Voluntary withdrawal does not imply that the product is defective

One of the first points made by the Court is that the mere voluntary withdrawal of a product from the market does not, in itself, constitute proof of its defective nature.

Safety measures such as the withdrawal of the product by a regulatory authority or by the company responsible may be taken into account by the court when assessing whether a product is defective. However, these actions should not, on their own, give rise to an automatic presumption of defectiveness. Their assessment must always be made in conjunction with the other circumstances and evidence of the specific case.

The existence of judicial precedents concerning the product

The Court also recalls that, when deciding on the alleged defective nature of a product, other judicial proceedings are not conclusive, even if they concern the same product.

Although precedents may be taken into account as one factor in the overall analysis, they do not by themselves determine whether the product is defective. Each proceeding must be resolved based solely on the evidence presented in that specific case and on the litigation strategy followed by each party.

In this regard, the Court emphasises that only evidence that is included in the case file and has been validly submitted within the framework of the proceedings in question is relevant.

The importance of clarifying that the product’s failure was not due to a defect

Finally, it is worth highlighting an additional consideration that emerges from the Judgment: the importance of identifying possible causes other than the alleged defect that may have contributed to or caused the damage claimed.

In this case, the Court considers that if it is not possible to clearly determine the cause of the damage, or reasonably rule out other explanations, the product may be considered defective by resorting to indirect evidence or even presumptions.

Conversely, if it can be demonstrated that the damage was caused by external factors unrelated to the product’s design or manufacture – such as incorrect use, improper handling, or lack of maintenance – such presumptions of defectiveness may be rebutted.

Evidentiary challenges and the impact of the new Directive

Overall, the Judgment underscores the central role of evidence in product liability claims.

As noted, the deadline for transposing the new Product Liability Directive expires at the end of this year, introducing significant changes to the evidentiary framework and the allocation of the burden of proof.

In order to assist claimants in proving their case, the new Directive establishes a number of evidentiary rules that must be carefully considered and that make it advisable for companies to adopt measures aimed at avoiding presumptions of defectiveness.

The new Directive allows courts to order the defendant to disclose relevant documents – even confidential ones – to enable the claimant to substantiate their case. If the defendant fails to comply with such a disclosure order, a presumption that the product is defective may arise.

Furthermore, courts may presume defectiveness in three additional situations:

i. where the product fails to comply with applicable safety requirements;

ii. where the damage results from an obvious malfunction during normal use; or

iii. where, considering all relevant circumstances, the claimant faces excessive difficulties due to technical or scientific complexity in proving the defectiveness of the product, or provided the claimant demonstrates that it is likely that the product is defective.

These rules may, in practice, lead to a partial reversal of the burden of proof, requiring manufacturers and suppliers to demonstrate that their product was not defective. This makes it essential to comply with any court-ordered disclosure, to maintain documentation evidencing regulatory compliance, and, where appropriate, to provide evidence of the product’s proper functioning under normal conditions.
For all these reasons, it is advisable to maintain documentation and records relating to product design and development, safety testing, manufacturing processes, storage conditions and quality control in a systematic and organized manner, as well as complete and traceable product file documentation. In addition, having protocols that facilitate compliance with any document disclosure request may be highly useful.

La entrada The value of evidence in claims for damage caused by a defective product aparece primero en Faus Moliner.

Non-absolute strict liability regime

The system will remain based on a regime of non-absolute strict liability. Liability is deemed strict because the injured party is not required to prove fault or negligence on the part of the producer or distributor. However, it is not absolute, as the obligation to compensate arises only if the product alleged to have caused the damage is deemed “defective”.

A clearer defective product concept

The new directive maintains the concept that a product is defective if it does not offer the safety that can legitimately be expected of it. However, with its new wording it aims to dispel some interpretative doubts.

Firstly, the new directive clarifies that “A product shall be considered defective when it does not provide the safety that a person is entitled to expect or that is required under Union or national law“. This clarifies that the safety that can be expected from a product is that required by EU or national law, disassociating the concept of defect from any subjective assessment that a particular person makes of the safety of the product.

