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(1)Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. 論説. Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability Erkin Abdurizaev Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability… ……………………………………………………………… 13 I.. Introduction… …………………………………………………………………………… 14. II.. Comparative Negligence and Assumption of Risk… ………………………………… 15. III.. Obvious and Known Danger Doctrine… ……………………………………………… 20. IV.. Learned Intermediary Doctrine………………………………………………………… 26. V.. State of the Art and the Development Risk Defense… ……………………………… 30. VI.. The Professional User Doctrine… ……………………………………………………… 32. VII. The Statute of Limitations… …………………………………………………………… 34 VIII. Conclusion… ……………………………………………………………………………… 37. 11.

(2) 横浜国際経済法学第 19 巻第１号（2010 年９月）. I. Introduction Product Liability Law imposes strict liability on a manufacturer. Differently from absolute liability the manufacturer in strict liability is not an insurer of a product and has some practical tools for protection before the court. Product Liability Law provides the manufacturer with a wide range of defenses. The defenses may be broadly classified into three groups: 1) user-misconduct defenses; 2) no-duty defenses; 3) other, so called, “special” defenses. The first group includes defenses which are based on a product user’s misconduct - comparative negligence and assumption of risk, product misuse and unreasonable reliance on a misrepresentation. These are the most pervasive forms of defense, potentially applicable in every type of products liability litigation and, in fact, the most frequent defenses1）. The second group of defenses - the no-duty type, gives rise to defensive claims that a manufacturer may assert but which may not be affirmative. The defendant must plead and has the burden of proof. This group includes issues such as the state of the art, the obviousness of the risk, the bulk supplier and professional user doctrines. Product misuse can be classified as the no-duty defense, but because its essential part includes consumer’s wrongdoing, it is often viewed as a misconduct defense. The prominent issue in no-duty defense group is the state of the art defense. Like product misuse, most courts consider the matter of the state of the art as a part of the plaintiff’s prima facie case. So, a plaintiff ordinarily must prove that, under the prevailing state of the art at the time a product was made and sold, the manufacturer reasonably should have known 12.

(3) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. of the risk and how feasibly to avoid it. This group defenses are normally viewed by defendants as defenses that may cut off liability as readily as proof of a plaintiff’s assumption of risk. The third group of defenses embraces all other remaining defenses. Some of these defenses concern litigation in special narrow areas, such as the governmental preemption defense or the governmental contract, applicable to situations where a products liability action may conflict with another Act; the “seat-belt defense,” pertinent to automotive products liability litigation; and the “sealed-container defense” which might protect retailers in certain situations. This paper examines the most significant and often used defense issues such as comparative negligence and assumption of risk, obviousness of the risk, learned intermediary and the state of the art. It also includes analysis of cases from the Japanese and American litigation where the defenses were applied either successfully or not. This paper is about how key products liability defenses work. The analysis of such defenses is intended to advance the knowledge of Product Liability Law and eliminate possible misunderstandings.. II. Comparative Negligence and Assumption of Risk An injured party’s dismissal or disregard of manufacturer’s cautioning may be of such a nature and degree as to relieve the manufacturer of liability for failure to warn. An affirmatively incautious conduct has been considered as enough cause to bar recovery not only when the claimant is the owner of the product or the employee of the owner, but also when an injured party is a guest.2） Failure to read or follow instructions involves conduct that may be considered contributorily negligent or an assumption of risk. The focus in 13.

(4) 横浜国際経済法学第 19 巻第１号（2010 年９月）. such cases is generally upon the adequacy of the notice. If the warnings or instructions are adequate the product is not defective, and the plaintiff cannot recover under a theory of strict liability in tort. The cause of the injury in such cases is the failure to read or follow the adequate warnings or instructions, and not a defective product. One who reads the warning and then proceeds voluntarily and unreasonably to encounter the danger thereby made known to him will assume the risk of that danger. Tokyo District Court’s rendered the decision for the defendant based on the mentioned rule. Although the plaintiff was adequately informed not to use the product at night time without the operator’s supervision, he did not heed provided warnings and instructions. The court based on the evidences relieved the defendant and confirmed the plaintiff’s assumption of risk.3） Commonly accepted criteria for proof of the defense of assumption of risk are the subjective showing that the plaintiff: 1. actually knew and appreciated the particular risk or danger created by the defect; 2. voluntarily encountered the risk while realizing the danger; and 3. d ecided to encounter the known risk and this decision was unreasonable.4） An injured claimant’s contributory fault will excuse a defendant who has failed to give adequate product warnings only if the claimant’s negligent conduct, but not inadequate warning, constitutes the proximate cause of the injury. In order to be considered as assumption of risk a defendant is required to show that the claimant voluntarily exposed himself to a known and appreciated danger.5） The claimant’s awareness of the general risk associated with the use of a product will ordinarily not be considered sufficient to show that the risk was assumed, unless there is evidence that he knew of and 14.

