Deadly fentanyl: García Furfaro requested the nullification of the expert reports that implicate him in the country's largest public health tragedy

The defense of the main defendant in the contaminated fentanyl case, Ariel García Furfaro, requested the nullification of the evidence that incriminates him in the case Ariel Fernando García Furfaro's defense attorney, lawyer Gastón Marano, filed a nullity challenge against what he considers one of the main pieces of evidence weighing on the owner of the HLB Pharma laboratories, the establishments that distributed and manufactured the contaminated fentanyl linked to at least 90 patient deaths. The brief, to which Infobae had access, targets the sterility test carried out jointly by the National Administration of Medicines, Food and Medical Technology (ANMAT), the National Institute of Medicines (INAME), and the private laboratory Gobbi Novag S. A., set out in a 991-page document titled "ANMAT Report on Sample Results." The challenged expert analysis examined "museum samples" (witness samples that must be kept by law) from lots 31201, 31202, 31244 and 31245 of fentanyl produced by HLB Pharma, as well as material sent by the Hospital Italiano de La Plata, with the aim of isolating bacteria for subsequent genetic sequencing at the Malbrán Institute. It was at that private hospital that the first fatal victims related to the potent anesthetic from HLB Pharma were recorded. The management of the Hospital Italiano filed the complaint with ANMAT, and this agency, which depends on the Ministry of Health of the Nation, reported it to the courts through the Argentine Federal Police. According to Marano's brief, that study constituted the "cornerstone" that led federal judge Ernesto Kreplak to his conviction regarding the genetic identity between the bacteria found in the museum samples and those detected in the victims' bodies. The defense argues that this was "the only time the museum samples of HLB Pharma and Ramallo were analyzed directly," which, in its view, makes any objection to their validity decisive. Gastón Marano, defense attorney for Ariel García García Furfaro, owner of HLB Pharma Group and Laboratorios Ramallo, was processed for the first time on September 25, 2025. In that ruling, Kreplak considered him "criminally liable as co-perpetrator of the crime of adulteration of medicinal substances resulting in the death of at least 20 people, in real concurrence with the crime of adulteration of medicinal substances in a manner dangerous to health," under articles 200 and 201 bis of the Criminal Code. The magistrate then ordered the businessman's preventive detention, as well as an attachment on his assets of one trillion pesos. On May 13, 2026, Kreplak expanded that accusation in a 382-page ruling and raised the number of judicially confirmed fatal victims from 20 to 90 deaths, adding 44 non-deceased patients with aftereffects: two with very serious injuries, 41 with serious injuries, and one with minor injuries. To arrive at that universe, the court cross-referenced the number of ampoules from lot 31202 purchased by each hospital with the medical records of patients who received five or more ampoules during the suspicion period, a criterion the ruling set as the sufficient threshold of exposure to the contaminated drug. The ruling itself notes that the figure could be higher, since "the circumstances emerging from the investigation allow us to affirm with certainty the existence of a greater number of cases than those charged." Estimates from epidemiological audits and parliamentary commissions cited in the case raise the total number of victims nationwide to a range of between 121 and 173. According to the judicial ruling, García Furfaro is attributed with decision-making power over all relevant aspects of both laboratories, full knowledge of the production deficiencies that led to the contamination of lots 31202 and 31244 —manufactured in December 2024 at the Ramallo plant—, the destruction of digital evidence through the erasure of the company's servers on May 6, 2025, and the omission of the pharmaceutical recall of the batches already sold despite knowing the situation. The central support of the accusation is the genomic match confirmed by the Malbrán Institute between the bacteria Klebsiella pneumoniae and Ralstonia mannitolilytica found in infected patients and those detected in the seized fentanyl ampoules, a finding that comes precisely from the sterility test that the defense now seeks to annul. Also processed in the case were his brother Diego Hernán García (detained like his brother Ariel), technical director José Antonio Maiorano (detained), general director Javier Tchukrán (house arrest), Ramallo's technical director Carolina Ansaldi (house arrest), and the García brothers' mother, Nilda Furfaro (house arrest), among other executives and quality control officers of both firms — 13 in total. The defenses appealed the expansion of the processing on September 24 before Chamber