This is particularly significant in the field of medicinal products, where the rigorous and exhaustive regulations governing them at European and national level stipulate that:

(i) the safety of a medicinal product is a relative concept that can only be assessed in relation to its efficacy and the benefit it provides; and

(ii) medicinal products are considered safe if, under normal conditions of use, they do not produce toxic or undesirable effects disproportionate to the benefit they provide (ex. Article 10 of Royal Legislative Decree 1/2015).

This clarification serves to provide greater legal certainty in the analysis of the defectiveness of medicinal products. A medicinal product may not be classified as defective if, under normal conditions of use, it has not produced a toxic or undesirable effect disproportionate to the benefit it provides.

Secondly, the safety that an individual is entitled to expect from a product must be assessed by considering all relevant circumstances surrounding the product and its placing on the market. This requirement was already included in the previous regulation; however, the new directive extends the list of circumstances that may be considered when conducting this assessment to include the following:

(i) The presentation and characteristics of the product, including its labelling, design, technical features, composition and packaging, and instructions for its assembly, installation, use and maintenance. These have been very relevant circumstances in the field of medicinal products and medical devices.

(ii) The reasonably foreseeable use of the product.

(iii) The effect on the product of any ability to continue to learn or acquire new features after it is placed on the market or put into service.

(iv) The reasonably foreseeable effect that may be caused by other products that are expected to be used with the product (also by interconnection). This was one of the criteria used by the High Court of Justice of the Canary Islands in its judgment of 14 December 2023 to determine that the damage caused to a patient during a cataract operation was not caused by an alleged defect in the FACO equipment used during the operation but by an incorrect use of the equipment.

(v) The moment in time in which the product was placed on the market. This is the relevant point in time for determining whether a product offers the safety to be expected (see the CJEU judgment of 21 June 2017, Sanofi Pasteur MSD, C-621/15 or the Supreme Court judgment of 1 March 2021).

(vi) Relevant product safety requirements (including cybersecurity requirements). In the case of medicinal products, this has been a highly valued element by the courts when analysing their adequate safety (for example in the judgments of the Supreme Court of 28 May 2012, 6 June 2012 or 18 June 2013, in relation to Agreal®; the judgments of the Provincial Court of Madrid of 10 February 2009 and 4 May 2011, in relation to the Viox® case; the Judgment of the National Audience of 10 July 2019 in the Gardasil® and Cervarix® cases; Judgment of the Audiencia Provincial de Madrid of 24 November 2011 in relation to Zyprexa® or the Judgment of the Provincial Court of Madrid of 4 May 2011 in relation to Nolotil).®

(vii) The recall of the product and other interventions made by a regulatory authority or an economic operator responsible for the product in relation to its safety. These circumstances have also been taken into account by the courts when analysing cases on medicinal products and medical devices (see the judgments of the Provincial Court of Madrid of 10 February 2009 and 4 May 2011, in relation to the Viox® case or the judgments of the Supreme Court of 9 December 2010, on Trilucentis breast prostheses®, and of 1 March 2021, in relation to ASR hip prostheses; the Judgment of the Provincial Court of Madrid of 30 December 2013 in relation to certain batches of Levothorid® or the recent Judgment of the Provincial Court of Barcelona of 9 May 2024 in relation to certain batches of Novaplus IUD®). However, these interventions, as stated in the explanatory memorandum of the new directive, should not in themselves create a presumption of the defective nature of the product.

(viii) The specific needs of the group of users for whom the product is intended. This circumstance was introduced by the CJEU in its judgment of 5 March 2015, Boston Scientific Medizintechnik, C-503/13 and C-504/13, when addressing the circumstances that may serve to specify the legitimate expectations of the general public.

(ix) In the case of a product whose very purpose is precisely to prevent damage (as stated in the explanatory part of the directive, e.g. a warning mechanism such as a smoke detector), the possible non-fulfilment of this purpose by the product.

