Main Judgments of Lower Courts

◆     13th March, 2003   1993 (wa) 12535 and 1996 (wa) 4262, Damages claims

Case numbers: 1993 (wa) 12535 and1996 (wa) 4262

Case subject: Damages claim

Date of trial: 13th March, 2003

Judgment given on 13th March, 2003

1993 (wa) 12535 Damages claim case (First Case)

1996 (wa) 4262 Damages claim case (Second Case)

Date of oral pleadings conclusion: 30th January, 2003

Judgment

Text

1 The claims made by A1 and A2, plaintiffs of the First Case are dismissed.

2 The defendants of the First Case and the Second Case shall collectively pay to A3 and A4, plaintiffs of the First Case

17,270,350 yen each and the sum of its 5% per year between 25th June, 1991 and payment completion

3 Other claims made by A3 and A4, plaintiffs of the First Case are dismissed.

4 The defendants of the First Case and the Second Case shall collectively pay 123,787,444 yen and the sum of its 5% per year between 24th April, 1991 and payment completion to A5, plaintiff of the Second Case.

5 The defendants of the First Case and the Second Case shall collectively pay to A6 and A7, plaintiffs of the Second Case

5,500,000 yen each and the sum of its 5% per year between 24th April, 1991 and payment completion

6 The other claims made by A5, A6 and A7, plaintiffs of the Second Case are dismissed.

7 The costs of the First Case between the plaintiffs A1 and A2 and the defendants of the First Case and the Second Case shall be paid by the plaintiffs. The costs of the First Case between the plaintiffs A3 and A4 and the defendants shall be divided by three, and two-thirds shall be paid by the plaintiffs and the rest by the defendants. The costs of the Second Case between the plaintiff A5 and the defendants shall be divided by ten, and one-tenth shall be paid by the plaintiff and the rest by the defendants. The costs of the Second Case between the plaintiffs A6 and A7 and the defendants shall be divided by two, and one half shall be paid by the plaintiffs and the rest by the defendants.

8 Clauses 2, 4, and 5 of this judgment can be provisionally executed for parts concerning a defendant of the First Case and the Second Case, Research Institute for Microbial Diseases (RIMD), Osaka University, an incorporated foundation.

Facts and Reasons

1 Claims

  1 First Case

(1)    The defendants of the First Case are to collectively pay 50 million yen and the sum of its 5% per year between 25th October, 1989 and payment completion to A1 and A2, plaintiffs of the First Case.

(2)    Same as Clause 2 of the Text except the amount is 50 million yen.

  2 Second Case

    Same as Clauses 4 and 5 of the Text except the amount for A5, plaintiff of the Second Case is 130 million yen and the amount for A6 and A7, plaintiffs of the Second Case is 10 million yen.

2 Summary of the case

This is a case in which children who were inoculated with Measles, Mumps and Rubella (MMR) Vaccine and their families, claiming that the children have died or suffered from damage with severe sequelae caused by side reaction of the vaccination, are claiming damages or compensation of loss and damage delay payment to the defendant country on the basis of Clause 1, Article 1 of the National Redress Law or Clause 3, Article 29 of the Constitution, and to the defendant, Research Institute for Microbial Diseases, Osaka University, an incorporated foundation (defendant RIMD, Osaka University) on the basis of their responsibility for default on financial obligation or for an unlawful act. The breakdowns and the amounts of their damage claim are as follows:

(1)    A1 and A2, plaintiffs of the First Case

50 million yen each to plaintiffs A1 and A2 as deposit of the following damage total, 107,729,878 yen:

a Loss of income                                      51,790,678 yen

b Hospitalisation sundry expenses                            31,200 yen

c Compensation for hospitalisation and outpatient attendance      300,000 yen

d Consolation money                                    40,000,000 yen

e Funeral and ceremonial expenses                          1,500,000 yen

f Attending and nursing fees                                 108,000 yen

g Lawyers’ fees                                         14,000,000 yen

(2)    A3 and A4, plaintiffs of the First Case

50 million yen each to A3 and A4 as deposit of 100,513,119 yen which is the remainder after deducting 21,123,950 yen, profit-and-loss offset from the following damages:

  a Loss of income                                        59,770,669 yen

  b Hospitalisation sundry expenses                             530,400 yen

  c Attending and nursing fees                                1,836,000 yen

  d Compensation for hospitalisation                           5,000,000 yen

  e Compensation for death                                  40,000,000 yen

  f Funeral and ceremonial expenses                            1,500,000 yen

  g Lawyers’ fees                                          13,000,000 yen

(3)    A5, A6 and A7, plaintiffs of the Second Case

a Plaintiff A5

130 million yen as deposit of 218,511,113 yen which is the remainder after deducting 17,457,527 yen, profit-and-loss offset from the following damages:

  (a) Loss of income                                      67,274,535 yen

  (b) Hospitalisation sundry expenses                           269,100 yen

  (c) Attending and nursing fees                               931,500 yen

  (d) Caring fees                                        108, 993,505 yen

  (e) Compensation for hospitalisation and outpatient attendance     3,000,000 yen

  (f) Compensation for sequelae                           27,000,000 yen

  (g) Lawyers’ fees                                        28,500,000 yen

b Plaintiffs A6 and A7

10 million yen each to plaintiffs A6 and A7 as peculiar compensation and lawyers’ fees.

1 Facts, etc. which do not involve disputes

(1) Parties concerned

a Plaintiffs A1 and A2 are parents and heirs of C1 who died after MMR vaccination.

b Plaintiffs A3 and A4 are parents and heirs of C2 who died after MMR vaccination.

c Plaintiff A5 has suffered severe after-effect impairment after MMR vaccination, and plaintiffs A6 and A7 are parents of A5.

d The defendant country established the then Ministry of Welfare whose duty was to improve and promote public health, and through the then Minister of Welfare,  has exercised the competence to secure the safety of manufacture approval, etc. of medicines on the basis of Pharmaceutical Affairs Law, in order to secure quality, validity and safety of medicines offered to the nation. On the other hand, it has administrators such as the Minister of Welfare and the Director-General of Health and Medical Bureau to control and manage the whole administration of vaccination and on the basis of Preventive Vaccination Law, have heads of public bodies implement vaccinations against certain diseases as matters entrusted to these bodies by the country.

e The defendant, Research Institute for Microbial Diseases (RIMD), Osaka University, an incorporated foundation, is a public-service incorporated foundation whose purposes are to research prophylactic treatment, to manufacture materials etc. for it, and a manufacturer of the MMR vaccines.

(2) Factual development concerning MMR vaccines

a The purpose of vaccination is to give a healthy person immunity which is equivalent to that gained upon recovery from an infectious disease. A vaccine is an immunogen used to immunise humans and animals for the purpose of preventing infectious diseases, and its main ingredients are attenuated or inactivated pathogenic microbes.

b Measles, mumps and rubella are all infectious diseases which can be caught from childhood. If a child without immunity plays with children who have measles or mumps, it can very easily be infected by the disease. If the child contracts measles, a severe complication such as encephalitis or SSPE (subacute sclerosing panencephalitis) may appear, and in the case of mumps, meningitis or deafness may appear, and also in the case of rubella, meningitis or congenital rubella syndrome.

c Live vaccines of measles, mumps and rubella are made by creating variants with weak pathogenicity which still retain immunogenicity and are used alive by vaccination. The live viruses proliferate in an organism and produce immunoreactions. Although live vaccines are attenuated, pathogenic microbes are given to create immunity in the human body, and it is impossible at present to eliminate side reactions. If the elimination of side reactions are emphasised, the vaccines will have very low immunity, therefore occurrence of side reaction is inevitable at a certain probability level, but it is necessary to contain this within a permissible range.

d It is stipulated that vaccines are biological preparations included in the so-called standard articles and the standards of their biological preparation are provided by Clause 1, Article 14 of the Pharmaceutical Affairs Law when the Minister of Welfare approves the manufacture of medicines. Article 42 of the said law stipulates that the Minister of Welfare can set the necessary standards of preparations, properties, quality, storage, etc. for these standard articles.

e In June, 1980, the Minister of Welfare approved the defendant RIMD of the manufacture of mumps vaccines (Urabe strain vaccines) made by the amnion culture method in which Urabe AM-9 is used as a strain and it is cultured with amnions of hens.

f In July, 1985, the defendant RIMD received the approval of the Minister of Welfare to partly change the manufacture method from amnion culture to cell culture in which the strain is cultured with cells extracted from hens’ embryos.

g In September of the same year, the Minister of Welfare approved the manufacture of the MMR vaccines (MMR vaccines with unified strains) as new medicine on the basis of the opinion of the Central Pharmaceutical Affairs Council. MMR vaccines were made by mixing the RIMD’s mumps vaccines (Urabe strain vaccines), measles vaccines (AIK-C) developed by The Kitasato Institute and the rubella vaccines developed by Takeda Pharmaceutical Co., Ltd. and unifying the composition.

h For the examination of the MMR vaccines with unified strains for Article 43, Pharmaceutical Affair Law, the defendant RIMD submitted the unapproved undiluted solution of mumps vaccines manufactured by mixing vaccine undiluted solution made by amnion culture method and solution made by cell culture method to the examining body, the National Institute of Health. The NIH approved this without knowing that the culture method had been changed.

     The defendant RIMD continued to manufacture vaccines by mixing undiluted solutions from amnion culture and cell culture methods and sold them until October, 1991 (Otsu 13).

i The Preventive Vaccination Law obliged mayors of cities, towns and villages to implement measles vaccination as matters entrusted to them, as regular preventive vaccination stipulated by Article 3 of the said law.

j The Preventive Vaccination Implementing Regulations were partially amended on 19th December, 1988, and it was provided that MMR vaccines could be used for those who requested that they would take rubella and mumps vaccinations at the same time as they would take the regular measles vaccination (Ko A10-3).

k When the manufacture was approved, it was known that aseptic meningitis could occur after MMR vaccination, but on the basis of the diacrisis used at that time (Plaque Method), it was considered that most of it was caused by natural infection from a wild strain (Ko A5, 15, 18). 

l In July, 1989, the PCR Method was introduced as a new diacrisis, and it was pointed out that aseptic meningitis could be caused by an attenuated strain instead of a wild strain (Ko A5, 15, Otsu 6).

m On 17th September, 1989, Dr. O, Maebashi Medical Association, reported at a Gunma District meeting of the Japan Pediatric Society that 3 children out of 1800 who took MMR vaccination developed aseptic meningitis in Maebashi City, between April and June of the same year (Ko A12).

n On 25th October of the same year, Infectious Disease Prevention Section, Public Health Council (Infectious Disease Prevention Section) concluded that it was necessary to cautiously implement the MMR vaccination at the time of regular measles vaccination based on Preventive Vaccination Law because it was possible that one child out of several thousand to 30 thousand would develop aseptic meningitis. As of the same date, the Head of Tuberculosis and Infectious Disease Measures Office, Department of Diseases Measures, Health and Medical Bureau, Ministry of Welfare (Head of Tuberculosis and Infectious Disease Measures Office) informed the Head of Health Supervision Department (Bureau) of each prefecture that the MMR vaccination was to be implemented cautiously at the time of regular measles vaccination in each prefecture (Ko A10-7).

o On 20th December of the same year, Infectious Disease Prevention Section concluded  that it was proper to use the MMR vaccine at the time of regular measles preventive vaccination only when the child’s guardian requested it, until a safer vaccine was developed , instead of actively promoting the MMR vaccination as before. As of 28th of the same month, the Head of Tuberculosis and Infectious Disease Measures Office informed the Head of Health Supervision Department (Bureau) of each prefecture that the MMR vaccine was to be used only when the child’s guardian requested it at the time of regular measles vaccination (Ko A10-9).

p On 27th April, 1993, Infectious Disease Prevention Section concluded that the use of the MMR vaccine at the time of regular measles vaccination based on the Preventive Vaccination Law should be withheld for the time being. As of the same date, the Head of Tuberculosis and Infectious Disease Measures Office informed the Head of Health Supervision Department (Bureau) of each prefecture that the use of the MMR vaccine was to be withheld for the time being (Ko A10-17).

q In the process of the above investigation, a site inspection of the defendant RIMD was carried out on 18th May, 1993 and it was discovered that the defendant RIMD was mixing  undiluted solutions made by the cell culture method and solutions made by the amnion culture method for the mumps vaccine used for the MMR vaccine until July, 1991, even though the manufacture was approved on the basis that the diluted solution was made by the cell culture method (Ko A9-38, 39)

r In June, 1993, the defendant country instructed the suspension of the manufacture and sale of the vaccine because of the above offense and its recall, and in February, 1994, carried out an administrative disposition on the grounds of an offence against the Pharmaceutical Affairs Law (Ko A50, Otsu13, 90).

(3)    Factual development concerning C1

a C1 (born on 1st June, 1988), child of plaintiffs A1 and A2, was vaccinated with the MMR vaccine manufactured by the defendant RIMD by Dr. P at P Pediatric Clinic about 12 midday on 25th October, 1989 (Ko B4-2).

b C1 had a temperature of about 38.7 to 39.9 degrees from about 9 pm on 2nd November of the same year, and had a temperature of maximum 39.0 degrees on the morning of 3rd of the same month.

c On 4the of the same month, C1 evidently had measles-like eruption all over the body and saw the doctor at P Clinic. He was diagnosed with pyrexia and eruption caused by the side reaction of the MMR (Hei 1-1).  

d On 15th of the same month, C1 had a temperature of 38.9 degrees and vomited, and saw the  doctor at P Clinic. The high temperature continued until 17th of the same month, and he saw a doctor at Minoo Municipal Hospital, introduced by Dr. P (Hei 1-1).

e Minoo Municipal Hospital diagnosed C1 with aseptic meningitis on the basis of the  results of the examination of the extracted cerebrospinal fluid (number of cells in cerebrospinal fluid 2144/3 (per 1mm³, same hereafter) mononuclear cell 95%), and he was hospitalised there. Later it was diagnosed that the above meningitis was caused by the MMR vaccine.

f On 8th December of the same year, C1 was discharged from the above hospital (Hei 1-1).

g On10th of the same month, C1 had pyrexia, vomiting and hydatoid diarrhea and saw a doctor at the same hospital. On 11th of the same month, he was diagnosed as infant vomitive diarrhea, and on 18th of the same month, the above symptoms were remitted (Hei 1-1).

h About 6 pm on 27th of the same month, C1 had a temperature of 39.2 degrees and he saw a doctor at the emergency outpatient clinic of Minoo Municipal Hospital. About 7 pm on the same day, he was administered antibiotics and antipyretics for upper airway inflammation (Hei 1-1).

i On 28th of the same month, C1 saw a doctor at Minoo Municipal Hospital, and showed a temperature of 41.0 degrees, upward stare, apathy and consciousness disorder. At 6:40 on the afternoon of the same day, he showed systematic clonism, vomiting, loose passage and incontinence and he was hospitalised there. The results of the examination of the cerebrospinal fluid at 8:30 pm of the same day were: number of cells in cerebrospinal fluid 11/3, peripheral blood leukocyte number 4, 400, GOT198, GPT28, LDH1168, and he was diagnosed with acute encephalopathy (Hei 1-1).

j On 29th of the same month, C1 vomited blood and his heart stopped at 2:30 am on the same day, and he died at 5:57 am on the same day (Hei 1-1).

(4)    Factual development concerning C2

a C2 (born on 2nd September, 1989), the child of plaintiffs A3 and A4, developed atopic dermatitis immediately after birth, and about March, 1991 he was found to be allergic to egg white and milk. He was treated with a diet, etc. after that (Ko B5, 10, Hei 2-1).

b About 10:55 am on 25th June of the same year, C2 was vaccinated with an MMR vaccine at Tomita Town Hospital (Ko B10, Hei2-1).

c On 26th of the same month, C2 cried fiercely and had a temperature. About 4 pm on 27th of the same month, he had a sudden convulsive seizure, and about 6:20 pm on the same day, he saw a doctor at Tomita Town Hospital. He lapsed into status epilepticus and was transferred to Ueda Hospital with suspicion of acute encephalopathy (Ko B10, 11, Hei 2-1).

d At Ueda Hospital, Reye syndrome was suspected after the blood test, and he was treated for hepatopathy and brain edema. He was treated in the ICU (intensive care unit) with assisted breathing, etc. About 9:45 pm on the same day, he was again transferred to the pediatric section of Takatsuki Hospital and hospitalised in the ICU. The results of the CT examination, brain edema was found (Ko B11, Hek 2-1).

e After he was admitted to Takatsuki Hospital, C2 had frequent seizures and respirator therapy was started, but he lapsed into a coma.

f Starting about 5th July of the same year, C2’s symptoms of flaccid paralysis in neck regions and below and severe mental disorder continued, and he had pulmonary emphysema and pneumonia repeatedly (Ko B10, Hei 2-1).

g At 7:13 am on 8th August, 1992, C2 died (Ko B12).

h As of 25th June, 1993, plaintiffs A3 and A4 were given a disposition of non-payment of medical expenses, medical allowance, lump-sum payment for death and funeral and ceremonial expenses based on the Preventive Vaccination Health Damage Relief System by the mayor of Takatsuki City, concerning the above disease and the death of C2 caused by the preventive vaccination. On 25th December of the same year, however, the Governor of Osaka Prefecture decided to cancel the above disposition of non-payment in response to the  request for an examination.

i Plaintiffs A3 and A4 received 427,930 yen for medical expenses, 483,950 yen for medical allowance, 20,500,000 yen as a lump-sum payment for death and 140,000 yen for funeral and ceremonial expenses, on the basis of the Preventive Vaccination Health Damage Relief System by the time the oral pleadings of this case concluded.

(5)    Factual development concerning the plaintiff A5

a A5 (born on 29th June, 1989), the child of plaintiffs A6 and A7, came to Q Clinic for asthma fit on 8th November, 1989 and was hospitalised at or attended as an outpatient,  Ofunato Hospital or Q Clinic (Ko C2).

b On 24th April, 1991, the plaintiff A5 was vaccinated with an MMR vaccine by Dr. Q at Q Clinic (Ko C2).

c The plaintiff A5 attended Q Clinic every 2-3 days because of slight stridor and cough between 26th of the same month and 3rd May, and was treated with Neophyllin intravenous injection, etc. She did not have any temperature then (Ko C2).

d About 5 am on 8th of the same month, the plaintiff A7 found that the plaintiff A5 had a great deal of night sweat which made her hair shine. The plaintiff A7 wiped the plaintiff A5’s hair and changed her clothes. The plaintiff A5 called the plaintiff A7, “Mummy, Mummy” (Ko C1).

e At 7:45 am on 8th May of the same year, the plaintiff A5 had a temperature of 37.5 degrees. About 8:20 am of the same day she showed such abnormalities as not responding and about 8:35 am of the same day was seen in Q Clinic. She was unconscious and had absent pulses and reparatory pause with severe dehydration.

     Dr. Q gave her artificial respiration and treated her with various resuscitation methods such as instillation for dehydration, and the plaintiff A5 regained natural respiration, but the convulsion did not stop and she was still unconscious. The doctor judged that it was severe encephalopathy and sent the plaintiff A5 to Ofunato Hospital about 9 am on the same day.

f It was suspected at Ofunato Hospital that the plaintiff A5 had Reye syndrome and on 10th of the same month, she was transferred to Tohoku University Hospital (Ko C2).

g Tohoku University Hospital diagnosed the plaintiff A5 with Reye syndrome and treated her. She was discharged from the hospital on 2nd September of the same year with appendicular spatic paralysis and severe mental disorder. She was transferred to Takuto Medical and Nursing Centre, Miyagi prefecture and received rehabilitation. In about November of the same year, she started receiving nursing care at home.  

h On 28th September, 1992, the Minister of Welfare acknowledged that the plaintiff A5’s disease was caused by the preventive vaccination on the basis of the provision of Clause 1, Article 16 of Preventive Vaccination Law. On 1st March, 1993, he acknowledged that the plaintiff A5’s disorder was caused by the preventive vaccination on the basis of the same clause of the same article. The disorder was determined as ‘mental retardation, epilepsy and cerebral palsy’, grade applied to be Grade 1 of maintenance pension for a handicapped child, and the date of becoming handicapped to be 8th November, 1992 (Ko A37-1 to 6).

i The plaintiffs A6, A7 and A5 received 167,902 yen of medical expenses, 4,466,160 yen of medical allowance, 436,980 yen of welfare allowance for a handicapped child and 17,902,467 yen of maintenance pension for a handicapped child by the time the oral pleadings of this case concluded.

2 Points of Dispute

(1)    The judgment criteria of cause and effect between the MMR vaccination and the patients’ symptoms

(The plaintiffs’ claim)

It is reasonable to apply so-called Shiraki’s Four Principles as criteria to judge cause and effect between the preventive vaccination and the side reaction:

 ① The preventive vaccination and accidents after the vaccination are close together time-wise and space-wise;

② Other causes than the vaccination cannot be envisaged;

③ In principle, accidents after the vaccination and sequelae are severe in quality and quantity (So-called Oremagari (broken and bent) is recognised);

④ The mechanism of the accident occurrence is scientifically and academically verifiable and valid from experimental, pathological and clinical points of view.

(The defendants’ claim)

     Substantiating the judgment of cause and effect in a lawsuit means to comprehensively examine all proofs in the light of empirical rules and to prove that there is a highly likely  relationship between a certain fact and a certain result. It is necessary for the judgment to be able to offer credibility in its veracity to the extent that a normal person would not raise any question. For a matter which requires highly specialised medical judgment concerning the probability of cause and effect between the vaccination and the disorders which followed, as in this case, it is necessary to examine it with medical knowledge and to judge the above probability on this basis. To be concrete, medical knowledge concerning the vaccination and its side reactions, etc. including the plaintiffs’ physical growth, details of lesions which occurred after the vaccination, symptoms, etc. should be disclosed. Factual relationships should be comprehensively examined and it should be individually examined whether a cause and effect relationship can be acknowledged between the vaccination and the lesions which followed.

