Product liability and medical devices in Brazil

Beatriz Gonçalves Marconi

Veirano Advogados, São Paulo

beatriz.marconi@veirano.com.br

Juliana Tedesco Racy Ribeiro

Veirano Advogados, São Paulo

juliana.tedesco@veirano.com.br

Renata Fialho de Oliveira

Veirano Advogados, São Paulo

renata.oliveira@veirano.com.br

Introduction: brief overview of civil liability in Brazil

Civil liability is the duty to compensate for damage caused to someone. In Brazil, it can be subjective or strict. Subjective liability is based on the theory of fault, in which the agent causing the damage will only be held responsible when they act with fault (negligence, malpractice or recklessness). Strict liability, on the other hand, is independent of the agent’s fault, that is, the obligation to compensate exists simply by proving damage and the causal link between the agent’s conduct and the damage caused.

According to the Consumer Defence Code (the CDC), the legal definition of ‘consumer’ is broad, its application embraces a large number of relationships, including, in some cases, relationships between legal entities.[1] Similarly, the definition of ‘supplier’ is comprehensive, including any natural or legal person, public or private, national or foreign, as well as non-personalised entities, which carry out the activity of production, assembly, creation, construction, transformation, importing, exporting, distribution or commercialisation of products or the provision of services.[2]

The CDC imposes a standard of strict liability on suppliers, in that consumers are not required to prove manufacturers acted with fault. Liability may be applied jointly, potentially to all entities in a supply chain.

Note that even if the company is not based in Brazil, but is a part of the supply chain, it will be considered liable to the consumer. Also, if the service provider is a foreign company with a subsidiary in Brazil, this subsidiary may be liable for damages, even if it is not involved in the operation.

Applicability of the CDC in the purchase of medical devices

Although the liability of suppliers in general is strict, the CDC has determined that the personal liability of self-employed professionals (such as doctors) will only be determined on verification of fault (subjective liability).

The liability of hospitals, clinics and medical device suppliers remains objective, so that if part of a device is defective, or in any way fails to serve its intended purpose, its manufacturer will be liable, regardless of fault.

As far as the patient (end user) is concerned, all suppliers are equally responsible. In the event of the hospital or clinic being tried to pay damages to an end user as a result of a manufacturing defect in the device, they may claim compensation from the manufacturer, importer or distributor or from all of them jointly.

It is worth mentioning that, in the context of the purchase of medical device, hospitals, clinics and doctors who buy the device will be considered consumers before the manufacturer, importer or seller of the device.

Duties of medical device suppliers

The CDC provisions apply in both the relationship between hospitals/clinics and the suppliers of medical device, and in the relationship between all suppliers in the chain and the end consumer. In this sense, a series of duties are imposed on suppliers.

Warranty and product liability

Medical devices must meet the expected quality and performance standards. The legal warranty period for durable devices is 90 days, but the supplier can offer a longer period if desired. During this period, the supplier is responsible for repairing any manufacturing defects. Repairs must be carried out within 30 days, otherwise the supplier must refund the purchase price or replace the defective device with a new one. The supplier’s obligations continue throughout the contractual warranty period regarding the repair of products due to defects or flaws not caused solely by the consumer or a third party. However, if the product presents a manufacturing defect after termination of the warranty period, and this defect could not have been identified immediately by the consumer (hidden defect), the supplier will be liable for repairing or replacing the product, even after the end of the warranty period. This obligation isonly cases of a manufacturing defect, (ie, it has not been caused by the consumer or a third party).

Clear and precise information

Suppliers have an obligation to provide clear, accurate and complete information about the device. This includes information on technical characteristics, instructions for use, contraindications, and possible side effects. Both the patient and hospitals, clinics and doctors have the right to receive as accurate information as possible, so that they can make informed decisions on consenting to treatments and possible side effects.

