Should Genetic Information About Mental Health Affect Civil Court Cases?
A rendering of DNA with a judge's gavel.
Imagine this scenario: A couple is involved in a heated custody dispute over their only child. As part of the effort to make the case of being a better guardian, one parent goes on a "genetic fishing expedition": this parent obtains a DNA sample from the other parent with the hope that such data will identify some genetic predisposition to a psychiatric condition (e.g., schizophrenia) and tilt the judge's custody decision in his or her favor.
As knowledge of psychiatric genetics is growing, it is likely to be introduced in civil cases, such as child custody disputes and education-related cases, raising a tangle of ethical and legal questions.
This is an example of how "behavioral genetic evidence" -- an umbrella term for information gathered from family history and genetic testing about pathological behaviors, including psychiatric conditions—may in the future be brought by litigants in court proceedings. Such evidence has been discussed primarily when criminal defendants sought to introduce it to make the claim that they are not responsible for their behavior or to justify their request for reduced sentencing and more lenient punishment.
However, civil cases are an emerging frontier for behavioral genetic evidence. It has already been introduced in tort litigation, such as personal injury claims, and as knowledge of psychiatric genetics is growing, it is further likely to be introduced in other civil cases, such as child custody disputes and education-related cases. But the introduction of such evidence raises a tangle of ethical and legal questions that civil courts will need to address. For example: how should such data be obtained? Who should get to present it and under what circumstances? And does the use of such evidence fit with the purposes of administering justice?
How Did We Get Here?
That behavioral genetic evidence is entering courts is unsurprising. Scientific evidence is a common feature of judicial proceedings, and genetic information may reveal relevant findings. For example, genetic evidence may elucidate whether a child's medical condition is due to genetic causes or medical malpractice, and it has been routinely used to identify alleged offenders or putative fathers. But behavioral genetic evidence is different from such other genetic data – it is shades of gray, instead of black and white.
Although efforts to understand the nature and origins of human behavior are ongoing, existing and likely future knowledge about behavioral genetics is limited. Behavioral disorders are highly complex and diverse. They commonly involve not one but multiple genes, each with a relatively small effect. They are impacted by many, yet unknown, interactions between genes, familial, and environmental factors such as poverty and childhood adversity.
And a specific gene variant may be associated with more than one behavioral disorder and be manifested with significantly different symptoms. Thus, biomarkers about "predispositions" for behavioral disorders cannot generally provide a diagnosis or an accurate estimate of whether, when, and at what severity a behavioral disorder will occur. And, unlike genetic testing that can confirm litigants' identity with 99.99% probability, behavioral genetic evidence is far more speculative.
Genetic theft raises questions about whose behavioral data are being obtained, by whom, and with what authority.
Whether judges, jurors, and other experts understand the nuances of behavioral genetics is unclear. Many people over-estimate the deterministic nature of genetics, and under-estimate the role of environments, especially with regards to mental health status. The U.S. individualistic culture of self-reliance and independence may further tilt the judicial scales because litigants in civil courts may be unjustly blamed for their "bad genes" while structural and societal determinants that lead to poor behavioral outcomes are ignored.
These concerns were recently captured in the Netflix series "13 Reasons Why," depicting a negligence lawsuit against a school brought by parents of a high-school student there (Hannah) who committed suicide. The legal tides shifted from the school's negligence in tolerating a culture of bullying to parental responsibility once cross-examination of Hannah's mother revealed a family history of anxiety, and the possibility that Hannah had a predisposition for mental illness, which (arguably) required therapy even in the absence of clear symptoms.
Where Is This Going?
The concerns are exacerbated given the ways in which behavioral genetic evidence may come to court in the future. One way is through "genetic theft," where genetic evidence is obtained from deserted property, such as soft-drink cans. This method is often used for identification purposes such as criminal and paternity proceedings, and it will likely expand to behavioral genetic data once available through "home kits" that are offered by direct-to-consumer companies.
