Product Liability and Safety 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

CHAMBERS GLOBAL PRACTICE GUIDES

Product Liability & Safety 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

Contributing Editor Rod Freedman Cooley LLP

Global Practice Guides

Product Liability & Safety

Contributing Editor Rod Freeman Cooley LLP

2025

Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair and Stephen Dinkeldein Content Reviewers Vivienne Button, Lawrence Garrett, Sean Marshall, Marianne Page, Heather Palomino and Adrian Ciechacki Content Coordination Manager Nancy Laidler Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Hannah Leinmüller Head of Production Jasper John Production Coordinator Genevieve Sibayan

Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com

Contents

INTRODUCTION Contributed by Rod Freeman, Cooley LLP p.4 AUSTRALIA Law and Practice p.9 Contributed by Clayton Utz Trends and Developments p.32 Contributed by Clayton Utz CHINA Law and Practice p.38 Contributed by King & Wood Mallesons

JAPAN Law and Practice p.152 Contributed by Nagashima Ohno & Tsunematsu Trends and Developments p.171 Contributed by TMI Associates NETHERLANDS Law and Practice p.178 Contributed by Claims Made Advocatuur

SOUTH KOREA Law and Practice p.195 Contributed by Kim & Chang SPAIN Law and Practice p.208 Contributed by Faus Moliner

DENMARK Law and Practice p.59 Contributed by Kennedys

FRANCE Law and Practice p.69 Contributed by LexCase Trends and Developments p.87 Contributed by LexCase

SWITZERLAND Law and Practice p.227

Contributed by Walder Wyss Ltd Trends and Developments p.246 Contributed by Walder Wyss Ltd

GERMANY Law and Practice p.93 Contributed by SZA Schilling, Zutt & Anschütz Trends and Developments p.110 Contributed by SZA Schilling, Zutt & Anschütz GREECE Law and Practice p.117 Contributed by Bahas, Gramatidis & Partners Trends and Developments p.131 Contributed by Bahas, Gramatidis & Partners INDONESIA Trends and Developments p.138 Contributed by Assegaf Hamzah & Partners ITALY Trends and Developments p.145 Contributed by RASS – Studio Legale Rinaldi e Associati

TÜRKIYE Law and Practice p.255 Contributed by Akin Legal

UK Law and Practice p.268 Contributed by Crown Office Chambers Trends and Developments p.292 Contributed by Crown Office Chambers USA Law and Practice p.297 Contributed by Campbell Conroy & O’Neil, P.C. Trends and Developments p.317 Contributed by Shook, Hardy & Bacon LLP

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INTRODUCTION

Contributed by: Rod Freeman, Cooley LLP

Cooley LLP is an international law firm with its roots in Silicon Valley and a reputation for being the leading firm for the world’s most innovative companies. Its renowned international product liability and safety team has market-leading ex -

perience in managing regulatory investigations, litigation, product recalls, risk assessments and international compliance in complex, fast-mov - ing and highly regulated industries including life sciences, cosmetics and consumer products.

Contributing Editor

Rod Freeman is an international products lawyer at Cooley LLP with more than 20 years’ experience supporting the world’s leading and most innovative companies. He is a

international companies. With a background in high-stakes product liability litigation, Rod understands the challenges faced by companies in an increasingly risky global environment. He is deeply embedded in the product liability and product safety community internationally, often working with policymakers within Europe and around the world to help shape the future of product liability and product safety regulation.

recognised global leader in this field, providing clients unique insights into the international liability and regulatory landscape, and has an instinct for finding practical solutions for

Cooley LLP 22 Bishopsgate London EC2N 4BQ UK

Tel: +44 (0) 20 7583 4055 Fax: +44 (0) 20 7785 9355 Web: www.cooley.com

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INTRODUCTION Contributed by: Rod Freeman, Cooley LLP

Modern Product Liability – Global Risks and Challenges Product manufacturers are facing an increas - ingly challenging liability and regulatory environ - ment around the world. This has been the trend for some time now, and it shows no signs of letting up. Those challenges have been exacer - bated by the pace and scale of change in legal regimes internationally. The wave of change has been unprecedented, both in terms of its scope, affecting all product sectors, and the volume of change. The main drivers for these changes have been, first, a perceived need on the part of regulators and policymakers to address challenges raised by new technologies, second, the rise of new marketing models based on e-commerce, and third, an outcome of the growing prioritisation of the circular economy. This is what we should consider to be “Modern Product Liability”. The risks, responsibilities and liabilities of companies involved in the manufacture and distribution of products are not what they used to be. They go way beyond what has been traditionally seen as “product liability”, and the regulations that need to be taken into account when designing prod - ucts now go beyond traditional considerations of “product safety”. The laws are more com - plex, covering a wider range of policy areas, and enforcement is being seen on multiple fronts. Over the last few years there has been a dra- matic shift in gears, with these debates and dis - cussions culminating in concrete reforms. Com - panies are starting to feel the pinch – needing to stay on top of upcoming new requirements across multiple jurisdictions (that may be incon - sistent), understand what they mean and imple - ment required changes to products, processes and procedures to comply – often before guid - ance or standards are available. Reforms are also

