Contemporary Legal Issues in Organ Transplantation

Contemporary Legal Issues in Organ Transplantation

This project is an initiative of the Faculty of Law, the Clinical School and the Cambridge Transplant Unit at Addenbrooke’s Hospital. The project is led by Dr Matt Dyson, Dr Kathy Liddell (Faculty of Law) and Mr Kourosh Saeb-Parsy (transplant surgeon).

The Cambridge Transplant Unit is one of the biggest in Europe, performing a total of almost 300 kidney, liver, pancreas and intestinal transplants annually. The LML advances research and teaching on legal and ethical challenges at the forefront of medicine and the life sciences.

This project focuses on two main areas of inquiry: 

(1)  Legal regulation of transplanting suboptimal organs

A shortage of suitable organs and the growing number of patients dying on transplant waiting lists have necessitated increasing use of less-than-ideal organs from deceased donors. This includes organs from older donors or those with co-morbidities, infections, current or previous cancers or history of high risk behaviour such as smoking, excessive alcohol and illicit drug use. The outcomes from transplantation of such ‘suboptimal’ organs are generally acceptable for the patient population compared to the even greater risk of death while waiting for an organ. However, compared to optimal organs, transplantation of sup-optimal organs exposes individual patients to greater risk of transmission of disease and major morbidity, graft loss or death. This necessitates the development of effective approaches that address not only the medical issues, but also the fundamental legal and ethical issues in the use of suboptimal organs.

The project focuses on two potentially relevant actions in tort law: negligence and product liability. It examines whether the definition of ‘product’ in product liability extends to transplanted organs and the implications of this issue. It further examines the impact of a patient’s awareness of the risks associated with suboptimal organs, and his or her informed consent to those risks, for liability in both areas of tort law.

See: Lancet (2015; 386: 719-21).

(2) Legal considerations on pre-mortem interventions in donation after circulatory death

The proportion of organs transplanted following donation after circulatory death (DCD) has steadily increased in the UK and is approaching that from donation after brain death (DBD). Because death must be declared after cessation of circulation following withdrawal of life-supporting treatment, DCD organs are necessarily exposed to a period of warm ischaemia before they can be perfused with cold preservation solution. This has significant deleterious effects on graft and patient outcomes after transplantation. The detrimental impact of warm ischaemia in DCD donors can potentially be ameliorated by pre-mortem treatments of the donor, such as systemic anticoagulation. However, such interventions are currently prohibited by UK law whereas they are permissible in the US. UK regulations stem from the legal definition of death and prohibition of interventions that are not directly intended to benefit the donor before declaration of death.

This project examines the UK legal framework that would govern potential regulatory changes to enable pre-mortem treatment of DCD donors in order to improve recipient outcomes. It also considers potential legal consequences if circulatory death is deemed to be hastened by an intervention, or if a donor experiences adverse effects without suffering circulatory death after withdrawal of life-supporting treatment