Class Action Lawsuit Against HPV Vaccine Filed in Colombia

A class action lawsuit has been filed in Colombia against the Colombian government and Merck Sharp & Dohme by a group representing 700 individuals who allege that they have been damaged by Gardasil, the company's human papillomavirus (HPV) vaccine.

An ongoing class action lawsuit over the HPV vaccine in Japan involves 63 plaintiffs.

The Colombian Rebuilding Hope Association (Asociación Reconstruyendo Esperanza), represented by the lawyer Monica León del Río, filed a class action on August 4 seeking compensation of at least 490,000 million Colombian pesos (approximately $30.5 million). The association is calling for compensation for the damage allegedly due to the vaccine, mainly symptoms that affect the immune and neurologic systems, and also is calling for a declaration that the vaccine is unsafe.

However, the safety of the HPV vaccine has been repeatedly confirmed by the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

In a 2009 JAMA article on the postlicensure safety surveillance for quadrivalent HPV recombinant vaccine, the authors reported that the most frequently reported side effects were lower grade, including excessive pain in the area of application and occasional headaches or dizziness, at rates of 7.5 cases per 100,000 doses.

The most comprehensive study on this subject followed up on more than 2 million women and reported a statistically nonsignificant association between exposure to the vaccine and severe adverse events, such as demyelinating diseases (including Guillain-Barré syndrome).

H PV Vaccines in Colombia

In Colombia, the use of HPV vaccine in government public health initiatives dates back to 2006, with implementation of the three-dose scheme in 2012.

Dr Lina María Trujillo, coordinator of the Gynecologic Oncology Group of the National Institute of Oncology in Colombia, commented to Medscape Medical News that the lack of trust started in 2014, when a group of girls who had recently been vaccinated presented various symptoms, possibly associated with food poisoning. Although a causal link was never shown, the rumor that the vaccine had caused the symptoms spread, and the association for the alleged victims of the vaccine, led by the local lawyer Monica León del Río, was formed.

León del Río had already submitted similar lawsuits, which were made public knowledge by the Colombian Rebuilding Hope Association. A 2015 lawsuit aimed to force the Colombian government to generate a record of cases of vaccine adverse effects, as well as to institute federal monthly compensation to the alleged victims.

This article was produced in collaboration with the Spanish edition of Medscape.

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