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PRODUCT | Products law and life sciences: year in progress insights and outlook

Product Law Outlook: Developments, Updates, Compliance, and Trends

18 September 2025

Throughout 2025, the intersection of product liability and life sciences has continued to evolve across key markets. In the EU, the new Product Liability Directive and AI Act represent a major reset, with countries such as Italy and Germany beginning to test how these frameworks will align with existing national regimes. Meanwhile, in the U.S., litigation trends remain dynamic, with courts grappling with both established claims and novel questions around AI-enabled devices and digital health. In the UK, progress has been slower, but recent reforms—including the Product Regulation and Metrology Act and changes to the Medical Devices Regulations—signal that a period of review and potential reform is now underway.

Against this backdrop of shifting regulation, innovation, and litigation, companies face the challenge of balancing opportunity with legal risk. In this edition of PRODUCT, we unpack the developments shaping the year so far and explore what lies ahead.

Chapter 1 EU

The recently adopted EU Product Liability Directive (Directive (EU) 2024/2853, PLD) and the AI Act constitute landmark reforms in the European legal framework. However, the European Commission's decision to withdraw the proposed AI Liability Directive (AILD) in February 2025 has curtailed prospects for harmonised rules on civil liability for AI-related damages. As a result, national courts are now tasked with determining whether liability regimes applicable to AI systems—particularly in high-risk sectors such as medical devices—will be fault-based, aggravated, or strict.

In Italy, the legal classification of damages caused by AI-powered medical devices remains unsettled. A recent ruling by the Supreme Court, although not directly concerning AI, clarified that lower courts retain discretion to apply either the general tort regime (Art. 2043 Civil Code), the consumer product liability regime (Art. 114 Consumer Code), or the strict liability regime for dangerous activities (Art. 2050 Civil Code). The latter appears particularly pertinent for AI systems designated as “high risk” under the AI Act. Importantly, the Court emphasized that such discretion is bounded by the principles of legal certainty and systemic coherence. It expressly rejected the conflation of liability regimes, notably the erroneous application of the “development risk defence” (Art. 118 Consumer Code) within the framework of strict liability under Art. 2050.

In Germany, due to the withdrawal of the proposed AILD liability continues to be governed by general tort law (Sections 823 et seq. of the German Civil Code (BGB)) and the national Product Liability Act (ProdHaftG), both of which currently lack tailored provisions for AI systems. Notably, German civil procedure adheres to the principle of party-led evidence presentation, generally offering no presumptions of defectiveness or causality in favor of claimants. This poses considerable challenges especially in cases involving autonomous decision-making by AI—particularly in high-risk domains such as medical diagnostics, where establishing causation may be complex. The adopted PLD, however, explicitly extends its scope to digital products, including AI, and introduces enhanced liability standards. These include presumptions of defectiveness and causality and evidentiary facilitation mechanisms designed to ease the burden of proof in technologically complex cases.

Looking ahead, EU Member States, including Germany and Italy, are required to transpose the PLD into national law by December 2026. While the modalities of implementation remain open, national legislators are bound to uphold the Directive's minimum standards. This development places increased responsibility on courts and lawmakers to address liability gaps in the context of AI. In parallel, closer monitoring of emerging case law will be essential to assess the evolving risk landscape for developers and operators of AI-based medical technologies. The application of the PLD and the AI Act is expected to intensify litigation risks, particularly in the domains of medical devices, vaccines, and digital health. Economic actors will need to reconcile innovation with heightened regulatory and liability requirements, including stricter standards for product development, documentation, and governance.

Chapter 2 UK

The UK product liability regime must adapt to ensure it remains fit for purpose and can respond to the challenges posed by new technologies, including AI, and new global supply chains. The UK is progressing slower than the EU in this regard (with the EU's new PLD already having come into force, which seeks to address such issues – while the PLD applies to Northern Ireland, it does not extend to the rest of the UK following Brexit). However, the new Product Regulation and Metrology Act (which came into force in July 2025) does at least now empower the Secretary of State to make regulations in respect of product law in the UK and the UK Law Commission has announced a project to review the law relating to liability for defective products. So we will have to ‘watch this space' to see how the UK intends to approach product liability in the coming years and the extent to which it chooses to mirror or diverge from the new EU PLD. In addition, UK businesses that export to the EU must remain alive to the changes imposed by the PLD, to ensure they remain compliant with the EU PLD.

Similarly, the UK regulatory landscape needs to stay up to date and in this regard the UK's Medical Devices Regulations have recently been amended (with the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which came into force 16 June 2025) to strengthen UK post-market surveillance requirements for medical devices.

Chapter 3 U.S.

In the U.S., product liability litigation within the life sciences sector remains dynamic, shaped both by evolving regulatory standards and by an increasingly aggressive plaintiffs' bar. Key areas of activity include pharmaceutical labeling, failure-to-warn claims, and post-market surveillance conduct. Courts continue to refine the contours of federal preemption, particularly in litigation over FDA-approved drugs and devices. At the same time, courts are tightening scrutiny on causation and the admissibility of scientific evidence, with Daubert challenges increasingly decisive in large-scale pharmaceutical and medical device MDLs. Mass tort litigation also remains prominent, with plaintiffs leveraging emerging sources of digital data and corporate communications to advance novel liability theories. Notably, plaintiffs are also reframing traditional product liability allegations as putative consumer protection class actions, pursuing claims under state deceptive trade practices statutes to avoid individualized injury issues and to open the door to aggregate statutory damages.

Looking ahead, U.S. product litigation is likely to be shaped by both technological advances and evidentiary innovation. AI-enabled diagnostics and medical devices raise new questions around design, labeling, and the duty to monitor algorithmic performance over time. The recent Florida decision allowing a wrongful-death claim involving an AI chatbot to proceed demonstrates how courts are beginning to treat AI-driven platforms as actionable products when their outputs have tangible real-world consequences. In parallel, consumer protection statutes are emerging as a favored vehicle for challenging product marketing, safety representations, and labeling, even in cases that historically would have been pled under strict liability or negligence. And the growing use of real-world evidence in clinical validation and regulatory submissions may both strengthen regulatory approvals and expand the scope of post-market liability if signals of risk are overlooked. The convergence of regulation, innovation, and litigation will require careful navigation, particularly as courts and regulators seek to apply long-standing doctrines to fast-moving fields like digital health technologies and biologics.

Authored by Lauren Colton, Ina Brock, Christian Di Mauro, Matthew Felwick, Matthias Schweiger, Stefan Mayr, Benjamin Schulte, Lara Knight, Julie Schindel, Pietro Orlandi, and Viktoria Riederer.