budny, PhD, CMI Certified Medical Investigator
of The Reference Manual on Scientific Evidence Published in the International Journal of Toxicology 2012 31: 95-96

Understanding, preparing and presenting medical information, as well as responding to the conclusions and opinions from opposing counsel’s experts, can be a daunting task for an attorney. It is particularly true for toxicity issues, where the pivotal issue is causation which is embedded in a dose-response relationship. Judges are faced with the same issues in determining what science and technical information can be admitted in the cases for which they are presiding. However, guidance is available to both judges and attorneys.

The Supreme Court, in its decision on Daubert v. Merrell Dow Pharmaceuticals, Inc. in 1993, instructed trial judges to be “gatekeepers” for expert opinions that were based on science and technology. Anything short of being experts themselves in all fields of science and technology, judges would need guidance in what proffered science and technology could enter the courtroom and which allegedly valid expert opinions would be denied admission.

1994, the Federal Judicial Center (FJC) saw the plight that the judges faced and subsequently published the Reference Manual on Scientific Evidence. Six years later, the FJC updated its manual with the Second Edition. Science and technology does not stand still; it expands and gets more complex. To equip the judges (and attorneys) with up-to- date guidance, the FJC, in conjunction with the National Academies of Sciences’ (NAS) National Research Council (NRC), released the Reference Manual on Scientific Evidence, Third Edition, in September, 2011. My review of the Third Edition, drawing upon my background as a Certified Medical Investigator-IV and a PhD in Medical Biochemistry, is not only for toxicologists, but for other scientists and legal professionals.

Any scientist who periodically serves as expert witness will certainly have an interest in the release of the book since it has been 11 years since the Second Edition was published, and technical advances, while having no effect on the execution of the scientific method, have expanded the knowledge-base of toxicology. Those toxicologists whose immediate reaction might be to discount the publication’s release should ponder the wisdom of the proverb: “Make haste slowly.” Rarely does a toxicologist go through his or her career without experiencing a request, and indeed demands, to explain toxicology and its practice to educated, but scientifically-challenged, misinformed or uninformed professionals.

The book is a 1,000-page explanation for the legal profession, most notably judges, on how science works and how technical information should be used to adjudicate civil disputes and criminal proceedings. The term “technical information” has a special meaning and importance for the toxicologist since the major portion of the book, by far, is either directly related to toxicology or disciplines and topics in which a toxicologist would have an interest. While the book is intended for the legal community, it has value also for the non-forensic toxicologist who is required to explain toxicology and its practice to project managers, business executives, investors and, yes, even those who may confuse toxicology with taxidermy.

Since the book was a National Academies of Sciences’ (NAS) Committee on Science, Technology and Law project employing scientists from the NAS under the direction of the NRC, it required the contributions of authors, reviewers, committee persons and other participants that, in numbers, rivaled Coxey’s Army. To count the number of contributing participants, much less identify them by name, is certainly beyond the scope of this review. However, over 25 contributors actually wrote the 15 chapters, along with an Associate Justice of the Supreme Court of the United States who wrote the “Introduction,” giving the extremely well-written publication its authority and authenticity.

The distribution of the workload for this task of no small dimensions was obviously planned with careful considerations. The chapters on the admissibility of expert testimony and forensic identification of expertise were written by lawyers, for lawyers and judges. The chapters entitled “How Science Works,” “Reference Guide on Exposure Science” and “Reference Guide on Mental Health Evidence” were written by scientists. The remaining 10 chapters were co-authored by accomplished scientists in their respective fields along with knowledgeable attorneys. The remaining chapters cover topics in which toxicologists would have a direct interest: DNA identification, statistics, exposure assessments, epidemiology and neuroscience. Other chapter subjects which may or may not be interesting to an average toxicologist include the following: survey research, estimation of economic damages, medical testimony, mental health evidence and engineering.

Each chapter begins with a comprehensive outline of the chapter, making it easy for the reader to locate a particular sub-topic in the chapter. A list of general references follows the text of most chapters. Some of the chapters have a section entitled “Glossary of Terms.” The value of each chapter lies in the text and how it is organized and presented.

Each chapter contains copious footnotes, some of which are extensive in length, providing ample explanations of the textual material. For example, the chapter on toxicology contains 117 footnotes, the chapter on epidemiology has 215 footnotes, and the treatment of statistics (two chapters) has 247 footnotes. On average, each page of text has almost three footnotes. At times, the footnotes contain scientific explanations, with and without references to published scientific literature. Other uses of the footnotes include reference to legal material and case law.

The book, or “Manual” as stated in the title, is a collection of structurally identical modular units, covering topics of interest to scientists, attorneys, and judges. The textured layer – comprehensive outline, textual information, supplemented with ample explanatory footnotes, ending with general references and sometimes a glossary – provides the reader with the option of exploring a topic to a depth that he or she feels necessary. For the reader, the content and structure are not so much a self-study or education but rather a path for presenting the multifaceted dimensions of science to non- scientists in a clear and concise manner.

A paperback version is available for purchase, but an electronic version of the book or individual chapters can be read and downloaded1 free – yes FREE!


This article discusses issues of general interest and does not give any specific legal or business advice pertaining to any specific circumstances. Before acting upon any of its information, you should obtain appropriate advice from a lawyer or other qualified professional.