- In the case of an identified or identifiable risk of self-endangerment to a care home resident suffering from dementia, whose actions appear constantly uncontrollable and unpredictable, it is impermissible to accommodate him in a room – especially one in an upper storey – that has easily accessible and openable windows. On the other hand, without any specific indications of self-endangerment there is no duty to take special (preventative) safety measures (German Federal Court of Justice, decision of 14.1.2021 – file ref. III ZR 168/19).
- The effects of anaesthesia on the vital organs means that when a patient is anaesthetised as part of a diagnostic or therapeutic procedure, he or she may remain in acute danger for a certain time afterwards. Falls must be prevented during such phases of acute endangerment, and are considered to come within the area of fully controllable risk (Dortmund Regional Court, judgement of 4.3.2021 – file ref. 4 O 152/19).
What safeguards does the institution in question have to take to protect its patients or residents from falls? This question was recently examined by both the German Federal Court of Justice and Dortmund Regional Court. In the case before the Federal Court of Justice, in a care facility a patient with dementia fell from the window of his room on the 3rd floor. Despite multiple operations, three months later the man died from his serious injuries. His wife then claimed damages under a right descended and assigned to her. The key finding of the decision issued by the III Senate in Karlsruhe was that, if there is an identified or identifiable risk of self-endangerment, that patients suffering from dementia may not be accommodated in upper floors with easily openable windows. The Court of Justice argued, however, that rather than a generally applicable finding, it was instead necessary to assess risks and clinical pictures on a case-by-case basis. In doing so, the crucial aspect was whether, from an ex ante perspective, the physical or mental condition of the resident was such that it had to be anticipated that he or she could injure himself in the absence of safety measures. Even a risk that is viewed as unlikely to occur, but which would have particularly serious consequences if it did, can create duties of care on the part of the institution.
In contrast, the case decided by Dortmund Regional Court concerned the question of the safety measures that must be implemented by a hospital in the recovery room in order to prevent injuries to post-operative patients. Here, the patient was in hospital to undergo a minor procedure. Following his operation, while in the recovery room the patient fell from his bed sustaining serious injuries to his spinal cord (incomplete paraplegia with tetraparesis), necessitating months of intensive medical treatment. Serious adverse effects on his health remained. Apart from claiming damages for pain and suffering, the patient also claimed home maintenance damages and additional nursing care costs. The Regional Court ruled that a fall experienced by a patient in the recovery room while still under the influence of anaesthesia, constituted a fully controllable risk to the hospital. The clinic was duty bound to implement safety measures to prevent falls occurring during this acute risk phase. In the event of the realisation of a risk that could and must have been fully controlled by the therapy provider – such as falling without any defensive reflexes due to the after-effects of the anaesthesia as in this case – it had to adduce evidence and prove that it took all necessary organisational and technical precautions to prevent the risk (Section 630h (1) German Civil Code (Bürgerliches Gesetzbuch – BGB)). This hospital was unable to present this proof. There was nothing contentious about deploying two members of staff to the recovery room. However, when all the attendant nursing staff – in this case the two witnesses, even be it for training purposes – leave the recovery room, it must still be ensured that patients remain safe in the recovery room during that period. The Regional Court deemed that it was possible and necessary to arrange for side rails to be mounted on the bed in such a situation. However, in this case an organisational instruction had been issued to only use side rails if patients became agitated. However, the competent medical malpractice division held that an organisational instruction to use side rails only in the case of agitated patients was not explicable, even considering the issue of deprivation of liberty. There are no legal concerns whatsoever to preclude the short-term securing of a patient generally at risk from falling, if that person is obviously vulnerable because he is not “in control of his faculties”.
German Federal Court of Justice, judgement of 14.1.2021 – file ref. III ZR 168/19
Dortmund Regional Court, judgement of 4.3.2021 – file ref. 4 O 152/19 (not res judicata)
- Because only if the requested secondary Caesarean section, from an ex ante perspective, does not constitute a medically viable alternative considering the constitution and state of the mother, will the respondent’s fulfilment of the mother’s request be viewed as medical malpractice (German Federal Court of Justice, judgement of 4.2.2021 – file ref. VI ZR 60/20).
- As the natural guardian of the unborn child, in the case of an – at least – relative indication of an alternative method of delivery, the expectant mother is free to change the previously defined delivery plan, whereby, in accordance with the general rules of interpretation of Sections 133 and 157 BGB and taking appropriate consideration of the ‘objective horizon’ of the recipient of the request, to this end it must be demanded that it is made explicitly clear to the treatment provider that the originally agreed delivery plan is now to be departed from (LG Hannover, judgement of 31.5.2021 – file ref. 2 O 115/17).
