11th Dengvaxia complaint filed vs. Garin, 36 others

MANILA Another parent, whose teenage son reportedly died after being vaccinated with the anti-dengue vaccine Dengvaxia, filed a criminal complaint before the Department of Justice (DOJ) against former Health Secretary Janette Garin and 36 others on Monday.

Rowena M. Villegas, assisted by Public Attorney's Office (PAO) Chief Persida Rueda-Acosta, filed the case for reckless imprudence resulting in homicide under the Revised Penal Code; and violations of Anti-Torture Act and Consumer Act against Garin, some health officials and executives of manufacturer Sanofi Pasteur Inc. and distributor Zuellig Pharma Corp., for the death of her 11-year old son Michael V. Tablate, a student of Calapacuan Elementary School, Subic, Zambales. Michael died on October 31, 2017.

It was the 11th criminal complaint filed against Garin and other respondents before the DOJ so far, as the PAO has already documented 67 cases of alleged deaths from the vaccine.

The 10th complaint involving the case of Naomi Nimura, a 14-year-old Grade 8 student from Pasay City who died in November last year after being inoculated with Dengvaxia, is being handled by another panel of prosecutors.

As in earlier cases, the latest complaint accused Garin and others of negligence through "arbitrarily, maliciously, and deliberately failure to inform the Dengvaxia recipients and their parents/families of the dangers and risks related to Dengvaxia and to obtain their informed consent."

In her complaint, Villegas said his son received Dengvaxia on March 29, 2016, followed by another shot on November 10, 2016, and the third shot on July 12, 2017.

One week after the last dose, he allegedly experienced dizziness, headache, and vomiting. He was given paracetamol and appeared better, but in October 2017 he experienced asthma several times.

"Around a week after receiving his last shot of Dengvaxia, Michael experienced dizziness, headache, and vomiting, causing him to miss school... Since Michael was inoculated with Dengvaxia, he started having frequent asthma attacks," read her complaint.

It also cited the failure of the DOH under Garin to conduct proper screening of Dengvaxia recipients and to implement active and aggressive monitoring and surveillance over the recipients, considering the risks posed by the vaccine to seronegative recipients or those who had no history of dengue.

"Simply put, based on the admissions and declarations of respondent Sanofi Pasteur, Inc., if Dengvaxia is administered to a person who has not yet contracted dengue, that person will have a greater risk of developing severe disease, which would have been otherwise had Dengvaxia not been administered upon him," the complaint pointed out.

The respondents "displayed grave recklessness, utter bad faith, lack of foresight, lack of skill, want of care, gross neglect and deliberate, arbitrary and even malicious disregard of the safety and lives of thousands of Filipino children," it stressed.

Apart from Garin, Department of Health (DOH) officials named as respondents in the complaint include Dr. Vicente Belizario Jr., Dr. Kenneth Hartigan-Go, Dr. Gerardo Bayugo, Dr. Lyndon Lee Suy, Dr. Irma Asuncion, Dr. Julius Lecciones, Dr. Joyce Ducusin, Rosalinda Viianzon, and Mario Baquilod.

Also named as respondents are Food and Drug Administration officials Dr. Maria Lourdes Satiago and Melody Zamudio; and officials of the Research Institute for Tropical Medicine, namely, Drs. Socorro Lupisan and Maria Rosario Capeding.

Executives of Dengvaxia manufacturer Sanofi Pastuer and local distributor Zuellig Pharma are also included as respondents.

Sanofi Pasteur executives named as respondents are Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald and Jean-Francois Vacherand. While, those from Zuellig Pharma are Kasigod Jamias, Micheal Becker, Ricardo Romulo, Imran Babar Chugtal, Rayumund Azurin, Nilo Badiola, John Stokes Davison, Marc Franck, Ashley Gerard Antonio, Ana Liza Peralta, Rosa Maria Chua, Danilo Cahoy, Manuel Concio III, Roland Goco, and Ma. Visitacion Barreiro.

Also on Monday, the preliminary investigation into nine similar complaints, which are also backed by the PAO, resumed. The complainants in these cases are Aejay Bautista, Angelica Pestilos, Lenard Baldonado, Zandro Colite, Abbie Hedia, Jansyn Bataan, Mark Axel Ebonia, Rey Justin Almagno and Alexander Jaime.

Acosta filed a reply rebutting the defense submitted by Garin and company in their respective counter-affidavits last June 25.

In her answer, Garin has insisted that she cannot be held liable considering that the procurement of Dengvaxia underwent thorough process and that it's supposed theoretical risks were not yet supported by any data at the time of its implementation.

But Acosta argued that Garin cannot escape liability as she was then concurrent head of the Food and Drugs Administration that approved the vaccine even if it was still on clinical trial stage.

"The theory here is that the poor school children would not be inoculated with Dengvaxia if she did not pave the way for the product registration. They knew that it was still on clinical trial, why did they allow the vaccine on the children when it was still on experimentation stage?" she told reporters after the hearing.

The DOJ investigating panel chaired by Assistant State Prosecutor Maria Emilia Victorio then ordered the respondents to submit their rejoinder in the next hearing set for August 30 before concluding the preliminary investigation and resolving the first nine complaints that were consolidated.

Acosta disclosed that PAO is readying the complaints that will be filed before the DOJ over the deaths of three more children who received Dengvaxia.

Meron pa po tatlo kaming inihahanda na another set kaya magiging labing-apat ang mga criminal case (We are preparing three more sets of complaints so there will be a total of 14 complaints)," Acosta said.

She added that the PAO has received reports of over 200 possible deaths related to the inoculation of Dengvaxia.

Among these, she noted that the PAO has autopsied 67 and is set to autopsy seven more.

Paakyat na ng paakyat ang bilang so yung kinatatakutan namin na magkakasunud-sunod kapag hindi naagapan (This is what we fear. The number of deaths will rise if nothing is done about it), Acosta said.

Kapag hindi agad nabigyan ng DOH ng lunas itong mga batang ito ay mas dadami pa po ang patay (If the DOH don't do something about it, more children will die), she warned. (PNA)

Source: Philippine News Agency

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