Genetic theft raises questions about whose behavioral data are being obtained, by whom, and with what authority. In the scenario of child-custody dispute, for example, the sequencing of the other parent's DNA will necessarily intrude on the privacy of that parent, even as the scientific value of such information is limited. A parent on a "genetic fishing expedition" can also secretly sequence their child for psychiatric genetic predispositions, arguably, in order to take preventative measures to reduce the child's risk for developing a behavioral disorder. But should a parent be allowed to sequence the child without the other parent's consent, or regardless of whether the results will provide medical benefits to the child?
Similarly, although schools are required, and may be held accountable for failing to identify children with behavioral disabilities and to evaluate their educational needs, some parents may decline their child's evaluation by mental health professionals. Should schools secretly obtain a sample and sequence children for behavioral disorders, regardless of parental consent? My study of parents found that the overwhelming majority opposed imposed genetic testing by school authorities. But should parental preference or the child's best interests be the determinative factor? Alternatively, could schools use secretly obtained genetic data as a defense that they are fulfilling the child-find requirement under the law?
The stigma associated with behavioral disorders may intimidate some people enough that they back down from just claims.
In general, samples obtained through genetic theft may not meet the legal requirements for admissible evidence, and as these examples suggest, they also involve privacy infringement that may be unjustified in civil litigation. But their introduction in courts may influence judicial proceedings. It is hard to disregard such evidence even if decision-makers are told to ignore it.
The costs associated with genetic testing may further intensify power differences among litigants. Because not everyone can pay for DNA sequencing, there is a risk that those with more resources will be "better off" in court proceedings. Simultaneously, the stigma associated with behavioral disorders may intimidate some people enough that they back down from just claims. For example, a good parent may give up a custody claim to avoid disclosure of his or her genetic predispositions for psychiatric conditions. Regulating this area of law is necessary to prevent misuses of scientific technologies and to ensure that powerful actors do not have an unfair advantage over weaker litigants.
Behavioral genetic evidence may also enter the courts through subpoena of data obtained in clinical, research or other commercial genomic settings such as ancestry testing (similar to the genealogy database recently used to identify the Golden State Killer). Although court orders to testify or present evidence are common, their use for obtaining behavioral genetic evidence raises concerns.
One worry is that it may be over-intrusive. Because behavioral genetics are heritable, such data may reveal information not only about the individual litigant but also about other family members who may subsequently be stigmatized as well. And, even if we assume that many people may be willing for their data in genomic databases to be used to identify relatives who committed crimes (e.g., a rapist or a murderer), we can't assume the same for civil litigation, where the public interest in disclosure is far weaker.
Another worry is that it may deter people from participating in activities that society has an interest in advancing, including medical treatment involving genetic testing and genomic research. To address this concern, existing policy provides expanded privacy protections for NIH-funded genomic research by automatically issuing a Certificate of Confidentiality that prohibits disclosure of identifiable information in any Federal, State, or local civil, criminal, and other legal proceedings.
But this policy has limitations. It applies only to specific research settings and does not cover non-NIH funded research or clinical testing. The Certificate's protections can also be waived under certain circumstances. People who volunteer to participate in non-NIH-funded genomic research for the public good may thus find themselves worse-off if embroiled in legal proceedings.
Consider the following: if a parent in a child custody dispute had participated in a genetic study on schizophrenia years earlier, should the genetic results be subpoenaed by the court – and weaponized by the other parent? Public policy should aim to reduce the risks for such individuals. The end of obtaining behavioral genetic evidence cannot, and should not, always justify the means.
Breakthrough therapies are breaking patients' banks. Key changes could improve access, experts say.
Single-treatment therapies are revolutionizing medicine. But insurers and patients wonder whether they can afford treatment and, if they can, whether the high costs are worthwhile.
CSL Behring’s new gene therapy for hemophilia, Hemgenix, costs $3.5 million for one treatment, but helps the body create substances that allow blood to clot. It appears to be a cure, eliminating the need for other treatments for many years at least.
Likewise, Novartis’s Kymriah mobilizes the body’s immune system to fight B-cell lymphoma, but at a cost $475,000. For patients who respond, it seems to offer years of life without the cancer progressing.