impacting multiple areas of a business, making it difficult to prioritise and allocate resources, especially with multiple areas of policy now over - lapping. The consequences of non-compliance are also increasing. This gives rise to very practi - cal challenges for all companies and increases product liability and litigation risks stemming from non-compliance with regulatory measures. Governments and regulators are also feel - ing the pinch, with last minute proposals to delay enforcement dates where the mechanics required to implement new laws are not yet in place. There are also increasing calls for simpli - fication to reduce overlapping requirements and burdens, with proposals to amend laws before they have even entered into application. Whilst reforms that give companies more time to com - ply and reduce burdens are often welcomed, the last-minute nature of some of the changes has led to uncertainty and wasted costs for busi - nesses. Companies are beginning to realise, sometimes the hard way, that their existing procedures and practices for managing product liability risks worldwide may not be adequate for confront - ing the challenges that exist now, and that lie ahead. As regulation becomes more complex and changes occur more rapidly, with traditional principles of regulation being overtaken by new approaches, companies are struggling to find practical ways to keep informed of requirements and effectively manage risk. These challenges are particularly acute when considering products currently under development, likely to launch in one or two years, and potentially remaining on the market for several years thereafter. If com - panies cannot anticipate the direction and shape of regulatory change on the horizon now, invest - ments and opportunities could well be lost. There is still no “magic wand” solution to this current

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INTRODUCTION Contributed by: Rod Freeman, Cooley LLP

dilemma; however, there are steps companies can take to manage this in a sustainable way. This guide is one example. It is an invaluable resource to help companies manage the interna - tional risks that arise from this changing liability and regulatory landscape. It highlights the cur - rent state of liability laws and applicable proce - dures, explains the key features of the product safety regulatory landscape in individual juris - dictions, highlighting the areas of greatest risk, and provides insight into what the future might hold and what changes might be on the horizon. Given the significant impact that future changes can have, necessitating months or even years of planning, it is becoming increasingly impor - tant for those managing modern product liability issues to understand and get to grips with any changes on the horizon. As you work through the chapters, you will see that there are certain trends and patterns in the laws. You will also see marked differences. Com - panies need to navigate this increasingly com - plex world of product law, and to find practical solutions to manage risks while meeting busi - ness demands to simplify product specifications, consolidate supply chains and get products to market quickly. In order to do so effectively, it can be important to take a step back and look for the global trends, and to try to understand why these trends exist. New Technologies Front and Centre Following policy debates and discussions over recent years around the perceived risks and challenges posed by new technologies, we are now seeing concrete reforms made to update legal frameworks in some jurisdictions. These have resulted in changes to the basic concepts that have underpinned product safety and lia - bility regimes for decades. The legal scope is

expanding beyond physical goods to include standalone software and digital services, and beyond risks to physical health and property damage to include risks to mental health. Lia - bility is also being extended to cover issues such as cybersecurity, software updates (or the lack thereof), connectivity, and AI functionali - ties. Companies are having to adopt their own compliance and risk management processes accordingly. One test will be whether these new laws are really future-proof and stay relevant as tech - nologies rapidly evolve. Another will be whether other jurisdictions follow the reforms or look to obtain perceived competitive advantages with lighter-touch regulatory approaches. E-Commerce Remains in the Spotlight Some major markets have also recently enacted reforms to deal with new marketing and distribu - tion models – particularly online marketplaces. However, tensions are already emerging, with growing concerns that recently passed product safety and liability laws do not go far enough to address the issues of this rapidly expanding market. These concerns extend beyond matters of product safety and liability, touching also on issues of unfair competition. We expect the policy and enforcement focus on online sales to continue as markets and market - ing models continue to evolve, and other juris - dictions decide how best to tackle these issues. This is an area where we have seen voluntary ini - tiatives to help address the specific issues pre - sented by online sales – for example, the “Prod - uct Safety Pledge+” initiated by the European Commission and expanded in 2023 to include a number of additional commitments by signato - ries. This initiative has had international influence

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INTRODUCTION Contributed by: Rod Freeman, Cooley LLP

– being replicated in some other countries, and promoted by the OECD. The Circular Economy Measures designed to promote the circular economy, and sustainable production generally, remain a prominent feature of regulatory reform, touching every aspect of the product life cycle, from design, through to manufacture, market - ing, repair and end-of-life. Manufacturers and others in the supply chain are having to grapple with new rules relating to “right to repair”, recy - clability, built-in obsolescence, and expanded responsibilities through the product life cycle, alongside reforms to product safety and liability laws attempting to deal with issues associated with circular economy activities. This increasing regulation leads to greater liabil - ity exposure for companies, as failure to meet new expectations can lead to regulatory action and consumer claims. Environmental Social Governance (ESG) Changing the Landscape A number of new sustainability and ESG meas - ures focus on themes of “transparency” and “traceability”, requiring companies to increase due diligence throughout their products’ life cycle – from inception and manufacture through to consumption and disposal. Companies also face a growing need to communicate the envi - ronmental and human rights impacts of their products and business models via public dis - closures or privately to customs officials and regulators in certain jurisdictions. Increasing regulation in this area is another factor impacting liability exposure. Companies may increasingly be held responsible for both the environmental and human rights impacts of their business models and how these are com -

