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6:Abstract

Background
Our article actually deals with a subject matter. It is not a report on a case. Indeed, the clinical case presented enables to illustrate a universal issue : " Can an organ, removed from a deceased patient suffering from a tumor, be transplanted within a medical-legal framework ?". Therefore, the article is multidisciplinary. It refers to experimantations, epidemiological data and legal regulations, within an international framework. 

Methods
From a unique clinical case in France ( verification with all forensic services in France ) we conducted a global evaluation of organ donation in a tumor context but also in judicial spheres of all countries. 

Results�: 
Transplanting the liver and the lungs was beneficial, especially since the esophageal tumor turned out to be benign. 

Conclusion
The aim of this innovative article is to show that it may be possible, in the context of a shortage of organs, to carry out post mortem organ removals, even in the presence of a tumor. In order ta apreciate the viability of such a transplant, the symbolism of a balance between advantages and risks is privileged for the patients. From then on, it is essential to refer to the epidemiological data enabling a thorough highlight of both advantages and risks.
Unfortunately, the medical community is often faced with a rather overcautious judicial community as regards scientific, ethical and societal issues. As a matter of fact, it also enables to highlight the fact that doctors should be granted a certain judicial role, to gain time. 


Key Words


transplantation, tumor, medico legal autopsy, international legislation, judicial context, coroner 





















Introduction



Organ removals for therapeutic purposes are a national priority in France, since the country suffers from a shortage of donors. Therefore, it is essential to identify alternatives to save the life of recipients on a transplantation waiting list. For that purpose, extending the scope of organ transplantation procedure would be necessary to make it possible even when supposedly hazardous. 

In order to appreciate the viability of such a transplant, the symbolism of a balance between advantages and risks is privileged for the patients. From then on, it is essential to refer to the epidemiological data enabling a thorough highlight of both advantages and risks.

However, the importance of societal stakes is not accurately recognised. When organ donations become complex, especially in a judicial context, there is a general call for contesting the practice on ethical and judicial grounds.

Moreover, ��the gift of life�� is often challenged by a restrictive judicial environment, through hegemonic magistrates. And yet, time does not play in favour of patients awaiting a transplantation. 

Therefore, it is essential to set up an efficient collaboration between the three main stakeholders, that is: hospital coordination, magistrates and forensic doctors.






Clinical Case


Le case was performed under legal authority and with with compliance with the legal ethical requirements. 
The case discussed reports an uncommon situation. A 50-year-old prisoner in a penitentiary, tries to commit suicide by hanging. Emergency medical services administer resuscitation (CPR) and take the patient to the nearest hospital. Neurological state shows a Glasgow score 3 and a normal scan. However, later on, the clinical state worsens due to aspiration pneumonia. The angioscan enables to pronounce the patient brain-dead. Neither family nor the public prosecutor contacted express a reservation concerning organ donation. Yet, because of the death circumstances in jail, the magistrate orders a judicial autopsy subsequent to organ removal. It shows no suspicious lesion on a forensic point of view; however, it shows a tumeral lesion of the inferior part of the oesophagus. The anatomopathological study analysis of the 5 cm large encapsulated mass reveals the existence of a fibroma type benign tumor.



Figure 1: Anatomopathological picture


The macroscopic aspects were those of an encapsulated tumor with a diameter of 2 cm, that developed in the bottom third of the oesophagus. It was totally removed and fixed in 10% formaldehyde. The microscopic examination showed a leiomyoma composed of bundles of muscular smooth cells with a low rate of mitosis.

In recent years, important medical technological improvements that allow a good evaluation of donors have taken place. Radiology is one of the main fields of progress. The best known radiological modalities such as computer Tomography (CT) and Magnetic and Resonance Imaging (MRI) permit a qualitative and quantitative exploration of the human body. These scans have also been used for 10 years for the evaluation of cadavers. In some centers, CT is particularly often used for a so-called virtual autopsy before a traditional one. In case of a virtual autopsy, the data set could be useful both from a forensic and clinical standpoint when organ transplantation is planned. Post mortem CT (PMCT) can reveal unexpected lesions or pathological conditions. 

Even when faced with a tumoral lesion, the medical community seems to favour organ transposition. One can wonder whether magistrates faced with a suspicious death are sensitive to such medical practice.
Thus, the following issue may be raised: ��Can the discovery of a tumor in the donor, in a judiciary context, hinder a post-mortem organ removal?��
To begin with, it is necessary to clarify the post-mortem organ donation judicial framework. The judicial vision may be extended to an official dimension when a tumor is diagnosed in the potential donor. Discussion

Maintaining post mortem organ donation in case of a tumor, sustainable expanding of an ambitious medical practice.