These single-treatment therapies are at the forefront of a new, bold era of medicine. Unfortunately, they also come with new, bold prices that leave insurers and patients wondering whether they can afford treatment and, if they can, whether the high costs are worthwhile.
“Most pharmaceutical leaders are there to improve and save people’s lives,” says Jeremy Levin, chairman and CEO of Ovid Therapeutics, and immediate past chairman of the Biotechnology Innovation Organization. If the therapeutics they develop are too expensive for payers to authorize, patients aren’t helped.
“The right to receive care and the right of pharmaceuticals developers to profit should never be at odds,” Levin stresses. And yet, sometimes they are.
Leigh Turner, executive director of the bioethics program, University of California, Irvine, notes this same tension between drug developers that are “seeking to maximize profits by charging as much as the market will bear for cell and gene therapy products and other medical interventions, and payers trying to control costs while also attempting to provide access to medical products with promising safety and efficacy profiles.”
Why Payers Balk
Health insurers can become skittish around extremely high prices, yet these therapies often accompany significant overall savings. For perspective, the estimated annual treatment cost for hemophilia exceeds $300,000. With Hemgenix, payers would break even after about 12 years.
But, in 12 years, will the patient still have that insurer? Therein lies the rub. U.S. payers, are used to a “pay-as-you-go” model, in which the lifetime costs of therapies typically are shared by multiple payers over many years, as patients change jobs. Single treatment therapeutics eliminate that cost-sharing ability.
"As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket,” says Patricia Goldsmith, the CEO of CancerCare.
“There is a phenomenally complex, bureaucratic reimbursement system that has grown, layer upon layer, during several decades,” Levin says. As medicine has innovated, payment systems haven’t kept up.
Therefore, biopharma companies begin working with insurance companies and their pharmacy benefit managers (PBMs), which act on an insurer’s behalf to decide which drugs to cover and by how much, early in the drug approval process. Their goal is to make sophisticated new drugs available while still earning a return on their investment.
New Payment Models
Pay-for-performance is one increasingly popular strategy, Turner says. “These models typically link payments to evidence generation and clinically significant outcomes.”
A biotech company called bluebird bio, for example, offers value-based pricing for Zynteglo, a $2.8 million possible cure for the rare blood disorder known as beta thalassaemia. It generally eliminates patients’ need for blood transfusions. The company is so sure it works that it will refund 80 percent of the cost of the therapy if patients need blood transfusions related to that condition within five years of being treated with Zynteglo.
In his February 2023 State of the Union speech, President Biden proposed three pilot programs to reduce drug costs. One of them, the Cell and Gene Therapy Access Model calls on the federal Centers for Medicare & Medicaid Services to establish outcomes-based agreements with manufacturers for certain cell and gene therapies.
A mortgage-style payment system is another, albeit rare, approach. Amortized payments spread the cost of treatments over decades, and let people change employers without losing their healthcare benefits.
Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
The new payment models that are being discussed aren’t solutions to high prices, says Bill Kramer, senior advisor for health policy at Purchaser Business Group on Health (PBGH), a nonprofit that seeks to lower health care costs. He points out that innovative pricing models, although well-intended, may distract from the real problem of high prices. They are attempts to “soften the blow. The best thing would be to charge a reasonable price to begin with,” he says.
Instead, he proposes making better use of research on cost and clinical effectiveness. The Institute for Clinical and Economic Review (ICER) conducts such research in the U.S., determining whether the benefits of specific drugs justify their proposed prices. ICER is an independent non-profit research institute. Its reports typically assess the degrees of improvement new therapies offer and suggest prices that would reflect that. “Publicizing that data is very important,” Kramer says. “Their results aren’t used to the extent they could and should be.” Pharmaceutical companies tend to price their therapies higher than ICER’s recommendations.
Drug Development Costs Soar
Drug developers have long pointed to the onerous costs of drug development as a reason for high prices.