(5) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. proceeded in the face of the specific danger that caused the injury. In other words, it is not enough to bar recovery by the plaintiff on the defense of assumption of the risk that the plaintiff knew that there was a general danger connected with the use of the product, but rather it must be shown that the plaintiff actually knew, appreciated, and voluntarily and unreasonably exposed himself to the specific defect and danger which caused his injuries. A representative example of when the plaintiff’s awareness of the risk has been held sufficient to bar the claim of failure to warn was described in the decision entered by Tokyo District Court.6 ） It was held there that the manufacturer of the foundation cream with adequate warnings “not to use in case of allergic reaction” is not liable for the damage to the consumer who ignored the warning. The court held that recovery was barred on all grounds, including the allegation of failure to warn, because the claimant had obtained “certain knowledge” of the risks but kept using the cream. The comparative negligence7 ） of a plaintiff in failing to heed a warning will bar only the cause of action in negligence. In strict liability for failure to warn actions the defendant’s assertion of the defense of plaintiff’s comparative negligence will raise a question of the adequacy of the warning. If the conduct of the injured party has been careless or somewhat negligent, the prevalent authority is that such behavior may suggest, but will not prove that the plaintiff would have behaved similarly even had a better warning been provided. The latter proposition was rebuffed in one action in which the plaintiff, who worked on an assembly line making pacemakers, inadvertently spilled some resinous substances on her hand and shortly thereafter brushed the side of her face with her hand.8） A component of the substance caused a severe chemical burn to her face. The court upheld a 15.

(6) 横浜国際経済法学第 19 巻第１号（2010 年９月）. jury verdict that the warning provided by the substance’s manufacturer as to the risks of dermal contact was inadequate, in light of, among other things, a much stronger warning proposed by the pertinent national trade association. It rejected the manufacturer’s claim that causation was broken on the logic that, if the plaintiff was careless with the warning already in place, she would behave identically even with a stronger warning. The court concluded, to the contrary, that it was at least possible that a clear warning as to the risk of severe chemical burns might cause a reasonably prudent person to be more careful than she would be if the only known risk was minor. Similarly, if the warning that a manufacturer provides is inadequate on its face, evidence that the injured plaintiff did not read or follow the warning that was offered should not necessarily bar recovery for the injuries sustained. This was one of the issues raised before the Nara District Court9） in the action which was brought by an elementary school student, suffered from the fragment of broken strengthened heat-resistant plate supplied by the defendant. The defendant’s evidences in that action showed that the plaintiff, who suffered an eye injury probably did not even read the label that was provided. The manufacturer’s argument on appeal stated that if the plaintiff had not read and followed the provided warnings, more detailed warnings would have done nothing to prevent injuries. Moreover, the plaintiff had had the similar incident before and had been aware of the higher than usual level of risk. The court, however, observed that even though the plaintiff has not read the warnings herself, the school administration had communicated the cautionary information. This phenomenon could be considered as a typical method by which information is disseminated. Additionally the court stated that if the manufacturer had warned adequately, school administration could have refused to purchase the dishes from the beginning or banned the usage 16.

(7) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. later on. For these reasons, the court held the failure of the manufacturer to provide an adequate warning could still be treated as a proximate cause of claimant’s injuries.10） Under some circumstances a plaintiff’s use of a product in a manner inconsistent with its express warnings may itself become the proximate cause of any consequent injury, precluding liability for the manufacturer. The plaintiff’s disregard of or ignorance of a warning will not, however, relieve the manufacturer of liability if the plaintiff can claim reasonably that the manufacturer was negligent in communicating the warning and should have employed better means of bringing the message to the attention of the user. One helpful example of such reasoning is offered in the appeal of an action in which the plaintiff was injured when battery acid exploded in his face as he used a match to aid his examination of a dead automobile battery. Although an extensive and vigorously worded warning against this hazard was stamped on the battery case, the plaintiff claimed that the manufacturer should have used more effective means of communication, “such as phosphorus paint that would be visible at night, advertising through the media, and verbal warnings issued by the seller.”11） Reversing summary disposition below on the plaintiff’s claim of negligent failure to warn, the appellate court found that notwithstanding the plaintiff’s failure to read the warning, inasmuch as plaintiff had not had the opportunity to read the warning in sufficient lighting, and had no experience in handling this battery, the plaintiff should be permitted to present proof that the manufacturer was “negligent in not attempting to convey the risk in a more effective manner.”12） Another important limitation upon the defendant’s use of the plaintiff’s conduct in a duty to warn action is recognized in some jurisdictions. The defense of assumption of the risk will not be available for injuries that occur 17.

(8) 横浜国際経済法学第 19 巻第１号（2010 年９月）. in the workplace where the injured individual “is an employee working at an assigned task on an industrial machine.”13 ） This exception represents recognition of the reality that in the workplace environment and, potentially, in other circumstances, the employee directed to work on, near or with a hazardous equipment may have no meaningful alternative.14） In duty to warn cases, the defenses based upon a plaintiff’s conduct suffer from the weakness of the defendant’s proposition that a plaintiff would have proceeded foolishly even had an adequate warning been given. The fact that the actual inadequate or nonexistent warning was not, in any event, connected causally with the injury can’t be considered as a manufacturer’s advantage. The court practice among the contributory fault cases shows that a defendant will not be relieved for a failure to adequately warn even if it can be shown that a claimant acted erroneously. It can be seen that courts decline to excuse the failure of a defendant to discharge its duty to communicate effectively safety-related information not known to the user or consumer even if a defendant brings evidences that the conduct of a user of the product could be described as contributorily at fault. The exceptions to this general rule, as reflected above, are that recovery may still be denied on the basis of the plaintiff’s conduct 1. when the facts show that the injured party’s knowledge of the hazard was so complete as the manufacturer’s; and 2. when an adequate safety-related information from a defendant was known and disregarded by a claimant.. III. Obvious and Known Danger Doctrine Over the last decades, “Obvious and Known Danger” Doctrine perhaps 18.

