On the liability of the manufacturer and the distributor of defective products

Responsabilidad productos defectuosos

 ¿Quien responde por los daños causados por productos, fabricante o distribuidor?

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La regla general es que responde el fabricante de los daños causados por productos defectuosos. El distribuidor podrá ser declarado responsable si no identifica al distribuidor dentro del plazo de tres meses que se establece en el artículo 138.2 del TRDCU.

La Sala de lo Civil del Tribunal Supremo ha resuelto uno de estos casos en sentencia el 20 July 2020, with No Resolution 448/2020, that we discuss below. Se desestimó el recurso de casación interpuesto por D. Bartholomew v. JOHNSON&JOHNSON, S.A. It considered that the manufacturer should have been sued and not the distribution company, because although they belonged to the same business group, the distributor fulfilled its obligation to inform D. Bartolomé on the identity of the manufacturer, therefore, the doctrine of the apparent producer was not applicable. The mere belonging to the same business group did not determine that the responsibility that the manufacturer could have for the damages caused by the defects of its hip prostheses was extended.

Fact background,,es,Juan Alberto and Paulina filed suit against FTA,,es,Asset Securitization Fund,,es,requesting the declaration of nullity for abusive of the floor and ceiling clauses contained in the novation contract of the mortgage loan of,,es,with the corresponding refund of amounts unduly collected,,es,The Securitization Fund Management Company,,es,Beech,,es,acting on behalf of FTA, he responded to said claim alleging that he lacked passive legitimacy since the entity had no legal personality and that it constituted only a private and open fund and that therefore the passive legitimization corresponded to BBVA as successor of Catalunya Banc that was the Company fund constituent,,es

D. Bartholomew was diagnosed on 6 August 2004 of avascular necrosis of the right femoral head (right hip).

A D. Bartholomew implanted the 20 January 2005 a hip prosthesis manufactured by the English company DEPUY INTERNATIONAL LTD., JOHNSON Group subsidiary & JOHNSON, S.A. The 11 May 2006 they discharged him, although with pain in activities of moderate effort.

In 2010, the manufacturer of the prosthesis, DEPUY ORTHOPAEDICS INC, issued a statement announcing the recall of the prosthesis that had been implanted in D. Bartolomé.

In 2012 underwent a revision procedure and a replacement of the prosthesis was recommended due to the problems he suffered. In 2013 was intervened, the prosthesis was changed by surgeon D. Eloy.

D's lawyer. Bartholomew sent the 14 May 2014 a bureau of extrajudicial claim to the manufacturer and distributor of the prostheses. The 18 June 2014, JOHNSON & JOHNSON, S.A., responded to the burofax, informing that they were mere distributors, and that the manufacturer was DEPUY INTERNATIONAL LTD.

D. Bartolomé filed a lawsuit 14 July 2014 against JOHNSON & JOHNSON, S.A., and against the two surgeons who intervened in the placement of the first prosthesis and its subsequent removal, D. Eduardo and D. Eloy, claiming compensation for damages attributed to the defective nature of the prosthesis. Invoked the art. 1101 Civil, contractual liability, alternatively, Article. 1902 CCivil, tort liability, as well as the arts. 5, 135, 137, 138, 146 and 148 LGCU.

Se planteó como cuestión jurídica quién respondía en el ámbito del derecho derivado de la Directiva 85/374/CEE, on liability for damage caused by products, when producer and distributor belonged to the same group of companies.

Primera Instancia

The Court of First Instance No. 46 Barcelona gave judgment on 5 February 2020, partially estimating demand. Condemned JOHNSON & JOHNSON, S.A., to pay to D. Bartholomew the amount of 24.042,93 € en concepto de indemnización, plus the anticipated interests of art. 576 LECivil. Condemned JOHNSON & JOHNSON, S.A. to compensate only the damages derived from the premature removal of the prosthesis, because it considered that there were damages caused by a previous pathology suffered and others that had not been proven. Dismissed the lawsuit against D. Eloy y D. Eduardo.

I consider that “Parent company and subsidiary form an economic unit and of legal imputation in front of the administration and in front of the injured, hence, they constitute a single company for the purposes of arts. 101 and 102 TFUE. ”

Provincial Court

D. Bartholomew and JOHNSON & JOHNSON, S.A. they filed appeals.

The 4th Section of the Provincial Court of Barcelona issued a ruling on 8 May 2017, upholding JOHNSON's appeal & JOHNSON, S.A., and dismissing that of D. Bartolomé. Revoke the sentence handed down in the first instance.

Estimó la excepción de falta de legitimación pasiva de JOHNSON & JOHNSON, S.A. The Section considered that D. Bartolomé should have sued the manufacturer and not the distributor since, although they belonged to the same group of companies, manufacturer and distributor were different legal entities.

