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Dr. David Schwartz is a founding partner of Innovative Science Solutions, LLC (ISS), a scientific consulting firm specializing in helping legal teams prevail in high-stakes litigation involving complex scientific principles. Dr. Schwartz has served as a consulting scientist to the legal industry for over 25 years and has provided support to cases involving environmental and occupational exposures, radiation, drugs, medical devices, dietary supplements, cosmetics, industrial chemicals. But over the course of the past several years, Dr. Schwartz has focused on the role of genetics as an alternative cause in toxic tort litigation. As part of a strategic alliance, ToxicoGenomica, Dr. Schwartz and other ISS consultants have been providing consulting support on asbestos and talc cases focusing on genetic evidence as an alternative cause of mesothelioma and ovarian cancer. In 2017, Dr. Schwartz (ISS), myself (A2L), and others co-hosted a pioneering conference on the subject of the role of genetics in civil litigation. Now two years later, I sat down with Dr. Schwartz to get a better understanding of how genetic science has evolved since then and how it is likely to change the way toxic tort cases will be litigated in the near future, specifically in talc and asbestos cases. Q: Give us a quick summary as to how genomic science will change toxic tort litigation. A: Modern medicine is advancing from broad-based treatment based on randomized controlled clinical trials to “precision medicine” where treatment is tailored to individual patients based on their genetic profile. Similarly, toxic tort litigation has been based on so-called black-box epidemiology studying large groups of people and trying to determine risk. We are bringing the field up to date by applying the tools of precision medicine to evaluate risk in toxic tort litigation. With genomics, we can directly ask if a person was born with genes that predispose them to develop a disease (like mesothelioma) instead of relying on statistical inferences from large populations. This is a watershed moment in toxic tort litigation. Q: Talc litigation is heating up. Last I read, there were 14,000 claims filed related to talc. Do you think genetic science has a role in talc litigation? A: Absolutely! Genetics provides a medically sound alternative cause argument no matter what the alleged injury: mesothelioma, lung cancer, ovarian cancer, lymphoma, autism. These conditions are all known to have well-established genetic underpinnings. If a defense lawyer can demonstrate that a plaintiff had a specific set of genetic factors, then it is legitimate to make the argument that the condition was caused by those factors. Q: What is a genetic mutation? A: A mutation, also referred to as a variant, is an error in the sequence of a gene that could drive specific types of cancer. A gene can have hundreds or thousands of different types of mutations. Some mutations have no known effect on a person’s life, while others will drive the onset of cancer. Q: If genomic testing is already being used in precision medicine, has that information ever been used for litigation purposes? A: Yes. Sometimes the genetic analysis at a hospital can be very informative. That’s especially true for cancer treatment at excellent cancer hospitals. Having the capability to review plaintiffs’ medical records for relevant genetic evidence will be a core skill set moving forward.

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  by Ken Lopez Founder/CEO A2L Consulting We have long participated in a joint publishing effort with Innovative Science Solutions (ISS), a company that provides strategic consulting services designed to ensure that you are prepared and knowledgeable about scientific and technical issues relevant to your case. A2L has partnered with ISS for the benefit of many law firms and corporations. We have already had the pleasure of working together on everything from tobacco litigation to hydraulic fracturing to alleged health effects of cell phones. Along the way, we have learned, often by overcoming enormous challenges, how to make science your ally -- whether inside or outside the courtroom. Today, A2L and ISS have just published the new and revised second edition of their e-book, The Litigator’s Guide to Combating Junk Science. The book is built on the following important concepts:

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by David H. Schwartz Managing Director, Scientific Support to Counsel, Innovative Science Solutions The key to any toxic tort case involving complex scientific concepts is retaining the right experts. However, as any experienced litigator well knows, finding the right expert is not a simple or straightforward matter. Although getting the right lead on a specific individual can be challenging, half the battle is often identifying the right type of expert for your case.

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by Ken Lopez Founder & CEO A2L Consulting

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A Q&A about using statistics in litigation with David Schwartz, Ph.D., Nathan Schachtman, Esq. moderated by litigation support specialist Ken Lopez

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This article is coauthored by A2L Consulting’s CEO, Kenneth J. Lopez, J.D., a trial graphics and trial consulting expert and David H. Schwartz, Ph.D. of Innovative Science Solutions. Dr. Schwartz has extensive experience designing programs that critically review the scientific foundation for product development and major mass tort litigation. For 20 years, he has worked with the legal community evaluating product safety and defending products such as welding rods, cellular telephones, breast implants, wound care products, dietary supplements, general healthcare products, chemical exposures (e.g., hydraulic fracturing components), and a host of pharmaceutical agents (including antidepressants, dermatologics, anti-malarials, anxiolytics, antipsychotics, and diet drugs).

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