© 2006 PROSKAUER ROSE LLP ® Brain-Stem Death and Donor Cards: Determination and Legal Ramifications Presented by: Edward S. Kornreich, Esq November 15, 2006

© 2006 PROSKAUER ROSE LLP ® 1 Topics 1.Organ Donation Generally 2.Determination of Death 3.Consent to Organ Donation 4.Equitable Allocation of Organs and Non-Discrimination

© 2006 PROSKAUER ROSE LLP ® 2 Organ Donation Generally Organ Procurement Organizations (“OPOs”) i.Coordinate organ procurement in designated service areas, which may cover all or part of a state. ii.Evaluate potential donors. iii.Discuss donation with family members and arrange for the surgical removal of donated organs. iv.Preserve organs and arrange for their allocation according to national organ sharing policies.

© 2006 PROSKAUER ROSE LLP ® 3 Organ Donation Generally (cont’d) Uniform Anatomical Gift Act (“UAGA”) i.Provides a uniform process for organ donation. ii.Adopted by all 50 states, including New York. iii.“Good faith provision” protects hospitals and other providers from civil and criminal liability. “a person who acts in good faith in accord with the terms of this article or with the anatomical gift laws of another state is not liable for damages in any civil action or subject to prosecution in any criminal proceeding for his act.” (New York Public Health Law § 4306(3))

© 2006 PROSKAUER ROSE LLP ® 4 Organ Donation Generally (cont’d) In August 2006, Governor Pataki signed into law a series of bills to encourage organ and tissue donation. These bills require: i.The prominent display of the words “Organ Donor” on a driver’s license or renewal in cases where the person has consented to donate. ii.A license application or renewal form to include a box for a voluntary one dollar donation to the “Life Pass It On” Fund, to be used for initiatives and research related to organ donation. iii.An outreach program to inform New Yorkers about the need and importance of organ and tissue donation.

© 2006 PROSKAUER ROSE LLP ® 5 Organ Donation Generally (cont’d) iv.A public report on presumed consent for organ donation by the Transplant Council, a division of the State Department of Health that advises the Commissioner on organ donation matters. v.The transformation of New York State Organ and Tissue Donor Registry (now renamed the “Donate Life” Registry) from one of intent to donate to one of consent to donate. vi.A state tax break of up to $10,000 for certain unreimbursed expenses incurred by a living organ donor.

© 2006 PROSKAUER ROSE LLP ® 6 Determination of Death Under New York regulations, death is determined when an individual has sustained either: i.irreversible cessation of all functions of the entire brain, including the brain stem (“brain death”); or ii.irreversible cessation of circulatory and respiratory functions (“cardiac death”).

© 2006 PROSKAUER ROSE LLP ® 7 Determination of Death (cont’d) Brain Death i.The brain death standard facilitates transplant of certain organs that are only suitable for transplant if they are removed when blood is still circulating. ii.Under New York Guidelines, the three essential findings for brain death are: 1.Coma; 2.Absence of brainstem reflexes; and 3.Apnea.

© 2006 PROSKAUER ROSE LLP ® 8 Determination of Death (cont’d) iii.Hospital responsibilities regarding brain death determination: 1. Provide reasonable accommodation of an individual’s religious or moral objection to use of the brain death standard to determine death; 2.Allow physicians with the proper training and competency to make brain death determinations in accordance with accepted medical standards; 3.Notify the next of kin or other person closest to the patient that brain death determination is in progress; and 4.Determine brain death via appropriate clinical examinations and tests in accordance with accepted medical standards.

© 2006 PROSKAUER ROSE LLP ® 9 Determination of Death (cont’d) iv.Physicians’ responsibilities regarding brain death determination: 1.Evaluate the irreversibility and potential causes of coma; 2.Initiate the hospital policy for notifying the next of kin; 3.Conduct and document the first clinical assessment of brain stem reflexes; 4.Observe the individual during a defined waiting period for any clinical inconsistencies with the diagnosis of brain death;

© 2006 PROSKAUER ROSE LLP ® 10 Determination of Death (cont’d) 5.Conduct and document the second clinical assessment of brain stem reflexes; 6.Perform and document the apnea test; 7.Perform confirmatory testing, if indicated; a.In some patients, skull or cervical injuries, cardiovascular instability, or other factors may make it impossible to complete parts of the assessment safely. In these circumstances, a confirmatory test verifying brain death is necessary.

© 2006 PROSKAUER ROSE LLP ® 11 Determination of Death (cont’d) 8.If the individual’s religious or moral objection to the brain death standard is known, implement hospital policies for reasonable accommodation; 9.Certify brain death; and 10.Withdraw cardio-respiratory support in accordance with hospital policies, including those for organ donation.

© 2006 PROSKAUER ROSE LLP ® 12 Determination of Death (cont’d) Cardiac Death i.Organ donation after cardiac death involves the scheduled withdrawal of a life-sustaining ventilator from a patient prepared for surgery. Following cardiac arrest and cessation of respiration, a prescribed number of minutes are permitted to elapse, and then death is declared and organ retrieval promptly commences. ii.In New York, for most patients only the single individual who has been appointed as the patient’s Health Care Agent under New York’s Health Care Proxy Law will be legally authorized to consent to the withdrawal of a patient’s life- sustaining ventilator. 1.But the Health Care Agent does not have the authority to consent to an anatomical gift.

