(1) The authors have investigated the special negligence in the previous sections and in this section, will review negligence in general. In the Civil Code, negligence has been discussed as an element constituting liability for a tort. In the Penal Code, negligence has been discussed as an element constituting a crime. Since the Civil Code differs from the Penal Code in legal systems, handling of negligence is also different between the two, for example, in terms of what constitute negligence and relation to illegality. According to the Civil Code, negligence is applicable to all acts. According to the Penal Code, negligence is only applicable to the items for which the Criminal Code prescribes punishment against negligence. The two Codes follow their own logic in many other aspects: the effects resulting from negligence and the basic principles (i.e. in the Penal Code, the principle of "no crime nor punishment without law" works and penalties for negligence shall be expressly stipulated; in the Civil Code, differences between intention and negligence are not a major problem). On the other hand, when these codes are applied to handle social problems in reality, it is found that the two Codes share similar concepts regarding the duty of care. Accordingly, someone can raise enormous discussion about the homogeneity and differences between the Civil Code and the Penal Code in negligence. The authors intend to discuss the characteristics of negligence of researchers in this section: we will not deeply get into the theory of negligence in the Civil Code and the Penal Code individually but only introduce the rough structure of negligence within the common concepts shared by the two Codes and then make a quick move to a discussion about researchers' responsibilities.
Negligence basically consists of the duty of foreseeing results and the duty of avoiding results. Both academic views and precedent cases regard either one or both of the two duties as key element(s) constituting negligence. The authors will review the traditional theory of negligence, the new theory of negligence, and the others.
(i) In the "traditional theory of negligence" (old theory of negligence) the duty of care constituting negligence is regarded as the duty of foreseeing results, according to which a person should exercise extreme caution to foresee specific results, and it is understood that the duty of foreseeing results is born of the foreseeability of results. This is accepted as the common view in both the Civil Code and the Penal Code (for the Penal Code, refer to "Multiple Revision: Penal Code of Japan" authored by Ei-ichi Makino, "New Version: Outlined Lecture on the Penal Code" authored by Sei-ichiro Ono, and "Introductory to the theory of crime" authored by Yukitatsu Takigawa; for the Civil code, refer to "Increased Version: Particulars of the Japanese Claim Law" authored by Hideo Hatoyama, "Voluntary administration of business, undue profit, and torts" authored by Sakae Wagatsuma, and "Torts" authored by Ichiro Kato). The traditional theory of negligence does not always eliminate the duty of avoiding results but interprets that violation of the duty of foreseeing will result in violation of the duty of avoidance, i.e. that these two are sequential.
(ii) On the other hand, the precedents in both civil and criminal cases tend to indicate that negligence is regarded as violation of the duty of avoiding results, which is contrary to the common view. In light of the tendency noted in these precedent cases, the "new theory of negligence" is born, which argues that negligence is violation of the duty of avoiding results, i.e. negligence is caused by a faulty act (an act which deviates from the standard act required for a person to live a social life). This new theory is based on the following idea: although acts with accompanying possible risks are foreseeable, e.g. when a medical doctor performs an operation, he/she can foresee a possibility of making a failure which may put a patient to death, or when a person drives a car, he/she can foresee a possibility of causing a traffic accident, the social life would be confused if none of those who perform such acts can be saved from negligence. For the acts useful for the society, the person of the act is not blamed for negligence as far as he/she has performed that act without any fault, i.e. he/she has observed the duty of avoiding results (the duty of objective carefulness). This concept is related to "the principles of reliance" or the theory of "permissible risks." (For the Penal Code, refer to "Structure of criminal negligence" authored by Masaharu Inoue, and "Total Revision: Outline of the Penal Code" authored by Taira Fukuda, and for the Civil Code, refer to "Theory of laws concerning liability for damage" authored by Norio Hirai, and "Civil Code VI" authored by Tatsuaki Maeda.)
