RODOLFO ONDARZA ROVIRA and SOLIDARY NETWORK DECADE AGAINST IMPUNITY A.C - Documents Presented to the Inter American Court of Human Rights

via La Cartita --
Mexico City. July 16th, 2012
Ref. Dr. Rodolfo Ondarza Rovira
Solidary Network Decade Against Impunity A.C.
Country Mexico: Inter-American Commission on Human Rights (IACHR)
Washington, D.C.
Dear members of the Inter-American Commission on Human Rights (IACHR), Dr. RODOLFO ONDARZA ROVIRA and SOLIDARY NETWORK DECADE AGAINST IMPUNITY A.C. , (hereinafter RDSDCIAC), are directed to you in order to submit to the Inter-American Commission H. Human Rights (hereinafter the Commission), a request to open a case against the Mexican State, in accordance with Articles 44 to 51 of the American Convention on Human Rights (hereinafter "the Convention") and Article 23 of Rules of procedure of the Commission; highlighting the fact that the Mexican State ratifies the day of March 2, 1981 the Convention; as well as the Inter-American Convention to Prevent and Punish Torture, which also confirms the day of February 11, 1987, and in accordance with the Principle of Pacta Sunt Servanda, and in full recognition of the warranty of protection which provides that the alleged victims have the right of access to justice, and to combat impunity, we respectfully appear before you in order to report violations of the Convention in which the Mexican state to ocurred in grievance of:

VICTIMS LIST PRESENTED

The list of victims presented below is a partial listing of patients who are victims of the surgical placement of the illegal experimental intracerebral ventriculoperitoneal shunt system already described above. The patients in this listing (194) and its relatives do not know the date having been subjected to a procedure of experimental surgery. This list does not correspond to the total number of victims. It is a sample of the total number of victims. It is not known if this number is still increasing at the present time, given that it is not known if the authorities of the National Institute of Neurology a nd Neurosurgery “Manuel Velasco Suaerez” (INNNMVS) still allow illegal experimentation in human beings. It is important to emphasize that in spite of being the realization of a “proyect” of experimental surgery, against the current regulations, patients were charged the preoperative and postoperative studies conducted in laboratory and cabinet, hospitalization, medicines and the testing procedure (operating room), etc. Nobody is exempt from payments by complications suffered. We have the following partial list of the victims of the placement of the experimental “ventricle peritoneal continuous flow bypass system” (SDVP type INNN) that probably correspond to part of the reports published by Dr. Julio Everardo Sotelo Morales).

**** VICTIMS LIST PRESENTED

By stating that the names of Dr. RODOLFO ONDARZA ROVIRA and the SOLIDARY NETWORK DECADE AGAINST THE IMPUNITY A. C., (the that we denounced), do not have to be guarded to the Mexican State, the same may be referred.

I. - BACKGROUND
In Mexico many people do not have health services; "In Mexico there are more than 10 million households living in material poverty; most of them do not have access to health services for any public institution. Many of this people receive services from private doctors or practitioners of traditional medicine in a business relationship, without the intermediation of another agent. In addition to this situation, along the entire length of the social structure, both poor and rich, insured and uninsured, pay out from their pocket to private providers of health services. In this scenario, the role of stewardship should be strengthened in at least two essential aspects in the enhancement of the health system as a whole: the quality and equity. The theme of quality must be regulated at all and each one of the units of attention, both public and private, and the standards should be comparable, when more differentiated by level of care. Also in the issue of equity, the regulation is very complex.