Misleading or abusive advertising

The CDC bans commercial practices that are considered abusive or misleading. This means that suppliers of medical devices cannot make false or exaggerated promises about the performance of a product, nor can they promise the effectiveness of a particular treatment using the device they sell.

Right to regret

When the medical device is purchased outside of the store, for example over the internet or via telephone, the consumer has up to seven days to exercise the right of withdrawal, which consists of returning the product and receiving the amount paid, even if the device is not defective.

Documentation and records

Hospitals and clinics are required to keep detailed records on the use and maintenance of medical devices. This includes records of preventive maintenance, regular inspections, repair history and parts replacement. These records are important not only to ensure patient safety, but also for legal liability purposes. Should a device failure occur, the records can be used as evidence to determine the cause of the problem and assign responsibility.

Specific regulations

In addition to the CDC and civil liability, there are specific regulations relating to the manufacture, import, distribution and use of medical devices. In Brazil, the National Health Surveillance Agency establishes technical requirements that must be followed. Suppliers who fail to comply are subject to administrative sanctions, such as payment of fines and suspension of activities.

In this regard, two ANVISA regulations should be highlighted: Resolution No 67/2009 and Resolution No 551/2021. Both provide for critical information on post-market surveillance to ensure compliance with safety and performance standards which are also known as the ‘technovigilance system.

Resolution No 67/2009 determines that all registration holders must implement a structured technovigilance system to monitor adverse events and technical complaints relating to medical devices. These events/complaints should be notified to ANVISA through the National Notification Health Surveillance System (Notivisa) to ensure control over post-marketing health safety of medical devices. The system encompasses not only the notification of adverse events and technical complaints to the authorities, but also the investigation and adoption of measures by the companies in order to eliminate any kind of problem.

Resolution No 551/2021 emphasises the responsibilities of manufacturers, importers, and distributors in ensuring the safety and quality of medical devices, including their liability in cases of product defects or failures. The Resolution defines situations in which the execution of field actions by registration holders in Brazil are mandatory, establishing the minimum requirements for performing such actions.

It should also be highlighted that to obtain the marketing authorisation of a medical device, companies must demonstrate that their products comply with determined safety and performance requirements. In this regard, ANVISA has recently published Resolution No 848/2024 updating the essential safety and performance requirements applicable to medical devices. According to these updates, manufacturers must establish, implement, document and maintain a risk management system to ensure ongoing quality, safety, and performance of each medical device. Such a system might include for example: the implementation of an appropriate protection indicators, with the inclusion of alarms if necessary, relating to risks which cannot be eliminated; and the provision of safety information, such as warnings, precautions and contraindications; and, as appropriate, user training. The resolution will come into force in September 2024.

Under these resolutions, manufacturers, importers, and distributors of medical devices bear responsibility for the safety and performance of their products. They are required to conduct risk assessments, maintain quality management systems, provide adequate labelling and instructions for use, and promptly report adverse events or defects to ANVISA. In cases of product defects or failures resulting in harm to patients or users, they may be held liable for damages under Brazil’s product liability laws.

Conclusion

In the context of the purchase and use of medical devices, hospitals, clinics and doctors can be considered consumers in relation to the manufacturers and distributors of such device. In which case they will be entitled to compensation for damages caused by device failure without the need to establish fault.

As patients, clinics and hospitals are part of the supply chain, they are therefore also liable for any damage caused by device failure. Patients can claim compensation directly from clinics and hospitals for damage they have suffered, and the clinic or hospital must then seek compensation from the device supplier.

To ensure that they are duly reimbursed by the manufacturer, hospitals and clinics must comply with the supplier duties described above, especially the adequate maintenance of the device and the keeping of records, as well as compliance with safety rules and standards because. Otherwise, the device manufacturer may claim that the hospital or clinic was solely at fault, characterising the exclusion of the manufacturer’s liability and overturning the request for refund.

Doctors, on the other hand, will only be personally liable if it is proven that they were at fault.