Subject: European Union

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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EU’s Proposed Product Liability Directive – More Trick than Treat?

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Americans love a good scare on Halloween.  But, of course – with ancient castles, centuries of folklore, and actual Transylvania, our friends in the European Union know how to celebrate the spooky season just as well as we do.  Unfortunately, there’s more than ghost stories to send a shiver down your spine in the EU these days.  This month, a joint committee of the European Parliament voted on new amendments to the proposed “digital age” update of the Product Liability Directive, which was initially enacted in the 1980s.  On the one hand, the proposal seems like a treat with its efforts to modernize the product liability framework to account for the changing product landscape and to address access issues for consumers.  But many European business leaders caution that this is more trick than treat.  Among other things, there are concerns that the traditional burden of proof requirements and safeguards on evidentiary disclosures will vanish into thin air.  Concerns abound that the proposals won’t benefit consumers or industry, but rather lawyers and litigation funders.  Scary stuff, indeed.

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Enforcement of Representative Actions is Here

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It’s finally here.  Enforcement of the Collective Redress / Representative Actions Directive (RAD) in the EU has now begun.  At this time, six member states have adopted a national translation of this law and nineteen states are engaged in ongoing discussion and drafting.  The landscape is changing rapidly and our team is tracking these developments.

Are you ready for this shift in litigation culture?  Backed and supported by the growing EU third party litigation funding industry, the RAD will provide an unprecedented procedural mechanism to bring class and consumer actions on a mass scale against EU traders.  These actions can be premised upon one or more of 66+ substantive regulations that cover everything from the finance industry to environmental regulations to product and artificial intelligence liability.  If you have not prepared, now is the time.

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