II. - FACTS OF THE CASE
Mexico account with 12 National Institutes of Health, whose main objective is to provide first level medical services to the national population, in particular to the population that does not have social security. One of these institutes is the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" (INNNMVS), located in Mexico City. Between the years 1994 and 2007, at least in the INNNMVS, without the consent of patients to whom it was assumed that suffered from hydrocephalus, neurosurgically was introduced, on an experimental basis and illegal, an experimental non-valvular device called "continuous ventricle peritoneal flow bypass system " (SDVP INNN type). Hydrocephalus is a condition in which the main feature is the excessive accumulation of cerebrospinal fluid intracerebrally. The excessive accumulation of cerebrospinal fluid results in the abnormal dilation of the spaces in the brain called ventricles. This dilation causes potentially harmful pressure on the tissues of the brain. The neurosurgical treatment of this condition consists in the ventricle peritoneal valvular bypass. A derivation is a silastic tube flexible but sturdy. A bypass system consists of a catheter and a valve. One end of the catheter is placed in the central nervous system - the most of the times within the ventricle in the interior of the brain. The other end of the catheter is usually placed within the peritoneal cavity (abdominal).A valve located along the catheter maintains the flow in one direction and regulates the amount of flow of the cerebrospinal fluid (National Institute of Neurological Disorders and Stroke (NINDS-National Institute of Neurological Disorders and Stroke. NINDS, part of the National Institutes of Health (NIH) of the United States of America). There are different designs of valvular systems of ventriculoperitoneal shunt, whose development has been decades in its development and the cost of millions of dollars, to be finally approved by the Food and Drugs Administration (United States of America) and by the Ministry of Health (Mexican Republic) for use in patients with hydrocephalus. Among the valvular derivatives systems available in Mexico we find: Hakim, Radionics, Pudenz, Orbis-Sigma , Biomed, etc., that are used routinely in patients with hydrocephalus, in both private and public hospitals.

This experimental procedure has been made illegal in vulnerable groups of the population, as 86.5 % of the people hospitalized in the INNMVS had an income less than 3 minimum wages and lacked any social security scheme in accordance with the Superior Audit of the Federation. This by-pass system pilot was placed permanently intracerebrally close to 500 victims employed for this purpose. Even were operated at least a group of newborns with this illegal experimental derivative system. Surgical interventions are performed not only in the INNNNMVS, but also in other hospital centers of the interior of the Mexican Republic. There is evidence to suggest that these illegal surgical procedures were also carried out in private hospitals. A group of patients died, another group called for the withdrawal of the derivative experimental system and its replacement with valvular systems internationally approved, another group of patients has suffered irreversible neurological damage as a result of this experimental surgical procedure. This is an unprecedented case in the History of Mexico. The placement of this derivative experimental system did not meet with the informed consent of the patients or their relatives, where according to the General Law of Health and its Reglament, the intentions of the experimental surgical procedure should have been reported to the patient. The internarional the alternatives accepted state that the study and experimental treatment should be free, and that, in the case of complications, the "protocol" should be responsible for paying its resolution, etc. The patients and their families were not given the opportunity to take a free decision on its right to life and health. During the implementation of these experimental procedures did not exist a Protocol approved by a Committee of Inquiry, or by a Committee on Bioethics, nor from the appropriate authorities of the Ministry of Health (SS) or a follow-up by the same.

In addition, a change was made from medical application of the material - Tygon -, used in the preparation of the experimental system type SDVP NINN, approved use in cardiovascular procedures, to a permanent application and internal human nervous system (something never before done) without carrying out the tests required by the Department of Health (SS). This device has been related to the death of patients who underwent this experimental procedure, the withdrawal of this device in other cases and its replacement by a valvular system standard, as well as to permanent neurological damage and disabling in patients who are victims of this procedure. On the other hand, there is a patent on the " ventricle peritoneal continuous flow by-pass system" obtained in a personal capacity, and non-institutional, by Dr. Julio Everardo Sotelo Morales Ex-Director General of the INNNMVS. He violated the General Law of Health in its Regulation in the field of research, different Official Rules, etc. This " continuous flow ventricle peritoneal bypass system" was applied in violation of the right to health referred to in the Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights "Protocol of San Salvador"

Article 10;
-Every person has the right to health, understood as the enjoyment of the highest level of physical fitness, mental and social dimension. With the order to enforce the right to health the States parties undertake to recognize health as a public good and particularly to take the following measures to ensure this right: b. the extent of the benefits of health services to all individuals subject to the jurisdiction of the State; Patients who were implanted an experimental ventricle peritoneal continuous of non-valvular flow bypass system (SDVP type INNN), without a free, transparent and clear information, and with the malicious promise offer of full recovery of health by health officials as Dr. Julio Everardo Sotelo Morales and Dr. Miguel Angel Celis Lopez, those who had ignored the fact that the Protocol of San Salvador gives special attention to vulnerable groups or in poverty. The National Institute of Neurology and Neurosurgery "Manuel Velazco Suarez" (INNNMVS), abused of the ignorance that the patients and their families had on experimental ventricle peritoneal continuous of non-valvular flow bypass system (SDVP type INNN), of their poverty and their hope of healing and relief to their illness. Medical interventions and the same appointments from the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" (INNNMVS) are inaccessible especially for those who lack economic resources, despite the fact that this institute is part of the health sector, which is implemented by the State for all those who do not have social security. This experimentation has transgressed the General Law of Health and about a dozen articles of its regulation in the field of research, as well as various Mexican Official Standards and International for more than a decade (sanitary specifications of the equipment for lead of cerebrospinal fluid NOM-098-SSA1-1994 and ISO 7197). The illegality in the realization of experimental surgery in human beings made in the National Institute of Neurology and Neurosurgery "Manuel Velasco Suarez "INNNMVS" is exposed in the Medical Opinion No 360/09, exp. CONAMED 2806/09, exp of the Internal Control Agency of INNNMVS (January 13 2010). Reports of the Supreme Audit of the Federation and the institutional medical opinion of the National Commission on Medical Arbitration, it is possible to affirm that the derivative system designed by Dr. Julio Sotelo Morales and employed in experimental surgery (SDVP INNN type) it is a:

a. “Ventricle peritoneal treatment of hydrocephalus By-pass system", "that depends more on the production of cerebrospinal fluid that the ventricular pressure", whose synonyms are "derivative ventricular open system" or "ventriculoperitoneal shunt system of continuous flow"; that is to say that this is not a system of valvular ventriculoperitoneal shunt, nor has a reservoir as valvular systems internationally approved for use in patients with hydrocephalus. b. That the material used in their design and development is Tygon tubing.
c. That is manufactured and produced at the National Institute of Neurology and Neurosurgery "Manuel Velazco Suarez" (INNNMVS) in "the Bioengineering Laboratory" of the Institute (J Neurosurg 101:762-766, 2004). In the previous publication, in the explanatory note end of the same, it is stated that "the conceptual framework and experimental system for the derivative of cerebrospinal fluid were developed by one of the authors (Dr. Julio Sotelo) in our laboratory; however, there is no commercial interest… ". (There is no mention of the sources of the economic resources to pay these).
d. That the material was purchased from the company "Norton".
e. That research was not carried out preliminary research in animals (Eur J Technol Biomed RBM 1993; 15:257-62).
f. It is a derivative system similar to the already designed in the decade of 1950's (Neurol Surg 1995; 43:324-32).
g. That his design had to be changed at different times due to ineffectiveness of the system which led to the withdrawal of the same in patients who undergo this surgical procedure and the absence of a proper scientific methodology) (Neurol Surg 1995; 43:324-32).
h. That all the patients who underwent newborns with this system they had to remove the system (we do not know the fate of these patients) (Arch Neurocien Vol 3. Not 1:25-30, 1998). It must be remembered that the newborns remain lying down most of the time.
i. That there were complications in different patients, such as hydrocephalus normotensive (Arch Neurocien Vol 3. Not 1:25-30, 1998), and that there are risk factors associated with inadequate surgical techniques, the surgeon inexperience, etc. , that can even lead to death of the patient (Neurological Surg 2002; 58:377-84).
j. That the Dr. Julio Sotelo moral claims that his study was known by the "Institutional Review Committee", and that in his report in the journal Surgical Neurology 63 (2005) 197-203, where he says that the patients who placed their by-pass system signed a A letter of informed consent, however, the patients who are victims of this experimentation claim that it was not true, and there is no "Institutional Review Committee" at the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" (INNNMVS). In addition to that the study was not approved by the Committee of Clinical Investigation, nor by the International Bioethics Committee of the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" (INNNMVS), neither the clinical records of patients have letters of informed consent that detailed special report no doubt to the patient and his family that the patient will be subjected to experimental surgery, nor such research has been approved by the Secretary of Health, was not carried out monitoring of the research protocol for the same Secretary, all this is contrary to the General Law of Health.

The Mexican State maintained Dr. Julio Everardo Sotelo Morales, as Director General of the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" (INNNMVS), same that lasted a period of 9 years (by reelection). Dr. Julio Morales Everardo Sotelo, a medical doctor who has no training in medical research (does not have in a master's degree or Phd), in neurosurgery, nor in biomedical engineering, and who has been denounced by patients and by staff of the INNNMVS, by torture, cruel and inhuman treatment by the realization of experimental surgery without authorization in humans, [treatment of hydrocephalus with devices similar to your invention in accordance with American investigators to teams of the years of 1950], this device has no record of the Department , not account with a protocol of Research, In contravention of the regulations of the Health Department,and whose responsibility is not only of professional commented on and of the doctors who have supported him (tops the list Dr. Miguel Ángel Celis López, who acted as Coordinator of the Committee of Epilepsy and as Head of the Radio Unit Neurosurgery, despite not count any longer with the required training for any of the two functions) is also one of the public policies of the Mexican State.