A 2020 study found the average cost to bring a drug to market exceeded $1.1 billion, while other studies have estimated overall costs as high as $2.6 billion. The development timeframe is about 10 years. That’s because modern therapeutics target precise mechanisms to create better outcomes, but also have high failure rates. Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
Skewed Incentives Increase Costs
Pricing isn’t solely at the discretion of pharma companies, though. “What patients end up paying has much more to do with their PBMs than the actual price of the drug,” Patricia Goldsmith, CEO, CancerCare, says. Transparency is vital.
PBMs control patients’ access to therapies at three levels, through price negotiations, pricing tiers and pharmacy management.
When negotiating with drug manufacturers, Goldsmith says, “PBMs exchange a preferred spot on a formulary (the insurer’s or healthcare provider’s list of acceptable drugs) for cash-base rebates.” Unfortunately, 25 percent of the time, those rebates are not passed to insurers, according to the PBGH report.
Then, PBMs use pricing tiers to steer patients and physicians to certain drugs. For example, Kramer says, “Sometimes PBMs put a high-cost brand name drug in a preferred tier and a lower-cost competitor in a less preferred, higher-cost tier.” As the PBGH report elaborates, “(PBMs) are incentivized to include the highest-priced drugs…since both manufacturing rebates, as well as the administrative fees they charge…are calculated as a percentage of the drug’s price.
Finally, by steering patients to certain pharmacies, PBMs coordinate patients’ access to treatments, control patients’ out-of-pocket costs and receive management fees from the pharmacies.
Therefore, Goldsmith says, “As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket.”
Transparency into drug pricing will help curb costs, as will new payment strategies. What will make the most impact, however, may well be the development of a new reimbursement system designed to handle dramatic, breakthrough drugs. As Kramer says, “We need a better system to identify drugs that offer dramatic improvements in clinical care.”
In today's podcast episode, law professor Gaia Bernstein talks about the challenges of keeping control over our thoughts and actions, even when some powerful forces are pushing in the other direction.
Each afternoon, kids walk through my neighborhood, on their way back home from school, and almost all of them are walking alone, staring down at their phones. It's a troubling site. This daily parade of the zombie children just can’t bode well for the future.
That’s one reason I felt like Gaia Bernstein’s new book was talking directly to me. A law professor at Seton Hall, Gaia makes a strong argument that people are so addicted to tech at this point, we need some big, system level changes to social media platforms and other addictive technologies, instead of just blaming the individual and expecting them to fix these issues.
Gaia’s book is called Unwired: Gaining Control Over Addictive Technologies. It’s fascinating and I had a chance to talk with her about it for today’s podcast. At its heart, our conversation is really about how and whether we can maintain control over our thoughts and actions, even when some powerful forces are pushing in the other direction.
Listen on Apple | Listen on Spotify | Listen on Stitcher | Listen on Amazon | Listen on Google
We discuss the idea that, in certain situations, maybe it's not reasonable to expect that we’ll be able to enjoy personal freedom and autonomy. We also talk about how to be a good parent when it sometimes seems like our kids prefer to be raised by their iPads; so-called educational video games that actually don’t have anything to do with education; the root causes of tech addictions for people of all ages; and what kinds of changes we should be supporting.
Gaia is Seton’s Hall’s Technology, Privacy and Policy Professor of Law, as well as Co-Director of the Institute for Privacy Protection, and Co-Director of the Gibbons Institute of Law Science and Technology. She’s the founding director of the Institute for Privacy Protection. She created and spearheaded the Institute’s nationally recognized Outreach Program, which educated parents and students about technology overuse and privacy.
Professor Bernstein's scholarship has been published in leading law reviews including the law reviews of Vanderbilt, Boston College, Boston University, and U.C. Davis. Her work has been selected to the Stanford-Yale Junior Faculty Forum and received extensive media coverage. Gaia joined Seton Hall's faculty in 2004. Before that, she was a fellow at the Engelberg Center of Innovation Law & Policy and at the Information Law Institute of the New York University School of Law. She holds a J.S.D. from the New York University School of Law, an LL.M. from Harvard Law School, and a J.D. from Boston University.
Gaia’s work on this topic is groundbreaking I hope you’ll listen to the conversation and then consider pre-ordering her new book. It comes out on March 28.