Before considering whether transplanting organs with a tumor keeps within the Law, it is appropriate to remind how organ donation is perceived in some States. 

According to national legislations, the donor�s consent is understood differently: it can be intentional or explicit (as in Australia, the United States, the United Kingdom, Germany�.), implicit or presumed (as in France, Belgium, Portugal, Greece, Israel, Japan�.). 
In Europe, all the member countries practicing organ removals have set up a system registering people�s will about the donation of their organs after their death.
In this context, Italy has the most permissive system. Indeed, a donor can express his will in 3 different ways: with a card issued by the Health Ministry; by registering with the ��Azienda Sanitaria Locale�� or declaring his will to the family doctor, writing a note dated and signed, with first name, family name, birthdate, and statement of intent.

Saudi Arabia alson intends to develop the practice of postmortem organ donation, despite the existence of a cultural exception. Actually, some decisions taken by the Academy of Muslim Law in Mecca, and by the International Council of Jurisprudence in Jeddah, remind that it can be read in the Coran that: �He who saves the life of a single person, saves the entire humanity �. 
The two major institutions hava also d�cided that it is legal to remove the organ from a deceased person and transplant it in the body of a living person when the survival of the latter depends on the operation, or when it is necessary to safeguard one of the vital functions [1].

In Japan [2], the� Land of the Rising Sun�, social cultural specificities have an impact on the legislation concerning organ donation (the influence of Shintoism and boudhism, the fact that organ donation is a taboo subject, and because of a collective suspicion as regards brain death).
Actually, organ removals on deceased donors by brain death are not common.
In 1997, a law allowed post-mortem removal without changing the major Japanese principles since it required both the patient�s and the family�s consent. Not only was the patient required to detain a donor�s card, but the family (the true societal foundation in Japan) also had to agree to the procedure. The law never had the expected result, in as much as remains a reluctance to admit the notion of �brain death�. In 2010, a law was enacted to remedy the constant lack of organs. It specifies that, unless the family refuses, the organs can be removed without a prior written notification of the deceased patient.

In Common Law countries, such as the United States, a strong Law defends the rights to self-determination. In the name of the patient autonomy principle, the person has to consent, as well as his�/her family, to the removal of his/her organs. Thus, even if a will from the deceased person to give his/her organs exists, health professionals may encounter difficulties, in case the family refuses. Due to medical and societal stakes entailed by this practice, stronger laws have been enacted in different states to enable doctors not to take into account families� will.

After having carried out an overview of differents models, the accurate question is: �Is the medical practice of post mortem organ donation with tumor legal?�

At the level of the European Council, an additional protocol to the Convention on Human Rights dated January 24th, 2002 [3] was implemented on May 1st, 2006 to remind that necessary authorizations are requested by law. Such a requirement has become an issue due to the outline of the case discussed. As a matter of fact, the discovery of a tumoral lesion a posteriori may indicate that the whole procedure was not entirely respected. To tell the truth, even legal experts might find those sanitary and ethical requirements confusing. They thus deserve to be clarified.

In France, according to Article R. 1212-13 in the Public Health Code (PHC) [4], doctors and midwives need to verify the potential donor�s identity and check that existing sanitary rules are respected. They will make a selection to eliminate donors whose organs could involve a risk,superior to the benefit expected for  the recipient.
To do so, compliance to a strict protocol is necessary: identify medical and surgery history, personal and family background of the potential donor, include a clinical examination, check relevant additional information to help the clinical selection of the donor.

The clinical case discussed presents a fundamental interest, as it is unique. Actually, even though doctors complied with the whole procedure, a tumoral lesion was discovered, during a judicial autopsy. The tumor presents both a medical and judicial interest.
Actually, the above-mentioned removal needs to respect a sort of balance between advantages and benefits as well as risks for the patient. Article L. 1211-6 provides that ��the elements and products from the human body will not be used for therapeutic purposes if the risk for the potential recipient, measurable according to current scientific and medical knowledge, is superior to the advantage expected��. The idea of a balance between advantages and risks entailed by the removal procedure and the organ graft should not have any precise judicial determination.
In this connection, health professionals obviously seem to be the most apropriate to assess whether such a complex yet essential practice at a sanitary and societal level is necessary. Thus, in the case studied, even though organ transplantation may be ethically puzzling, it should nonetheless be generalised.