(iii) In addition, several new theories of negligence have been proposed. In the Penal code, there is the "theory of apprehensive feeling" (i.e. the new version of new negligence theory). In the new negligence theory, the foreseeability of results is required as a precondition that results may be avoidable and this foreseeability of results should be considered not merely in an abstract manner but in connection to progress of specific causality. On the other hand, the theory of apprehensive feeling argues that feelings of apprehension or anxiety are sufficiently enough as elements which increase strictness of the duty of avoiding results in connection with unknown risks such as environmental pollution or scandals regarding drug regulation or production, and as a precondition which acknowledges the duty of avoiding results (for the Penal Code, refer to "Penal Code" authored by Hideo Fujiki). On the other hand, there are several opinions proposed in the area of Civil Code. One theory is as follows: the duty of care as a precondition of negligence should be based on the ordinary person as the standard as far as the duty is related to the ordinary citizens' lives, whereas a business entity which uses high-level expertise and complicated organization to perform a large-scale business should take the duty of conducting investigations and surveys in organized and continuous manners in order to explore a possibility of occurrence of risks and prevent such risks from occurring; and if the business entity fails to conduct such surveys, resulting in occurrence of damage or loss, then that entity is blamed for negligence on the ground of violation of the duty of care with which they had to foresee occurrence of risks (for the Civil Code, refer to "Study of environmental pollution from the viewpoint of private laws" authored by Hiroshi Sawai). The second theory is as follows: negligence is separated from the issue related to subjective mental state and is an objective issue, and in other words, negligence is the issue of whether or not the person concerned has taken reasonable actions to prevent damage or loss which exceeds acceptable levels; and if such damage or loss beyond the acceptable levels should be caused, the person should be blamed for negligence whether the results are foreseeable or not (for the Civil Code, refer to "Intention, negligence and illegality" in the book "Establishment and development of environmental pollution laws" edited by Ichiro Kato).
(2) Importantly, the background to the above-described changes over time in negligence theories, i.e. from the traditional theory of negligence to the new theory of negligence and further to the new version of new theory of negligence, is the progress in science and technology and their application to society. The new theory of negligence is intended to provide ease for users of technologies which are useful for society but also possesses potential risks such as automobiles and medical practices, for which the traditional theory of negligence may blame such users for negligence. The most recent theory of negligence is intended to impose strict liability on acts of business entities which, through the use of new technology, may cause damage to an unspecified number of the general public, e.g. environmental pollution, scandals regarding drug regulation or production, and adverse effects on safety of foods.
Negligence theories are closely related to the progress in science and technology and their application to the society, as described above. The debut and widespread use of life sciences related technology, i.e. totally novel technology, have raised the necessity of investigating negligence theories from the new points of view. For example, reproductive medical technology differs from the above-described technologies supporting the new negligence theory, such as automobiles and medical care technologies, because application of reproductive technology may cause abstract and extensive risks. Life sciences related technology differs from environmental pollution and scandals regarding drug regulation or production, which support the most recent theory of negligence, since reproductive technology is not a type of business performed by large enterprises having complicated organizations and large-scale facilities but may be a type of small-scale research and in some cases, as small as personal research. On the other hand, the recent progress in life sciences allows a certain technology to be applicable to not only a specific area but also every corner of the society, creating the situations in which we should not only focus on individual issues separately. This is also true for information technology, the field of science and technology that has also attained remarkable progress like life sciences related technology. The authors consider it necessary to keep these points in mind when investigating regulation of life sciences related technology in the future.
(3) Apart from the issue of whether violation of the duty of foreseeing results is directly regarded as negligence or violation of the duty of avoiding results is regarded as a precondition of negligence, foreseeability is an important element constituting negligence. For the foreseeability, there exist several opinions regarding what should work as the standard.
(a) Objective theory: The ordinary person's ability of exercising caution works as the standard. When results are foreseeable by the ordinary person, the duty of foreseeing results is valid even if the person who did the act concerned was not able to foresee the results.
(b) Subjective theory: The ability of exercising caution of the person who does the act concerned works as the standard.
(c) Compromise theory: The ability of exercising caution of the person who does the act concerned works as the standard, but if that ability exceeds the ordinary person's ability, then the ordinary person's ability works as the standard. Precedent cases are based on the objective theory and many of the conventional views agree with the objective theory. There are different opinions regarding laws: some claim that laws prescribe standardized duties irrespective of differences in abilities among individuals and force citizens to observe such duties, through which they try to function as rules and regulations; and others claim that laws are based on the idea that unlawful acts break confidence by the person receiving damage or the third individual, although such confidence is regarded as a precondition for ordinary community life. However, those following the subjective theory criticize that whether the act conducted is blamed or not, i.e. whether or not the person who conducted the act concerned is held responsible for negligence or not, should be based on the ability of exercising caution of the person him/herself who conducted the act, as indicated by the following case: when a person drives a car and causes an accident because of a disease which is not foreseeable by the person, it is not appropriate to blame that person for negligence.
