Product Liability Research Articles

Product Liability in an Age of Development Risks: Should South Africa Reconsider Adopting a Development Risk Defence?

AbstractTo provide protection against harm caused by defective, unsafe products and to promote product safety, the law of product liability has developed as a specialized area of the law of delict (tort). The vexing question is, who should bear such liability? This contribution interrogates the notorious EU development risk defence, which exonerates manufacturers that meet certain stringent requirements for undiscoverable development risks in products that consequently inflict harm on consumers. In particular, it considers the election by South Africa, which recently adopted a “strict” product liability regime with the introduction of the Consumer Protection Act 2008, not to adopt such a defence. The purpose of this contribution is to consider the nature and scope of the development risk defence as contained in article 7(e) of the European Union (EU) Product Liability Directive and to determine whether it was prudent for South Africa to steer clear of incorporating a similar defence in its new statutory product liability regime.

Regulating algorithmic care in the European Union: evolving doctor-patient models through the Artificial Intelligence Act (AI-Act) and the liability directives.

This article argues that the integration of artificial intelligence (AI) into healthcare, particularly under the European Union's Artificial Intelligence Act (AI-Act), poses significant implications for the doctor-patient relationship. While historically paternalistic, Western medicine now emphasises patient autonomy within a consumeristic paradigm, aided by technological advancements. However, hospitals worldwide are adopting AI more rapidly than before, potentially reshaping patient care dynamics. Three potential pathways emerge: enhanced patient autonomy, increased doctor control via AI, or disempowerment of both parties as decision-making shifts to private entities. This article contends that without addressing flaws in the AI-Act's risk-based approach, private entities could be empowered at the expense of patient autonomy. While proposed directives like the AI Liability Directive (AILD) and the revised Directive on Liability for Defective Products (revised PLD) aim to mitigate risks, they may not address the limitations of the AI-Act. Caution must be exercised in the future interpretation of the emerging regulatory architecture to protect patient autonomy and to preserve the central role of healthcare professionals in the care of their patients.

A Study on Revision of Product Liability Act for AI Mobility

A Study on Revision of Product Liability Act for AI Mobility

Multimarket firms and product liability: uniform versus variable rules

Abstract When a multimarket firm’s product causes harm to consumers, should the firm bear uniform or variable liability across markets? We analyze a model in which the firm faces the same standard liability in two markets under uniform liability, while its liability rises above and falls below the standard level in markets 1 and 2, respectively, under variable liability. Allowing variation in product liability across markets has broad implications for the firm’s incentive to invest in product safety, total output, and output allocation across markets, as well as for the optimal choice of standard liability in the first place. We show that welfare is higher under variable liability if demand elasticity is lower and demand curvature is weakly higher in market 2 than in market 1, but welfare can be higher under uniform liability otherwise.

LEGAL LIABILITIES OF ARTIFICIAL INTELLIGENCE: AN OVERVIEW

Objective: The main objective of the paper is to study the need for Special Regulatory legislation for Technology especially Artificial intelligence (AI) as well as examine how AI and law work together. The paper evaluates the liability of AI when it violates Human Rights and Data Privacy. The paper evaluates how AI has created new possibilities and had posed challenges by interfering Human Rights and challenging Sustainable Development comparing the developments happening in European Union (EU) with countries like India. The paper also attempts to make the complex debate more comprehensible for those with no expertise in this area. Method: The Comparative research approach was administered by highlighting the EU methods to tackle and address the AI liabilities. Analogy and review of the Product Liability Directive (PLD) which is proposed and published by European Union (EU) for an AI system liability and suggestions of National Institution for Transforming India (NITI) Aayog of India to attain Sustainable National Economic Development. The paper analyses from financial and lucrative perspective, what liability rules would curtail the financial damages and other harms caused by AI systems which affect Sustainable Development. Results: The paper findings suggest that influence factor of AI applications should be included in existing Liability framework and must be consistently updated as AIs are characterised by unpredictability and independence. Both the EU and India NITI Aayog states that regulatory insight must be an ethical reinforcement for AI practice and hence ensure the sustainability of AI technologies. Originality/Value: The recent government initiatives in EU and India are discussed with respect to the AI liability. The study provides positive insights of Artificial Intelligence (AI) technology and its liabilities to achieve Economic Sustainable Development. The key findings of the paper highlight the importance of Salmond’s defined Tortious liability during British Era for AI technologies for protecting Human Rights and also achieve Sustain Development.

