13 for trial in health scandal that killed 291

The diethylene glycol poisoning scandal that took the lives of nearly 300 Panamanians using government supplied medicine was the result  of a cultural laxity in the Social Security Fund (CSS).

The tragedy came to light over five years ago, when it was discovered that patients had received cough mixture prepared from diethyline glycol and  after five  years of investigation a Panama court ruled in December that  it was caused by the "simultaneous collapse of structures and levels of control over the chain of procurement, production and development and service of drugs.”  This was the result of "lax culture, known to the then director of the  (CSS), René Luciani, said the court ruling, reported by La Prensa.

Thirteen people are going to trial and 14 cases have been dismissed.

René Luciani, is accused of crimes against public health because in the opinion of the judges he was aware of the precarious situation of Drug Production Laboratory.

As director of the CSS, Luciani "must exercise the proper administration of the institution, establishing and maintaining effective internal control system that had as its purpose the obtaining reasonable assurance, and be responsible for maintaining an organizational culture that will not tolerate the perpetuation of practices that fostered the work climate that gave rise to serious deviations in internal control, and possible contaminated drug development."

According to the ruling: “The situation in the CSS reveals how the same quality control laboratory on two occasions examined the toxic diethylene glycol, first as a raw material and then as part of a finished drug product, and on both occasions certifies that it was examined examined  and complies with the requirements of law for human consumption."

The judges also noted that  Luciano  was aware of a "precarious situation" in the laboratory after the Internal Audit Department of the CSS, listed at least 17 listed failings and  the absence of a manual of procedures and control.

Exonerated

The court's decision,  exonerated former directors of the CSS John Jované and Rolando Villalaz, Jovane because  he was separated from the office five weeks before  the diethylne glycol was shipped and for  Villalaz, the ruling said that although he had knowledge of laboratory conditions, management  had signed an agreement with the University of Panama to  better conditions

Prosecutions against a group of managers were dismissed because  although they knew that drugs were made in conditions of risk of contamination and poisoning, they  had no operational responsibility.

The judges indicated that managers "are involved in top management issues and macro-management, which have no connection with material operations in drug development."

In contrast, the court said  that former Ministry of Health Director of Pharmacy and Drugs, Pablo Solis and a former official of that office Ralph Anderson,  undermined public health and  breached the law that made them "responsible for the pre and post control, and pharmacological vigilance in the country to ensure the quality, safety and efficacy of medicines."

The judges considered that both Solis as Anderson had as one of their functions: "to conduct inspections  of pharmaceutical establishments, with the possibility of taking actions such as suspension of the operation to operate or import of pharmaceuticals, chemical or biological."

Angel De La Cruz, manager of the company Medicom, which imported to Panama, the poison is the only person arrested and faces charges of culpable homicide, drug crimes and falsifying public documents.

According to the court, De La Cruz came fixed notices on drums containing the poison labels with a false expiration date, which coincided with the expiration of the product specified by the Spanish company Rasfer International.

The court also opened criminal proceedings for crimes against public health Medicom's legal representative, Josefa De La Cruz, but acquitted her other directors: Alejandro De La Cruz and Alexander De Silks, since the latter had resigned prior to  the importing the poison.

The court  noted that the Medicom Group, with operations from June 11, 2001, was inspected by the Pharmacy and Drug Directorate of the Ministry of Health and did not meet the minimum requirements to operate, but despite this was issued an operating license on April 25m 2002.

Also called for trial  is  Theophilus Gaten, owner of the company Davivienda SA, who gave the funds to import Medicom toxic. The court noted that Gaten emerged linking the business relationship between both companies.

The court also assigned responsibility for crimes against public health by former Director of Procurement and Supplies of the CSS Alexis Zuleta, and officers of the entity Nereida Isabel Quintero Velasco and Marta Sanchez Cristelly Castle, "for failing to comply with its functions of supervising the Laboratory of Drug Production and Quality Control. "

Edward Taylor, Linda Thomas, Miguel and Ignacio Torres Algandona, officers in the entity must respond to charges of manslaughter crimes against public safety and, after the court noted that should ensure the quality of medicines produced for human consumption and that his conduct was "highly negligent".

The ruling states that in the case of Taylor, this was not consistent as head of Quality Control Laboratory, as it failed to exercise its oversight function.

Meanwhile, in the case of Thomas, head of Drug Production Laboratory, the court indicated that it acted negligently in accepting the certificate of analysis as glycerin for human use, when in fact it was poison.

Miguel Algandona shares responsibility for who certified that the glycerin sent by the Spanish company Rasfer International was for human consumption, without having the tools to ensure that it did, and Torres, laboratory assistant, for supporting these

According to the latest figures from the Public Ministry, in addition to the 291 confirmed deaths there are another 111 cases of patients who survived.

Dismissals appealed

The public proseuctor has appealed the dismissals to the Criminal Chamber of the Supreme Court and has appealed against the decision of the Second High Court granted a temporary stay of six members of the Board of Directors of the Social Security Fund (CSS ), the former director of Jované, two directors of the company Medicom SA and the legal representative of the Spanish company Rasfer International, Assumption Criado, defendants in the case..

Attorney General  Joseph Ayú Prado, disagreed with the court in its decision to preempt Jované and managers of the CSS, as there is sufficient evidence in the record proving their connection with the offense of violating public health.

Moreover, in the case of the International Rasfer legal representative, the attorney said his involvement was also evident in the research, as it was the person responsible for handling the purchase of glycerol consumption, which, however, the ultimately proved to be the toxic diethylene glycol.

René Luciani questioned the arguments of the Second Court of Justice to call  him to trial for crimes against public health. 

Luciani said that the court used a subjective assessment by stating that his administration promoted "a lax corporate culture", as he always maintained a high professional level, with hours of work over 12 hours.

He also said that his predecessors in the direction of the CSS never reported the situation of the Laboratory of Drug Production and never had a direct communication to the requesting person inputs to improve their condition.