(d) In criminal law studies, the following opinion regarding handling of the objective theory becomes predominant: the ordinary person works as the standard when violation of the duty of objective carefulness is evaluated as an element constituting negligence, and the person who did the act works as the standard when violation of the duty of subjective carefulness is evaluated as responsibility (when an individual injures another individual by negligence, the awareness that the subject to be injured was a human is evaluated according to the standard of the ordinary person, but legal causes for exclusion of responsibility such as the state of unsound mind are evaluated according to the standard of the person who did the act concerned).
In this section, the authors cannot complete discussion about whether these theories are right or wrong. We instead focus on matters which support these theories and also are extremely important when discussing responsibilities of researchers. First of all, we will focus on foreseeability. It seems to us that there has existed the assumption that what is foreseeable by the ordinary person is right, when discussing foreseeability by comparing the ordinary person with the person who did the act concerned in terms of the ability of exercising caution. The compromise theory assumes that in some cases, the person who did the act concerned is superior to the ordinary person in the ability of exercising caution. However, none of the theories regards the following as a proper assumption: irrespective of the ability of exercising caution, i.e. no matter what caution is exercised, the ordinary person is always wrong and the person who did the act concerned has always right understanding. Such reversal can frequently be noted in the field of science. In the area of life sciences in particular which is the subject of our discussion in this Report in connection with regulation of technology, we frequently encounter the following situation: what is believed right by not only the ordinary citizens but scientific associations is not considered by specific researchers to be correct, and these researchers perform their own studies according to their independent opinions. Results obtained by these researchers are highly appreciated since their studies and results have originality. Even if regulation of life sciences is imposed not by restricting research but by limiting application of technology, researchers are the subjects to be regulated and in most cases, application of technology in their studies may be restricted. Under such circumstances, although the common idea throughout the society is important, the yardstick of researchers' judgment is decisive. It is therefore likely that the general conditions accepted by researchers' groups such as scientific associations are always opposed to what researchers individually foresee.
In light of these points, the following cases are considered: <1> when the ordinary person (the ordinary citizens' views or average opinions of scientific associations or any other relevant bodies) foresees the presence of risk, but the person conducting an act foresees the absence of risk and performs an experiment, resulting in occurrence of harm; <2> when the ordinary person foresees the absence of risk and the person conducting an act foresees the presence of risk and performs an experiment, resulting in occurrence of harm; and <3> when the ordinary person cannot foresee the presence nor absence of risk and the person conducting an act foresees the presence of risk, and harm occurs. In the case of <1>, the person who conducted the act may be responsible for negligence according to the objective theory but excused for negligence according to the subjective theory. In cases <2> and <3>, the person who conducted the act may be excused for negligence according to the objective theory but may be responsible for negligence according to the objective theory. In cases <2> and <3> in particular, what is foreseeable agrees with what actually occurs. These cases may indicate that researchers have foresight, apart from whether it may constitute a crime or a tort. The authors will not move forward here regarding these issues. Considering the fact that researchers improve together through friendly rivalry every day, regulation of advanced science and technology on the basis of the subjective theory may prevent the purpose of such regulation from being achieved. On the other hand, it may be a problem if the person conducting the act is not responsible for negligence even in the case of <1>. The authors consider it necessary to review again opinions (a) through (d) regarding what should work as the standard, in connection with negligence of researchers.
{Note}
In 1989, it was reported that Professors Fleischman and Pons at Utah University in the US electrolyzed heavy water (more strictly speaking, deuterided lithium hydroxide and heavy water solution was electrolyzed at constant current with a cathode (palladium) and anode (platinum)), resulting in continuous generation of heat at 10 W/1 cm3 for over 100 hours (which was sufficient heat generation to exceed that produced by the experimental measurement conditions). It was reported that at the time of this experiment, no one was present in the laboratory room and there was no personal loss. Calculation indicated that this quantity of heat required generation of 1011-1014 neutrons, which is presumed to be lethal to humans. (However, the readings obtained from the gamma ray measuring unit in the laboratory room indicated that only 104 neutrons were generated per second.) On the basis of the scientific knowledge and information available at the time, no one was able to foresee occurrence of nuclear fusion during electrolysis of heavy water. This experiment, known as "cold fusion," created a considerable sensation within society. Following this, in Japan also, universities and the Ministry of International Trade and Industry conducted similar experiments. Regarding the experiment conducted by Professors Fleischman and Pons, however, subsequently performed studies came to the same conclusions that "it was judged difficult to confirm their experiment because the reproducibility of neutron measurement was insufficient" and "it is not considered that theories supporting the presence of ordinary-temperature nuclear fusion have been investigated substantially enough to give convincing explanation to that presence" (JAERI Review "Nuclear fusion" by the Study Group of "Ordinary-Temperature Nuclear Fusion" of the Japan Atomic Energy Research Institute in 1995). Up to now, no convincing evidence has yet been obtained.