municated – through regulatory action or claims brought by consumers, NGOs or other impacted stakeholders. The Move Towards Digital Compliance Requirements for product information and cus - toms procedures are becoming increasingly dig - itised. One example is the EU’s new framework for Digital Product Passports (DPP) to electroni - cally register, process and share certain product- related information amongst supply chain busi - nesses, authorities and consumers. This is to be complemented by a new IT system to screen DPPs at the border and a proposed overhaul of the EU customs regime, all aiming to make enforcement more targeted and effective. Companies are also increasingly using digital solutions and AI applications as part of their internal processes. Associated risks need to be understood and mitigated to reduce potential liability, especially around high-impact deci - sions. Continued Drive for Increased Enforcement Enforcement of product safety rules continues to be sporadic and inconsistent across the world. However, there remains a clear overall trend towards increased enforcement. Policymakers and regulators continue to look at more effective ways to enforce laws and regula - tions, taking a number of different approaches. Some have been increasing the use of the exist - ing levers that they have available, while others have been focused on ensuring regulators have better resources – in terms of funding, powers and the information available. New tools such as AI are being used, for example, to scrub large data pools, such as consumer complaints, with an increasing level of sophistication.

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INTRODUCTION Contributed by: Rod Freeman, Cooley LLP

Another approach is to empower third parties to participate in the enforcement of product safety regulation; for example, by enabling consumers to bring claims for breaches of product safety regulation more effectively against companies, as seen in the EU with the introduction of the Representative Actions Directive. Online mar - ketplaces are also being given something of a quasi-regulatory role, with increasing obligations to report safety incidents and co-operate with regulators in certain jurisdictions. Sitting alongside this, emerging regimes are increasingly benefitting from increased co-oper - ation with more established regimes, significant - ly escalating the risk for companies operating in multiple jurisdictions. Resources for Managing Changing Risks The increasing complexity and risks of the prod - uct law world, and the rapid pace of change now upon us, are a significant source of new chal - lenges for product manufacturers and suppli - ers seeking to succeed in global markets. The costs of failing to understand, anticipate and manage the risks can be high, as many high- profile brands have discovered in recent years, and continue to do so.

On the other hand, it is also important to rec - ognise the opportunities and benefits. The development of rules and regulations, together with the emergence of more active enforcement agencies, can help to ensure a level playing field and stable markets for companies that have an interest in ensuring they comply with the rules. Companies with valuable brand names and rep - utations to protect, and who pride themselves on delivering good customer experience, can be especially exposed when marketing their products in markets that have few controls and where players take advantage of the lack of reg - ulation. Proportionate laws, fairly and effectively enforced, can help companies to fully realise the benefits of their investments and manage their risks. The key is for companies to find practical ways to keep abreast of the changes, understand their implications and develop future-proof systems. This guide, authored by experts in their field around the world, is part of the toolkit that com - panies can use to help them on that path.

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AUSTRALIA

Australia

Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim Clayton Utz

Sydney

Tasmania

Contents 1. Product Safety p.12 1.1 Product Safety Legal Framework p.12

1.2 Regulatory Authorities for Product Safety p.12 1.3 Obligations to Commence Corrective Action p.13 1.4 Obligations to Notify Regulatory Authorities p.14 1.5 Penalties for Breach of Product Safety Obligations p.15 2. Product Liability p.18 2.1 Product Liability Causes of Action and Sources of Law p.18

2.2 Standing to Bring Product Liability Claims p.20 2.3 Time Limits for Product Liability Claims p.20 2.4 Jurisdictional Requirements for Product Liability Claims p.21 2.5 Pre-Action Procedures and Requirements for Product Liability Claims p.21 2.6 Rules for Preservation of Evidence in Product Liability Claims p.22 2.7 Rules for Disclosure of Documents in Product Liability Cases p.23 2.8 Rules for Expert Evidence in Product Liability Cases p.23 2.9 Burden of Proof in Product Liability Cases p.24 2.10 Courts in Which Product Liability Claims Are Brought p.24 2.11 Appeal Mechanisms for Product Liability Claims p.24 2.12 Defences to Product Liability Claims p.25 2.13 The Impact of Regulatory Compliance on Product Liability Claims p.26 2.14 Rules for Payment of Costs in Product Liability Claims p.26 2.15 Available Funding in Product Liability Claims p.26 2.16 Existence of Class Actions, Representative Proceedings or Co-Ordinated Proceedings in Product Liability Claims p.27 2.17 Summary of Significant Recent Product Liability Claims p.28 3. Recent Policy Changes and Outlook p.29 3.1 Trends in Product Liability and Product Safety Policy p.29 3.2 Future Policy in Product Liability and Product Safety p.30

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

Clayton Utz is an independent Australian firm established in 1833. It has nearly 200 partners and 1,400 employees across six offices, as well as one of the largest commercial litigation prac - tices in Australia, including a specialist six-part - ner product safety and product liability team. The firm handles the most complex, significant and high-profile matters for clients, including

many of Australia’s top financial institutions, multinational corporations operating in a range of sectors, and state and Australian govern - ment departments and agencies. Clayton Utz is also a global leader in pro bono, with one of the largest pro bono practices of any law firm outside the USA.