Finally, like the previous regulation, the new directive establishes that in no case will a product be considered defective because a better product or an improved or updated version of it is subsequently placed on the market

With regard to this last element, it should be recalled that, in the field of medicinal products, the information provided in the summary of product characteristics and the package leaflet is regularly updated on the basis of the latest available data. Thus, a medicinal product that at the time it is marketed is not considered defective will not cease to offer the “safety that can legitimately be expected” simply because its summary of product characteristics and package leaflet are updated at a later date, including, for example, new warnings, risks or adverse effects (see the judgment of the Barcelona Provincial Court of 18 April 2008 in relation to Agreal® or the judgment of the Madrid Provincial Court in its judgment of 24 November 2011, in relation to Zyprexa®).

New liable economic operators

The directive extends the list of liable parties. In the case of products whose manufacturer is established outside the EU, the importer and also the manufacturer’s authorised representative will be liable.

The distributor of the product (and the provider of an online platform allowing consumers to conclude distance contracts with traders) may also be liable if, after receiving a request from a consumer, the distributor fails to identify, within one month, the economic operator established in the European Union who should be liable.

Where two or more economic operators are liable for the same damage, the injured party may claim compensation from any one of them. The operator who is jointly and severally liable for compensation shall be entitled to recourse against the other liable economic operators.

Measures in relation to evidence

The burden of proving the defectiveness of the product, the damage suffered and the causal link between the defect and the damage shall remain on the claimant.

However, in order to facilitate the claimant’s evidentiary task in complex cases, the new directive establishes the following measures that represent relevant developments in this area:

a) Disclosure of evidence by the parties

A claimant who submits sufficient facts and evidence on the plausibility of the claim may request the courts to order the defendant to produce relevant evidence at his disposal which the claimant considers necessary to support the claim. The defendant may also make such a request in relation to evidence in the possession of the claimant, where the defendant submits sufficient facts and evidence on the necessity of access to this evidence in order to be able to oppose the claim.

Courts shall ensure that such discovery between the parties is limited to necessary and proportionate matters, taking into account the legitimate interests of all persons concerned, and in particular the protection of confidential information and business secrets.

This measure marks a significant innovation in the Spanish procedural system, which is based on the principle that each party must provide the evidence it holds. Only in exceptional circumstances is it permissible for one party to request the disclosure of documents held by the other party.

b) Burden of proof

The product shall be presumed to be defective if the defendant refuses to disclose the evidence requested by the court.

Defect shall also be presumed where the claimant proves that:

(i) the product does not comply with the mandatory safety requirements laid down in the applicable regulations; or

(ii) the damage was caused by an obvious malfunction of the product during use under ordinary circumstances.

In addition, a causal link between the defectiveness of the product and the damage shall be presumed where it has been established that the product is defective and that the damage caused is of a kind typically consistent with the defect in question.

Finally, the court may also presume product defectiveness or causal link, or both, where, considering all the relevant circumstances of the case:

(i) the claimant faces excessive difficulty, due to technical or scientific complexity, in proving the product defect or the causal link, or both; or

(ii) the claimant demonstrates that it is likely that the product is defective or that there is a causal link between the defectiveness of the product and the damage, or both.

In any such case, the defendant shall have the right to rebut these presumptions by presenting counterevidence.

Limitation and expiry periods

The limitation period for bringing product liability actions will continue to be 3 years. As a novelty, the new directive establishes some modifications regarding the rules for its computation: the limitation period will start to run from the day on which the injured party becomes aware (or should reasonably have become aware) both of the damage and of the defective nature of the product, as well as of the identity of the economic operator who may be held liable. This limitation period may be interrupted in accordance with the applicable rules of national law.

On the other hand, the 10-year expiration period remains in force. Once this period has elapsed since the product was placed on the market, claims for damages cannot be brought. However, this period is extended to 25 years for claims for damages that become apparent after these 10 years have elapsed due to the latency of the injury caused.

Global liability and limits or exclusion of liability

Another important novelty is that the new directive removes the possibility for Member States to set an overall monetary limit of liability per product of the same kind with the same type of defect. Member States will also have to ensure that the liability of economic operators under the new directive cannot be excluded or limited, vis-à-vis the injured party, by a contractual provision or by national law.

