Product Liability & Safety 2021

Last Updated June 24, 2021

Spain

Law and Practice

Authors



Faus & Moliner is a modern boutique law firm, specialising in legal matters typical of the pharmaceutical industry and of other companies which operate in the “life sciences” sector. The firm, which was founded in 1997, focuses on pharmaceutical law, commercial contracts, corporate transactions, corporate governance, compliance, competition law, public procurement, product liability, advertising, litigation and arbitration. Since its foundation, Faus & Moliner has been widely recognised as a market leader in the area of pharmaceutical law in Spain. The product liability and civil and commercial litigation space is one of the leading areas of expertise of the firm. The team is well known for assisting industrial and insurance companies in complex high-stakes cases regarding medicinal products, medical devices and other products of the life science sector.

Royal Legislative Decree 1/2007, which approves the consolidated text of the General Law on the Protection of Consumers and Users and other complementary regulations (RLD 1/2007), is the main law setting out the legal regimen for product safety in Spain.

RDL 1/2007 establishes the main rules and obligations that, in general, must be respected by companies that make products available on the market in order to guarantee the protection of the health and safety of consumers and users.

Other laws and regulations set forth additional rules and obligations depending on the type of product and its impact on the health and safety of consumers. This is the case with the following laws and regulations: 

  • Royal Legislative Decree 1/2015, which approved the consolidated text of the law on guarantees and rational use of medicinal products and medical devices;
  • Law 17/2011, regarding food safety and nutrition;
  • Law 14/1986, on general public health;
  • Royal Decree 1801/2003, on general product safety;
  • Royal Decree 1345/2007, which regulates the authorisation, registry and dispensation conditions of medicinal products for human use prepared industrially;
  • Royal Decree 1591/2009, which regulates medical devices; and
  • Royal Decree 85/2018, which regulates cosmetic products.

In general, the General Directorate of Consumer Affairs of the Ministry of Consumer Affairs and the competent consumer authorities of the autonomous regions of Spain are the main authorities in charge of ensuring that the products made available to consumers and users meet the requirements established to provide a high level of health and safety at the same time as they respond to demands related to quality.

Other key sector-specific regulators are also in charge of ensuring that the specific products made available to consumers and users meet the requirements established to provide a high level of health and safety at the same time as they respond to demands related to quality. Such regulators include:

  • the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), which is the regulatory authority in charge of technical requirements and surveillance of medicinal products, medical devices, cosmetics and personal care products; and
  • the Spanish Agency for Food Safety and Nutrition (“AESAN”), which is in charge of technical requirements and surveillance of food and nutritional products.

In addition, regional authorities are also responsible for controlling advertising, performing inspections of manufacturing and distribution premises, and performing all necessary controls to ensure that products comply with the applicable regulations.

According to the provisions of RLD 1/2007, any entity involved in placing a product at the disposal of consumers and users, within the limits of its activity, must withdraw from the market, suspend marketing, or recover from the consumer or user, through effective procedures, any product that does not meet the conditions and requirements of RLD 1/2007 or which, for any other reason, represents a foreseeable risk to personal health or safety on any other grounds.

Additionally, the competent authorities may adopt all the measures that are necessary and proportionate to eliminate the risk, including direct intervention regarding the product and direct compulsion of the entity involved. In these cases, all the expenses incurred will be charged to the involved entity that, with its conduct, had provoked such measures, regardless of the sanctions that, if applicable, may be imposed. The levying of such expenses and penalties may be carried out through the administrative enforcement procedure. Public authorities, taking into account the nature and severity of the risks detected, may also inform affected consumers and users through the most appropriate means about the existing risks or irregularities, the affected product, the measures adopted, as well as the appropriate precautions, both to protect themselves from the risk, and to obtain their collaboration in the elimination of its causes.

The trigger for notification to authorities in respect of product safety issues may vary depending on the type of product at issue and the applicable regulations.

Medicinal Products

For instance, with regard to medicinal products, applicable regulations establish that the holder of a marketing authorisation is obliged to:

  • comply with its pharmacovigilance obligations;
  • observe the conditions under which the marketing authorisation was granted, in addition to the general obligations established in the legislation;
  • submit periodic safety reports established by regulation, in order to keep the safety file updated;
  • make the results of clinical trials public, regardless of the favourable (or not) outcome of their conclusions; and
  • collaborate in the control programmes, guarantee the suitability of the products on the market and report any possible withdrawal of batches from the market and notify the AEMPS, the autonomous regions and authorities of all countries where it has been distributed, with the appropriate speed for each case and stating the reasons and any action undertaken to withdraw a batch from the market.

