Having clerked for a federal district judge and cut our litigation teeth in MDLs, federal court practice has burrowed deep. When we think of procedural issues, our brains reflexively think in FRCP terms, and sometimes in state court the mental shift takes a beat.
Most of the time, it is a pretty short beat. Sometimes, say in Louisiana or Pennsylvania state court, when they start throwing around the “dilatory exceptions” and “praecipes”, that beat takes a tad longer. Things are similar but not quite the same.
Now think about product liability litigation in the U.S.—the general substantive legal principles we work with daily, as well as the broader litigation framework entailing document discovery, depositions, dispositive motion practice, the whole enchilada.
It would be a mistake to take a brain stewed in the U.S. product liability milieu over to the European Union and not pause it to think through whether E.U. discussions of “strict liability” or “disclosure” or even “presumptions” mean what we think they do.
We bring this up now because the new E.U. Product Liability Directive (aka “E.U. PLD” or Directive (EU) 2024/2853) will replace the nearly 40-year-old Product Liability Directive 85/374/EEC and take effect in less than 3 months, on December 9, 2026.
Once it takes effect, all of us in the U.S. may do well to take a beat and figure out if the Directive’s language and procedures really mean what one might assume on first glance.
As an initial matter, we talk about “the” Directive, but it isn’t really one thing. We rely on the English version of the E.U. PLD because we are essentially monolingual, but the European Union’s Official Journal has published the Directive in all E.U. languages, so the Polish version might be your touchstone for the E.U. PLD, or the Portuguese. It’s a fair guess that there may be significant differences amongst the various translations, and no one version is more authoritative than the others. That alone presents a definite opportunity for definitional arbitrage.
Then there is transposition. Each E.U. member nation is obliged to transpose the Directive into national law by December 9, 2026. A few have done so, and those presumably were able to figure out where the Directive best fit into their existing national law (both substantive and procedural) and had time to think through and resolve potential conflicts and inconsistencies. Others have just started, and yet other countries have not yet begun (see here for a tracker regarding implementation). The procrastinators likely will have no time to attend to where the Directive may create ambiguities or problems with laws already in force. The point being that the E.U. Product Liability Directive may be a pretty clunky fit with existing national law in any particular country, so particular member states’ transposition laws are another place to look for differences and distinctions that may work to a defendant’s advantage once litigation commences under the new regime.
Turning back to the language of the E.U. PLD itself (English version), we cannot stress this enough: The E.U. set out to increase the number of lawsuits, increase the number of product liability claimant victories, and increase the monetary recoveries, and they designed legislation to accomplish those goals.
But while we are confident that the E.U. PLD will increase the number of lawsuits, we also think that whether the E.U. PLD meets the rest of the drafter’s stated goals will turn on the vigorousness of the defense once litigation begins. That means not giving in to quick glosses on, or AI summaries of, the various E.U. PLD provisions (in whatever language you are litigating in). The Directive itself has inconsistencies and knowing these exist will allow the unfortunate first few defendants to argue for the best possible version of conflicting language.
For example, take the term “defect.”
If you are in the U.S., you hear the term defect and you immediately wonder, manufacturing, design, or warning? Under the E.U. PLD, there is just “defect” and no sub-categories.
Do good warnings help a defendant avoid a finding of defect under the E.U. PLD? No. Or, maybe. Yes, definitely?
In one place, the drafters declare that “warnings or other information provided with a product cannot be considered sufficient to make an otherwise defective product safe.” See Whereas Para. 31. On the other hand, Article 7(2) declares: “In assessing the defectiveness of a product, all circumstances shall be taken into account, including: (a) the presentation and the characteristics of the product, including its labelling….” Right there is one gap, and we’d fight for the Article precluding a finding a defect because of good labeling, and a rejection of the inconsistent (and incomprehensible) prefatory language.
The standard for “defect” presents other openings for the defense as well.
Under Article 7(1): “A product shall be considered defective does not provide the safety that a person is entitled to expect or that is required under Union or national law”. (Set aside the first part for a minute, but let’s not assume it automatically signifies a U.S.-style consumer expectations test).
Look at the second part, “safety…that is required under [E.U.] or national law.” It is written in a one-way fashion—non-compliance equals defect.
But there are cracks. Article 7(2) makes “relevant product safety requirements, including safety-relevant cybersecurity requirements” one of the “all circumstances” taken into account in “assessing the defectiveness of a product”. That’s good. Article 10(2(b) makes defectiveness a presumption upon the claimant’s demonstration “that the product does not comply with mandatory safety requirements laid down in Union or national law that are intended to protect against the risk of the damage suffered by the injured person.” That’s less good.
