Claimants seen raising U.S. FDA ruling in Dengvaxia lawsuits

MANILA – Claimants seeking compensation for loss or injury are expected to raise the U.S. Food and Drug Administration’s adverse finding against Dengvaxia to bolster their lawsuits, a senior member of Congress said on Sunday.

“Offhand, the U.S. FDA’s discovery – that Dengvaxia ‘appears to act like a first dengue infection’ in people with no prior dengue virus infection – tends to favor the claimants,” said Surigao del Sur Rep. Johnny Pimentel.

“The advantage of a civil action for damages is that the claimants only need a preponderance of evidence to establish their entitlement to potential awards,” Pimentel said.

Pimentel’s remarks came not long after several Quezon City regional trial courts consolidated the various claims for restitution filed by parents of Filipino schoolchildren who died allegedly of complications from severe dengue disease after receiving Dengvaxia shots.

The plaintiffs are seeking reparation from respondents Sanofi Pasteur, the French maker Dengvaxia, and distributor Zuellig Pharma Holdings Pte. Ltd.

The U.S. FDA recently ruled that: “Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection – without actually infecting the person with wild-type dengue virus – such that a subsequent infection can result in severe dengue disease.”

Pimentel is former chairman of the House good government and public accountability committee that conducted a joint inquiry with the House health panel into the Philippines’ controversial anti-dengue vaccination program using Dengvaxia.

Some 730,000 children received Dengvaxia shots – regardless whether they were previously infected by dengue or not – under the school-based program launched in April 2016.

The inoculation program was abandoned in December 2017, when adverse findings against the world’s first anti-dengue vaccine first became public.

The Department of Health is spending another P213 million this year to deploy an additional 425 nurses to keep an eye on children who received Dengvaxia shots, according to Pimentel.

Pimentel said the nurses will visit public schools to check on the health condition of vaccinees. Others will be assigned to hospitals to keep close tabs on admissions of vaccinees.

The P213 million is on top of the P1.16 billion that Congress earmarked in 2018 “to provide the necessary health and medical assistance to Dengvaxia vaccinees,” Pimentel said. (Photo Source: ABS-CBN News)