The Convention stipulates the obligation of the State party to guarantee the right of everyone to the physical, mental, and moral integrity. The American Declaration of the Rights and Duties of Man establishes the right of every person to have their health may be preserved by health and social measures as well as the medical assistance without discrimination and the Protocol of San Salvador provides that any person has the right to health care without discrimination, understood as the enjoyment of the highest level of physical, mental and social wellbeing.

The Tokyo Declaration of the World Medical Association expressly condemned the participation of doctors in torture and cruel, inhuman or degrading treatment, or any act.

The Hippocratic Oath declares that doctors should treat all patients the best they can, respecting their privacy and not damaging or committing injustices against them.

III.- RIGHTS PROTECTED BY THE AMERICAN CONVENTION ON HUMAN RIGHTS DENOUNCED AS VIOLATED:
The petitioners express that through the facts described in the previous paragraphs of this writing the following human rights that protect the survivors and to the lives of those massacred in accordance with the American Convention on Human Rights have been violated: The Inter-american Convention in its article 4 with connection to the article 1 to the detriment of patients:

*** PATIENT NAMES PRESENTED ***

The Mexican State is responsible for the violation of article 5 in connection with article 1 of the Convention to the detriment of patients previously appointed, and as a form of specific protection of personal integrity against torture, (hereinafter referred to as the Convention against Torture), in accordance with article 1 that sets: "For the purposes of this Convention, it is understood by the term "torture" any act by which intentionally inflicting severe pain or suffering, whether physical or mental, in order to obtain, from him or a third party information or a confession, punishing him for an act that has been committed or is suspected has committed, or to intimidate or coerce a person or other, or by any reason based on discrimination of any kind, when such pain or suffering is inflicted by a public official or other person in the exercise of public functions, at the instigation from him or with his consent or acquiescence. It does not include pain or suffering arising only from legitimate sanctions, inherent in or incidental to these.”

It should be emphasized that to the Inter-american Court, "health is a public good whose protection is in charge of States", and that the Inter-american court has reaffirmed that the right to personal integrity is essential to the enjoyment of human life and cannot be suspended under any circumstances, In addition to the fact that the Inter-american Court has developed the link between the rights to personal integrity and to the life and the right to health, establishing that they are both directly and immediately related to the human health care.

The Court has also stated that; "the States are responsible for regulating and supervising the delivery of health services to ensure the effective protection of the rights to life and personal integrity, regardless of whether the entity that provides such services is a public or private. The same Commission considers that the right to personal integrity implies the obligation of States to respect and ensure that nobody is subjected to acts of aggression or physical injury and/or mental to do this, while the Commission has indicated that States must provide evidence that the adoption of reasonable measures at its scope and unobstructed to offer medical treatment required to the people who need them.

**** PATIENT INFO REDACTED ****

The Mexican State is responsible for the violation of articles 8 in connection with article 1 of the Convention, because of the seriousness of the case due to its responsability to thoroughly investigate, but didn’t. The same Inter-american Court of Human Rights has stated that "the protection of the law is basically constituted if the resources that are available for the protection of the rights guaranteed by the Convention, which, in the light of the positive obligation that article 1.1 provides for States to respect and guarantee them, involves, as the Court has already stated the duty of the States Parties to organize the whole governmental apparattus and, in general, all the structures through which it expresses the exercise of public power, so that they are capable of ensuring legally free and full exercise of human rights (Velásquez Rodríguez Case, Judgment of July 29,1988. Series C No. 4, Para. 166; Godínez Cruz case, Judgment of January 20,1989. Series C No. 5, Para. 175) . "This duty to organize the governmental apparatus and to create the necessary structures for the guarantee of human rights is related, in which legal assistance is concerned, with the provisions of article 8 of the Convention. This article distinguishes between accusation[s] of a criminal nature and procedures of a civil, labor, tax or any other character. Eventhough it states that every person has the right to be heard, with the hearing by a judge or court in both circumstances, stipulates in addition, in cases of offenses, minimum guarantees. The concept of due process in criminal cases includes, then, at the very least, those minimum guarantees. If minimum denominated the Convention assumes that, in specific circumstances, other additional guarantees may be necessary if it is a due process of law. The Mexican State violent the obligation to protect, respect and guarantee the rights contained in the Convention in accordance with the provisions establish in article 1. The Inter-american court of Human Rights expressed in relation to this obligation of the States that; "This article [1.1 ] contains the obligation of States, some in relation to each of the rights protected by [the Convention], in such a way that all pretense that has injured any of these rights, necessarily implies that it has been also violated the article 1.1 of the Convention" The Mexican State concluded its duty to protect the guarantees above mentioned.

