Post invitado de Antonio Selas: «Cuidado con la publicidad de tu empresa en USA»

Noticias de la PI Post invitado de Antonio Selas: "Cuidado con la publicidad...
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Este post viene de la mano de Antonio Selas (Cremades & Calvo Sotelo):

Un juez federal norteamericano acaba de desestimar la demanda interpuesta por un antiguo administrador y tres altos cargos de Purdue Frederick Company Inc., a los que se prohibió participar en proyectos federales de salud durante 12 años, por la publicidad realizada de uno de los medicamentos de dicha sociedad. La responsabilidad se extiende por tanto a cuatro empleados de la sociedad. Lo más curioso de la Sentencia es que no se basa en su participación en los hechos (como se exige por ejemplo en el art. 34 de nuestra LCD), sino en el hecho de que dichos trabajadores se declararan culpables en el procedimeinto penal previo (lo que pactaron con la fiscalía para evitar el riesgo de una condena privativa de libertad).

Tal y como se indica en la sentencia la sociedad hizo una camapa agresiva para aumentar las ventas de OxyContin, atribuyendo unas supuestas ventajas frente a otros calmantes.

En relación con los hechos se lee en la Sentencia:

… aggressive campaign to increase the sale of OxyContin. (AR 743) The investigation revealed that “[b]eginning on or about December 12, 1995, and continuing until on or about June 30, 2001, certain Purdue supervisors and employees, with the intent to defraud or mislead, marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.” (AR 2225-26) Company representatives made these claims despite the fact that Oxycontin’s approved new drug application “did not claim that OxyContin was safer or more effective than immediate-release oxycodone or other pain medications,” and the company “did not have, and did not provide the FDA with, any clinical studies demonstrating that OxyContin was less addictive, less subject to abuse and diversion, or less likely to cause tolerance and withdrawal than other pain medications.””.

En relación con la pretension de los demandantes:

“plaintiffs Michael Friedman, Paul Goldenheim, and Howard Udell seek review of a final decision of the Secretary of the Department of Health and Human Services (“the Secretary” or “the Department”) excluding them from participation in Medicare, Medicaid, and all other federal health care programs for twelve years. The Secretary’s exclusion decision was based on plaintiffs’ misdemeanor guilty pleas to charges that they served as “responsible corporate officers” of the Purdue Frederick Company during a five-and-a-half-year period in which that company has admitted to marketing misbranded drugs with “the intent to defraud or mislead” in violation of the Food, Drug, and Cosmetic Act”.

En relación con el que parece el argumento determinante de la desestimación de la demanda:

“Although plaintiffs repeatedly attempt to characterize their convictions as “purely status-based” offenses that were “‘related to’ their own status as senior executives at the relevant time [and] nothing else” (Pls. Mem. at 2, 31), this description of plaintiffs’ role in the misbranding of OxyContin simply cannot be squared with the elements of the statutory offense to which they pled guilty or the statement of facts to which they agreed.

… plaintiffs can hardly be heard to argue now, over three years after pleading guilty to the criminal charges against them, that they did not engage in any “wrongful” or “culpable” conduct. The Agreed Statement of Facts accompanying their plea agreements specifically acknowledged that plaintiffs served as “responsible corporate officers” of Purdue over a five-and-a-half-year period during which they had “responsibility and authority either to prevent in the first instance or to promptly correct certain conduct resulting in the misbranding of a drug introduced or delivered for introduction into interstate commerce,” but that they failed to do so”.

Blog Lucentinus
Aurelio López-Tarruella
Profesor Titular de Derecho internacional privado. Universidad de Alicante (España), Abogado Of Counsel de Baylos, Profesor del Doctorado Europeo EIPIN – Information Society (Horizon 2020 Marie Skłodowska Curie Action ITN-EJD 2016-2019) y de diferentes Masters y cursos en España y el extranjero. Consultor para OMPI, la Comisión Europea y el Parlamento Europeo en proyectos de propiedad intelectual. Autor y editor de diferentes publicaciones.

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