After the Federal Court of Justice had to examine the issue of liability in connection with an elective secondary Caesarean section quite recently, the Hanover Regional Court was tasked with the same subject, but with the situation reversed. The starting point in both cases was the initiation of a natural birth, during which the mother-to-be expressed a wish for a Caesarean section. In neither case was there any absolute medical indication for a Caesarean section. In the case adjudicated by the Federal Court of Justice, the expectant mother’s wish was fulfilled and a Caesarean section performed, whereupon a uterine atony occurred. The mother died that same night due to multiple organ failure. Among other things, the Federal Court of Justice had to decide if meeting the mother’s wish for a Caesarean section, constituted a failing. The Federal Court of Justice answered this question by stating that the crucial aspects not only included the mother’s wish, but also the medical standpoints: “Because only if the requested secondary Caesarean section, from an ex ante perspective, does not constitute a medically viable alternative considering the constitution and state of the mother, is the respondent’s engagement with the mother’s request to be viewed as medical malpractice.” In other words: The doctor may not fulfil the patient’s request if it is untenable from a medical perspective.
In the second case decided by the Hanover Regional Court, the obstetrician did not meet the expectant mother’s request for a Caesarean section. The birth was instead performed by the natural method, but the child suffered a shoulder dystocia. Various manual obstetric interventions, including the McRoberts manoeuvre, were applied during the birth. The child sustained permanent plexus injuries as a result. So, the court not only had to assess if the non-fulfilment of the Caesarean section request constituted medical malpractice, but was also required to examine the issue of “violent “ manual assistance during the birth and the possible connection with birth defects. Firstly, in relation to the documented recording of the obstetric interventions, the court stated that the documented terms “manual assistance” was adequate, and did not constitute a failure in the documentation. The purpose of the documentation was to ensure proper treatment and as information to the medical personnel, and not to create and secure evidence on behalf of the patient for any subsequent medical malpractice suit. The court also held that there was not the required degree of certainty regarding the cause of the plexus injuries, and therefore whether the interventions made had actually caused those injuries. According to the convincing submissions of the court expert, it could not be readily concluded that the plaintiff’s trauma was attributable to any improper response/procedure in resolving the shoulder dystocia. The court said that there is contradictory literature regarding the causes of serious plexus injuries in a shoulder dystocia situation, with the result that there was not the required degree of certainty that only an (erroneously) strong application of force on the head and neck of the plaintiff could possibly be the cause of the plexus injuries. For example, the literature contained discussions on the extent to which force applied by the mother could be at least partly responsible for the permanent plexus injury to the arm, and even what forces could at all cause plexus paresis. According to the evidence taken, the resolution of the shoulder dystocia was devoid of any medical malpractice, and there was no flaw in the procedure.
Regarding the question of whether the non-fulfilment of the expectant mother’s wish for a Caesarean section constituted medical malpractice, the court said this was not the case due to the very absence of the medical indication here. During the proceedings, the expert told the court that the mother’s fears and her associated wish to have a Caesarean section would only ever be relevant, if she could no longer be kept calm. In addition, the risks of a Caesarean section and the issue of any onset of a lack of capacity to consent that might possibly occur during the birthing process, also had to be factored into these considerations.
Both decisions demonstrate both the fulfilment and non-fulfilment of a request for a Caesarean section can be relevant to the question of legal liability. It is medicine itself that draws the boundaries here, namely by way of the medical indication and the definition of medical non-viability.
Federal Court of Justice, judgement of 4. 2.2021 – file ref. VI ZR 60/20 (with comment Vogeler, GuP 2021, 154)
Hanover Regional Court, judgement of 31. 5.2021 – file ref. 2 O 115/17 (not res judicata)
This was now the third time that the law firm Dres. Vogeler, Hanover had organised the symposium on “Legal issues in day-to-day hospital activities”. This conference series focuses on current and particularly intriguing issues in medical law today. The purpose of these events is to intensify the communication and understanding between the players that frequently encounter one another in the medical law field (from the healthcare, law and insurance sectors). Whereas the previous two years saw in-person events at which fifteen to twenty participants conducted a face-to-face dialogue, this symposium was hosted online under “corona regulations”. This meant that a much larger number were able to attend the event. With more than fifty attendees, the symposium was so well received that the plan is to organise it on a hybrid basis from now on, to also and not least enable participants from other cities and German provinces (Länder) to attend future symposiums. The event was accompanied by wine tasting sessions during the breaks, and a convivial atmosphere was enjoyed even under the online setting.
