In this, the Year of Our Lord 2025, that title could apply to so, so, so many things. Soooooo many things.
But this is the Drug and Device Law Blog, product liability is our niche, and what we are referring to is the new, 2024 European Union Product Liability Directive (the “PLD”), also known as Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024).
We have spoken and written about the issue before. And now we are starting to jump up and down to get attention on this.
Why the cause for alarm? Look at the litigation funding industry. Rumor has it that they are so excited about the new PLD, they already have set up camp in Amsterdam and London in anticipation of the disputes to come.
You may be thinking to yourself, I’ve defended mass torts in some of the most plaintiff-friendly jurisdictions in the U.S., how bad can it be?
How about not actually requiring proof of defect, particularly because the product at issue is a life-saving medical device:
Some products, such as life-sustaining medical devices, entail an especially high risk of causing damage to people and therefore give rise to particularly high safety expectations. In order to take such expectations into account, it should be possible for a court to find that a product is defective without establishing its actual defectiveness, where it belongs to the same production series as a product already proven to be defective.
PLD, at 19 (emphasis added).
How about holding subsequent remedial measures against manufacturers? The silver lining (?) is that subsequent remedial measure “should not in itself lead to the conclusion that a product is defective.” PLD, at 22, id. at 60.
How about a rebuttable presumption of defectiveness where a defendant has failed to comply with an “obligation to disclose information.” PLD, at 31, id. at 67 (“relevant evidence”).
How about a rebuttable presumption of defectiveness “in a case of obvious malfunction… since it is unnecessarily burdensome to require a claimant to prove defectiveness when the circumstances are such that its existence is undisputed” PLD, at 31, id.at 67. Obvious to whom? Undisputed by whom?
How about a rebuttable presumption of causation “[w]here it has been established that a product is defective” (maybe through one of the defectiveness presumptions above) “and the kind of damage that occurred is, based primarily on similar cases, typically caused by the defectiveness in question” because “the claimant should not be required to prove the causal link and its existence should be presumed.” PLD, at 32, 68. Should we call this the “you win one, you win them all rule” for plaintiffs?
Perhaps worst of all is the rebuttable presumption of both defectiveness and causation, which will arises just because the issues are hard:
National courts should presume the defectiveness of a product or the causal link between the damage and the defectiveness, or both, where, notwithstanding the defendant’s disclosure of information, it would be excessively difficult for the claimant, in particular due to the technical or scientific complexity of the case, to prove the defectiveness or the causal link, or both…. While a claimant should provide arguments to demonstrate excessive difficulties, proof of such difficulties should not be required.
PLD, at 33 (emphasis added); see also PLD, at 68.
And again, our clients’ essential products are called out as deserving of punishment through this evidentiary shortcut designed to lead straight to a liability finding:
Technical or scientific complexity should be determined by national courts on a case-by-case basis, taking into account various factors. Those factors should include the complex nature of the product, such as an innovative medical device.
PLD, at 33 (emphasis added).
Also mind-boggling are the rationales given for the new PLD. For example:
Liability without fault on the part of economic operators remains the sole means of adequately addressing the problem of fair apportionment of risk inherent in modern technological production.
PLD, at 2 (emphasis added). Really? How about the regulatory systems in place in the E.U. already? They work quite well for the pharmaceutical and medical device sectors. How about national health care programs that provide medical care to all without risk of personal bankruptcy or the inefficiency of litigation, and the already-existing possibility of recovery from pharmaceutical manufacturers, when necessary and if appropriate, by those national health care programs?
One very modest (very modest) beneficial (or at least not openly harmful) provision that we see in the new PLD is a sort-of regulatory compliance defense:
An economic operator . . . shall not be liable for damage caused by a defective product if that economic operator proves . . . that the defectiveness that caused the damage is due to compliance of the product with legal requirements.
PLD, at 69.
Another is the “state of the art” defense:
An economic operator . . . shall not be liable for damage caused by a defective product if that economic operator proves . . . the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered.
PLD, at 70. But don’t get too excited: individual E.U. nations can opt out of this one. PLD, at 79-80.
There is a lot more about the new PLD that warrants discussion.
For example, it isn’t only pharmaceutical and medical device manufacturers who are in the cross-hairs. If there is a nuclear accident, or you make free and open-source software, you are in the clear. PLD, at 4, 47. But other software, AI, digital manufacturing files (as for 3D printers), electricity, and raw materials are products falling within the PLD. See PLD, at 8, 49-50. And the new PLD applies to goods and related services. See PLD, at 11.
The new PLD was published in the Official Journal of the European Union on November 18, 2024.
EU Member States now have two years to “transpose” it into their national laws, i.e. by December 9, 2026, and the new PLD will apply to products put on the market in the EU after December 9, 2026.
In the coming months, we will continue to pick apart the new PLD—and continue to sound the alarm.