HvJ EU: Wanneer een medisch hulpmiddel potentieel defect is, zijn alle producten van dat model defect

HvJ EU 5 maart 2015, LS&R 1082; gevoegde zaken C-503/13 en C-504/13 (Boston Scientific Medizintechnik tegen AOK en Betriebskrankenkasse RWE)
Zie eerder Conclusie AG: LS&R 1017. Uit het persbericht: Where a medical device has a potential defect, all products of the same model may be classified as defective. The manufacturer of such a defective device must reimburse the costs relating to the replacement of the product where such replacement is necessary and to restore the level of safety which a person is entitled to expect.

The Product Liability Directive provides that the producer is liable for damage caused by a defect in his product.
A company which sold pacemakers and implantable cardioverter defibrillators in Germany found, after carrying out quality control checks, that those products might be defective and constitute a danger to patient health. In view of that situation, the producer recommended physicians to replace the pacemakers implanted in patients with other pacemakers provided free of charge. At the same time, the manufacturer recommended treating physicians to deactivate a switch in the defibrillators.

The insurers of the persons whose pacemaker or defibrillator has been replaced claim reimbursement of the costs relating to the replacement from the manufacturer.  (...persbericht...)

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