Superior Court of Justice upholds conviction for side effects of bingo addiction.

Although the package insert is the most important health document for conveying information about a medication, the administrative process of requesting an update from Anvisa (Brazilian Health Regulatory Agency) cannot be used to evade the duty to inform the public about the inherent risks of its use.

With this understanding, the 3rd Panel of the Superior Court of Justice upheld the liability of a laboratory for side effects that caused a consumer to develop a gambling addiction.

The patient, who was taking medication for Parkinson's disease, after increasing the dose, considerably depleted her personal assets by compulsively participating in bingo games for three years.

The laboratory claimed there was no lack of information, as it followed Anvisa's regulations and initially included the warning in the package insert: “This product is a new medication and, although research has shown efficacy and safety when properly indicated, unpredictable adverse reactions may occur that are not yet described or known. In case of suspected adverse reaction, the doctor should be notified.”

According to the rapporteur, Minister Nancy Andrighi, the fact that a medication causes side effects does not in itself constitute a product defect if the user is previously and duly informed and warned about such risks. Thus, they can even freely and consciously decide on the treatment prescribed to them, in addition to minimizing any potential harm they already know they will experience.

That was not the case here, however. The minister states that it is an uncontested fact that compulsive gambling—a disease even recognized by the World Health Organization—was acknowledged as a side effect of the medication. When the patient began using the product, this was not listed in the package insert. Although it is now listed, this does not absolve the laboratory of responsibility.

Proof of damages and liquidity

In a special appeal, the laboratory contested the proof of the value of the damages, according to a simple arithmetic calculation — the amount of the patient's assets depleted due to the compulsion would reach R$ 1,1 million. On the other hand, the plaintiff attempted to prove lost profits: the amount she failed to earn due to the effects of this compulsion.

The Third Panel applied Precedent 7 and, unable to analyze evidence, upheld the decision. On the other hand, it dismissed the contributory negligence of the plaintiff determined by the court of origin. It was considered, initially, that the increase in the dose of the medication and its combined use with another drug worsened the clinical picture. And for this, the plaintiff would also have a share of the blame.

“At no point is the patient accused of ingesting a dosage higher than that recommended by the laboratory or prescribed by the doctor. The basis of the judgment to recognize contributory negligence on the part of the patient is unsustainable, in the sense that the lack of technical expertise to assess medication changes does not negate the duty of care for one's own health and to consult a medical specialist,” pointed out Minister Nancy Andrighi. (REsp 1.774.372) ( Revista Consultor Jurídico – Brasília – Danilo Vital)