DOH studying lawsuit vs Sanofi

MANILA, Philippines — The Department of Health (DOH) is looking at laws and documents to sue French pharmaceutical firm Sanofi Pasteur for rejecting its two demands in connection with the mess created by the Dengvaxia vaccine.

There are provisions in the Civil Code that pertain to liability for products that do not offer the safety or benefits they were expected to have, according to Health Secretary Francisco Duque III.

“It’s in the Civil Code, in case of defective products,” he said yesterday in a phone interview, apparently referring to Republic Act No. 7394 or Consumer Act of the Philippines approved in 1992.

Under Chapter 5, Article 96 of the law, “any Filipino or foreign manufacturer, producer and any importer, shall be liable for redress, independently of fault, for damages caused to consumers by defects resulting from design, manufacture, construction, assembly and erection, formulas and handling and making up, presentation or packing of their products as well as for the insufficient or inadequate information on the use and hazards thereof.”

Duque noted that DOH lawyers have also been reviewing the contract that the agency signed with Sanofi to establish the company’s liability, since Dengvaxia was found to have harmful effects on individuals who did not have history of dengue prior to vaccination.

“I have not seen the contract but our lawyers are reviewing it now,” he added.

Last Monday, Sanofi turned down Duque’s demands to reimburse some P1.9 billion for the vaccines used in the DOH’s anti-dengue immunization program and to financially support an indemnification fund for vaccinated children.

Sanofi said it agreed to reimburse the government for unused vaccines amounting to some P1.2 billion but not to return the payment for vaccines already administered.

It said that agreeing to a full refund “would imply that the vaccine is ineffective, which is not the case.”

The company added they could not support the indemnification fund because “data remain quite clear that, in absolute terms, dengue vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden associated with this disease.”

Hysteria spreading

Duque and medical experts yesterday warned about the spread of panic triggered by the Dengvaxia controversy that could lead to casualties because of parents’ fear of having their children vaccinated against various diseases.

At the resumption of the joint hearing of the Senate Blue Ribbon and health committees into the controversy, Duque and other health experts called for closer cooperation among concerned agencies in investigating the reported deaths of those inoculated with the vaccine.

Duque cited a case in Davao City last week where a local official reported that mothers are refusing to have their children injected with anti-measles vaccine.

He said the controversy has “tainted other innocent vaccines” that even the DOH’s deworming programs are running into difficulties with parents.

“We’ve seen other versions of this. Parents tend to absorb everything mentioned about this even from questionable sources,” Duque told the inquiry presided over by Sen. Richard Gordon, chairman of the Blue Ribbon panel.

Duque asked that pronouncements from the government be evidence and science-based, as he noted an effort to create hysteria among parents.

University of the Philippines-Philippine General Hospital director Dr. Gerardo Legaspi appealed for sobriety.

“I’d like to ask everyone in power, I think if you want to stop the hysteria, since you have the power, tell everyone to stop talking, including us,” Legaspi told the hearing.

He said the government stakeholders should have a “common message” to allay fears on Dengvaxia, which was injected to over 830,000 people, mostly schoolchildren, in 2016.

Meanwhile, Sen. Joseph Victor Ejercito, chairman of the health committee, moved to subpoena Public Attorney’s Office (PAO) chief Persida Acosta and forensic laboratory director Dr. Erwin Erfe after they skipped the hearings three times in a row.

Ejercito noted that the PAO has been conducting autopsies on children who allegedly died after being injected with Dengvaxia and refused to share information with the DOH expert group investigating the vaccine’s effects.

He noted that there are only two certified forensic pathologists in the country and one of them, Dr. Cecilia Lim, is with the expert group.

Ejercito, whose son was injected with Dengvaxia, said the PAO appears to be rushing its investigation to file charges and causing alarm among concerned parents in the process.

“If you’re a parent and you read and listen to the news from the PAO, you will definitely be agitated,” the senator said.

During the hearing, members of the DOH panel of experts also clarified there remains no definitive and conclusive test yet that can determine whether the controversial vaccine caused the reported deaths.

Dr. Mary Ann Lansang, a member of the panel, however, said the collection of samples and close surveillance of those injected with Dengvaxia must continue.

Gordon said the lack of conclusive tests could make it difficult for the government to prosecute Sanofi.

Garin cries foul

Former health secretary Janette Garin cried foul over how some people are promoting a mob mentality among the parents who lost their children supposedly because they were administered Dengvaxia.

 Garin recalled how she was mobbed last Monday at the House of Representatives after her attendance at a hearing on the Dengvaxia issue, which she said appeared to be staged.

She said that she understood how many of the parents were hurting from the loss of their children but lamented how the issue is being used by some sectors to create a rift between the doctors and their patients.

 “It’s with a heavy heart that I see some victims again being victimized by groups,” Garin said on the sidelines of the hearing by the Senate Blue Ribbon committee on the Dengvaxia vaccine.

 Garin recalled reports coming out that some of the parents wanted to have a dialogue with her and said that she refused, which she denied.

 She noted how she was mobbed while she was walking out of the committee room and that no one approached her beforehand to ask for dialogue.

 “But it’s something that I don’t expect to be happening in the Philippines where some people are promoting others to go into a mob mentality. One of them was even screaming that they no longer want an investigation and just want blood. Why is this happening to us? Why isn’t this happening in other countries? This is happening because of all the hysteria and panic that is being created,” Garin said.

 She lamented how some groups were exploiting the situation by making the parents believe that the deaths of their children were caused by the vaccine. – With Paolo Romero, Marvin Sy