IV.- ADMISSIBILITY REQUIREMENTS

The Article 46 (1) (a) of the Convention requires that have been pursued and exhausted all the domestic jurisdiction resources, in order for a petition to be declared admissible by the Commission, it is necessary to emphasize that the majority of patients who survive do not know which were the object of experimentation and that the patient Maria de Lourdes Walkup Mentado knows that was the subject of experimentation, and has interposed the domestic resources because has been the subject of delays in their national procedures, for which we welcome to the article 31 of the Regulation of this H. Commission. The Inter-american Court of Human Rights, as any body with jurisdictional functions, has the power to its inherent powers to determine the scope of its own competition (competence de la competence). In this regard, it has considered cannot leave it to the will of the States the determination of which facts are excluded from its jurisdiction. The Inter-american Court of Human Rights finds that the American Convention produces effects binding with respect to State once forced the same, Mexico joined March 24 1981. The Court also stated that the implementation of an effective investigation is an essential element and condition for the protection of certain rights that are affected or nullified by such situations, as they are [ …] the rights of personal liberty, personal integrity and life".

V.- NAME OF THE VICTIM AND THE AUTHORITIES INVOLVED
The names and last names of the victims are reflected in the header and the body of this request and are who had their human rights, recognized in the Convention, violated, which has been described in this request. The Mexican authorities that are responsible for the violations of the above-mentioned human rights are: the President of Mexico, Dr. Julio Everardo Sotelo Morales, as Director General of the National Institute of Neurology and Neurosurgery "Manuel Velasco Suárez" and Dr. Miguel Ángel Celis Lopez.

V.- PETITION

1.- Start the processing of this case in accordance with the Convention and the regulation of the Commission
2.- Declare that the Mexican State has violated the guarantees for the protection of life, which is enshrined in article 4, on the right to life, article 5 on the right to personal integrity, and all of them in relation to the general obligations of the State contained in articles 1.1 and 2 of the Convention.
3.- Order that the Mexican State repairs the damage done to the survivors of the experimentation and the families of the people who suffered the experimentation without authorization.
4.- Pay a fair compensation to understand moral and material damage by economic losses, considering the wages that were perceived by the people who suffered the experimentation and the survivors at the time of the facts until the judgment by estimating the period of life of the deceased and the survivors.
5.- Ensure that the act would not be repeated and recommend other appropriate forms of repair.
6.- Recommend to the Mexican State investigating and punishing those responsible for the violations of the Convention set forth in this request.
7.- We adhere to the principle of iura novit curia
8.- Declare that the Mexican State has violated the guarantees of protection of life. Given that the experimental surgical procedure was carried out repeatedly against vulnerable groups by authorities and officials of the Health Sector of the Mexican State, to the detriment of the physical, mental, and moral integrity of the victims, with full knowledge of cause by these authorities, it is respectfully requested to consider and declare these facts by the IACHR as a crime against humanity and torture medical carried out against the previously named victims.

VII.- AUTHORIZATION FOR LEGAL PROCUREMENT AND ADDRESS TO RECIEVE CORRESPONDENCE.
We authorize Archbishop José Raúl Vera Lopez, Ernesto Rodriguez Cabrera, Maria Magdalena Lopez Paulino, Rodolfo Ondarza Rovira and other members of the Organization of Human Rights Solidarity Network Decade Against Impunity acting on our behalf during the processing of this request.
Here is our mailing address as well as e-mails and telephone numbers:
2da Cda de Ojo de Agua, No. 8, Col. Lomas de San Bernabé, Del. Magdalena Contreras, C.P. 10350, México, D.F.
Tel: (55) 24 62 88 96
E-Mails:
rddhorg@gmail.com
juridico_decada@yahoo.com.mx
ernestrodcab@hotmail.com
rondarza@scientist.com