Without prejudice to their own responsibility, all authorities and health professionals, as well as pharmaceutical companies and distribution entities, are obliged to collaborate diligently in the dissemination of knowledge of the safety of the product. Likewise, health professionals, pharmaceutical companies and distribution entities are obliged to notify the health authorities of anomalies of which they have news.

Medical Devices

With regard to medical devices, Royal Decree 1591/2009 establishes that manufacturers, authorised representatives, importers and/or distributors must notify the AEMPS of:

  • any malfunction or alteration of the characteristics or performance of the product, as well as any inadequacy in the labelling or the instructions for use that may have led to the death or serious deterioration of the health of a patient or a user; and
  • any reason of a technical or sanitary nature linked to the characteristics or benefits of a product that, for the reasons mentioned above, has induced the manufacturer to take systematic action regarding products of the same type.

Additionally, if a notified body observes that the manufacturer does not comply or has ceased to comply with the relevant requirements established in the laws, or that a certificate should not have been issued, it will suspend, subject to restrictions, or withdraw the issued certificate, bearing in mind the principle of proportionality, unless the manufacturer guarantees compliance with these requirements by applying effective corrective measures. In those cases, or in cases in which the intervention of the competent authority may be required, the notified body will inform the AEMPS, who will inform the other EU member states, the European Commission, and the autonomous regions of Spain about said events.

Furthermore, the AEMPS and the other competent health authorities, when they consider that a medical device may compromise the health and/or safety of patients, users or third parties, will proceed to adopt the appropriate precautionary measures. In such cases, the AEMPS will immediately notify the European Commission of the measures that have been adopted, indicating the reasons.

Food and Nutritional Products

In accordance with Article 19 of Regulation No 178/2002, if a food business operator considers or has reasons to believe that any of the food that it has imported, produced, processed, manufactured or distributed does not meet the safety requirements, it shall immediately withdraw that food from the market when the food is no longer subject to its immediate control and shall inform the competent authorities thereof. In the event that the product may have reached consumers, the operator will effectively and accurately inform consumers of the reasons for the withdrawal and, when the competent authorities deem it necessary, will recover the products that have already been supplied to them when other measures are not sufficient to achieve a high level of health protection.

The intentional or negligent breach of product safety obligations may be subject to administrative and criminal sanctions. Additionally, any person responsible for such a breach can be also liable for damages.

The most notorious criminal case in this regard is the rapeseed oil case. This case involved more than 30 industrialists that were prosecuted during the late 1980s due to their participation in the commercialisation of a supposedly edible oil which was adulterated with rapeseed oil (for industrial use and forbidden for foodstuffs) that contained a toxic chemical substance, which caused the death of more than 300 people and left more than 25,000 affected. In 1992, the Supreme Court sentenced the responsible industrialists to significant convictions of imprisonment and the payment of the correspondent compensation to the affected persons. Due to the large compensation, some of these industrialists became, and were declared, insolvent. As a result, the affected persons started legal proceedings against the Spanish State to also declare its responsibility due to the negligence of its officials in the process. The judicial battle ended in 1997 when the Supreme Court sentenced the State as a subsidiary liable party to pay compensation to those affected for more than half a billion pesetas.

Liability under RLD 1/2007

In Spain, the general liability for defective products regime is established in RLD 1/2007. Articles 128–146 of RLD 1/2007, set the main rules on product liability.

This general regime for product liability set forth in RLD 1/2007 is mainly of a strict nature. Under this regime, the “producer” of a defective product will be liable for any damage caused by death or by personal injuries, and/or any damage to, or destruction of, any item of property other than the defective product itself, provided that the item of property is of a type ordinarily intended for private use or consumption and was used by the injured person mainly for their own private use or consumption. It will be on the claimant to prove that the product was defective, that damage occurred and that there was a causal link between the defective product and the damage suffered.

Under this regime of RLD 1/2007, a product is defective when it does not offer the safety that could legitimately be expected, considering all circumstances and, especially, its presentation, the reasonably foreseeable use of the product and the moment when the product was put into circulation. As has been established by the Spanish Supreme Court, in its judgment 495/2018 of 14 September 2018, this concept of a "defective product" is a normative concept that must be interpreted in accordance with the criteria established by law.

