In today's global economy, product manufacturers and distributors face a dizzying array of overlapping and sometimes contradictory laws and regulations around the world. A basic familiarity with international product liability is essential to doing business in this environment. An understanding of the international framework will provide thoughtful manufacturers and distributors with a strategic advantage in this increasingly competitive area. This treatise sets out a general overview of product liability in key jurisdictions around the world, giving manufacturers a place to start in assessing their potential liability and exposure.
Readers of this publication will see that each country's product liability laws reflect a delicate balance between protecting consumers and encouraging risk-taking and innovation. This balance is constantly shifting through new legislation, regulations, treaties, administrative oversight and court decisions. But the overall trajectory seems clear: as global wealth, technological innovation and consumer knowledge continue to increase, so will the cost of product liability actions.
This edition reflects a few of these trends from 2018. Most notably, various jurisdictions continued to experiment with regulatory and procedural innovations that may augur increased exposure for product manufacturers. In 2018, the first collective action was brought under the Collective Redress Act in Japan, which joined the ranks of other nations (such as France and Belgium) that have newly embraced class adjudication. A draft law on class actions is currently under consideration by the Russian State Duma as well. In Europe, implementation efforts continued apace on the European Databank on Medical Devices, an initiative designed to strengthen market surveillance and transparency for medical devices. The EUDAMED Database is slated to be launched in March 2020, a mere two months prior to the deadline for medical device companies to recertify their products under the EU's new Medical Device Regulation. Meanwhile, as the incidence of product recalls has escalated globally, various jurisdictions in Asia are establishing new regulatory bodies to monitor product safety and respond to crises. For instance, the Singapore Food Agency is being formed to oversee food safety and security, while India has introduced the Consumer Protection Bill 2018, which will establish the Central Consumer Protection Authority and a broad mandate to protect consumer rights. Perhaps most notably, China has established the State Administration for Market Regulation, an institution housed directly under the State Council, that is responsible for ensuring product quality and safety and guiding the China Consumers Association.
Other novel challenges facing product manufacturers were spawned by judicial decision, rather than legislative decree. For example, France's Court of Cassation ruled that, when adverse reactions to a drug are severe enough relative to the expected benefits, the product should be deemed 'defective,' regardless of whether the manufacturer provided express warnings about those side effects on the product label. Moreover, the Spanish Supreme Court ruled in favour of a plaintiff property owner who argued that damages caused by a metal pipe leak resulted from a manufacturing or design defect – rather than external causes – even though the piping had performed without incident for more than six years after installation. By placing the burden on the product manufacturer to rebut the presumption of a defect, the Court's opinion abrogated prior case law holding that the chain of causation is presumptively broken once sufficient time has elapsed since the product was placed into circulation. And in the United States, the Supreme Court is poised to decide a landmark pre-emption case that may provide valuable guidance to product manufacturers seeking to minimise their exposure to failure-to-warn claims arising under state law. Additionally, this edition highlights how certain countries' product liability laws have grappled with cutting-edge issues in the modern economy, including e-commerce innovations and the emergence of autonomous vehicles and artificial intelligence. Although these changes and trends may be valuable in their own right, they also create a need for greater vigilance on the part of manufacturers, distributors and retailers.
This edition covers 17 countries and territories and includes a high-level overview of each jurisdiction's product liability framework, recent changes and developments, and a look forward at expected trends. Each chapter contains a brief introduction to the country's product liability framework, followed by four main sections: regulatory oversight (describing the country's regulatory authorities or administrative bodies that oversee some aspect of product liability); causes of action (identifying the specific causes of action under which manufacturers, distributors or sellers of a product may be held liable for injury caused by that product); litigation (providing a broad overview of all aspects of litigation in a given country, including the forum, burden of proof, potential defences to liability, personal jurisdiction, discovery, whether mass tort actions or class actions are available and what damages may be expected); and the year in review (describing recent, current and pending developments affecting various aspects of product liability, such as regulatory or policy changes, significant cases or settlements and any notable trends).
Whether the reader is a company executive or a private practitioner, we hope that this edition will prove useful in navigating the complex world of product liability and alerting you to important developments that may affect your business.
We wish to thank all of the contributors who have been so generous with their time and expertise. They have made this publication possible. We also wish to thank our colleague Alex Gray, who has been invaluable in assisting us in our editorial duties.