Product liability in modern conditions: European reform experience

At the end of September 2022, the European Commission presented two notable documents designed to fundamentally change the current system of product liability in Europe. In part, these projects were a response to the challenges posed by digitalization and modern technology. The first document is designed to regulate liability for harm caused by artificial intelligence systems, while the second is aimed at adapting the EU Council Directive of July 25, 1985 No. 85/374/EEC to contemporary conditions. The present article sets out to review the key developments in the field of product liability in Europe. To this end, a review of the existing system of product liability in Europe is carried out. The existing product liability system is comprised of two parts: norms enshrined in national laws, as well as harmonized liability under the EU Council Directive of July 25, 1985 No. 85/374/EEC 1985. However, there is no consensus in European doctrine and practice regarding the regime of harmonized liability. While on the one hand, this regime is based on the idea of strict liability, on the other hand, there is also a reasoned opinion that the Directive factually establishes a regime of liability based on fault. On the example of German law, it is revealed that, despite the strict liability regime approved by special law, courts often focus in practice on a manufacturer’s breach of the duty of care, which once again testifies to liability based on fault. Possible factors behind the decision on the part of the European regulator to reform the existing liability system include: the increasing complexity of the goods themselves; the expansion of intermediary chains and emergence of new potential subjects of liability, including owners of aggregators; difficulties in proving the existence of a product defect and a causal link between such a defect and the resulting harm; the concept of harm in the digital age and the special role of data; providers’ liability for goods equipped with artificial intelligence technology.

Do large language models have a legal duty to tell the truth?

Careless speech is a new type of harm created by large language models (LLM) that poses cumulative, long-term risks to science, education and shared social truth in democratic societies. LLMs produce responses that are plausible, helpful and confident, but that contain factual inaccuracies, misleading references and biased information. These subtle mistruths are poised to cumulatively degrade and homogenize knowledge over time. This article examines the existence and feasibility of a legal duty for LLM providers to create models that 'tell the truth'. We argue that LLM providers should be required to mitigate careless speech and better align their models with truth through open, democratic processes. We define careless speech against 'ground truth' in LLMs and related risks including hallucinations, misinformation and disinformation. We assess the existence of truth-related obligations in EU human rights law and the Artificial Intelligence Act, Digital Services Act, Product Liability Directive and Artificial Intelligence Liability Directive. Current frameworks contain limited, sector-specific truth duties. Drawing on duties in science and academia, education, archives and libraries, and a German case in which Google was held liable for defamation caused by autocomplete, we propose a pathway to create a legal truth duty for providers of narrow- and general-purpose LLMs.

Next Generation EU Product Liability – For Digital and Other Products

Abstract The new Directive on Product Liability is hard to overestimate, as it is nothing less than a complete overhaul of the 1985 Product Liability Directive (PLD), which still lies at the heart of EU tort law. One focus of the reform act is the challenge posed by digital transformation. To accommodate the new category of digital devices, the concept of product is widened so as to include software and related services, and the strict ex ante perspective for the finding of product defect is attenuated to account for continued control of the manufacturer post-marketing. Further to broadening the scope of application, the protective perimeter of the Directive is expanded, namely to include data used for private purposes. The second focus of the reform act, of at least equal importance, are changes to the liability regime for products of any kind, regardless of their digital nature or elements. Thus, e-commerce intermediaries such as platforms are ushered into the scope of the Directive as new defendants, alongside manufacturers, importers, and distributors. With a view to quantum, the € 500 retention for property damage had to go, together with the authority of the Member States to impose a cap on liability under the Directive. Unfortunately, there was no time to revisit the foundations of product liability. Thus, the new Directive holds on to the consumer protection gospel of product liability and excludes commercial property from the scope of protection, even though there is no good reason to discriminate against business interests. As before, national law must and will step in to fill in the gaps in Union law, perpetuating the double-track liability systems that the 1985 Directive helped to create.

The Revised Product Liability Directive: A Law and Economics Analysis

Abstract On 12 March 2024, the European Parliament adopted the text for revising the current Product Liability Directive (revised PLD), which was implemented in 1985. The revised PLD adapted the rules for the damage caused by defective products for the challenges from digitalisation, the circular economy and international supply chains. In particular, the new rules aim to ensure that new technologies, such as AI, could be well reflected, so that residents in the European Union could be effectively protected. Conventionally, a law and economics analysis has played a crucial role in shaping product liability. The objective of this paper is to discuss the major changes in the revised PLD via the lens of insights of law and economics. In specific, we focus on the influence of these changes on multiple key elements, including deterrence effect, risk-shifting and local preferences.