Therefore, within the framework of the regime for product liability established in RLD 1/2007, a defect is defined as “the lack of safety that could legitimately be expected from the product, ie, based on the criterion of the consumer’s reasonable expectations”.

For the purposes of this regime “producer” means:

  • the manufacturer or the importer in the European Union of a finished product, any raw material, or a component part of the finished product; and/or
  • the “apparent producer” of the product (ie, any person who, by putting their name, trademark, or other distinguishing feature along with the product, whether on the container, wrapping or any other protective or presentational component, presents themselves as its producer).

The “producers” responsible for the same damage by application of this regime will be jointly and severally liable before the injured party. However, the one who responded to the injured party will have the right to file an action for recovery against the other responsible “producers”, according to their participation in the damage.

Where the “producer” of a product cannot be identified, each supplier of this product (ie, the distributor or the “retail” supplier) will be considered as its “producer”, unless they inform the injured party of the identity of the “producer” or of the person who supplied them with the product, within a term of three months before they are required to give such information. This has been clarified, among others, by the judgment of the European Court of Justice of 2 January 2009 (case C-358/08) and the judgments of the Spanish Supreme Court of 21 January 2020 and of 20 July 2020. Additionally, it must be noted that the suppliers of a defective product will also be treated as if they were its “producer” if they supplied the product being aware that the defects exist. In such a case, the supplier is also able to file an action for recovery against the producer.

Other Forms of Liability

This strict liability system set forth in RLD 1/2007 does not preclude other liability systems providing an injured party with greater protection, nor does it affect any other right to damages, including moral damages, that the injured party may have as a consequence of contractual liability, based on the lack of conformity of the goods or any other cause of non-performance or defective performance of the contract, or of any other non-contractual liability that may apply.

Every injured party has standing to bring a product liability claim based on RLD 1/2007.

The statute of limitations for bringing a claim for product liability under the regime of RLD 1/2007 is three years, counted from the date the damages were incurred by the injured party, provided that the identity of the party liable for the damages is known to the injured party.

The limitation period may be interrupted by the injured party by filing a claim before the courts or by means of an extrajudicial claim, or through any act of acknowledgment by the liable party.

Nevertheless, the right to claim the recovery of damages as provided in the product liability regime of RDL 1/2007 expires ten years after the defective product was placed on the market. The only way to stop this expiration date is to start legal proceedings.

The requirements to invoke the jurisdictions of the courts of Spain for product liability claims will depend on whether the defendant is domiciled in an EU member state or in a third country that has subscribed to an international treaty with Spain regarding these matters.

Domiciled in an EU Member State

If the defendant is domiciled in an EU member state, the provisions of Regulation (EU) 1215/2012, on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, will be applicable.

According to the rules of this Regulation, the Spanish courts have jurisdiction over any dispute when the defendant is domiciled in Spain. This is regardless of where the claimant is domiciled. Therefore, if the producer of the defective product is domiciled in Spain, a claim may be brought against them before the Spanish courts. Additionally, defendants not domiciled in Spain may also be sued before the Spanish courts on product liability claims if (i) if the events leading to the product defect occurred in Spain, or (ii) the damage occurred in Spain.

In this regard, see the judgment of the Court of Justice of the European Union, case C 45/13, of 16 January 2014, or the judgment of the Spanish Supreme Court of 21 January 2019.

Domiciled in a non-EU Member State

If the defendant is domiciled in a non-EU member state that has subscribed to an international treaty with Spain, the jurisdiction of the Spanish courts will be governed by the provisions of that treaty.

In the absence of an international treaty, the jurisdiction of the Spanish courts will be governed by the internal rules of Spain. In this regard, defendants not domiciled in Spain may be sued before the Spanish courts in, among others, the following situations:

  • if the parties agree to do so, or if the defendant appears before a Spanish court (this shall not apply where appearance was entered to contest the jurisdiction);
  • regarding non-contractual obligations, when the harmful event has occurred in Spain; and
  • in matters related to consumers, if the consumer has its habitual residence in Spain.

There are no mandatory steps that must be taken before a proceeding can be commenced for product liability cases.

However, it is common that before filing a lawsuit, the claimant addresses an extrajudicial claim to the one who is intended to be sued in order to try to resolve the dispute out of court.

