OGH on Product Liability for Medical Devices

Dec 6, 2024 Benn-Ibler Rechtsanwälte

In the case at hand, the Austrian Supreme Court (Oberster Gerichtshof, hereinafter OGH) had to decide on the product liability of a sleep apnoea ventilator.

The plaintiff had purchased a ventilator imported into the EEA by the defendant. After several years of use, the plaintiff received a safety notice from the manufacturer warning of possible problems with the foam in its ventilators, which could decompose or release chemicals and cause health damage.

The plaintiff went to court, claiming damages for pain and suffering. The foam material was present in his device according to the findings of the court of first instance, but there had been no deterioration in the plaintiff’s state of health from the foam material. However, it could not be ruled out that the use of the device might have long-term effects.

The OGH upheld the decision of the lower courts: The claim for damages was dismissed in this respect. However, the defendant’s liability for future damages was upheld.

Product liability requires the presumption of a defect within the meaning of Sections 5 of the Product Liability Law. According to the OGH, the decisive factor in this case was whether the product showed an unexpected lack of safety and not whether an injury had already occurred.

The OGH ruled that if a respirator intended for use every night for many hours over a long period of time contains a material that is potentially harmful to health, the product does not meet the reasonable safety expectations of the average user within the meaning of the Product Liability Act.

Non-pecuniary damages for a mere impairment of the psychological well-being, such as the discomfort that the plaintiff found after receiving the security message cannot be claimed in this respect. Mental distress cannot be classified as a serious intrusion into an individual’s psychological sphere as it lacks the independent value of an illness.

OGH 4 Ob 109/24v (22 October 2024)