(4) Article 4-1 of the Products Liability Act prescribes that if the manufacturer of the product concerned proves that the manufacturer cannot discover a defect in the product, on the basis of the scientific and technological knowledge and information available at the time of delivery by the manufacturer, the manufacturer shall not be liable for damage stipulated in Article 3 (regarding products liability of manufacturers, etc.). This is interpreted as the defense of failure to discover risk during product development.
It is understood that the reasons why the scientific and technological knowledge and information is made the legal ground for exemption of responsibility is because "the Products Liability Act assumes that science and technology progresses, and accepts the defense of failure to discover risk during product development while trying to avoid hindrance to advances in science and technology which contribute to improvement of stability of national life and to growth of national economy." What the Act considers as a problem is impossibility of awareness of defective based on "the knowledge and information regarding science and technology." Accordingly, "the "knowledge and information" in the Products Liability Act means the whole knowledge established that may be affected when the presence or absence of defective is evaluated and that is not owned by any specific person or entity, and is therefore defined as the whole knowledge that exists in the society from the objective viewpoint. ¡ÄIn other words, since this means the knowledge established that may affect the others, this includes everything from a rudimentary knowledge to the state-of-the-art knowledge. A manufacturer who wants to be exempted from liability is required to prove that even on the basis of the state-of-the-art knowledge available that was necessary for them to determine if the product concerned was defective or not, they failed to be aware that the product was defective. ¡ÄAccordingly, whether or not a defense of failure to discover risk during product development is accepted or ruled out in a case is determined by the level of state-of-the-art knowledge and information in science and technology available upon the relevant time." (Refer to "Explanation on individual articles of products liability" issued by the Consumer Administration Division 1, the National Life Bureau, the Economic Planning Agency.)
No specific cases have occurred, which are related to the defense of failure to discover risk during product development on the basis of products liability. Of the previous cases in which the legal issue was negligence in torts, we found out many precedent cases examined at lower courts in which the level of scientific and technological knowledge and information was examined in connection to foreseeability.
(i) In the Tokyo SMON (Subacute Myelo-Optico-Neuropathy) law suit, the Tokyo District Court adjudicated as follows on August 3, 1978: Since the drug concerned was a new drug, the defendant had the duty of foreseeing results and had to performed, prior to marketing the drug, in vitro experiments, animal experiments and clinical studies using the state-of-the-art knowledge and information. It was evident that Chapter 42 of the La Semana Medica Journal which carried the report authored by Gravietsu and Barosu (written in Spanish) was retained in the Annex of Tohoku Imperial University School of Medicine as of June 15, 1937, two years later. Considering this fact, together with the fact that Gravitsu wrote his statements in the Ciba Jiho Journal No. 62, it is not acceptable that the defendant had difficulties in obtaining information regarding case reports by Gravitsu, Barosu¡Äas of 1935.
(ii) In the second law suit of the chloroquine case, the Tokyo District Court made the following judgment on May 18, 1987: Drugs are manufactured and improved on the basis of the state-of-the-art academic knowledge available at each relevant time. ¡Ä.drug manufacturers are required, when developing and manufacturing drugs, to perform thorough literature survey, experiments and studies to confirm not only the efficacy but also the safety of the drug concerned. The occurrence of retinopathy caused by chloroquine preparations was evident by the Hobuz report published in the Lancet journal issued in October 1959 and the subsequent report by Furudo. It was possible for the defendant pharmaceutical manufacturer to obtain and examine the above-mentioned Lancet issue to discover the occurrence of retinopathy caused by chronic use of chloroquine preparations.
Specifically, it is understood that what these judgments required is as follows: nothing in the scientific and technological information, reports, etc. available indicated the existence of the defect concerned, on the basis of which the defendant performed a series of experiments and was not able to be aware of the existence of the defective. It is impossible to find direct evidence indicating the non-existence or unavailability of literature. There exist several systems for retrieval of scientific and technological information, reports, etc. available in Japan, e.g. retrieval systems by Chemical Abstract, Index Medica, and the Scientific and Technological Information Center. It is presumed that these systems would indicate the non-existence of information indicating risk at the time concerned. (Refer to "Defense of failure to discover risk during product development" authored by Hideyuki Kobayashi and Motoko Yoshida in the book "New Modern Lecture on Damage Compensation Laws: No. 3: Products Liability" edited by Takuo Yamada as representative editor).