Before the initiation of any court proceeding, the one who intends to initiate it or any of the litigants during the course thereof, may request the court to adopt, by means of an order, any useful measures to prevent the destruction of any evidence due to human conduct or natural events. 

Among other things, the one who requests the adoption of any of these measures should prove that:

  • the evidence to be insured is possible, pertinent and useful at the time of proposing its assurance/preservation;
  • there are real reasons to fear that, if the preservation measures are not adopted, the use of said evidence may be impossible in the future; and
  • the preservation measure proposed, or another measure that the court deems preferable for the same purpose, may be deemed conducive and carried out within a short time and without causing serious and disproportionate damage to the persons involved in the litigation or to any third parties.

Under Spanish civil law, there is no discovery obligation between the litigating parties – neither before court proceedings are commenced nor as part of the pre-trial procedures. The Spanish civil system is based on the principle of parties’ own production of evidence (ie, each litigant shall obtain and present its own evidence to support its claims in court proceedings).

Exceptionally, and only in those cases in which the applicant is unable to obtain by themselves certain data necessary to file a claim, they may request the judge, prior to filing the lawsuit, to provide access to certain sources of evidence specifically provided for, by way of preliminary proceedings, in the Code of Civil Procedure 1/2000. Among other preliminary proceedings provided in the law:

  • any interested party may request a copy of the medical records from the health centre or professional with custody of said records; and
  • an individual who considers himself to have been damaged by an event that could be covered by civil liability insurance may request the exhibition of the insurance contract.

Additionally, at the pre-trial hearing, any litigant may request the judge to order the other party, or third parties unrelated to the proceedings, to exhibit any document related to the subject of the dispute. In said request, the applicant must:

  • prove that the document is not available to them and prove the impossibility of obtaining it;
  • prove that the document refers to the subject of the process (because it is documentary evidence relevant to the case) or to the effectiveness of other means of proof (because it gives, or does not give, effectiveness to other evidence presented); and
  • provide a photocopy or simple copy of the document or indicate its content in the most exact terms.

In this type of proceeding, the proposal of the examination of expert evidence corresponds to the litigants, and the only restriction regarding its nature and scope is that it must be necessary to have scientific, artistic, technical, or practical knowledge to ascertain any facts or circumstances that are relevant to the matter or to acquire certainty about them.

The parties are allowed to present their own evidence and bring their own technical specialists and/or request that the court appoint any technical specialist in order to assess the evidence presented by the parties or ascertain any facts or circumstances that are relevant to the matter of the case.

Generally, in this type of proceeding, the court may not ex officio propose the examination of expert evidence or appoint technical specialists in order to assess the evidence presented by the parties. However, in exceptional cases, once the proceedings have been concluded and before judgment is rendered, the court may ex officio order the examination of new evidence (including expert evidence) on relevant facts, in the event that the evidence already examined is found to be insufficient. In practice, this is very unusual.

The product liability regime places the burden of proving the existence of the defect, the damage and the causal relationship between that defect and the damage upon the claimant. In order to establish such causal relationship, the claimant must provide solid and substantial evidence that supports such a link and that shows damages to be an appropriate and sufficient result of the defect.

Proximate Causation

However, occasionally, the Spanish courts also accept that the causal relationship may be proven by means of presumption or circumstantial evidence.

In Spain, the principle of generic causation (ie, in order to prove the causal relationship it would be enough to demonstrate that a product is capable of causing the alleged injury) is not applied. The Spanish courts have established that the mere fact that a product can cause damage is not enough to establish the defective nature of that product. In order to prove that a product is defective, the claimant must prove that the damages suffered are effectively caused by the defective product. It is sufficient that the claimant proves the existence of a defect, but it is not strictly necessary that the claimant provides evidence of the specific defect of the product. We can thus conclude that in Spain the proximate causation principle operates.

Defective Batches/Series of Products

On 5 March 2015, the Court of Justice of the European Union (CJEU) issued a ruling on joined cases C-503/13 and C-504/13, under which certain kinds of products can be considered defective under the proximate causation principle. In these particular cases, the (CJEU) concluded that the Directive 85/374/CEE regarding damages caused by defective products should be interpreted in a manner sensitive to the particular product in question. In the case of medical devices such as pacemakers and cardioverter defibrillators, considering their purpose and the vulnerability of patients who use them, the security requirements that patients can expect from such products are particularly high. Under these conditions, as they are products of the same model and production series, after a defect has been detected in a unit, the other units of the same model or batch can be classified as defective without being necessary to prove the existence of the defect in each of the units.