At a supranational scale, there is a shortage of organs. Is it necessary to remind that Article L.1231-1 A of the Public Health code says: ��organ removal and organ graft are a national priority��, when the problem of the imbalance between the number of donors and potential graft recipients remains so far unsolved. 
Therefore, to save the life of some patient�s doctors would be likely to want to remove and transplant organs presenting some risks. They obviously rely on scientific data, more precisely on epidemiology. According to recent data, the risk induced by an organ transplantation whose donor suffered from a non-detected cancer seems very low: 6, 1% for the Spanish register [5], 1, 7% for the ��UNOS�� register [6].
Besides, from the recipient�s perspective, the balance obviously needs to be taken into account. When in a desperate clinical condition, he could give his assent and accept a graft from a donor with a detected tumoral lesion.

In the context of a shortage, it can be assumed that it is essential to identify donors who might potentially transmit a tumor to recipients, rather than eliminate outright potential donors with a tumor. The risk of transmitting cancer must be counterbalanced by the fact that some patients on waiting lists are likely to die, all the more that the international literature advocates those most unusual���gifts of life��.
Actually, cancer rate with a donor is an estimated 3% and the risk of transmission of a malignant tumor after transplantation is estimated at 1 out of 10000 [7]. In the UK, a Health ministry committee reported that between April 2003 and March 2013, among the 358 donors who died of cancer, only 15 recipients suffered from the donor�s disease. Thus, identifying a tumoral lesion highlights the role of forensic doctors as mediators between Justice and Health.
It is essential for the coordinating team that a tumor be detected to monitor recipients of the different organs. Had the tumor been detected with the pre-operation investigations, the benefit/risk balance report would have been rated differently. Assessing the transmission rate varies according to countries, different types of tumors and even organs transplanted. Because of the scarcity of���the gifts of life��, executing the organ transplantation procedure must be privileged, even with a known tumor [8].
Besides, even if the transmission rate of a hidden tumor in relation to the overall number of transplantations is low [9], the fact remains that when the donor has cancer of either category, the overall transmission rate remains low. 

Actually, it is necessary to analyse right away some of the characteristics of the tumor once it has been discovered, before taking any decision: its size and margins on the one hand; its nature (benign or malignant), and its histological type, with an anatomopathological analysis, on the other hand.
Among the tumors, those of the central nervous system, malignant melanomas [10-11-12], chorionic carcinomas [13], kidney carcinomas, bronchial cancers, colon cancers and breast cancers are the ones most often detected with organ donations, with a transmission that might go unnoticed to begin with. When the tumor was not detected before removal, it is necessary to identify which type it belongs to in order to enable recipients to benefit from a relevant health monitoring and a possible preventive treatment. Recipients, due to the immunosuppressive treatments inherent in grafts, are more likely to quickly develop a tumor related to the graft. The notion of chronic immunosuppressive treatment may be an accelerating factor of proliferation.

In principle at an international scale, even after discovering a tumor, the symbolism of the balance advantages/risks permits organ donation. However, it is highly regrettable that a predominant restrictive judicial context should hinder an ambitious yet necessary medical practice. A comparative study of the most favorable foreign legislations is necessary to expect improvements in the collaboration between Justice and Medecine.

In principle at an international scale, even after discovering a tumor, the symbolism of the balance advantages/risks permits organ donation. However, it is highly regrettable that a predominant restrictive judicial context should hinder an ambitious yet necessary medical practice. 


Judiciary impediment to post mortem organ donation in case of a suspicious death, a perfectible collaboration Justice/Medecine. 

Investigating on the causes of death is essential in search for the judicial truth mechanisms human rights require. The ECHR and the ACHR both established that judicial protection granted by the right to live included identifying the causes of death [14]. This procedural requirement leads us to analyse the given situation when a prisoner is found hanged in a penitentiary. Since numerous deaths in prison may be attributed to criminal offense or negligence of sanitary and/or safety requirements, any death in prison is suspicious. This inevitably leads to a forensic autopsy, which is the issue, since it first annihilates a possible post mortem organ donation. 

Under the Act of May 17th, 2011 [15], judiciary autopsy can be ordered in a criminal investigation, according to articles 60, 74 and 77-1 of the criminal code, or in a judicial investigation, according to articles 156 and seq.
However, these legal provisions do not provide extended information regarding the articulation between judicial procedure and post mortem organ donation. The decree of October 29th, 2015 [16] reminds that the Prosecutor (or the investigating judge) shall be contacted without delay for any death whose cause is unknown or suspicious, whether a violent death or not [17].

Judicial oppositions to organ removals should not be neglected in the current context of a shortage of grafts, which makes it necessary not to miss any opportunity of donation. According to the European recommendation R (99)3 ��to harmonize rules regarding forensic autopsies�� [18], most potential organ donors identified go through a judicial investigation procedure and are potentially prevented from donating by such oppositions. As a consequence, forensic doctors have a major part to play, as ideal interlocutors for magistrates to clarify, as for any expertise mission, technical aspects they are not familiar with.