  (2) Cause and effect between the MMR vaccination and C1’s symptoms and death

     (Claims of the plaintiffs A1 and A2)

     a On 25th October, 1989, C1 was vaccinated with the MMR vaccine and from 8 days after that, he had noticeable side reactions such as high temperature and continuous diarrhea. He was diagnosed with aseptic meningitis caused by the MMR vaccination and was hospitalised on 17th November of the same year. After he was discharged from the hospital on 8th December of the same year, the symptoms did not disappear completely. He had a high temperature from 27th of the same month, and he died of acute encephalopathy on 29th of the same month after all. Therefore there is a cause and effect relationship between C1’s death and the MMR vaccination.

      b Even if the direct cause of C1’s death is encephalopathy caused by an influenza virus, there is a cause and effect relationship between his death and the MMR vaccination in this case because his health was damaged by the side reactions to the MMR vaccine .The measles virus in the MMR vaccine has an infectious effect or immune suppression effect on the brain system. These factors contributed to his infection with the influenza virus.

      (The defendants’ claim)

           No cause and effect relationship is recognised between C1’s symptoms and death and the MMR vaccination. The cause of C1’s symptoms (death) is Reye syndrome (acute encephalopathy) caused by an influenza virus infection, and not the side reactions caused by the MMR vaccination. Therefore there is no cause and effect relationship between C1’s death and the MMR vaccination in this case.

      a The temperature and the eruption C1 experienced on 2nd November, 1989 can be considered to be the side reactions to the MMR vaccine because of the time of the occurrence and because these symptoms represent a measles-like disease. The occurrence of aseptic meningitis on 15th November of the same year can also be considered side reactions to the MMR vaccine because mumps antibodies were found in the cerebrospinal fluid.

           However, the symptoms were remitted and cured after that, and C1 was discharged from the hospital on 8th December of the same year.

      b Influenza was very prevalent in the Hokusetsu district where the plaintiffs A1 and A2 lived in December of the same year. The plaintiff A2 had a temperature of 38 degrees on 26th of the same month. C1 showed symptoms such as pyrexia, vomiting, loose passage and incontinence which are different from the clinical symptoms of measles, rubella and mumps. Hong Kong influenza A virus (AH3) was isolated from the tube which was inserted in C1’s trachea and an influenza antigen was found in a bronchiolar epithelial cell of C1’s right lung lobe. Considering these, the cause of C1’s symptoms is a typical Reye syndrome (acute encephalopathy) caused by an influenza virus infection.

      c The typical clinical image of child influenza encephalitis/encephalopathy matches C1’s clinical symptoms.

      d The attenuated measles virus contained in the MMR vaccine does not have immunity suppression effect.

  (3) Cause and effect between the MMR vaccination and C2’s symptoms and death

     (Claim of the plaintiffs A3 and A4)

     a It is reasonable to apply what are called Shiraki’s Four Principles to judge the cause and effect in the lawsuit.

     b C2’s case meets all the requirements of Shiraki’s Four Principles, therefore there is a cause and effect relationship between the MMR vaccination and C2’s death.

(a)    Cranial nerve lesions occurred as a complication to occur with the vaccine in a short period of time after the MMR vaccination, and this meets ① of Shiraki’s Four Principles, closeness of time and space.

(b)    He had no lesion to cause such a severe cranial nerve disorder as above according to the  clinical development and test results. The above lesion cannot be envisaged to come from the atopy’s diet, therefore ② of Shiraki’s Four Principles is met.

(c)    A convulsion, consciousness disorder and brain edema occurred 2-3 days after the vaccination. These symptoms show Oremagari, ③ of Shiraki’s Four Principles.

(d)    Surveillance reports show that side reactions concerning cranial nerves caused by a preventive vaccination can occur not only immediately after it but also 2-3 days later. The CDC Report reports that there are 17 cases in which side reactions occurred 0 to 1 days  after the MMR vaccination and 10 cases in which they occurred in 2-3 days (CDC Report) (Ko B15-1). Also it is possible that this is a delayed allergic reaction caused by the vaccine’s additives, etc. or a multiple combination of the allergic reaction and side reactions caused by the virus. Therefore ④ of Shiraki’s Four Principles is met.

c Herpetic encephalitis, which the defendants claim it to be, occurs from a herpes simplex virus infection. The key points of its definitive diagnosis are: ① The value of herpes virus antibodies in the cerebrospinal fluid is 4 times or more; ② The value of the virus antibodies in the serum is 4 times or more; and ③ The presence of an antigen of the herpes virus is attested by the conserved cerebrospinal fluid. As far as C2 is concerned ,the above ① and ③ were not recognised. Also a local cerebral lesion was not specified. The minutes of a meeting of the  Reexamination Committee, Preventive Vaccination Health Damage Acknowledgement Section, Public Health Council, dated 26th September, 1997 record that the results of the test did not specify a pathogen of viral encephalitis/encephalopathy (Otsu 79).

(The defendants’ claim)

     The cause of C2’s symptoms is viral meningoencephalitis including herpes simplex virus. The symptoms are not side reactions caused by the MMR vaccination, and there is no cause and effect relationship between the MMR vaccination and C2’s death.

a The MMR vaccine is a live vaccine and the period required for the vaccine virus to proliferate in an organism (the incubation period) is generally between 7 and 21 days. The occurrence of side reactions in a short period of time as seen in C2’s case is not possible in the light of medical knowledge.

     The CDC Report mechanically processes data from the period during which adverse events occur after the vaccination, regardless of the presence of any cause and effect relationship, without an epidemiological screening, and it cannot be used as an evidence.

b Dr. R states that the most problematic of the four types of allergic reaction, particularly  among the ones related to a vaccination, is a Type I allergy which is accompanied by immediate reactions. One day elapsed between the MMR vaccination and the occurrence of clinical symptoms and reactions, and he denies the possibility of a Type I allergy because of this length of time. As for the possibility of a Type IV allergy (delayed irritable reactions which require 24 to 48 hours before occurrence), it seems reasonable to surmise that Type VI allergy reactions appear in the areas of the injection where antigens are relatively well preserved. In the present case, no clinical observations such as flare and eruption were found on the skin, and it is not possible to explain the clinical development including encephalitis/encephalopathy from the viewpoint of Type VI allergy reactions. Even if the vaccine ingredients were spread throughout the whole body by the injection and Type VI allergy reactions occurred, it is not possible for observations to be found only in the cerebral system and the meninges and not in any other parts of the body, and he clearly denies the possibility that this is a case of a Type VI allergy (Hei 12).

     Also during the discussion at the meeting of the above Reexamination Committee, one member present stated that reactions such as pyrexia one day later and encephalitis two days later cannot possibly occur because of the ingredients of the hen’s cell culture and that allergy cannnot occur because of the ingredients supplied.

c C2’s symptoms such as pyrexia, convulsions and a consciousness disorder which started a day after the MMR vaccination are rapid encephalitis symptoms, but test results showed the rise of an enzyme system in the liver, hyperammonemia and hypoglycemia and the disease was clinically considered to be Reye syndrome. However observations of the cerebrospinal fluid test found an increase in leukocytes and protein in the cerebrospinal fluid and especially the increase in the mononuclear cells in the leukocytes was remarkable (Mononuclear cells increase in the case of viral diseases), and it is strongly suspected that C2 had contracted some kind of viral encephalitis or meningoencephalitis at that time.

d According to C2’s cerebrospinal fluid test at the time of the attack, the virus which caused his death was not identified. No test for herpes simplex viral antibodies was carried out 2-3 weeks or 1 month after the occurrence. It was instructed to carry out a herpes simplex viral antibodies test 3 months after the attack, but it was not done, and varicella/herpes zoster virus antibodies were examined instead. Therefore it cannot be verified now.

     However Dr. R states that it is possible to infer the existence of herpes simplex viral antibodies from the value of varicella/herpes zoster antibodies during convalescence. The protein of herpes simplex, glycoprotein B and glycoprotein H of varicella/herpes zoster cross-react in immune reaction (fluorescence antibody technique, immunoprecipitation, etc.). He states that the positive value of varicella/herpes zoster antibodies in the test results of 27th September suggests the possibility of herpes simplex viral infection (Hei 12). Dr. T considers this view to be virologically valid (The witness T’s written response dated 12th August, 2000 (Dr. T’s written response) and the same witness’s written response dated 11th December of the same year (Dr. T’s counterargument response)).

e A report written by Dr. U and Dr. V (Dr. U et al. report) (Ko B15-1) and a report written by Dr. W (Dr. W’s report) (Ko B-21) state that cerebrospinal fluid observations 3 days after the vaccination (27th June, 1991) are not medically valid because a large quantity of erythrocytes were mixed in it. However, in the daily pediatric practice, the test values are corrected by subtracting the cell number of peripheral blood from the cell number in the cerebrospinal fluid when peripheral blood is mixed in the cerebrospinal fluid due to an unsuccessful lumbar puncture (Hei 12, 14, Dr. T’S written response).

f Dr. V’s supplementary report (Ko B17) attaches importance to the fact that the results of DNA diacrisis of C2’s frozen cerebrospinal fluid using the PCR method did not find herpes simplex virus and it was negative, and denies the possibility of herpes encephalitis. Dr. W takes a similar view in his report (Ko B-21).

However, Dr. R states that not all herpes encephalitis which is virologically confirmed by a brain biopsy, etc. and cerebrospinal fluid in very good state of preservation (-70℃ or less) are positive (Hei 12). He makes it clear that the fact that herpes simplex virus DNA was not found in the above DNA diacrisis does not immediately deny the possibility of herpes encephalitis. Furthermore, Dr. T himself who conducted the above diacrisis supports Dr. R’s view in his written response. The PCR method is a very sensitive virus detection technique and it is possible that the virus DNA is destroyed depending on the state of preservation of the specimen, especially by repeated freezing and thawing or leaving it at room temperature and that the results of the PCR method are negative even though the disease is herpes simplex encephalitis.

  (4) Cause and effect between the MMR vaccination and the plaintiff A5’s pathology

     (Claims of plaintiffs A6, A7 and A5)

    There is a cause and effect relationship between the plaintiff A5’s pathology and the MMR vaccination.

    a It is reasonable to apply so-called Shiraki’s Four Principles to judge the cause and effect in the lawsuit.

    b A5’s case meets all the requirements of Shiraki’s Four Principles, therefore there is a cause and effect relationship between the MMR vaccination and the plaintiff A5’s pathology:

(a)    The sudden high temperature, consciousness disorder and deterioration of heart and lung functions which occurred on 8th May, 1991 were completely different from the symptoms of asthma which were experienced before that, and ③ of Shiraki’s Four Principles , Oremagari is met by this.

(b)    The crisis occurred about 2 weeks after the MMR vaccination on 24th April of the same year and this coincides with the incubation period of the mumps viruses included in the preventive vaccination. Also a disorder of the brain which is easily invaded by the mumps viruses occurred. Therefore ① of Shiraki’s Four Principles, closeness of time and space is also met.

(c)    Furthermore, encephalopathy caused by the MMR vaccine or the mumps vaccine is reported in a report by David M. Morens, et al, CDC report, a case in which acute encephalopathy was caused by natural infection of mumps, a case in which encephalopathy was caused by the MMR vaccine, etc. and there is a reporting system in Canada assuming encephalopathy occurrence. A mumps virus was isolated from A5’s cerebrospinal fluid and it is highly possible that it came from the vaccine strain. Such steroids as Selestamine and Prednin had been used for a long time before and after the vaccination and it is believed that they suppressed immunity and made the crisis occur easily. Therefore ④ of Shiraki’s Four Principles, scientific and academic verifiability and the validity requirement on the mechanism of the occurrence of the accident is also met.

(d)    As for ② of Shiraki’s Four Principles, other causes, no other cause is envisaged.

ⓐ Concerning the possibility of infectious gastroenteritis, it is certain that three members of the family who lived with her had symptoms such as diarrhea, pyrexia and stomachache, but their cause is not specified in the medical records of Q Clinic. The plaintiff A5’s feces were cultured at Tohoku University Hospital, but no bacteria were found. As stated above, a mumps virus was found in the cerebrospinal fluid, which seems to have come from the vaccine, and it is difficult to accept the defendant RIMD’s claim that it was microbism.

ⓑ As for the possibility of infections such as adenovirus or rotavirus, diarrhea, vomiting, etc. usually precede them when a person is infected with these viruses. No such symptoms were found when A5 had the crisis in the early morning of 8th May, 1991. Her feces were only produced by an enema at Q Clinic at 8:52 am, 8th May of the same year, and they were not whitish and water-soluble as are typical of rotavirus infection. The plaintiff A5 had no diarrhea and abruptly had consciousness disorder, deterioration of heart and lung functions, pyrexia and convulsion. These were completely different from both the symptoms the three members of the family had and the symptoms of rotavirus, etc. Also A6, A7, D1 and D2 of the family had no infection at all. Furthermore, A5’s crisis occurred in May (spring), while rotavirus is prevalent in winter. It is difficult to envisage that such a sudden encephalopathy as in this case occurs with rotavirus, in the first place.

ⓒ As for the possibility of hypoxemia caused by a respiratory pause which followed fits such as bronchial asthma, etc., her pulse was 120 and her blood pressure 80 when she came to Q Clinic at 8:35 am on the same day, according to their medical records. At 8:40 am, her blood pressure was 104/70. No mouth-to-mouth artificial respiration was given, and it is impossible to assume that a situation in which the brain was not provided with oxygen continued. It is impossible that she had already had hypoxemia before 8:35 am of the same day.

(e)    As a result of an isolation test of the mumps virus conducted at Sendai City Health Institute, the mumps virus was isolated. It is understandable if a wild strain virus is mixed in by chance during the test. However, there is a strong possibility that the virus isolated in this case was a strain which came from the vaccine, and it is not possible that such a virus was mixed in by chance during the test.

     (The defendants’ claim)

          Plaintiff A5’s pathology is Reye syndrome (acute encephalopathy) caused by continued anoxic state which followed viral gastroenteritis, and it has no cause and effect relationship with the MMR vaccination.

     a Plaintiff A5’s pathology matches clinical symptoms of Reye syndrome in general, and it is considered that she had a noticeable dehydration following gastrointestinal symptoms caused by a preceding infection with some kind of pathogenic microbe. Then she developed acute encephalopathy or Reye syndrome caused by anoxia because of a delay in consulting a doctor.

     b Plaintiff A’s clinical symptoms such as frequent diarrhea, pyrexia and dehydration are completely different from symptoms including aseptic meningitis which occur with measles, mumps and rubella viruses in the MMR vaccine,.

     c As a result of the isolation test of the mumps virus conducted at Sendai City Health Clinic, a vaccine strain virus was identified, however, the cerebrospinal fluid extracted during the period of convalescence (19th June) was used rather than that of the acute phase. Also it was cultured for as long as 72 days and two different kinds of cells were used. The mumps virus was finally isolated after four subcultures lasting 72 days. This method is not a conventional one for medical professionals, and the result has no validity.  

  (5) Negligence of defendant RIMD

     (The plaintiffs’ claim)

     a Responsibility for manufacturing and selling the defective vaccine

(a)    There is a remarkable information gap concerning the safety of the vaccine between the manufacturer and the recipients of the vaccine. In order for the plaintiffs to claim that the defendant manufacturer has been negligent in the obligation to provide a safe vaccine in such a preventive vaccination damage case as this, the claim should be valid if the following two points are substantiated:

① The recipients, with no special abnormality in health conditions, were vaccinated with the vaccine concerned in accordance with the doctor’s examination by interview, his instructions and normal usage.

②Damages to health which should not normally occur if the vaccine concerned had the safety which the recipients rightfully expected for a preventive vaccination occurred within a reasonable period of time after the vaccination was administered using the vaccine (product) the manufacturer made.

It should be said that the defendant cannot escape from its responsibility unless it can concretely prove that the damage to health in question were brought about by a cause other than the vaccine’s defects.

Aseptic meningitis occurred with high frequency within a reasonable period of time after the MMR vaccination in this case. It is obvious that the MMR vaccine in this case was a defective product lacking the safety which recipients should rightfully expect for a preventive vaccination. The defendant RIMD who manufactured and marketed such a defective vaccine and should be obliged to compensate for the damages which were caused by the defect, on the basis of their responsibility for the unlawful act.

(b)    Also the defendant RIMD manufactured the MMR vaccine in this case using a manufacturing method which was different from the one which was approved by the government and it did so without permission. Such a change in the manufacturing method as this may change the quality of the product, and it was possible for it to cause side reactions. It should be said that a cause and effect relationship is suspected if side reactions occur from the vaccination concerned, unless the manufacturer demonstrates that there is no cause and effect relationship between the change in manufacturing method and the occurrence of side reactions. A manufacturer who acts in such a way as to produce the possibility of side reactions is responsible for negligence.

     b Negligence of obligation to recall and suspend the supply

          Vaccine manufacturers are obliged to make efforts to ensure safety by conducting  continuous follow-up checks after the vaccination or by actively collecting information about side reactions after manufacturing and marketing the vaccine. They are obliged to give the maximum warning concerning the possibility of side reactions with the use of the vaccine concerned to the government, local governments, doctors and the vaccination recipients, based on the highest standards of scientific information at the time, and to warn them in an appropriate way such as by attaching a statement to the product to warn of the risk of severe side reactions to make them aware of it. Furthermore they are obliged to give doctors and  recipients an opportunity to carefully consider if they should use it. When they obtain information that many cases of severe side reactions are occurring, from medical practitioners’ reports, surveys and research reports in medical journals, etc., they are obliged to take as many actions as possible to avoid further occurrence of side reactions including voluntary and rapid suspension of the manufacture of the vaccine concerned and a recall of the products which have already been shipped.  

           The defendant RIMD had a great deal of information about the side reactions when they introduced the MMR vaccine and thereafter, and it was easy for them to quickly take necessary actions such as inspection of the quality control system, suspension of sales and a recall in order to prevent the occurrence and spread of damage to health caused by the vaccination. Nevertheless, they did not take any positive action such as suspension of the sale and a recall of the product, to prevent the spread of damage to health caused by the MMR vaccination, except by partially revising the usage advice in the notes attached to the vaccine, even at the end of December, 1989. They left the matter as it was and continued to manufacture and sell the defective vaccine until the vaccination was suspended in April, 1993.

          Therefore the defendant RIMD knew that aseptic meningitis was already occurring frequently after the MMR vaccinations by the middle of October, 1989 at the latest, but they neglected the obligation to avoid further occurrence and spread of damage to health by disclosing the information about side reactions to medical institutions and the nation in order to warn them and by taking decisive actions such as early suspension of the manufacture and sale of the vaccine and a recall of the product.  

  (6) The defendant country’s negligence

     (The plaintiffs’ claim)

     a Negligence at the time of approving the manufacture (September, 1988)

          The defendant country made the mistake of letting damage to health occur by neglecting the obligation to fully discuss and confirm the safety of the vaccine, using its authority to investigate it and regulate its use by urging them to submit necessary information such as domestic and international reports on the side reactions and carefully examining the information submitted.

     b Negligence after approving the manufacture (unlawfulness)

(a)    Obligation to be attentive as the implementer of preventive vaccinations

  ⓐ The Preventive Vaccination Law obliges people to take certain preventive vaccinations (compulsory vaccinations) mainly from the viewpoint of social protection, paying attention to the great effect of preventing the occurrence and spread of infectious diseases by giving  people preventive vaccinations in the local community or across the country. The nature of the MMR vaccination was equivalent to these compulsory vaccinations.

ⓑ A preventive vaccination involves injecting a vaccine which is a foreign body into a human body, and naturally this is accompanied by certain risks. It is known that severe side reactions can sometimes occur. The defendant country which imposes preventive vaccinations on its people has a legal obligation to make every effort not to let these accidents occur in relation to each individual who takes them. This applies to the MMR vaccination which is equivalent to the compulsory vaccinations.

Even if the MMR vaccination is a recommended one, the defendant country carries out recommended vaccinations as a social protection measure in a wide sense, and it can be said that the main implementer is in effect the defendant country just as in the case of  compulsory vaccinations. The Minister of Welfare who supervises the business of the Ministry of Welfare has a reasonable legal obligation to avoid the occurrence of events to lead to serious accidents to each individual who takes the vaccination, following the recommendation.   

      ⓒ The defendant country has a legal obligation to collect information on side reactions after the implementation of the preventive vaccination with the vaccine concerned and to instruct local governments to immediately suspend the implementation when it becomes clear that side reactions which cannot be overlooked have occurred. When many accidents which cannot be overlooked occur after a preventive vaccination and there is a possibility that they are side reactions with the vaccination, even when it cannot be clearly determined that the symptoms occurred are side reactions to it at that point, it has a legal obligation to take action such as suspension of the preventive vaccination concerned until the cause of the accidents becomes clear. It is unlawful that it did not suspend the vaccination and continued with it unless there is a rational reason for not suspending it.

(b)    The obligation to be attentive with the Pharmaceutical Affairs Law

     Clause 1, Article 74-2 of the Pharmaceutical Affairs Law gives the Minister of Welfare the authority to cancel the approval to manufacture the medicine concerned even if it was manufactured with approval, if it has come to be recognised as useless because it has a very harmful effect compared with its virtues, effects and performance thanks to accumulated information and knowledge concerning it after the manufacture was approved. Furthermore, Article 69-2 of the said law gives him the explicit authority to issue an emergency order, the authority to order emergency actions to prevent the occurrence or spread of health hazards such as suspending sales or transfer of the medicine concerned to its manufacturer , when he recognises the need to prevent the occurrence or spread of health hazards. 

     Non-use of these emergency orders authorised for the Minister of Welfare to use does not immediately mean unlawfulness with the State Compensation Law. However, it becomes unlawful in relation to the parties who suffered the damages caused by the side reactions, when the non-use of emergency orders is considered to go beyond what is permitted and to greatly lack rationality. 

     Emergency orders are temporary measures until academic validity is established. Vaccines used for preventive vaccinations are used with healthy children and are quite different from treatment, and the discretion of the Minister of Welfare concerning the use of his authority is limited. When there is a reasonable doubt about the safety of the medicine concerned, the Minister of Welfare has a legal obligation to immediately issue an emergency order concerning the vaccine in question. Not exercising this authority goes beyond what is permitted and greatly lacks rationality, and is unlawful with the State Compensation Law. 