Proving Liability When Medical Research is Inconclusive

On 21 June 2017, the (CJEU) issued another decision (C-621/15) referring to the product liability of manufacturers in the event that their products have a defect which poses a risk to the consumer. The Court, in these circumstances, decided that European law does not preclude a national court from considering, when medical research does not establish or 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 there is a causal link between that defect and the disease. On the other hand, the Court also ruled that judges should ensure that when applying this evidence regime, they do not reverse the burden of proof. According to the Court, the Directive precludes rules based on presumptions in which medical research neither establishes nor rules out the 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 affected party will always be considered established if certain predetermined factual evidence is presented.

In the five judgments issued between 2017 and 2019 by the National High Court (AN) regarding different liability claims filed in connection with human papillomavirus vaccines, the Court confirmed 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 absolved the Ministry of Health and the pharmaceutical company of all wrongdoings attributed to them. The AN rejected the evidence proposed by the claimants consisting of opinions which, according to the court, did 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 rejected the complaints because the claimants had not demonstrated that the pathologies they were diagnosed with were a frequent adverse reaction, and therefore the obligation to inform did not include this risk since it was not known. Moreover, the AN considered that the causal relationship between the diagnosed diseases and the vaccines had not been demonstrated, as the medical history did not associate the ailments and symptoms from which the claimants suffered with the vaccine. The liability of the pharmaceutical companies for defect of information in the summary of product characteristics and the leaflet was also rejected because the claimants had not proved that their diseases were caused by the vaccine.

Product liability cases are usually brought before civil courts. These cases shall be resolved by a judge.

The amount of compensation will depend on the damage suffered by the injured party. However, the producer's civil liability for damages caused by defective products is subject to the following rules:

  • EUR500 will be deducted from the amount of compensation for material damage; and
  • the global civil liability of a producer for death and personal injury caused by identical products that present the same defect will be limited to approximately EUR63 million.

In legal proceedings on product liability, it is possible to file an appeal before the Provincial Court of Appeal against the judgment rendered at first instance by the Court of First Instance.

Against the judgment on appeal rendered by the Provincial Court of Appeal, there are two appeal options:

  • an extraordinary appeal for infringement of procedure; or
  • a cassation appeal, provided that the amount at stake in the proceedings exceeds the sum of EUR600,000 or the decision on the appeal has reversal interest, because the judgment subject to appeal contradicts the Supreme Court’s jurisprudence or decides on points and issues on which contradictory case law from the Provincial Courts of Appeal exists, or applies rules that have been in force for less than five years, as long as, in the latter case, no jurisprudence from the Supreme Court exists concerning previous rules that have identical or similar content.

The producer shall not be liable if they can prove that the product is not defective because it provides the safety which could legitimately be expected from it, taking all circumstances into account, including the time when the product was put into circulation, the presentation of the product and the use to which it could reasonably be expected that the product would be put.

The producer shall also not be liable if they can prove:

  • that they did not put the product into circulation;
  • that, given the circumstances of the case, it may be presumed that the defect did not exist when the product was put into circulation;
  • that the product had not been manufactured for sale or for any other form of distribution with an economic purpose, nor that it was manufactured, imported, supplied or distributed within the context of a professional or entrepreneurial activity;
  • that the defect is due to the fact that the product was elaborated in accordance with existing mandatory rules; and/or
  • that the state of scientific and technical knowledge existing at the time the product was put into circulation did not allow for the discovery of the existence of the defect.

The producer of a part that is integrated into a finished product shall not be liable if they prove that the defect is attributable to the design of the product into which the part was integrated, or to the instructions provided by the manufacturer of the finished product.

Additionally, the doctrine points out that the apparent producer shall not be liable if they can prove that they were not the one who placed the sign, brand, logo or stamp that identifies them as the apparent producer into the defective product or its packaging.

In the case of medicinal products, foods or foodstuffs intended for human consumption, the producer liable shall not be able to invoke the state of scientific and technical knowledge defence set out in the final bullet point above.

Compliance with regulatory requirements relating to the development, manufacture, licensing, marketing and supply of a product can be used as a defence, if such requirements impose the obligation on the producer to develop, manufacture, license, market and/or supply the product in strict compliance with and observance of such regulatory requirements. If this is the case, the manufacturer could invoke the ground for exoneration in the fourth bullet point in 2.12 Defences to Product Liability Claims.

