Rules are meant to be broken: the organ procurement and transplantation network should allow pediatric transplantation of adult lungs.

• Author: Parish, Ciera

1. INTRODUCTION II. ORGAN TRANSPLANTATION IN THE UNITED STATES A. Governance of the United Network for Organ Sharing B. Policy 3.7 "Organ Distribution: Allocation of Thoracic Lungs C. Allocation of Thoracic Lungs for Candidates Ages Twelve and Older D. The "Under 12 Rule" III. PEDIATRIC LUNG TRANSPLANTATION DATA IV. PURPOSE OF THE "UNDER 12 RULE" V. "UNDER 12 RULE" LITIGATION VI. PROPOSED LUNG ALLOCATION LEGISLATION FOR THE OPTN A. Why the Lung Allocation Policy Should be Amended B. Model Lung Allocation Statute VII. CONCLUSION I. INTRODUCTION

   Imagine being told that your dying child could potentially be saved; however, a single regulation prevents doctors from doing so. (1) Imagine being told that your child has only days to live and the life-saving procedure is not available to your child simply because of his or her age. (2) This is exactly what happened to Janet Murnaghan and her dying ten-year-old daughter, Sarah. (3) Diagnosed with cystic fibrosis as an infant, Sarah Murnaghan spent most of her life in and out of hospitals. (4) At the young age of ten years old, Sarah found herself clinging to life in desperate need of a lung transplant for survival. (5) However, this live-saving procedure was within Sarah's reach yet still escaping her grasp.

   Due to the extreme shortage of pediatric donors in the United States, Sarah's doctors knew that she would die waiting for a pair of life-saving pediatric lungs. (6) Exploring all options, Sarah's doctors proposed a solution that would save her life: pediatric transplantation of adult-sized lungs. (7) Without this solution, Sarah may have never seen her eleventh birthday. (8) However, this new-found hope was shattered when the Murnaghan's were told that the life-saving procedure was prohibited by a discriminatory and arbitrary regulation: the "Under 12 Rule." (9)

   Enacted in 2005, The Organ Procurement and Transplant Network's "Under 12 Rule" essentially prohibits children under the age of twelve from ever receiving a set of adult donor lungs, regardless of physician recommendation or medical necessity. (10) Desperate to keep their child alive, Sarah's parents sought relief through the justice system. On June 5, 2013, United States District Judge Michael M. Baylson sparked controversy when he temporarily suspended the "Under 12 Rule," permitting dying ten-year-old Sarah Murnaghan to be placed on the adult lung transplant waitlist. (11) The Pennsylvania District Court Judge ordered Health and Human Services Secretary, Kathleen Sebelius, to direct the Organ Procurement and Transplant Network ("OPTN") to place Sarah on the adult waitlist, a placement that became effective with the OPTN at 10:34 p.m. that same night. (12)

   Following Judge Baylson's order, the OPTN called an emergency meeting to reevaluate transplant allocation laws in the United States. (13) Unfortunately, not much change was made. (14) The "Under 12 Rule" remains in place, but now, as a result of Judge Baylson's order, children under twelve awaiting a lung transplant may now elect to have their cases reviewed by a national board of lung transplant surgeons. (15) However, this "review board," policy change is set to expire in September of 2015 again threatening the availability of adult donor lungs for children under the age of twelve. (16) Due to the limited availability of pediatric lungs, stories such as Sarah's are becoming far more common. (17) After Sarah's success, an increasing number of parents have turned to federal courts to keep their dying children alive. (18)

   This note analyzes the "Under 12 Rule" and advocates for its abolishment. This note analyzes the consequences and discrimination faced by children under the age of twelve since its enactment in 2005 as well as the benefits stemming from the allowance of using adult lungs for pediatric transplantation. Part II discusses the history of organ transplantation law and the current organ transplantation laws as they stand. Part III provides statistical data demonstrating the disparity between pediatric lung transplant candidates and adult lung transplant candidates. Part IV discusses the reasons for the implementation of the "Under 12 Rule," and analyzes the emerging study associated with the benefits of a lung transplantation using larger lungs. Part V discusses the litigation which ensued due to the "Under 12 Rule," and the legal arguments that were raised. Part VI proposes a new regulation for the pediatric allocation of donor lungs, and Part VII concludes this Note, advocating for the abolishment of the Organ Procurement and Transplant Network's "Under 12 Rule."