But which is it? If we are representing the defendant facing this word salad (in whatever language, and through and with qualified local counsel of course) we might decide to take a run at just arguing that Article 7(1) contains an implicit, and automatic, regulatory compliance defense that Articles 7(2) and 10(2)(b) do not foreclose.
The infamous E.U. PLD presumptions provide additional openings for defendants to try to take back some ground. Even within the U.S., how presumptions work is always a complicated matter. They might help a plaintiff survive a dispositive motion and then disappear for trial purposes, they might form part of a jury instruction, they might be rebuttable, or not, or something else.
We are guessing here, but we suspect that most E.U. member nations do not have a well-established and developed practices regarding the effect and operation of presumptions, so defendants should have a real opportunity—country to country, judge-by-judge—to advocate for what these presumption parts of the E.U. PLD mean, and how they should function.
And the presumption provisions (Article 10) are particularly messy and confusing.
Article 10(2) says a product is presumed defective where:
- (a) The defendant fails to comply with Article 9(1), newly requiring defendants to cough up evidence;
- (b) The claimant demonstrates that the product does not comply with mandatory safety requirements under E.U. or national law (as noted above); or
- (c) The claimant demonstrates that the damage was caused by an “obvious malfunction” of the product during reasonably foreseeable use or under ordinary circumstances—whatever that means.
Article 10(3) says that a causal link between defectiveness and damage is presumed where the product has been established as defective and the damage is “of a kind typically consistent with the defect in question”. Again, whatever that means.
Article 10(4) says that where, despite disclosure of evidence, the claimant faces “excessive difficulties, in particular due to technical or scientific complexity,” in proving defectiveness or the causal link, the court shall presume defectiveness, causation, or both — provided the claimant “demonstrates” it is likely that the product was defective or that there is a likely causal link.
Frankly, we think these all are awful. But nothing about these presumptions is self-apparent, and so every term, every phrase, presents an opportunity to imagine what they could mean, or should mean, under this entirely new regime. Why litigate Article 10(2)’s “obvious malfunction” as some form of U.S.-style res ipsa loquitur when the Directive’s “obvious malfunction” is so undefined that it calls for some new definition of its own? At most, the drafters gave “a glass bottle that explodes in the course of reasonably foreseeable use” (Whereas para. 46) by way of explanation, but that hardly answers the question of what “obvious malfunction” means. Maybe “obvious malfunction” in the E.U. PLD means the claimant must come forward with proof that the product deviated from its manufacturing specifications in a way that caused it to work improperly and caused harm. We could live with that.
There are more E.U. PLD inconsistencies, ambiguities, and internal tensions worth exploring and defining for the better. Additional ones include:
- The “excessive difficulties” presumption standard of Article 10(4), which is utterly vague. The Directive states that a claimant who “demonstrates” excessive difficulties in proof gets a presumption of defect, causation, or both. What does “demonstrate” mean? Article 10(4) does not say, but the prefatory language suggests it won’t take much—elsewhere the Directive says the claimant “should provide arguments to demonstrate excessive difficulties” but that “proof of such difficulties should not be required.” (Whereas, para. 47). We see no reason to roll over on the proof of requirement, particularly because the concept of “technical or scientific complexity” is left entirely to case-by-case judicial interpretation.
- Article 3 mandates “maximum harmonization” in that E.U. countries “shall not” diverge from the Directive. But at the same time, national law and each country’s judicial system provides an overlay that will help determine the standard of proof for the claimant’s prima facie case, rules on calculating compensation and damages (including “non material” damages like pain and suffering), how the disclosure requirements work, and procedural rules for bringing claims.
- The “development risk defense”, which countries are expressly allowed to reject or modify pursuant to Article 18.
All of the above thoughts go to things to think about once the Directive takes effect and the first lawsuits are filed under it. You have 76 days left until then, and the action items for now remain the same:
- Audit your supply chain to figure out who is an economic operator subject to liability the Directive;
- Review and update any indemnification, distribution, and software integration agreements;
- Review and update any product liability insurance coverage for E.U. activities;
- Audit regulatory compliance and systems;
- Prepare for new disclosure obligations by reviewing document and data creation and retention practices, and consider both the GDPR and the Directive’s provisions about “excessive difficulties” of proof; and
- Look closely at software components and digitally-connected products, including lifecycle management and expectations for updates under the Directive.
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