Policies and practice in the disclosure of medical error: Insights from leading countries to address the issue in Italy

Introduction

Communication is very important in medicine, especially with regard to the thorny question of medical error disclosure. One of the major issues is defining when a physician has a duty to tell a patient that an error has occurred and how this should be done. In countries such as Germany, the USA and the UK, there is a lively debate on this topic and on policies regarding medical error disclosure. The present contribution is a short overview of how different countries currently deal with this delicate issue in order to provide useful suggestions in this field, which is still in its infancy in Italy. The present article summarises what was presented at the Italian Society of Legal Medicine (SIMLA), Verona, Italy, on 18–20 September 2018. Particular attention is given to the different approaches adopted in Germany, the UK and the USA.

Germany

In order to answer the question of when and how a doctor should tell the patient that an error has occurred, it is necessary to find a compromise between good medical practice and the civil law principle nemo tenetur se detergere [no man is bound to accuse himself]. ¹ Germany, with the introduction of the above-mentioned Patientenrechtsgesetz (Gezetz zur Verbesserung der Rechte von Patientinnen und Patienten) [Patients’ Rights Improvement Law], can be considered a pioneer in this sensitive field. Case law played an important role in reaching this milestone and still plays an essential role in highlighting the road forward. Although doctors must be held accountable for the adopted surgical or medical procedure (good medical practice), they cannot be forced to incriminate themselves when something goes wrong. ¹ The Bundesgerichthof [German Federal Supreme Court] has defined boundaries that allow for a good balance, paving the way for the legislative implementation of Fehleroffenbarungspflicht, namely doctors’ duty to disclose medical errors. Otherwise, it could be very dangerous. Also, in Germany (unlike other countries such as Italy), the law remains faithful to consolidated principles wherein there are no rules specifically covering medical liability – they are the same as for any other culpable offence.

What are the limits of Fehleroffenbarungspflicht? The Bundesgerichthof states that a physician must honour the Fehleroffenbarungspflicht when there is an explicit request by the patient or when corrective surgery is required (informed consent). ¹ Although the nemo tenetur se detergere principle does not translate into a right to lie, it does not call for self-incrimination either; doctors can still challenge accusations. ¹ It is therefore essential to define the meaning of error – Fehler within the German system.

The Buergerliches Gesetzbuch [The German Civil Code] states that Fehler is the result of an incorrect action, where this action is sanctioned under law, no matter who commits it. This loose definition of error could easily lead to court cases. If physicians are required to disclose their errors when questioned directly by a patient, they could easily become the object of litigation. This would hinder the Patientenrechtegesetz’s aim of promoting communication between physicians and patients, and is the reason why the Fehleroffenbarungspflicht places some limits on the use of error disclosure in court. First, in the context of a legal action, an admission of fault (error) by a physician has probative value only if this admission has been ^a confined to a legal situation. ¹ Second, the duty of disclosure is fulfilled only when the error has been explained to the patient, while the need of providing details on how it could have been avoided is not required. For example, if a patient is affected by a neoplasm and the tumour is not totally removed, the patient has the right to know this but not to be informed about alternative actions unless another procedure is required, as mentioned earlier. ¹

On the other hand, possible drawbacks of reporting errors, such as patients’ diminished trust in physicians, should be taken into account. In addition, there is currently no evidence of any positive effect of medical error disclosure, neither in terms of increasing patient trust nor in terms of improving the diligence of physicians. On the contrary, a patient is likely to react to medical error with a progressive lack of trust in the physician and the health-care system.

Common law systems: the USA and the UK

The duty to disclose is also deeply felt in common law systems, where trust in a system itself is an essential condition: trust calls for transparency, consistency and openness. Empathy with the patient, as well as a sincere apology, is essential in the case of a medical mistake. ² The available medical literature notes the importance of the above-mentioned principles, as well as the right to just compensation. Nevertheless, medical personnel who are not provided with information and training on how to empathise with patients may find themselves in a very awkward position. If they do not have the means to manage communication adequately with the patient in the case of error, they could act improperly, thus losing the patient’s trust.^3–6 The lack of trust in a single physician may then easily translate into a general lack of trust in the health-care system.^4,5,7,8 Another possible drawback of the lack of communication and trust between doctor and patient is the well-known overtreatment of patients aimed at reducing the risk of being sued for malpractice (i.e. defensive medicine), since physicians are torn between the fear of malpractice and the request for greater transparency. Frequently left alone to find a way out of their dilemma, professionals run the risk of developing psychological conditions (i.e. ‘the second victim’^2,3), which profoundly affect their professional and personal lives.

