By Diane Hoffmann, Director, Law & Health Care Program; Professor of Law, University of Maryland School of Law

As someone who has been greatly concerned about and devoted much of my scholarship to legal obstacles to the treatment of pain, I applaud Professor Pustilnik for increasing attention to the role of neuroimaging in our efforts to understand our experience of pain and how the law does or does not adequately take into account such experience. Pustilnik has written eloquently about this issue in several published articles but her efforts to bring together scientists, medical experts, legal academics, and judges (see also here) deserves high praise as a method for illuminating what we know and do not know about pain and the brain and to what extent brain imaging can serve as a diagnostic tool or an external validator of pain experience.

In this post, I discuss how DNA testing serves as a precedent for how to develop responsible uses of new technologies in law, including, potentially, brain imaging for pain detection. The ethical, legal, and social implications (ELSI) of DNA research and testing were integral to developing national protocols and rules about DNA. Brain imaging of pain needs its own ELSI initiative, before zealous adoption outpaces both the technology and the thinking about the right guiding principles and limitations.

The idea of brain images serving as a “pain-o-meter” to prove or disprove pain in legal cases is clearly a premature use of this information and likely an over simplification of the mechanisms of pain expression. However, the potential for an objective diagnostic tool or indicator of the pain experience is something that lawyers representing clients in criminal, personal injury, workers comp or disability cases may find too attractive to resist and attempt to have admitted in the courtroom. This state of affairs brings to mind the ways in which lawyers have attempted to use genetic test results, initially obtained for medical purposes, in litigation.  (Read on for more about ELSI in DNA and several national pain initiatives that could adopt the Human Genome Project and DNA ELSI model).

The mapping of the human genome, completed in 2003, led to the proliferation of genetic tests for over 1,000 diseases. While the Human Genome Project (HGP) was established to improve our understanding of health and genetic disease and to develop diagnostic tests, therapies and preventive measures for genetically based illnesses, relatively early on in the development of these genetic tests they began to be used for non-health related purposes. Such purposes included, for example, employment and insurance decisions. Lawyers also attempted to introduce health-related genetic test results into trials in civil lead paint, toxic tort, medical malpractice (in particular birth injury), and workers comp cases.

In most of these cases it was the defendant attempting to establish that exposure to a toxic or harmful substance was not the cause of the plaintiff’s injuries or disabilities. Plaintiffs then sought to introduce a negative test result to refute the defendant’s claim. In some toxic court cases, however, plaintiffs sought to establish that they had a genetic susceptibility to the toxic substance thus overcoming the evidentiary hurdle for establishing cause. Defense attorneys have also suggested using tests of genetic predisposition to establish life expectancy in determining damages. Similarly, in criminal cases lawyers have attempted to get in evidence of genetic test results, primarily in the sentencing phase to mitigate the penalty.

These uses of genetic tests in the courtroom have been criticized as being premature when we still don’t know, in many cases, the relationship between having a gene or gene mutation and the manifestation of disease or illness, e.g., mild or severe, age of onset of the disease, and many other factors that could affect susceptibility and outcome. Also, gene expression may be strongly affected by environmental factors, making it challenging to reach conclusions about the implications of a particular test result.

I see many similarities between the use of health-related genetic tests in the courtroom and the use of neuroimaging to document the experience of pain in legal decision-making. There is still much we don’t know about what these images mean and how accurate they are. As Karen Davis pointed out in her blog post, someone’s experience of pain and what we see on brain scans may or may not be closely related. And, the patterns of brain activation or structural change that look the same on brain scans may, in different people, correlate with very different pain experience.

The example Prof. Pustilnik referred to in her remarks of the case of Carradine v. Barnhart, 360 F3d 751 (7^th Cir. 2004), confirms my fears of judges misinterpreting results of neuroimaging, because in this case both the majority and the dissent misinterpreted the likely significance of another, more basic form of imaging – MRIs of the appellant’s spine. This suggests the need for more study and restraint in the use of these images until we know more. Both the majority opinion by Judge Posner and the dissenting opinion by Judge Coffee are problematic – because both see the absence of visual, objective evidence of pain as evidence of lack of physically-caused pain. (Posner does not find the lack of objective evidence dispositive of her disability claim because he believes the patient’s pain may of psychological origin. Yet, Coffee sees such evidence as a compelling reason to deny Carradine disability benefits, and further argues that psychological or psychiatric pain, is not physically “real,” a culturally common misperception disavowed by doctors who research and treat pain conditions.)

While the use of genetic tests and neuroimaging in the court room raise some similar issues, there are also some significant differences. Genetic tests were developed to assist in diagnosing and treating of genetic illnesses. The purpose of a putatively objective test for pain, as pointed out by Dr. Davis in her talk, and by Frank Pasquale in his contribution to this series, is not so clear. Experts in pain management focus on the patient’s experience, because the patient’s distress is the reason they seek treatment and the problem that the treating team needs to solve. Would a “pain-o-meter” improve patient diagnosis or treatment? If not, will it create more problems than benefits? If the drive toward brain-based pain measurement is not related to improving patient diagnosis and outcomes, but is motivated primarily by suspicion in the legal arena of pain claimants as liars, malingerers, or neurotics, can such an adversarial impetus ever lead to fair outcomes?

After Congress approved the funding for the Human Genome Project, a percentage of the funds were allocated to study the ethical, legal and social implications (ELSI) of the project. These funds were ultimately used to support the ELSI Research Program. Perhaps we need an ELSI Research Program for pain or neuroscience research. The implications of what we are learning and will learn in the coming years about pain from neuroscience are profound not only for medicine but for law.

The Affordable Care Act included a provision for the creation of an Interagency Pain Research Coordinating Committee by the Department of Health and Human Services. The Committee has been up and running and recently made publicly available a National Pain Strategy for public comment. That 71-page document is relatively comprehensive but doesn’t touch on the legal or ethical issues associated with pain research. Its focus on pain treatment does not address the link between diagnosis and access to resources for supportive services for individuals with chronic pain which may come in large part as a result of legal determinations about disability or damage awards.

My suggestion of an ELSI component to neuroscience research is consistent with the recommendation of the Presidential Commission for the Study of Bioethical Issues. In its report: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (2014), the Commission calls for the integration of ethics into neuroscience research “from the earliest planning phases” and one mechanism it mentions to accomplish this is through research about the ethical, legal and social implications of neuroscience research. The Commission further mentions the HGP ELSI Program as a model for consideration. Such a program would allow further research on and dialogue about the ethical and legal issues raised by the use of neuroimaging to establish objective evidence of pain.

Earlier posts in this series:

• Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & the Law, by Amanda C. Pustilnik
• Pain-o-meters: How – and Why – Should We Develop Them?, by Karen Davis
• Some Optimism on Brains, Pain & Law – Let’s See What We Can Achieve, by Martha Farah
• Emotion and Pain – Beyond “All in Your Head”, by David Seminowicz
• Emotional Harm as “Bodily Injury” in the Law – and in the Brain, by Francis X. Shen

This post is part of the series on pain, brain imaging, and the law sponsored by the Center for Law, Brain & Behavior at Massachusetts General Hospital, the Petrie-Flom Center, and Harvard University’s Mind/Brain/Behavior Initiative. Contributors participated in the conference Visible Solutions: Now Neuroimaging Helps Law Reenvision Pain. For inquiries, please contact the organizer Amanda C. Pustilnik (@apustilnik on Twitter).