This year’s symposium examined three subject areas. The first focal topic was medical malpractice law for doctors and lawyers. In order to explore this topic, five current medical malpractice cases were introduced. The substantive analysis of these cases was preceded with a declaration to the effect that gaps had to be bridged, and that it was necessary to intensify the level of communication between medicine and the law, whereby it is the lawyers who were particularly called upon to step up here.
The first case to be presented concerned a decision of Dresden Higher Regional Court (OLG Dresden) (decision of 16.03.2020 – file ref. 4 U 2626/19), which focussed on the medical duty to inform patients and the associated question of when a “self-determination notice” (information provided to a patient to enable them to determine if he or she wish to proceed with the proposed medical therapy) can still be deemed valid. The case in question concerned the performance of an out-patient colonoscopy procedure. When the consent form already signed beforehand by the patient could not be found, a second informed consent meeting took place on the day of the colonoscopy, and which explicitly included the possibility of a polyp removal procedure. A polyp was removed during the colonoscopy, and the plaintiff was allowed to go home a few hours later. On that same day, the plaintiff was urgently admitted to hospital having suffered a perforation. Emergency surgery was performed, resulting in further complications. The plaintiff maintained that he had not consented to a polyp removal procedure at the time of the initial informed consent meeting. He further argued that the second informed consent meeting was not conducted in time because he had already been administered the colon cleanser, and his decision was therefore taken under pressure. On this point, the Dresden Higher Regional Court declared that in the case of out-patient procedures “it sufficed to conduct the informed consent meeting on the day of the operation, provided that the decision on whether to conduct the procedure still rests with the patient. In the case of a colonoscopy performed on an out-patient basis, the informed consent meeting […] should be regarded as conducted within time, even if the patient has already completed the necessary preparatory medicinal colon cleansing procedure.”
The core issue in the case just described therefore was about when a patient self-determination notice may still be viewed as issued in good time. In considering the issue, the examining judges applied principles taken from the case law to date. Accordingly, the patient’s right of self-determination can only be upheld if he is able to exercise his freedom of choice by adequately weighing up the pros and cons of having the procedure. The informed consent meeting should then, if possible, take place at the point in time when the date for the procedure is determined. However, an informed consent meeting that takes place at a later date is not automatically out-of-time. The question of whether an informed consent meeting takes place in good time should, the court said, be based on the existing circumstances and if the patient still had adequate opportunity to mentally and freely make a decision. If there is any doubt, then hypothetical consent can be factored into the assessment of the case. The examining judges pointed out that the introduction of the German Patients’ Rights Act meant that the informed consent meeting was now a statutory prerequisite for effective patient consent. This meant that the established case law had become incorporated into the Patients’ Rights Act. However, it was determined that these rules were already applicable before that time, and had now been made law through the Patients’ Rights Act. Rather than this being an instance of strengthening patients’ rights, it instead concerned the stabilisation of legal positions. Regarding questions of evidence, in particular, the stipulated acknowledgement of receipt that now accompanies the hand-over of the consent form has strengthened the medical practitioner’s hand here.
Next, on the basis of a decision of the Dresden Higher Regional Court (decision of 12.5.2020 – file ref. 4 U 1388/19), the question concerned who was authorised to conduct the informed consent meeting, and what criteria had to be met by the physician delivering the relevant information for the purpose of this question (cf. Section 630e (2) no. 1 German Civil Code (Bürgerliches Gesetzbuch – “BGB”). Diagnosed with an adenocarcinoma, the plaintiff was admitted into in-patient care. An informed consent discussion was conducted by the attending urologist, and a radical prostatectomy performed one day later. Following post-operative checks, the plaintiff was discharged and allowed to go home, whereupon he was again urgently readmitted to in-patient care suffering from urinary retention. Further hospital treatment was necessary, and he was left with grade II stress urinary incontinence. The court determined that, in view of the relative indication, the radical prostatectomy did not constitute medical malpractice. Nevertheless, alternative treatment could have been given in the form of percutaneous radiotherapy in combination with hormone withdrawal therapy. The court said that this alternative treatment should have been explained to the plaintiff. In relation to this informed consent meeting, it was particularly relevant that the information was provided to the patient by the surgeon. Although she did mention the alternative, as a surgeon she did not give preference to it. The Dresden Higher Regional Court looked to the continuing medical education regulations (‘Weiterbildungsordnung’), so that it ultimately came down to the qualifications for clarifying the procedures. The examining judges thereby raised the question regarding what criteria had to be placed on the qualifications of the individual providing the explanatory information. This question has yet to be conclusively decided in law. Possible solutions here are firstly to regard Section 630e (3) no. 1 BGB as merely a formality and procedural requirement, or to rely on the “scope of the rule” context (‘Schutzzweckzusammenhang’). On this basis, the crucial question would be why the lack of training on the part of the person providing the information had impaired the decision-making process. The ensuing discussion led to the subject of operating outside of one’s actual discipline. The patient information process has not yet been considered for these cases to date , but may nevertheless be relevant to the assessment.
