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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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The Top 10 Litigation Articles of 2018

It's my eighth year writing an end-of-year top-10 style article. That feels pretty great because in that time, we have published more than 600 articles and A2L's Litigation Consulting Report blog has been visited one million times. Wow, right?

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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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by Ken Lopez Founder/CEO A2L Consulting We recently had the opportunity to co-host a conference focused on the use of genetics in the courtroom. The conference was entitled Genetics in Civil Law: Litigation, Regulation, Business Opportunities, and Risks. A2L was joined in hosting by three science-focused expert firms that are pioneers in the law and genetics field. For me, the real pleasure of participating in the conference was how much I learned. That's kind of unusual for a conference, right? There are just a handful of valuable takeaways at most conferences I attend. Here, there were dozens of them, simply because of the nature of the material and the state of the art. The work being done by the speakers, the hosts, and many of the participants is genuinely pioneering -- both as it applies inside the courtroom and outside. Here are seven key takeaways that highlight some of the most valuable aspects of attending the conference. Please note that number 7 is your ability to download the slides for free from the key speakers without further obligation of any kind.  The use of DNA evidence in the courtroom is relatively new. From watching TV, from the OJ case, and from our practices, we're all generally familiar with how DNA evidence is used in criminal cases. Many people are surprised to learn that its use as evidence in the courtroom dates only to the mid-1980s. That's right, in the courtroom, DNA evidence is just 25 years old. The use of genetic evidence in civil cases is just beginning. For trial lawyers involved in big-ticket litigation, the present is the equivalent of the mid-1980s for criminal lawyers. Genetics and DNA evidence are being used by plaintiffs and defendants in big cases. Genetics have been successfully used in many big cases. Not many cases of this sort have made it to trial, but some have. The cases thus far have been related to exposure to substances like benzene, asbestos, and tobacco. Companies have found a successful defense with the use of genetics. We can expect to see such a defense in talc litigation and other emerging pattern litigation soon.  Genetics can be used to establish an alternative cause. Genetic profiling can not only be used to question or prove causation, but it can also be used to establish an alternative cause, because exposure to certain substances leaves a genetic trace and certain cancers have unique genetic profiles. The science is accepted. There is ample precedent for the use of genetic evidence at trial. Indeed, there is 25 years of precedent.  The eggshell plaintiff worry is just a worry. Defense lawyers know that they have to accept plaintiffs as they find them. That is, if a plaintiff is extra-sensitive to a chemical exposure, that extra sensitivity might provide the plaintiff with extra ammunition. So, the worry I've heard expressed is that if we genetically profile a plaintiff and find that he or she is indeed extra sensitive, we help make the plaintiffs case. However, I learned at this conference that one can assess a case and make a decision about whether genetic analysis will be worthwhile without doing the work and potentially find valuable and powerful alternative cause defenses. Click here to download an e-book containing the slide decks from the conference for free.

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