Around the early 1960s, reports surged of babies born with limb and external-ear malformations, as well as miscarriages and stillbirths caused by internal organ damage. The cause was thalidomide contained in certain antacids and sedatives—intake during early pregnancy impedes fetal development. Even after warnings were issued worldwide, thalidomide products continued to be sold in Japan, leading to further damage and suffering. Affected children underwent repeated surgeries and rigorous rehabilitation and were subjected to stigma and bullying. In Japan, parents brought lawsuits against the government and pharmaceutical companies; the resulting settlement promoted major revisions to the Pharmaceutical Affairs Law.
| 1957 | Isomin sales begin in Germany Dainippon Pharmaceutical receives manufacturing approval |
| 1958 | Commencement of Isomin sales |
| 1960 | “Proban M” sales commence Health damage occurs (around the 1960s) |
| 1961 | Dr. Lenz’s warning and recall in Europe. Japan ignores Lenz’s warning as “lacking scientific basis” |
| 1962 | Due to successive incidents, thalidomide manufacturing and sales are halted in Japan; recall initiated |
| 1963 | Lawsuits filed against the government and pharmaceutical companies |
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1. Emergence of Thalidomide-Induced Suffering
Thalidomide preparations were developed in 1957 by Grünenthal in (then) West Germany and were subsequently marketed worldwide. Barely three months after the drug was launched in West Germany, Japanese pharmaceutical companies independently developed manufacturing methods, obtained approval, and began selling the drug as Isomin (a sedative) under the slogan “Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.” The drug was later incorporated into Proban-M (an antacid). Soon after marketing, reports mounted worldwide of babies born with limb malformations. In 1961, Dr. Widukind Lenz, a pediatrician at the University of Hamburg, warned of a causal link between maternal thalidomide intake and fetal malformations, prompting suspension and recall across Europe. In Japan, although the former Ministry of Health and Welfare (MHW) and pharmaceutical companies discussed the issue, sales continued on the strength of Grünenthal’s assurances that there was “no problem.” When Japanese media began reporting domestic cases of limb malformations, the MHW in 1962 ordered suspension and recall—roughly 9 months after West Germany. Continued sales and incomplete recall meant that the number of affected babies in Japan eventually reached 309.
2. Litigation and collaboration with scientists
Children harmed by thalidomide and their parents endured prejudice from medical staff and family members. Many children underwent repeated surgeries and strenuous rehabilitation; appearance-based stigma led to family strain—including divorce—and bullying at school. Despite their role in allowing sales to continue, neither the state nor manufacturers initially took action. Victims and supporters organized, and from 1963—beginning with a filing at Nagoya District Court—parents sued pharmaceutical companies and the state. The defendants categorically denied causality, prolonging the trials. Researchers and medical professionals joined the support network, assisting the lawsuits and public advocacy. In 1969, Prof. Sugiyama (School of Engineering, Osaka University) published “A Statistical Consideration of the So-Called Thalidomide Problem,” challenging Lenz’s warnings and later testifying for the defense; his claims were subsequently refuted on scientific grounds. While repeatedly refusing to accept responsibility, the state and companies floated settlement proposals. In 1974, they declared that they would “cease disputing causality and responsibility,” leading to settlement. Compensation was extended even to victims who had not sued, and, as a condition of settlement, welfare measures for victims were instituted. The foundation Ishizue was established as a support center for thalidomide victims and continues its activities today.
3. Implications for pharmaceutical regulation
The thalidomide litigation played a pioneering role in drug-induced suffering lawsuits and forced a re-examination of pharmaceutical regulation. In 1967, the Drug Affairs Bureau issued a notice, “Basic Policy on New Drug Manufacturing Approval,” tightening dossier requirements and restricting certain prescription drugs. However, the amendment of the Pharmaceutical Affairs Law itself would not occur until 1979, after the SMON litigation. Thalidomide has since been re-approved—under strict risk management—for multiple myeloma (2008) and for Hansen’s disease (2012). Its use is tightly controlled under the Thalidomide Education and Risk Management System (TERMS). The thalidomide tragedy is, therefore, not merely “past history”; continued vigilance, public education, and robust control systems for high-risk drugs remain essential to preventing new sufferings.
Reference
- The Pharmaceutical and Medical Device Regulatory Science Society of Japan (2012), 『知っておきたい薬害の教訓――再発防止を願う被害者からの声』YAKUJI NIPPO, (ISBN 4840812136).