Product Safety and Liability with Deceptive Advertising and Moral Hazard

Product Safety and Liability with Deceptive Advertising and Moral Hazard

가습기살균제 피해사건의 국가배상책임 인정 판결에 대한 고찰

The “Humidifier Disinfectant Incident,” where numerous citizens suffered serious health damages from humidifier disinfectants sold in Korea from 1994 to 2011, can be attributed to the irresponsible actions of companies that failed to ensure product safety and the negligence of the government and related organizations in properly managing and supervising these products. Victims and their families claimed damages against manufacturers and the state, but only the manufacturers' liability for damages was primarily recognized, with state compensation liability not being acknowledged. Additionally, the court decided on the liability of manufacturers and sales companies based on whether the primary ingredient of the humidifier disinfectant was of the P series (PHMG/PGH) or C series (CMIT/MIT). Around January 2012, the Seoul Central District Court, through the 2012Gahab4515 damages case, dismissed the claims of the victims and their families on January 19, 2015, not recognizing the state's fault. However, recently, on February 6, 2024, the Seoul High Court issued a significant ruling through case 2015Na2014486, marking the first time state compensation liability was recognized in this matter. This judgment emphasizes the responsibility of the state and relevant agencies in the safety assessment and supervision process of chemicals, reaffirming the importance of state measures to protect the health and safety of its citizens. Notably, this ruling provides critical insights on how the state should respond to ensure citizens' rights to a healthy and comfortable environment against harmful chemicals. Therefore, this study examines the significant legal grounds and principles through this landmark decision, affirming the state's legal responsibilities and duties in public health management and crisis response through chemical management, thereby contributing to reestablishing the role of the state in protecting the lives and safety of its citizens.

인공지능의 민사책임에 대한 소고

The recent development of artificial intelligence (AI) technology is bringing about changes at a faster pace and on a larger scale than any other period in human history. With technological advancements overcoming the limitations of medical AI through training with databases, AI technology has made remarkable progress since the inception of deep learning for image processing with convolutional neural networks (CNN) in 2012. The recent advancements in natural language processing (NLP) have accelerated the utilization of AI through sophisticated natural language processing, enabling machines to identify and understand data regardless of the complexity of the language. This has laid the foundation for the rapid and precise development of generative AI. In the era where generative AI is being utilized without pausing in its developmental speed, we considered the civil liability of AI in our civil law principles, taking into account the inherent characteristics of AI such as unpredictability, opacity, and the black box effect. To do this, we first examined the legal liability considering the stages of AI technology development in discussing the tort liability caused by AI. Even “Weak AI,” created by AI developers, may fall under “Gefahr,” and while not all types, some may apply to strict liability in terms of risk liability. Furthermore, while reviewing civil liability applicable to AI under fault-based and no-fault liability, we also looked at the trends in the EU comparatively. In discussing no-fault liability, particularly under the Product Liability Act, we examined the possibility and implications of applying risk liability to pharmaceutical manufacturing using generative AI technology as a representative example to overcome the limitations of the existing Product Liability Act. Humanity currently lives in an era of rapid technological development and exploding big data, enjoying numerous benefits due to these advancements. As user convenience improves and massive added value is created through technological progress, the meaning of risk liability in the realm of civil liability can gain more significance. Generative AI has already drastically reduced the costs and time required for new drug development, providing substantial profits to pharmaceutical companies. However, even if the existing Product Liability Act is applied, it may be difficult to adequately remedy the harm to victims due to the reasonable alternative possibility defense regarding design defects. In the era of generative AI, we examined the possibility of applying enhanced risk liability by assuming the case of pharmaceutical manufacturing.

AI liability in Europe: How does it complement risk regulation and deal with the problem of human oversight?

