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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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A couple of years ago, I was involved in running a genetics conference focused on using genetics as a defense tactic in civil cases, much in the way that DNA evidence is used in criminal cases. I've been working with experts in this field ever since. A few months back, I wrote an article about the clever use by plaintiffs of litigation graphics and genetics in the baby powder (talc) cases (see Some Lessons for Defendants From the Talc Liability Trials), including a $4 billion verdict against a major talc manufacturer. When I write about various types of cases, I often hear from lawyers who handle the types of cases I write about. On my post on the use of genetics evidence in the talc litigation, how many talc defense lawyers do you think I heard from? If you guessed zero, you'd be exactly right. And that's a problem. Not ready to accept that this is a problem for defendants? Then I will ask whether the plaintiffs’ talc bar was similarly unresponsive. As you can probably guess from the way I posed the question, the answer is no. Out of discretion, I won't say exactly who or how many responded, but it was more than zero. Even though there is more to gain for the defense bar from understanding and leveraging these critical tools, it’s the plaintiffs’ lawyers who are most active in the field, striving to improve their approach. From the defense bar — crickets. And that's the problem I'm seeing in the way some of these talc cases are being defended. Defense counsel appear to be playing defense – and completely ignoring the key point that the best defense in litigation is a good offense. These verdicts are having an impact on the companies involved. Last Friday, on December 14, 2018, shares of Johnson & Johnson fell 10 percent and were set to have their largest percentage drop in more than 16 years, after Reuters reported that the company knew for decades that there was some asbestos in its baby powder. Yesterday, December 18, 2018, Johnson and Johnson ran the full page ad seen here in an attempt to manage this growing crisis. For trial lawyers and litigation consulting firms like ours, these asbestos allegations are not new or surprising. It's what plaintiff's have alleged recently and have used to prevail in these cases. The surprising thing in these cases is defense counsel's unnecessarily passive approach. When products are accused of causing harm, defense lawyers often choose one of the following defense strategies: Assert the harm was caused by something else but we don’t know what (the “idiopathic” defense) Assert the harm was caused by something else and we know exactly what. Typically, most defendants have chosen the ‘we don’t know what other thing caused it’ strategy because it avoids giving up the favorable allocation of the burden of proof and assuming the very specific (and often difficult) burden of proving an alternative cause – much as criminal defendants take advantage of the “beyond a reasonable doubt” standard. Not surprisingly, this argument generally falls flat. Recently, the plaintiffs’ bar won a multi-billion-dollar verdict by asserting that there is asbestos in talc and that it causes mesothelioma. This is highly improbable for several logical reasons — but jurors tend to follow emotion first and logic second when deliberating. If asbestos is present in baby powder at all, it would be in such small amounts that one could not reasonably connect mesothelioma to it. If defense counsel asserts (as they have been) that the mesothelioma was caused by some other identified source of asbestos, and not by talc, that leaves jurors without the necessary tools to argue for a defense verdict during deliberations. So, what if defense counsel could instead prove that the plaintiff’s mesothelioma was caused by something other than asbestos in baby powder? Something identifiable, measurable, and specific. Using modern genetics, this is now possible. And it is a major sea change.

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I’ve been watching the baby powder/talc trials closely for the past several years. They feature some of the world’s best lawyers, and they are pushing the boundaries of scientific evidence. For anyone in the litigation business, the talc trials, as well as the trials involving the alleged cancer-causing properties of Monsanto’s herbicide Roundup, form a fascinating window into how big-ticket cases are being tried right now. In both lines of cases, plaintiffs are showing early dominance, and I think the defense accordingly needs to adjust both how it handles demonstrative evidence and how it deals with scientific evidence. Interestingly, both of these types of trials can be watched on the Courtroom View Network (CVN). I have long advocated that trial attorneys should be watching other trial attorneys on CVN because there’s almost no other way to see today’s great lawyers in action. In the most recent talc trial, famed plaintiffs lawyer Mark Lanier of Houston took on Johnson & Johnson, which makes talcum powder products. He asserted that his clients, 22 women who used the products, were exposed to asbestos found in talc and that this exposure caused them to contract ovarian cancer. The case is notable for many reasons. The result was certainly remarkable as this past July, plaintiffs were awarded nearly $4.7 billion in damages by a jury in a Missouri state court. The case is also one of the most high-profile cases to utilize genetic evidence. And that aspect was particularly interesting to me as this is an area that A2L and its partners at Innovative Science Solutions have been discussing for the last couple of years. We even held a conference on the topic of the use of genetic evidence in civil litigation. So let me discuss two aspects of this case. First, while I am not an expert in analyzing genetic evidence in civil cases, I do understand how to use it and how to present it. In this case, the defense was clearly reluctant to use genetic evidence, and it only lightly cross-examined plaintiffs’ genetics expert. I don’t know for sure, but I’ll speculate that like other defendants, Johnson & Johnson may have feared that by presenting genetic evidence as a defendant it would position the plaintiffs as a so-called eggshell plaintiffs, making liability easier for plaintiffs to prove. See takeaway #6 in this article where we discuss why this thinking is specious. Whether or not defendants were concerned about the role of genetics in conveying to the jury that these may be eggshell plaintiffs, Lanier appeared to adopt this approach anyway. He utilized genetics to affirmatively allege that the plaintiffs were especially vulnerable to the effects of talc. This highlights an apparent growing trend of the plaintiff utilizing genetics to demonstrate plaintiff susceptibility to alleged toxins and a need for the defense to effectively address and rebut this assertion. I haven’t seen that tactic before. and similarly situated defendants must get ready for this tactic in other cases. A good place to start would be talking to my friend and frequent collaborator Dr. David Schwartz at Innovative Science Solutions who is doing pioneering work with the group ToxicoGenomica. The second element of this trial that I found fascinating was Lanier’s use of demonstrative evidence. In most big-ticket litigation demonstrative evidence is exchanged a day or so before it is used, to allow for objections to be made. Clearly, Lanier has figured out a workaround by drawing (or having his colleague draw) a highly prejudicial demonstrative that for whatever reason the defense did get excluded. It's the featured picture in this article, but let me show you what I mean in this clickable video clip and transcript below from our friends at CVN. Here Mark Lanier perfectly combines the eggshell plaintiff approach with an objectionable piece of demonstrative evidence to powerfully drive a point home. His message is that some people are genetically more susceptible to cancer-causing agents like asbestos and that Johnson and Johnson and their baby powder products pushed plaintiffs over the cliff where cancer happens. Other free A2L Consulting resources related to genetics in civil litigation, litigation graphics, and demonstrative evidence include: With So Few Trials, Where Do You Find Trial Experience Now? 7 Key Takeaways from the Genetics in Civil Law Conference Free slide decks from the Genetics in Civil Law Conference Free E-Book: The Litigator's Guide to Combating Junk Science - 2nd Edition Repelling the Reptile Trial Strategy as Defense Counsel - Part 3 - Understanding the Bad Science The Importance of Litigation Graphics in Toxic Tort Litigation 10 Key Expert Witness Areas to Consider in Your Next Toxic Tort Case Free Download: Using Science to Prevail at Trial or As an Advocate 7 Reasons the Consulting Expert is Crucial in Science-Based Litigation Using Trial Graphics & Statistics to Win 12 Questions to Ask When Hiring a Trial Graphics Consultant Repelling the Reptile Trial Strategy as Defense Counsel - Part 1 Teaching Science to a Jury: A Trial Consulting Challenge 5 Valuable (and Free) Complex or Science-Focused Litigation Resources Winning BEFORE Trial - Part 3 - Storytelling for Lawyers