Temporal application and level of harmonisation

The rules that Member States must adopt to comply with the new directive will apply to products placed on the market or put into service on or after 9 December 2026.

Member States may not maintain or introduce, in their national law, more or less stringent than those laid down in the new directive in order to achieve a different level of protection of injured parties, unless they are expressly authorised to do so by the new directive.

La entrada New features in product liability framework aparece primero en Faus Moliner.

Apparent producer concept

One of these concepts is that of the apparent producer of a product.

Legislation defines an apparent producer as an economic operator who, without actually being the producer of a product, presents himself to the market as its producer, by putting his name, trade mark or other distinguishing feature on the product.

The apparent producer of a defective product is just as responsible as the producer and, therefore, it is important to clearly define the characteristics to identify it.

To be presented as producer

The judgment analyses the claim made in relation to a prosthesis that was implanted in the claimant.

The claimant filed the lawsuit against a distributor of the product to whom, however, he attributed the status of apparent producer. The claimant did so despite knowing that this company had only acted as a distributor of the product and that the producer was another company within its group of companies.

The Provincial Court dismissed the claimant’s claim and emphasized that merely having a company’s name, brand or distinctive sign on the product packaging is insufficient to establish it as an apparent producer. The company must identify itself as the producer of the product, even if it is not actually the producer.

The mere mention of the company name, trade mark or other distinctive sign on the product, without more, is not sufficient to confer the status of apparent producer.

Reference to the companies’ group trademark

Additionally, the Provincial Court recalls that, if the prosthesis label and packaging indicate that the producer is part of a corporate’ group, this information cannot be used to sue another company of within the same companies’ group which presents itself to the market only as a distributor of the product.

Consequently, the figure of the apparent producer cannot be used to file a claim against the distributor of a product on the grounds that it belongs to the same corporate group indicated on the label and packaging of the product.

La entrada Who is the apparent producer? aparece primero en Faus Moliner.

Purpose of the proposal and main features

The proposal aims to address a number of shortcomings identified by the Commission in the application of the rules that have been in place for the past decades. It seeks to ensure that product liability rules adapt to the nature and risks of products in the digital age and the circular economy.

The system will continue to be based on a strict liability regime, where the burden of proof lies on the claimant to prove the defectiveness of the product, the damage suffered and the causal link between the defect and the damage.

However, the proposal aims to make it easier for the claimant to prove the defect, the damage and the causal link. To this end, it will facilitate access to evidence and introduce presumptions in favour of the claimant.

Let’s explore some of the key changes in the proposal.

A clearer concept of defective product

The test for determining whether a product is defective will remain substantively the same. A product is defective if it does not provide the safety which the public at large is entitled to expect, taking all circumstances into account.

However, in order to clarify the concept, the proposal extends the non-exhaustive list of circumstances  to be considered when assessing defectiveness. These include, for example, (i) the presentation of the product (including its instructions for use); (ii) the reasonably foreseeable use and misuse of the product; (iii) product safety requirements; (iv) any intervention of by a regulatory authority or an economic operator responsible for the safety of the product. As in the previous regulation, the proposal provides that in no case shall a product be considered defective because a better product or an improved or upgraded version of the product is subsequently placed on the market.

In this way, the proposal aims to clarify the concept of a defective product. In the field of medicinal products and medical devices, this greater clarity may be beneficial in order to put an end to unsubstantiated claims relating to off-label use of a product or relating to a risk or adverse effect that is duly warned in the package leaflet or in the SmPC.

Measures to facilitate evidence

In order to make it easier for the claimant to prove the defect and the causal link in complex cases, the proposal presents a new system of access to evidence and presumptions of proof.

a) Disclosure of evidence by the defendant

An injured party who presents facts and evidence sufficient to support the plausibility of their claim for compensation may ask the court to order the defendant to disclose relevant evidence that is at its disposal, or produce it, which may be necessary to support the claim.

b) Presumptions of evidence

The product is presumed to be defective if the defendant refuses to disclose or produce evidence accepted by the court. The product is also presumed to be defective if the claimant proves that the product does not comply with the mandatory safety requirements set out in the applicable regulations; or if the claimant proves that the damage was caused by an obvious malfunction of the product during normal use.