One special case recently adjudicated by the German Federal Court of Justice, concerned the question of medical malpractice in connection with an elective secondary Caesarean section. Following an unremarkable pregnancy, the expectant mother presented herself to the gynaecology clinic in the 39th + 1 week of pregnancy with a suspected preterm rupture of membranes and due to slight vaginal bleeding. She was admitted into in-patient care, and a spontaneous vaginal delivery attempted. The option of a Caesarean section was not discussed. With cervical dilation at 6 cm accompanied by strong contractions, the woman stated that she wanted to have a Caesarean section. Following a consultation with the senior consultant, the Caesarean section was performed with no initial complications. Immediately thereafter occurred a massive uterine atony, with 1,200 ml of blood loss. During the ongoing emergency treatment, the senior consultant had to leave the operating theatre due to a high-risk birth proceeding elsewhere at the same time, but she nevertheless remained in telephone contact. The mother had to be reanimated several times, and died that same night due to multiple organ failure. The questions this case throws up are whether medical malpractice can be identified when the patient’s wishes are fulfilled, and what standard of care should be applied in stressed treatment scenarios. According to the Federal Court of Justice, medical malpractice occurs if, from an ex ante perspective, the fulfilment of the patient’s wishes in a specific situation does not constitute a viable medical alternative. Therefore the wish of the patient alone does not automatically justify the medical procedure. According to the speakers presenting the case, the question was unanswered regarding whether a “stressed treatment scenario” entailed any lowering of the applicable standard of care. If this question were to be answered in the affirmative, the foreseeability of the stressed situation would also be relevant.
Given the advanced time of day, this was followed by just a brief presentation of the issue of one-to-one care as a material prerequisite for approving a four-point restraint (Local Court of Kassel, decision of 23. 2.2019 – file ref. 786 XVII Mi 417/19), as well as the question of whether an infringement of a contracted physician agreement rendered the patient’s consent invalid (Regional Court of Essen, judgement of 6.11.2020 – file ref. 16 O 229/19).
Then came the second subject area of the symposium: “The reorganisation of the arbitration process”, presented by the speaker Till Neuhof (attorney and mediator) who himself had worked for a long time with a northern German medical liability arbitration board, the “Norddeutsche Schlichtungsstelle für Arzthaftpflichtfragen”. In the 1970s, the increasing number of civil and criminal proceedings led to the nationwide establishment of arbitration boards at every locally competent regional medical council. These regional medical councils merged over the years, with the result that in 2016 ten regional medical councils amalgamated to form the “Norddeutsche Schlichtungsstelle” (Northern German Arbitration Board). The huge importance of the Norddeutsche Schlichtungsstelle is reflected in the figures. For example, it issued some 2000 decisions between 2010 – 2020. No more new proceedings have been taken up by the [Northern] German Arbitration Board since 1.4.2021, and the plan is to close the Norddeutsche Schlichtungsstelle by 31.12.2021 at the latest. The participants heard how there was no single cause for this closure. The various partners in the arbitration board were beginning their own procedures, and to successively admit new applications. Once again, the arbitration boards are established under the individual regional medical councils, resulting firstly in differences within the individual procedures, along with the risk that regional ties may mean that the impartiality of experts cannot be guaranteed to the same degree as before. The benefits of the Norddeutsche Schlichtungsstelle, which operated at a supra-regional level, appear to be no more. So, for the resolution of civil law disputes there remain the civil and criminal procedures, along with the option of an out-of-court procedure conducted with mediators or lawyers, for example, or with the support of the regional medical councils.