Liability of the Republic of Austria for Breakage of Contraceptive IUD

Benn-Ibler Rechtsanwälte

IUD  breakage  compensation  intrauterine device  medical devices  pregnancy  unwanted  All tags

The Austrian Supreme Court (Oberster Gerichtshof, hereinafter OGH) recently examined the question of whether the federal government is liable under the principle of state liability in the event of an unwanted pregnancy resulting from a contraceptive IUD breaking due to a material defect.

In the case at hand, the plaintiff had an intrauterine device (IUD) implanted. However, the IUD was from a defective batch, and the material defect created an increased risk of breakage. The intrauterine device broke within the plaintiff's uterus without her awareness, resulting in an unintended pregnancy.

Obligations of the Republic of Austria Regarding Information

Alongside the manufacturer, named as the primary defendant (whose ongoing extraordinary appeal proceedings are paused until the Court of Justice of the European Union decides on the OGH’s preliminary ruling request from May 20, 2026, in Case 8 Ob 52/26v, Case C-582/26), the Republic of Austria has also been listed as a defendant. The plaintiff argues that Austria should be held liable under official liability, claiming that the Austrian Federal Office for Health Safety (BASG)—tasked with overseeing medical device markets—failed to meet its monitoring and communication duties. Specifically, despite being aware—or negligently unaware—of the increased risk of breakage, BASG did not properly inform gynecologists or the general public in a timely and thorough way, thus violating its obligations. The plaintiff informed BASG about the material defect and heightened risk of intrauterine device breakage from the relevant batch in February 2018, but a public warning was only issued in September 2020.

The second defendant countered that there were objective reasons for initially informing only the specialist doctors (gynecologists) - and not the ‘general public’ - of the risk of breakage, because as users of the medical device they were obliged to take all necessary measures within their sphere of responsibility to ensure the protection and safety of their patients.

Telling the difference between a breakage that happens in situ and one that occurs during extraction

The OGH affirmed the judgment rendered by the trial court.

A distinction exists between coil breakage occurring in situ (within the body) and those that happen during removal. In its initial communication to the second defendant and at the time of the plaintiff’s pregnancy, the manufacturer—serving as the first defendant—had only identified the potential risk of breakage during removal. It was not until the safety advisory issued on September 25, 2019, that awareness emerged regarding the possibility of IUDs breaking inside the body (in situ). Because the plaintiff’s IUD had already broken prior to this official notice, BASG cannot be held responsible for neglecting to warn patients or the public about a risk that was not known at the time.

OGH 1 Ob 73/26f (24 June 2026)




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