National / Crime & Legal

Cervical cancer vaccine suit filed over side effects

by Tomoko Otake

Staff Writer

Sixty-three women and girls who reported side effects from cervical cancer vaccines sued the government and drugmakers on Wednesday as a sharp divide remained over the risks the medicine poses.

The plaintiffs, ranging in age from 15 to 22, filed suits in district courts in Tokyo, Nagoya, Osaka and Fukuoka, demanding compensation of at least ¥15 million each.

The plaintiffs say they experienced a wide range of health problems including headaches, fatigue and mobility impairment after receiving the human papillomavirus (HPV) vaccines between 2010 and 2013.

The plaintiffs also are demanding the state set up a nationwide network of specialists to help them with their symptoms. 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.

The drugmakers involved are GlaxoSmithKline PLC and Merck Sharp & Dohme Corp., who make the HPV vaccines Cervarix and Gardasil, respectively.

“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.”

More plaintiffs are expected to join the suit and the amount of claims could rise, the lawyers’ group said. It said 180 families so far have asked for consultations.

“I was not adequately informed of the benefits and hazards of the HPV vaccine when I received the shots,” said Nanami Sakai, a 21-year-old plaintiff from Saitama Prefecture.

Sakai said that said she fainted and came down with a high fever after receiving the second of the three recommended shots of Cervarix in March 2011.

After that, she began to experience multiple symptoms including muscle weakness, loss of memory and sensitivity to loud sounds.

“Hospitals and government agencies have not set up a system to handle side effects properly, even though it is the government that recommended the immunization,” she said.

In April 2013, the Health, Labor and Welfare Ministry began recommending that girls between 12 and 16 be vaccinated.

But the ministry ceased recommending the vaccines in June that year as allegations of side effects emerged.

According to the ministry, 2,945 of the 3.39 million women who had received the vaccines by the end of April, or 0.09 percent, have reported side effects.

Questions remain about what risks HPV vaccines pose and how exactly the side effects are caused.

While a panel of experts under the health ministry concluded in January 2014 that the side effects were “psychosomatic reactions” to the vaccine shots, the ministry also decided to compensate for the medical bills of some of the affected recipients in September last year, saying a causal link with the shots cannot be ruled out.

Health minister Yasuhisa Shiozaki told a news conference on Tuesday that while the causal link remains unclear it is important to continue support for people who have suffered after receiving an HPV vaccine.

Meanwhile, the two drugmakers released statements after the suit was filed.

GSK said the firm’s clinical trials, both before and after marketing of the product, show that the benefits of Cervarix outweigh the risk of side effects.

And MSD said there is “overwhelming scientific evidence” that its product prevents cervical cancer, adding that the firm will present evidence in court to counter claims made by the plaintiffs.