Subject: European Union

Significant Drug & Device Developments of 2025

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As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

Ten Things to Know About the European Union’s New Product Liability Directive

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After it was initially proposed more than two years ago, the European Union passed a new product liability directive (PLD) on Dec. 9, 2024, which prescribes a new legislative framework to expand and modify product liability laws created by the current PLD (originally enacted in 1985). As with other EU directives, the PLD sets legislative and policy goals that the EU’s 27 member states are obligated to implement into national law. For the PLD, they must do so within two years — by December 2026.

The new PLD was presented during the legislative phase as a modernization of pre-Internet Age laws from the 1980s. But beneath that exterior, the new PLD makes various substantive changes that are likely to increase litigation risk and costs for companies doing business in Europe. These changes will impact not only manufacturers of consumer products traditionally subject to product liability law, but also other businesses such as technology and software companies, which will be subjected to product liability law for the first time.

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New EU Product Liability Directive Published in Official Journal

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The countdown has begun towards the transformed European product liability landscape! The recently adopted European Union Product Liability Directive (PLD) was published in the Official Journal of the European Union today. Transposition of the PLD into domestic law of the EU member states must be completed by December 9, 2026. As we previously discussed, products put on the market after December 9, 2026, will be subject to the new PLD, while products placed on the market prior to this date will be subject to the laws currently in place.

Further information about the new PLD (including new risks and opportunities for businesses operating in the EU) can be found in our previous updates here and here. Faegre Drinker will continue to monitor developments as the member states transpose the PLD and the new rules take shape.

Affirmative Defenses; Collective Redress Directive; Discovery

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On October 10, the European Council adopted the European Union’s new Directive on Liability for Defective Products (PLD). The Council’s adoption of the new PLD represents a momentous step towards a complete restructuring of the EU’s product liability landscape as it will replace the current 40-year-old directive and soon become the EU’s new governing regime. The new PLD will enter into force 20 days after its publication in the Official Journal of the European Union. Thereafter, member states will have two years to transpose the directive into national law. Alongside the new Representative Actions Directive implemented last year, the product liability legal landscape is in the process of a great transformation in Europe.

Read the full article on the Faegre Drinker website.

FDA Publishes New Artificial Intelligence & Medical Products White Paper

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On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability Directive

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Last week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the elected European Parliament and the European Council (comprised of government representatives of the 28 member states) must agree on final language and separately pass the draft legislation through their respective bodies. After extensive legislative efforts and negotiations, the European Council (currently led by the Government of Spain) and the European Parliament issued press releases announcing that they have reached a political agreement regarding the proposed updates to the directive.

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