     The defendant country could have obtained information about the side reactions in Canada at the end of 1988 and it could have obtained information about the side reactions in Maebashi City which were highly likely to come from the vaccine and not at all acceptable around September of the same year at the latest. Many cases of the side reactions, aseptic meningitis, which were not assumed to occur at the time of introducing the MMR did occurr and it was possible for it to question its safety. It was easy to implement the compulsory administrations of the measles vaccine and the rubella vaccine independently, and the defendant country should have suspended the MMR vaccination or issued an emergency order and investigate/research its safety. However, it left it as it was and the negligence of its obligation of care is acknowledged.

(c)    The defendant country’s negligence of its supervising obligation

     The defendant country had the obligation to supervise the vaccine manufacturers including the defendant RIMD so that they manufactured safe vaccines following the manufacture method approved by it, on the basis of its obligation to avoid adverse results as the main implementer of the above preventive vaccination, and to be attentive with the Pharmaceutical Affairs Law. However it neglected the above obligation to supervise them and did not take sufficient supervisory measures, and let the defendant RIMD change the manufacture method without permission and let the damage of this case occur.

(The claim of the defendant country)

a With Clause 1, Article 1 of the State Compensation Law, unlawfulness should be interpreted as when a civil servant who exercises the public authority of the state or a public body doing the act concerned against his legal professional obligation which he bears to each individual of the state, on the assumption that there is a violation of a right or an interest to be legally protected. 

b In a case where exercising the regulation authority depends on discretion, not exercising the authority should be evaluated as unlawful only when it goes beyond the range of the given discretion and is considered highly unreasonable, in relation to each individual. from the viewpoint of the aims and objectives of the law concerned.

c The Pharmaceutical Affairs Law has nature of legal monitoring measure to prevent risks accompanying the supply of defective medicines. Principles of reactive monitoring are its guiding principles, and it is not allowed to regulate something for an active purpose of enhancing social and public welfare, exceeding its purpose of the police-like control or to punish someone based on the regulation.

     The Pharmaceutical Affairs Law does not include any provision to oblige the Minister of Welfare to actively carry out a certain act, in relation to each individual. The direct purpose of the Law is not to impose on the Minister of Welfare a legal obligation to actively intervene in social and public welfare, to regulate the freedom of sales and to thereby prevent concrete damage any individual may suffer and attempt to compensate him for it. Various authorities of the Minister of Welfare related to the securing of safety of medicines under the Law were only established to clarify his responsibilities in the national administration of pharmaceutical affairs.

     Therefore the following judgment criteria should be used concerning the unlawfulness of the approval of the Minister of Welfare under the Pharmaceutical Affairs Law and non-exercise of the regulation authority after that:

(a)     When it is still possible to affirm the usefulness of the medicine concerned after considering its side reactions judging from the medical and pharmaceutical knowledge at that point, such acts of the Minister of Welfare as recording medicines in the Japanese Pharmacopoeia and the approval of manufacture, etc. are not unlawful when Clause 1, Article 1 of the State Compensation Law is applied.

(b)    Judgment of the usefulness of the medicine on which the exercise of the authority should be based requires highly technical and comprehensive judgment, and it is inevitable that the judgment is based on current medical and pharmaceutical knowledge at that point. Also even when it is not possible to deny the usefulness of the medicine concerned, the exercise of the authority under the Pharmaceutical Affairs Law and the possibility of implementing administrative guidance and how and when it is done, etc. have to be entrusted to the specialist and discretional judgment of the Minister of Welfare based on current medical and pharmaceutical knowledge at that point because of the nature of the matter.

(c)    Considering such nature or characteristics concerning the exercise of the authority of the Minister of Welfare under the Pharmaceutical Affairs Law, even when damage caused by side reactions to the medicine occurs, the Minister of Welfare not exercising the authority under the Pharmaceutical Affairs Law to prevent the occurrence of damage caused by side reactions to the medicine is not immediately judged as unlawful with respect to Clause 1, Article 1 of the State Compensation Law. When it is acknowledged that the non-exercise of the authority goes beyond its remit and is highly irrational, in the light of the purposes of the Pharmaceutical Affairs Law and the nature of the authority given to the Minister of Welfare, etc. judging from current medical and pharmaceutical knowledge at that point regarding the medicine concerned including its side reactions, such non-exercise becomes unlawful in relation to the person who has suffered the damage from its side reactions, with respect to Clause 1, Article 1 of the State Compensation Law.

d At the point of the approval of the manufacture (September, 1988)

     The approval of the Minister of Welfare concerning medicines based on the Pharmaceutical Affairs Law should be entrusted to high-level specialist discretion because of the specificity of medicines. Concerning various authorities exercised by the Minister of Welfare to secure the safety of medicines under the Pharmaceutical Affairs Law, as is clear from the wording of each article, the law reserves him the right to make rational administrative judgments according to his purposes as the administrator of pharmaceutical affairs, not only with the judgment of the applicability to the requirements, but also as to whether he should exercise the regulatory authority on this basis.

     The Minister of Welfare made a full and necessary examination on the basis of scientific knowledge at that time and of the application materials submitted by the defendant RIMD and approved the manufacture of the MMR vaccine. There is no irrationality in the process of the judgment.

e After the approval of the manufacture

There is a difference between the aim of the Pharmaceutical Affairs Law which is to implement necessary regulations to secure the quality, validity and safety of medicines, etc. and to contribute to the improvement of health and hygiene, and the aim of the Preventive Vaccination Law (Article 1 of the law) which is to ‘prevent the occurrence and spread of disease which may be infectious’ and to ‘contribute to the improvement and enhancement of public health’ are different. Therefore the judgment of whether to affirm the usefulness of the medicine even after considering its side reactions and the judgment of whether to use the MMR vaccine for a preventive vaccination are essentially different. It is not possible to discuss without distinction the measures under the Pharmaceutical Affair Law and those under the Preventive Vaccination Law in confusion.

     The lawfulness of the non-exercise of the regulatory authority by the Minister of Welfare under the Pharmaceutical Affairs Law should be judged on the basis of whether it is recognised that it goes beyond what is permitted and is highly irrational, in the light of the purposes of the Pharmaceutical Affairs Law, the nature of the authority given to the Minister of Welfare, etc., from the viewpoint of medical and pharmaceutical knowledge at that time about the medicine concerned.

(a)    As of September, 1989

     It cannot be said that the usefulness of the MMR vaccine was denied and that its safety was found to be problematic as of September, 1989 even if the suspension of MMR vaccine use in Canada and the report by the Maebashi Medical Association are taken into consideration. The decision to acknowledge the usefulness of the MMR vaccine was given and there was no other case of suspension of the MMR vaccine in countries other than Canada at that time. Considering these, it is impossible to conclude that the safety problem was clearly and widely known. Its usefulness was denied neither by the Preventive Vaccination Committee, Infectious Disease Prevention Section nor by The Investigation Meeting of the Biological Preparation, the Central Council of Pharmaceutical Affairs.

     The Ministry of Welfare instructed the revision of the notes attached to the vaccine in September, 1989, and took rapid and appropriate measures such as collecting information concerning cause and effect between the MMR vaccine and aseptic meningitis on the basis of the report by the Maebashi Medical Association in October, 1989. In view of these facts, it can in no way affirm that the minister’s not issuing an emergency order exceeded the range of reasonable discretion, in the light of the purpose of the Pharmaceutical Affair Law and the nature of the authority given to the minister, and it should be said that no unlawfulness is involved here.

(b)    As of May, 1990

     Even if Canada’s Department of National Health and Welfare made enquiries about the side reactions to the MMR vaccine to the Japanese parties concerned with public health and cancelled the permission to use the MMR vaccine containing Urabe strains, many people  acknowledged the usefulness of the MMR vaccine as a medicine and its necessity and usefulness as a preventive vaccination even at that time. In view of this fact and the occurrence of aseptic meningitis occurrence after the vaccination in Canada and other countries and considering that the Pharmaceutical Affairs Bureau, the Ministry of Welfare in a notice from the Head of Safety Division dated 18th January, 1990 instructed the manufacturers to revise the usage advice in accordance with newer information, and published information about side reactions to the MMR vaccine in its newsletter on side effects of medicines in March of the same year, attempting to make it widely known to the parties concerned, it can in no way be said that the Minister of Welfare’s not issuing an emergency order exceeded the range of the allowed reasonable discretion, in the light of the purpose of the Pharmaceutical Affairs Law and the nature of the authority given to the Minster of Welfare. It should be said that no unlawfulness is involved.

  (7) The claims for the loss compensation and their range based on Clause 3, Article 29 of the Constitution

     (The plaintiffs’ claim)

     a The country in effect implements preventive vaccinations compulsorily by laws and administrative recommendations for the public purpose of preventing the occurrence and spread of infectious disease and contributing to the improvement and enhancement of public health. Since it is inevitable that preventive vaccinations cause side reactions accompanied by death or severe sequelae, the affected children in this case had special suffering imposed  upon them. On the other hand, the spread of infectious diseases was prevented and the majority of the nation enjoy the common benefit of society. For these victims who had special suffering imposed on them for the public interest, the need to compensate it borne by the whole nation exceeds the expropriation of the property rights provided by Clause 3, Article 29 of the Constitution.

           Certainly the loss of lives and health seen in the accidents from side reactions to the preventive vaccination is different from property rights which can be expropriated. However, if we look at Article 13 of the Constitution which stipulates that the rights of the people for life, freedom and pursuit for happiness requires the highest respect in legislation and other national politics unless they are against public welfare, the provisions of Article 25 which provides the people’s right to live and the country’s obligation to guarantee the right and further, the basic principles of the Constitution, it is obvious that the current law and order guarantees the health and lives of the people far better than their property rights.

           Therefore it is highly irrational to consider that the Constitution provides the compensation for a special sacrifice of property rights but does not provide anything for such far more serious matters of life and health as fatal accidents caused by a preventive vaccination. It is reasonable to interpret that the point of the above Clause 3, Article 29 is that a special sacrifice of people’s life and health requires compensation which is at least equal to or more than the compensation for property rights, taking provisions of Article 14 and Article 25 of the Constitution into consideration.

      b Clause 3, Article 29 of the Constitution should be interpreted that it is not impossible to claim compensation directly on the basis of this clause, even if there is no clause providing  compensation for loss of property rights. This interpretation is naturally valid for special sacrifice of life and health. By the way, if the ‘rightful compensation’ in Clause 3, Article 29 of the Constitution is applied to the case of the preventive vaccination, the purpose of the compensation is to attempt to repair the special sacrifice of lives and health which the victims suffered from the side reactions, for the needs of the public interest which are to prevent the spread of infectious diseases. Therefore compensation which is more or less equal to the evaluation system of compensation for damage should be made so that the situation of the victims before and after the death caused by the side reactions will be equal to compensation for damage, because a financial evaluation accompanying a human death can only be done by using current laws and established practical adjustment.

     (The defendant country’s claim)

          As is clear from its wording, Clause 3, Article 29 of the Constitution provides the expropriation of ‘private properties’ on the basis of Clause 2 of the same article, and it does not provide for the infringement of people’s lives, bodies and health. Also if we look at the processes of establishing the French Declaration of Human Rights and other foreign regulations which are considered to be the root of the provisions of Clause 3, Article 29 of the Constitution, it is unquestionable that this is a provision which has a historical origin as compensation for property rights centred on land property rights. The damage to lives, bodies and health which is at issue in this case is completely different from the circumstances and process of the infringement of property rights because of expropriation. Furthermore, it is easy to assess property rights objectively because properties have market prices, but damage to lives, bodies and health are complicated and varied and it is difficult to assess it objectively. There are essentially major differences between the two. Therefore even if the issue is accidents caused by preventive vaccinations, it should be said that the provisions of Clause 3, Article 29 of the Constitution cannot be used by analogy in order to receive compensation for the damage.

           Also, the idea that serious infringements to lives and bodies can be resolved in the form of a human burden for public utility by the provisions for compensation for loss, this itself is difficult to accept, to begin with. If such an idea is accepted, it is possible to consider that the country can ‘expropriate’ human lives, bodies and health only if it offers rightful compensation. It is obvious that such an interpretation notably lacks validity and it is not at all possible to approve it.

  (8) Extinctive prescription

     (The plaintiff’s claim)

     a The plaintiffs A6, A7 and A5 were acknowledged as victims by the Minister of Welfare under the provision of Clause 1, Article 16 of the Preventive Vaccination Law as of 28th September, 1992 and knew about the damage and the wrongdoer on 25th December of the same year at the latest, when they were handed the above letter of acknowledgement by the officer in charge of Ofunato City.

     b It is now later than 24th December, 1995.

     c The defendants indicated their intention to invoke the above extinctive prescription to the plaintiffs A6, A7 and A5 on the day of the oral pleadings of this case, 28th March, 2002. 

3 Judgment concerning the points of dispute

  1 About points of dispute (1) (The judgment criteria of cause and effect)

(1)    The plaintiffs claim that the cause and effect relationship between the vaccination and the diseases which occurred after that can be acknowledged if it meets each requirement of the so-called Shiraki’s Four Principles: ① The vaccination and accidents after the preventive vaccination are close together time-wise and space-wise; ② Other causes than the vaccination cannot be envisaged; ③ The degrees of the above symptoms are more severe in quality and quantity than others whose causes are considered to be unknown (the so-called Oremagari (broken and bent) is recognised); ④ The mechanism of the accident occurrence is scientifically and academically verifiable and valid from experimental, pathological and clinical points of view.

        On the other hand, the defendants claim that such matters which need high-level medical judgment as judging the probability of the cause and effect relationship between the preventive vaccination and the disorders which occurred after that should be examined using medical knowledge and judged whether it is highly probable or not on the basis of that. Concretely, the plaintiffs’ physical growth, details of lesions which occurred after the vaccination, symptoms, etc. and medical knowledge about the side reactions, etc. should be disclosed. Factual relationships should be comprehensively examined and it should be individually examined whether a cause and effect relationship can be acknowledged between the vaccination and the lesions which followed.

(2)    Proving a cause and effect relationship in a lawsuit is not a natural-science-like  demonstration where there is no room for any doubt. It means to comprehensively examine all proofs in the light of empirical rules and to prove the high probability between the fact and result. It is necessary for the judgment to be able to offer credibility in its veracity to the extent that a normal person would not raise a question, and also it is understood to be sufficient if it can be. The judgment should be made comprehensively considering everything which appeared in the records.

(3)    Shiraki’s Four Principles which the plaintiffs claim should be adopted to establish abstract and general judgment principles concerning judgment of cause and effect relationships between a preventive vaccination and its side reactions, etc. and it is said that a cause and effect relationship is inferred to exist as far as its criteria are met.

        However, there is no rational reason to adopt special criteria only to judge a cause and effect relationship of a preventive vaccination. Also there is no rational reason to decide that there are fixed and general principles only for the judgment of a cause and effect relationship of a preventive vaccination.

        It is certain that the situation of side reactions to a preventive vaccination is ectremely varied depending on the type of the preventive vaccination. There are almost unlimited combinations depending on various conditions such as the individual recipient’s physical constitution, physical condition at the time of the vaccination, pathology of the damage to health, mechanism of the occurrence, etc. and it is said that there is no identical combination and that there are cases in which it is virtually impossible to seek complete medical verification for cause and effect with a preventive vaccination. Also symptoms of diseases caused by side reactions to a vaccination are not peculiar to them and it is difficult to distinguish them from symptoms of diseases with other causes. Small children who are targeted for the preventive vaccination naturally contract many diseases, irrespective of the vaccination. These facts make the judgment of a cause and effect relationship difficult

         However, in order for a cause and effect relationship between a preventive vaccination and damage to health to be medically and scientifically proved, it can be said that it is necessary that research activities using medical experiments, etc. are accumulated and the results are integrated to be established as a theory. As stated above, for the establishment of a cause and effect relationship in a lawsuit, it is not necessary to wait for such medical and scientific verification. It is sufficient if a high probability is established between facts and results, comprehensively examining all evidence in the light of empirical rules. It is necessary for the judgment to be able to offer well-founded credibility to the extent that a normal person would not raise a question. It is considered that this is sufficient. It is of course necessary for the judgment not to contradict general medical knowledge and empirical rules, but the above medical and scientific verification is not needed. The judgment of a cause and effect relationship should judge whether it can offer credibility in the veracity to the extent that a normal person would not raise a question, comprehensively considering every circumstance.

            Therefore the difficulty in judging the above cause and effect relationship cannot be denied, but it is possible to make a judgment using the above general criteria, and it is not necessary to use separate criteria only for the judgment of a cause and effect relationship of a protective vaccination.

             In any case, although the plaintiffs’ claim concerning the cause and effect relationship is based on the application of Shiraki’s Four Principles, it discloses the knowledge about ① the recipients’ physical growth, the development of lesion occurrence after the MMR vaccination, the occurrence situation, etc. and ② the MMR vaccination and its side reactions, etc. respectively on the basis of evidence. The plaintiffs have comprehensively examined the factual relationships and claim that a cause and effect relationship is recognised, on the basis of empirical rules, between the MMR vaccination and the lesions which occurred after that. They claim that there is in effect high probability between facts and results.

    (4) Therefore medical and technical knowledge concerning ① the each plaintiff’s physical growth up to the MMR vaccination, the development of lesion occurrence after the MMR vaccination, the occurrence situation and ② the MMR vaccination and its side reactions, etc. is to be recognised and the existence of a cause and effect relationship between the MMR vaccination and the lesions which occurred to each plaintiff is to be judged on the basis of the synthesis of these.

  2 The points of dispute (2) (Cause and effect relationship between C1’s pathology and the MMR

vaccination)

(1)    According to the above facts, etc. which do not involve disputes and evidences (Ko B13, Otsu 48, Hei1-1, Witness X, Witness Y), the following facts can be acknowledged about C1’s physical growth up to the MMR vaccination, the development of lesion occurrence after the MMR vaccination and its occurrence situation:

a C1 was as the first child of the plaintiffs A1 and A2 on 1sst June, 1988 (Weight at birth: 3,396 grams). He grew without any particularly severe illness after birth and was in good health condition.

b C1 was vaccinated with the MMR vaccine manufactured by the defendant RIMD at P Clinic about 12 midday on 25th October, 1989. He had a temperature of about 38.7 to 39.9 degrees from about 9 pm on 2nd November of the same year.

c C1 had a temperature of maximum 39.0 degrees on the morning of 3rd of the same month, but it was a public holiday and the clinic was closed, and he was seen at P Clinic on 4th of the same month. Measles-like eruption was apparent on the whole body, and he was diagnoses with pyrexia and eruption, side reactions caused by the MMR.

d Later C1’s symptoms became better and the above measles-like eruption began to gradually disappear on 6th of the same month.

e On 14th of the same month, C1 was low-spirited and had a temperature of 38-39 degrees on 15th of the same month. He also vomited and was seen at P Pediatric Clinic.

f On 16th of the same month, C1 had pyrexia of 40.9 degrees.

g On 17th of the same month, C1 had pyrexia of 40.1 degrees and nuchal rigidity (+-). He was seen at Minoo Municipal Hospital, introduced by Dr.P.

h On the same day, C1’s cerebrospinal fluid was extracted. As a result of the test, the number of cells in the cerebrospinal fluid was 2144/3 and mononuclear cells were 95%. He was diagnosed with aseptic meningitis and admitted to the hospital. Later the results of the test of cerebrospinal fluid extracted on the same day were obtained and the value of the mumps virus IgM antibodies was positive.

i On 20th of the same month, the number of C1’s cells in the cerebrospinal fluid was 1421/3.

j Then C1’s temperature started to drop around 21st of the same month. On the 24th of the same month, the number of cells in the cerebrospinal fluid was 335/3. He had a good appetite from about 25th of the same month.

k On 26th of the same month, C1 again had pyrexia of 38. 2 degrees. Pyrexia of about the same degree was repeated several times until about 2nd December of the same year. Then his temperature went down.

l Dr. X who was treating C1 conducted an EEG on the 1st December of the same year and a cranial CT test on 6th of the same month, and both results were normal.

m On 7th December of the same month,, C1 had a cerebrospinal fluid test. The protein marrow was 32 mg per 1 dl with sugar 51mg, which were normal values, and the number of cells was 65/3 and mononuclear cells 98%.

n Dr. X et al judged from the above results and C1’s condition that the meningitis was alleviated. C1 was discharged from Minoo Municipal Hospital on 8th of the same month.

o On 10th of the same month, C1 had pyrexia of 38 degrees, pharyx flare, vomiting 4-5 times and hydatoid diarrhea, and was seen at the emergency outpatient clinic of Minoo Municipal Hospital.

p C1’s hydatoid feces continued and on 11th of the same month, he was seen at Minoo Municipal Hospital. Y saw C1 , suspected rotavirus enteritis and diagnosed him with infant vomitive diarrhea.

q Then C1 recovered and on 18th of the same month, Y judged that C1 was cured.

r On 26th of the same month, C1’s mother had a temperature of 38 degrees and had general malaise and a pharyx ache, symptoms of cold. Hong Kong influenza A was prevalent in this area at that time.

s C1 had pyrexia of 39.2 degrees about 6 pm on 27th of the same month. About 7 pm he was seen at the emergency outpatient clinic of Minoo Municipal Hospital and was administered antibiotics and antipyretics.

t On 28th of the same month, C1 was seen at Minoo Municipal Hospital. He had pyrexia of 41 degrees, consciousness disorder, ocular fixation, convulsion, vomiting, loose passage and incontinence, and was admitted to the hospital.

u On the same day, a cerebrospinal fluid test was conducted and the number of cells in the cerebrospinal fluid was 11/3. The results of a biochemical test were GOT198 and GPT28 (per litter. the unit is U. these are the same hereafter.) Since the results of the above tests were that the number of cells was normal, he was diagnosed with acute encephalopathy rather than meningitis.

v About 0:40 am on 29th of the same month, C1 had hematemesis of dark red blood and was treated with stomach irrigation, etc. His heart stopped at 2:03 am and intubation into the trachea was given.

w Then resuscitation was given to C1, but C1’s condition never improved. According to the test conducted at 3:40 pm on the same day, GOT was 578, GPT 129 and the ammonia concentration was 271 micrograms (per 1 dl. Same hereafter.).

x C1 died at 5:57 am.

y On the same day C1’s autopsy was conducted and the anatomicopathologic diagnosis was brain edema and lung hemostasis.

z Osaka Prefectural Institute of Public Health conducted an examination and Hong Kong influenza A (AH3) viruses were found in the intubation tube tubed in C1’s trachea.