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We are delighted to announce the publication of a new free e-book, the Trial Lawyer’s Guide to Environmental, Toxic Tort, and Product Liability Litigation, 3rd Edition. It is a guide to all the issues and all the possibilities that can come up in environmental, toxic tort, and product liability litigation – whether related to PowerPoint, scientific expert witnesses, competing scientific theories, body language, or any of a myriad of questions that can come up in this complex field. This is the third edition of a book that we first released in 2011. We have dramatically expanded the scope and the depth of the book to add dozens of new and relevant articles, including articles on the importance of litigation graphics in toxic tort litigation and on demonstrative evidence in product liability and failure-to-warn cases. The book is now 256 pages long and packed with valuable articles. Environmental, toxic tort, and product liability cases have similar challenges. Each typically involves disputes over science and often results in a battle of expert witnesses. As a result, these cases are some of the hardest cases to litigate. These cases can include technical issues similar to patent cases, scientific elements similar to pharmaceutical cases, and damages issues similar to construction cases. In addition, for many jurors, these cases are fraught with political ramifications in a way that many other cases are not. Jurors often harbor a basic belief that if a big company is on trial, it has probably harmed people or the environment in pursuit of profits and has caused long-term damage to people and the planet – either by directly causing human health effects, polluting the air, water, or ground, or by contributing to global warming. It is important for a lawyer representing such a company to overcome jurors’ biases and to do so while keeping the case from seeming dull and boring. If you are to be successful litigating these cases, you have to be among the best in the profession. The natural complexity of these cases means that demonstrative evidence must be used extensively, jury consulting is often appropriate, and the use of trial technicians allows you to focus on maintaining your connection with the jury – rather than staying connected to the technology. This e-book will help you better prepare to litigate environmental, toxic tort, and product liability cases. From making the most of your mock trial, to managing trial team psychology, to specific demonstrative examples, there is something in here for all trial lawyers. I hope you enjoy this book and will take a moment to share some feedback by contacting me. If you ever have a question about how to prepare an environmental, toxic tort, or product liability case anywhere in the world, please ask. You may download the book by clicking this link or by clicking the download button below.

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by Tony Klapper Managing Director, Litigation Consulting A2L Consulting If anyone thought the era of toxic tort litigation was coming to an end, they were wrong. The Environmental Protection Agency recently announced its priority list of 10 chemicals, including asbestos, that it is considering banning under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Although it remains an open question how aggressive the Trump administration will be with safety regulations, the reality is that regulatory lists like this, and the inevitable studies that follow, often become a treasure trove of “support” for a plaintiffs’ bar eager to add scientific credibility to their legal claims. This presents challenges for defense lawyers – especially given the continued currency of quasi-scientific principles or principles that are fine for regulators to rely on, but have no place in today’s courtroom, such as the “precautionary principle.” This is most evident with the mantra of “no safe dose” that asbestos lawyers and some environmental groups trumpet as justifying liability for even the most meager and infrequent of chemical exposures. Of course, toxicology, epidemiology and other scientific disciplines have exposed the fallacy of principles like “no safe dose” (after all, Paracelsus teaches us that “dose makes the poison – more about this later). But the appeal of the seemingly aphoristic “no safe dose” is tough to counter in court when an effective advocate plays to a jury’s fears and is buttressed by governmental pronouncements that, albeit for different reasons, embrace the notion that there is some theoretical, modeled risk from exposure to virtually any chemical. So the task for the defense bar is how to convince juries to reject these and other fallacious concepts that serve as easy, digestible substitutes for the more complex elements of true causation.

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by Tony B. Klapper, Managing Director, Litigation Consulting & GC, A2L Consulting and David H. Schwartz, Ph.D., Co-Founder, Innovative Science Solutions 

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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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