Authors

Greg Williams is the national practice group leader of commercial litigation at Clayton Utz. He is a highly regarded lawyer who specialises in class actions, product liability litigation

Alexandra Rose is a leading practitioner in the product liability arena and has a wealth of knowledge and expertise in the defence of large-scale high-stakes litigation across

and products regulatory advice. Greg’s impressive track record of success in some of the most high-profile cases across the pharmaceutical, medical device, automotive and financial sectors has earned him a reputation as a skilled and accomplished practitioner. Greg is known for his considered strategic litigation advice and his ability to align litigation strategy with clients’ commercial objectives. He is a member of the International Association of Defense Counsel and also has a master’s degree in biochemistry.

product liability, class actions, and medical device, pharmaceutical and regulatory matters throughout Australia and internationally. In her rapidly growing practice at Clayton Utz, Alex advises clients across the automotive, health, consumer goods and financial services industries. Clients benefit from her adept ability to manage disputes in a manner that enhances global defence strategies, drives efficiencies and allows clients to focus on their core business priorities. Alex is a member of the Defense Research Institute (DRI) and International Association of Defense Counsel (IADC).

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

Caitlin Sheehy is a special counsel in the Clayton Utz product liability team and an experienced commercial litigator who acts in complex product liability litigation, including class

Sarah Aljassim is a lawyer in the Clayton Utz product liability team and has experience of

acting in product liability litigation, including class actions. She is also involved in advising clients in relation to regulatory issues, including with regard to the Australian Consumer Law. Before joining Clayton Utz, Sarah was the associate to his Honour Judge Long SC of the District Court of Queensland in 2021.

actions. She has represented Australian and overseas pharmaceutical and medical device clients both in contentious and advisory matters, including in relation to regulatory issues, advertising and labelling requirements, and product safety and recall issues.

Clayton Utz Level 15 1 Bligh Street Sydney New South Wales 2000 Australia

Tel: +61 2 9353 4000 Fax: +61 2 8220 6700 Email: gwilliams@claytonutz.com Web: www.claytonutz.com

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

1. Product Safety 1.1 Product Safety Legal Framework Australian Consumer Law The principal law governing product safety in Australia is the Australian Consumer Law, which codifies a single set of consumer protection laws for the whole of Australia, including (but not lim - ited to) laws relating to product safety and prod - uct liability. The Australian Consumer Law is Schedule 2 to the federal Competition and Consumer Act 2010 (Cth). However, its operation across Aus - tralia also depends on state and territory laws, which provide that it has effect as a law of each Australian state and territory. Other Laws In addition to the Australian Consumer Law, there are a number of specific types of prod - ucts that have their own safety regimes. By way of example, gas and electrical safety continues to be regulated at a state and territory level, so that each Australian jurisdiction has its own gas and electrical safety legislation, which applies to gas and electrical appliances. Other areas ‒ such as therapeutic goods (ie, medicines and medi - cal devices), food, agricultural and veterinary products, genetically modified organisms, and industrial chemicals (including cosmetics) ‒ have their own federal safety regimes, pursuant to: • the Therapeutic Goods Act 1989 (Cth); • the Australia New Zealand Food Standards Code; • the Agricultural and Veterinary Chemicals Act 1994 (Cth) and the Agricultural and Veterinary Chemicals Code Act 1994 (Cth); • the Gene Technology Act 2000 (Cth); and • the Industrial Chemicals Act 2019 (Cth).

In each case, these regimes do not prevent the products in question from being subject to the Australian Consumer Law, subject to certain lim - ited carve-outs. In addition to these statutory obligations, prod - uct manufacturers and suppliers are subject to obligations under common law. Specifically, per - sons who are injured by a product may have a right to sue the supplier of the product in neg - ligence (as well as under statutory causes of action created by the Australian Consumer Law), and an analysis of a supplier’s duty to users of its product in negligence will often be important in assessing the appropriate response to a poten - tial product safety risk. 1.2 Regulatory Authorities for Product The principal Australian product safety regula - tor is the Australian Competition and Consumer Commission (ACCC), which is responsible for administering the Competition and Consumer Act 2010 (Cth), including the Australian Consum - er Law. The ACCC has regulatory, investigatory and prosecutorial powers granted to it under the Competition and Consumer Act 2010. In rela - tion to product safety, those powers include the power to require the production of documents or the provision of information, including the power to examine witnesses and to enter premises, conduct searches and seize consumer goods, equipment and documents. Typically, the pow - ers of entry, search and seizure must be exer - cised pursuant to a warrant, unless there are circumstances that require their exercise without delay in order to protect life or public safety. The ACCC also has powers to take a range of actions to protect consumer safety, including commencing compulsory recall actions, issu - Safety Federal