     Also the National Institute of Infectious Diseases examined the lung system at the time of the autopsy and found influenza antibodies in the epithelial cells of the bronchiole in the right lung lobe.

(2)    When C1 left Minoo Municipal Hospital on the morning of 8th of the same month, his symptoms had not fully disappeared and he had a great deal of nosebleed. The plaintiffs A1 and  A2 communicated this to the doctor, but he said ‘It is not important.’ and they claim that he disregarded it. The plaintiff A2 wrote a report on this (Ko B13) and submitted it. According to the above report, they told Dr. X and the nurse about the nosebleed , but they told them not to worry because he just had a rush of blood or picked his nose. Therefore the amount of C1’s nosebleed was such that the doctor and nurse told them not to worry and it is recognised that he was not specially bleedingto a great extent.

(3)    As described above, C1 was vaccinated with the MMR vaccine on 25th October, 1989 and had notable side reactions such as high temperature and continuous diarrhea 8 days later. He was diagnosed with aseptic meningitis caused by the MMR vaccine and hospitalised on 17th November of the same year. After leaving the hospital on 8th December of the same year, he continued to vomit and have diarrhea and never completely recovered. He had high temperature from 27th of the same month, and eventually died of acute encephalopathy on 29th of the same month. Therefore the plaintiffs A1 and A2 claim that the aseptic meningitis was followed by encephalopathy which led to his death.

        On the other hand, the defendants claim that the cause of C1’s death is Reye syndrome (acute encephalopathy) caused by influenza infection, and contests side reactions to the MMR vaccine.

(4)    The pyrexia and eruption which occurred to C1 on the 8th day after the MMR vaccination (2nd November of the same year) are considered to be side reactions to the MMR vaccine because of the time relationship and the measles-like symptoms. The aseptic meningitis is also considered a side reaction to the MMR because the mumps virus antibodies were found in the cerebrospinal fluid.

        However, C1 was discharged from the hospital on 8th December of the same year and the aseptic meningitis, etc. are considered to have remitted and been cured. According to the exhibits (Hei 1-1, 12), the value of the mumps virus IgM antibodies measured by ELISA method was positive on 17th November of the same year, pseudo-positive on 20th of the same month, positive on 24th of the same month, positive on 30th of the same month and pseudo-positive on 7th December of the same year. On 28th of the same month, it was pseudo-positive the first time, but negative the second time. Also according to the exhibits (Otsu 51, 52 and witness X), it is acceptable to clinically judge that the disease has been cured even if the number of cells in the cerebrospinal fluid does not fall to a normal value and it is empirically used as a criterion for discharge from hospital that the number of cells in the cerebrospinal fluid falls to 100/3 or below.

(5)    On 26th December of the same year (62nd day after the vaccination) when influenza was very much prevailing in the Hokusetsu district, C1’s mother had pyrexia of 38 degrees. It was followed by C1’s above symptoms of pyrexia, vomiting, yellow loose passage, etc. which match the clinical symptoms of influenza and not those of measles, mumps and rubella. 

(6)    Also Hong Kong influenza A viruses were isolated from C1’s intubation tube, and influenza virus antibodies were found in the lower lobe of C1’s right lung.

        The plaintiffs claim that it is unclear whether the influenza viruses were in C1’s body or not because the viruses were found in the intubation tube and not in his bronchia.

    However, according to exhibits (Hei 12), it is acknowledged that there were influenza viruses in C1’s body because influenza viruses cannot be isolated from droplet nuclei and droplets in natural environment, and they have not been isolated from the surface of the utensil.

(7)    Furthermore, according to exhibits (Hei 6 and 12), it is acknowledge thatC1’s symptoms on and after 27th of the same month which include hyperammonemia, rise in values of liver enzyme system such as GOT and GPT, appearance of encephalopathy symptoms such as high temperature, vomiting, consciousness disorder and convulsion match those of Reye syndrome, which is reported to often follow virus infections such as influenza.

(8)    Therefore it is acknowledged that C1 was infected by Hong Kong influenza A (the incubation period is 24 to 72 hours) through his mother and others, developed influenza whose main feature was pyrexia on the evening of 27th of the same month, which was accompanied by typical symptoms of Reye syndrome caused by influenza such as convulsion, vomiting, upward rotation of the eyes, liver disorder, hyperammonemia, and died of Reye syndrome at 5:57 am on 29th of the same month.

(9)    The plaintiffs A2 had a sore throat on 27th December, but she was not diagnosed with influenza at that time. Immediately after C1’s death a virus isolation test was conducted at Osaka Prefectural Public Health Institute and the influenza viruses were found not in the bronchi but in the intubation tube. It is possible that the intubation tube was contaminated from the aerial infection, etc. The isolation results were negative with any of the cerebrospinal fluid, nasal cavity tube, blood, lungs, cerebellum, frontal lobe and pons (Hei 2-2). The test on the value of virus antibodies with the serum (blood) showed negative results with the value of Hong Kong influenza A antibodies and the results of virus antigen detection using fluorescent antibody technique were also negative (Hei 1-1). It is completely unknown at what stage from the trachea to removal the virus found in the intubation tube adhered to the tube. Therefore the plaintiffs A1 and A2 are disputing against C1’s influenza contraction.

         However, it is unlikely that the influenza virus was isolated even if the virus in the air adhered to the intubation tube as described above. According to exhibits (Witnesses X and Y), influenza viruses cannot always be isolated even if they exist and it is acknowledged that the negative results do not immediately disprove the existence of influenza virus. Synthesising all these and judged on this basis, the above test results on C1 are reliable.

(10)The plaintiffs A1 and A2 claim that it is extremely rare to develop Reye syndrome from influenza viruses (Hei 1-1) and that the disease cannot have come from influenza viruses even if it was Reye syndrome. The written response of the National Institute of Health (Otsu 48) also states that ‘The distribution is diffusive and the observations are not histologically typical of influenza pneumonia’. The written opinions of Dr. U et al (Ko B15-1) states that the possibility of pneumonia can be denied because no pneumonia observations were seen at the time of autopsy and no virus was found in the central nervous system and that it is impossible that the virus affected the cranial nerves.

         However, it is possible to acknowledge that he was infected by influenza virus from the fact that influenza virus antigen was found in the trachea and lung. Also the influenza viruses cannot always be isolated even if they exist as described above. According to exhibits (Hei 13), it is acknowledged that hitological changes caused by virus infection normally appear in functional disorders after several hours to several days. The possibility of influenza virus infection cannot be denied because there were no pneumonia observations and no influenza virus was found in C1’s central nervous system.

(11) The plaintiffs A1 and A2 claim that the fact that the measles-like symptoms and aseptic meningitis which are considered to be side reactions to the MMR vaccination adversely affected C1’s health condition and the fact that the measles virus contained in the MMR vaccine directly infected C1’s cranial system or suppressed C1’s immunity, both indirectly contributed to C1’s contraction of the virus infection such as influenza.

a However, concerning the point that C1’ health condition was adversely affected, even if the measles-like symptoms and aseptic meningitis C1 had are caused by the MMR vaccination, it is acknowledged that the aseptic meningitis C1 contracted was not particularly severe compared with its normal development, according to exhibits (Witnesses X and Y). Also these symptoms clinically remitted and were cured as of 8th December. Even if C1 had infant vomiting diarrhea and influenza virus infection following that, it cannot be immediately acknowledged that the MMR vaccine adversely affected C1’s health condition and contributed to the crisis.

b Also concerning the point that the measles virus infected C1’s cranial system, the plaintiffs claim that intranuclear inclusion which is typically seen with measles encephalitis existed in C1’s cranial system. Dr. U et al submitted written opinions (Ko B15-1 & 2) as a proof to be in accordance with this, and the witness V gave a testimony which is parallel to this.

     However, according to exhibits (Hei 13), concerning the photo which V et al. claim to be the intranuclear inclusion (Ko B15-2, figure 93F), the image shown there cannot be clearly acknowledged it to be intranuclear inclusion. Even if V’s testimony is taken into consideration together with this, it cannot be acknowledged that intranuclear inclusion existed in C1’s cranial system and there is no other evidence sufficient to acknowledge that measles virus affected C1’s cranial system. 

c Concerning the point that the measles virus contained in the MMR vaccine suppressed C1’s immunity, the plaintiffs A1 and A2 submitted exhibits (Ko A73, 74 and KoB17).

       However, according to exhibits (Otsu 66-1 & 2, Hei 12, 14 and Witness T’s written response), it is acknowledged that wild strain measles virus may have immunity suppression effect, but that the vaccine strain is considered not to have any such effect or to have it very slightly even if it does. The above exhibits the plaintiffs submitted only concern limited vaccine strain. Considering these, it cannot be acknowledged that the measles virus contained in the MMR vaccine suppressed C1’s immunity or that it contributed to C1’s influenza virus infection.

(12) Also the plaintiffs A1 and A2 claim that C1 contracted aseptic meningitis caused by mumps virus and that it is possible that the mumps virus caused C1’s Reye syndrome, but that there is no evidence to support this and their claim cannot be adopted.

(13) As stated above, a cause and effect relationship cannot be acknowledged between C1’ s death and the MMR vaccination.

  3 The points of dispute (3) Concerning a cause and effect relationship between the MMR vaccination and C1’s death

(1)    According to the above facts without dispute and exhibits (Ko B5, 10, 11, 12, 16, Hei 2-1 & 2 and 3-1 & 2), the following facts are acknowledged concerning C2’s physical growth up to the MMR vaccination and the lesion occurrence process and situation after the MMR vaccination:

a C2 was born as the first child of the plaintiffs A3 and A4 on 2nd September, 1989.

b C2 developed atopic dermatitis immediately after birth, and about 3-4 months after birth his face skin was rough with red eczema and he had some of the same kind of eczema on the body as well. Later C2 was diagnosed with atopic dermatitis at Takatsuki Hospital and the intake of eggs was prohibited.

c About March, 1991, as a result of a blood test at Tomita Town Hospital, C2’s allergic tendency toward milk was found and he was treated with a diet, etc., after that.

d About 10:55 am on 25th June of the same year, C2 was found to have febricula of 37.1 degrees at the body temperature measurement at Tomita Town Hospital, but following the doctor’s judgment, he was vaccinated with the MMR vaccine.

e On 26th of the same month, C2 cried intensely from early evening, had pyrexia and slept without eating dinner. In the middle of the night, he drank a large quantity of tea. About 12 noon on 27th of the same month, he had a temperature of 38.5 degrees and took one tablet of an antipyretic, Albini suppository. About 4 pm of the same day, he had a sudden convulsion fit and about 6:20 pm, he was seen at Tomita Town Hospital. He was found to have pyrexia of 39 degrees, clonicotonic convulsion, lowering of consciousness (100 to 200) and dehydration. The convulsion was temporarily settled by an injection but it soon recurred and finally he fell into status epilepticus fit. Then C2 was suspected of acute encephalopathy, was given emergency life-saving treatment and transferred to Ueda Hospital.

f He was suspected of Reye syndrome as a result of a blood test and treated for liver disorder and brain edema. He was treated with respiratory management, etc. in the ICU (intensive care unit) and about 9:45 pm on the same day, he was transferred back to the pediatric clinic of Takatsuki Hospital. He was admitted to the ICU and brain edema was found as a result of a CT test.

     The results of C2’s cerebrospinal fluid test on the same day were: number of cells 1376/3; polynuclear cells 432/3; mononuclear cells 944/3; erythrocytes 60000/3; protein 35; and bacteria and virus negative.

g C2 had frequent convulsions after being admitted to Takatsuki Hospital and a respirator therapy was started, but he fell into coma. The result of the cerebrospinal fluid test on 29th of the same month were: number of cells 87/3; polynuclear cells 82/3; mononuclear cells 5/3; erythrocytes 3700/3; sugar 24; protein 459; and bacteria and virus negative. From about 5th July of the same year, C2’s symptoms of flaccid paralysis in neck regions and below and severe mental disorder continued and high temperature, pulmonary emphysema and pneumonia were repeated.

h On 29th of the same month and 1st July of the same year, Type I herpes simplex virus antibody test was carried out at Takatsuki Hospital and the both results were negative. On 27th September of the same year, another Type I herpes simplex antibody test was ordered , but because of some misunderstanding the herpes simplex encephalitis antibody test was not carried out, and a varicella/herpes zoster virus test was given instead. 

     Also on 29th June of the same year, 19th August of the same year and 27th September of the same year, antibody value tests on Cocksackivirus, ECHO virus, Cytomegalovirus, varicella/herpes zoster virus, etc. were carried out at Takatsuki Hospital, but no antibody was found.

i C2 died at 7:13 am on 8th August, 1992.

j The pathological dissection diagnosis of C2’s autopsy carried out at Takatsuki Hospital on the same day was as follows:

Main lesions: cerebrospinal malacia caused by cerebrovascular circulation disorder, hydrocephalus

Side lesions: pneumothorax on both sides, celomic edema, right heart hypertrophy, pneumonia, lung hemorrhage, low weight (12 kilogrammes), spleen tumor (76 grammes), stomach and duodenal ulcer, trachea ulcer, alveoli interstinal fiber increase, right heart failure (hemostasis in liver, kidney and spleen), artificial pulmonary emphysema.

(2)    As acknowledged above, C2 had atopic dermatitis soon after birth and was diagnosed by the doctor and treated with restriction of the intake of eggs and milk which cause allergic symptoms. He did not have any particular disease or disorder other than that. At about 10:55 on 25th June, 1991, C2 was found to have febricula of 37.1 degrees as a result of temperature measurement, but with the doctor’s judgment, he was vaccinated with the MMR vaccine. In the light of these circumstances, C2 did not have any chronic disease to cause a sudden high temperature and convulsion. He had febricula before the vaccination, but the doctor knew it and judged that it was light enough to be vaccinated, therefore it is recognised that he showed no sign of any kind of virus infection.

(3)    As described above, C2 cried intensely, had pyrexia and slept without eating dinner from early evening of the day after the MMR vaccination. On the second day (27th June of the same year), he had a temperature of 38 degrees and had a sudden convulsion fit. About 6:20 pm of the same day, he was seen at Tomita Town Hospital and found to have pyrexia of 39 degrees, clonicotonic convulsion, lowering of consciousness and dehydration. Finally he fell into status epilepticus fit and was taken to Ueda Hospital. He was suspected of Reye syndrome and treated for liver disorder and brain edema. After he was treated with respiratory management, etc. in the ICU (intensive care unit), at about 9:45 pm on the same day, he was transferred to the ICU of Takatsuki Hospital. As a result of a CT test, he was found to have brain edema and admitted to the hospital. He had frequent convulsions and a respiratory therapy was started, but he fell into coma and died on 8th August, 1992.

            Therefore it is acknowledged that C2 showed abnormality with pyrexia on the day after the MMR vaccination and two days later, a severe lesion with a risk to life occurred. Then the symptoms became worse and he finally died. 

(4)    The defendants claim that C2’s above symptoms appeared too early to be side reactions to the MMR vaccine and too late to be allergic reactions.

         According to the exhibits (Otsu 79, Hei 12), it is certainly acknowledged that side reactions to live vaccines occur after the time required for vaccine viruses to proliferate had passed, which is generally considered to be between 7 and 21 days after the vaccination and that anaphylactic reactions among allergic reactions occur several hours after the vaccination on the hand.

         Conversely, it is acknowledged that side reactions can occur 2-3 days after the vaccination according to the exhibits (Ko A39, 55, 60, Ko B15-1, Otsu64). The defendants claim that the American surveillance report on side reactions accompanying preventive vaccinations (Ko A39, 60) statistically processes the time period up to the adverse event which occurred after the vaccination mechanically regardless of the existence of a cause and effect relationship without epidemiological screening and therefore cannot be used as a basis. However even if the existence of the individual cause and effect relationship is not clear, it is acknowledged that there are cases in which an adverse event occurred after the vaccination from the above report. Therefore the fact itself that adverse events similar to the side reactions can occur 2-3 days after the vaccination is acknowledged from the above report.

(5)    Dr. R’s statement of an expert opinion (Hei 12) states: ① The symptoms of herpes simplex encephalitis are encephalitis symptoms such as convulsion and consciousness disorder following pyrexia. The clinical record of Takatsuki Hospital dated 28th June, 1991 records the disease as ‘general herpes simplex infection’ and a specific medicine against the virus was administered, suspecting herpes simplex encephalitis from an early stage; ② A noticeable cell increase dominated by mononuclear cells was recognised in the cerebrospinal fluid test. The cerebrospinal fluid contained erythrocytes, but correction is possible and a noticeable increase dominated by mononuclear cells was still recognised after the correction. Therefore this case is considered to be meningoencephalitis. ③ The MMR vaccine is a live virus vaccine which proliferates in the body and it is impossible that it should proliferate in a short time and causes meningoencephalitis. On the other hand, an intense inflammation occurred, caused by allergic reactions only in the central nerves and no symptoms and observations caused by allergy were found in other parts of the body including the area vaccinated. Therefore it is impossible to say that the lesion was caused by the vaccination. It is highly likely that C2 contracted viral meningitis including herpes simplex viruses and developed menigoencephalitis as a result. Also Dr. Mori’s statement of opinion (Hei 13) states that C2’s symptoms are strongly suspected to be those of menigoencephalitis caused by viral infection.

        On the other hand, Dr. V’s statement of opinion (Ko B17) states: ① There is almost no infiltration of inflamed cells of the intracerebral hemal walls in the cranial pia mater  and the possibility of encephalitis or ADEM isrejected. ② The measurements of herpes simplex antibodies on C2 on 29th March, 1991 and 1st July of the same year were both negative and the results of Professor T’s DNA diagnostics on the herpes simplex virus in the frozen cerebrospinal fluid using the PCB method were also negative. ③ The possibility of encephalomyelitis caused by an unknown kind of virus can be denied because no inflammation image was found in the spinal cord/brain stem area such as spinal cord, medulla oblongata and pontine and no inclusion in the cell nuclear was found. Dr. W’s statement of opinion (Ko B21) states: ① The protein value of 459 (average 44±29) in C2’s test on 29th June, 1991 was abnormally high. It makes us suspect that the lumbar puncture was unsuccessful or that the primary disease was encephalopathy. In the cerebrospinal fluid test at Takatsuki Hospital on 27th June of the same year, it was possible that blood mixed in and the accuracy was lower because the figure was approximate even if a corrected value was used. Therefore it is not possible to establish from the above cerebrospinal fluid results that it was meningitis; ② If C2’s symptoms were those of herpetic encephalitis, it is considered to have begun with pyrexia on 26th June of the same year. However, the results of the antibodies test on 4th July of the same year were negative. The diagnosis of herpetic encephalitis is determined by proving the presence of viruses using either virus isolation or the PCR method. But it was not proved even by the PCR method using a brain specimen whose positive rate is the highest, and the possibility that this case was herpetic encephalitis is extremely low; ③ It is natural to judge that C2’s symptoms were acute encephalopathy caused by the MMR vaccination because pyrexia, status epilepticus, loss of consciousness and severe neurological  sequelae clinically match symptoms of acute encephalopathy, and there is a similar report on influenza-related encephalopathy.

         As described above, there are different opinions among doctors. In the present case, it is mainly pointed out as the basis to support menigoencephalitis that: ① Such symptoms as pyrexia followed by convulsion and consciousness disorder appear in herpes simplex encephalitis. C2 had similar symptoms and he was diagnosed with general herpes simplex infection at Takatsuki Hospital; ② Noticeable cell increase dominated by mononuclear cells was found in C2’s cerebrospinal fluid test. Some erythrocytes were found in the cerebrospinal fluid, but correction is possible and the same results were gained after the correction.

         However, Dr. W points out in his statement of opinion (Ko B21) that pyrexia, status epilepticus, loss of consciousness and severe neurological squela clinically match the symptoms of acute encephalopathy and that there is a similar report on influenza-related encephalopathy. Then it is not possible to judge that it was menigoencephalitis caused by viruses from the symptoms. Takatsuki Hospital diagnosed it as herpes simplex infection despite that the results of the virus test were negative, and the possibility that it was diagnosed as the infection from the symptoms cannot be denied.

         Also it is questionable to use as a basis the point of ② Noticeable cell increase dominated by mononuclear cells was found in the cerebrospinal fluid test. As is pointed out by the statement of opinion by Dr. U et al. and Dr. T’s, the observations of the cerebrospinal fluid on the 3rd day after the vaccination (27th June, 1991) were that a large quantity of erythrocytes were mixed in, and they cannot be medically valued, and cannot be directly used as a basis. Even if the correction mentioned in Dr. R’s statement of an expert opinion etc. (Hei 12 and 14) and Dr. T’s written response was carried out, the corrected value was approximate and the accuracy was lower, therefore it cannot be established that it was meningitis from the above results on the cerebrospinal fluid, according to Dr. W’s statement of opinion.

         On the other hand, the measurements of herpes simplex antibodies on C2 given on 29th June, 1991 and 1st July of the same year were both negative. The results of DNA diagnostics by T on herpes simplex viruses in the frozen cerebrospinal fluid using the PCR method were also negative. Also no other virus was found in tests on C2, and the possibility of menigoencephalitis caused by viruses is not supported by any objective evidence and it has to be said that it is only a possibility.

         Furthermore, the MMR vaccine is a live virus vaccine and the viruses proliferate in the body. It is not possible for them to proliferate in a short period of time, causing menigoencephalitis. Only the central nerves had an intense inflammation caused by allergic reactions and no allergic symptoms or observations were found in other areas of the body including the vaccination area. On the other hand, the period of time in which side reactions to preventive vaccinations related to cranial nerves appear can depend on the atypicality of the vaccine side reactions and the individual condition and health condition of the recipient, therefore the possibility of symptoms appearing in cranial nerves 2-3 days after the vaccination cannot be denied.

