Liver failure is a terrible way to die: a painful belly full of fluid, vomiting blood, mental confusion, and repeated hospitalizations. The only cure is liver transplantation but, as is the case for all types of transplants, there aren’t nearly enough donor livers to go around.
This shortage raises two important questions: Who should receive a transplant? And what rights do transplant candidates have?
Choosing who gets a transplant is among the most charged and challenging tasks of modern medicine. In the U.S., about 60,000 people die from all forms liver disease each year; more than 8,000 get liver transplants. Even those these individuals are so sick that no operation other than transplantation itself would be considered safe, 90% of liver transplant recipients survive the year after transplant, and 75% survive for five years. The cost of transplantation, including the necessary supportive care afterward, exceeds $800,000 per transplant.
To maximize the use of donated livers, a valuable and scarce resource, it is essential to select patients who are most likely to survive the surgery and thrive afterward. This is done by each transplant center’s liver transplant selection committee. It is a difficult task. Under half of patients evaluated by liver transplant committees are put on the waiting list. But there is a dark side to this calculus: deciding who will get a new liver also means deciding who won’t, which means they could die from liver failure within months, or possibly even days.
So it isn’t surprising that disagreements regarding candidacy for a liver transplant (or any other organ, for that matter) or how organs are allocated wind up in court. When an individual’s request for a transplant is declined for reasons he or she perceives as discriminating against a protected class — age, race, religion, nationality, and the like — the case may involve a constitutional claim.
The mission of liver transplantation is to extend and enrich the lives of patients with liver failure. The systems that make transplantation possible must respect the donor’s gift, the patient’s rights, and the public’s investment. Understanding constitutional challenges to transplantation is one way to better promote equity and justice for the growing number of Americans who need organ transplants. To do this, we and two colleagues searched legal databases for cases claiming constitutional violations against liver transplant candidates. The 14th Amendment, which guarantees freedom from arbitrary or capricious rules and regulations, was the most pertinent constitutional challenge for transplant candidates.
Here are three ways in which 14th Amendment claims can inform the development of transplant policy.
First, alcohol-related liver disease is now the top cause of liver failure leading to liver transplant. Most insurers require that all transplant candidates show proof of sobriety before the transplant, often for six months. Recent studies, however, have shown that outcomes after transplant, including survival and alcohol relapse, are similar between those with and without extended pre-transplant sobriety. That is likely because subjective factors such as insight and social support are better predictors of drinking alcohol again than duration of sobriety. In this context, policies limiting access to transplant on the basis of arbitrary waiting periods are vulnerable to 14th Amendment claims. Lifting such restrictions would allow transplant centers the flexibility to select the candidates most likely to benefit from lifesaving transplantation.
Federal courts haven’t offered clear direction in this area. A Wisconsin court denied a man’s claim for his insurance to cover his liver transplant because he wasn’t able to show he had abstained from alcohol for six months before his transplant. In contrast, a Michigan court ruled that the state’s two-year abstinence requirement was arbitrary and unreasonable and ordered the state to approve Medicaid funding for a resident’s liver transplant.
Second, as the U.S. population ages, older people are increasingly in need of liver transplants. They can benefit as much from the procedure as younger individuals. Multiple cases have been brought in which age discrimination has been alleged by patients denied transplant candidacy without definitive decisions.
Age is just a number and should not be the sole criterion for patient selection. To forestall the risk of age-based 14th Amendment claims while optimizing patient selection, frailty — a useful, less legally contentious criterion — could be employed. Frailty broadly captures an individual’s “reserve” or ability to survive a major surgery. It helps discern which patient, regardless of age, may be less likely to benefit from or require further supportive care prior to transplantation. Frailty can be measured by hand-grip strength, ability to rise from a seated position multiple times, and walking speed, all of which help predict survival after transplantation.
A recent case from New Mexico challenged an age cutoff for transplant of 70 years. In contrast to age, frailty is both more just and specific for the outcome of interest — survival before and after transplant. National adoption of frailty standards has been recommended by a workgroup sponsored by the American Society of Transplantation.
Third, organs are currently allocated within 11 arbitrary geographic units. Because the number of donor organs varies across regions, this division may lead to disparities in access. The organization charged with overseeing transplant allocation and policy in the U.S. — the United Network for Organ Sharing (UNOS) — aims to maximize the supply of donor organs while improving the quality of, equity in, and access to this precious resource. How the regional borders are drawn can have unforeseen consequences for these aims.
In a case involving lung transplantation, for example, attorneys for 21-year-old Michelle Holman argued that a system that allowed an objectively sicker patient in Manhattan to wait longer for a transplant than those in nearby New Jersey was arbitrary and capricious.
Cases decided on the basis of the 14th Amendment can have sweeping implications for transplant policy. Indeed, the Holman case led to an abrupt change in lung allocation policy. UNOS’s successful track record in pursuit of its mission speaks to the strength of its process.
New challenges to UNOS policy, however, are emerging. In an attempt to decrease disparities in wait times for livers, the organization recently revised its rules about the geographic area from which transplant centers can locate organ donors. The revision allows centers to find donors for the sickest patients beyond their traditional boundaries. The highly populated coastal areas, which currently have the longest liver transplant wait times, will likely benefit most from this policy. But this may set up conflict with states in the Midwest and South that fear they will lose organs to patients in the Northeast and West who simply have more wait-listed patients with liver failure.
In late January, 22 U.S. senators co-signed a letter voicing their concerns over this change. Last month, the Kansas legislature’s Committee on Public Health and Welfare recommended passage of Senate Bill 194, which is designed to keep organs donated by Kansas residents within the state.
To avoid 14th Amendment claims, careful implementation and study are necessary to ensure that transplant policy does not harm constitutionally protected classes such as race and ethnicity that often cluster by geography.
Gaps in current policy and insurer standards with respect to alcohol-related disease, age, and transplant regions are vulnerable to legal claims on constitutional grounds. Efforts to close these gaps will be beneficial, not solely to avoid litigation but also to identify opportunities for improving on vague rules and procedures, affirming the mission of transplantation, and limiting opportunities for discrimination and exclusion.
Elliot Tapper, M.D., is assistant professor of medicine at the University of Michigan. Michael Volk, M.D., is chief of the Division of Gastroenterology and Hepatology at Loma Linda University.