2. ORGAN TRANSPLANTATION IN THE UNITED STATES

   The United Network for Organ Sharing ("UNOS") is a non-profit private organization based in Richmond, Virginia, that manages the organ donation, organ procurement, and organ transplantation system in the United States. (19) UNOS originated in 1977 as an initiative of the South-Eastern Organ Procurement Foundation, the first organization to develop a computerized system used to match organ donors with transplant candidates. (20) The South-Eastern Organ Procurement Foundation established a Kidney Center in 1982, which eventually evolved into the UNOS organ center. In 1984, UNOS was formally incorporated into a non-profit, private organization. (21)

   Following its incorporation, The United States Congress enacted the National Organ Transplant Act of 1984. (22) In addition to prohibiting the sale of human organs, the Act called for a unified transplant network to be operated by a private, non-profit organization under federal contract. (23) UNOS was the recipient of this contract and the Organ Procurement and Transplantation Network ("OPTN") was formed. (24) Through this contract with the federal government, UNOS was given the authority to oversee the operation of the OPTN and was given the main task of developing equitable organ distribution policies for the OPTN. (25) To date, UNOS is the only organization to ever operate the OPTN. (26)

   1. Governance of the United Network for Organ Sharing

      UNOS is led by a forty-two-member board of directors who meet twice a year, overseeing management of the organization. (27) It is composed of a wide-range and diverse pool of professions in order to capture different viewpoints within the field of organ transplantation. (28) The board determines and constantly reviews the policies for transplants of the kidney, pancreas, liver, intestine, heart, lung or a combination of two. (29) UNOS has a different transplantation policy for each organ. (30) When making these policy determinations, UNOS receives input from more than twenty permanent and ad-hoc committees. (31) These committees were formed to address specific perspectives and interests including: patient and donor family issues, medical issues specific to the various transplantable organs, needs and concerns of ethnic minorities and children needing transplants, technical aspects of organ recovery and matching, ethical principles, and the collection and reporting of scientific data. (32)

      The UNOS board also acts as the board of directors for the OPTN. (33) Through the UNOS's collaborative policy development, monitoring and enforcement processes have been put in place for the OPTN. (34) Accordingly, the overall purpose of the OPTN is to help ensure the success and efficiency of the United States organ transplant system. (35) Consistent with this purpose, the OPTN has several duties including: facilitating the organ matching and placement process through the use of the computer system, maintaining a fully staffed Organ Center operating 24 hours a day, developing consensus based policies and procedures for organ recovery, overseeing the distribution of organs, and transportation of organs. (36) The OPTN is also tasked with collecting and managing scientific data about organ donation and transplantation; providing transplant data to the government, the public, students, researchers, and the Scientific Registry of Transplant Recipients; developing and maintaining a Web-based computer system that maintains the nation's organ transplant waiting list and recipient/donor organ characteristics; and providing professional and public education about donation and transplantation. (37)

   2. Policy 3.7 "Organ Distribution: Allocation of Thoracic Lungs "

      To ensure that these duties are fulfilled, the OPTN has created several policies, regulations, and bylaws governing the organ transplant process. Accordingly, Policy 3.7 "Organ Distribution: Allocation of Thoracic Lungs" was created. (38) Within this policy, however, lies an arbitrary and discriminatory regulation responsible for the controversy in Sarah Murnaghan's case: the "Under 12 Rule." (39)

      Prior to 2005, the "Under 12 Rule" was nonexistent. (40) Before Policy 3.7 was revised to include this rule, lung allocation was based on how long a patient had been on the waiting list. (41) This applied to all lung transplant candidates, regardless of age. Doctors, however, began to realize that this system had many disadvantages. People who were less ill and could afford to wait longer, received transplants first only because they were on the transplant waiting list longer. (42) People who suddenly became very ill and joined the list had virtually no chance of receiving a lung transplant in time to save their lives. (43) Thus, in 2005 the system was redesigned. (44) This new redesign was implemented to take into account the severity of a candidate's illness, rather than base lung allocation on how long a candidate was on the transplant waiting list. (45) This redesign, however, only applied to adults and children ages twelve and older. (46) Instead, children under the age of twelve fall victim to the UNOS priority system, a discriminatory system which will be explained at length below. (47)

      Regardless of age, when a deceased lung donor becomes available, a transplant coordinator from an organ procurement...