(6)    Medical considerations concerning C2’s physical growth, etc., the development of the lesions which occurred after the MMR vaccination, symptoms, etc., the MMR vaccination and its side reactions are as follows: ① C2 had chronic allergies, but he did not have any chronic disease to cause a sudden high temperature and convulsion. He only had febricula before the MMR vaccination. The day after the vaccination, he showed abnormalities accompanied by a high temperature, and two days later, a severe lesion certainly accompanied by a risk of life occurred. ② The possibility that the above symptoms were those of menigoencephalitis-caused viruses such as herpes simplex encephalitis, as the defendants claim them to be, cannot be totally denied, but the objective evidence is slender. On the other hand, the measurements of herpes simplex antibodies given twice at that time showed negative results and it has to be acknowledged that the probability of the lesion with the above cause is low. Nothing else to cause the above acute lesion to C2 at that time can be conceived and there is no evidence to acknowledge it. ③ There are cases in which side reactions related to cranial nerves appear 2-3 days after the MMR vaccination. It can be pointed out that it is not unnatural or unreasonable if the above lesion was caused by the MMR vaccination, influenced by C2’ s allergic constitution and health condition at the time of the vaccination.

(7)    Considering the above points taken together , it has to be considered that a high probability is acknowledged between the MMR vaccination and C2’s lesion and death on the basis of empirical rules and it is reasonable to acknowledge a cause and effect relationship.

  4 Points of dispute (4) A cause and effect relationship between the plaintiff A5’s condition and the MMR vaccination

(1)    According to the above facts, etc. without dispute and the exhibits (Ko A36-1 to 36-4, Ko C1, 2, 5, 7, Otsu 55, Witness Q, Witness F, Witness G, plaintiff A7 herself), the following facts can be acknowledged concerning the plaintiff A5’s physical growth up to the MMR vaccination, and the occurrence process and circumstances of the lesion after the MMR vaccination:

a The plaintiff A5 was born as the second daughter of the plaintiffs A6 and A7 on 29th June,1989. She weighed 2,474 grammes at birth. She was healthy and had no particular observations to be a problem until about November of the same year.

b The plaintiff A5 had a asthma fit and came to Q Clinic on 8th November of the same

year. She was either an outpatient or an inpatient of Ofunato Hospital or Q Clinic until May, 1991.

c The plaintiff A5 received the 1st and 2nd preventive vaccinations of Phase I of the diphtheria pertussis tetanus vaccine (DPT vaccine) on 17th January and 7th February, 1991. She had no such symptom as pyrexia and did not have any particular health problem.

d The plaintiff A5 had pyrexia of 39 degrees with acute bronchitis on 15th of the same month, but it was cured on 1st March of the same year.

e The plaintiff A5 received the 3rd vaccination of Phase I of the diphtheria pertussis tetanus vaccine (DPT vaccine) on 11th of the same month, but she had no such symptom as pyrexia and did not have any particular health problem.

f The plaintiff A5 was vaccinated with the MMR vaccine by Dr. Q at Q Pediatric Clinic on 24th April of the same year. Her temperature was 36.6 degrees with no pyrexia and she had slight stridor, but had no particular symptom. 

g The plaintiff A5 had slight stridor and cough between 26th of the same month and 3rd May. She was seen at Q Clinic every 2-3 days and treated with a Neophylin intravenous injection, etc. She had no pyrexia then.

h The plaintiff A5’s grandfather D3, her elder brother D5 and her elder sister D4 had pyrexia and diarrhea and were seen at Q Clinic on 7th of the same month. D5’s diarrhea started on 4th of the same month, the grandfather D3’s on 5th of the same month, and D4’s on 6th of the same month. When they were seen on that day, their diarrhea was beginning to subside, but they complained they had a stomachache. The grandfather D3 had diarrhea and febricula between 5th and 6th of the same month, and complained of diarrhea and stomachache on 7th. D4’s symptoms were severe and her diarrhea was frequent. She had severe dehydration, pyrexia of 39.3 degrees and diarrhea. Dr. Q treated her with infusion. He diagnosed the grandfather D3, D4 and D5 with viral infectious gastroenteritis.

     The plaintiff A5 had a temperature of 36.7 degrees on that day and her throat was reddened, but her health condition was good and she was high-spirited. She played as usual and went to bed about 9 pm.

i The plaintiff A7 found that the plaintiff A5 had a great deal of night sweat which made her hair shine about 5 am on 8th of the same month. The plaintiff A7 wiped the plaintiff A5’s hair and changed her clothes. The plaintiff A5 called the plaintiff A7, “Mummy, Mummy”.

j At 7:45 am on 8th May of the same year, the plaintiff A5 had a temperature of 37.5 degrees.

k About 8:20 am of the same day her grandfather D3 and others noticed her abnormalities such as not responding, cold right hand, no strength, unnatural breathing and pituita, and about 8:35 am of the same day they took her to Q Clinic.

l When the plaintiff A5 came to the clinic, she was unconscious and had absent pulses with a slow pupillary reflex. Her pupilla was dilated and her breathing had stopped. Her body had no tonicity and a strong cyanosis with a severe dehydration.

m Dr. Q gave the plaintiff A5 mouth-to-mouth artificial respiration and treated her with various resuscitations such as instillation for dehydration, and she regained natural respiration, but had a severe dyspnea. When Dr. Q gave her aspiration, a great deal of phlegm came out while convulsion was repeated to be status epilepticus.

     Dr. Q found noticeable abdominal distension and status epilepticus in the plaintiff A5 , gave her an enema to relieve them and found diarrhea in her. The results of a peripheral blood test carried out at Q Clinic with the blood drawn from her were leukocytes 27100, ESR 17/44 and GOT 102 with the liver function test.

     Despite the above treatment by Dr. Q, the plaintiff A5’s convulsion did not stop and she remained unconscious. Dr. Q judged that it was a severe encephalopathy and sent the plaintiff A5 to Ofunato Hospital. The plaintiff A5’s temperature was 40. 3 degrees at that time.

n The results of the plaintiff A5’s tests at Ofunato Hospital were: number of leukocytes 7700; number of cells in the cerebrospinal fluid 3/3; protein 18 mg; GOT 136; ammonia 36. The results of blood biochemical test carried out on 10th of the same month were: number of leukocytes 26000; GOT 226; ammonia 85. Also a CT scan at Ofunato Hospital found brain edema in the plaintiff A5.

     H who is the physician of the hospital suspected of Reye syndrome in A5 from the observations of the CT scan and the data of the blood biochemical test. He treated her with a therapeutic course to prevent and treat brain edema, convulsion and liver failure. He transferred her to Tohoku University Hospital on 10th of the same month for her to receive higher level treatment.

o Tohoku University Hospital diagnosed the plaintiff A5 with Reye syndrome and intensively treated her with hepatopathy treatment (exchange transfusion), respiration management, brain hypertension abatement, etc. Later the plaintiff A5’s brain hypertension gradually improved, but the CT observations found brain edema. About one month after the hospitalisation, brain atrophy was found. The results of the plaintiff A5’s cerebrospinal fluid test given on 19th June of the same year were: number of cells 3/2; protein 17 mg.

p The plaintiff A5 was discharged from the hospital with appendicular spatic paralysis and severe mental disorder on 2nd September of the same year and transferred to Takuto Medical and Nursing Centre, Miyagi prefecture to receive rehabilitaion. From about November of the same year, she received nursing care at home.

     The final diagnosis of the plaintiff A5 at Tohoku University Hospital was acute encephalopathy because the ballooning of the cell mitochondria with electronic microscope observations was negative and it was not established to be Reye syndrome.

q Dr. F who was the plaintiff A5’s physician at Tohoku University Hospital drew cerebrospinal fluid from her on 19th June of the same year and sent it as a specimen for mumps virus isolation to Sendai City Health Institute, requesting them to test it.

r G who is on the staff of Microbe Section, Sendai City Health Institute, attempted mumps virus isolation from the plaintiff A5’s cerebrospinal fluid using vero cells for 30 days with 4 subcultures, but no mumps virus was found. He tried again using vero cells, but the results were negative.

     Then G attempted the isolation using LLCMK2 cells, and after 42 days with 4 subcultures, mumps viruses were isolated from the plaintiff A5’s cerebrospinal fluid.

s An identification test was carried out on the mumps viruses isolated from the plaintiff A5’s cerebrospinal fluid at the National Institute of Health, and on 11th December of the same year, it was determined that it was highly likely that they came from the Urabe strain used for the MMR vaccine.

t The plaintiff A5’s sequelae include acute encephalopathy sequela (spastic type of appendicular paralysis, mental and motor development retardation, dislocation of both hip joints) and she cannot live any normal daily life including eating.

(2) As described above, the plaintiff A5 had an asthma fit about 5 moths after birth and was treated for it after the MMR vaccination until the day before she had severe symptoms. She did not have any particular disease or disorder. She was vaccinated with the MMR vaccine at Q Clinic on 24th April, 1991. She had no pyrexia although she had a slight stridor. Other than that, she had no particular symptoms. In the light of these facts, it is acknowledged that she had no anamnesis to cause sudden high temperature, severe convulsion and brain edema and that she had no particular health problem at the time of the vaccination.

(3) According to the facts described above, it is acknowledged that the plaintiff A5 had no particular health problem until 7th May of the same year, on the 13th day after the MMR vaccination. About 5 am on 8th May of the same year, on the 14th day after the vaccination, the plaintiff A5 had a great deal of night sweat and at 7:45 am, she had pyrexia of 37.5 degrees. At about 8:20 am, she had no response, her right hand was cold, had no strength, her breathing was unnatural, and had pituita. When she went to Q Clinic about 8:35 am on the same day, the plaintiff A5 was unconscious, had absent pulses, her pupillary reflex was slow, her pupilla was dilated and her breathing had stopped. Her body had no tonicity and a strong cyanosis with severe dehydration. Dr. Q gave her artificial respiration and treated her with various resuscitations such as instillation for dehydration, and she regained natural respiration, but had a severe dyspnea. When Dr. Q gave her aspiration, a great deal of phlegm came out while convulsion was repeated to be status epilepticus. When he sent her to Ofunato Hospital about 9 am, her temperature was 40.3 degrees. After she was sent to Ofunato Hospital, a CT scan found brain edema in the plaintiff A5 there.

        In the light of the above development, it is acknowledged that the plaintiff A5 had sudden abnormalities such as pyrexia, dyspnea and convulsion on the 14th day after the MMR vaccination, and that symptoms accompanied by severe brain disorders appeared.

(4)    As for medical knowledge about vaccinations and their side reactions, etc., according to the exhibits (Ko A39, 60, Ko B15-1, Ko C2, Otsu 64 and 65), it is acknowledged that there are cases in which acute encephalopathy is caused by the MMR vaccination and that cases in which side reactions related to cranial nerves appear about the 14th day after the MMR vaccination are not unknown. The statement of opinion by Dr. U et al. (Ko B15-1) acknowledges a cause and effect relationship between the MMR vaccination and the plaintiff A5’s lesion because it fully corresponds to the incubation period of a virus proliferating type of encephalopathy.

(5)    Also it is acknowledged that it was determined that mumps viruses were isolated from the plaintiff A5’s cerebrospinal fluid and that it is highly likely that they come from the MMR vaccine strain as stated above.

        Concerning this point, the defendants claim that the test results concerned have no validity because the plaintiff A5’s cerebrospinal fluid was collected during the convalescence period (19th June, 1991), the mumps viruses were finally isolated from A5’s cerebrospinal fluid after 72 days with 4 subcultures and it may very well be suspected that something else was mixed in during the test.

         According to the above acknowledgement and the exhibits (Ko B21, Ko C2, Hei 21-2, Witness G), the following facts concerning general virus isolation methods and the isolation test of the viruses from the plaintiff A5 are acknowledged:

       a The plaintiff A5’s cerebrospinal fluid was collected on 19th June (42nd day after the occurrence) and no cell increase was found in the fluid at the general test and no pathological observation was found.

       b Vero cells are generally used to isolate mumps viruses and the results are obtained in about a week.

       c The results of the two vero cell tests of the plaintiff A5’s cerebrospinal fluid were both  negative. The results of the first subculture were not positive, but there was degeneration. In order to verify the results, it was subcultured four times for 42 days using LLCKM2 cells, and the result was positive.

       d The viruses isolated from the plaintiff A5’s cerebrospinal fluid were identified as vaccine strain viruses which do not exist in the natural world.

       e Generally it is not possible for a specimen’s cerebrospinal fluid to mix with another patient’s fluid during transport and the process of testing or with mumps virus in the natural world during storage.

            Considering the above facts, it certainly cannot be denied that the plaintiff A5’s cerebrospinal fluid test was noticeably different from cerebrospinal fluid tests in general in the period of the fluid collection, test duration, test method, etc., but in the end vaccine strain viruses which do not exist in the natural world were isolated from the plaintiff A5’s cerebrospinal fluid, and it is reasonable to acknowledge the existence of the vaccine strain viruses in her cerebrospinal fluid. 

             On the other hand, according to the written response by E, Director of the National Institute of Infectious Diseases (Hei 21-2), Dr. R’s statement of opinion (Hei 12) and his written statement titled “My view concerning the statement of opinion by Dr. W, pediatrician, Osaka Red Cross Hospital (Ko B documentary evidence No. 21)” (R’s statement of view, Hei 14), the proliferation of mumps viruses is suppressed by immune reactions after virus infection, and the infectivity of the viruses, once they have proliferated, is neutralised by antibodies. It is impossible to isolate viruses from the cerebrospinal fluid about 5 days or more after the occurrence, therefore the test results have no validity.

             However, there is not sufficient evidence to state that it is impossible to isolate viruses from the cerebrospinal fluid collected during convalescence. Even if the specimen, the plaintiff A5’s cerebrospinal fluid, was collected during convalescence, the validity of the test results cannot immediately be denied because of that.

             Also it cannot be said that there was no possibility at all of vaccine strain viruses mixing in from the outside by confusion or by mistake, because of the particularity of the test in this case as described above. In general, there is no possibility for the specimen cerebrospinal fluid to be mixed with another patient’s fluid during transport and in the process of testing or with mumps virus in the natural world during storage. Also there is no concrete evidence to prove that there was such mixing-in in this case, and these possibilities remain speculations which are not sufficient to influence the above judgment.

(6)    Medical information concerning the possibility of acute encephalopathy with continued anoxic state caused by viral gastroenteritis.

a Dr. R’s statement of expert opinion (Hei 12) and his statement of view (Hei 14) are as follows: ① About 10 days after the plaintiff A5’s MMR vaccination, her family had infection with main symptoms in digestive organs, although the pathogen causing this cannot be specified, and the plaintiff A5 caught the infection causing Reye syndrome; ② It is possible to assume edema in the airway mucous membranes, discharge and lesion in the plaintiff A5 because she had an allergic predisposition and had stridor after the MMR vaccination; ③ the Reye syndrome was accompanied by bronchial asthma and dehydration caused by viral infection, which led to respiratory pause, hypoxemia and brain disorder.

b Dr. T’s written response also states that the strongest possibility is considered to be clinical Reye syndrome accompanying some kind of infection because of the pathology such as acute respiratory pause, noticeable brain edema and brain disorder seen on 8th May and the blood test results, especially sGOT, sGPT and ammonia rise. Also the possibility of the involvement of the already found allergic predisposition cannot be denied, as regards the sudden respiratory pause. This view seems almost the same as Dr. R’s view above. It states that the diagnosis of aseptic meningitis is impossible because the results of the cerebrospinal fluid test at the acute phase were normal.

c The statement of opinion by Dr. U et al. (Ko B15-1) and Dr. V’s statement of opinion (Ko B17) affirm that no other cause than the vaccination of this case can realistically be envisaged because the plaintiff A5 had never had a convulsion fit before, although she was treated for an asthma tendency at the time of the MMR vaccination. Also even if three members of her family had pyrexia on the day before the occurrence, the plaintiff A5 did not have pyrexia on the day of the vaccination and no virus, etc. was found in A5’s body.

(7)    Certainly it is acknowledged: ① The grandfather D3, D4 and D5 were complaining of such symptoms as stomachache, diarrhea and pyrexia on the day before the plaintiff A5’s attack (7th May); ② When the plaintiff A5 was given an enema at Q Clinic on 8th May, the feces reacted in the form of diarrhea; ③ The plaintiff A5 had an anamnesis of asthma and Dr. Q’s observations included the reddening of her throat; ④ About 8:20 am on the same day, the grandfather D3 and others noticed that the plaintiff A5’s breathing was unnatural; ⑤ When the plaintiff A5 arrived at Q Clinic at 8:35 am on the same day, she was in a state of respiratory pause.

            However, ① Even if the plaintiff A5 had diarrhea on 8th May, no bacteria were found in her feces according to the test by Tohoku University Hospital (Ko C2). Also there is no sufficient evidence to specify the pathogen causing the symptoms of the plaintiff A5, D3 and others. Neither is there sufficient evidence to maintain that the grandfather D3, D4 and D5 were infected by the same kind of pathogen.

Also ② According to Dr. Q’s observations, A5’s condition was good on 7th May and she was playing as usual on the day. Even if the plaintiff A5 had inflammation, etc. in her bronchia, it is considered to have been slight.

Then it is impossible to rule out the possibility that the plaintiff A5 had an infection with main symptoms in digestive organs which caused Reye syndrome, worsened by bronchial asthma and dehydration, leading to respiratory pause, hypoxemia and brain disorder, but no concrete fact to support this isrecognised, and it is only a possibility.

(8)    According to the above considerations concerning the plaintiff A5’s physical growth, etc., development of the lesion which occurred after the vaccination, symptoms, etc., and the vaccination and its side reactions, etc., the plaintiff A5 had no particular anamnesis to cause a sudden high temperature and convulsion, and she had no particular abnormality before and after the vaccination. However, abnormalities such as a sudden pyrexia, convulsion, etc. occurred 14 days after the MMR vaccination, followed by severe lesions such as brain disorder. The possibility that the plaintiff A5 had an infection with main symptoms in the digestive organs which caused Reye syndrome, worsened by bronchial asthma and dehydration, leading to respiratory pause, hypoxemia and brain disorder, as the defendants claim, cannot be completely denied. However putting together the facts that mumps viruses from the vaccine strain were found in the plaintiff A5’s cerebrospinal fluid and that cases in which side reactions related to cranial nerves appear 14 days after the MMR vaccination are not unknown and that it can be considered to be the incubation period of the mumps viruses, it is highly likely that the plaintiff A5’s lesion was caused by the MMR vaccination, and it is reasonable to acknowledge a cause and effect relationship.

  5 Development concerning the MMR vaccine

(1)    As a basis of the judgment concerning points of dispute (5) and (6), the development concerning the MMR vaccine is acknowledged.

(2)    According to the facts, etc. without dispute and the exhibits (Ko A5, 6, 9-38 to 9-41, 10-2 to 10-13, 10-14, 10-16, 10-17, 12, 15, 20-1, 1 and 2 of 20 to 24, 43, 45, 46, 48, 50, 81 to 84, 95, 96, 97-1 to 97-3, 105-1-1, Otsu 6, 7, 9 to 13, 18, 19, 35, 70 to 74, 82, 84, 88 to 91, 95, 101, Witness I, Witness J), the following facts are acknowledged:

a In June 1980, the Minister of Welfare licensed the defendant RIMD to manufacture  the mumps vaccine (Urabe strain vaccine), made by the amnion culture method, in which the prototype strain, Urabe AM-9 strain is cultured with hens’ amnions.

     The defendant RIMD received the approval of the Minister of Welfare to partially change the manufacture method of Urabe strain vaccine from the amnion culture method to the cell culture method in which the vaccine is cultured with cells extracted from hens’ embryos in July, 1985.

b In Canada, three cases of aseptic meningitis occurred several months after the vaccination of MMR vaccine (Trivilix vaccine) containing Urabe strain mumps vaccine, which was approved of in 1986, as reported in a medical journal “Canada Disease Weekly Report” published on 5th September, 1987.

     Aseptic meningitis is a syndrome which is caused by many benign pathogens. Representative pathogens of aseptic meningitis include enteric virus, mumps virus (which caused mumps), etc. Aseptic meningitis suddenly occurs, whose three major symptoms are pyrexia, headache and vomiting. Other than those, general malaise and gastrointestinal symptoms are seen. The symptoms naturally and rapidly disappear, and the patient is cured generally in 3 to 10 days. There is basically no complication, and the convalescence is often satisfactory. It was known that aseptic meningitis sometimes occurs after the administration of the MMR vaccine or mumps vaccine, but the distinguishing method then used (the Plaque method) could not distinguish between natural infection by a wild strain and a side reaction to the vaccine.

c On 1st June, 1988, Preventive Vaccination Committee, Infectious Disease Prevention Section submitted an opinion that the MMR vaccination should be actively promoted because only one preventive vaccination is needed to prevent the prevalence of measles, rubella and mumps with the MMR vaccine, which reduces the physical, economical and time burden of the recipient child and it was already implemented in foreign countries such as the USA.

d On 5th May of the same year, infectious Disease Prevention Section concluded that the MMR vaccination should be implemented without delay at the current vaccination time and the vaccination should be actively promoted. Measles continued to be present on a small scale, and the complication rate of pneumonia was high. At the ratio of one in 1,000 to 2,000, measles patients had severe complications such as encephalitis, etc. Rubella spread nationwide every several years mainly among children and grown-up males, and sometimes severe complications occurred. Mumps spread every year, sometimes accompanied by complications such as aseptic meningitis, etc. and sequelae such as deafness etc, Therefore it is desirable to attempt improvement in the rate of measles vaccination and to suppress the spread of rubella and mumps by promoting the vaccination. The MMR vaccine is effective and has few side reactions. It has begun to be implemented  in Europe and the USA, and its implementation has become a world-wide tendency. 

e There were a unified strain and the pharmaceutical companies’ own strains of the MMR vaccine. It was preferable to introduce only one kind of vaccine in order to follow up and evaluate the validity and side reactions after the vaccination, therefore it was decided to introduce the vaccine with the unified strain. In September of the same year, the Minister of Welfare approved the manufacture of the unified strain MMR vaccine made by mixing the mumps vaccine (Urabe strain vaccine) of the defendant RIMD, the measles vaccine (AIK-C) developed by the The Kitasato Institute and the rubella vaccine (TO-336) developed by Takeda Pharmaceutical Co., Ltd. and unifying the composition, as a new medicine on the basis of the recommendations of the Central Pharmaceutical Affairs Council. 

f The partial revision of the Preventive Vaccination Implementation Regulations of 19th December of the same year provided for the MMR vaccination, ‘For the measles vaccination, a dried and attenuated live, mixed vaccine for measles, mumps and rubella can be used if there is a request also for preventive vaccinations for rubella and mumps as well as a dried and attenuated live vaccine for measles.’

g When the defendant RIMD took the examination provided by Article 43 of the Pharmaceutical Affairs Law for the unified strain MMR vaccine, it submitted to the National Institute of Health the undiluted solution manufactured by mixing the undiluted solution of the vaccine made by the amnion culture method which was not approved and the undiluted solution of the vaccine made by the cell culture method. The NIH passed this with the above examination without knowing the change of the culture method. 