(9) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. one of the most interesting issues in Product Liability Law. It has been the source of much confusion because the expansion of its applicability has added even more confusion to what is already a vague concept. With the development of new high-tech products it becomes more and more difficult to decide what danger is obvious and what is not, to what group of people it is obvious, etc. However, in many situations a user or consumer knows the nature of the risk associated with the use of a product without any warnings. In other words, risk is apparent to the casual consumer. In most instances where there is such knowledge or obviousness of the risk, there exists an equilibrium between the safety-related information held by the seller and that known by the consumer, and there should be no duty to warn. However, even where the hazard is apparent, but no hazard-avoidance means are provided, a manufacturer should still have a duty to warn or offer instructions to the consumer.15） It is generally accepted that where dangerous condition of a product is obvious or the danger is of a common knowledge the manufacturer does not need to warn. For example, not need to label warning of possible risk of cut on the knife, or about the danger of a stove to burn. The law has been summarized that manufacturers owe no duty to warn of product-related risks that are obvious to reasonable users.16 ） The policy of preventing future harm neither strengthened nor it does any benefit from imposing a manufacturer with a duty to warn a person who is unaware of an obvious danger. The futility of imposing a duty to warn in cases of open and obvious dangers was acknowledged. In one famous case court stated that: “A manufacturer cannot manufacture a knife that will not cut or a hammer that will not mash a thumb or a stove that will not burn a finger. The law does not require him to warn of such common dangers.”17） 19.

(10) 横浜国際経済法学第 19 巻第１号（2010 年９月）. The comments to the Restatement (Second) of Torts section 388 suggest that a manufacturer has a duty to warn of dangerous features of the product: “if, and only if, he has no reason to expect that those, for whose use the chattel is supplied, will discover its condition and realize the danger involved.”18） The rule has been further developed and detailed in the Restatement (Third) of Torts:. Warnings: obvious and generally known risks. In general, a product seller is not subject to liability for failing to warn or instruct regarding risks and risk-avoidance measures that should be obvious to, or generally known by, foreseeable product users. When a risk is obvious or generally known, the prospective addressee of a warning will or should already know of its existence. Warning of an obvious or generally known risk in most instances will not provide an effective additional measure of safety. Furthermore, warnings that deal with obvious or generally known risks may be ignored by users and consumers and may diminish the significance of warnings about non-obvious, not-generally-known risks. Thus, requiring warnings of obvious or generally known risks could reduce the efficacy of warnings generally.19 ） The obviousness of a danger, including the possibility that it will be appreciated is a factor which reduces the likelihood of danger and work against the need for precautions. The sharpness of knives and scissors, or the natural feature of fresh fish to spoil are so well known that a warning cannot add anything useful to the awareness gained from one’s senses and the knowledge common to all men. Nor does any alternative feasible precaution suggest itself. People generally can and do protect themselves against the dangers, thus they are not unreasonable ones. An extensive discussion of the open and obvious doctrine and its rationale 20.

(11) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. appears in the decision in Glittenberg v. Doughboy Recreational Industries20 ） where the defendant noted that there must be limits on a manufacturer’s duty to warn: “if there was an obligation to warn against all injuries that conceivably might result from the use or misuse of a product, manufacturers would find it practically impossible to market their goods.”21 ） Moreover, the court noted, warnings of obvious dangers are purposeless. Warnings serve “to protect consumers where the manufacturer or seller has superior knowledge of the products’ dangerous characteristics and those to whom the warning would be directed would be ignorant of the facts that a warning would communicate.”22） If, however, the risks are obvious, then “the consumer is in just as good a position as the manufacturer to gauge the dangers associated with the product.”23） A warning about such dangers, therefore, adds nothing. Similarly courts denied plaintiffs’ claims upon a finding of the obviousness of the danger of lack of leg protection of a motorcycle,24 ） lighter used by a child,25） and putting one’s hand in a meat grinder during operation.26） The almost invariable issue in the discussion of the effect of hazard obviousness on the duty to warn is the subject of the injured party’s actual knowledge of the danger as to which it is later claimed defendant should have warned. In the workplace setting, the majority rule is that there can be no liability for failure to warn of a hazard known specifically and individually to the user, or even sometimes the user’s employer. It might be timely to describe here the Toyama District Court decision27） where the plaintiff, the user of the incinerator, claimed the compensation of damage because of the absence of any warnings concerning the danger of opening the hatch of the incinerator while in operation. The defendant presented the evidence that the opening of the hatch was an obvious danger and there was no need to warn about it. The court stressed that the specific danger should be obvious to the user, not to 21.

(12) 横浜国際経済法学第 19 巻第１号（2010 年９月）. the manufacturer. The crucial point in the case was the fact that the defendant advertised the product as “can be used without any special knowledge” and the absence of operation license of the plaintiff. The danger should be of a common knowledge, not the specific one. Thus, concerning injuries in the workplace, the doctrine denies the recovery for inadequate or absent warning where a product’s perils are obvious and the party to whom the warning would be properly directed is already aware of the danger.28） Importantly, under the obvious and known danger doctrine, the user’s general awareness of some peril will not defeat recovery unless the user knows about specific risk as well as its seriousness.29） Thus, a manufacturer may be found to have breached its duty to warn where the evidence shows that the injured party was aware of some, but not all, of the danger. As an example it is possible to show one action in which the court found that the plaintiff, severely injured by a fragment of a broken plate, raised sufficient issue of material fact to avoid summary judgment since the evidence suggested that the plaintiff had some knowledge of some risk, but no appreciation of the entirety of such risk or its severity.30） Although the doctrine is sometimes stated that recovery may not be rendered for failure to warn where the hazard posed by the product is both known and obvious, it is better to state the more supportable expression of the law “if the danger is known or obvious, a warning will not be required.” Thus, for the application of this defense, the manufacturer is required just to show that the risk was either known or obvious.31） The manufacturer of the obviously defective product will not be released from the liability if the product had alternative safe design. It is important to remember that the obviousness of the risk is the matter of warning defect 22.