The causal link between the defectiveness of the product and the damage is presumed if it is established that the product is defective and that the damage caused is of a kind typically consistent with the defect in question.

Finally, if a court considers that the claimant faces excessive difficulties , due to technical or scientific complexity, to prove the defectiveness of the product or the causal link, or both; the defectiveness of the product or the causal link, or both, shall be presumed if the injured party has proved the probability that the product is defective or that its defect is a likely cause of the damage, or both.

The defendant will be entitled to contest both the existence of excessive difficulties and the referred likelihood.

The defendant is also entitled to rebut any such presumption by providing evidence of the suitability of the product or the absence of a causal link between the alleged defect and the damage.

The defendant’s defence

The defence in a product liability case is usually based primarily on proving that the product was not defective because it offered the safety that could reasonably be expected, taking all circumstances into account.

The assessment of defectiveness should involve an objective analysis and should relate not to the safety that a particular person is entitled to expect, but rather to the public at large. For this purpose, the intended purpose of the product, its objective characteristics and properties and the specific needs of the target group of users should be assessed. In the case of medicinal products and medical devices, it can be argued that a product offers the safety that can reasonably be expected if the benefits of the product outweigh its risks and it has been authorised (which proves that society is prepared to place such a product on the market despite its risks because of the benefits it offers).

A second possible argument is that the alleged damage was not caused by the alleged defect in the product.

Furthermore, the defendant will not be liable for damage caused by a defective product if it can prove that:

• in the case of a manufacturer or importer, it has neither placed the product on the market nor put it into service;

• in the case of a distributor, it has not commercialised the product;

• that the defect which caused the damage was probably not present when the product was placed on the market or put into service or, in the case of a distributor, when it was commercialised, or that the defect occurred after that date;

• that the defect is due to the fact that the product conforms to mandatory regulations issued by public authorities;

• that the objective scientific and technical state of the art at the time when the product was placed on the market or put into service, or during the period when the product was under the control of the manufacturer, did not allow the discovery of the defect;

• in the case of the manufacturer of a component, that the defectiveness of the product is attributable to the design of the product in which the component is incorporated or to the instructions given by the manufacturer of the product to the manufacturer of the component; or

• in the case of a person who modifies a product, that the defect which caused the damage relates to a part of the product not affected by the modification.

La entrada Something is going on in product liability aparece primero en Faus Moliner.

In today’s globalised world, it is increasingly common to see claims for damages allegedly caused by defective products being filed with little precision. In many cases, the corporate group to which the manufacturing company belongs is sued as a diffuse entity. In other cases, a specific company of the group is sued, despite not being the manufacturing company.

This is clearly not the correct way to proceed. According to the judgment of the Supreme Court of 18 January 2021, these practices are not compliant with the law.

The general rule and its exceptions

The Supreme Court begins by recalling that, in our legal system, the general rule is to respect the concept of separate legal personality of companies, this meaning that:

(i) each company is only liable for the fulfilment of the obligations it assumed as well as those arising from its own actions;

(ii) belonging to a corporate group does not entail that a company may be held liable for acts carried out by other group companies.

Although the doctrine of veil piercing allows the plaintiff to sue a company other than that which performed the acts leading to the alleged damage, this is only possible on an exceptional basis.

In order to apply such veil piercing doctrine, the plaintiff must prove that the company liable for the acts leading to the alleged damage was used abusively by another group company for the very purpose of impeding future claims. In these cases, the other group company may indeed be sued.

In the remaining cases, suing a group company other than the one that performed the acts leading to the alleged damage will pose serious difficulties to the claimants.

Having similar names is not relevant

The Supreme Court further states that partially coincident names between companies belonging to a corporate group is not a sufficient reason to sue a company for the acts carried out by another company of the same group.

