Drug recall complies with legislation and minimizes damage, assess lawyers

Consumer Law

The recall by two pharmacists of some batches of drugs used to treat gastric ulcers caused concern among users this week. According to Medley and Aché, the risk of possible contamination with a potentially carcinogenic substance was verified.

Also according to the manufacturers, the remedies, based on ranitidine hydrochloride, may contain N-nitrosodimethylamine (NDMA), a molecule in the group of nitrosamines.

Experts assess that recall is the right measure to prevent lawsuits and reduces damage to the image of companies.

The National Health Surveillance Agency (Anvisa) warns that, in the long term, these substances may increase the risk of cancer. In the evaluation of experts, companies are right to adopt the preventive measure, quickly and objectively.

Marília Gusso, partner at WZ Advogados, explains that the drug recall procedure follows the same rule as any other product, involving, among other measures, publicizing the discovery of a potential harmful to the consumer, collecting the product and meeting the consumers who may have suffered losses as a result of the defect – or possible defect – found.

“It is worth calling attention, however, to the willingness of pharmacists to promptly comply with the guidelines of health authorities, even though, in this specific case, it was found that the risk of developing cancer due to contamination with nitrosanima is relatively low” .

The lawyer also points out that currently there is a great concern to contain reputational losses. According to Marília, with the Consumer Protection Code, it is clear that the supplier / manufacturer is liable for damages arising from defects in the product.

“Avoiding damage to the health of consumers, even though the effective impact of contamination on human beings can be discussed, is the priority, and so it must be treated by the industry”, she concludes.

Wilson Sales Belchior, partner at Rocha, Marinho e Sales Advogados and Federal Adviser at OAB, praises the pharmaceutical sector’s commitment to Brazilian consumers by “adopting a precautionary measure, at no cost to patients, through the preventive collection of medicines”.

“It is important to note that the action, of a precautionary and preventive character, results from studies with nitrosamines, which are found in some foods and drinking water supplies, with no potential for damage when ingested at very low levels. In fact, Anvisa Resolution No. 283/2019 regulates the investigation and control of these substances. In this way, the concern of pharmaceutical companies is demonstrated in meeting high standards of transparency, responsibility and legal and regulatory compliance ”, evaluates Belchior.

Source: ConJur

https://www.conjur.com.br/2020-jan-21/recall-medicamento-atende-legislacao-minimiza-dano