The Criminal Court of Milan, in the judgement no. 3314/2023, held Johnson & Johnson Medical S.p.a. liable for the inadequacy and ineffective implementation of the organisational model, convicting the company under articles 5(1)(b), 7 and 25(2) of Legislative Decree 231/2001.
The case in question provided an opportunity for the Judges to clarify the criteria to determine the adequacy and effectiveness of the implementation of the organisation, management and control model (hereinafter also referred to as the “Model”), depending on whether the perpetrator of the predicate offence is a manager or a subordinate.
In particular, in the judgment in question, as a preliminary point, the Court stated that under articles 6 and 7 of Legislative Decree 231/01, the Model is not mandatory because “the 231 system represents a burden (an opportunity, in a certain sense) for companies, but not an obligation” and, consequently, “the organisational fault – ontologically impersonal – may also consist in a deliberate disorganisation: the entity deliberately chooses not to adopt the organisational model”.
However, when the entity decides to adopt the Model, as in this case, those obligations must be considered as being ‘incorporated' and formalised in the Model itself, and their correct and effective implementation prior to the commission of the offence is indeed a reason to exclude the entity's liability.
On this point, the Court held that there were no significant differences – for the purposes of assessing the adequacy and effective implementation of the Model – between the regime laid down in Article 6, in relation to liability for offences committed by senior management, and that provided in Article 7, in relation to offences committed by employees.
The Court explained that “culpa in vigilando, which incorporates the element of a link between the offence and the organisation in the case of offences committed by non-key managers, does not necessarily involve the “culpable” conduct of a natural person in a position of control, but is (and in any event remains) linked to the structural guilt of the organisation, which is a form of “impersonal guilt” peculiar to the societas and directly related to the collective organisation, even if – as was also found in this case and as will be repeated below – it is innervated by the inadequate behaviour of individuals superior to the employees to whom the offence is attributed”.
In order to assess the liability of the entity for the offence, it is necessary to put oneself in the position of the entity at the time of the facts, assessing the conduct of the persons subject to the direction of others on the basis of the elements known and knowable at that time.
In particular, it will be necessary to consider whether: i) the employees (or other subordinates) correctly framed the activity at risk and complied with the policy and procedures laid down in the Model in relation to that activity; and ii) if not, whether the dysfunction in relation to the Model was identified and therefore corrected.
Applying the principles set out above, the company was convicted on the basis of the outcome of a complex investigation which revealed organisational and control system deficiencies and the systematic disapplication of sanctions.
Originally Published by 23 June 2023
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.