Additionally, compliance with regulatory requirements can be considered in the context of assessing whether a product meets legitimate safety expectations, and therefore when determining whether a product is defective or not. These cases should be evaluated on a case-by-case basis.

At the end of the proceedings, the costs of the proceedings are imposed on the party who has had all their pleas rejected, unless the court considers that the case posed serious de facto or de jure doubts.

When the payment of costs is imposed on the party who has lost the case, that party shall pay all court fees and other incidental expenses, the fees of experts who have intervened in the proceedings, and, also, the fees of the attorneys of the party who has won the case, up to an amount that shall not exceed one third of the total claimed in the proceedings for each of the litigants who have obtained such an award. If the court declares the recklessness of the litigant ordered to pay, this limitation shall not apply.

However, if the pleas were partially accepted or rejected, each party shall pay the costs generated on its behalf, and half of the common costs, except when there are reasons to impose their payment upon one of the parties due to reckless litigation.

Third-party funding is not forbidden in Spain. There is no specific provision that regulates this method apart from Article 1255 of the Civil Code that sets forth the following: “The contracting parties may establish any covenants, clauses and conditions deemed convenient, provided that they are not contrary to the laws, to the morals or to public policy.” Therefore, if it is not contrary to the law, morals or public order, any agreement in this regard is valid.

An attorney’s professional fees shall be freely agreed upon between the client and the attorney, in observance of the rules on ethics and on free competition. Lawyers are also allowed to charge a success fee if they agree so with their client. The form in which the fees are to be paid shall also be freely agreed upon and may include payment of a percentage of the outcome of the claim. However, in any case, the client shall pay the minimum expenses that the lawyer may incur as a result of its designation. Therefore, "no win, no fee" arrangements are not permissible.

Additionally, parties that provide evidence that they do not have sufficient economic resources to litigate may be beneficiaries of legal aid if they comply with the requirements established in the Law 1/1996, of January 10th, on Legal Aid.

Article 11 of the Code of Civil Procedure 1/2000 foresees the possibility of bringing collective legal proceedings and establishes that legally constituted associations of consumers and users shall have standing in court to defend the rights and interests of their members and of the association, as well as the general interests of consumers and users, without prejudice to the individual legal standing of the persons who have suffered the damages.

When those damaged by a harmful event (eg, by a defective product) are a group of consumers or users that are perfectly determined or may be easily determined, the standing to apply for the protection of these collective interests corresponds to (i) associations of consumers and users, (ii) legally constituted entities whose purpose is the defence or protection of such consumers and users, or (iii) the affected groups themselves.

In contrast, when those damaged by a harmful event are an undetermined number of consumers or users or a number difficult to determine, the standing to bring court proceedings in defence of these collective interests shall correspond exclusively to the associations of consumers and users, which form part of the Council of Consumers and Users. If the territorial scope of the conflict mainly affects one specific autonomous region, the specific legislation of that autonomous region shall apply.

The Attorney General’s Office also has legal standing to bring any action in defence of the interests of consumers and users.

Despite these procedural provisions, collective actions and representative proceeding for product liability claims are not very common in Spain. Such claims are usually brought by individual plaintiffs.

Regarding product liability and medicinal products and medicals, there are three different judgments of the Spanish Supreme Court that deserve special mention.

The Judgment of 20 July 2020

In this judgment the Supreme Court dismissed the claim brought against the distributor in Spain of a hip replacement that identified the producer. The Spanish Supreme Court highlighted that the mere fact that the producer and the distributor have become part of the same corporate group does not imply, per se, that the distributor shall assume producer’s liabilities in product liability claims. Companies belonging to the same corporate group are different companies with own personality, unless they have been incorporated in order to wilfully obstruct legitimate rights of third parties. The potential confusion between the producer and the distributor is already solved in the regulation on product liability, which imposes on distributors the obligation to identify the producer. Therefore, a distributor may only be held liable for a producer’s liabilities regarding defective products if the distributor does not identify the producer. If the distributor correctly identifies the producer, it shall not be held liable for any producer’s liability.

