Brazil: Inherent Risk Of Medications - Application Of The Consumer Protection Code And Related Legal Provisions

The Consumer Protection Code is soon to turn 25. This law brought indisputable advances in the protection of consumer rights, especially as regards protection of consumers' health, a social right provided for in article 196 of the Brazilian Federal Constitution and supplemented by article 2, Law no. 8.080/90, which sets up the conditions for health promotion, protection and recovery, as well as the organization and operation of corresponding services. To this effect, on determination by the Consumer Protection Code and related legislation that as a rule products cannot entail risks to consumers' health, the most important effect to society certainly was the offer by suppliers in general, of products with higher quality and safety to consumers.

The general rule is that whenever the consumer suffers damage to health or safety as a result of defective or faulty product, the manufacturer's duty to indemnify will arise. As to pharmaceutical products, the rule is the same: in case a certain medication causes damage to consumer's health, the manufacturer must indemnify the consumer, be this damage of pecuniary nature (such as medical treatment, for instance), or mental distress. This opinion derives from the regulation in article 8 of the Consumer Protection Code, which provides that "The products and services placed on the consumer market shall not entail risks to consumers' health or safety, except for those deemed normal and predictable as a result of their nature and use, whereas in any event the suppliers are liable to provide the required and appropriate information thereon".

However, the second portion of this legal provision presents an exception to the rule that products placed on the consumer market shall not entail risks to consumers' health. This article determines that the risks to consumers' health and safety, where normal and predictable, are legally accepted. This is the so-called inherent risk of the product. A high rate of such normal and predictable risks is found in pharmaceutical products. Some renowned jurists appropriately point out that in view of their nature, nearly all medications present a normal noxiousness rate.

The aforementioned noxiousness rate results mostly from the unpredictability of physiological responses intrinsic to each person when making contact with a certain chemical substance in the composition of the medication. Normally, the normal and predictable risks are classified as "adverse responses'" to, or 'side effects" of, the medication. Another possibility that cannot to be discarded is that the risk to the consumer's health may result from drug interaction, that is, the effects of a medication are changed in view of simultaneous ingestion of another medication. Nevertheless, we are of the opinion that under the consumer rights standpoint, medication manufacturers cannot be held liable for events resulting from this "normal noxiousness rate" of the product, provided that the consumer is duly informed of the issue.

It is important to stress that the information on the risks is deemed lawful and appropriate where it is expressly mentioned in the printed directions of the medication, which in turn must comply with the regulatory legislation on the subject. As to this issue, the information must conform to Resolution no. 47 issued by ANVISA (Brazilian Health Surveillance Agency), which sets up the rules for preparation, conformity, update, publication and availability of directions in medications to patients and health professionals. Some argue that on enactment of the current Brazilian Civil Code, the supplier became civilly liable for the damage caused to consumer, even that resulting from inherent risk. This opinion is grounded on article 931 of the Brazilian Civil Code, which provides that "Except for other cases provided for in special law, individual entrepreneurs and companies are liable for the damage caused by products placed on the market, irrespective of fault".

This opinion seems mistaken to us, as under the principle of specialty of regulations, the provisions in the Consumer Protection Code should prevail in cases of consumer transactions. Moreover, application of this Civil Code provision to consumer transactions would impose an excessive burden on the product supplier, which could entail a lack of incentive to exploit economic activities. Within the scope of pharmaceutical companies, what attractiveness would there be in the technological and scientific development of medications if such economic activity has a significant probability of naturally entailing a liability to indemnify?

Certainly, this scenario would mitigate the advances made by scientific studies of medications and lead to a lack of investors' interest in this business field, with an adverse impact on the social right to health. For this reason, in our opinion pharmaceutical industries could not be held liable for events deriving from inherent risks of medications, provided that such events are validly and lawfully informed in the directions of the product. Under this context, the inherent risk should be deemed a cause barring product manufacturer's liability.

The great issue that raises controversy and dispute on the subject concerns the concepts of normality and predictability provided in the Consumer Protection Code, which enable application of cause barring liability. Within the judicial sphere, it may be mentioned that only a rigorous technical evidence presented by a specialist in the pharmaceutical or medical area would be capable of determining whether the risk may in fact be deemed normal and predictable in view of the product nature.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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