Scott D. Halpern, MD, PhD
Disclaimer: The author is a member of the Scientific Registry of Transplant Recipients Technical Advisory Committee and the Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability. The views expressed in this article are his own and do not necessarily reflect the views of these committees or the United States government.
Acknowledgment: The author thanks Vivek Ahya, MD; Nancy Blumenthal, CRNP; Edward Cantu, MD; Robert Kotloff, MD; David Lederer, MD, MS; and Peter Reese, MD, MSCE, for comments on an earlier draft of the manuscript.
Grant Support: The author was supported by a Greenwall Foundation Faculty Scholar Award in Bioethics.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1487.
Requests for Single Reprints: Scott D. Halpern, MD, PhD, University of Pennsylvania, 719 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104; e-mail, email@example.com.
Author Contributions: Conception and design: S.D. Halpern.
Drafting of the article: S.D. Halpern.
Critical revision of the article for important intellectual content: S.D. Halpern.
Final approval of the article: S.D. Halpern.
Obtaining of funding: S.D. Halpern.
Administrative, technical, or logistic support: S.D. Halpern.
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Stephen G. Harvey
Pepper Hamilton LLP
June 28, 2013
Conflict of Interest:
Stephen G. Harvey was lead counsel for the plaintiffs in the federal court lawsuits in Philadelphia involving Sarah Murnaghan and Javier Acosta.
A RESPONSE TO CRITICISM OF LEGAL SYSTEM IN PEDIATRIC LUNG ALLOCATION CASES
In his June 25 opinion piece in the Annals of Internal Medicine, Scott D. Halpern, MD, PhD, refers to the temporary restraining orders issued on June 5 and 6 by Judge Michael M. Baylson, a federal judge in Philadelphia, as “a troubling precedent,” “circumvention of due process,” and “legal wrongs.” He says that the TROs suggest “either failure to recognize that preferential treatment for some recipients will adversely affect others (who may not be much older than 12) or that the court considered these 2 children's lives more valuable than others'.”
With all due respect to Dr. Halpern, his assertions are incorrect. I assume that he is aware that a specific federal regulation, a binding law, requires that organs be allocated based on medical urgency, with no exception for children under 12 years old. He may not know that the legal complaint filed on behalf of Sarah Murnaghan and Javier Acosta asked only that they be given access to adult lungs based on the medical urgency of their conditions, and that they sought no special preference. Certainly there was no suggestion made at any time that their lives were more valuable than others. Quite to the contrary, their parents took the position that each life is equally valuable and that Sarah and Javier should be treated equally with persons over 12 absent some compelling reason to do otherwise. They questioned whether there was any compelling reason for treating their children differently from persons 12 and over, when it would likely result in the deaths of both children. As it turned out, we never learned through the legal system whether there is any compelling reason for differential treatment of children in the circumstances of Sarah and Javier – that is, children under 12 who are closer to 12 than infancy and who suffer from fatal diseases that present in children and in adults where their doctors have expressed confidence in a lobar transplant procedure -- because, four days after the second TRO, the Organ Procurement and Transplantation Network authorized the OPTN Lung Review Board to waive the “Under 12 Rule” in certain cases and the Board decided to waive it in Sarah’s and Javier’s case.
We can all agree that organ allocation systems are difficult and that we don’t want to engage in frequent second guessing of the doctors responsible for the organ allocation system. But we do have a legal system that provides for review of OPTN’s policies by the Secretary of Health and Human Services and by a court if necessary. The possibility of baseless claims is not a reason to reject meritorious claims. In this case, the failure of the system to allocate adult lungs to persons under 12 in the circumstances of Sarah and Javier based on the medical urgency allocation principle presented an important legal issue that deserved the attention of a federal court authorized to decide it. There is no question that one or both children could have died before that decision could have been thoughtfully made. Under these circumstances, the court acted appropriately and well within its power to prevent the possible death of two children pending the outcome of the OPTN’s decision.
Scott D. Halpern, MD, PhD
University of Pennsylvania
July 8, 2013
Stephen Harvey raises issue with my characterization of the judicial review process in the cases of Sarah Murnaghan and Javier Acosta due to a specific rule, commonly referred to as the Organ Procurement and Transplantation Network Final Rule (or 42 CFR 121),(1) dictating that medical urgency be a basis for organ allocation. The relevant sections of this rule state that “transplant candidates shall be grouped by status categories ordered from most to least medically urgent,” and that “criteria for status designations shall contain explicit thresholds for differentiating among patients and shall be expressed, to the extent possible, through objective and measurable medical criteria.(1)” Current lung allocation policies in both adults and children meet these criteria. Existing policies categorize children as Priority 1 or Priority 2 based on explicit criteria reflecting medical urgency.
The Final Rule is silent on the question of what, if any, special priority ought to be accorded to patients of different ages. Thus, the fact that the urgency-based prioritization in children differs from the urgency-based prioritization in adults in no way violates the Final Rule. Indeed, the multivariable prediction models included in the Lung Allocation Score (LAS), which gauge both urgency and anticipated benefit in ranking adults on the waitlist, cannot be applied with any confidence or statistical precision to children because the paucity of children requiring lung transplantation led to their exclusion from the development of these complex models.(2) Applying these models to children might therefore cause inequitable prioritization, conflicting with the Final Rule's mandate.
These facts raise serious questions regarding the merits of the case brought by Mr. Harvey. Mr. Harvey is correct that as it happened, the step in the judicial process where the merits of the Murnaghan case would be considered was never reached because Murnaghan was transplanted within the 10-day window of the temporary restraining order. He is also correct that Murnaghan might have suffered irreparable harm without the restraining order. In most legal circumstances, this would make issuance of a restraining order appropriate until the merits could be fully evaluated. However, issuing a restraining order that interferes with national organ allocation policy is very different from nearly all contexts in which restraining orders have been used to date because the order protects one identifiable person while causing direct disadvantage to on one or more other Americans awaiting lung transplantation. This conflict creates unusually broad responsibilities for Judge Baylson in contemplating a restraining order, making him ethically (if not also legally) obliged to give serious consideration to the merits of the claim prior to intervening. Had such prudent steps been taken, it is unlikely that the claims could have been sustained that existing policies violated the Final Rule or discriminated against children. There may indeed be ways to improve upon the existing allocation system, but granting one-off waivers to well-resourced patients and families is not the path to such improvement.
1. Department of Health and Human Services. The Final Rule. Accessed at: http://www.gaonet.gov/special.pubs/organ/appendd.pdf on July 1, 2013.
2. Egan TM, Murray S, Bustami RT, Shearon TH, McCullough KR, Edwards LB, et al. Development of the new lung allocation system in the United States. American Journal of Transplantation. 2006;6(5):1212-27.
Halpern SD. Turning Wrong Into Right: The 2013 Lung Allocation Controversy. Ann Intern Med. 2013;159:358–359. doi: 10.7326/0003-4819-159-5-201309030-00684
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Published: Ann Intern Med. 2013;159(5):358-359.
Ethics, Healthcare Delivery and Policy, Pulmonary/Critical Care.
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