© 2006 PROSKAUER ROSE LLP ® 13 Consent to Organ Donation Who may donate: any individual of sound mind and 18 years of age or more may give all or any part of his or her body for the following permissible purposes: i.Any hospital, surgeon or physician, for medical or dental education, research, advancement or medical or dental science, therapy or transplantation; ii.Any accredited medical or dental school, college or university or the State Anatomical Board for education, research, advancement of medical or dental science or therapy; iii.Any bank or storage facility, for medical or dental education, research, advancement of medical or dental science, therapy or transplantation; or iv.Any specified individual for therapy or transplantation needed.

© 2006 PROSKAUER ROSE LLP ® 14 Consent to Organ Donation (cont’d) Manner of executing anatomical gifts: i.By will, effective upon the death of the testator without waiting for probate. ii.Document other than a will, which may be a card designed to be carried on the person, signed by the donor. iii.Gift may be made either to a specified donee or without specifying a donee.

© 2006 PROSKAUER ROSE LLP ® 15 Consent to Organ Donation (cont’d) Revocation of authorization i.If the will, card, or other document or executed copy thereof has been delivered to a specific donee, the donor may amend or revoke the gift by: 1.the execution and delivery to the donee of a signed statement; 2.an oral statement of revocation made in the presence of two persons, communicated to the donee; 3.a statement during terminal illness or injury addressed to an attending physician and communication to the donee; or 4.a signed card or document, found on his person or in his effects.

© 2006 PROSKAUER ROSE LLP ® 16 Consent to Organ Donation (cont’d) Next of Kin i.If the deceased has not indicated his or her wishes regarding organ donation, next of kin may make an anatomical gift. ii.Authorization for donation shall not be rescinded by an objection by next of kin, except upon a showing that a donor revoked the authorization.

© 2006 PROSKAUER ROSE LLP ® 17 Consent to Organ Donation (cont’d) iii.Historically, out of fear of liability, practice has been to permit next of kin to revoke anatomical gifts. However: 1.the legislative history of this law indicates it was meant to reaffirm the primacy of the intentions of the donor; and 2.providers who act in good faith in accordance with the UAGA, which does not permit such revocation, are protected. iv.If you would like to be an organ donor, talk to your next of kin about your decision.

© 2006 PROSKAUER ROSE LLP ® 18 Consent to Organ Donation (cont’d) v.The following classes are considered “next of kin” in this order of priority: 1.spouse 2.son or daughter 18 years of age or older 3.either parent 4.brother or sister 18 years of age or older 5.guardian of the person of the decedent at the time of death 6.any other person authorized or under the obligation to dispose of the body

© 2006 PROSKAUER ROSE LLP ® 19 Consent to Organ Donation (cont’d) New York Bill A11883/S8379 – Amends New York Public Health Law regarding anatomical gifts: i.Changes the organ and tissue donor registry from indicating an “intent” to donate to providing “consent” to donate. ii.Allows registered individuals to indicate which organs and tissues they want to donate and if the donation can be used for transplantation, research, or both. iii.Indicates that any person registered in the organ and tissue donor registry before the law takes effect shall be deemed to have expressed intent to donate, until and unless he or she files an amendment to his or her registration or a new registration expressing consent to donate.

© 2006 PROSKAUER ROSE LLP ® 20 Consent to Organ Donation (cont’d) iv.Requires the Commissioner of Health to contact each person registered before the law goes into effect, in writing, to inform him or her that at the time he or she registered, that the registry was one of intent and that the registry is now one of consent. v.Requires the Commissioner of Motor Vehicles to provide a space on the driver’s license application for the applicant to register in the organ and tissue donor registry.

© 2006 PROSKAUER ROSE LLP ® 21 Equitable Allocation of Organs and Non-Discrimination Directed donations i.Directed donations—the gift of an organ to a recipient named by those authorized to make the donation—are permissible. ii.To receive a directed donation, the recipient must be formally accepted for a transplant by a transplant center and medically compatible (blood type, size, etc.) with the donor.

© 2006 PROSKAUER ROSE LLP ® 22 Equitable Allocation of Organs and Non-Discrimination (cont’d) The network of OPOs is required to establish policies for the equitable allocation of organs, including the reduction of inequities resulting from socioeconomic status. Allocation policies, among other requirements, shall: i.be based on sound medical judgment; ii.seek to achieve the best use of donated organs; iii.preserve the ability of a transplant program to decline an offer of an organ or not to use the organ for the potential recipient in accordance with the regulations;

© 2006 PROSKAUER ROSE LLP ® 23 Equitable Allocation of Organs and Non-Discrimination (cont’d) iv.be specific for each organ type or combination or organ types to be transplanted into a transplant candidate; v.be designed to avoid wasting organs, avoid futile transplants, promote patient access to transplantation, and promote the efficient management of organ placement; and vi.not be based on the candidate’s place of residence or place of listing.

© 2006 PROSKAUER ROSE LLP ® 24 Equitable Allocation of Organs and Non-Discrimination (cont’d) Can a donor request that his or her donated organs be allocated only to Jewish recipients? Should a donor be permitted to do so? i.OPOs and hospitals are subject to laws prohibiting discrimination.