The Legal Implications of Detecting Alzheimer’s Disease Earlier Joshua Preston Joint-Degree Program in Law, Science & Technology Consortium Student Scholar

Background In 2010, 4.7 million Americans aged 65 and older suffered from Alzheimer’s Disease (AD). By 2050 this number is projected to reach 13.8 million. New neuroimaging techniques are being developed to detect biomarkers for AD in its earliest stages. Biomarkers can identify atrophying neural tissue in people with AD before they manifest observable behavioral changes. Positron Emission Tomography (PET) scanning with radioactive tracing compound florbetapir F-18 can identify accumulation of amyloid-b plaques, which are believed to play central role in AD.

More Questions Than Answers Is a neurological indicator of increased risk for AD a legally relevant brain state before there are outward behavioral manifestations of AD? How should courts address evidentiary challenges to the admissibility of AD- related neuroimaging? How should government regulate the commercial use, advertising, and marketing of neuroimaging diagnostic tools? Who should—and should not—have access to a patient’s AD neuroimaging data? Should insurance providers provide coverage for the use of these increasingly informative, but not yet dispositive, tools?

More Questions Than Answers Is a neurological indicator of increased risk for AD a legally relevant brain state before there are outward behavioral manifestations of AD? How should courts address evidentiary challenges to the admissibility of AD- related neuroimaging? How should government regulate the commercial use, advertising, and marketing of neuroimaging diagnostic tools? Who should—and should not—have access to a patient’s AD neuroimaging data? Should insurance providers provide coverage for the use of these increasingly informative, but not yet dispositive, tools?

Determining the Legal Relevance of Increased Risk for AD Most bodies of law (e.g. tort, contracts, and criminal law) traditionally demand outwardly manifested behavior as a prerequisite for legal recognition of physical injury. So how should the law treat a person who does not exhibit behavioral symptoms but whose brain is documented to have altered in such a way as to suggest a higher likelihood of AD?

Admissibility in Court Daubert Standard considers the following: Whether the theory or technique in question can be (and has been) tested; Whether it has been subject to peer review and publication; Its known or potential error rate and the existence and maintenance of standards controlling its operation; and Whether it has attracted widespread acceptance within a relevant scientific community. Frye Standard requires “have gained general acceptance in the particular field in which it belongs.” These neuroimaging techniques are not diagnostic tools. Under Daubert evidence need not be dispositive to be admissible. The traditional methods of challenging admissible but shaky evidence are cross-examination and use of expert witnesses.

Regulating Early Detection Technology In 2012, a UCLA research lab launched the company MindGenesis, which claimed to be the “Rocky Mountain region’s first imaging center focused on finding and confirming Alzheimer’s disease and dementia sooner.” It used the tagline: “Life plan imaging begins here.” A good analogy may be the company 23andMe.

The Need for Continued Dialogue Both courts and administrative agencies have failed to incorporate evidence of AD into legal doctrine and practice. The early detection of AD will complicate this already broken system. Here I only focus on Alzheimer’s Disease, which is only one form of dementia (e.g. dementia with Lewy bodies, vascular dementia, and frontotemporal dementia). The law is broad and early AD detection could have effects in estate law, end-of-life care, and family law.

Moving Forward I was awarded a 2017 Consortium in Law and Values Research Award to pursue this topic. This support will allow me to: Review current and promising state of early AD neuroimaging technologies and techniques. Synthesize literature on how scholars, courts, and administrative agencies engage the question of accommodating not only individuals with AD but those who test positive for other diseases’ biomarkers prior to physical manifestation of symptoms. This will include categorizing ~4,200 cases available in LexisNexis and Westlaw that mention “Alzheimer’s Disease” or “biomarker/s” This will allow me to identify emerging trends and legal problems Survey existing policy recommendations that can be adapted to those diagnosed as having high, probabilistic risk of AD.

Joshua Preston Prest202@umn.com www.JPPreston.com