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

ing substantiation notices and product safety notices, and prohibiting the making of certain representations in relation to a consumer prod - uct. Finally, the ACCC can issue penalty notices for breach of the Australian Consumer Law or commence proceedings seeking declaratory and injunctive relief as well as civil penalties. It may also refer certain breaches of the Australian Consumer Law to the Commonwealth Director of Public Prosecution for consideration of crimi - nal prosecution, with associated criminal penal - ties. State In addition to the federal regulator, each state and territory has a Department of Fair Trading or similar ‒ although the role of these entities in relation to product safety diminished following the commencement of the Australian Consum - er Law in 2011. Each state also has offices or regulators responsible for safety issues relating to gas, electricity and home building products. Product liability issues in these subject areas will often require engagement with both federal and state (or territory) authorities. Sector-Specific The other important sector-specific regulators are: • the Therapeutic Goods Administration (TGA) in respect of medicines, medical devices and a range of other therapeutic goods; • Foods Standards Australia New Zealand (FSANZ) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) in respect of agricultural and veterinary chemi - cals; • the Office of the Gene Technology Regula - tor (OGTR) in respect of genetically modified organisms;

• the Australian Industrial Chemicals Introduc - tion Scheme (AICIS) in respect of industrial chemicals; and • state and territory fair trading, electrical safety and home building regulators (as mentioned previously). The TGA, the APVMA, the OGTR and the AICIS each operate registration or licensing regimes that require certain products to be assessed and registered before they may be supplied or used in Australia. These regulators also have various investigatory, regulatory and enforcement pow - ers – the precise scope of which varies from regulator to regulator, but which are generally similar in scope to the ACCC’s powers in rela - tion to consumer goods, tailored to the par - ticular products in question. Subject to certain carve-outs, the regimes are not exclusive, so a product that falls, for example, within the TGA’s remit may also be ‒ in some circumstances ‒ a consumer product that is regulated by the ACCC and subject to the Australian Consumer Law. 1.3 Obligations to Commence Corrective Action The powers of the ACCC and other Australian regulators, as summarised in 1.2 Regulatory Authorities for Product Safety , include pow - ers to compel local sponsors, suppliers and/or manufacturers to take certain actions in relation to goods. By way of example, the ACCC may require corrective action or information to be supplied regarding goods, order a compulsory recall (in rare circumstances), issue an interim or permanent ban on the supply of specified prod - ucts, or create an information or safety standard in relation to particular products. However, outside situations where the ACCC or the TGA has created a specific obligation in relation to particular goods, the institution

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

of voluntary recall action is generally a matter for manufacturers or suppliers to determine for themselves. The concept of product recall is well recognised under Australian law as covering a range of cor - rective actions in relation to products in the mar - ketplace. The analysis of whether a recall is nec - essary in respect of a particular product safety issue is typically conducted by reference to the standards established by the tort of negligence – that is, what are the reasonable steps required of the supplier as a result of a foreseeable risk of injury to users of the product? If a supplier initiates a recall action, there are no specific legal requirements as to how such recalls must be conducted. However, the vari - ous regulators (in particular, the ACCC, the TGA, FSANZ and the electrical safety regulators) publish guidelines in relation to the conduct of recalls. As a result of those guidelines, there are: • common notification requirements to regula - tors regarding recall actions; • commonly expected formats for recall notic - es; and • common ongoing reporting obligations regarding the progress of recalls. 1.4 Obligations to Notify Regulatory Authorities There are two notification obligations in relation to consumer goods in Australia: one risk-based and one incident-based. Risk-Based A supplier who voluntarily takes action to recall consumer goods because of a safety risk (including non-compliance with bans and certain safety standards) must, within two days of taking such action, give the relevant federal minister

(which is, in effect, the ACCC) written notice that such action has been taken (Section 128 of the Australian Consumer Law). Such notice is typi - cally given using the online form available on the ACCC’s recalls website . The online form requires the provision of relatively detailed information about the nature of the product, the extent of its distribution in Australia, and the reason for the recall. Careful and detailed completion of the notification is recommended because the infor - mation provided could otherwise be formally compelled by the ACCC. The ACCC continues to take an active and detailed interest in the initiation and continuing conduct of recall actions, so as to ensure that the best possible return rates are achieved and that continuing recall actions are taken by sup - pliers and manufacturers. Incident-Based There is a broad-ranging requirement to report incidents related to products to the ACCC. A supplier of consumer goods who becomes aware of the death or serious injury or illness of any person that was caused or may have been caused ‒ or, in the opinion of any other person, was or may have been caused – by the use or foreseeable misuse of those consumer goods must notify the ACCC of that fact within two days of becoming aware of it (Section 131 of the Australian Consumer Law). The Australian Consumer Law defines “serious injury or illness” as meaning “an acute physical injury or illness that requires medical or surgi- cal treatment by, or under the supervision of, a medical practitioner or a nurse (whether or not in a hospital, clinic or similar place), but does not include:

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

an ailment, disorder, defect or morbid condition (whether of sudden onset or gradual develop- ment); or the recurrence, or aggravation, of such an ail- ment, disorder, defect or morbid condition” . There are certain limited exceptions to this obli - gation where: • it is clear that the death or serious injury or illness was not caused by the use or foresee - able misuse of the consumer goods; • it is very unlikely that the death or serious injury or illness was caused by the use or foreseeable misuse of the consumer goods; or • the goods in question are subject to one of a number of alternative incident-based notifica - tion regimes in accordance with an industry code of practice or Commonwealth, state or territory law that is specified in the regula - tions to the Competition and Consumer Act 2010 (Cth) (these include notification regimes relating to therapeutic goods, agricultural and veterinary chemicals, and motor vehicles). Notification pursuant to Section 131 is also typi - cally undertaken using an online form available on the ACCC’s recalls website. 1.5 Penalties for Breach of Product Under the Australian Consumer Law, the maxi - mum pecuniary penalties that may be imposed for breach of product safety obligations gener - ally are, in the case of a corporation: • a fine of up to AUD50 million; • if the court can determine the value of the benefit that the body corporate (and any body Safety Obligations Pecuniary Penalties

corporate related to the body corporate) have obtained directly or indirectly and that is rea - sonably attributable to the act or omission, a fine of three times the value of that benefit; or • if the court cannot determine the value of the benefit, a fine of 30% of the adjusted turnover of the corporation during the breach turnover period for the act or omission. The maximum penalty that may be imposed on an individual is a fine of AUD2.5 million. In either case, the above-mentioned pecuniary penalties can be sought in either a criminal pros - ecution or a civil penalty proceeding. The above-mentioned fines are the maximum fines payable in respect of breaches of substan - tive provisions of the Australian Consumer Law. There are some breaches that may attract lesser penalties – for example, penalties for breach of the recall notification obligations outlined under 1.4 Obligations to Notify Regulatory Authori- ties include (at present) AUD16,500 for a corpo - ration and AUD3,300 for an individual, but can also include orders disqualifying individuals from managing corporations for a period (on applica - tion by the regulator). Civil penalties There are numerous examples of the ACCC seeking and obtaining civil penalties in respect of breaches of the Australian Consumer Law. By way of example, in relation to product safety, in June 2024 a national wholesale distributor of gifts, toys, novelty products and homewares and an owner /operator of family entertainment centres were each required to pay $49,500 for alleged non-compliance with the Consumer Goods (Products Containing Button/Coin Bat -

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

teries) Safety Standard, which came into effect on 22 June 2022. The following are recent examples of civil penal - ties being imposed in relation to breaches of the Australian Consumer Law that did not relate to product safety. • In May 2021, a telecommunications provider was ordered to pay AUD50 million in respect of unconscionable conduct in its dealing with more than 100 Indigenous consumers across Australia. • In June 2021, an energy retailer was ordered to pay AUD1.2 million in penalties and to pay consumer redress in respect of false or mis - leading representations that it made in selling electricity plans to consumers. • In April 2022, a company operating an online hotel booking site was ordered to pay AUD44.7 million in respect of misleading rep - resentations in its advertisements about hotel room rates. • In August 2022, a multinational technology company was ordered to pay AUD60 mil - lion in respect of misleading representations made to consumers about the collection and use of their personal location data on Android phones. • In December 2022, a global ride-sharing company was ordered to pay AUD21 mil - lion in respect of misleading representations made about ride cancellation messages and fees associated with a specific ride option available to consumers. • In March 2023, an Australian online booksell - er was ordered to pay AUD6 million in respect of misleading statements made on its website in relation to consumer guarantee rights. • In July 2023, a former Australian vocational training college and its marketing arm were ordered to pay a record penalty of AUD438

million for acting unconscionably and mis - leading students into thinking vocational courses they were enrolling in were free. • In August 2023, an Australian technology company was ordered to pay AUD10 million in respect of false and misleading represen - tations made on its website about discount prices for add-on computer monitors. • In December 2023, a US-based wearable technology company was ordered to pay AUD11 million after it admitted to making false, misleading or deceptive representations to 58 consumers about their consumer guar - antee rights to a refund or a replacement after they claimed their device was faulty. • In December 2023, an Australian car com - pany was ordered to pay AUD6 million in respect of false or misleading representations made to customers that certain dealerships had closed and would no longer service vehicles. • In February 2024, an Australian car company was ordered to pay AUD11.5 million in penal - ties for false or misleading representations it made to nine consumers about their consum - er guarantee rights. • In March 2024, an Australian online floral company was ordered to pay AUD1 million after it admitted to making false and mislead - ing representations on its website ‒ namely, by publishing misleading star ratings for its products, advertising products at a discount when they had not generally sold products at the “strikethrough price” , and adding sur - charges that were inadequately disclosed. • In May 2024, Australia’s national carrier Qan - tas reached an agreement with the ACCC to pay an AUD100 million penalty (and, in addi - tion, approximately AUD20 million in compen - sation) for false and misleading conduct in selling tickets on flights that had in fact been cancelled. This agreed penalty was confirmed

