The case law of the Supreme Court has played a decisive role in this evolution.
The regime governing liability for defective products is highly specialised. Whilst it is now incorporated into the Consolidated Text of the General Law for the Protection of Consumers and Users, issues relating to proof of defect, the causal link, the identification of those liable and the scope of compensable damages continue to give rise to significant disputes.
The Supreme Court’s most recent rulings reveal several trends that are likely to shape the development of this area in the coming years.
I. The shift in the debate: from the isolated incident to a comprehensive analysis of product safety.
The first of the most significant aspects of the evolution of case law is the gradual move away from a perspective focused exclusively on the specific incident.
In other words, the issue is no longer limited to determining whether the product actually caused damage. The legal analysis requires a determination of whether the product offered the level of safety that could legitimately be expected, taking into account all relevant circumstances. This approach is particularly relevant in the case of medical devices and implantable products.
A product may function formally in accordance with its technical specifications and yet still be deemed defective from the perspective of the civil liability regime if its design, composition, performance, the information provided or the associated risks do not offer the level of safety that can legitimately be expected.
The consequence is that a defect cannot be confused with a mere technical non-conformity, the existence of a fault or the proof of negligent conduct on the part of the manufacturer.
The central question then becomes whether the product was sufficiently safe.
II. The particular significance of the legitimate expectation of safety
The notion of ‘safety that can legitimately be expected’ has become one of the essential elements in interpreting the regime of liability for defective products.
The level of safety required of an ordinary consumer product cannot be compared to that of an implantable medical device intended to remain in a patient’s body for years.
The fact that a medical device has been authorised, lawfully marketed or used by medical professionals does not automatically rule out the possibility that it may be considered defective.
Administrative authorisation is a relevant factor, but it does not exhaust the civil assessment of the product’s safety.
This distinction is particularly important because it allows us to separate two aspects that are frequently confused:
- Compliance with the regulatory requirements for the marketing of the product; and
- Civil liability towards the person who has suffered harm as a result of its use.
Administrative compliance does not necessarily equate to the absence of a defect for the purposes of compensation.
III. Implantable medical devices
Litigation relating to prostheses, implants and other medical devices is likely to be one of the areas in which case law over the coming years will have the greatest significance.
Medical devices have one key characteristic: the harm may only become apparent a long time after implantation.
The victim may suffer progressive deterioration, the need for further surgery, organ damage or permanent sequelae, the link between which and the product is not always immediately apparent.
There are three scenarios to be analysed:
–Proof of the existence of the defect; proof of the causal link; and the distinction between the manufacturer’s liability and the potential liability of other parties involved, such as healthcare centres, distributors or medical professionals.
The significance of this issue is reflected in the recent case law of the Supreme Court. Among the cases brought before the First Chamber is a dispute concerning a claim for damages arising from health problems, injuries and after-effects resulting from the implantation of xxx hip prostheses. The significance of the case lies in the fact that this type of litigation requires a joint examination of issues relating to product defect, scientific evidence, causation and long-term physical injury.
IV. Proof of the defect
Between the victim’s burden of proof and the difficulty of providing evidence. It is generally incumbent upon the injured party to prove the damage, the defect and the causal link.
In the case of technically complex products, this requirement presents the victim with an extraordinary burden of proof.
The manufacturer normally has access to technical information, design data, test results, post-marketing information and scientific knowledge regarding the product’s behaviour that is not available to the consumer.
In certain cases, proof of the defect does not stem from the identification of a specific visible physical anomaly in the product.
It may be established on the basis of a variety of factors, including:
- an abnormally high number of failures;
- the subsequent recall or modification of the product;
- warnings issued by health authorities;
- post-market scientific studies;
- recall or replacement rates;
- comparison with the expected performance of equivalent products;
- and the emergence of consistent patterns of damage.
The problem lies in determining when this body of evidence allows for a sufficiently robust conclusion to be reached regarding the existence of the defect.
V. Scientific causation and legal causation
The complexity of medical devices leads us to make an increasingly important distinction: the difference between absolute scientific certainty and legally sufficient proof of causation.
In many medical and pharmaceutical disputes, it is impossible to achieve absolute scientific certainty regarding the specific cause of an injury.
Demanding such certainty as a prerequisite for obtaining compensation could, in practice, make it impossible to claim for harm arising from complex products.
Consequently, the development of civil liability is moving towards a legal assessment of the evidence based on reasonable probability, the consistency of the evidence and the exclusion of relevant alternative causes.