(13) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. while a claimant might bring design defect action. The law discourages misdesign rather than encourage it in its obvious form. The obviousness of the danger should not prevent a plaintiff from establishing a case.32） Relevant to the question of safety-related information held by the seller and the buyer respectively, it is further urged that, in measuring the likelihood of harm, “one may consider the obviousness of the danger since it is reasonable to assume that the user of an obviously hazardous product will exercise special care in its operation, and consequently the likelihood of harm diminishes.” Concerning this issue recent legislature suggests implementation of, so called, “risk-utility” test. This test includes the following questions: (1) the usefulness and desirability of the product; (2) the availability of other and safer products to meet the same need; (3) the likelihood of injury and its probable seriousness; (4) the obviousness of the danger; (5) common knowledge and normal public expectation of the danger (particularly for established products); (6) the avoidability of injury by care in use of the product (including the effect of instructions or warnings) and (7) the ability to eliminate the danger without seriously impairing the usefulness of the product or making it unduly expensive.33） In brief, the rationale for the obvious and known danger defense consists of the following: 1. People generally can and do protect themselves against the dangers they know, thus they are not unreasonable ones. 2. Warning of obvious and known danger will weaken the attention to warnings of latent risk. 3. Society and the Product safety policy will not benefit from imposing a 23.

(14) 横浜国際経済法学第 19 巻第１号（2010 年９月）. duty to warn a person who is unaware of an obvious danger.. IV. Learned Intermediary Doctrine The learned intermediary doctrine34） rose from the development of failure to warn actions in strict product liability law. The doctrine recognizes that the warnings and instructions which come with medicines and medical devices are directed not to ultimate consumers or the end users of those products, but to the physicians who prescribe them and who are in the best position to evaluate the risks associated with their use. The physician is a person who possesses the specialized knowledge and skills to delivery medicines to consumers and must determine whether the medicine is appropriate for the patient. This involves diagnosing the condition, knowing what therapies may treat the condition, understanding the risks and benefits of each of the available therapies, assessing the overall condition of the patient, determining whether the patient is an appropriate candidate for a particular treatment, and selecting the therapy the physician believes is applicable after weighing all the circumstances. Thus, the learned intermediary doctrine is based on the principle that the physician is in the best position to know both the medicine and the patient, and the duty of the manufacturer of the medicine is to provide the physician with accurate and complete information so that the physician can do his job. The rule was worked out first time in Sterling Drug, Inc. v. Cornish35） in 1966 where a plaintiff was granted a recovery for a permanent injury to her eyes caused by drug manufacturer’s failure to warn her doctors of a prescribed drug’s side effect The rationale for the doctrine was stated by the Fifth Circuit Court as 24.

(15) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. follows:. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer36） The justification for the learned intermediary doctrine is grounded in the fact that consumers cannot buy prescription drugs directly from a manufacturer. Rather, they must first consult with a physician, who upon the circumstances decides what drug to prescribe. As a matter of fact, patients tend to rely on their physicians rather than manufacturers, to determine the appropriateness of prescription products. By providing adequate warnings and instructions to a prescribing physician, who in turns provides appropriate patient-specific warnings and instructions, the manufacturer discharges its warning responsibilities. The Tokyo High Court in its decision on 30/04/1993 confirmed the applicability of the learned intermediary doctrine in Japan.37 ） In this case plaintiff claimed that the warnings of the anesthetic drug were not adequate and not up-to-date. The Court in its decision dismissed the claims based on the fact that the medicine was a prescription drug and that the warnings were accurate and complete enough for the learned anesthesiologist to apply it 25.

(16) 横浜国際経済法学第 19 巻第１号（2010 年９月）. correctly. While the rule is straightforward enough and it seems as though it should be simple to apply, problems may arise. The rationale underlying the rule is based on the assumption that a very traditional doctor-patient relationship will exist. However, the fact is that now we live in an era of high technologies and reduced personal interaction between physician and patient. This fact makes a question of vitality of the doctrine. The learned intermediary doctrine has been challenged in some aspects. One of the questions is whether a medical device manufacturer would be liable for the incomplete warnings if there was a doctor’s misconduct. The Tokyo District Court on 20/03/200338 ） recognized both the manufacturer and the doctor liable. This decision in some content contradicts with the Tokyo High Court decision on 30/04/1993. However, it would not be wrong to say that the court considered the social aspect of the matter and split the sum of the compensation. The breadth of the doctrine also has been limited in some contexts. The limitations typically come into play when the physician is not involved with or has a very limited role in connection with the dispensing of a prescription medicine. In the following circumstances, the manufacturer may have a duty to warn the patient directly. An exception to the learned intermediary doctrine has been recognized in mass immunization cases. In such cases, the physician cannot provide individualized balancing of the risks posed by a vaccine, especially where the medicine is provided to most anyone who requests it.39） Courts, in addition to the mass immunization cases, have carved out an exception to the learned intermediary rule in connection with birth control pills.40 ） The court held that a manufacturer of oral contraceptives owes a 26.