The Judgments of 21 December 2020, and 21 and 28 January 2021

In these judgments the Supreme Court has resolved different appeals for the unification of doctrine and case law, regarding whether a hospital that has used a product whose toxicity is discovered and alerted after it has been used, shall be liable for the injuries caused to the patient or if such liability must only fall upon the “producer” and the competent authorities that authorised the medicinal product, if applicable. The Supreme Court has clarified that, in such cases, liability must lie solely with the “producer” and, if applicable, upon the authorities that authorised the product. The Supreme Court rejected any liability of the hospital as the competence for monitoring the adequacy of such products relied on the competent authorities (not the hospital). The Supreme Court also pointed out that the hospital cannot be held liable for the risk created by allowing the use of the product, since that risk derives from the defective manufacture of the product.

The Judgment of 1 March 2021

In this judgment the Supreme Court ruled on the concepts of “defective product” and “safety which may reasonably be expected” with regard to a hip prosthesis that, after being commercialised, showed a revision rate higher than expected. Its manufacturer issued a safety notice recommending that users of the affected prosthesis follow a specific monitoring and control plan and several months later voluntarily withdrew the product from the market.

The Supreme Court pointed out that a manufacturer may be held liable under the product liability regime of RLD 1/2007 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 court proceeding, the manufacturer alleged that the prosthesis only had minor failures and that, in the majority of cases, it worked well in accordance with its purpose. Furthermore, 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 considered that the fact that the prosthesis had an unexpectedly 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 concluded 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.

On 24 December 2020, the Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC entered into force.

The Directive contains important modifications which must be transposed no later than 25 December 2022, and the regulations resulting from such transposition must enter into force as of 25 June 2023. Therefore, important legislative initiatives must be carried out in the coming months to transpose the Directive. This may lead to significant modifications of the structure of the Spanish civil procedure regarding representative actions for the protection of the collective interests of consumers related, among others, to product safety infringement and product liability.

On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, which contains significant modifications to the previous law regarding product safety, new technologies and medicinal products became applicable.

Among other things, the Regulation increases its scope of application to software programs, when they are specifically intended by their manufacturer for one or more of the medical purposes established in the definition of a medical device.

Additionally, Article 10 of the Regulation establishes the obligation for manufacturers, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, to implement measures to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

Most significant measures to streamline and stimulate the development and approval of COVID-19 vaccines have been adopted by the European Union Authorities.

In this regard, on 23 February 2021 the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency published a reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2. This reflection paper contains important considerations regarding the quality standards, non-clinical-data, and clinical data that pharmaceutical companies may submit in the process of approval of vaccines intended to provide protection against variant strain(s) of SARS-CoV-2.

Among other measures, due to the lack of medical respirators during the first months of the COVID-19 pandemic, the AEMPS authorised the use of different prototypes without CE marking through the authorisation of products in clinical research contemplated in Royal Decree 1591/2009, on medical devices, and Royal Decree 1616/2009, which regulates active implantable medical devices.

From a legislation perspective, no specific modifications to the product liability and product safety regulations or special exemptions to response to the crisis generated by the COVID-19 pandemic have been adopted by the Spanish government or the legislative powers in Spain.

As detailed in 2.1 Product Liability Causes of Action and Sources of Law, under the product liability regime of RLD 1/2007, a product is defective when it does not offer the level of safety that could legitimately be expected taking into account all circumstances and, especially, its presentation, the reasonably foreseeable use of the product and the moment when the product was put into circulation.

Therefore, despite the lack of regulatory modification, when analysing the possible liability that may arise from a vaccine, medicinal product or medical device developed, manufactured, and commercialised to face the COVID-19 pandemic, our view is that Spanish judges and courts must take into account the special circumstances in which such products were developed, approved and made available to the public.

Faus & Moliner

Rambla Catalunya 135
08008 Barcelona

+34 93 292 2100

bcn@faus-moliner.com www.faus-moliner.com
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Faus & Moliner is a modern boutique law firm, specialising in legal matters typical of the pharmaceutical industry and of other companies which operate in the “life sciences” sector. The firm, which was founded in 1997, focuses on pharmaceutical law, commercial contracts, corporate transactions, corporate governance, compliance, competition law, public procurement, product liability, advertising, litigation and arbitration. Since its foundation, Faus & Moliner has been widely recognised as a market leader in the area of pharmaceutical law in Spain. The product liability and civil and commercial litigation space is one of the leading areas of expertise of the firm. The team is well known for assisting industrial and insurance companies in complex high-stakes cases regarding medicinal products, medical devices and other products of the life science sector.

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