La entrada Liability for damages in corporate groups aparece primero en Faus Moliner.

A manufacturer of a hip prosthesis, after becoming aware that the product had to be revised more often than expected, issued a safety notice recommending wearers of the affected prosthesis to follow a specific monitoring and control plan. Several months later, the manufacturer voluntarily withdrew the product from the market. Afterwards, a patient underwent a clinically indicated surgery for the replacement of one of the manufacturer’s prosthesis that had previously been implanted to her. Such patient filed a product liability claim against the manufacturer which was dismissed by the lower Courts because the prosthesis could not be proven as defective.

In this judgement, the Supreme Court reverses the decisions of the lower Courts and provides interesting statements regarding how the concepts “defective product” and “safety which may reasonably be expected”, both very relevant to determine the liability of manufacturers for defective products, should be interpreted. 

Safety which may reasonably be expected

As per the Supreme Court, a manufacturer may be held liable under product liability regulations not only for damages caused by products infringing safety and quality regulations but also for damages caused by products that, despite having undergone safety and quality controls, remain “unsafe”.

The relevant time to determine whether a product is unsafe/defective is the time when the product is put into circulation. According to the Supreme Court, although the voluntary withdrawal of a product from the market does not necessarily mean that the product was defective at the time it was put into circulation, it may indeed constitute an indication that at that time the product did not comply with the safety standards which may reasonably be expected from it.

In the proceeding, the manufacturer alleged that the prosthesis only had minor and punctual failures and that, in the majority of cases, it worked well in accordance with its purpose. Further, the manufacturer alleged that there was no proof that the damages were caused by the prosthesis itself and that the withdrawal of the product from the market had been entirely voluntary.

The Supreme Court does not accept these claims and considers that the fact that the prosthesis had an unexpected high rate of revisions must prevail. As per the Court, this high rate of revisions, which was neither identified nor disclosed by the manufacturer at the time the product was put into circulation (and therefore was not known by the medical community and the relevant notified bodies at that time), shows that the risks posed by the prosthesis were higher than expected. In these circumstances, the Supreme Court concludes that it falls on the manufacturer to prove why it was not possible to identify and disclose the true risks of the device (that ultimately caused the need to withdraw the product from the market) at the time the product was put into circulation.

Loss of the allegedly defective prosthesis

The lower Courts dismissed the claims of the plaintiff because, among other reasons, the allegedly defective prosthesis was lost, and it was therefore impossible to prove that it was defective.

The Supreme Court rejects this argument and considers that the fact that the prosthesis was lost does not prevent the Court to determine that the prosthesis was unsafe to the extent it posed a higher risk than expected. Further, the Court notes that the plaintiff’s need for a prosthesis replacement was related to the reasons why the manufacturer previously withdrew the product from the market.

No causes attributable to the plaintiff

To uphold the product liability claim, the Supreme Court takes into account that the replacement of the prosthesis was not attributable to the plaintiff. Blood values consistent with the wear of the prosthesis and the absence of other reasons explaining the need to replace it are the proven facts that allow the Court to conclude that the replacement of the prothesis was not attributable to the plaintiff. Finally, the Court clarifies that the consequences of the replacement of the prosthesis cannot be deemed as an “unavoidable risk” of the product.

Conclusions

Safety and quality controls performed by manufacturers before putting a medical device into circulation are of utmost importance. If such controls are not adequate to identify a defect of the product, the manufacturer may be liable for such defect. If unexpected risks arise after the product is put into circulation, it falls on the manufacturer to prove why it was not possible to identify and disclose such risks at the time the product was put into circulation. Finally, it will be on the Court to decide on a case-by-case basis whether the allegations of the manufacturer are sufficient to exonerate manufacturer from liability or not.

La entrada The importance of quality and safety controls for medical devices aparece primero en Faus Moliner.

In our Capsulas Newsletter of September 2019 we explained that a supplier may be able to avoid the direct product liability foreseen in Royal Decree 1/2017 if it identifies the producer of the product or if it is notorious that the injured party, before addressing any communication to the supplier, knew who was such producer.

