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SEC DISCLOSURES IN THE UNITED STATES

Sanofi swamped with 2,000 lawsuits

/ 07:10 AM March 09, 2018

CITY OF SAN FERNANDO—The French pharmaceutical giant Sanofi Pasteur, maker of the controversial dengue vaccine Dengvaxia, is dealing with more than 2,000 lawsuits in several countries involving various issues, including ill effects of its products, a public interest lawyer has informed Malacañang.

In a letter he sent to Executive Secretary Salvador Medialdea on Wednesday, lawyer Ernesto B. Francisco Jr. said the information was contained in Sanofi Pasteur’s disclosures to the US Securities and Exchange Commission (SEC).

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Francisco sent copies of his letter to Justice Secretary Vitaliano Aguirre II, Health Secretary Francisco Duque III and Solicitor General Jose Calida.

Dengvaxia mess

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The government had threatened to sue Sanofi Pasteur to get back P3.5 billion it had paid for supplies of Dengvaxia used in a massive immunization program that the Department of Health halted last Dec. 1 after the company disclosed that the vaccine worsened symptoms in vaccinated people who had not previously been exposed to the  dengue virus.

P1.6-B reimbursement

More than 830,000 schoolchildren had been vaccinated since April 2016, many have fallen ill and some have died, though the deaths have never been directly linked to Dengvaxia.

Sanofi Pasteur last month agreed to reimburse the government P1.6 billion for unused doses of the vaccine, but refused to give back the cost of used doses, saying that would mean Dengvaxia was ineffective, “which is not the case.”

Collaboration

Francisco earlier asked Malacañang to pursue legal action against Sanofi Pasteur in the United States, suggesting collaboration with the US Department of Justice and the US attorney general to determine whether the pharmaceutical company had violated US laws, including the Foreign Corrupt Practices Act and federal statutes on healthcare.

In his latest letter to Malacañang, Francisco said Sanofi Pasteur disclosed in 2012 that it was cooperating with the US justice department, which investigated the promotion in the United States of the drugs Seprafilm and Sculptra.

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He said Sanofi Pasteur paid $109 million in claims related to the sampling of a third drug, Hyalgan.

More cases

Francisco said the company was investigated in 2012 for complaints related to a supposed variability of response to the drug Plavix in the United States, for allegations it inhibited the entry of the same drug in France, and for alleged improper payments in the sale of products in two small markets.

In 2016, Francisco said, Sanofi Pasteur disclosed that it  and its affiliates were “involved in litigation, arbitration and other legal proceedings.”

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TAGS: Dengvaxia, lawsuit, Philippine news updates, Sanofi Pasteur, Securities and Exchange Commission
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