Supreme Court

D. Bartolomé filed an extraordinary appeal for procedural infraction and appeal for cassation. La Sala desestimó ambos recursos.

The reasons alleged in the appeal fueron los siguientes:

first plea: the sentence handed down in the Provincial Court opposed the jurisprudence of the Supreme Court on the so-called “levantamiento del velo”. Violation of Arts. 6.4, 7.1 and 7.2 CCivil, in relation to the art. 4 Act 22/1994, of 6 July, manufacturer's liability for damage caused by defective products.

He stated that, the fact that the subsidiary had separate legal personality was not enough to exclude its behavior from being attributed to the parent company, particularly when the subsidiary essentially applied its instructions.

second reason: the sentence handed down in the Provincial Court opposed the jurisprudence of the Supreme Court on the “Doctrine of estoppel”, in relation to the art. 4.1.d) Act 22/1994, of 6 July, manufacturer's liability for damage caused by defective products.

Lifting the veil

The Chamber brought up the STS 34/2020, of 21 January, to express that "The European legislator wanted to channel responsibility in the person of the producer (manufacturer), deliberately leaving out the dealer (supplier or supplier) of the defective product, considering that you lack the ability to intervene in the product and do not have the knowledge or opportunity to inspect the goods with which you trade. The dealer responds exceptionally, only in the case that the producer (manufacturer) cannot be identified and the dealer does not identify you, or do not identify who, and the embroidery, He supplied the product to himself. It is about the injured party being able to find a person responsible and claim compensation in those cases in which they cannot identify any of the persons primarily responsible. (…)” (Directive 85/374, Law 22/1994 and LGCU).

For the Board, in this particular case, JOHNSON & JOHNSON, S.A., as a distributor of prostheses, yes cumplió con la obligación de informar sobre la identidad del fabricante en el plazo legalmente estipulado. Also, I consider that el hecho de pertenecer a un mismo grupo empresarial, both manufacturer and distributor, it could not be understood that the liability to indemnify JOHNSON was extended & JOHNSON, S.A., for damages caused by defects in the manufacturer's products.

In order to apply the so-called "levantamiento del velo”, It was required by law that the circumstances that put in evidence, a clear, abuse of the legal personality of the capital company.

Economic unit theory

Regarding the theory of economic unit, which was drawn up in the area of ​​sanctioning liability for conduct contrary to Competition Law, for the Chamber, it was not applicable in this case.

Para el TWENTY, make the distribution company respond under the same conditions as the production company, was an infringement of art. 3 of the exposed Directive. El TJUE, in various sentences handed down, “Has admitted that the national judge can determine, in light of the specific circumstances of each case and the factual situation before them, if the ties between the producer and another entity are close enough so that the concept of producer, in the sense of the arts. 7 and 11 Directive, also includes the latter entity (…)”.

For the Board, JOHNSON & JOHNSON, S.A., diligently identified who was the manufacturer of the prostheses, being the latter who should answer. It also considered that DEPUY INTERNATIONAL LTD AND JOHNSON & JOHNSON, S.A., they were two subsidiaries of the same group made up of a large number of different companies. Both societies had autonomy in the functions performed by each one. It was proven for the Chamber that DEPUY INTERNATIONAL LTD “Was the only one that developed all the functions of the manufacturer before marketing the prostheses and, subsequently, has exclusively proceeded to its voluntary withdrawal and collection for analysis. "

Doctrine of estoppel, of the apparent producer

Brought up the art. 3 Directive 85/374, where it was established that "Is understood by producer, the person who makes a finished product, that produces a raw material or that manufactures an integral part, and all that person who presents himself as a producer putting his name, brand or any other distinctive sign on the product. ".

For his part, the art. 4 of the same Directive, established which manufacturer was "Any person who presents himself to the public as a manufacturer, putting your name, social denomination, your brand or any other sign or distinctive on the product or on the packaging, the wrapping or any other element of protection or presentation. "

Ultimately, la Sala compartió el mismo criterio que estableció la Audiencia Provincial, considerando que el distribuidor no era el fabricante., namely, que JOHNSON & JOHNSON, S.A., no era el productor aparente, no habiendo infringido el art. 4 Act 22/1994.


Existe responsabilidad de los distribuidores cuando el producto es defectuoso si no identifican al fabricante en el plazo de tres meses fijado en el artículo 138.2 del TRDCU. El hecho de que fabricante y distribuidor pertenezcan al mismo grupo empresarial no siempre permite el “levantamiento del velo”,  doctrina que debe ser interpretada restrictivamente.

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