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

Criminal penalties Examples of criminal penalties and referral to the Commonwealth Director of Public Prosecutions are much rarer and relate to breach of the cartel provisions in the Competition and Consumer Act 2010 (Cth). By way of example, in 2017 Aus - tralia’s first criminal cartel case concluded with a fine of AUD25 million in a global vehicle shipping company cartel case. In 2022, the Federal Court of Australia sentenced four individuals to sus - pended prison terms in relation to price fixing of the Australian dollar/Vietnamese dong exchange rate and transaction fees charged to customers. This was the first time that individuals in Aus - tralia were sentenced for criminal cartel conduct. More recently, in 2024, the Federal Court of Australia convicted and sentenced two waste management companies (and the CEOs of the companies during the period of the offending) for criminal cartel offences relating to a price fix - ing arrangement for demolition waste services in Sydney. The companies were fined AUD30 million and AU3.5 million respectively, while the directors each received terms of imprison - ment to be served as intensive correction order (including community service), monetary fines and bans from managing corporations for a period of five years each. Infringement Notices In addition to the above-mentioned criminal and civil penalty regimes, the ACCC also has the power ‒ pursuant to Section 134A of the Competition and Consumer Act 2010 (Cth) – to issue infringement notices in respect of certain breaches of the Australian Consumer Law. The ACCC may issue an infringement notice if it has reasonable grounds to believe that a person has contravened one of the provisions of the Austral - ian Consumer Law specified in Section 134A.

by the Federal Court of Australia in October 2024. • In July 2024, an Australian supplier of loung - ewear was ordered to pay AUD101,280 in penalties for allegedly failing to include high fire danger warning labels on six different styles of its loungewear, as required by the Consumer Goods (Children’s Nightwear and Limited Daywear and Paper Patterns for Chil - dren’s Nightwear) Safety Standard 2017; • In July 2024, an Australian online auction business was ordered to pay AUD10 million in penalties for making false or misleading rep - resentations in the descriptions of hundreds of cars listed for sale on its website between 1 July 2020 and 30 June 2022. • In July 2024, an Australian course and men - toring programme provider was ordered to pay AUD5 million in pecuniary penalties for making false or misleading representations to consumers in the promotion and sale of two education programmes and to pay students who had enrolled in one of the programmes redress totalling AUD14.7 million. The com - pany’s sole director was also ordered to pay AUD1 million in penalties, in addition to being disqualified from managing corporations for five years. • In August 2024, an Australian operator of car park facilities was ordered to pay AUD10.95 million in penalties for making false or mis - leading claims about its pre-book online park - ing services. • In September 2024, one of Australia’s largest energy retailers was ordered to pay AUD14 million in penalties for making false, mislead - ing or deceptive statements to hundreds of thousands of consumers about electricity prices, as well as for failing to provide man - datory information required by the Electricity Retail Code.

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

An infringement notice issued pursuant to Sec - tion 134A will specify a pecuniary penalty that must be paid for the purported breach of the Australian Consumer Law. The maximum pen - alties that may be imposed by an infringement notice vary according to the particular provi - sion said to have been breached. Payment of an infringement notice precludes any further penalty (civil or criminal) being sought from that person in respect of the breach. The use of infringement notices is quite com - mon and almost exclusively related to breaches of Section 29 of the Australian Consumer Law (which prohibits false or misleading representa - tions about goods or services). The ACCC pub - lishes a register of such notices, which identifies the person or company that is the subject of the notice and the provisions of the Australian Con - sumer Law (or other applicable industry stand - ard) that have been breached. However, the reg - ister does not disclose the particular products or conduct to which the notice relates. 2. Product Liability 2.1 Product Liability Causes of Action and Sources of Law Liability for a faulty or defective product that causes injury, loss or damage may be brought on a number of grounds. The causes of action most commonly pleaded are the common law tort of negligence or a breach of the Australian Consumer Law. The Australian Consumer Law creates a number of bases for liability, including: • engaging in false, misleading or deceptive conduct (although these claims may not be relied on in personal injury cases);

• breach by a supplier of consumer goods of statutory guarantees – eg, guarantees of acceptable quality; • derivative liability for manufacturers in respect of goods that breach the statutory guarantee of acceptable quality; and • the manufacture of goods with a safety defect. Negligence Under common law, a manufacturer or supplier of products also owes a duty of care to both the purchaser and the user to take reasonable steps to protect them from any foreseeable injury when using a product as intended. The extent of the duty owed by a particular manufacturer or sup - plier will depend on the role they play in the sup - ply chain and the steps that are reasonably and practicably available to them to address the risk. Since the early 2000s, common law negligence in Australia has been substantially impacted by statutory reforms designed to create a uniform national approach and curtail excessive negli - gence claims. These led to the introduction of various civil liability regimes, which are in place in Australian states and territories. False, Misleading or Deceptive Conduct The Australian Consumer Law prohibits persons from engaging in false, misleading or deceptive conduct in trade or commerce. It does not mat - ter whether the person intended to mislead. Breach of this prohibition gives rise to a right to sue for loss or damage (although not for per - sonal injury) in respect of losses suffered as a result of that conduct. This prohibition is relied on in all manner of claims, including product liability claims for economic loss. By way of example, if goods are represented – expressly or impliedly – to have

