Product Risks Today: Implications of implementing the new Product Liability Directive for Pharmaceutical Liability in Germany

Introduction

In Germany, product liability for the pharmaceutical and medical sector is shaped by a dualist framework: the Medicinal Products Act (MPA) covering liability for pharmaceuticals on the one hand, and the Product Liability Act (PLA) covering liability for medical devices on the other. Historically, liability under the MPA has been considerably stricter than the liability under the PLA. However, with the introduction of the new EU Product Liability Directive (PLD) and the ensuing national legislation to implement the directive, products other than pharmaceuticals will become subject to considerably higher liability standards, including enhanced procedural mechanisms such as disclosure obligations and rebuttable presumptions regarding defect and causation. As a result of these increasingly strict standards, companies marketing products which fall under the new PLA will be exposed to a higher litigation risk arising from future liability claims. 

The German Ministry of Justice presented its draft bill to transpose the PLD in September 2025, and the government passed the largely unchanged draft on 17 December 2025 (Draft Bill). According to Section 21(1) Draft Bill, the Product Liability Act will not apply to pharmaceuticals, confirming that the dualist system will remain in place. However, this is not the case in other European Member States where pharmaceuticals do fall in the scope of strict product liability and it remains to be seen whether the German legislator will eventually align the MPA with the PLA.

The dual system of product and pharmaceuticals liability in Germany

The evolution of liability for pharmaceuticals was profoundly shaped by the Contergan incident of the 1950s. In its aftermath, the German legislator enacted the MPA in 1961, introducing a strict no-fault liability regime for pharmaceuticals (Sec. 84 et seq. MPA) to close perceived liability gaps.

Almost fifteen years later, the EU established harmonised product liability standards through Directive 85/374/EEC, implemented in Germany via the PLA. Intending to safeguard Germany’s unique approach to pharmaceutical liability, Article 13 of the Directive expressly allowed existing special national liability rules to remain in place, thus entrenching a dual system of liability that continues today.

Accordingly, different liability regimes apply to medicinal products on the one hand and medical devices on the other. The MPA applies exclusively to human medicinal products subject to regulatory approval and dispensed to consumers, while the PLA governs liability for all other medical devices (e.g., implants, technical equipment), veterinary medicinal products, and products outside the MPA approval requirement. Section 15(1) PLA explicitly excludes from its scope medicinal products falling under the MPA, establishing exclusive applicability of either the MPA or the PLA.

The MPA in the PLD era

The new PLD and the new PLA substantially expand both scope and liability standards and pursue a strict harmonisation of product liability law in the EU (Article 3 PLD). Naturally, this raises the question whether the MPA and its mutually exclusive relationship with the PLA will continue to persist after the implementation of the European reform. The answer is yes: Article 2(4)(d) PLD expressly preserves national liability regimes predating July 1985, including Germany’s MPA. Recital 10 PLD further clarifies that such special national liability systems for medicinal products remain permissible and only amendments are subject to the condition that they do not undermine the effectiveness or objectives of the PLD. 

Consequently, the Draft Bill provides for an almost exact replica of Section 15(1) of the current PLA in Section 21(1) Draft Bill. Furthermore, the FAQs published by the Ministry in December 2025 explicitly state that pharmaceuticals remain out of scope of the PLA. Despite the extensive substantive and procedural expansion of liability in the PLD, there is no indication that the legislator currently considers amendments to the MPA.

PLD standards exceeding the MPA

The PLD introduces sweeping changes that set a higher standard than the MPA. These new standards are also reflected in the corresponding provisions in the Draft Bill:

• Wider circle of liable parties: While Section 84 MPA focuses on the pharmaceutical company that places the product on the German market, the PLD also covers component manufacturers, importers, fulfilment service providers, significant modifiers, suppliers, and (under certain conditions) online marketplace operators (transposed in Sections 4(1), 5(1), 10-13 Draft Bill).
• Broader material scope: The MPA covers in Section 84 only death and substantial injury to the body or health, whereas the PLD extends to all kind of personal injury, property damage and even introduces liability for certain data losses (Section 1(1) Draft Bill). While the latter is unlikely to be of great significance for the pharmaceutical and medical sector, the lack of liability for less serious personal injuries for medicinal products under the MPA falls short of the level of protection provided by the PLD.
• Alleviated evidentiary requirements: The PLD establishes rebuttable presumptions for a product to be defective (e.g. in case of obvious malfunction, breach of mandatory safety requirements, or failure to disclose relevant evidence, transposed in Section 20 Draft Bill). In addition, the PLD allows courts to presume both defect and causation if the claimant faces particular difficulties due to technical or scientific complexity or can show that defect or causation is likely.
• Disclosure of evidence: The PLD introduces extensive rules on the disclosure of evidence. Both claimants and defendants can request the court to order the disclosure of relevant evidence from the parties to support or defend against the claim, provided they make this request plausible with supporting facts or evidence (Section 19 Draft Bill).
• No liability caps: The MPA sets strict liability caps (Section 88 MPA). The new PLD, however, abolishes such liability limits, increasing potential financial exposure for producers.
• Extended limitation period: Both the MPA and the PLD provide for a similar three-year limitation period based on knowledge of the circumstances giving rise to the claim and a maximum limitation period of ten years, commencing either on the date the product was put into circulation (PLD) or the damage occurred (MPA). However, the PLD introduces a notable extension for cases involving latent personal injuries, allowing claims to be brought within 25 years of the product's circulation (Section 17(3) Draft Bill). Notably, the ten-year extinction period under the old liability law was under scrutiny for progressive injuries, but in case C-338/24 (Sanofi Pasteur), the ECJ upheld its validity, rejecting the Advocate General's proposal to declare it invalid where victims cannot fully assess their damage within that period. 

MPA provisions exceeding the PLD

Conversely, the MPA continues to provide claimant advantages beyond those in the PLD. Most notably, Section 84a MPA grants a direct right to information not only from manufacturers but also from regulatory authorities, covering even abstract risk and suspicion data – going well beyond the PLD’s disclosure rules. The MPA also provides a broader presumption of causation: it is sufficient that a medicinal product was merely capable of causing the damage, and manufacturers are largely prevented from rebutting this presumption by pointing to alternative causes. By contrast, the PLD (Art. 10(3)) requires that the harm be “typically consistent” with the defect in question, making causation harder to prove. In addition, the MPA offers narrower liability exemptions and imposes a compulsory insurance requirement (Sec. 94).

Conclusion

The current Draft Bill clearly shows that Germany’s dualist system of pharmaceutical liability will remain in place, even after the PLD is implemented into the PLA. The MPA will remain a separate, specialized regime that is in some aspects less stringent and in some ways stricter than the general product liability framework. While future amendments to incorporate select, more stringent PLD elements cannot be ruled out, there is no sign of such changes at present. In any event, pharmaceutical companies operating in Germany will continue to face one of Europe’s most demanding liability frameworks.