     The defendant RIMD continued to manufacture the vaccines by mixing undiluted solutions from the amnion culture and cell culture methods and sold them until October, 1991.

h In July, 1988, the Ministry of Health, Province of Ontario, Canada prohibited the use of the MMR vaccine containing Urabe strain vaccine and recalled its stock. It was reported in the medical journal “Canada Disease Weekly Report’ issued on 19th November of the same year. In the same month, the distributors suspended the use of the MMR vaccine containing Urabe strain vaccine upon the request of Canada’s Department of Health.

i In April, 1989, the municipalities started to use the MMR vaccine in their preventive vaccinations.

j In March of the same year Head of Virus Section, L et al. of the National Institute of Health introduced the PCR method to determine whether side reactions after vaccinations come from wild strains or vaccine strains, and pointed out that it was possible that they came from vaccine strains.

k On 7th of the same month, Fukushima Prefecture informed the Ministry of Welfare that a child who was vaccinated with the MMR vaccine on 9th May of the same year died of acute heart failure on 16th of the same month.

l The Ministry of Welfare investigated the frequency of occurrence through the vaccine manufacturers such as the defendant RIMD and the National Institute of Health and collected opinions from concerned parties and specialists. As a result, it was estimated that about 600,000 to 700,000 children received the MMR vaccination from April of the same year onwards. It was confirmed that there were four patients who were suspected to have developed aseptic meningitis caused by the MMR vaccination by 4th September of the same year (two more by 8th of the same month), and that the disease was mild with all these patients and they were discharged from the hospital in 2 to 3 weeks and cured without any sequelae.

m On 8th September of the same year, the Preventive Vaccination Committee, the Infectious Disease Prevention Section, concluded that the MMR vaccination should continue to be promoted at the time of measles vaccination because it was useful. If the accuracy of the PCR method were insufficient, it would be possible for one in 100,000 to 200,000 children who were vaccinated with the MMR vaccine to develop aseptic meningitis. However, in the case of mumps natural infection, a far higher probability of one in several hundred had aseptic meningitis and some patients had a complication of severe encephalopathy. Compared with this case of mumps natural infection, aseptic meningitis after the vaccination was extremely rare and it was cured with no sequelae.

n On 19th of the same month, the Head of Tuberculosis and Infectious Disease Measures Office notified the Head of Health Supervision Department (Bureau) of each prefecture that they should thoroughly inform municipal mayors under their control and concerned parties of the opinion of the above committee. At the same time the Head of Tuberculosis and Infectious Disease Measures Office instructed that the specimen (cerebrospinal fluid) should be smoothly sent from the local health institute to the National Institute of Health if a medical institution requested an examination of virus strains isolated from an aseptic meningitis case after the MMR vaccination. Also the mention of ‘There is a report that aseptic meningitis which is suspected to come from the mumps vaccine occurs very rarely (about one in 100,000 to 200,000 recipients).’ was added to the “Guide to the use of dried, attenuated and mixed vaccine for measles, mumps and rubella” and he instructed that the content should be thoroughly known to general public through municipals.

o On 17th of the same month, Dr. O of Maebashi Medical Association reported that 3 recipients out of 1,800 who were vaccinated with the MMR vaccine in Maebashi City between April and June of the same year developed aseptic meningitis, and this report was published in Gunma Pediatric Newsletter of the same date.  

p On 11th of September of the same year, the Investigation Section of the Biological Preparation, the Central Council of Pharmaceutical Affairs mentioned, “ This is not something to affect the judgment of the usefulness of the MMR vaccine and the necessity of the vaccination, but there is a report that aseptic meningitis which is suspected to come from the mumps vaccine occurs very rarely (one in 100,000 to 200,000)”, and concluded that concerned parties should be informed of this as soon as possible, that the reliability of the PCR method as a distinguishing method should be further examined and confirmed, and that case studies of aseptic meningitis which is suspected to come from the vaccine should be carried out, attempting to accurately understand the frequency and the degrees of the symptoms.

     On 19th of the same month, the Ministry of Welfare instructed the manufacturers to revise the ‘Notes on usage’ written in the document attached to the MMR vaccine to conform to newer information and to reinforce the supervision after the sale.

q On 13th October of the same year, following the above report by Dr. O, etc., the Ministry of Welfare asked the Head of Tuberculosis and Infectious Disease Measures Office to report on the occurrence of aseptic meningitis after the MMR vaccination and each prefecture to report on aseptic meningitis and similar diseases known to administrators and medical associations, etc. by 23rd of the same month. As a result, it was informed that there were 125 cases, out of about 500,000 recipients who were vaccinated from April to 23rd of October of the same year, in which the recipients had some kind of abnormalities within 2 months after the vaccination. Among those cases, 80 were suspected of having aseptic meningitis, none of which were accompanied by sequelae, and the convalesce was satisfactory.

r On 23rd October of the same year, the Metropolis of Tokyo reported to the Ministry of Welfare that a child vaccinated with the MMR vaccine on 17th May of the same year had a severe hearing disorder of about Class 2.

s On 25th of the same month, the Protective Vaccination Committee, Infectious Disease Prevention Section was reported by Dr. O that there were 10 cases of aseptic meningitis after the vaccination among 1,834 MMR vaccination recipients, i.e. at the high rate of one in 184 but that they did not involve any death or severe disorder, etc. and the convalescence was satisfactory.

     According to the committee, the rate of occurrence frequency varied considerably depending on the prefecture. Some of them had no reports of aseptic meningitis cases after the MMR vaccination, while others had one in several thousand or one in 30,000. Among them, the rate of occurrence was exceptionally high in Maebashi City compared with other prefectures, and there was much discussion about it, e.g. the age of recipients was lower in Maebashi City. Therefore it was considered too early to judge whether the case of Maebashi was an accurate example of the rate of occurrence and it was concluded that it was necessary to further determine this more accurately.

t On 25th October, 1989, the Infectious Disease Prevention Section concluded the following:

(a)    The case reports from prefectures include ones where it is difficult to consider that they come from the vaccine. It is necessary to grasp the exact rate of occurrence, etc. by rapidly carrying out screening tests, etc. using the PCR method, to hold a committee meeting again on the basis of the test results and to examine measures for the time being.

(b)    For that purpose, it is necessary to decide the procedure for the patients’ cerebrospinal fluid, etc., to be smoothly sent to the National Institute of Health, and to immediately instruct prefectures to do so.

(c)    So far there is no case in which the convalescence is poor among those reported by prefectures, etc. which seem to be aseptic meningitis cases. However, according to the survey, it is possible that aseptic meningitis is occurring at the rate of approximately one in several thousand to 30,000 after the MMR vaccination, and the situation cannot  be disregarded.

(d)    Until the results of above (a) become clear, taking into consideration the fact that both measles and mumps are becoming less prevalent, it is necessary to carry out the MMR vaccination cautiously at the time of regular measles vaccination based on the Preventive Vaccination Law.

u The Head of Tuberculosis and Infectious Disease Measures Office instructed the Head of Health Supervision Department (Bureau) of each prefecture, as of the same date, to investigate the occurrence of aseptic meningitis after the MMR vaccination up to the end of October, 1989 again in detail and asked them to report the results by 20th November of the same year. He instructed them to be cautious about the implementation of the MMR vaccination at the time of the regular measles vaccination, based on the Preventive Vaccination Law in each prefecture, considering the natural prevalence of measles and mumps until the results of the survey become clear. He also informed them that the National Institute of Health will conduct screening tests by the PCR method and determine whether the occurrence of aseptic meningitis is caused by wild strains or vaccine strains, and decide the procedure.

v On 31st of the same month, the Head of Environment and Health Department, Osaka Prefecture issued a notice to municipal heads in the prefecture that they should be prepared to suspend the MMR vaccination. Takatsuki City decided to suspend the MMR vaccination on 1st November of the same year, and Toyonaka City on 2nd November of the same year.

x On 25th October of the same year, the Investigation Section of the Biological Preparation, the Central Council of Pharmaceutical Affairs discussed the autonomous suspension of the sales of the MMR vaccine containing Urabe strain mumps vaccine in Canada. It decided that it was necessary to meet again after investigating the exact rate of occurrence of aseptic meningitis caused by the vaccine in Japan and other countries and rapidly to examine measures for the future.

     On 26th of the same month, the Director-General of the Pharmaceutical Affairs Bureau, the Ministry of Welfare verbally instructed vaccine manufactures such as RIMD to investigate cases and literature, etc. and as of 1st November of the same year, requested Japanese diplomatic establishments in the U.S.A., Canada, the U. K. and West Germany to investigate the matter, through the North American Affairs Bureau and the European and Asian Affairs Bureau of the Ministry of Foreign Affairs, in order to find out the rate of occurrence of aseptic meningitis after the MMR vaccination and mumps vaccination in other countries.

y The Ministry of Welfare decided to provide information, available at the time, concerning the occurrence of aseptic meningitis after the MMR vaccination upon request from guardians, etc. As of 14th of the same month, under the name of the Head of Tuberculosis and Infectious Disease Measures Office, it informed the Head of Health Supervision Department (Bureau) of each prefecture of the following: Concerning the MMR vaccination, risks of symptoms and diseases which can be prevented by the vaccine, side reactions which can occur after the vaccination, aseptic meningitis which seem to be caused by the vaccination, there were 125 reported cases in which some kind of abnormality occurred within 2 months after the vaccination among about 500,000 recipients who were vaccinated with the MMR vaccine between April, 1989 and 23rd October of the same year; As well as aseptic meningitis, these included many other cases such as gastroenteritis, cold and urticaria; There were 80 cases suspected of aseptic meningitis with no sequelae, and the convalescence was satisfactory; Among the above 80 cases which went through the PCR method at the National Institute of Health, one case was concluded to have been caused by the mumps vaccine, and two were suspected to have been caused by it; The MMR vaccination was optional; It should be widely known that there was a relief system for health damage caused by a preventive vaccination if there were side reactions to the vaccination.

z As of 18th January, 1990, the Subsection Chief of Preventive Vaccination, the Tuberculosis and Infectious Disease Measures Office, informed the subsection chief in charge of preventive vaccinations of the Health Supervision Department (Bureau) of each prefecture of the following: Concerning aseptic meningitis following the MMR vaccination, about 630,000 children were vaccinated with the MMR vaccine between 1st April, 1989 and 31st October of the same year; among them 311 recipients were clinically diagnosed with aseptic meningitis after the MMR vaccination; the cerebrospinal fluid was collected from 302 of them; the mumps virus isolation test was carried out with the cerebrospinal fluid of 222 individuals; the viruses were isolated from the fluid of 79 cases; it was determined that the virus came from the vaccine in 67 cases using the PCR method; the rate of occurrence of aseptic meningitis which is considered to be caused by the mumps vaccination after the MMR vaccination is estimated to be one in about several thousand, bearing in mind the fact that some of the 311 patients did not have their cerebrospinal fluid tested as above; Among the 311 patients, one was diagnosed with cerebrospinal meningitis and another with lower limb flaccid paralysis; The patient diagnosed with lower limb flaccid paralysis completely recovered and the patient with cerebrospinal meningitis was making satisfactory progress; therefore no patient had a severe complication or sequelae and the progress of the patients was satisfactory; there were reports of a case of hearing disorder and a case of facial paralysis after the MMR vaccination, although it was not known whether they had a cause and effect relationship with the preventive vaccination; the components of the MMR vaccination will be implemented one by one.

aa On 18th December of the same year, the Investigation Section of the Biological Preparation, the Central Council of Pharmaceutical Affairs, examined aseptic meningitis after the vaccination, comparing it with the risks involved with the naturally infected mumps in the convalescence situation, etc. It recognised the usefulness of the MMR vaccine as a medicine, but concerning the occurrence of aseptic meningitis, it recommended the revision of ‘Notes on usage’, calling for caution and reinforcement of the investigation on the rate of occurrence, etc. of aseptic meningitis caused by the vaccine.

bb On 20th of the same month, the Infectious Disease Prevention Section examined information edited by collecting various cases, etc. which occurred after the MMR vaccination, reported by all prefectures, the usage situation of the MMR vaccine in different countries, the investigation report on aseptic meningitis after the MMR vaccination and the mumps vaccination in Canada, a report on risks caused by the natural infection of mumps edited by an officer in charge of the Ministry of Welfare on the basis of such widely esteemed literature as the Lancet, and the Morbidity and Mortality Weekly Report (MMWR) from the CDC and the literature concerning complications of mumps published in the MMWR from the CDC, and concluded:

(a)    Aseptic meningitis attributed to the mumps virus after the MMR vaccination has occurred very rarely so far and most of it has been considered to be natural infection by the wild strain. However, the survey carried out recently which became possible because of the development of the distinguishing method of the mumps virus strains using the PCR method, has made it clear that the probability of occurrence is one in several thousand, which is far higher than was envisaged before.

(b)    However, according to the investigation so far, the symptoms of aseptic meningitis attributed to the vaccine are light and there seems to be no fear of sequelae, while natural infection of mumps causes aseptic meningitis with a probability from tens to hundreds times higher and it is sometimes accompanied by such complications as encephalitis, etc. and such sequelae as hearing disorder, etc. Also several deaths from mumps are reported every year. Therefore it can be said that the MMR vaccine is effective compared with the natural infection of mumps.

(c)    Considering (a) and (b), it is necessary to be able to continue using the MMR vaccine if there is a request at the time of the regular measles vaccination based on the Preventive Vaccination Law. However, instead of actively promoting the vaccination as before, it is necessary to establish a system in which people can choose to be to be vaccinated or not, understanding the effects and side reactions, etc. of the MMR vaccine. In concrete, it is appropriate to use the MMR vaccine at the time of the regular measles vaccination only when the guardian requests it, until a safer vaccine is developed. 

cc The Head of the Tuberculosis and Infectious Disease Measures Office wrote a document entitled, ‘Concerning the vaccination of the MMR vaccine’. As of 28th of the same month, he informed the Health Supervision Department (Bureau) of each prefecture of the following: in principle, monovalent measles vaccine is to be used as a preventive vaccination measure at the time of the regular measles vaccination based on the Preventive Vaccination Law and the MMR vaccine is to be used only when the guardian requests it; guardians are to be informed of the effects and side reactions of the MMR vaccine.

dd The Head of the Tuberculosis and Infectious Disease Measures Office wrote an explanatory booklet about the MMR vaccine for medical institutions and on 18th January, 1990, he informed the Health Supervision Department (Bureau) of each prefecture of it.

     The Pharmaceutical Affairs Bureau of the Ministry of Welfare reported the results of the discussion of the Investigation Section of the Biological Preparation, the Central Council of Pharmaceutical Affairs to the Side Reactions Inquiry Committee and gained its approval. As of 18th January, 1990, the Safety Section Chief of the Bureau instructed the manufacturers to revise the notes for usage according to newer information. In March of the same year, the Bureau published information about side reactions to the MMR vaccine in ‘Information on Side Effects of Medicines’ which is published by the Bureau itself, attempting to make it widely known among the parties concerned.

ee In May, 1990, Canada’s Department of National Health and Welfare prohibited the sale of the MMR vaccine containing Urabe strain vaccine in Canada, upon receiving a report that aseptic meningitis is occurring at the rate of one in 62,000 and consulting a report on the side reactions published in a Japanese medical journal in 1990. This was reported in the medical journal ‘Canada Disease Weekly Report’ published on 15th December, 1990.

ff As of 26th November, 1990, the Head of the Tuberculosis and Infectious Disease Measures Office requested the Health Supervision Department (Bureau) of each prefecture to report on the occurrence of aseptic meningitis, etc. in order to find out the current state of the implementation of the preventive vaccination concerning the MMR vaccine.

gg The plaintiff A5 was vaccinated with the MMR vaccine on 24th April, 1991.

hh On 31st May of the same year, the Infectious Disease Prevention Section concluded the following on the basis of the above reports:

(a)    The rate of aseptic meningitis cases among the recipients of the MMR vaccine between April, 1989 and October, 1990 is one in 1,200, which is higher than the frequency envisaged in the past.

(b)    On the other hand, the occurrence frequency of aseptic meningitis caused by a natural mumps infection is about 2.4%. Encephalitis very rarely occurs as a complication and one in several ten thousands retains a sequela of deafness after the natural infection of mumps, and several patients die every year. Therefore the MMR vaccine is considered to be a useful vaccine, compared with the cases of a natural mumps.

(c)    Considering (a) and (b), the following are appropriate for handling the MMR vaccine as a preventive vaccination measure:

   ⓐ At the regular measles vaccination based on the Preventive Vaccination Law, monovalent measles vaccine is to be used in principle. The MMR vaccine is to be used only when the guardian requests it. Also, the guardian’s explicit consent is to be obtained when using the MMR vaccine.

ⓑ The country and the local public bodies are to attempt to thoroughly inform medical institutions and guardians of the effects and side reactions of the MMR vaccine, and in particular, symptoms and the rate of occurrence, etc. of aseptic meningitis.

ⓒ When the doctor carries out the MMR vaccination, s/he is to explain the side reactions including the symptoms, the rate of occurrence, etc. of aseptic meningitis to the guardian in advance.

       On 21st June of the same year, the Head of the Tuberculosis and Infectious Disease Measures Office revised the explanatory booklets concerning the MMR vaccine for guardians and medical institutions according to newer information. At the same time, he informed the Health Supervision Department (Bureau) of each prefecture of the use of a new medical interview sheet to obtain the guardian’s explicit consent mentioned in above ⓐ, the distribution of the above revised explanatory booklets for doctors and guardians for ⓑand ⓒ and the instructions for reporting the number of recipients of the MMR vaccination and the occurrence of aseptic meningitis after the vaccination.

     Also in August of the same year, the Safety Section of the Pharmaceutical Affairs Bureau of the Ministry of Welfare instructed the manufacturers to revise the notes on usage in accordance with newer information. In November of the same year, it published new information about side reactions to the MMR vaccine in ‘Information on Side Effects of Medicines’ which is published by the Bureau itself, seeking to communicate it to parties concerned and make it widely known.

ii On 25th June, 1991, C2 was vaccinated with the MMR vaccine.

jj On 8th April, 1992, the Infectious Disease Prevention Section of the Public Health Council met and concluded the following on the basis of the results of the monitoring survey, etc. carried out following the notice of the Head of the Tuberculosis and Infectious Disease Measures Office, Department of Disease Measures, Health and Medical Bureau, Ministry of Welfare dated 21st June, 1991:

(a)    The MMR vaccine is used not only in Japan but also in America and Europe and it is highly effective in preventing diseases. In particular, it can give immunity against three kinds of diseases with one vaccination and it is a positive measure against infectious diseases.

(b)    The rate of occurrence of aseptic meningitis after the vaccination with the MMR unified strain vaccine is one in about 1,000 between April, 1989 and December, 1991, which is slightly higher than before. However, it is still low compared with the occurrence frequency of aseptic meningitis by a natural mumps infection.

(c)    Regarding aseptic meningitis after the use of the vaccines using the company’s own strain which was introduced in October, 1991, 10 cases were reported between October and December of the same year. However, the number of recipients with all the three companies is still only about 3,000 in total, and it is currently difficult to establish the detailed rate of occurrence of aseptic meningitis for the MMR vaccine of each company’s own strain.

(d)    Considering the above validity of the MMR vaccine and the occurrence situation of the side reactions to the vaccine, as far as the handling of the MMR vaccine for preventive vaccination measures is concerned, monovalent measles vaccine is to be used at the time of the regular measles vaccination, in principle, as before and the MMR vaccine is to be used if the guardian requests it. The mayor is to attempt to thoroughly inform doctors and guardians of the effects and side reactions of the MMR vaccine in advance. The doctor is to explain the symptoms and the rate of occurrence, etc. of aseptic meningitis to guardians at the time of vaccination. It is important to make arrangements for doctors and guardians to select and implement the vaccination on the basis of the knowledge of the occurrence of aseptic meningitis after the use of the MMR vaccine with the unified strain and the vaccine with the company’s own strain, while fully recognising the preventive effects of the MMR vaccine against diseases.

        As of 15th April, 1991, the Head of the Tuberculosis and Infectious Disease Measures Office instructed the Health Supervision Department (Bureau) of each prefecture to attempt to thoroughly inform doctors and guardians of the effects and side reactions of the MMR vaccine in advance as before, referring to the above opinion of the Infectious Disease Prevention Section.

kk On 8th August, 1992, C2 died.

ll On 27th April, 1993, the Infectious Disease Prevention Section concluded that the use

of the MMR vaccine at the time of the regular measles vaccination based on the Preventive

Vaccination Law should be suspended for the time being. There were differences in the

rate of occurrence of aseptic meningitis among the MMR vaccines with a company’s

own strain. The rate of occurrence of aseptic meningitis was apparently lower with the

RIMD’s strain (using Urabe strain) than that of the other two companies, therefore it was

necessary to investigate the possibility of report omissions from municipalities. Also there

were cases in which family members were infected by the viruses from the recipients of

the unified strain MMR vaccine (using Urabe strain). Therefore it was considered

necessary to further investigate the rate of occurrence of aseptic meningitis and to

request the manufacturers to submit the data examination. As a result, as of the same

date, the Head of the Tuberculosis and Infectious Disease Measures Office informed the

Health Supervision Department (Bureau) of each prefecture of the suspension of the MMR

vaccination for the time being.

mm On 18th May of the same year, the site of the defendant RIMD was inspected. As a

result, the following became clear: The undiluted solution of the mumps vaccine made by

the defendant RIMD and used in the unified strain MMR vaccine had been approved for

manufacture on the basis of manufacturing it by the cell culture method; however, RIMD

mixed undiluted solution made by amnion culture with solution made by the cell culture

method; it passed the inspection with the mixed undiluted solution, calling it cell culture

undiluted solution; it manufactured this until July, 1991; it used the said mixed diluted

solution for monovalent mumps vaccine as well between April, 1987 and August, 1991; it

used the undiluted solution with the approved manufacture method for the MMR vaccine

with the company’s own strain, but it did not take the test required with the undiluted

solution. On 7th February, 1994, the defendant RIMD received an administrative disposition suspending the manufacture of medicines for 50 days from 9th of the same

month to 30th of March of the same year, on the grounds of the violation of the

Pharmaceutical Affairs Law.

nn In September, 1997, the use of the MMR vaccine was suspended in the UK.