(17) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. duty to consumers to warn of the product’s dangers. The argumentation was that oral contraceptives are different from other prescription medicines because the patient is more actively involved in the decision-making process. Moreover, women tend to take oral contraceptives over long periods of time, often without contact with their physicians. The court reasoned that physicians perform a “relatively passive role” in connection with the prescription of oral contraceptives, as opposed to the role taken with respect to most other prescription medicines.. The oral contraceptive … stands apart from other prescription drugs in light of the heightened participation of patients in decisions relating to the use of “the pill”; the substantial risk affiliated with the product’ s use; the feasibility of direct warnings by the manufacturer to the user; the limited participation of the physician; and the possibility that oral communications between physician and consumer may be insufficient or too scanty standing alone fully to apprise consumers of the products dangers at the time the initial selection of a contraceptive method is made as well as at subsequent points when alternative methods may be considered.41 ） The breadth of the doctrine has been limited when medicine was directly advertised to the consumer. Thus, the New Jersey Supreme Court settled that the learned intermediary defense is inapplicable in cases where pharmaceuticals have been directly marketed to consumers.42） Expressing all of this clearly and shortly, section 6(d) of the Restatement (Third) provides:. A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warning regarding foreseeable risk of harm are not provided to: 27.

(18) 横浜国際経済法学第 19 巻第１号（2010 年９月）. 1. Prescribing and other health care provider who are in a position to reduce the risk of harm in accordance with the instructions or warnings; or 2. The patient when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risk of harm in accordance with the instructions or warnings.. V. State of the Art and the Development Risk Defense An examination of court decisions on state of the art issue confuses even the most learned jurist. It is necessary to differentiate the state of the art evidence from the affirmative state of the art defense and this makes a lot of misunderstandings. The comments to the Restatement (Third) highlight the confusion that courts have created by defining state of the art in various ways, noting “the confusion brought about by these various definitions is unfortunate.” 43） As evidence, state of the art might be presented by both parties. In order to convince court that the defendant knew or should have known the danger the plaintiff may represent some facts of scientific development. The defendant, on the other hand, should bring evidences to show that all of the available knowledge on a subject at a given time, and this includes scientific, medical, engineering, and any other knowledge was not such as to define the defect. If the manufacturer succeeds in its showing, the evidence becomes the affirmative defense. Japanese Product Liability Act establishes that the manufacturer is not liable if he provides “that the state of scientific or technical knowledge at the time when the manufacturer, etc. delivered the product was not such as to 28.

(19) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. enable the existence of the defect in the product to be discovered.44） As it has been mentioned in the warning defect litigation the manufacturer should adequately warn and instruct the user. However, the manufacturer cannot provide warning upon the risks that are unknown not only to him, but to all humanity. The rationale of this defense is that a producer shall not be liable for not warning of unknown danger; otherwise the producer will be discouraged of inventing and developing new products. According to the Cabinet Office report during the period between 1995 and 2006 there were five cases when manufacturers employed this defense in Japan. In one case decided by the Tokyo District Court45） the defendant, a restaurant owner, who caused injury to the restaurant customers by serving poisoned fish, claimed that even the risk was known the means to avoid it were not available. The court found that the defendant should have applied the most developed methods to provide the safe product and rendered the decision for plaintiffs. The close relationship between state of the art and the industry standards might cause some confusion. It is necessary to clarify that they are two distinct concepts. One constructive way to distinguish between the two standards is to consider the industry standards as an actually practice done by the industry and state of the art as what is possible to be done by the industry. Whereas state of the art includes all product-related knowledge, the industry standards concern the actual practices of the producers in a particular sphere. Thus, state of the art places a greater burden on a manufacturer than merely meeting industry standards, because scientific knowledge develops faster than an industry can incorporate such knowledge. The defense does not permit the manufacturer to ignore the state of the art, as it develops after the date of manufacture. A manufacturer has a post29.

(20) 横浜国際経済法学第 19 巻第１号（2010 年９月）. sale duty to warn of dangers in the use of its product that come to its attention after manufacture or sale, including subsequent accidents. The extent of the duty depends on the degree of danger involved and the number of incidents reported.46）. VI. The Professional User Doctrine Another relieve for manufacturer in failure to warn cases is so called “sophisticated or professional user” defense. This defense generally states that manufacturer has no duty to warn a professional user of a product. Manufacturer has to warn foreseeable user of all danger inherent in the product’s normal use not within ordinary user’s knowledge, but this duty does not extend to a user who had particular knowledge of or experience with the inherent dangers.47） There is no duty to give a warning to professional users against dangers generally known to that group. Adherence to this approach is demonstrated by decisions holding that there is no duty to give warnings of the dangers of propane, because decedent and other users knew or should have known of the dangers. A propane serviceman and defendant employer was experienced professionals in the propane business. Even if defendant’s carrier and seller had a duty to warn, the lack of warning was not the proximate cause of decedent’s death, because decedent was already aware of the dangers. Further, there was no evidence that the warnings misled decedent by minimizing the danger.48） One obvious rationale for distinguishing the professional user defense from the defenses discussed above, concerning the duty to warn about known or obvious dangers, is that the product sold to or coming into contact with the professional may frequently be sold only to members of that group. It is 30.