The main constraint is a time constraint. When the removals of sound organs are practiced immediately after brain death was pronounced, grafts have a better chance to succeed. Thus, not to delay removals, it is necessary to proceed with the findings as early as possible, all the more since early forensic findings are of better quality. So, findings must start as soon as a patient�s state seems likely to evolve towards brain death.
Appointing local referents for the relevant professions such as forensic doctors and hospital graft coordinators might help in reducing the number of interlocutors and the dispersion of information. Existing actors, close to the ongoing operations should be given more credit. Forensic doctors are the ideal interlocutors between removal coordinating teams and judicial authority. They are familiar with the legal vocabulary and know what the magistrates they work with on a dayly basis expect. Immediate contact is recommended every time a potential donor�s death subject to a forensic impediment is pronounced. Even though a list of the forensic doctors on duty 24 hours a day is available, a local forensic referent should be appointed. On a judicial point of view, he could begin autopsy findings while removing the organs. Operating on a fresh body, before rigor mortis occurs helps observation.

In Belgium, �in case of a violent death, the doctor in charge of removing the organs or tissues has to write a report and transmits it to the Crown Procurator without delay. The report must mention the details concerning the state of the body of the deceased and the parts of the body removed, any detail relevant to the cause and circumstances of death �� [19]. Since initial assent of the Crown Procurator is not necessary, it is a gain of time. Furthermore, when the cause of a violent death is not suspicous, a report is established with all the essential details in case the Crown Procurator would later on order a judiciary investigation or an autopsy.

In Common Law countries, suspicious deaths must be reported to a coroner. Under the Law on Research of the Causes and Circumstances of Death, the public officer�s function is to legally investigate on the identity of the deceased when death circumstances are unclear or violent [20]. In the United States, a retrospective study carried out between 2000 and 2001 [21] enabled to highlight the organ donation success rate in a judiciary context.
It is about 88,2%. The percentage takes into account 353 refusals of organ donations for the same year. The success obviously results in the close collaboration between the coroner�s character and the people proceeding to the medical examination of the deceased person.
It also results in the fact that some states, such as New Jersey and Texas [22], legally stated priority of organ donation over the search for the judicial truth.

The necessary search for judicial truth is one of the major obstacles to an efficient post mortem organ transplantation, intended to preserve a patient's life or integrity. Some States, such as the United States, Canada, Belgium....do not encounter the same difficulties, since they have medical figures with a judicial role.
Therefore, it would be essential to promote the coroner's figure in countries such as in France, where the practice of post mortem organ transplantation is impeded by the search for judicial truth. To do so, a reform is required and forensic physicians, strictly appointed by public authority should be granted the prerogative to decide whether or not to initiate public action. As for the States, strongly opposed to implementing a coroner, forensic physicians should at least be granted the right to apply to a court or not, which would make them de facto, mandatory referents within the medical institution. 

References


[1] Hepatotransplant, ��Islam, Donation and Transplantation��, Brussels, 2012. Available on�:  HYPERLINK "http://www.hepatotransplant.be/islam_transplantation.html"http://www.hepatotransplant.be/islam_transplantation.html 

[2] El Rahal (A.), Ro) El Rahal (A.), Romailler (E.), Immersion en communaut�, ��Transplantation d'organes et SIDA au Japon, o� en sont les tabous�?��, 2010, 27-40 Disponible sur   HYPERLINK "http://www.medecine.unige.ch/.../immersion/archives/...2010/.../10-r-japon_transplantation.pdf"www.medecine.unige.ch/.../immersion/archives/...2010/.../10-r-japon_transplantation.pdf

[3] European Council, January 24th 2002, additional protocol to the Convention on Human Rights and Biomedecine ��relating to human organ and tissue transplant��, STCE, n� 186. Available on�:  HYPERLINK "http://www.coe.int/fr/web/conventions/treaty/186?desktop=false"www.coe.int/fr/web/conventions/treaty/186?desktop=false 

[4] Created by n� 2003-462 Decree, May 21st 2003 ��relating to the statutory regulations in parts I, II and III of the Public Health Code��, JORF May 27th 2003, 37006
 
[5] Biomedecine Agency ��Helping Decision-taking On Multi Organ Retrieval From Donors With Cancer Or Haematological Malinancies History Appearing To Be Cured��, Recommendation, May 15th 2007 version. 

