In the U.S., the human papillomavirus (HPV) vaccine has been a subject of controversy from the very beginning after Merck’s Gardasil vaccine was licensed in 2006.1 Japan is one of the many nations raising concerns about HPV vaccine following persistent reports that girls are suffering severe adverse effects after getting vaccinated.2
Controversy Surrounding Safety of HPV Vaccine in Japan
Here is what happened in Japan in a nutshell. In December 2010, the HPV vaccine (both Merck’s Gardasil and Cervarix manufactured by GlaxoSmithKline) was provided at no cost to Japanese girls between the ages of 12-16 years old. In April 2013, the vaccine was officially included in Japan’s national immunization program. However, two months later, Japan’s Ministry of Health, Labor and Welfare publically announced that it had decided to withdraw its HPV vaccine recommendation.3 The decision was in response to numerous reports that formerly healthy vaccine recipients were experiencing alarming side effects ranging from short-term memory loss to paralysis.4 In October 2013, a special taskforce was formed to investigate the side effects of the HPV vaccine.5
Interestingly, HPV vaccines were not withdrawn from the market in Japan and continued to be available, but local governments, as advised by Japan’s Ministry of Health, Labor and Welfare, did not actively promote its use. Girls can still receive the vaccine if they chose to do so but doctors and other vaccine providers must inform them that the health ministry does not recommend it.6
The Nationwide Liaison Association of Cervical Cancer Vaccine Victims and Parents in Japan and Dr. Sotaro Sato, director of the Sato Cardiovascular Internal Medicine Hospital in Osaki speculate that the motive behind this decision is more than likely due to:
fear of potential lawsuits being filed by the association on behalf of numerous desperate families whose beloved, previously healthy daughters have been seriously impaired, paralyzed or horribly devastated by HPV vaccinations. Japanese courts would be likely to find health bureaucrats responsible for the serious adverse effects inflicted on the girls if they did not take precautionary measures beforehand and leave some evidence that could later be used to prove they had at least tried to do something to block the further spread of health impairments to upcoming generations of teenage girls. This would be a particular problem if the government moves to reinstate their recommendation of these vaccines during the current fiscal year ending on 31 March 2014, due to pressure from politicians and academics with financial ties or other links to the vaccine manufacturers, lobbying activities, and consulting ‘experts’ hired by the manufacturers.7
Almost three years later, The Japan Times recently reported that a class action lawsuit will be filed after June 2016 against the Japanese government, Merck and GlaxoSmithKline by victims who have suffered severe side effects as a result of receiving the former government recommended vaccine. Twelve plaintiffs will file the lawsuit at four district courts in Tokyo, Nagoya, Osaka and Fukuoka.
The plaintiffs are demanding answers as to why they were not informed of the risks of HPV vaccine prior to receiving it.8 The defense team will be hosting seminars in the next two months in hopes of seeking additional plaintiffs.8
Vaccine-Injured Victims Cannot Sue Vaccine Makers in the U.S
Unlike in Japan where vaccine-injured victims can directly file a lawsuit against the state and the vaccine manufacturers, the judicial process in the U.S. for vaccine-injured victims of HPV and other government recommended or mandated vaccines is remarkably different, to say the least.
Under current U.S. federal law, no one can directly sue a vaccine manufacturer in civil court after a vaccine causes the injury or death of a minor child or adult.9 To understand how this came about, it is important to understand the historical context of this issue.
Back in the early 1980s, parents were filing lawsuits on behalf of their minor children who were damaged or died from reactions to the diphtheria-tetanus-pertussis (DPT) vaccine and the live polio vaccine.
It was during this period when pharmaceutical companies demanded that Congress pass a law protecting them from all product liability from vaccine injuries and deaths by establishing a federal Vaccine Injury Compensation Program (VICP) to compensate vaccine-injured children.11 But with strong opposition from co-founders of the National Vaccine Information Center (NVIC) and other consumers, the 1986 National Childhood Vaccine Injury Act preserved product liability if compensation was denied or there was evidence the drug company could have made a vaccine safer.10
NVIC co-founder and president, Barbara Loe Fisher, said:
Parents successfully argued that, if Congress was going to give drug companies partial liability protection through the creation of a federal vaccine injury compensation alternative to a lawsuit, then language had to be written into the National Childhood Vaccine Injury Act of 1986 that protected a citizen’s right to sue drug companies when federal compensation was denied, or the company had the technological ability to make a vaccine less toxic but refused to do it. Continued civil liability was the safety net for American consumers in that law. Continued civil liability was the leverage that gave some financial incentive for drug companies to make vaccines safer and gave some political incentive for government officials to award federal compensation to the vaccine injured.”10
Fast-forward to 2011, in a split decision with Justices Ruth Bader Ginsberg and Sonia Sotomayor dissenting, the U.S. Supreme Court gave complete product liability protection to vaccine manufacturers and banned lawsuits against pharmaceutical companies for injuries and deaths caused by FDA licensed vaccines, even in cases of design defect. The ruling was in response to a 2005 lawsuit filed against Wyeth Inc. (now Pfizer, Inc.) and brought to the high court by the parents of Hannah Bruesewitz, who suffered encephalopathy and a residual seizure disorder after being given a third DPT shot in 1992.
Initial claims brought forth by Bruesewitz’s parents under the national VICP in 1995 were rejected driving them to file a civil court lawsuit against Wyeth, Inc. based on design defect.13 According to American Medical News, the U.S. Supreme Court stated:
The act reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the [Food and Drug Administration] and the National Vaccine Program, rather than juries.12
So, now, unlike the original National Childhood Vaccine Injury Act of 1986 that gave plaintiffs the option to sue drug companies when denied federal compensation, today Americans are restricted from suing vaccine manufacturers and instead are required to sue the Secretary of DHHS by filing a vaccine injury claim through the VICP.12
The 2011 Supreme Court ruling was a corporate bailout of vaccine manufacturers that excused the industry from any sort of accountability, leaving them with no incentive to make vaccines safer.10 The increasing number of states mandating more vaccines and restricting or removing vaccine exemptions, together with the failures of the VICP and Pharma’s total liability shield, is leading to more widespread questioning of U.S. vaccine policies and laws.
The fact that vaccine victims in Japan (and other countries) have the legal right to hold pharmaceutical companies liable for the safety of their products in civil court and vaccine victims in the U.S. do not, is adding more fuel to the debate about vaccine safety and choice.