Causality must not become a requirement that is scientifically impossible to prove. Nor, however, can it be replaced by a mere temporal coincidence between the use of the product and the onset of the injury. The solution lies in ‘maintaining a balance between these two extremes’.
The occurrence of damage following the use of a product does not, in itself, prove the existence of a defect or a causal link; however, if there is a convergence of multiple scientific, statistical and clinical indications, the absence of a convincing alternative explanation may become of decisive importance.
VI. The distinction between strict liability and fault-based liability
Liability for defective products does not, in principle, require proof of specific negligence on the part of the manufacturer.
The victim does not have to prove that the manufacturer acted carelessly.
They must prove that they suffered harm caused by a defective product.
The procedural consequences are as follows:
The manufacturer’s defence cannot be limited to asserting that they acted with due care or that they complied with the technical standards in force at the time of manufacture.
The absence of negligence does not necessarily preclude liability where the legal conditions of the defective product regime are met.
The analysis must therefore focus on the objective safety of the product and its causal link to the harm.
VII. The problem of multiple liable parties
Products reach the consumer through complex economic chains. The manufacturer, component suppliers, importer, distributor, healthcare facility and healthcare professional may all be involved, directly or indirectly, in making the product available or in its use.
This multiplicity gives rise to one of the main practical problems in litigation. Not all liabilities have the same basis. The manufacturer may be liable for a product defect.
The healthcare professional may be liable, in certain cases, for negligent conduct or for breaches relating to treatment or information.
The healthcare facility may be liable for its own duties regarding organisation and service provision.
The coexistence of several potential liable parties means that two errors must be avoided.
- The first is to automatically attribute any harm arising after the product’s use to the manufacturer.
- The second is to dilute the manufacturer’s liability by attributing the harm exclusively to medical intervention.
The correct identification of the legal basis for each liability will be decisive in future litigation.
VIII. Long-term harm and the quantification of compensation
Defective products may cause harm whose progression is not yet complete at the time the claim is brought.
This is particularly the case with implants, prostheses and products that produce cumulative or progressive effects.
The assessment of compensation must take into account not only the damage already suffered, but also any future consequences that can be substantiated.
These may include:
- further surgical procedures;
- future treatments;
- loss of earning capacity;
- the need for care;
- cosmetic damage;
- permanent sequelae;
- and harm resulting from a substantial impairment of quality of life.
The complexity increases when the victim needs to have a product removed or replaced as a precautionary measure due to the existence of a significant risk.
In such cases, a particularly interesting question arises: whether the damage eligible for compensation requires waiting until the definitive injury occurs, or whether certain costs and damages arising from a preventive intervention may already form part of the compensable loss.
IX. The impact of new European law
Developments in Spain cannot be analysed in isolation.
European law is driving a profound overhaul of the regime governing liability for defective products.
The traditional model was designed for conventional physical products.
Future interpretation of the liability regime will have to address issues that, until a few years ago, were considered marginal.
- Can a product be defective as a result of a software update?;
- Who is liable when the defect stems from a digital component?;
- How is the defect proven when operation depends on algorithms?;
- What information must the producer provide regarding risks that arise after the product has been placed on the market?;
- and How should liability be addressed in the case of products whose behaviour evolves during their useful life?
Although many of these issues have not yet been fully addressed in the case law of the Supreme Court, their incorporation into European law suggests that litigation is set to undergo a profound transformation.
X. Conclusion
Civil liability for defective products is not limited solely to traditional consumer accidents.
The most significant litigation in the coming years will relate to complex products, long-term damage, scientific uncertainty and evidential difficulties.
Firstly, determining the defect will require a broader analysis of the safety that can legitimately be expected, rather than focusing exclusively on the existence of an individual material fault.
Secondly, proving causation will require mechanisms capable of rationally assessing scientific evidence without demanding an impossible level of certainty from the victim.
Finally, the complexity of production and distribution chains will make it necessary to define more precisely the liability of each of the economic and healthcare operators.
In this context, litigation concerning implantable medical devices represents one of the most significant testing grounds for the future development of civil liability.
The Supreme Court’s forthcoming rulings on this matter may play a decisive role in defining the balance between the necessary protection of victims and the requirement for sufficiently rigorous proof of the defect and the causal link.
The question is no longer merely who manufactured the product or whether they formally complied with the applicable technical standards.
The central question will, increasingly, be another:
did the product actually offer the level of safety that the person who suffered its consequences could legitimately expect?
At Belzuz Abogados S.L.P., as a law firm specialising in Insurance Law and Civil Liability, we are available to advise you on the impact of this reform, both from the perspective of insurance practice and in defending the interests of victims and policyholders.