In the present case, the foregoing rationale is used by the Court of First Instance which dismissed the claim presented by an injured party against a distributor on the basis that, according to the available evidence, it was clear and notorious that the plaintiff knew the identity of the producer. However, the Court of Appeal reached a different conclusion.

If the supplier presents himself as the manufacturer/importer, it may be held liable as such

The Court of Appeals partially revoked the judgement of the Court of First Instance because it understood that the distributor presented himself before the injured party not only as a distributor but also as the producer of the product. Among other considerations, the Court pointed out that in the communications exchanged between the distributor (defendant) and the injured party (plaintiff) before the initiation of the judicial procedure, the distributor requested to the injured party very specific information that went far beyond the information usually requested by a distributor. In particular, such information was aimed to allow the distributor to check if the prosthesis was in fact defective, and to determine what was the behavior of such prosthesis once installed in the patient. This information, according to the Court of Appeals, was information that was not relevant for a distributor. Additionally the distributor did not express any intention of sending this information to the manufacturer.

According to the Court of Appeals, the behavior of the distributor made the injured party believe (and this was a reasonable belief according to the Court) that the distributor was, in fact, the manufacturer of the product or, at least, an entity that would respond before him as such. On the basis of the foregoing, the Court of Appeals, unlike the Court of First Instance, understood that the claim was properly filed against the distributor.

Tips for suppliers

If a supplier receives a product liability claim, the first reaction should be to identify the producer which is the one that, according to the applicable law, must bear the corresponding product liability. In the event a supplier is finally sued on the basis that it did not fulfilled its duty to identify the producer, then it will be important that, during the judicial procedure, the supplier provides sufficient evidence to the court in order to prove that the injured party knew or could have easily known, the identity of the producer.

What is not advisable is for suppliers to act before the consumers as if they were the   producers. If a supplier does so, it may be held liable for product liability.

La entrada How a supplier should act upon receiving a product liability claim aparece primero en Faus Moliner.

As we have previously commented in our Capsulas newsletter, the strict liability regime for defective products foreseen in Royal Legislative  Decree 1/2007 (“RLD 2007”) states that the only one responsible for the damages caused by a defective product should be the so-called “producer” of the same. Such “producer” being understood as (i) the manufacturer or the importer of the product in the European Union, or (ii) whomever presents himself as manufacturer or importer by indicating its name, brand or other distinctive sign on the product. If the “producer” cannot be identified, responsibility then falls with the supplier unless, within a period of three months, such supplier indicates to the harmed party the identity of the manufacturer or the provider of the product.

Background

In the present case, a patient who was implanted an allegedly defective hip prothesis sued the distributor of such prothesis under the RLD 2007 strict liability regime.

Previously, the patient addressed an out-of-court complaint to the distributor of the product, which responded by identifying itself as distributor and requesting additional information about the allegedly defective prothesis in order to carry out the appropriate verifications. In the response, the distributor did not identify the manufacturer or the supplier of the product.

On the basis of such lack of identification, the Court considered the distributor as “manufacturer” of the product and ordered it to pay the amount claimed by the patient.

The identification of the manufacturer is not always necessary

The case reached the Court of Appeal of Barcelona which revoked the first instance judgement and acquitted the distributor.

The Court of Appeal, in view of the documents provided with the claim, considered that the patient had the capacity to know who the manufacturer was without the distributor identifying it. For this reason, the Court of Appeal considered that the claim should have not been directed against the distributor.

The Court of Appeal also highlighted that the fact that the distributor showed interest for the incident, requesting additional information about the allegedly defective product, did not imply the assumption of any type of liability. Also, the distributor subsequent refusal to respond was not a violation of the doctrine under which one cannot act contrary to its previous conduct.

La entrada The distributor of a defective product might be exempted from liability without identifying the manufacturer aparece primero en Faus Moliner.