(21) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. reasonable that the producer of a professional saw, sold only to professionals to cut wood, can expect that the product will be used only by professional in its foreseeable purposes. A like supposition can be said to have led one court to conclude that a manufacturer should not have to warn a professional cutter about the dangers of using a saw in an unforeseeable use.49） The important is that an unreasonably dangerous means, inter alia, dangerous to the extent beyond which it would be contemplated by an ordinary user of the product in that community, considering that product’s characteristics, propensities, risks, dangers, and uses, together with any actual knowledge, training, or experience possessed by a particular user.50） One early articulation of this approach was offered in Helene Curtis Industries, Inc. v. Pruitt,51 ） which the injured party claimed, among other things, that the instructions accompanying the hair preparation inadequately described precautions that could have been taken and which would have lessened the likelihood or severity of the plaintiff’s injuries. The manufacturer countered that its product was plainly marked “For Professional Use Only,” that its warnings and other cautionary information was sufficient for the safe administration of the product by beauticians, and that it should not be required also to have prepared information for the audience of, the plaintiff and her friend who assisted in the casual home administration of the product. With this latter proposition the court agreed, stating: “When these products were marketed, the makers could only foresee that they would be applied by a trained beautician. Therefore, the directions had to be adequate only for the professional’s use.”52） If the experienced worker, knowledgeable of the risks inhering in the use of a product not itself inherently dangerous, proceeds incautiously to attempt to use the product, it may be found that a later claim of failure to warn will be 31.

(22) 横浜国際経済法学第 19 巻第１号（2010 年９月）. barred for lack of any causal connection between the injuries sustained and the lack of warning. Such was the result in Crook v. Kaneb Pipe Line Operating Partnership.53） Subsection (b) of Restatement (Second) of Torts section 388 has been interpreted as supporting the proposition that there is no duty to warn if the user knows or should know of the potential danger, especially when the user is a professional who should be aware of the characteristics of the product. The professional user doctrine has been generated to identify a lesser duty to warn for the manufacturer who sells to a professional buyer who may be expected to know of any hazards posed, without regard to whether employees or others working at the direction of the buyer are “professional users” as that characterization is understood in common usage or in the sense of the fairness of a presumed familiarity with any risks. The professional user defense is best applicable in the cases where a product is not available for general consumption. The product is to be used or handled either by the purchaser exclusively or by purchaser’s employees who are already experienced in the use of the product or have been effectively informed concerning safe use and handling.. VII. The Statute of Limitations Time-based defenses to legal actions have been available for centuries. The most longstanding and common of such defenses is the statute of limitations. Statutes of limitations serve several functions. They prevent the adjudication of stale claims and protect potential defendants from the unfairness that can result when documents have been lost or destroyed, witnesses can no longer be found or have died, and memories have faded. They also help to give 32.

(23) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. potential defendants peace of mind by fixing the amount of time they need to worry about and plan for possible liabilities arising out of certain events. The statute of limitations is another affirmative defense that releases a producer from liability. In Japanese legislation, as a general rule, suits must be brought to a court within 3 years of the date of injury.54） Although the goals of statutes of limitation remain the same throughout the United States, the specific terms of such statutes as applied to products liability actions can vary widely from jurisdiction to jurisdiction and within jurisdictions in a number of aspects. For example, some limitations periods are as short as one year, while others are as long as six years. Additionally, some states vary their limitations periods depending on the type of product alleged to have caused a plaintiff’s injury, while other states make no such distinction. However, in both countries the crucial point is the date of injury and the date when the product was made is usually irrelevant. Additionally, the Japanese legislature made a reasonable step forward in consumer protection policy. The time of limitation may be counted from the date when the claimant became aware of the liable party. Article 5 of the Product Liability Act of Japan reads:. (1) The right for damages provided in Article 3 shall be extinguished by prescription if the injured person or his legal representative does not exercise such right within 3 years from the time when he becomes aware of the damage and the liable party for the damage. The same shall also apply upon the expiry of a period of 10 years from the time when the manufacturer, etc. delivered the product. Japanese law likewise some of the USA states55 ） have statute of repose. It typically put an outside limit on products liability claims, usually a certain amount of time after the delivery or sale of the product. Thus, for example, 33.

(24) 横浜国際経済法学第 19 巻第１号（2010 年９月）. in Japan the statute of repose focuses on the age of the product, not on the date of injury, and imposes an absolute barrier on a cause of action after a 10 years period of time. For the tort actions the Civil Code of Japan Article 72456） establishes the 20 years period. Product Liability Act can be considered as draconian rules because some actions may be barred by the statute of repose even before a claim arises. A person might be injured without knowing about it. For example, a person may be infected with a latent disease but may not know of it until three years have passed. Does the three-year statute of limitations run from the date of the exposure? The victim used to be barred from bringing suit before even knowing of the injury. However, court in the USA corrected it in practice.57） The rule has been changed for certain cases in the middle of 1980s. Where the injury is caused by the “latent effects of exposure” to a toxic substance, the three-year statute of limitations begins to run from either the date the injured person first discovered or should have discovered the injury, whichever was earlier. Section 2 of the article 5 of the Japanese Product Liability Act reads:. (2) The period in the latter sentence of section 1 of this Article shall be calculated from the time when the damage arises, where such damage is caused by the substances, which are harmful to human health when they remain or accumulate in the body, or where the symptoms for such damage appear after a certain latent period. When a product causes a minor injury that is followed by a more serious injury, it was established that where the second injury is a separate one, a new limitations period begins to run upon discovery of the second injury. The rationale of the statue of limitations is understandable and comprehensible; in majority hearings it is either impossible or costly to keep all 34.

