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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 Ryan H. Flax, Esq. (Former) Managing Director, Litigation Consulting A2L Consulting

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In our work as trial graphics specialists, many cases require us to prepare a demonstrative exhibit that simplifies a complex process. This could be a scientific or technical matter such as how environmental remediation is conducted, how surgical mesh is used, or how data backups are migrated, or it could be a business or governmental matter such as how a form of bond obligation is created and sold or how a government contract is bid and awarded.

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Pharmaceutical companies can be embroiled in many types of litigation. Very often, because of the length of time and the tremendous investment of money that it takes to develop a new drug and bring it to market, these cases can be crucial to the company’s continuing financial health.

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by Ken Lopez Very often, trial attorneys in complex cases need to explain extremely difficult and elusive scientific concepts to jurors who are not well versed in science. The lawyer’s job is to convey the science correctly to the jury so that they can make a rational decision – yet not to bury the jury under a blizzard of scientific terms and concepts that they will never understand. The answer is to use visuals in the form of photographs, schematic diagrams, animation, timelines, demonstrative evidence, document call outs or whatever is suited to the situation, and to explain them in terms that jurors who are not specialists in the scientific subject can understand.

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Timelines can be extremely helpful in many types of trials. Whenever the order in which events occurred is a significant issue, or a jury or judge needs to understand how a story began and ended, a timeline is appropriate. As Texas attorney and legal technology expert Jeffrey S. Lisson has written [pdf], “Timelines are the most effective way to give a judge or jury a sense of who did what, when, and to whom. Just as bar charts and graphs help the uninitiated make sense out of a sea of facts and figures, timelines show the relationship between events. Timelines generally show events laid out on a horizontal, constant chronological scale. Events – the writing of a memo, the reading of an x-ray, or the shooting of a gun – are listed in the order they occurred. While tables of dates and facts require effort to understand, timelines are instantly clear.”

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The passage of the Drug Price Competition and Patent Term Restoration Act in 1984 and its subsequent amendments (collectively the Hatch-Waxman Act) gave rise to more competition in the pharmaceutical industry and a new era of litigation.  The act itself provides a mechanism for generic drug companies to quickly gain approval to sell a generic version of an existing brand name drug. The application that begins the FDA approval process for the generic firm is called an Abbreviated New Drug Application (ANDA).  Brand name drug manufacturers have an understandable incentive to delay approval of the ANDA.  Simply, if the ANDA approval is delayed, the brand name firm continues to enjoy the lawful ability to sell their brand name drug without a lower priced generic equivalent in the market. One lawful mechanism brand name manufacturers use that may have the effect of delaying the approval of an ANDA is the filing of a Citizen Petition with the FDA. The Citizen Petition filed by a brand name firm would typically allege that the proposed generic drug is not equivalent and thus should not be approved for sale.  Should the Citizen Petition be deemed only a mechanism for delaying approval of the ANDA/generic drug rather than one filed with the public's health interest at heart, the brand name firm would be liable for antitrust violations. Such was the question our firm faced when working on behalf of a brand name pharmaceutical firm recently.  A Citizen Petition had been filed and a jury was going to be asked whether it had been lawfully filed.  Were the jury to find that the Citizen Petition had been unlawfully filed with the intent to simply delay approval of the generic drug, they could possibly award hundreds of millions of dollars in damages.  One quirk in this case that proved advantageous was the fact that it was not the generic drug firm suing the brand name firm, but instead it was the middleman or drug wholesaler who was alleging antitrust violations. Our challenge in creating an effective trial presentation was to create trial exhibits that both taught the jury and persuaded the jury simultaneously. The trial exhibits shown below were part of an opening PowerPoint presentation that explained who was involved in the case (i.e. the typical parties/players trial exhibit) and who was not involved.  We sought to emphasize that the brand name firm was being sued not by the generic drug manufacturer but instead the wholesaler who we painted as the delivery guys in these opening trial exhibits.  The story told is this: Brand name firms seek approval for a new drug from the FDA; Brand name firms distribute their product through wholesalers who then sell them to pharmacies; Generic firms receive approval to sell through an ANDA; The brand name firm here is BrandName Pharma, generics will be mentioned and then there are the wholesalers.  In this case HatchWax Wholesale Drug; One would think the generics are involved, but they are not.  Only the wholesalers or the delivery guys are suing.  What business do they have suing? Who is HatchWax Wholesale Drug?  They are professional antitrust plaintiffs. 

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