  6 Points of Dispute (5) (The negligence of the defendant RIMD)

(1)    The plaintiffs claim that the legal principle of product liability should be adopted in order for the plaintiffs to claim the defendant vaccine manufacturer’s negligence of the obligation to supply safe vaccines in a lawsuit of preventive vaccination damage such as this, because there is a noticeable gap in the availability of information about the safety of the vaccine between the vaccine manufacturer and the recipients. However it is not reasonable to immediately apply the legal principle of product liability, as the plaintiffs claim, to this case which occurred before the enforcement of the Product Liability Law (Law No. 85, 1st July, 1994).

(2)    The plaintiffs claim that the manufacturer who carried out an act which has a risk of causing side reactions is liable for negligence concerning the side reactions. The defendant RIMD manufactured the MMR vaccine in this case using a method which was different from the one approved by the defendant country. This change of manufacturing method had a risk of causing side reactions because of the change of the quality of the vaccine. If side reactions occur from the vaccination concerned in a case such as this, a cause and effect relationship should be presumed unless the manufacturer proves that there is no cause and effect relationship between the change of manufacturing method and the occurrence of side reactions.

(3)    As is recognised above, concerning C2 and the plaintiff A5, a cause and effect relationship is recognised between the death and the pathology and the MMR vaccination.

(4)    According to the recognised facts above and the exhibits (Otsu 90, Ko A105-1-2 & 3, Witness K), on 21st April, 1981, at the meeting of the Attenuated-virus-mixed Vaccine (MRM) Study Group, a vaccine made by the cell culture method was demanded in order to commercialise the MMR vaccine in the future, because the vaccine made by the amnion culture method had the risk of egg allergy and an examining problem (Cell Culture Safety Examination), and the defendant RIMB changed the manufacturing method to the cell culture method. However, at the First MMR Vaccine Field Examination between November, 1981 and November, 1982, the mumps vaccine made by the cell culture method was used, and it was concluded that its rate of antibody change to positive was worse than Urabe strain vaccine. It is recognised that the then manufacturing manager felt uneasy about the vaccine made by the cell culture method, which only had clinical test results, compared with the vaccine made by the amnion culture method, which had been on sale for several years and had sufficient records in vaccinations, the rate of antibody change to positive, and maintaining immunity. Thinking that fewer subcultures may be better and on the basis of the groundless inference that adding the undiluted solution subcultured once by the cell culture method from the amnion-cultured proto-virus MRS-03 may further improve the antibody change to positive and secure a good rate of antibody change to positive, he manufactured the undiluted solution (A + B), mixing the undiluted solution made by culturing the proto-virus cultured by the amnion culture method by the cell culture method (B) with the undiluted solution made by culturing the proto-virus cultured by the cell culture method, which was approved by the defendant country, by the cell culture method (A). He used the undiluted solution to manufacture the unified strain MMR vaccine, and applied for the inspection test using the undiluted solution (A + B) as the undiluted solution by the cell culture method (A). He also used the undiluted solution (A + B) which he thought had a good antibody production ability for export, and used the undiluted solution (A) for the MMR vaccine with the company’s own strain which was manufactured in and after December, 1991.

(5)    Moreover, according the exhibit (Ko 2), when applying for the approval of manufacturing vaccines, the applicant has to add information such as the results of the clinical trial to the application. The defendant country is to examine the submitted information, etc., investigate the safety of the vaccine concerned and approve the one which was shown to be safe for the time being. As described above, it is recognised that the defendant country strictly examined the MMR vaccine and approved its manufacture.

        Also, concerning virus culture, it is possible that some kind of change in the properties occurs, caused by a subtle change in the environment, e. g., it is possible for the same kind of viruses to produce strains of different properties depending on the culture conditions (Ko A9-44, 45). Furthermore, there are unknown areas in the process of side reactions occurrence after the vaccination, not only at the time of this case but also with the current scientific standards, and it is possible for unknown side reactions to occur, caused by the change in the properties of the virus used for the vaccine.

     Also as above, the rate of occurrence of aseptic meningitis after the unified strain MMR vaccination was in effect considered to be one in about 1,000 recipients between April, 1989 and December, 1991. According to the exhibits (Ko A9-45, 10-17, 75, 89, 105-1-2 & 3, Otsu 13), the defendant RIMD started selling the MMR vaccine with the company’s own strain, made by culturing the Urabe vaccine viruses with the approved method (cell culture) in October, 1991, and the rate of occurrence of aseptic meningitis after its vaccination was one in 35,907 recipients. Also according to other statistics, it is recognised that the rate of occurrence of aseptic meningitis with the unified strain MMR vaccine was 1/1,044, while the rate of occurrence of aseptic meningitis was 1/12,458 using the MMR vaccine with the company’s own strain made by using the undiluted solution produced by the cell culture method and the monovalent mumps vaccine. Therefore aseptic meningitis occurred at a high rate by manufacturing and selling the vaccine whose manufacture was not approved.

     Thus in manufacturing a live vaccine such as the MMR vaccine, in a case in which side reactions occurred from a live vaccine made by the manufacture method which is different from the approved method, a cause and effect relationship can be recognised between the occurrence of side reactions and the change of manufacturing method, unless another cause is recognised.

     As above, it is recognised that the death of C2 and the pathology of the plaintiff A5 of this case were caused by the side reactions to the unified strain MMR vaccine using the Urabe strain vaccine, made with the above undiluted solution (A + B). Other MMR vaccines such as the vaccine with the company’s own strain have not caused such severe results, therefore a cause and effect relationship can be inferred and recognised between the above change of the manufacture method to the undiluted solution (A + B), and the death of C2 and the plaintiff A5’s pathology caused by the vaccination of this case.

(6)    Moreover, according to the exhibit (Ko 2), an applicant for the approval of vaccine manufacture has to apply supplying information such as clinical trial results. The defendant country is to consider the submitted information, etc., to examine the safety of the vaccine concerned, and to approve the one which has been confirmed to be safe. 

        A vaccine is something to be directly injected into a living body, and the reality is

that more than a few cases in which side reactions occurred have been reported. It has a certain inherent risk itself, and especially a live vaccine such as the MMR vaccine, even though it is attenuated, puts a live pathogen into the body. It has to be said that it is necessary to  manufacture it taking stringent care of safety.

     According to the exhibits (Ko A105-1-2 & 3), the vaccine made by the amnion culture method, which was avoided because of the risk of egg allergy, was mixed with the approved vaccine made by the cell culture method in order to increase the rate of the antibody change to positive.

     It is natural to think that there is some relationship between the rate of change to positive and the side reactions, and it should be said that it was predictable that the side reactions might cause some severe results.

     Then the defendant RIMD who manufactured the vaccine taking such a risk could predict the occurrence of side reactions and such severe results as this case, and it should be said that it cannot escape liability for negligence.

(7)    The defendant RIMD mixed the two kinds of undiluted solution, the one made by the amnion culture method (A) and the one made by the cell culture method (B) to make the undiluted solution (A + B) in this case. The defendant claims that the manufacture of both solutions had been approved respectively at the time of this case or before that, and that the safety of the solutions had been confirmed. However, as described above, viruses sometimes come to have different properties through subtle environmental changes, and it is not impossible for  undiluted solutions made by different culture methods to have their properties changed if they are mixed. Much about vaccines is unknown, and the possibility that some kind of change in their properties occurs by mixing undiluted solutions made by different methods cannot be denied.

        Also the defendant RIMD claims that the MMR vaccine from the undiluted solutions (A + B) passed the examination even if its manufacture was not approved.

        However, the examination for the national approval (Hei 24) is a limited one and side reactions may occur differently because of the differences in properties which cannot be detected by the examination. Also, according to the exhibits (Ko A105-2), the virus Plaque sizes of the undiluted solution made by the method approved by the country and that of the MMR vaccine were compared, and a statistically significant difference was found. Therefore it cannot be said that the vaccine manufactured was not exactly the same as the one whose likely safety in the manufacturing method was finally confirmed. It cannot be said that there is no cause and effect relationship between the change of the manufacturing method and the occurrence of side reactions. Therefore the fact that the MMR vaccine with the unified strain passed the national examination does not affect the above recognition.

(8)    Therefore negligence of the defendant RIMD concerning the death or disorder which occurred to C2 and the plaintiff A5 is recognised 

  7 Points of Dispute (6) (Negligence of the country)

(1)    The preventive vaccination system is an attempt to give each individual resistance against infectious diseases as a susceptibility measure, one of the preventive measures against infectious diseases, and to prevent the spread of these diseases. 

        A preventive vaccination is something to give a human body resistance (immunity) against infectious diseases by inoculating an inactivated or attenuated pathogen of (various) immunogenic infectious diseases. A preventive vaccination gives an individual who has been vaccinated resistance against the infectious disease (personal defence effect) and has the effect of preventing the spread of the disease to the social group (collective defence effect) by increasing the number of people who have immunity. In general, infectious diseases transmitted by air have no satisfactory prevention methods other than preventive vaccinations. Naturally the individual who has been vaccinated benefits by gaining resistance against the infectious disease, but the effects of preventive vaccinations are not limited to that. A collective defence effect can also be expected. They secure safety of the group by preventing the spread in the group and indirectly protect people who should not take preventive vaccinations such as the young, the old and the sick from infectious diseases.

         However, in order to plan for such a collective defense effect, it is considered necessary to maintain a certain high rate of people who take preventive vaccinations.

         It is recognised that the main purpose of the Preventive Vaccination Law before the revision of 1994, which required any person to take certain preventive vaccinations, was to secure such a collective defence effect.

(2)    According to the recognised facts above and the exhibits (Otsu 14 to 19), the purpose of adopting the MMR vaccine is recognised to be as follows:

        Rubella occurs nationally every few years, mainly among children and male adults, and is sometimes accompanied by severe complications. Mumps breaks out every year, sometimes accompanied by complications such as aseptic meningitis and sequelae such as deafness. It is considered desirable to suppress the spread with collective defence effect by promoting vaccinations against rubella and mumps. By using the MMR vaccine, the number of episodes of preventive vaccination can be reduced and consequently labour, time and cost for both administrators and recipients can be reduced alike. In particular, in the case of children, if each vaccine against measles, mumps and rubella is vaccinated separately, it is necessary to give the next vaccination some prescribed time after the previous one, managing the recipient’s health condition. Therefore vaccination with the MMR vaccine is beneficial for the recipient and the guardian. Since the measles vaccination was compulsory, if the MMR vaccine was used at the time of the vaccination, it could be expected that the recipients and the guardians would choose this because of the above benefits. If a certain high rate of vaccination was maintained as a result, it can be envisaged that the collective defence effect against rubella and mumps, leading to the prevention of the spread of the two, could be secured, which could not be expected with the current vaccination method  

     Therefore the MMR vaccination itself was not compulsory, but its purpose was the social defence effect, which was the main intention of the Preventive Vaccination Law. The defendant country actively recommended the vaccination of the MMR vaccine or let it be used upon request as described above, in order to make this intention a reality.

(3)    On the other hand, as described above, a live vaccine is a varied strain with weak pathogenicity but with immunogenicity still remaining, used alive by inoculation. Live viruses proliferate in the living body and cause immune reactions. It is impossible to eliminate side reactions, since inoculation gives the human body immunity by administering a pathogenic microbe to the body, even though it is attenuated. If eliminating side reactions is given priority, the vaccine will have a very low immunity, therefore the occurrence of side reactions is considered inevitable at a certain probability.

(4)    Thus the main purpose of the Preventive Vaccination Law was the social defence effect and the vaccination of the MMR vaccine was promoted as well and the opportunity to use it was created as a measure of the defendant country, with an expectation of a social defence effect. If the recipient has side reactions, and severe results such as this case occur as a result of the vaccination, it can be said that the recipient was forced to undergo such a special sacrifice as health damage by a measure taken by the defendant country for social defence. Therefore the argument that the plaintiffs claim, that compensation for loss based on Clause 3, Article 29 of the Constitution can be sought in the Points of Dispute (7), is worth listening to in this respect. Also it can be considered that the relief system for health damage caused by a preventive vaccination provided by the current Preventive Vaccination Law is a piece of legislation based on such spirit of national compensation.

        However, it is not reasonable, from the point of view of the legal system as a whole, to recognise that compensation can be claimed for damage caused by vaccination, using Clause 3, Article 29 of the Constitution as a direct basis. It should be examined primarily in the framework of the State Compensation Law, and it is thought sufficient to consider the above circumstances within the range of the law; accordingly, it will then be judged whether there was negligence on the part of the defendant country.

(5)    Negligence at the stage of approval of the manufacture

a The Minster of Welfare is to approve the manufacture of a medicine examining its name, ingredients, quantity, usage, dosage, efficacy, effectiveness, performance, side reactions, etc. (Clause 2, Article 14-1, the Pharmaceutical Affairs Law). He is not to approve the manufacture of the medicine if it has noticeably harmful effects compared with its efficacy, effectiveness or performance concerning the application and the value in use as a medicine cannot be recognised, etc. (Clause 2, Article 14, the Pharmaceutical Affairs Law). Since medical and pharmaceutical knowledge at a high level is required to approve the manufacture of medicines, the Minister of Welfare grants approval based on the Pharmaceutical Affairs Law, on the basis of the results of discussion at the Central Council of Pharmaceutical Affairs which is composed of medical and pharmaceutical specialists. The plaintiffs claim that the defendant country neglected its obligation and let the health damage occur: side reactions concerning the mumps vaccine with Urabe strain used in the MMR vaccine were reported in 1983 and after; the possibility of enhancing side reactions by mixing the three vaccines for measles, mumps and rubella was pointed out among the researchers at that time; side reactions concerning the MMR vaccine made by using the mumps vaccine with Urabe strain, exported by the defendant RIMD were reported in Canada; the defendant country was able to observe that aseptic meningitis was occurring with high frequency concerning the MMR vaccine, on the basis of the information of the results of clinical trials about the MMR vaccine with the company’s own strain, submitted by the defendant RIMD at the time of application for the approval of the manufacture of the MMR vaccine in this case; it was possible for the defendant country to find out fully about the occurrence of side reactions abroad through various organisations; it was possible to fully predict that side reactions such as aseptic meningitis could occur to no small extent through the use of the MMR vaccination of this case at the time of the approval of its manufacture in September, 1988; however, it did not fully examine the information about domestic and international reports on the side reactions and their countermeasures or actively collect information; the defendant country had the obligation to fully examine and confirm the safety of the vaccine using appropriate authority to investigate and regulate it when approving the manufacture of the MMR vaccine, but it neglected to do so; it gave the defendant RIMD the approval of the manufacture of the MMR vaccine in this case after only carrying out an insufficient examination with only 320 cases of the final field vaccination examination of the vaccine with the unified strain.   

       b According to the facts recognised above, the facts not in dispute and the exhibits (Otsu

29, 30, Witness K), the following points concerning the approval of the MMR vaccine

manufacture are noted:

       (a) The Kitasato Institute, a corporate juridical person, Takeda Pharmaceutical Co, Ltd. and

the defendant RIMD applied for approval of manufacture to the Minister of Welfare, on the basis of the Pharmaceutical Affairs Law, concerning 4 kinds of MMR vaccines in total; 3 kinds of MMR vaccines made by combining virus strains developed by each company on its own and an MMR vaccine with unified strains made by combining virus strains which were considered to be particularly valid and safe among those of measles, mumps and rubella from the results in use, etc.

(b) The Biological Preparation Section, the Pharmaceutical Affairs Bureau of the Ministry of Welfare checked the submitted raw data concerning the application material, confirmed the reliability of the data and submitted it to the Central Council of Pharmaceutical Affairs.

(c) The Central Council of the Pharmaceutical Affairs discussed this in the Investigation Meeting of Biological Preparation on 22nd June, 1988 and 5th July of the same year, and in the Special Section of Biological Preparation on 3rd August of the same year. On 1st September of the same year, the Special Section of Biological Preparation reported the evaluation of the quality, validity and safety of the vaccines in the Standing Section.

(d)    Three committee members of the Central Council of Pharmaceutical Affairs examined

them on the basis of the application material of the MMR vaccines with the unified

strains including the origin, development, standards of manufacture methods, test

methods, safety tests, vaccination tests on monkeys, first phase test and field

vaccination test, etc.

(e)    According to the submitted information, Merck & Co., Inc., USA started selling the

MMR vaccine in the USA in 1971. It was also adopted in Sweden, Finland and Norway in 1982. Among them, a large-scale implementation plan using the MMR vaccine was carried out in Finland. 

(f)     Field vaccination tests of the MMR vaccine with the unified strains were carried out as

a research project for development of medicines, etc. between 1984 and 1986 fiscal

years, and a total of 320 children were vaccinated at 27 institutions. 320 cases were considered sufficient to check changes in validity and safety after the mixture since there had been considerable experience in the use of monovalent vaccines constituting  the MMR vaccine. As a result, there was no change in the antibody change rate to positive and side reactions from the monovalent vaccines. However, this was before the PCR method was introduced, and pyrexia was mainly considered as a side reaction and aseptic meningitis was not given much consideration.

(g)    On 20th September, 1988, the Minister of Welfare approved the manufacture of the 4

kinds of the MMR vaccine, following the above report of the Central Council of

Pharmaceutical Affairs.

       c The plaintiffs point out that there were only 320 cases of field vaccination tests of the MMR vaccine with the unified strains, but it cannot be said that it was insufficient to the point of being clearly unlawful, because each monovalent vaccine constituting the MMR vaccine with the unified strains had already had some results in use, such as the use abroad after a manufacture approval.

       d The plaintiffs claim that there had been reports that side reactions occurred after inoculation using the mumps vaccine with the Urabe strain and that it had been pointed out that the possibility of side reactions would be enhanced by mixing the vaccines. However, the defendant country carried out field vaccination tests emphasising the point of side reactions as described above, and furthermore the PCR method had not been developed at that time and aseptic meningitis was not envisaged as a side reaction. It cannot be affirmed that the defendant country neglected its obligation as far as this point is concerned.

       e As described above, 3 cases of aseptic meningitis occurred in Canada several months after inoculation with the MMR vaccine (Trivilix vaccine) including the mumps vaccine with the Urabe strain approved in 1986, and this was reported in the medical journal, ‘Canada Disease Weekly Report’ published on 5th September, 1987. In July, 1988, the Ministry of Health, Province of Ontario, Canada prohibited the use of the MMR vaccine containing the Urabe strain vaccine and recalled its stock. This was reported in the medical journal ‘Canada Disease Weekly Report’ published on 19th November of the same year. In the same month, the distributors suspended the use of the MMR vaccine containing Urabe strain vaccine upon the request of Canada’s Department of Health. These facts are recognised, however, at the time of the manufacture approval of the MMR vaccine, only 3 cases of aseptic meningitis had been reported several months after the vaccination. The PCR method had not been introduced and these cases had not been confirmed to be side reactions caused by the MMR vaccine. Therefore it cannot be said that the defendant country neglected its obligation to fully discuss and confirm the safety of the MMR vaccine in this case.

(4)    Negligence after the approval of the manufacture

a The plaintiffs claim that the defendant country had the legal obligation to collect information on side reactions after carrying out inoculation with the MMR vaccine in this case and to administratively guide local governments to suspend immediately the preventive vaccination concerned when the occurrence of non-trivial side reactions became clear. They also claim that the defendant country had the obligation to take action such as suspending the preventive vaccination in question until the cause of the incidents was made clear, when many non-trivial incidents occurred and it was possible that they were side reactions caused by the preventive vaccination in question, even if it was not possible at that point to determine that they were clearly side reactions caused by the preventive vaccination. Furthermore, when reasonable doubt about the safety of the medicine concerned arose, the Minister of Welfare had the obligation to immediately issue an emergency order concerning the vaccine concerned, based on the Pharmaceutical Affairs Law. The defendant country was able to observe the report on the side reactions in Canada, and the report on the side reactions to the MMR vaccine in this case by the Maebashi Medical Association. It was also able to observe, by the establishment of the virus test using the PCR method, that many health damage cases beginning with aseptic meningitis were being caused by the MMR vaccine in this case around September, 1989. Therefore the defendant country had the obligation to suspend the vaccination itself, or to exercise the authority to issue an emergency order against the defendant RIMD who was the manufacturer of the vaccine, on the basis of the Pharmaceutical Affairs Law, as of the middle of October of the same year, at the latest. However, it neglected its obligation and left the matter as it was.

b It is recognised that the defendant country certainly had the following opportunities to consider the action of suspending the vaccination of the MMR vaccine as described above by the time C2 was vaccinated on 25th June, 1991: 

(a)    In Canada, it was reported that 3 aseptic meningitis cases occurred several months after the vaccination of the MMR vaccine (Trivilix vaccine) in the medical journal, ‘Canada Disease Weekly Report’ published on 5th September, 1987. In July, 1988, the Ministry of Health, Province of Ontario, Canada prohibited the use of the MMR vaccine containing the Urabe strain vaccine and recalled its stock. This was reported in the medical journal ‘Canada Disease Weekly Report’ published on 19th November of the same year. In the same month, the distributors suspended the use of the MMR vaccine containing Urabe strain vaccine upon the request of Canada’s Department of Health. The defendant country knew about these matters by around August, 1989.

(b)    In March, 1989, the PCR method was introduced by the Virus Department Head, L et al of the National Institute of Health, and in July of the same year, the possibility  that aseptic meningitis considered to be caused previously by wild strains may come from the vaccine strains was pointed out.

(c)    The Ministry of Welfare found out from their survey that there were 4 patients who were suspected to have developed aseptic meningitis from inoculation with the said vaccine by 4th September of the same year (two more by 8th of the same month) among the recipients of about 600,000 to 700,000 (at the rate of one in 100,000 to 200,000) in and after April of the same year.  