Who should compensate you if you get hit by a car in “autopilot” mode: the safety driver or the car manufacturer? What about if you find out you were unfairly discriminated against by an AI decision-making tool that was being supervised by an HR professional? Should the developer compensate you, the company that procured the software, or the (employer of the) HR professional that was “supervising” the system's output?These questions do not have easy answers. In the European Union and elsewhere around the world, AI governance is turning towards risk regulation. Risk regulation alone is, however, rarely optimal. The situations above all involve the liability for harms that are caused by or with an AI system. While risk regulations like the AI Act regulate some aspects of these human and machine interactions, they do not offer those impacted by AI systems any rights and little avenues to seek redress. From a corrective justice perspective risk regulation must also be complemented by liability law because when harms do occur, harmed individuals should be compensated. From a risk-prevention perspective, risk regulation may still fall short of creating optimal incentives for all parties to take precautions.Because risk regulation is not enough, scholars and regulators around the world have highlighted that AI regulations should be complemented by liability rules to address AI harms when they occur. Using a law and economics framework this Article examines how the recently proposed AI liability regime in the EU – a revision of the Product Liability Directive, and an AI Liability effectively complement the AI Act and how they address the particularities of AI-human interactions.

Legal and ethical facets of robotic surgery: a suggestion for a guideline

Surgical negligence being a branch of medical negligence is considered a widely extended topic in the territory of Sri Lanka. The central focus of this paper is the use of robotic systems in the performance of surgical procedures and its legal and ethical facets. ‘Robotic Surgery’ is a novel form of technology that is efficient and productive and mostly preferred in sophisticated health systems and used in different fields of medicine namely cardiology, urology, oncology etc. In this method, the robots assist the surgeon in the performance of the surgery. The assistance given by a surgical robot is useful due to the efficiency, fewer incisions, less bleeding, and the lower possibility of infections. However, there are risks as well. If the risk and the injury were a result of the surgeon’s fault, this gives rise to medical malpractice litigation. If the injury is a consequence of the malfunctioning of the surgical robot, it will create a defective product liability on the side of the manufacturer of the robotic system. If the hospital has undertaken the specific surgical venture without sufficient resources, expertise, and institutional stability, that will lead to the hospital's liability. Even, the liability of an error caused by robotic surgery can be imposed in different ways; the ultimate accused will be the health sector. The author’s attempt in this paper is to discuss the legal and ethical implications of a surgeon-patient relationship in the performance of robotic surgery and thereby recommend a guideline to address legal and ethical issues relevant to robotic surgical procedures.

RECYCLING OF PHOTOVOLTAIC CELLS – A REVIEW

The growth of solar energy has been remarkable between 2013 and 2022, with a doubling of capacity from 80 GW to 197 GW. To recover valuable materials and mitigate environmental impact, it is imperative to have effective waste management practices in place. While recycling technologies are still in the experimental phase, the EU has put in place legal frameworks for manufacturer liability. There are continuous efforts being made to develop commercially viable technologies for the management of end-of-life PV module waste. An important part of the system of renewable sources is the establishment of a high-quality and efficient waste management system, which is contained within the concept of the circular economy. PV modules will at some point reach the end of their life cycle, which is estimated to be around 25 years, and become waste, therefore a lot of effort is currently being put into research and development of different waste treatment technologies of PV modules. They are still in the experimental phase, and few technologies become commercially available. Also, the management of waste generated at the end of the life cycle of photovoltaic technology is not yet fully regulated. However, at the level of the European Union, there is a legal framework for the liability of PV module manufacturers according to Directive on electric waste and electronic equipment. This paper is a detailed review of recycling technologies based on existing literature.

A Products Liability Framework for AI

A products liability framework, drawing inspiration from the regulation of FDA-approved medical products—which includes federal regulation as well as products liability—holds great promise for tackling many of the challenges AI poses. Notwithstanding the new challenges that sophisticated AI technologies pose, products liability provides a conceptual framework capable of responding to the learning and iterative aspects of these technologies. Moreover, this framework provides a robust model of the feedback loop between tort liability and regulation.The regulation of medical products provides an instructive point of departure. The FDA has recognized the need to revise its traditional paradigm for medical device regulation to fit adaptive AI/ML technologies, which enable continuous improvements and modifications to devices based on information gathered during use. AI/ML technologies should hasten an even more significant regulatory paradigm shift at the FDA away from a model that puts most of its emphasis on (and resources into) ex ante premarket approval to one that highlights ongoing postmarket surveillance. As such a model takes form, products liability should continue to play a significant information-production and deterrence role, especially during the transition period before a new ex post regulatory framework is established.

