As scientists in the field of toxicology, we are trained to rely on the science. The data from studies drives our decisions and resources are allocated based on those decisions. As two specific examples from TigerTox, we have literally spent $1,000,000s of US dollars on a study to generate data. And we have also, literally, withdrawn from a study where the science would tax our resources to the breaking point. All of this is in the name of science and the importance of the data.
Interestingly, it’s often not just about the science of the data. As we’ve found planting seeds in the minds of our legal teams, understanding evidence law can have a profound impact on how we allocate resources. While there are many areas of our practice where this is relevant, for the current series of articles, I’ll take extrinsic evidence as an example of one aspect of evidence law.
A definition of evidence law is not just about the data, and yet, the science of the data is at the center of our concern…what is extrinsic evidence in evidence law? A basic definition of extrinsic evidence (remembering that I’m not a lawyer) is “documentary evidence that relates to an issue outside of the document that is being considered”. The key is that the evidence must be used for a purpose beyond the document itself. (For example, evidence related to the intention in a contract is extrinsic). Dictionary.com has a similar definition of extrinsic evidence, in addition to the more specific, “such evidence being admissible to explain, modify, or contradict the terms of a contract, will, etc.”
This provides a general technical understanding of what it is, but what does it mean from a practical point of view and how does it relate to the development of pharmaceuticals? The answer to both questions generally lies in how understanding evidence law, especially evidence law in contracts, allows for improved strategic resourcing for clinical studies. When seeking to control and limit liability, limiting the interpretation of contracts and cabling expert testimony are common legal strategies. Understanding extrinsic evidence, and how it impacts several key contractual concepts such as “integrated” and “final expression” provides incredibly useful parameters to those strategies.
As you might imagine, the consequences of improper use or interpretation of extrinsic evidence can be quite significant and interestingly, the unintended consequences of improper use or interpretation is a topic of interest within the legal community as well (by now, you might be thinking about the cover of Dr. Seuss’s book, “Oh The Places You’ll Go!”).
So, what are some of the issues and challenges of extrinsic evidence and interpretation of evidence in the pharmaceutical industry? For example, in consideration of US based patents, extrinsic evidence is considered in interpretation of what words contained in a patent application mean. However, there are different approaches in interpretation of patents in other countries and thus, one must carefully consider which country’s laws apply. Coupled with the notion that extrinsic evidence cannot be used to add to the contract, but only to explain the contract, having good expert testimony to provide the court with context and an explanation of the intended meaning is critical.
Is extrinsic evidence ethical? And how would we expect TigerTox to respond to this question? To be fair, we believe there can be ethical and unethical applications of legal strategy. However, as a scientific company, the bulk of our experience leads us to see forensic questions in law about extrinsic evidence in the context of going behind the curtain to determine whether or not the intent of the contract was what the contents of the contract exhibit (which is often readily apparent). In our experience, there is significant variation among states that we’ve worked with in terms of how courts apply the concept of extrinsic evidence to interpreting contracts. This variation definitely underscores the political and cultural underpinning of the States where the cases are being tried, and is inherently outside the scope of my focus on the science.
As scientists, we do not actually personally set out to be directly involved in questions of law and extrinsic evidence, but often we are called upon in a consulting capacity to help in questions of liability and the basis of contracts. We have been very actively sought out when evidence interpretation was central to setting the stage for a successful legal outcome in clinical studies that we have had active roles in designing and executing. In these situations, it is a particularly uncomfortable position to find oneself in! Often, we have had limited knowledge about legal strategy and tactics and we have frequently been surprised by the contribution that understanding contracts make to the ability to accurately predict the degree of sensitivity of the decision makers to scientific data that has been generated. Although perhaps significant, it has not always been surprising that a specialty field in questions of law can provide insight that provides to be useful for hospitals, insurance agencies, medical providers, and lawyers. For example, how much more risk can be reasonably turned back on the prenatal vitamin versus the commercial industry that makes the products that are ultimately in the prenatal vitamin bottle?
The reality is that every year it seems like the number of pharmaceutical companies from around the globe that request TigerTox to help examine the effect of extrinsic evidence in cases has been a steady increase. Over the last 5 years, the number of studies of this type has visibly increased. We’ve been asked to provide scientific context for expert testimonies that included questions of extrinsic evidence interpretation. We have also been asked to help with evaluating the quality of evidence and studying the weight of that evidence for use against clinical data points. In short, we’ve been brought in to strategically determine where and how to disproportionally allocate our time and resources to get a small but powerful win in the court.
Because the study of extrinsic evidence is a transdisciplinary overlap between what is extrinsic evidence in evidence law and toxicology / pharmaceutical research, TigerTox has made a point to integrate questions of evidence law into how we think about consultation and leadership in projects where studies and reports with questions of extrinsic evidence exist. Because there is such a variety in how the issues arise, we strongly recommend that clients set us up with a working group of appropriate consultants for their specific needs. We are increasingly working in tandem with other firms in the fields of law, Confined Space Document Review and other areas that you could benefit from. If you have a question about extrinsic evidence used in pharmaceutical clinical studies or customized tests, we’d love to learn about it!