Announcement of Partnership

Announcement of Partnership for Genomics in Civil Litigation

Strategic Alliance to Establish Best Practices for Analysis, Research, and Testimony for Genomics in Civil Law

The use of genomic evidence revolutionized identification practices in criminal law, and today genomic evidence is increasingly used in civil litigation to explain the “why and how” of the occurrence of diseases, injuries or conditions. Over the past three years genomic analyses to judges and juries have been on the rise in civil lawsuits involving drugs and vaccines, and exposure to radiation, benzene, and asbestos.

The use of genomic analyses in civil litigation is now unstoppable. Now is the time for multidisciplinary collaborations to accelerate development of best practices and standards related to use of genomics. Best practices are needed to ensure the legitimacy of the science when presented and applied in cases. Best practices also need to be developed so that information collected in litigation is preserved and ultimately shared with scientists for research purposes. Finally, there is a need for best practices related to translating genomic information into thoughtful legal rules and principles, including multidisciplinary participation in the framing of pertinent medical-legal discussions.

To that end, a multidisciplinary group of scientists and lawyers have created The Genomics in Civil Law Consortium to accelerate the development of best practices related to genomic information in civil litigation. The first step is the establishment of a group of multidisciplinary stakeholders and scientific experts, including occupational health researchers, medical institutions, biotech businesses developing diagnostic devices and medical therapies, government agencies, companies that manufacture products, science-focused advocacy groups for genetically linked diseases, and legal advocates for persons and entities involved in civil litigation as either plaintiffs or defendants.

A second step is the development of a transparent and open access repository of information pertinent to genomic issues in civil litigation. To that end, the group is compiling examples of the use of genomic information in civil litigation as well as some working ideas for next steps that will become available on the partnership’s website: www.toxictort.net The consortium welcomes submission of additional examples and will expand the collected information as rapidly as possible. The consortium anticipates developing additional web site for more specialized collections of information, and organizing and/or promoting related workshops. The consortium also assumes and hopes that a wide range of professional medical, legal and scientific groups will create additional resources, and will foster exchanges of information and ideas.

The impetus for the Genomics in Civil Law Consortium arises from the need to start filling gaping holes in knowledge related to the use of genomics in civil litigation, and to foster trusted, transparent and open access repositories for relevant information on genomics in civil litigation. The initiators of this effort have collectively spent decades at the leading edge of thinking about, working on and/or writing about the uses of genomic information in civil litigation. There has been a broad range of requests from judges, doctors, research scientists, patient advocates, lawyers and corporations who seek access to unbiased information and new ideas. But many stakeholders have expressed concerns that individual actions might be seen as a mechanism to inappropriately influence legal outcomes. A goal of the Genomics in Civil Litigation Consortium is to eliminate those concerns by creating an initial framework for a range of interested persons and entities to become part of group oriented around open access, transparency and multidisciplinary cooperation. We see there are many groups with personal and financial stakes in the creation and use of genomic knowledge in civil litigation. We believe the development of best practices should provide direct benefits to all stakeholders, and should provide benefits to society that go well beyond the courtroom.

There are vast possibilities for new approaches. New datasets of sequenced genomes and personal histories could be created that would be available to medical professionals for improving decision making in diagnostics and treatment. Courts overseeing cases with genomic information could develop new legal rules to help researchers obtain access to information collected in civil litigation. Relevant genomic information could be shared so that others to can identify modes of action and potential targets for developing new drugs and therapies. One day, the data could even help to provide better bases for determining, on an individual basis, individual susceptibility factors that will help with decision-making on lifestyle and workplace protections.

The founders are initiating this business partnership to take concrete steps to accelerate collection of and dissemination of relevant information in the area commonly called “toxic tort” litigation. The consortia also expects to provide education about and expert data for civil cases where genomic information is applied through “molecular signatures” and data that are now a growing part of peer reviewed scientific literature due to the incredible pace of new discovery. Our premise is that our actions must be transparent, and should involve working with advocates for all groups of personal and financial stakeholder, including patient advocacy groups and lawyers who are advocates for both plaintiff and defense stakeholders, along with other financially interested entities.

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About ArrayXpress – ArrayXpress’ investigational genetics and genomics studies are designed to work hand in glove with epidemiological, toxicological, medical, and environmental data to help determine causation. Genetics and genomics data can often indicate whether exposure and resulting DNA damage did or did not occur due to a particular toxicant, as well as, show the individual’s genetic predisposition through familial inheritance to a particular disease or disorder. www.ArrayXpress.com

About Innovative Sciences – Innovative Science Solutions (ISS) is a leading scientific consulting firm serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of scientists, regulatory strategists, and consultants providing a wide range of fully-integrated services to industry and counsel to support services for litigation and product stewardship involving complex scientific or medical issues. ISS provides strategic consulting services designed to ensure that counsel and corporations are prepared and knowledgeable on scientific and technical issues relevant to their case. www.innovativescience.net

About LSP Group LLC – Law Science Policy. In 2011, Kirk Hartley created LSP as new law firm focused on the increasing intersections between molecular science and civil law issues. Hartley’s other endeavors include serving as the current chair of the Risk Law Policy specialty group of the Society for Risk Analysis, providing free legal advice and/or litigation services to persons denied access to life-saving therapies or diagnostics, and serving as an unpaid director for Triage Cancer, a 501(c)(3) entity focused on educating a wide range of professionals, patients and caregivers on the legal rights of persons during and after cancer. In 2008, Hartley created a still-ongoing blog focused on the increasing intersections between molecular science and civil litigation; www.GlobalTort.com

For More Information, Contact: mz3@ArrayXpress.com