[6] Committee of experts on the organisational aspects of cooperation in organ transplantation, Council of Europe Transplant Newsletter, ��International Consensus Document Standardization Of Organ Donor Screening To Prevent Transmission Of Neoplastic Diseases��, 1997�; 2 : 4-10, quoted in ��The Use Of Organs From A Multi Organ Donor When Discovering Kidney Cancer During Retrieval Surgery. Guidelines To Help Decision-taking��, Biomedecine Agency, December 2nd 2008
 
[7] Vignot (S.), Faivre (S.), Aguirre (D.), Raymond (E.), ��Mtor Targeted Therapy of Cancer with Rapamycinn Deritatives��, Ann Oncol, 2005; 16: 525-537
 
[8] Ye (Q.), Zhang (S.), Yuan (J.), Li (W.), ��Organ Transplantation from Donors (cadaveric or living) With A History of Malignancy: Review of The Literature. Transplantation Reviews��, 2014; 28 (4): 169-175
 
[9] Desai (R.), Collett (D.), Watson (C. J. E.), Johnson (P.), Evans (T.), Neuberger (J.), Estimated Risk of Cancer Transmission from Organ Donor to Graft Recipient in A National Transplantation Registry��, BJS Society Ltd, 2014; 101: 768-744
 
[10] Strauss (D. C.), ��Transmission of Donor Melanoma by Organ Transplantation��, Lancet Oncol, 2010; 11: 790-796

[11] Buell (J. F.), Beebe (T. M.), Trofe (J.), Gross (T. G.), Alloway (R. R.), Hanaway (M. J.), Woodle (E. Steven), ��Donor Transmitted Malignancies��, Annuals of transplantation, 2004, 53-56

[12] Bajaj (N. S.), Watt (C.), Hadjiliadis (D.), Gillespie (C.), Haas (A. R.), Pochettino (A.), Mendez (J.), Sterman (D. H.), Schuchter (L. M.), Christie (J. D.), Lee (J. C.), Ahya (V. N.), ��Donor Transmission of Malignant Melanoma in A Lung Transplant Recipient 32 Years After Curative Resection. Journal Compilation��, European Society for Organ Transplantation, 2010; 23: 26-31




[13] Braun-Parvez (L.), Charlin (E.), Caillard (S.), Ducloux (D.), Wolf (P.), Rolle (F.), Golfier (F.), Flicoteaux (H.), Bergerat (J.-P.), Moulin (B.), ��Gestational Choriocarcinma Transmission Following Multiorgan Donation. American Journal Of Transplantation��, 2010�; 10�: 241-246

[14] European Court of Human rights, The Right to live, a thematic sheet, June 2013, CEDH, September 27th 1995, ��McCann c/ United Kingdom��, request N� 18984/91
 
[15] N� 2011-525 Act, May 17th 2011 ��On simplifying and improving Law value��, JORF May 18th 2011, 8537

[16] Decree October 29th 2015 ��on the ratification of the regulations of good clinical practices relating to organ retrieval for therapeutic and scientific purposes on a deceased person��, JORF November 25th 2015, 21839

[17] Article 74 of the Criminal Procedure Code, amended by N� 2009-526 Act, May 12th 2009 ��on simplifying and clarifying the Law as well procedures��, JORF May 13th 2009, 7920

[18] Delannoy (Y.), Averland (B.), Hedouin (V.), Ludes (B.), ��Organ Retrieval And Forensic Deaths��, Recommendation from the French Forensic Medecine Society, 7
 
[19] Squifflet (J.-P.), ��Organ Donation And Transplantation�: A book on the procedures relating to organ retrieval��, Organ Transplantation Center, Catholic University of Louvain, 1997
 
[20] Joyal (R.), Marcel TRAHAN�: In Search of Justice And Fraternity��, Paris�: septentrion, 2005, coll. National Library of Quebec

[21] Shafer (T.), Schkade (L.), Evans (R.), O'Connor (K.) et Reitsma (W.), Vital Role of Medical Examiners and Coroners In Organ Transplantation, American Journal of Transplantation, f�vrier 2004, 160

[22] Shafer (T.), Schkade (L.), Evans (R.), O'Connor (K.) et Reitsma (W.), ibid., 165-166
 

Abreviations list



ACHR�: American Court of Human Rights

and seq.�: and following

coll.�: collection

CPR�:  Emergency medical services administer resuscitation

CT: Computer Tomography

ECHR�: European Court of Human Rights

ibid.�: ibidem

JORF�: Official Journal of the French Republic 

L.�: Law

MRI�: Magnetic and Resonance Imaging

PHC�: Public Health Code

PMCT�: Post mortem Computer Tomography

R.�: Regulatory  article

UK�: United Kingdom

UNOS: United Network for Organ Sharing
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