Drug-induced muscle contracture

From 1960 to 1970, children who were injected with antipyretics and antibacterial agents in the muscles developed symptoms such as difficulty walking and muscle pain. In 1978, a group of victims filed a lawsuit in the Kyoto District Court to seek responsibility and compensation for damages. After 18 years of litigation, the victims’ group reached a settlement with the medical institution and the pharmaceutical company. Today, as the victims age, their lives and activities are becoming more difficult, and they are seeking support from the national government.

1960Damage occurred (circa 1960-1970)
1974Notice from the Japan Medical Association on Measures to Prevent Muscle Shortening
1976Apology Statement by the Japan Pediatric Society
1978Lawsuit filed by the Keiji Council for the Protection of Children from Injection-Induced Muscle Shortening
1996Settlement with medical institutions and pharmaceutical companies; no state or physician liability
chronology
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1. injection-induced muscle shortening

Muscle shortening is a drug-induced disorder in which muscle contractures in the thigh muscles and other parts of the body caused by muscle injections in children result in movement disorders such as difficulty walking and living. In the past, injections were used to treat minor illnesses such as a cold, as it was believed that injections had more immediate and effective effects than oral medications. In addition, the economic benefits-oriented operation of the universal health insurance system that started in 1961 and the marketing of injectable solutions by pharmaceutical companies are believed to have led to the abuse of injections for minor illnesses that should have been unnecessary.

In the mid-1960s, there were outbreaks of sudden difficulty in walking in young children in Shizuoka, Fukui, and Nagoya prefectures, They were called “Izumida disease,” “Imadate disease,” and so on, after the names of the regions. Later, in 1973, a major outbreak occurred in southern Yamanashi Prefecture, which became a social problem when it was reported by the mass media. At the time of the outbreak, the cause of the damage had not been identified, so it was called “infantile stiffness of the knees,” etc., and was thought to be genetic, a freak disease, or endemic, but doctors eventually discovered that the cause was muscle injection, and the disease was named “muscle shortening disease.

2. organization of victims’ associations and start of trial

Following the outbreak of myasthenia in the southern part of Yamanashi Prefecture, parents’ associations and support groups for patients were organized, and the damage caused by myasthenia was brought before both the House of Representatives and the House of Councillors by a Diet member elected from Yamanashi Prefecture. The former Ministry of Health and Welfare (MHW) also began to investigate, with Professor Takahashi 晄正 of the University of Tokyo appearing as a witness in the House of Representatives, claiming that the mass occurrence of quadriceps shortening was caused by muscle injection. The results of the former Ministry of Health and Welfare’s investigation, together with those of the “Voluntary Medical Examination Group,” organized by doctors, estimated the number of victims at about 20,000.

However, the national government was slow to respond, and the Japan Medical Association only issued a notice to avoid the abuse of injections for children to combat myasthenia. In 1974, a group of parents formed the “National Council to Protect Children from Injection-Induced Myasthenia” to seek relief from the government. In addition, class action lawsuits were filed in various parts of the country, beginning with lawsuits filed by some parents of victims against the government, the pharmaceutical companies that sold the injections, and the doctors and medical associations that administered the injections. Of all the drug-related accidents that have occurred to date, this is the only case in which a medical association was named as a defendant. In 1977, in the midst of these struggles, the former Ministry of Health and Welfare’s “Myasthenia Research Group and Outbreak Prevention Subcommittee” announced the “constitutional cause theory” that “constitutional factors” may be involved in the mechanism of occurrence of myasthenia. The government submitted a theory that obscured the defendant’s responsibility, saying that the occurrence of myasthenia was caused by intravenous injections.

In the first trial, the pharmaceutical companies were found liable, but the government was not found liable because it “could not have foreseen” the occurrence of myasthenia. However, the lawsuits were protracted due to the large number of defendants, including the government, pharmaceutical companies, and doctors, and since more than a decade had passed since the lawsuits were filed, the cases were gradually settled. In both cases, the government’s liability remained unrecognized.

3. post-trial activities

The National Council to Protect Children from Injection-Induced Muscle Shortening Syndrome” closed its history with the conclusion of the trials in various regions. However, even after the trials were over, there was still a need for an organization that could deal with and resolve the physical and mental suffering of the victims and the various problems they would face in the future. For this reason, the “Keiji Council to Protect Children with Quadriceps Shortening Syndrome,” an association of victims in the Keiji region, continued its activities on its own. Since its members live in a wide area, it has changed its name to the “Association for Drug-Induced Muscle Shortening Syndrome.” As a national organization, it continues to conduct educational activities, support activities for victims whose lives have become more difficult due to aging, and negotiate with the government to have the government take action.

References

  1. Foundation for Regulatory Science of Pharmaceuticals and Medical Devices, 2011, “Lessons Learned from Drug Injury: Voices from Victims Hoping for the Prevention of Recurrence,” Pharmaceutical Affairs Daily, Inc.
  2. Yamanashi Prefecture Injection-induced Shortening of Muscle Syndrome Children’s Relief Task Force, 1994, “Yamanashi Prefecture Muscle Shortening Syndrome Children’s Relief Movement Record: Let’s look into the stone we stumbled upon.

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