(d)    On 17th of the same month, Dr. O of Maebashi Medical Association reported, at the Gunma District meeting of Japan Pediatric Society held in Takasaki City, that 3 children out of 1800 who received the MMR vaccination developed aseptic meningitis in Maebashi City, between April and June of the same year. This was published in the Gunma Pediatric Society newsletter of the same date.

(e)    Around 23rd October of the same year, the Ministry of Welfare found out, concerning the occurrence of aseptic meningitis after inoculation with the MMR vaccine, that there were 125 cases in which some kind of abnormality occurred within 2 months after the vaccination among about 500,000 recipients who were inoculated with the MMR vaccine between April and 23rd October of the same year, and that 80 cases out of the 125 were suspected of aseptic meningitis.

(f)     On 25th October, 1989, Dr. O reported to the Ministry of Welfare that aseptic meningitis occurred to 10 recipients out of 1,834 after the MMR vaccination, at a high rate of one in 184.

(g)    On 31st of the same month, the Head of Environment and Health Department, Osaka Prefecture issued a notice to municipal heads in the prefecture that they should be prepared to suspend the MMR vaccination. Takatsuki City decided to suspend the MMR vaccination on 1st November of the same year, and Toyonaka City on 2nd November of the same year.

(h)    On 25th of the same month, the Ministry of Welfare discussed the independent suspension of the sale of the MMR vaccine in Canada.

(i)      Around 18th January, 1990, the Ministry of Welfare found out that 311 recipients were clinically diagnosed with aseptic meningitis after the MMR vaccination, among about 630,000 who were inoculated with the MMR vaccine between 1st April and 31st October of the same year, and that it was considered to have been caused by the vaccination in the case of 67 of them. The rate of occurrence of aseptic meningitis caused by inoculation with the mumps vaccine after the MMR vaccination was considered to be one in several thousand. Also, the ministry noted that the 311 patients above included one diagnosed with cerebrospinal meningitis and another diagnosed with lower limb flaccid paralysis caused by myelitis.

(j)      As a result, around December, 1990, the Ministry of Welfare started to recognise that aseptic meningitis after the inoculation with the MMR vaccine was occurring at a far higher rate than one in several thousand as was considered previously.

(k)    In May, 1990, Canada’s Department of National Health and Welfare prohibited the sale of the MMR vaccine containing Urabe strain vaccine in Canada, upon receiving a report that aseptic meningitis was occurring at the rate of one in 62,000 and consulting a report on the side reactions published in a Japanese medical journal in 1990. This was reported in the medical journal ‘Canada Disease Weekly Report’ published on 15th December, 1990.

(l)      Around 31st May, 1991, the Ministry of Welfare found out that the rate of aseptic meningitis cases among the recipients of the MMR vaccination between April 1989 and October 1990 was one in about 1,200, which was higher than the previously considered rate. 

        Also, the plaintiffs point out that Fukushima Prefecture reported to the Ministry of Welfare in July, 1989 that a child who received the MMR vaccination on 9th May of the same year died of acute heart failure on 16th of the same month and that the Metropolis of Tokyo reported to the ministry in October of the same year that a child who took the MMR vaccination on 17th May of the same year had a severe hearing disorder of about Class 2. However the relationship of these cases to the MMR vaccination is not clear, considering the symptoms.

       c In the course of these events, the fact that a considerable number of aseptic

meningitis cases occurred as side reactions to the MMR vaccination became clear after the

PCR method as a distinguishing method was introduced as described above. Clearly it can

be said that severe results such as this case would not have been brought about if the use of

the MMR vaccine had been rapidly suspended, even if temporarily, and the cause and

effect relationship and the rate of occurrence had been re-examined as in Canada, after the

facts became clear. 

     Also, it is considered desirable, as an administrative judgment, to suspend, as a precaution, the MMR vaccination under the circumstances in which there were more side reactions than expected and it was gradually becoming clearer that the rate of occurrence was high as further investigation was carried out. According to the Ministry of Welfare’s own survey, the rate of occurrence of aseptic meningitis was considered to be one in 100,000 to 200,000 as of September, 1989. In October of the same year, Dr. O of Maebashi Medical Association directly reported to the ministry that it was occurring at the high rate of one in 184. By about October of the same year, the ministry knew about the independent suspension of the sale in Canada. By about January, 1990, it found out from its own survey that the rate of occurrence of aseptic meningitis was about one in several thousand. By about May, 1991, it came to know that the rate was one in about 1,200.

d However, even if the country recognised the above facts, particularly the information on side reactions in Canada and the report on side reactions by Maebashi Medical Association, it cannot be said that information on which the facts to be based, accuracy of the analysis of the information and cause and effect relationships between each case and the MMR vaccination were immediately clear at the point of these reports. It was not possible to judge that many non-trivial incidents, concerning the MMR vaccine were occurring, from those reports. Therefore it is considered that it cannot be said that a reasonable doubt about the safety of the MMR vaccine immediately arose from these reports, nor that the safety of the MMR vaccine was clearly disproved.

     Also, concerning rubella and mumps, which still break out repeatedly as described above, sometimes accompanied by severe complications and sequelae, the usefulness of the MMR vaccine to suppress their prevalence with its collective defence effect by promoting the vaccination was recognised. Aseptic meningitis as a side reaction is generally recognised as a disease with a good prognosis, and the convalescence of the patients diagnosed with cerebrospinal meningitis and lower limb flaccid paralysis caused by myelitis was satisfactory as describe above. Even though the survey results of the side reactions as above were available, we cannot go so far as to say that the defendant country had an obligation to suspend the MMR vaccination. 

     Therefore if the country should deal with this cautiously enough not to allow any side reaction caused by the vaccination, regardless of the usefulness of the vaccine, suspension of the MMR vaccination can be envisaged, but it is considered to be within the range of administrative discretion.   

     Therefore it cannot be said that the defendant country had a legal obligation to suspend the MMR vaccination, nor that it had an obligation to issue an emergency order on the basis of the Pharmaceutical Affairs Law.

(5)    The plaintiffs claim that the defendant country neglected its obligation to supervise the manufacturers and did not take sufficient supervisory actions, despite having an obligation towards each individual who takes these vaccinations, having made preventive vaccinations compulsory, and on the basis of the obligation to avoid adverse results as the main body of the implementation of the above preventive vaccinations and the obligation to maintain an overview on the basis of the Pharmaceutical Affairs Law, to supervise them so that unsafe vaccines are not manufactured, such as this case where the defendant RIMD was not manufacturing the MMR vaccine with the unified strain following the approved manufacture method.

            The defendant country claims, against this, that the Preventive Vaccination Law has no provision to obligate the Minister of Welfare to take certain actions against vaccine

manufacturers.

(6)    Preventive vaccinations are implemented as a measure of the defendant country from the

viewpoint of social defence, in order to protect the health of the nation from infectious diseases as described above. Not only each individual who takes the vaccination but also the whole society are beneficiaries.

     Also the vaccines used in preventive vaccinations are manufactured by private pharmaceutical companies, and the defendant country enacts the standards of the whole manufacturing processes including the approval of the manufacture, the manufacturing processes, quality control, the safety of the products, etc. The defendant country has an important decision-making authority and use it for such things as carrying out examinations to see whether these standards are met. It also has an authority to investigate and uses it for entering the premises of a pharmaceutical company for investigation, etc. It enacts penal regulations against a pharmaceutical company which violates these standards. It is recognised that the defendant country has the authority to supervise pharmaceutical companies so that products meeting the standards concerned are supplied.

     Furthermore, the defendant country acted to promote the introduction of the MMR vaccine instead of separate vaccinations of measles, rubella and mumps which were carried out before the introduction of the MMR vaccine. It took actions to promote the introduction of the MMR vaccine such as sending notice documents and manuals to prefectures, and the defendant country admits these facts.

     Considering the nature of preventive vaccinations whose main purpose is a social defence effect as described above, it can be said that the defendant country is the main body to promote preventive vaccination. Also the manufacture of vaccines has a close and inseparable relationship with preventive vaccinations and constitutes a part of the vaccination process, therefore pharmaceutical companies which manufacture vaccines have a relationship with the defendant country in which they assist the defendant country when promoting preventive vaccinations.

     Therefore it is considered that the relationship between pharmaceutical companies which manufacture vaccines and the defendant country is, the Preventive Vaccination Law expects, not restricted to the supervisory control of the defendant country on the basis of the Pharmaceutical Affair Law, but also includes a relationship between the main body to implement preventive vaccinations and its collaborators.

     On the other hand, people who receive the preventive vaccination have little specialist knowledge concerning preventive vaccinations and information to be used for judgment, and it is difficult for them to judge its risks themselves and refuse the vaccination even concerning preventive vaccinations to be taken voluntarily. The reality is that they rely on the main body, the defendant country rather than the pharmaceutical company which manufactures the vaccine concerning the safety of the preventive vaccination and receive it. It is clear that this reliance on the defendant country is the basis of the continuation of preventive vaccinations which have the potential risks as described above.

     Thus preventive vaccinations involve certain risks such as the possibility of unknown side reaction occurrence cannot be excluded. They are implemented by the defendant country as the main body from the viewpoint of social defence, and the whole society benefits. A preventive vaccination involves injecting a pathogen into a body and directly affects the lives and bodies of people. It is recognised that the supervisory obligation and responsibility of the defendant country are considerably heavy correspondingly. Also, the defendant country has an important authority over the vaccine used for it and a supervisory authority. People who receive the preventive vaccination do not always have sufficient information and specialist knowledge to be used for judgment. Considering these, the defendant country has a reasonable obligation to supervise vaccine manufacturers at least to manufacture vaccines observing the manufacture method approved by the defendant country on the basis of the Pharmaceutical Affairs Law and it should be understood that the defendant country has a supervisory responsibility.

(7)    Concerning this case, it is considered that the defendant country has the obligation to

generally supervise vaccine manufacturers so that they do not change the manufacture method without permission by sufficiently guiding and supervising vaccine manufacturers for each individual who receives the preventive vaccination. 

     However, as described above and according to the exhibits (Ko A-89, Witness K), K, who was directly responsible for vaccine manufacture at the Kannonji Institute of the defendant RIMD, heard at that time that the mumps vaccine made by the defendant RIMD had a lower rate of antibody change to positive than those manufactured by other companies. It was considered that vaccines made by the amnion culture method generally had a higher rate of antibody change to positive than those made by the cell culture method, and K instructed the change of manufacture method. He made the decision without specially verifying the safety at that time, although that action was against the Pharmaceutical Affairs Law. K testifies that there may have been a recommendation implying such a change from the headquarters of the defendant RIMD. It is inferred and noted that the headquarters of the defendant RIMD did not, at least, instruct him to fully follow the manufacture method and it is difficult to suppose that the awareness that the approved manufacture method must be followed was not thoroughly raised at least at the manufacture site of the defendant RIMD who was the vaccine manufacturer. Also, it is recognised that any such awareness was not necessarily thoroughly raised at the headquarters of the defendant RIMD and it is inferred and recognised that regulations of the Pharmaceutical Affairs Law were not thoroughly and sufficiently known among the vaccine manufacturers at the time of the manufacture of the MMR vaccine in this case. 

     Then, it has to be recognised that the guidance and supervision of the defendant country over the vaccine manufacturer, the defendant RIMD, was insufficient judging from the above results. There is no other sufficient evidence to demonstrate that the defendant country did their best to carry out their obligation of guidance and supervision, therefore it is judged that the defendant country neglected the above guidance and supervisory obligation. The risk of changing the manufacture method without permission was as described above, and the defendant country regulates it on the basis of the Pharmaceutical Affairs Law, therefore it is recognised that it was possible to predict the damage results of side reaction occurrence caused by the above negligence of the guidance and supervisory obligation. Therefore it is judged that the defendant country is at least liable for negligence.

(8)    Therefore the claim by the plaintiffs A3 and A4 and the claim by the plaintiffs A6, A7 and

A5 to the defendant country are well-founded.

  8 Points of dispute (8) (Extinctive prescription)

(1)    The defendants claim that the plaintiffs A6, A7 and A5 received the official

acknowledgement provided by Clause 1, Article 16 of the Preventive Vaccination Law from the Minister of Welfare as of 28th September, 1992 and that it can be said that they knew about the damage and the wrongdoers on 25th of December of the same year at the latest, when they were handed the above acknowledgement by the officer in charge of Ofunato City. Therefore they claim that the right to claim damages to the defendants expired by prescription on and after 24th December, 1995. 

(2)    The extinctive prescription of the right to claim damages based on an unlawful act is

understood to progress from the point when the victims find out about the wrongdoers and the damage incurrred. In order to say that the victims found out about the damage incurred, it is understood, it is necessary for them to find out that the act of the wrongdoers is unlawful.

(3)    Moreover, concerning the Preventive Vaccination Law, a relief system for health damage

caused by preventive vaccinations was established in order to simply and rapidly relieve damage which inevitably occurs by preventive vaccinations carried out for the public purpose of preventing the spread of infectious diseases, and this is considered to have the nature of national compensation.

     Then it is noted that the above acknowledgement was given from the viewpoint of administrative relief, independently from the judgment of lawfulness of the act. The above acknowledgement has nothing to do with the lawfulness of the preventive vaccination, and it cannot be said that the plaintiffs A6, A7 and A5 could find out that the MMR vaccination in this case was unlawful only by the fact that the above acknowledgement was given, and there is no other sufficient evidence to recognise this.

(4)    Therefore it cannot be said that the extinctive prescription of the right to claim damages of the plaintiffs A6, A7 and A5 started to progress from the point when the Minister of Welfare gave the above acknowledgement, and the defendants’ claim is groundless.

  9 Damages of the plaintiffs

(1)    Loss of income

     C2 (born on 2nd September, 1989) was 2 years old when he died. It is reasonable to infer and recognise that he would work for 49 years between the ages of 18 and 67 and be able to earn annually an amount which is not less than the average salary of all age male workers of overall educational backgrounds, companies of different sizes and industries according to Table 1, Volume 1 of the Wages Census, 1991 if this case had not occurred. If 50% is deducted from the annual income as the cost of living and C2’s loss of income is calculated using Leibnitz's coefficient 8.323 to deduct interim interest at the ratio of 5% per annum (it is reasonable to calculate it using 5% per annum provided by the Civil Code) using Leibnitz's rule on the basis of the above, C2’s loss of income is 22,206,180 yen.

(2)    Funeral expenses

     1,500,000 yen is reasonable for funeral expenses in this case.

(3)    Hospitalisation sundry expenses

     Considering the circumstances in this case such as the period of hospitalisation (408 days), etc., 530,0400 yen, which is the total of 1,300 yen per day, is reasonable for sundry

expenses needed for C2’s hospitalisation.

(4)    Attending and nursing fees

     Considering the circumstances in this case such as the above period of hospitalisation, etc., 1,836,000 yen, which is the total of 4,500 yen per day, is reasonable for attending and nursing fees needed for C2’s hospitalisation.

(5)    Compensation (Consolation money)

a C2 received the MMR vaccination in this case and died at only 2 years of age. It is obvious that he experienced mental suffering thanks to this case. Considering the circumstances such as that the defendant RIMD changed the approved manufacture method without any particular necessity and manufactured the MMR vaccine used in this case and that C2, the plaintiffs A3 and A4, beginning with C2, did not commit  any particular fault, 22 million yen is reasonable for compensation for C2’s mental suffering.

b Also C2 was attacked by symptoms such as severe pyrexia during his hospitalisation after the side reactions caused by the MMR vaccination occurred until he died, and it is obvious that he suffered mental anguish. Further considering the circumstances in this case such as physical symptoms which occurred to C2 and the period of hospitalisation, 3,020,000 yen is reasonable for the hospitalisation compensation for C2’s mental suffering during the hospitalisation.

(6)    Lawyers’ fees

     It is clear that the plaintiffs A3 and A4 entrusted their legal representatives with the filing and pursuit of the lawsuit from the evidence, and considering the circumstances such as the nature of this case, development of the trial and the allowable amount, 5 million yen is reasonable for the lawyers’ fees in this case.

(7)    The plaintiffs are C2’s heirs and inherited C2’s right to claim damages, following the

legal inheritance amount (one half each). 

(8)    As described above as facts, etc. without dispute, the plaintiffs A3 and A4 have received

the payment of 21,551,880 yen in total concerning the MMR vaccination in this case, and this should be deducted from the above right to claim damages as profit-and-loss offset.

(9)    Therefore the plaintiffs have the right to claim damages of 17,270,350 yen each to the

defendants.

 10 The damage of the plaintiff A5

(1)    Loss of income

     The plaintiff A5 (born on 29th June, 1989) has had mental retardation, epilepsy and cerebral palsy caused by this case, and it is recognised that her class is Class 1 and that she has completely lost her ability to work from the sequelae. The plaintiff A5 was 3 years old when her symptoms were fixed in November, 1992. It is reasonable to infer and recognise that she would work for 49 years between the ages of 18 and 67 and be able to earn annually an amount which is not less than the average salary of all age female workers of overall educational backgrounds, companies of different sizes and industries according to Table 1, Volume 1 of the Wages Census, 1992 if this case had not occurred. If A5’s loss of income is calculated deducting interim interest at the ratio of 5% per annum using Leibnitz's rule on the basis of the above and using Leibnitz's coefficient 8.7395, A5’s loss of income caused by the sequelae is 27,031,273 yen.

(2)    Hospitalisation sundry expenses

     Considering the circumstances in this case such as the period of hospitalisation (207 days), 269,100 yen, which is the total of 1,300 yen per day is reasonable for the sundry expenses needed for the plaintiff A5’s hospitalisation

(3)    Attending and nursing fees

     Considering the circumstances in this case such as the above period of hospitalisation and the plaintiff A5’s symptoms, 931,500 yen, which is the total of 4,500 yen per day, is reasonable for attending and nursing fees needed for A5’s hospitalisation.

(4)    Caring fees

a Considering the circumstances in this case such as the plaintiff A5’s age and degrees of disorders, 33,112,000 yen, which is the total of 8,000 yen per day, is reasonable for A5’s caring fees needed between 1st December, 1991 and 30th January, 2003 which is the date of the oral pleadings conclusion in this case (4,139 days).

b Also for A5’s caring fees needed in the future, 56,656,760 yen, which is the total of 2,920,000 yen per annum, is reasonable, considering the circumstances such as the plaintiff A5’s current age (13 years old), average life expectancy (72 years) and its Leibnitz's coefficient 19.403.

(5)    Compensation (Consolation money)

a A5 received the MMR vaccination in this case and developed severe sequelae caused by the side reactions. It is clear that she experienced mental suffering thanks to this case. Considering the circumstances such as the facts that the defendant RIMD changed the approved manufacture method without any particular necessity and manufactured the MMR vaccine used in this case and that the plaintiffs A6, A7 and A5 did not have any particular fault, 14 million yen is reasonable for compensation for the plaintiff A5’s mental suffering.

b Also the plaintiff A5 was attacked by symptoms such as severe pyrexia during her hospitalisation after the side reactions caused by the MMR vaccination occurred and severe sequelae remained after she was discharged from hospital, and it is obvious that she suffered mental anguish from these. Further considering the circumstances in this case such as physical symptoms which occurred to the plaintiff A5, degrees of the disorders and the period of hospitalisation and outpatient attendance, 3,300,000 yen, which is the total of the hospitalisation compensation of 1,820,000 yen and compensation of 1,480,000 yen, is reasonable for the plaintiff A5’s mental suffering during the hospitalisation and outpatient attendance.

(6) Lawyers’ fees

     It is clear that the plaintiff A5 entrusted her legal representatives with the filing and pursuit of the lawsuit on the basis of the evidence, and considering the circumstances such as the nature of this case, development of the trial and the allowable amount, 13 million yen is reasonable for the lawyers’ fees in this case.

(7) As described above as facts, etc. without dispute, the plaintiff A5 has received the payment

of 24,513,189 yen in total concerning the MMR vaccination in this case, and this should be deducted from the above right to claim damages as profit-and-loss offset.

(8) Therefore the plaintiff A5’s damages are 123,787,444 yen in total.

  11 The damage of the plaintiffs A6 and A7

(1)    Compensation (Consolation money)

     The plaintiff A5 developed mental retardation, epilepsy and cerebral palsy caused by this case, and her class is Class 1.It is recognised that severe sequelae which are equal to death developed and it is obvious that the plaintiffs A6 and A7, who are the plaintiff A5’s parents, suffered mental anguish. Considering the circumstances such as the plaintiff A5’s age, the degrees of the disorders and the fact that the plaintiffs A6, A7and A5 did not have any particular fault, 5 million yen each is reasonable for compensation for the plaintiffs A6 and A7’s mental anguish.

(2)    Lawyers’ fees

     It is clear that the plaintiffs A6 and A7 entrusted their legal representatives with the filing and pursuit of the lawsuit from the evidence, and considering the circumstances such as the nature of this case, development of the trial and the allowable amount, 500,000 yen each is reasonable for the lawyers’ fees in this case.

(3)    Therefore the plaintiffs A6 and A7 have the right to claim damages for 5,500,000 yen each

to the defendants.

4 Conclusion

       Therefore the claims by the plaintiffs A3 and A4 and the plaintiffs A6, A7 and A5 are justified within the limits of the Text, and they are upheld. Other claims by the plaintiffs A3 and A4 and the plaintiffs A6, A7 and A5 and the claims by the plaintiffs A1 and A2are groundless, and they are dismissed. As for the admitted part upheld concerning the defendant country, it is certain that the rights will be put into practice and it is not reasonable to add a declaration of provisional execution, therefore it is not added and the judgment is delivered as the Text.

The 23rd Civil Division, Osaka District Court

Shinichi Yoshikawa, Presiding Judge 

Isao Nakajima, Judge

Yasuharu Matagi, Judge

Translator’s notes

1)      sum (page 1)

It seems to mean ‘interest’, but the Japanese term used means ‘sum ‘or ‘amount’.

2)  Health and Medical Bureau (page 4)

    The official English translation for this office has not been found.

3)      Selestamine and Prednin (page 16)

These are Japanese product names, and I am not sure how they are spelt in English.

4) Pharmaceutical Affairs Bureau (page 24)

The official English translation for this office has not been found. 

5) Albini (page 35)

This is a Japanese product name, and I am not sure how it is spelt in English.

6) Trivilix (page 47)

This is a Japanese product name, and I am not sure how it is spelt in English.