Exploring the Relationship between Consumer Protection and Product Liability: Civil and Islamic Perspectives

Consumer protection is an aspect which aims to ensure that consumers are always given adequate protection from a legal perspective and also to increase the level of consumers’ trust in the quality of goods and services, which will, in turn, contribute to the economic growth of a nation. However, today, issues surrounding product liability cases are no longer uncommon, where consumers or third parties face the risk of suffering injury or property damage due to the existence of defects in a particular product. Thus, the main objective of this study is to analyze the relationship between consumer protection and product liability from both civil and Islamic perspectives. The type of research being carried out is doctrinal legal research. The data sources, including case law and statutory provision, are analyzed using content and critical analysis methods. The results show that according to civil and Islamic perspectives, consumer protection in the context of product liability plays a crucial role in conferring legal protection to consumers who are adversely affected by the use of particular products that pose a risk to health and safety. Further, the authors expect that the results of this study shall contribute new and significant knowledge by proving that the aspect of consumer protection is not only related to product liability issues from a civil perspective, but it is also can be evaluated from the Islamic perspective, which the earlier researchers have rarely discussed.

Product Liability and Reasonable Product Use

Product Liability and Reasonable Product Use

THE EXPLANATIONS ONE NEEDS FOR THE EXPLANATIONS ONE GIVES—THE NECESSITY OF EXPLAINABLE AI (XAI) FOR CAUSAL EXPLANATIONS OF AI-RELATED HARM:DECONSTRUCTING THE ‘REFUGE OF IGNORANCE’ IN THE EU’S AI LIABILITY REGULATION

This paper examines how explanations related to the adverse outcomes of Artificial Intelligence (AI) contribute to the development of causal evidentiary explanations in disputes surrounding AI liability. The study employs a dual approach: first, it analyzes the emerging global caselaw in the field of AI liability, seeking to discern prevailing trends regarding the evidence and explanations considered essential for the fair resolution of disputes. Against the backdrop of those trends, the paper evaluates the upcoming legislation in the European Union (EU) concerning AI liability, namely the AI Liability Directive (AILD) and Revised Product Liability Directive (R-PLD). The objective is to ascertain whether the systems of evidence and procedural rights outlined in this legislation, particularly the right to request the disclosure of evidence, enable litigants to adequately understand the causality underlying AI-related harms. Moreover, the paper seeks o determine if litigants can effectively express their views before dispute-resolution authorities based on that understanding. An examination of the AILD and R-PLD reveals that their evidence systems primarily support ad hoc explanations, allowing litigants and courts to assess the extent of the defendants' compliance with the standards enshrined in regulatory instruments, such as the AI Act. However, the paper contends that, beyond ad hoc explanations, achieving fair resolution in AI liability disputes necessitates post-hoc explanations. These should be directed at unveiling the functionalities of AI systems and the rationale behind harmful automated decisions. The paper thus suggests that ‘full’ explainable AI (XAI) that is, both ad hoc and post hoc, is necessary so that the constitutional requirements associated with the right to a fair trial (access to courts, equality of arms, contradictory debate) can be effectively met. Keywords: AI, Causation, Explainability, Fair Trial, Procedural Fairness, Equality of Arms, Effective Participation, AI liability, Product Liability, AI Act, AI Liability Directive, Product Liability Directive

Safeguarding human values: rethinking US law for generative AI’s societal impacts

AbstractOur interdisciplinary study examines the effectiveness of US law in addressing the complex challenges posed by generative AI systems to fundamental human values, including physical and mental well-being, privacy, autonomy, diversity, and equity. Through the analysis of diverse hypothetical scenarios developed in collaboration with experts, we identified significant shortcomings and ambiguities within the existing legal protections. Constitutional and civil rights law currently struggles to hold AI companies responsible for AI-assisted discriminatory outputs. Moreover, even without considering the liability shield provided by Section 230, existing liability laws may not effectively remedy unintentional and intangible harms caused by AI systems. Demonstrating causal links for liability claims such as defamation or product liability proves exceptionally difficult due to the intricate and opaque nature of these systems. To effectively address these unique and evolving risks posed by generative AI, we propose a “Responsible AI Legal Framework” that adapts to recognize new threats and utilizes a multi-pronged approach. This framework would enshrine fundamental values in legal frameworks, establish comprehensive safety guidelines, and implement liability models tailored to the complexities of human-AI interactions. By proactively mitigating unforeseen harms like mental health impacts and privacy breaches, this framework aims to create a legal landscape capable of navigating the exciting yet precarious future brought forth by generative AI technologies.