Defective By Design: Europe’s New Product Liability Rules Aim To Help Consumers Take On Powerful Manufacturers

For nearly four decades, Europe’s product liability rules remained largely unchanged. In October 2024, the European Union adopted a new Product Liability Directive, replacing a framework that had been in place since 1985. The aim is to bring consumer protection into the age of artificial intelligence, circular-economy business models and sprawling global supply chains. It also tackles a persistent problem: injured consumers have long struggled to prove their cases against manufacturers armed with superior technical knowledge and deep pockets.

The new rules, which apply to products placed on the market after December 9th, 2026, introduce several mechanisms designed to level the playing field between consumers and producers. For those harmed by faulty goods, the changes could mean the difference between winning compensation and going home empty-handed.

The Burden Of Proof

Claimants must still prove three things: that the product was defective, that they suffered damage, and that the defect caused that damage. That sounds simple enough. In practice, it has been anything but. Manufacturers typically know far more about how their products are made and how they work than the people injured by them. This information asymmetry has long stymied claims, particularly those involving sophisticated technology.

Show Your Workings

The directive’s most significant innovation is a beefed-up right to disclosure. Member states must ensure that defendants hand over relevant evidence in their possession, provided the claimant has presented facts sufficient to make their case plausible. That shifts some of the investigative burden onto those best placed to bear it.

The right is not unlimited. Disclosure must be necessary and proportionate, and courts must weigh the legitimate interests of all parties, including the protection of confidential information and trade secrets.

Courts may also require that evidence be presented in an accessible and understandable manner—a provision that should prove handy when dealing with complex digital products or impenetrable technical documentation.

Manufacturers cannot simply hide behind claims of commercial confidentiality. Where trade secrets are at stake, courts can take measures to preserve confidentiality - restricting access to documents, limiting who may attend hearings, or allowing only redacted materials. The goal is to balance legitimate business interests against consumers’ right to justice.

Presumed Guilty

The directive introduces several rebuttable presumptions that tilt the scales towards claimants. These let courts infer defectiveness or causation from other proven facts, while still allowing defendants to argue otherwise.

Faulty Until Proven Otherwise

A product is presumed defective in three situations: when the defendant refuses to disclose relevant evidence; when the product fails to comply with mandatory safety requirements intended to prevent the type of harm suffered; or when damage results from an obvious malfunction during normal use.

The first presumption gives manufacturers a powerful incentive to cooperate. Stonewalling now carries a hefty legal cost.

Connecting Cause And Effect

Once a product is established as defective, causation is presumed if the damage is of a kind typically consistent with that defect. If similar cases have shown that a particular type of defect typically causes a particular type of harm, claimants need not prove the link afresh.

The Complexity Defence

Most significantly, courts must presume defectiveness or causation, or both, when claimants face “excessive difficulties” in proving their case, particularly due to technical or scientific complexity. The claimant need only demonstrate that defectiveness or causation is likely.

What counts as excessive difficulty? Courts will decide case by case, weighing factors such as the complexity of the product (an innovative medical device, say), the technology involved (machine learning, for instance), the data requiring analysis, and the intricacy of the causal chain.

Crucially, claimants need only argue that they face excessive difficulties - they need not prove it. Someone injured by an AI system, for example, should not have to explain precisely how the system works or why its characteristics make causation hard to establish.

Levelling The Playing Field

The new directive marks a meaningful shift in the balance of power between consumers and manufacturers. By introducing robust disclosure obligations, multiple presumptions, and special provisions for technically complex cases, it gives injured parties a much better shot at proving their claims.

Several landmark cases illustrate the challenges the new rules seek to address. In Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt (C-503/13 and C-504/13, 2015), the Court of Justice of the European Union held that pacemakers and implantable cardioverter defibrillators belonging to a product group with a significantly higher than normal failure rate could be classified as defective without proof that the specific device implanted was itself faulty. In Sanofi Pasteur MSD SNC v OB (C-621/15, 2017), the Court ruled that national courts may use serious, specific and consistent presumptions to establish both defectiveness and causation in vaccine injury cases, even in the absence of scientific consensus—a precursor to the presumption-based approach now enshrined in the directive.