(25) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. evidences. Thus legal theory establishes a period of time after that all claims should be dismissed.. VIII. Conclusion At the end of this article the author would like to remind that a manufacturer is failed to warn a user of a danger inherent in a product when there is the imbalance between the knowledge obtained by the parties. In other words, verdicts in a warning defect lawsuits should be rendered for a plaintiff if a manufacturer knew or should have known of the hazard and as a reasonable person should have communicated the hazard and the way of its avoidance to a consumer, but failed to do so. Defendants still may use the benefit of product liability defenses where they should show equilibrium in knowledge of danger and ways to avoid it known to manufacturer and consumers or users. Proof of equilibrium relives manufacturer from liability A battery of defenses discussed in this article reflects the current state of the product liability law. In general the Japanese and American manufacturers use the benefit of defenses in the similar way. However the number of product liability lawsuits in Japan remains small and the case-study shows that defendants still do not have clear understanding how and where to apply each particular defense. Manufacturers in the United States in some lawsuits have additional requirements, while Japanese manufacturers are in the better position. For example, for the American manufacturer who has not issued post-sale recall, “state-of-the-art” defense is mere a theoretical defense. Courts are eager not to “punish” manufacturers who do not conduct adequate care of 35.

(26) 横浜国際経済法学第 19 巻第１号（2010 年９月）. consumers. Japanese business, on the other hand, may protect itself using “the development risk” defense, but it more often prefers issuing recall statements before any accident happens or settle the claims before it goes to a court. There is no unification concerning defenses in the United States. Legislature in Japan does not give exact list of defenses either. However, product liability litigation keeps showing its dynamism. Thus, in relatively recent times, a significant number of state legislatures in the United States have added or codified “misuse” as a defense, often as part of tort reform or product liability reform legislation. Thus, in these states it is treated as a true affirmative defense to be pleaded and proved by the defendant. The analysis shows that the applicability of that or another defense mostly depends on circumstances of the each case. Even a small difference might cause courts to reject the application of the defense. The author believes that there is not any affirmative defense that makes the defendant’s position stronger and weakens plaintiff’s. Every case should be decided on “case-by-case” basis. (Endnotes) 1）See M. A. Kinzie & Ch F. Hart “Product Liability Litigation” Cengage Learning, 2001, p. 149. There are other categorization of the defenses, for example, common law defenses and statutory defenses. However, in this article the author considers defenses in the above mentioned groups. 2）See Van Dike v. AMF. Inc., 146 Mich. App. 176, 379 N.W.2d 412 (1985), where in an action brought by the guest of the owner against the manufacturer of a trampoline for injuries sustained while attempting a sophisticated flip on the product in the owner’s backyard, recovery was denied where evidence showed that the guest had not read the manufacturer’s cautionary label advising use only by trained and qualified participants under supervised conditions, and further evidence that the injured party had been warned prior to the accident to cease use because of the hazard. 36.

(27) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. 3）Shinno ltd v. Kitamura machine ltd, Tokyo District Court decision on 05/02/2007 4）Sheehan v. Anthony Pools, aff’d, 295 Md. 285, 455 A.2d 434 (1983). 5）See Tokyo High Court decision on 12/04/2001. The case involving a fatal injury to the worker when he intentionally entered into the operating grinder used to crush plastic materials. The action alleged, among other things, that the manufacturer failed to design the grinder safely. The appellate court found the design defective, however, reduced the amount of compensation because of the decedent’s comparative negligence. It was found that the decedent voluntarily exposed himself to a known and appreciated danger. 6）Tokyo District Court decision on 22/05/2000 7）Comparative negligence came out from absolute defense which called “Contributory negligence”. Contributory negligence is the negligence of the plaintiff that contributed to his own injuries. Under common law negligence principles, plaintiff was held 100 % responsible if he contributed any of his own negligence to his injuries and for that reasons his claims were completely barred. However, modern tort law principles have lightened up the contributory negligence as an absolute defense. Now plaintiff’s negligence, if any, is compared to that of the defendant and percentage of fault assigned to each. This comparative principle is called “Comparative negligence.” 8）Billiar v. Minnesota Mining & Mfg. Co., 623 F.2d 240, 246-247 (2d Cir. 1980) 9）Nara District Court decision on 08/10/2003. Hanrei jijyo # 1840 p. 49 10）Id. 11）Rhodes v. Interstate Battery System of America., 722 F.2d 1517, 1518-1519 n.2 (11th Cir.), reh’g denied, 727 F.2d 1116 (1984). 12）Id. at 1520. 13）Colella v. Safway Steel Prods., 201 N.J. Super. 588, 592, 493 A.2d 634, 636 (1985). 14）See Suter v. San Angelo Foundry & Mach. Co., 81 N.J. 150, 167 n.5, 406 A.2d 140, 148 n.5 (1979), in which the court observed: “an employee engaged at his assigned task on a plant machine as in Bexiga has no meaningful choice.” Id., 406 A.2d at 148.. 15 ）S. Madden “The duty to warn in Product Liability: Contours and Criticism” West Va. L. R. Vol 89, 1987, p. 253 16）Restatement (THIRD) of Torts: Product liability § 2 cmt. j (1997) 17）Jamieson, 101 U.S. App. D.C. at 36, 247 F.2d at 26. Jamieson involved the plaintiff’s purchase of an elastic exerciser that was essentially “an ordinary rubber rope, about the thickness of a large lead pencil, about 100 cm long, with loops on the ends.” Plaintiff was injured when the extended exerciser slipped and struck her in the eye. 18）RESTATEMENT (SECOND) of Torts § 388, comment k. Importantly, however, the 37.