III of the Federal Court of Appeals of La Plata, which has not yet ruled on the appeals. The former heads of ANMAT and INAME, Agustina Nélida Bisio and Gabriela Mantecón Fumado, processed in the contaminated fentanyl case In a second stage of the investigation, the court also processed the then-top authorities of the control agencies involved in the challenged expert analysis: Nélida Agustina Bisio, former head of ANMAT, and Gabriela Mantecón Fumadó, former director of INAME. Both were detained but regained their freedom after paying a real bail of 75 million pesos each. The first argument of the nullity challenge is based on article 258 of the National Criminal Procedure Code (CPPN). Marano explains that the court did not notify any defense of the request for the expert analysis nor allowed the offering of party-appointed experts, "not even —as is customary— at the expense of a public defender." According to the brief, by the time the study was carried out there were already identified suspects: the HLB and Ramallo laboratories had been raided and their executives were sending information to the court "in an act of material defense." The prosecution and the court maintain that all procedural steps were followed, giving each of the defenses the possibility of supervising each step throughout the complex judicial investigation. The document adds that, since the act was not formalized as an expert analysis in the technical sense, the intervening professionals did not take an oath or accept the appointment under the terms of article 257 of the CPPN, "their conduct being left solely to their conscience." For the defense of the defendant, who may face a prison sentence of 25 years: "The foregoing, I believe, implies a failure to comply with the provisions of Art. 258 of the CPPN, which is explicitly sanctioned with the penalty of nullity (see Art. 166 CPPN), without prejudice to the fact that it also implies an impairment of the defendant's representation." Judge Ernesto Kreplak, in charge of investigating Argentina's greatest health tragedy The brief states that the study of the "museum samples" was left in the hands of "experts who turned out to be employees of a laboratory that is a competitor of Ramallo and HLB Pharma, supervised by experts dependent on the Ministry of Health of the Nation, specifically INAME." For the defense, that combination "represents the worst imaginable nightmare for any defense," since those who were to establish the defendant's criminal responsibility "were selected from among dependents of the complainant and dependents of a commercial competitor." The challenge highlights that there is no documentation on the technical criterion followed to choose the laboratory Gobbi Novag S. A. among other laboratories with validated sterility systems, so the designation "appears to have been completely discretionary." According to Marano, the technical director and other executives of that firm were previously charged in a smuggling case for connivance with INAME personnel, from which they were later dismissed, and the company has recent records of quality deviations, including a ban ordered by ANMAT on June 8, 2024 on a batch of Clindanovag for presenting particles in suspension, and another on June 12, 2026 on batches of Gobbifol/Propofol. One of the complainants consulted by this outlet about the objections raised by García Furfaro's defense, which has not yet been resolved by Judge Kreplak, opined: "It is relatively irrelevant because the Malbrán Institute detects genetic identity anyway, and bacteria from patients from several hospitals match bacteria from sealed ampoules that remained at the Hospital Italiano de La Plata, and also those sent by ANMAT are the museum samples seized at Ramallo, the manufacturing laboratory." Twelve of the 90 fatal victims related to the contaminated fentanyl from HLB Pharma The defense devotes an extensive section to questioning the impartiality of INAME personnel, the control agency that, together with ANMAT, depends on the Ministry of Health. The brief recalls that, through the ruling of August 20, the court itself had revoked the complainant status of the Health Ministry by acknowledging that "a sufficient degree of suspicion has been generated to orient the continuation of the investigation toward possible responsibilities derived from omissions and/or connivances that may exist in the control agencies." For criminal lawyer Marano, that same suspicion "a fortiori" should extend to the technical opinions produced by those agencies, especially when the then national administrator of ANMAT and the director of INAME were later charged in the case. The brief cites statements incorporated into the case file, including that of Mantecón Fumadó herself, who reportedly stated that no report from the agency could be issued "without being previously authorized and the response evaluated and corrected by Ministry personnel." According to that statement, cited in the challenge, the minister would