ToxicoGenomica: Visualizing the Invisible

Causation is often the key to toxic tort cases. The issues can be especially difficult if a would-be plaintiff has developed a “signature” disease typically associated with a “toxin,” but the evidence of exposure is thin. That type of fact pattern can create uncertainty for counsel on both sides of the v., to say nothing of the sick person who is wondering “why me?”

When a defendant is confronted with a case with “thin” exposure, the defense strategies can vary. Some defendants will simply argue a disease is “idiopathic,” and will not seek to provide jurors with concrete information that may help a jury to see and accept a “genetic” cause of a disease. At the other end of the spectrum, some defendants will retain experts to investigate the “invisible” for evidence of other factors (call them X factors) that may be present and may be used to provide a jury with an accurate and “concrete” set of facts that can be argued regarding an alternative cause for the disease.  Some lawyers and consultant we respect feel strongly that the latter approach is truly required for some cases involving some cancers.

We have formed ToxicoGenomica to assist counsel in visualizing these invisible factors.

Who and what is ToxicoGenomica?

We are a multidisciplinary group of scientists and lawyers who created ToxicoGenomica Partners, a strategic alliance between ArrayXpress, the LSP Group, LLC and Innovative Science Solutions, LLC. See our About Us page for more specifics about each member entity.

Why did you create ToxicoGenomica?

Our mission is to offer fully integrated genomic analysis services in toxic tort litigation. We also intend to accelerate the development of best practices related to genomic information in civil litigation. We already sponsored one comprehensive workshop on genomics in civil law. We intend to do more to expand professional knowledge as to how correct application of genomic information can visualize the invisible.

What is meant by ‘visualizing the invisible’?

We believe and can prove that accurate and thoughtful use of modern genomic and systems biology tools can shed light on currently invisible genetic and molecular information (visualize the invisible) to transform civil law in ways even more revolutionary than the use of DNA-evidence in criminal law. Our group has proven that powerful and increasingly precise molecular and genomic tools can generate highly material evidence which has already strongly influenced conclusions reached in recent civil law cases. We are confident we can do the same for a multitude of cases to come.

How do we know this to be true?

From our combined knowledge and skills built through decades of experience in our respective areas of expertise.  We are “outliers,” to borrow Mr. Gladwell’s term.  That said, there is objective evidence to support our premise. Consider how DNA evidence revolutionized criminal law and the constant changes brought about by other molecular technologies in medicine and therapeutics. In family law alone, DNA testing has become standard practice in determining paternity.

What do you mean by X factors?

“Signature” diseases may arise due to factors other than exposure to the “toxin” typically associated with disease. Careful and thoughtful investigation of the biology of such persons can be used in some cases to make visible the X factors that were at work in that person, and/or other people in that family or some other group of people. And, when the proper genomic or systems investigation is started early and phased in a thoughtful manner, the costs can be more effectively managed for a particular case, or a set of cases. At the end of an agreed-on process, some number of X factors will or will not be visible. Depending on the presence or absence of one or more X factors, different arguments may be made about how and why one or more diseases occurred in that individual. In addition, broader conclusions ultimately may be drawn when more and more of the individual situations are systematically analyzed and considered as group.

What is a Systems Biology Approach?

Other types of molecular analysis also can be powerful. For example, systems biology analysis in an increasingly powerful tool that ArrayXpress uses every day for all kinds of projects for clients who are biotech companies, hospital groups and other science-focused organizations. Over time, we’ve also seen and shown that systems biology also can be highly useful to persons involved in litigation about why and how diseases arose in a particular person, or groups of people. Systems analysis arises from the fact that our bodies are made up of inter-related biologic systems that are more or less “the same” at the general level. And, in general, the systems interact in repetitive processes. Therefore, as more research builds more understanding of how systems work and more data about the actual operations of systems, researchers can look across that data to see patterns in the data. In turn, the patterns can be examined to generate hypotheses, testing methods, and then conclusions about the patterns that arise when those systems are operating “normally” or when factor X interacts with one or more systems.

At some point, enough knowledge is developed to conclude that there are “signatures” that can be reliably associated with one or more X factors. The X factors could be the presence of particular levels of one or more “toxins,” or may be the presence of one or more proteins that are not “typical” because the proteins were built from atypical instructions due to an inherited (germline) mutation and/or because of one or more “somatic” mutations that arose during life.

Where do things stand for genomics in civil law? 

Developments are much more advanced than many people realize. Indeed, for a subset of cases, we believe legal professionals will soon be “second guessed” if they do not actively explore genomics as part of their causation arguments. We’ve had direct experience bringing genomics techniques into a number of toxic tort cases. We also monitor developments related to genetic defenses in cases where we have no direct involvement. We have seen genomic information significantly shift the thinking and perspectives in several of these cases. We are at the forefront of educating colleagues about these genetic techniques, tools, and knowledge, and how they can be used in court.

When the molecular tools of today (and tomorrow) are deployed correctly, we believe better, more informed decisions will be made in current cases by lawyers, litigants and judges. And from these decisions, new issues will be identified and new legal rules will follow. Beyond the courtroom, better presentation and use of genomic information will improve long-term decision-making by other stakeholders, such as individuals, companies, government agencies and legislatures.

Our next post will present the basic outline of five cases where we used genomic and systems science to visualize the invisible. In those cases, a plaintiff had asserted claims about one or more well-known “toxins” and had alleged the presence of a so-called “signature” disease. We helped the lawyers, jurors and judge to see alternative causation possibilities in potentially high value cancer cases (most involving relatively young plaintiffs). In each case, the analysis was requested by one or more defendants. All findings were made available to plaintiff.


Do you have a toxic tort or pharmaceutical case where you want to visualize the invisible? Fill out the form below and we’ll contact you to discuss how we can help.