Customer Service as a Source of Legal and Regulatory Risks in the Regulated Products Industry

Abstract: Standardized customer service responses may expose companies that manufacture regulated products to significant legal and health risks. This article identifies recurring examples: the use of operational jargon that suggests confirmation of deviations; terms with technical and regulatory connotations that may trigger mandatory reporting obligations to ANVISA, or even precautionary measures; references to corrective actions that, in theory, could constitute an admission of liability; and specific risks associated with communications involving off-label use and products used outside their registered scope (including for veterinary use).

The Customer Service Department (“SAC”) of companies that deal with regulated products (pharmaceuticals, food, cosmetics, health products, etc.) occupies a particularly sensitive position on the corporate risk map. It is simultaneously a legal obligation (Law No. 8,078/1990 and Decree No. 11,034/2022), a channel for pharmacovigilance or technovigilance (as provided, for example, by the Resolutions of the National Health Surveillance Agency—“Anvisa”), and a repository of statements that, in the event of a dispute (whether administrative, before Anvisa, or judicial), will be read not by the customer service team, but by health authorities, judges, and lawyers. The disconnect between, on the one hand, the operational language of the company’s customer service department and, on the other, the technical and legal language appropriate for a given corporate position goes far beyond a mere communication problem and has consequences on both administrative and judicial fronts.

A primary and recurring risk factor lies in the use of operational jargon in external communications. Expressions such as “valid complaint,” “confirmed conclusion,” or “confirmed/valid record,” for example, may suggest that the consumer’s complaint has been received, recorded, and accepted for follow-up, without necessarily implying a judgment on the technical or health-related merits of the claim. However, without proper context, the result can be a document that leaves room for various interpretations. For example, it may suggest that the alleged deviation reported by the consumer has been effectively confirmed by the company, which is not always the case. This terminological oversight can, under certain circumstances, broaden the scope of interpretation regarding the same fact, thereby also increasing the challenge of establishing the truth when that case becomes the subject of administrative or judicial litigation.

A second and recurring element lies in the use of words that carry specific meanings in the regulatory context. As an example, we cite the frequent mentions, in customer service responses, of the words “effectiveness,” “quality,” “safety,” “risk,” and “deviation” in relation to the product. In technical vocabulary, these words have specific meanings, and when they appear in response to a complaint about an alleged deviation in regulated products, an interpretive link is created—albeit unintentionally—between the consumer’s report and a possible technical issue associated with the product. This can automatically lead to the adoption of more severe measures by regulatory authorities (for example, with immediate implications for the mandatory reporting obligation to Anvisa and, in extreme cases, for precautionary measures such as product recalls and the suspension of marketing, distribution, and use). A single misplaced word can turn a routine complaint into a highly complex regulatory trigger. If such responses are provided on a large scale (i.e., multiple similar complaints being answered in a standardized manner using sensitive language), this may indicate a recurring, serial problem—all of which has been misclassified or described imprecisely.

A third and recurring element lies in the use of terms that suggest the company has taken action in response to the fact alleged by the consumer. This is also a response commonly given by companies’ customer service departments, but great caution is required. Stating that the company engages in continuous improvement of its processes is absolutely true and, in theory, positive. This, however, is different from claiming that measures were implemented in response to the fact reported by the consumer, as this approach produces two simultaneous and potentially harmful effects. Depending on how the information is presented, (i) it may suggest that there was an individualized investigation of the case that concluded there was a specific failure; and (ii) it may suggest that the company took corrective measures in response to that specific incident described by the consumer, which is entirely distinct from the routine maintenance of a program for the continuous improvement of best practices, unrelated to any specific occurrence related to a complaint. The distinction is not merely semantic: it determines whether or not the company is admitting liability, and this has direct legal implications in any dispute, whether in an administrative proceeding or a judicial proceeding.

A fourth issue that has always been a concern for the pharmaceutical industry—and one that has recently gained prominence in the medical device sector—pertains to discussions regarding the off-label use of regulated products. Communication about off-label use must be scientifically grounded, with due regard for limitations of liability, particularly when the decision was made at the discretion and under the sole responsibility of the prescribing physician or other healthcare professional. Particularly in the field of medical devices, there has been an increase in customer service inquiries regarding questions, reports of adverse events, or requests for maintenance of products that, although registered for human use, have been used to provide veterinary services. It is not uncommon for the industry (manufacturer or importer) to register the product solely for human use and not have a sales channel in the animal health sector, yet to spontaneously receive inquiries from consumers or service providers who have purchased these products to meet the growing demand in the pet/vet market. Here, again, as in previous cases, care must be taken with the language and context of each response provided through customer service.

It is always important to remember that customer service operates using templates developed by internal teams, in line with the customer relationship management system; however, these templates must always undergo legal and regulatory review before implementation. It is always recommended to establish a protocol for reviewing customer service responses, consisting of at least three stages. The first stage is regulatory: the response must be consistent with the status of the investigation and with the quality system records (nothing can be stated to the consumer that contradicts or anticipates conclusions not yet formally established internally), and the use of words that carry specific regulatory connotations should be avoided (except when there is, in fact, certainty regarding the concept being conveyed). The second stage is consumer-oriented: the Consumer Protection Code (Law No. 8,078/1990) requires transparency and good faith, but does not require the company to make statements against its own interests that go beyond what is necessary to adequately inform the consumer about the action taken in response to their complaint. The third stage is litigation-related: every response must be drafted as if it were to be made public, presented in court, or submitted to the regulatory authority (because there is always a chance that it actually will be).

In short, the customer service department of companies that deal with regulated products is not merely a support function: it is a risk management function. Every response sent to a consumer is simultaneously a regulatory act, a consumer protection act, and a potentially evidentiary act. Therefore, a systematic review of the responses used by the company’s customer service department, along with a critical assessment of this issue, can significantly help mitigate risks. The cost of learning this lesson the hard way is invariably disproportionate to the cost of preventing it.

This material is for informational purposes only and should not be used in isolation for decision-making. Specific legal advice may be provided by one of our attorneys. Copyright is reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.