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Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and expert witness experience. He is a recognized expert in developmental toxicology, with many publications, including several authored or edited books, and participation in expert panels for both government and industry. Expert has had an extensive consulting practice in developmental and reproductive toxicology, designing and reviewing study protocols, reviewing data, critiquing study reports, and preparing publication manuscripts for pharmaceutical and chemical companies and regulatory agencies. For example, he recently assisted a pharmaceutical company in evaluating rat and rabbit developmental and reproductive toxicity data on a candidate drug, and he obtained the additional expertise of an expert on primate teratology to aid in evaluating primate study conduct and data. Expert evaluated the existing information on chemicals that could potentially leach from a medical device and prepared an analysis of the potential for the device to cause reproductive or developmental toxicity. His report was crucial for obtaining FDA approval for the device. Expert also authored a manuscript for a chemical company from their existing data, shepherded it through journal publication, and assisted in designing further studies on the chemicals involved. He has also served as an expert witness in a number of cases related to birth defects and miscarriage, including serving as a defense expert in several Bendectin cases. Expert has provided expertise on such things as the state of vulnerability of specific human embryonic structures during the time of exposure to actual or alleged teratogens. However, the main area in which he can provide useful testimony is the use of animal studies to support or refute allegations of birth defect causation.

Expert taught a university course on human embryology for over twenty years. In addition to his understanding of human developmental anatomy, he can supplement his knowledge with an extensive personal library of embryology texts. Thus he can provide answers to questions regarding the process and timing of the development of specific structures and organs.

Expert has assisted pharmaceutical and medical device companies in designing and implementing nonclinical developmental and reproductive toxicity studies and by evaluating the results from such studies. He has also aided such companies by critiquing and editing study reports produced by their in house staff or by CROs. It has been Expert’s observation that such study reports are often flawed because of lack of specific experience and expertise on the part of the report authors or perhaps by their working under severe time constraints. For example, they may not only misinterpret data but they may also inappropriately use “boiler plate” text that does not apply to the study at hand. Expert has also helped to design “nontraditional” studies for the purpose of answering specific questions that may shed light on mechanisms of toxicity and whether such mechanisms may or may not act in humans. His extensive collection of reprints from the developmental and reproductive literature has also proven valuable in answering obscure questions that may support regulatory submissions. Further, Expert has an extensive network of colleagues with a wide range of experience and expertise on whom he can call for additional consultation if needed.

Expert has taught university courses on toxicology, environmental toxicology, and developmental toxicology. He is a recognized expert in developmental toxicology, with many publications, including several authored or edited books, and participation in expert panels for both government and industry. Expert has had an extensive consulting practice in developmental and reproductive toxicology, designing and reviewing study protocols, reviewing data, critiquing study reports, and preparing publication manuscripts for pharmaceutical and chemical companies and regulatory agencies. For example, he recently assisted a pharmaceutical company in evaluating rat and rabbit developmental and reproductive toxicity data on a candidate drug, and he obtained the additional expertise of an expert on primate teratology to aid in evaluating primate study conduct and data. Expert also evaluated the existing information on chemicals that could potentially leach from a medical device and prepared an analysis of the potential for the device to cause reproductive or developmental toxicity. His report was crucial for obtaining FDA approval for the device. In addition, Expert authored a manuscript for a chemical company from their existing data, shepherded it through journal publication, and assisted in designing further studies on the chemicals involved. Expert’s broad background, including expertise in environmental toxicology and in agriculture, resulted in his being chosen by the Veterans Administration to prepare a monograph on “Agent Blue” (cacodylic acid), a Vietnam era herbicide. And although he has a broad and varied background in toxicology, with an emphasis on developmental and reproductive toxicology and the toxicology of arsenic, Expert can call on an extensive group of colleagues throughout the U.S. to provide additional expertise. These colleagues cover virtually all areas and aspects of toxicology, as well as epidemiology and the pharmacology and toxicity of pharmaceutical drugs and drugs of abuse. Expert has also served as an expert witness in a number of cases related to exposure to environmental and workplace toxicants and involving allegations of a variety of toxic effects, although the majority of his litigation-related work has involved cases dealing with birth defects, miscarriage, or arsenic exposure. Further, Expert has lectured on developmental and reproductive toxicology to personnel of the U.S. FDA's Center for Drug Evaluation and Research and organizes training courses for Canadian Government regulatory personnel (Health Canada).

Expert has authored or co-authored numerous research articles dealing with the toxicology of arsenic compounds. He has published more research related to the developmental toxicity of inorganic and organic arsenicals than any other individual. Expert has also published articles on the biotransformation and toxicokinetics of arsenic and has served as an expert witness in arsenic-related litigation. In addition, his broad background, including expertise in environmental toxicology and in agriculture, resulted in his being chosen by the Veterans Administration to prepare a monograph on “Agent Blue” (cacodylic acid), a Vietnam-era arsenical herbicide. That monograph covered everything known about cacodylic acid, from its chemical structure and properties to its environmental fate, as well as all aspects of its toxicity to a variety of species and its pharmacology. Copies of the monograph can be viewed at all Veterans Administration facilities and they can be obtained from Expert.

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Expert has served as a consultant to industrial clients, trade associations, Federal and State regulatory agencies, and law firms since 1978. He has served as a grant or document reviewer for the American Chemistry Council, the U.S. Environmental Protection Agency, the Agency for Toxic Substances and Disease Registry, the Congressional Office of Technology Assessment, ICCVAM, and the National Research Council. Expert also conducts training courses in developmental and reproductive toxicology for regulatory personnel of the government of Canada. Expert was contacted by a company that was attempting to obtain FDA approval for marketing a biomedical device. The company had been working with other consultants, but the FDA had concerns about the potential of the device to cause developmental or reproductive toxicity. The company was in a particularly problematic situation, because there was no appropriate animal model by which the device could be tested for these endpoints. Expert was able to present a well researched argument maintaining that because of considerations such as the nature of the materials that were in question, the minimal potential exposures to leached chemicals, and the timing of possible exposures, the likelihood of the toxicities of concern was negligible. This lead the FDA to conclude that approval for marketing of the device was warranted.

At the request of attorneys for the U.S. Dept. of Justice, Expert provided an extensive review of the literature on the potential of exposure to certain chemicals to cause a specific type of birth defect. He was also asked to assess all identifiable alternative sources of causation for the defect in question. Although the agency’s attorneys had initially retained him for litigation support only, they were sufficiently impressed by the expertise and thoroughness evident in the literature review and by an in-person interview that they decided to name Expert as a testifying expert in the case.He served as a “special consultant,” providing needed expertise in developmental, reproductive, and environmental toxicology to the Environmental Health Committee of the U.S. EPA’s Science Advisory Board for a period of ten years. Expert prepared a monograph for the U.S. Veterans Administration on an arsenical herbicide, “Agent Blue,” used in the Vietnam War. The agency contacted Expert because of his expertise on the toxicology of arsenicals, as well as his diverse background in fields such as environmental toxicology and agriculture. The completed monograph, which details what was known at the time regarding chemical properties, analytical methods, production and use, environmental sources and fate, pharmacology, animal and human toxicology, human exposure, and research needs related to cacodylic acid (dimethylarsinic acid), was published by the Veterans Administration.