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Frank Sarangi LL.M. - Attorney at Law and Specialist in Medical Law

15. February 2023

With a decision that has now been published, the Federal Supreme Court (BGH) has caused many hospitals to breathe a loud sigh of relief. With its ruling of 20.12.2022 – VI ZR 375/21, the BGH clarified that #information is not invalid if the #patient consents to the #intervention immediately after the information, for example by signing the information sheet. But what happened?
In November 2021, the Higher Regional Court of Bremen (5 U 63/20) ruled that an informed consent is invalid if it is formally correct in terms of content, but the patient signs the #information sheet on the day of the #information. The reason was banal in the view of the OLG Bremen: If the patient would sign on the day of the clarification, he would have no time to think about it. Even if a patient would then go for inpatient treatment after the clarification, this behavior would not be an implied consent to the intervention. The case was based on an ENT surgery. The plaintiff patient was admitted to the defendant hospital by an ENT physician in private practice for surgical straightening of a #septum deviation and a #paranasal sinus operation. In the course of a prehospital presentation, the correct information was provided and the information sheet was signed. 3 days later, the patient presented for inpatient admission and surgery as planned.

Intraoperatively, there was an arterial hemorrhage, an injury to the dura mater and the olfactory nerve, all of which are typical complications of this procedure. The Higher Regional Court of Bremen considered the information to be ineffective for the above-mentioned reasons. The objection that the patient had at least impliedly consented to the intervention by presenting himself at the hospital and undergoing the operation was not accepted by the OLG Bremen. The ruling caused displeasure not only among hospitals, especially since it clearly disregarded the wording of the law.

With the decision cited above, the Federal Supreme Court has now clarified that no mandatory reflection period must be observed between the information prior to an operation and the signing of the information sheet (consent). Rather, the patient may decide to undergo treatment immediately after being informed. This follows not least from § 630e Abs. 2 S. 1 No. 2 BGB.

Practical advice: Despite the BGH’s absolutely welcome decision, the statutory principles and those developed by case law on preoperative risk disclosure continue to apply. The patient must therefore be informed in good time before the operation about the risks on the whole and about individually increased risks, so that he has sufficient time to consider for and against the operation. This applies in particular to elective procedures. In the case of outpatient procedures, the courts allow the patient to be informed on the day before or even on the day of the outpatient treatment. However, a distinction must be made here as to whether the patient is confronted for the first time with such risks on the day of the outpatient procedure that come as a surprise to him (e.g., damage to the median nerve during carpal tunnel surgery). In such a case, an explanation on the same day would indeed be ineffective.