by Richard Hogan December-11-2018 in Healthcare Law, Litigation & Dispute Resolution

In 2018 the European Court of Justice (“ECJ”) gave its first substantive decisions on the issues of defect and causation under the Product Liability Directive 85/374/ECC (the “Directive”) in the decisions of N W v Sanofi Pasteur MSD SNC (C-621/15) and Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt Die Gesundheitskasse (C-503/13)


W v Sanofi Pasteur MSD SNC (Case C-621/15)

The ECJ examined whether under Article 4 of the Directive, Member State laws could allow evidentiary presumption that a defective vaccine caused a disease when the onset of the disease followed shortly after the vaccine was administered.  Article 4 of the Directive provides that “the injured person shall be required to prove the damage, the defect and the causal relationship between the defect and damage”.



A claim was brought by the family members of a patient (W) who was vaccinated against hepatitis B and then contracted multiple sclerosis prior to his death. The family claimed the vaccine was the cause of the multiple sclerosis. They relied on a previous decision of the French courts that allowed proof of causation by way of an evidentiary presumption where the patient had no family history of the disease and the onset of the disease followed soon after the vaccine was given. This enabled the claimant establish causation despite the notable lack of scientific evidence that the hepatitis vaccine causes multiple sclerosis.

The French Court asked the ECJ to consider whether:

  1. The evidentiary presumption and the systematic application of those presumptions was compatible with the directive; and

  2. If such presumption was incompatible with the Directive, what scientific evidence of a causal link must be presented by the claimant.



The ECJ considered that in this case, the use of evidentiary presumptions was permissible under Article 4 of the Product Liability Directive. The Court concluded:

  • "causal relationship” is not strictly defined in the Product Liability Directive and it is up to Member States how evidence was to be elicited; what evidence would be admissible; and the principles surrounding the probative value of evidence.

  • The evidentiary presumptions did not change the burden of proof.

  • To only allow certain proof based on medical research would be unfair on claimants.

The ECJ decision confirmed national courts have discretion in determining what evidence a claimant has to present to prove causation. This discretion is subject to national courts evidential requirements not reversing the onus of proof under Article 4 of the Product Liability Directive.


Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt Die Gesundheitskasse (C-503/13)

The ECJ considered whether for the purposes of proving a ‘defect’ under Article 6(1) of the Directive, it was possible to prove that a product, which belonged to the same group or production series of products (product group), was defective on the basis of an unacceptably high failure rate within that product group. Article 6 of the Directive provides that "A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account…..".



Boston Scientific advised customers that a pacemaker and cardioverter defibrillators they produced may be defective. Boston Scientific claimed the issue with defibrillators could be corrected simply by deactivation of a magnetic switch, however they advised customers to consider replacing the pacemakers. The insurers for two patients sought to recover the costs of implantation of the original pacemakers. The potentially defective pacemakers were destroyed during revision surgery.

The German Bundesgerichtshof (German Supreme Court) referred two questions to the General Court:

  1. Where it is established that a group of products or products forming part of the same production series are potentially defective, is it possible to classify any particular such product as defective without proving that it actually has the relevant defect?

  2. Does the damage caused by an operation to explant and replace a defective product constitute “damage caused by death or personal injuries” within the meaning of Article 1 and 9 of the Directive?



The Court answered yes to both questions. The Court concluded:

  • The high failure rate was sufficient to prove that any product in the group was defective. “Where it is found that products belonging to the same group or forming part of the same production series, such as pacemakers and implantable cardioverter defibrillators, have a potential defect, such a product may be classified as defective without there being any need to establish that product has such a defect”.

  • Damage caused by a surgical operation for the replacement of a defective product is ‘damage caused by death or personal injuries’ within the meaning of the Directive if the operation was required to overcome the defect.


The facts that the products were implanted medical devices performing a life-sustaining function and the manufacturer had admitted unacceptably high failure rates were pivotal to the Court’s decision that the products were defective. Whether this decision will make it easier to prove defect for other cases involving medical devices or pharmaceutical products remains to be seen.

For further information please contact Richard Hogan at Hayes solicitors.

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