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

certain qualities that they do not have, a pur - chaser or end user of the product may sue for damages on the basis that the representations are misleading. Statutory Guarantees Part 3-2 Division 1 of the Australian Consumer Law provides that a supplier of goods to a con - sumer supplies those goods subject to a num - ber of statutory guarantees. These guarantees cannot be limited or excluded by contract. They require that the goods: • correspond with their description; • are of acceptable quality; • are fit for any disclosed purpose; • conform to any sample provided or demon - stration model in quality, state or condition; and • comply with any express warranties given in relation to them. Remedies for breach of the above-mentioned consumer guarantees are provided in Part 5-4 of the Australian Consumer Law. For actions against suppliers, consumers have a number of remedies available, including in some cases the right to return the goods and demand a refund, as well as the right to recover any reasonably foreseeable losses suffered by reason of the fail - ure of the goods to comply with the guarantee. Part 5-4 also provides an extended right to sue the manufacturer of goods for damages if they breach guarantees of acceptable quality, in terms of supply of goods by description, as to repairs and spare parts or express warranties. Strict Liability Regime Part 3-5 of the Australian Consumer Law impos - es liability on manufacturers of goods with safety

defects. It is closely modelled on the European Product Liability Directive. Goods have a safety defect if their safety is “not such as persons generally are entitled to expect” . Relevant surrounding circumstances must be taken into account in making this safety inquiry. If such goods cause personal injury or damage to land, buildings or fixtures, persons who suffer loss as a result of such injury or damage may sue the manufacturer for damages. Expanded Concepts of Consumer and Manufacturer Under the Australian Consumer Law There are specific definitions of “consumer” and “consumer goods” as well as “manufacturer” in the Australian Consumer Law. “Consumer goods” or “goods acquired as a con- sumer” are goods that: • cost AUD100,000 or less, are a vehicle or trailer acquired for use principally in the transport of goods on public roads, or are otherwise goods that are of a kind ordinarily acquired for personal, domestic or household use or consumption; • were not acquired for the purposes of using them up or transforming them, in trade or commerce, in the course of a process of pro - duction or manufacture or repair or treatment of other goods or fixtures on land; and • were not acquired: (a) (for goods other than gift cards) for the purpose of resupply; or (b) (for gift cards) for the purpose of re‑sup - ply in trade or commerce. The term “manufacturer” has a deeming func - tion, and it means not only the actual manufac - turer of goods (ie, a person who grows, extracts,

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AUSTRALIA Law and Practice Contributed by: Greg Williams, Alexandra Rose, Caitlin Sheehy and Sarah Aljassim, Clayton Utz

produces, processes or assembles goods), but also: • a person who causes or permits their name (or a name by which the person carries on business or a brand or mark of the person) to be applied to the goods; • a person who causes or permits themselves to be held out as the manufacturer of the goods; and • a person who imports the goods into Aus - tralia (if the actual manufacturer of the goods does not have a place of business in Aus - tralia). Contract Another cause of action for a person who has been injured or who has suffered loss or dam - age is under the law of contract. However, the number of these claims has diminished owing to the growth of statutory remedies and remedies available under the tort of negligence. 2.2 Standing to Bring Product Liability Claims Under the Australian regime, the original pur - chaser is not the only person who may make a claim for injuries caused by a product. Apart from the remedies available for breach of con - sumer guarantees, which may only be sought by the consumer who received the goods from the supplier, the other causes of action outlined in 2.1 Product Liability Causes of Action and Sources of Law may be relied upon by any per - son who suffers loss and damage that is com - pensable under the relevant cause of action. 2.3 Time Limits for Product Liability Claims The limitation period for bringing a product liabil - ity claim depends on a number of factors, includ - ing the cause of action, the type of claim (eg, in

relation to an alleged safety defect), whether the claim is brought under common law or statute, the relevant Australian jurisdiction, and the date of the alleged act or omission. However, in relation to claims for personal injury, the applicable limitation period for an action to be commenced is: • in most jurisdictions, either within three years of the date the cause of action is discoverable by the plaintiff (the date of discoverability) or 12 years from the date of the act or omission alleged to have caused the death or injury (the long-stop period); or • three years from the date the cause of action accrued. There may also be a mechanism for an exten - sion to be granted by the courts in relation to the applicable limitation period for personal injury claims. In determining whether to grant an extension, a court is generally required to consider a number of factors, including having regard to the justice of the case. Again, in most jurisdictions an extension of up to three years can be granted. There are also circumstances in which limitation periods are suspended, such as: • where a claimant is suffering from a legal incapacity (eg, the claimant is a minor or suf - fers from a mental or physical disability); or • when a class action is commenced ‒ in which case, the limitation period will not begin to run again until a group member opts out or the proceedings are determined. The limitation period for claims that do not relate to personal injury is, in most cases, six years from when the cause of action accrued.

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