(28) 横浜国際経済法学第 19 巻第１号（2010 年９月）. comment goes on to state that the supplier will have a duty to warn where the condition “readily observable,” represents “one which only persons of special experience would realize to be dangerous.” 19）Restatement (THIRD) of Torts: Product liability § 2 cmt. j (1997) 20）Michigan Supreme Court decision 491 N.W.2d 208 (Mich. 1992). 21）Id at 212 22）Id at 213 23）Id 24）Brewer v. Harley-Davidson, Inc., No. 98-6198 (US Court of Appeals 10th Cir. 1999) 25）Welch v. Scripto-Tokai Corp., No. 29A02-9409-CV-552, Court of Appeals of Indiana, 651 N.E.2d 810; 1995 26）See Ward v Hobart Corp. 450 F.2d 1176. However, in a similar case later the United States Court of Appeals for the Second Circuit in Liriano v Hobart Corp. 170 F.3d 264 (2d Cir. 1999) rendered a decision in the plaintiff’s favor. This decision was strongly criticized. See “Liriano v. Hobart Corp.: Obvious Dangers, the Duty to Warn of Safer Alternatives, and the Heeding Presumption”, Hildy Bowbeer & David S. Killoran, 65 Brooklyn L. Rev. 717, 1999 27）Toyama District Court decision on 20/12/ 2005. Hanrei times #1251 p. 333 28）See details in the subsection “The Professional User Doctrine” 29）See e.g., Hopkins v. E. I. Du Pont de Nemours & Co., 199 F.2d 930 (3d Cir. 1952). 30）See Nara District Court decision on 08/10/2003. Hanrei jijyo # 1840 p. 49. In this case the defendant also used the benefit of the “assumption of risk” defense 31）Mather v. Caterpillar Tractor Corp., 23 Ariz. App. 409, 533 P.2d 717 (1975) (Alleged design defect and failure to warn concerning absence of tractor roll-over bars). 32）See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W. 2d 328 (Tex. 1998), cert. denied, 526 U.S. 1040 (1999). 33）See Restatement the (Third) of Torts, §2 34）The rule was worked out first time in Sterling Drug, Inc. v. Cornish 370 F.2d 82, 85 (8th Cir. 1966) In this case plaintiff was granted a recovery for a permanent injury to her eyes caused by drug manufacturer’s failure to warn her doctors of a prescribed drug’s side effect 35）Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). 36）Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974). 37） Tokyo High Court decision on 4/30/1993 (first instance decision is Tokyo District Court decision on 1/30/1992) Hanrei times #854 p. 253 38.

(29) Comparative Analysis of the Japanese and American Product Liability Defenses: Aspects of Defense Applicability. 38）See Tokyo District Court decision on 20/03/2003, Hanrei times #1133 p. 62 where a patient was fatally injured when a doctor wrongfully connected medical tubes sold by two different companies. Importers of the product were found liable because of inadequate warnings. The court found importers liable even though the proximate cause of damage was doctor’s negligence. 39）See Davis v. Wyeth Lab., Inc., 399 F.2d 121, 131 (9th Cir. 1968). See also Edwards v. Basel Pharmaceuticals, 933 P.2d 198, 301 (Oklahoma. 1997). 40）McDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 72 (Mass.), cert. denied, 474 U.S. 920 (1985) 41）Id at 70. Also see Larkin v. Pfizer, Inc., 2004 WL 1361954 (Ky. 2004) (“manufacturer of oral contraceptives is not justified in relying on warnings to the medical profession to satisfy its duty to warn, and that the manufacturer’s obligation encompasses a duty to warn the ultimate user.”) 42）Perez v. Wyeth Laboratories, 161 N.J. 1, 21 (1999).New Jersey Supreme Court 43）Restatement (Third) of the Law of Torts: Products Liability § 2 cmt. d. (1997). 44）Art. 4 (1) of the Product Liability Act (1994) of Japan. Japanese scholars tend to consider a product defective even if the defect was unknown at the time the product was launched, but preempt a manufacturer from liability. American scholars in contrast, do not consider that product as defective at all. Although the interpretation is different, the effect is the same. 45）Tokyo District Court decision on 13/12/2002 Hanrei times # 1109 p. 285 46）Post-sale duty to warn is another vital topic to discuss in the current Product Liability Law. This article does not purpose to expand on it, therefore it remains as a theme for following researches. 47）Mozeke v. Internatioanl Paper Co. 933 F.2d 1293, 1991 48）Crook v. Kaneb Pipe Line Operating Partnership, 231 F.3d 1098; 2000 The district court found that the plaintiffs knew or should have known of the dangerous condition of the product and methods available to protect themselves 49） Wood v. Stihl, Inc., CCH Prod. Liab. Rep. P9605, 1993 50）Erling v. American Allsafe Company. No. 99-3403. 2000 51）Helene Curtis Indus. Inc., 385 F.2d 841. 52）Id. 53）Supra note 48 54）The Product Liability Act art 5 55）See e.g. Arizona, Colorado, Idaho state’s legislature. 39.

(30) 横浜国際経済法学第 19 巻第１号（2010 年９月）. 56）Civil Code of Japan, art. 724 “Extinctive prescriptions” The right to claim compensation for damage in tort shall be extinguished by the operation of prescription if it is not exercised by the victim or his/her legal representative within three years from the time when he/she comes to know of the damages and the identity of the perpetrator. The same shall apply when twenty years have elapsed from the time of the tortious act 57）See Steinhardt v. Johns-Manville Corp., 54 N.Y.2d 1008, 430 N.E.2d 1297, 446 N.Y.S.2d 244 (1981) (holding that the claim for asbestos exposure accrued at time of inhalation of asbestos and was therefore time-barred), cert. denied, 456 U.S. 967 (1982); Thornton v. Roosevelt Hosp., 47 N.Y.2d 780, 391 N.E.2d 1002, 417 N.Y.S.2d 920 (1979) (holding that the action was time-barred because claim accrued at time of injection of substance that caused cancer twenty years later). 40.

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