In our previous Capsulas we commented the judgement of the Court of Justice of the European Union of 21 of June and we warned about the uncertainty generated by the judgement as it included the possibility that a judge might consider that a vaccine is defective and that there is a causal link between the defect and the disease based on firm, specific and consistent evidence.

However, we added that such evidence regime could not reverse the burden of proof and that the Directive precludes rules based on presumptions that lead to consider the causal relationship proved, in any case, if certain evidence is presented.

Judgement of the National High Court

The judgement issued by the National High Court (AN) that we are now commenting also resolves a case of liability for damage caused by the administration of a vaccine, which is addressed against the Ministry of Health, Social Services and Equality (MOH) and against the pharmaceutical company that had marketed the product

The judgement of the AN confirms that the burden of proving the defect, the damage and the causal relationship lies with the claimant and, in the absence of evidence from the claimant, it absolves the MOH and the pharmaceutical company of all the wrongdoings attributed to them.

The AN rejects the complaint on the basis that the burden to prove that the competent authorities, based on the state of scientific knowledge, did not act according to the scientific data and evidence available at that moment lies with the claimant. The claimant did not provide any firm and scientific evidence which would lead to the conclusion that such risk-benefit balance was unfavourable and that, therefore, the vaccine should not have been authorised.

The AN rejects the evidence proposed by the claimant consisting of opinions which, the Court states, do not undermine the studies and clinical trials that endorsed the efficacy of the product.

With respect to the alleged lack of informed consent prior to its administration, the AN rejects the complaint because the claimant has not demonstrated that the hypereosinophilic syndrome (eosinophilia) he was diagnosed with was a frequent adverse reaction, and therefore the obligation to inform did not include such risk since it was not known.

Moreover, the AN considers that the causal relationship between the diagnosed disease and the vaccine has not been demonstrated, since the medical history does not associate the ailments and symptoms from which the claimant suffered with the vaccine.

The liability of the pharmaceutical company for defect of information in the Summary of Product Characteristics and the leaflet is also rejected because the claimant has not proved that his disease was caused by the vaccine.

La entrada There is no need to panic: the burden of proof of the defect, the damage and the causal relationship continues to be for the plaintiff aparece primero en Faus Moliner.

The judgment of the European Court that we are discussing in this Capsulas is one example of the complexity of constructing European Community law. Given that accepting that a supranational organization approves and  enforces common rules on some matters is very complicated, it is common that European Community law does not succeed in regulating with full details all those matters which it wishes to address. Therefore there are always gaps that will need to be governed by national rules.

This case refers to product liability of manufacturers in the event that their products have a defect and they cause a damage to the consumer. The European directive which aims to eliminate the discrepancies between national laws in this area establishes that manufacturers are responsible for damages caused by defects of their products; and that the injured person that claims a compensation has to prove the damage and the defect as well as the causal relationship between the defect and the damage. However, the directive does not specify if in order to prove the existence of the defect and the relation of causality, the injured person must provide specific and concrete evidence or if, on the contrary, the judges may consider that these circumstances have been proven on the basis of a set of evidence, the seriousness, specificity and consistency of which allows them to consider, with a sufficient high degree of probability, that such a conclusion corresponds to the reality of the situation. As you see, the matter is highly complex.

Evidence based on presumptions

The Court, in these circumstances, has decided that European law does not preclude a national court to consider, when medical research does not establish nor reject a relationship between the vaccine and the occurrence of a disease, that some facts alleged by the injured person constitute serious specific and consistent evidence enabling the court to conclude that there is a defect in the vaccine and that there is a causal link between that defect and the decease.

On the other hand, the court also rules that judges should ensure that when applying this evidence regime, they do not reverse the burden of the proof. The directive, the court says, precludes rules based on presumptions according to which where medical research neither establishes nor rules out existence of a link between the vaccine and the disease, the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established if certain predetermined factual evidence is presented.

In Spain, accepting presumptions to prove the causal link between a defect and a damage has been exceptional, and this ruling by the court should not entail substantial changes in the rigorousness that must be applied in connection with evidence in these cases.

La entrada Vaccines and liability for defective products aparece primero en Faus Moliner.