Bernadete de Figueiredo Dias
CGM Advogados, São Paulo
bernadete.dias@cgmlaw.com.br

The import, manufacturing and sale of medical devices^[2] in Brazil require prior registration with the Brazilian Health and Surveillance Agency (Agência Nacional de Vigilância Sanitária or 'ANVISA') with evidence of the product's safety, effectiveness and quality.

The product registration holder is technically and legally responsible for the medical device before ANVISA, and has the obligation to respond to and notify the National System of Sanitary Surveillance (Sistema Nacional de Vigilância Sanitária or 'SNVS') of any technical issues or adverse events, a situation that may result in serious threat to public health and any other occurrences that represent a sanitary risk that are related to the product.^[3]

ANVISA Resolution No 67/2009 is the main regulation regarding the procedures applicable in the event of a defective medical device. However, as Brazil is a civil law country, when dealing with product liability, sanitary regulations must be interpreted in the context of the general liability laws, mainly the Civil Code^[4] and Consumer Protection Code (Código de Defesa do Consumidor or 'CDC').^[5]

In this article we focus on the rules applicable to product liability involving implantable medical devices^[6] in Brazil.

Product liability rules

The Brazilian Civil Code

Based on the Brazilian Civil Code a party is generally liable for the actual damages inflicted on another. The concept of 'actual damages'^[7] includes: (1) losses effectively incurred by the injured party (ie, material and, possibly, moral damages); and (2) profits that the injured party has reasonably lost, in each case, as a direct result of the injurious action or inaction. While material damages are determined by reference to the actual reduction in value of the property of the injured party, moral damages are determined by reference to the extent of the harm to the reputation of or the emotional distress caused to the injured party.

To hold one liable, the injured party must demonstrate that: (1) damage has occurred; (2) such damage has been directly caused by an action or inaction of another party; and (3) such action or inaction has been the consequence of negligence, recklessness, unskillfulness or wilful misconduct.^[8]

No liability will exist if damage: (1) results from events beyond the reasonable control of a party, the effects of which could not have been avoided or prevented (force majeure); or (2) has been caused exclusively by the other party or a third party (except if the contracting party has assumed liability for the actions or inactions of such a third party).

The sale of a defective product may trigger liability for actual damages, including moral damages and lost profits, mainly related to the replacement of the defective medical device; the procedure that may be required for said replacement (in the case of implanted devices); patient pain and suffering; and lost profits (eg, loss of income for malfunctioning of the device or for stopping work due to the defect or new procedure).

Consumer relations

Under the CDC: (1) a consumer is an individual or legal entity that acquires or uses a product or service as the final user; and (2) a supplier is every individual or entity that develops an activity in the production, assembly, creation, construction, transformation, import, export, distribution or commercialisation of products (movable or immovable, and tangible or intangible assets), or the rendering of services.

The safeguarding of life, health and safety against risks caused by means of the supply of products considered hazardous or harmful is among the consumers' basic rights established by CDC.

As a result, if a supplier, after introducing a product in the Brazilian market, becomes aware that this product may be harmful to the health or safety of consumers (except if the harmfulness is considered normal and predictable as a result of the product's nature and use, and consumers are duly informed), the supplier shall notify the competent authorities and consumers, mainly informing them about the defect, the risks associated with the defect, the actions to correct the defect and the actions to mitigate the risks.

In the case of medical devices, the supplier must notify the Ministry of Justice (through a consumer protection division called SENACON) and ANVISA.

ANVISA regulations

ANVISA Resolution No 67/2009 provides for technological vigilance standards applicable to medical product registration holders in Brazil. It establishes that they must have a surveillance system for adverse events and technical complaints related to medical products, and recommends the adoption of measures for the protection and promotion of health.

As the registration holder is legally responsible for the health product it has registered in Brazil, it must notify the SNVS within a maximum period of 72 hours^[9] after becoming aware of the occurrence of a serious threat to public health associated with a medical product, subject to civil and administrative liability for non-compliance with applicable regulations.

Product liability and implanted medical devices

When dealing with implantable medical devices, the liability of the product registration holder may go beyond the duty to inform the competent authorities and repair or replace the defective medical device. Pain and suffering, lost profits and the cost of the procedure required for this replacement may also be indemnifiable.

The fact that the Brazilian health system includes universal access to healthcare offered by the government and that some Brazilians are covered by private health insurance does not reduce this liability.

Public Health System (Sistema Único de Saúde or SUS)

In Brazil, every person is entitled to access goods and services to promote, prevent, protect, treat and recover health. This access includes exams, vaccination and appointments, and minor and major procedures, provided they are included in a list of procedures covered by SUS.

Therefore, if a duly qualified physician indicates the replacement of a medical device as a necessary course of action to protect the health of a patient, this procedure (including the device) should be covered by SUS. The fact that the replacement of the medical device is caused by a possible defect in the product should not serve as basis for denial of coverage by SUS because the patient/consumer is the vulnerable party protected by law.

In practice, however, there is a long list of patients waiting for assistance in all medical areas, so the timing in which a patient can actually replace the medical device through SUS may not be adequate, considering the risk of the defect. Thus, a patient may opt to demand that the procedure is paid for by the product registration holder and have it conducted in a private hospital rather than wait on the SUS patient list to have the procedure.

Private health system: health insurance

The health insurance system is regulated by an agency called Agência Nacional de Saúde Suplementar ('ANS'). Among other things, ANS sets forth basic terms and conditions that must apply to all health insurance plans in Brazil and issues a list of procedures that must be covered by all health insurance providers.

Therefore, if a duly qualified physician indicates the replacement of a medical device as a necessary course of action to protect the health of a patient, this procedure (including the device) should be covered by the health insurance plan. The fact that the replacement of the medical device is caused by a possible defect in the product should not serve as basis for denial of coverage by the health insurance provider because the patient/consumer is the vulnerable party protected by law.

However, if the health insurance plan held by the individual is new, there is a chance that the procedure is denied on a basis that this is a pre-existing condition.^[10] Besides, a patient that had the first procedure covered by health insurance may no longer have access to the private health system at the time the replacement is needed, so the alternative for the patient would be to have the procedure through SUS, as indicated above.

A patient that is not covered by health insurance for any reason may opt to demand that the procedure is paid for by the product registration holder and have it conducted in a private hospital rather than wait on the SUS patient list to have the procedure.

Despite the above, even if the patient has the procedure paid for by SUS or a health insurance plan, nothing prevents SUS or the health insurance provider from charging the amount spent in the procedure for the replacement of the medical device to the product registration holder. Therefore, SUS or the health insurance provider would have recourse against the product registration holder for the reimbursement of the costs associated with the replacement of the defective medical device.

Notes