have personally instructed the closure of García's laboratories: "Yes, close it, close it." García Furfaro's defense does not say it, but the statement also makes clear that the urgency in closing HLB Pharma and Ramallo was due to the serious irregularities detected in the latest audits and, above all, in the previous one carried out weeks before the production of the contaminated fentanyl. An infographic details the hierarchical structure and positions of the 15 defendants in the judicial case over the contaminated fentanyl at Laboratorios Ramallo SA and HLB Pharma Group. (Illustrative image Infobae) The second technical pillar of the challenge relies on a report by biochemist Pablo César Ramírez (M. N. 10,700), submitted by the defense, which according to the brief "identifies three methodological aspects that did not conform to the mandates of the Argentine Pharmacopoeia." The first refers to the failure to comply with the environmental conditions required for the sterility test, which according to the current protocol had to be performed "under aseptic conditions under Class A or its equivalent designation." The document details that Gobbi Novag's own environmental controls detected microbiological contamination in 15 areas, including the laminar flow bench and the operator's gloves, when the regulations require less than one colony-forming unit on each analyzed surface to validate the study. Raid by the Argentine Federal Police at Ariel García Furfaro's laboratories To that defect are added other alleged irregularities: the Microbiology Air Unit (UMA11) presented calibration failures and its qualification report "was left without a final verdict: the 'SUITABLE' and 'NOT SUITABLE' boxes were not marked and the signature boxes are blank." The personnel in charge of the incubation stove, as recorded in the file cited by the defense, "had no completed training" in its handling, despite which the equipment was declared suitable. The party-appointed expert report also questions the transport of the material. It states that, in violation of ANMAT regulations requiring one sample per container, 16 plates were placed together inside the same reused box, identified as No. OI 2025/963-INAME 169. According to the brief, the analysis of the photographs revealed that this container originally belonged to the laboratory Bioartis, a firm that markets reference cultures of Klebsiella pneumoniae, the same bacteria that the expert analysis claimed to have found in the museum samples. "Why use one from a laboratory that uses them to send the same bacteria that was being sought?" the document asks. At this point, it is worth recalling that the contaminating bacteria had already been detected by the laboratory of the Hospital Italiano de La Plata, which led to the complaint being filed with ANMAT. The third pillar of the technical challenge refers to the lack of chain of custody of the samples. The brief states that there is no "instrument —spreadsheet, form or record— that documents, leg by leg, who delivered, who received, on what date and time, in what condition and under what identification the material, with the signatures of those involved." According to the defense, the procedure provided for in article 233 of the CPPN was not followed either, nor was Resolution PGN 74/2024 taken into account, which establishes a guide of good practices for the preservation of evidence in criminal investigations. The deaths from the contaminated fentanyl are considered the country's greatest health tragedy The document also cites a contradiction between records: while one report mentions "14 (thirteen —sic—) ampoules in a box labeled as original sample" at folio 9, the same figure is repeated identically at folio 14, without it being clear whether the actual remainder was 13 or 14 units. For the defense, these inconsistencies, added to the lack of documented records, make it impossible to guarantee that the ampoules analyzed at Gobbi Novag were effectively the same ones originally sent by ANMAT. Based on the set of irregularities described, the defense asked the court to declare the nullity of the proceedings carried out by INAME and Gobbi Novag, and, subsidiarily, to repeat the expert analysis "with impartial court-appointed professionals and with the participation of party-appointed experts," with a preference for the involvement of public universities. The brief argues that "each of these defects, considered in isolation, is sufficient to declare the requested nullity" and that, "considered together, it becomes unavoidable." The document also introduces a federal case reservation under the terms of article 14 of law 48, invoking articles 18 of the National Constitution, 8.2 of the American Convention on Human Rights, and 14 of the International Covenant on Civil and Political Rights, and leaves open the possible intervention of international human rights organizations should the challenged evidence continue to sustain the processing of Ariel García Furfaro.