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

(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.

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.