This appears to be an extremely stringent element constituting liability. The Products Liability Act is interpreted as follows: "When only a specific single scholar has pointed out risk, it is not interpreted that in such a case, the defense of failure to discover risk during product development becomes unacceptable immediately (refer to "Explanation on individual articles of products liability" mentioned above). There seem to exist subtle differences between the purport of the judgments and the issue of whether it is permissible to use the established academic knowledge as a basis or not (since another possible interpretation of the documented judgments can be that as far as the defendant just follows popular opinions of scientific associations, the defendant cannot be exempted from liability and that ultimately, the defendant is required to make confirmation by themselves).
It is a delicate issue how this standard is utilized in actual specific cases. However, investigation from the different viewpoint from that of product liability may be necessary: when regulating research itself, whether this standard based on the interpretation of Products Liability Act would be sufficiently significant and effective or not; and it might be a problem for a person to be blamed for liability regarding unrealizable prospects.
In the US, state laws and precedent cases indicate that product liability actions are generally grounded on theories of negligence, strict liability and breach of warranty. Strict liability is not always the issue. Advantages of individual defendants vary depending on awarded damages. Among these theories, the concept of technology standards is primarily based on strict liability in particular. There are four opinions for these technology standards, i.e. <1> traditional practices in an industry which have been commonly performed regarding manufacture of a similar type of products to the product concerned, <2> legal, administrative, or industrial voluntary quality and safety standards, <3> level of knowledge attainable in fields of science and technology, and <4> feasibility and availability from the factual and economic points of view. There are no uniform nor fixed definitions. (Refer to the report authored by Hideyuki Kobayashi and Motoko Yoshida mentioned above.)
(5) The authors have discussed regulation of cloning technology from the viewpoint of risk in the previous section. There are several points to be considered, which will be discussed here. When regulating cloning technology from the viewpoint of invasion into the legally protected interests for the reasons described above, that form of a crime is regarded as criminal endangerment (not criminal invasion) according to the Penal Code. The criminal endangerment in connection with cloning technology would constitute abstract types of criminal endangerment, in contrast to specific types of criminal endangerment such as endangerment of traffic, criminal attempt and crime of setting fire.
In Japan, the criminal endangerment has not frequently been discussed but the popular views indicate that this crime is based on the theory of formal requisite: a person who conducts an act is not accused because he/she merely violated the prescribed code of practice (this is the theory of non-observance) but because the act conducted by the person, i.e. an act prescribed in legal documents, has abstract risk of invading the legally protected interests. In addition, the abstract risk is determined by the extent of possibility of occurrence of such invasion and by the extent of abstraction upon evaluation of risk (e.g. as the subject to be damaged by invasion extends from a specific person to unspecified persons, causing social anxiety, the extent of abstraction is greater). (Refer to "Study of criminal endangerment" authored by Atsushi Yamaguchi.)
The above-described view is not wrong. If the abstract risk described in the above theories means effects caused by prohibited acts, effects caused by permissible acts, effects which occur naturally, etc. such as the genetic effects attributable to exposure to radiation, then it becomes possible to make evaluation from the viewpoint of probability along with progress in science and technology, and following this, evaluation standards may be investigated for risk or safety of whole matters including the above. In Japan, from the legal point of view, none of rules or regulations may currently incorporate this way of evaluation from the viewpoint of probability, into safety evaluation. We have heard, however, that some safety-related administration of the national government started to try to incorporate this way of probability-based evaluation when setting safety management objectives. The future issue to be addressed may be a relation between such administrative objectives and legal risk.
Specifically, persons driving cars cause traffic accidents at a certain probability. According to the old theory of negligence introduced above, car drivers can foresee that they might cause traffic accident and therefore, cannot escape negligence. Criticism against this created the new theory of negligence, according to which persons who invaded the legally protected interests (i.e. who caused a traffic accident) can escape negligence as far as they fulfill the duty of avoiding results (i.e. they observe the relevant rules and ordinances). However, if the method of probability-based evaluation becomes accepted by the society (or internationally), then the risk of facility or equipment concerned is evaluated by comparing the risk of the others and within such comparative evaluation results, duties for persons conducting acts to fulfill are defined. The debut of such new regulation may trigger reexamination of the existing theories of negligence or create new duties of avoiding results (new duties of care).