Class Action Lawsuit Against HPV Vaccine Filed in Japan

Zosia Chustecka

July 27, 2016

A class action lawsuit has been filed today in Japan against the human papillomavirus (HPV) vaccines, which are given to protect against cervical cancer.

The lawsuit has been filed against the Japanese government and the manufacturers of the HPV vaccine (GlaxoSmithKline, which markets Cervarix, and Merck & Co, which markets Gardasil).

It has been filed by lawyers on behalf of 63 plaintiffs (aged 15 to 25 years) who allege that they have experienced adverse effects after receiving the vaccine and are demanding compensation of at least ¥15 million ($140,682) each.

The plaintiffs say they experienced a wide range of health problems, including headaches, fatigue, and mobility impairment, according to a report in The Japan Times.

The plaintiffs have filed suits in four district courts in Tokyo, Nagoya, Osaka, and Fukuoka. In addition to compensation, the plaintiffs are demanding that the state set up a nationwide network of specialists to help them with their symptoms, the newspaper reports. In addition, they want it to subsidize research for finding a cure and to support victims as they seek to continue their educations and search for jobs.

"This lawsuit aims to bring the victims back to health and ensure a secure life for them, by clarifying the legal responsibility of the defendants," Masumi Minaguchi, a lawyer representing the women, told a news conference in Tokyo. "We want to prevent any recurrence of drug-induced illness."

The lawyer also said that the number of plaintiffs in the class action lawsuit was likely to increase, as 180 families so far have asked for consultations.

Vaccine Was Recommended, and Then Not

The HPV vaccines were first launched in Japan in 2009, and vaccination programs were funded first by local and then the central government.

In April 2013, the Ministry of Health, Labor and Welfare recommended that girls between 12 and 16 years of age should receive the HPV vaccine and included it in the National Immunization Program (so it was given for free).

However, the Ministry then withdrew that recommendation a few months later, in June 2013, after highly publicized reports of alleged health problems that appeared after vaccination, as previously reported by Medscape Medical News.

The Japan Times newspaper notes that, according to the Ministry, side effects have been reported by 2945 women (0.09%) from among the 3.39 million women who had received the vaccines by the end of April 2013.

A television report about the class action lawsuit on "NHK World" says that the plaintiffs argue that the government should not have recommended and subsidized the HPV vaccines before ensuring that they were safe.

The TV report notes that the Ministry and GlaxoSmithKline have refused to comment on the lawsuit but that Merck & Co has said that "it will present evidence in court that will prove the claims are baseless."

The TV report also notes that cervical cancer is responsible for 3000 deaths annually in Japan and that the incidence in young women is increasing, which is causing concern among experts.

Japanese experts in obstetrics and gynecology have been petitioning for the HPV vaccine program to be reinstated in Japan, arguing that the current low rates of vaccination could lead in the future to highly preventable cervical and other HPV-related cancers.

Speaking recently in a Lancet podcast, Ryo Konno, MD, from Jichi Medical University, Saitama Medical Center, Japan, emphasized that in 2013, the Ministry of Health did not clearly communicate whether there was a causal relationship between the vaccine and the adverse events. Health officials said that girls could be vaccinated if parents understood the risks and efficacy, but the HPV vaccines could not be actively promoted, he said.

"Health officials were so confused," he said. "Consequently, coverage from the vaccine dropped from 70% to only 1%."

Dr Konno has received honoraria from Roche Diagnostics and BD and is the director of the Executive Board of the Japanese Expert Board for the Eradication of Cervical Cancer, which has received unrestricted funding from Qiagen; Merck, Sharp & Dohme; and GlaxoSmithKline.

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