Medi­cal devices – The Ger­man Fede­ral Court of Jus­ti­ce has ruled on pro­duct defects in hip prostheses


In 2007, the plain­ti­ff had been implan­ted with a total hip endo­pro­sthe­sis (“arti­fi­ci­al hip joint”) manu­fac­tu­red by the defen­dant. About four years after the implan­ta­ti­on, the hip pro­sthe­sis had to be repla­ced. The reason for this was a mal­func­tion of the pro­sthe­sis, trig­ge­red by the breaka­ge of a cup built into the prosthesis.

The plain­ti­ff con­side­red the defec­ti­ve cup to be a pro­duct defect of the hip pro­sthe­sis and clai­med dama­ges from the medi­cal device manu­fac­tu­rer. The Ger­man Fede­ral Court of Jus­ti­ce (BGH), howe­ver, ruled that the plain­ti­ff was not entit­led to the asser­ted cla­im for dama­ges – neither accor­ding to the rules of no-fault lia­bi­li­ty pur­su­ant to §§ 1, 3, 8, 9 of the Ger­man Pro­duct Lia­bi­li­ty Act (Prod­HaftG) nor accor­ding to tort lia­bi­li­ty under § 823 subs. 1 of the Ger­man Civil Code (BGB).

Pro­duct defect – yes or no?

In order to estab­lish a pos­si­ble defec­ti­ve­ness of the hip pro­sthe­sis, the BGH first drew on the com­mon con­cepts of defect. The rele­vant safe­ty expec­ta­ti­ons under the Ger­man Pro­duct Lia­bi­li­ty Act are gene­ral­ly asses­sed accor­ding to the same objec­ti­ve stan­dards as the manufacturer’s obli­ga­ti­ons to ensu­re safe­ty in the con­text of tor­tious lia­bi­li­ty. The­r­e­fo­re, it is gene­ral­ly pos­si­ble to refer to manu­fac­tu­ring, design and ins­truc­tion defects, which cate­go­ri­se the spe­ci­fic obli­ga­ti­ons to ensu­re safe­ty in the con­text of tor­tious pro­duct lia­bi­li­ty. The BGH held that the­re was no manu­fac­tu­ring, design or ins­truc­tion defect in the spe­ci­fic case in ques­ti­on. In the opi­ni­on of the BGH, the manu­fac­tu­rer had com­pli­ed with its obli­ga­ti­ons to ensu­re pro­duct safe­ty. Howe­ver, the plain­ti­ff could not bene­fit from the rever­sal of the bur­den of pro­of in favour of the inju­red par­ty in the pre­sent case.

Poten­ti­al seri­al defect?

Fol­lo­wing the prin­ci­ples of the so-called “suspec­ted defect judgment” of the Euro­pean Court of Jus­ti­ce (ECJ, NJW 2015, p. 1163), the court also addres­sed the ques­ti­on of whe­ther the hip pro­sthe­sis suf­fers from a poten­ti­al seri­al defect.

In the case of medi­cal devices of hig­her risk clas­ses, a pro­duct defect pur­su­ant to § 3 subs. 1 Prod­HaftG is alre­a­dy dee­med to exist if a mal­func­tion has occur­red in a signi­fi­cant num­ber of pro­ducts of the same pro­duct group or pro­duc­tion series. The requi­re­ments for the safe­ty of cer­tain medi­cal devices need to be par­ti­cu­lar­ly strict, sin­ce a poten­ti­al pro­duct defect invol­ves an extra­or­di­na­ri­ly high poten­ti­al for harm to affec­ted per­sons. Accor­din­gly, a defect in other pro­ducts of the same pro­duct group or pro­duc­tion series is dee­med to estab­lish a firm sus­pi­ci­on of a defect in the spe­ci­fic pro­duct, the defec­ti­ve­ness of which then need not be spe­ci­fi­cal­ly pro­ven, but is presumed.

Howe­ver, the BGH did not assu­me a poten­ti­al seri­al defect in the spe­ci­fic case in ques­ti­on eit­her. In this con­text, the BGH con­side­red the frac­tu­re rate of cera­mic inlays with a size of 36 mm and drew a com­pa­ri­son with cera­mic inlays of all sizes. Alt­hough mar­gi­nal dif­fe­ren­ces were found, they were not con­side­red as rele­vant. The BGH explai­ned that only tho­se parts that were com­pa­ra­ble to the rele­vant pro­duct in terms of size, mate­ri­al and con­s­truc­tion should be taken into account, becau­se other­wi­se it could not be assu­med that the pro­duct group was the same. Moreo­ver, the breaka­ge rate its­elf was so low that it was not suf­fi­ci­ent to assu­me a seri­al defect. Regard­less of the­se con­side­ra­ti­ons, the BGH found that the manufacturer’s lia­bi­li­ty also had to be denied becau­se even if a poten­ti­al seri­al defect had been assu­med, it would not have been the cau­se for the plaintiff’s phy­si­cal inju­ry. The BGH did not address the ques­ti­on of whe­ther the ECJ’s case law can be appli­ed at all to hip pro­s­the­ses as medi­cal pro­ducts simi­lar to, for ins­tance, defi­bril­la­tors. The courts curr­ent­ly hold dif­fe­rent posi­ti­ons on this ques­ti­on. Medi­cal device manu­fac­tu­r­ers can expect fur­ther deve­lo­p­ments on this issue.


The ruling is a wel­co­me deve­lo­p­ment for medi­cal device manu­fac­tu­r­ers. It demons­tra­tes that the courts do not make undif­fe­ren­tia­ted rulings to the detri­ment of manu­fac­tu­r­ers, which was feared in the light of the “suspec­ted defect judgment”. It also pro­ves that a well-functioning qua­li­ty manage­ment sys­tem can suc­cessful­ly imple­ment com­pli­ance with manu­fac­tu­rer obli­ga­ti­ons to ensu­re safe­ty and thus mini­mi­se lia­bi­li­ty risks.


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