The USA seems to be moving towards the adoption of an ‘apology law’ – a legal statute that encourages health-care providers to acknowledge and disclose medical errors openly, much like Germany’s Patientenrechtegesetz through the Fehleroffenbarungspflicht. ⁹

In the UK, the debate on disclosure includes another important aspect: near-miss errors. In particular, if the patient did not experience clinical harm as a consequence of the error, then disclosure to the patient is not seen as an obligation. Although near-miss errors do not have to be reported to the patient, full information must be given if specifically requested. Attempts have been made to define when an error must be disclosed to the patient: the National Advisory Group on the Safety of Patients in England recently claimed that ‘where an incident qualifying as a serious one occurs, it should be required that the patient … be notified and supported’. This must not be considered an ‘obligation’ to inform the patient of every single incident (consider the consequences in terms of the potential volume of lawsuits), but rather a suggestion to be taken into consideration when attempting to regulate the matter. ¹⁰

One must also consider the psychological effects of such events on patients. The lack of appropriate information about a medical error may result in a long list of undesired side effects that can compromise patient recovery. The phenomenon identified by psychologists as ‘unforgiveness’, when the victim of the error overthinks the situation, is resolved only when the patient is able to forgive the people identified as responsible for the event. Again, it is of utmost importance that physicians receive proper training on how to admit, communicate and explain medical errors. Modern medicine has to focus on improving communication, especially in light of the holistic approach to patients adopted in most modern medicine. ³ This is not an easy task, given the short amount of time devoted to such activities in daily medical care routines, which are increasingly demanding in terms of the services provided.

In the UK, physicians are prosecuted only for gross negligence, and here there are still very few lawsuits. As of 31 March 2019, the National Health System indemnified users for approximately £2.4 billion. ¹¹ In the USA, however, the problem is enormous, costing about $20 billion and resulting in 100,000 patient deaths annually due to clinical errors. ¹²

The limits of error disclosure

Error disclosure is surely a valuable process which has many benefits for patients, but this procedure needs to be framed in hospitals, and physicians must be trained and well educated in how to face an error disclosure meeting. A lack of training leads to the failure of the process, resulting in harmful consequences for patients and their trust in the health-care system. This is not the only reason. Inadequate legal protection for health-care professionals and organisations and their fear of litigation are also often barriers for error disclosure. To improve error disclosure acceptance by doctors and organisations, a culture of learning from adverse effects has to be promoted, together with the approval of adequate apology laws. Lastly, it must be accepted by doctors and hospitals that open disclosure in some cases fails, even if the procedure is well conducted and the hospital has a framework for it with a training programme for physicians. Sometimes, patients are not willing to forgive, especially when an adverse event involves children. In these cases, the challenge becomes particularly difficult, and physicians require additional support and training. ¹³

Italian law regarding medical liability

On 24 March 2017, the Italian government approved a new law called Legge Gelli-Bianco which is an attempt to change the approach to medical liability radically in our country by limiting lawsuits against physicians. It contains an article (590 sexies) that excludes the liability for imprudence in cases where guidelines were strictly followed by the doctor. Furthermore, communication between physician and patient is promoted in order to give each party a chance to clarify their position and hopefully avoid resorting to legal action. This approach has some clear advantages but also critical issues. One of the most important is the role of the guidelines, which seem to become an obstacle for the physician, who must act according to science and ethical duty to ensure the best treatment for the patient. To do this, the doctor must feel free in making decisions regarding treatments and not be limited by the guidelines. In a country where medical malpractice costs €10 billion every year, a law in this field would help to address this unresolved issue.

Conclusions

Although policies and practice in disclosing medical errors may vary among countries, everyone seems to agree on the relevance of the subject for the practice of medicine in a modern health system. Institutions need to coordinate their efforts to strengthen relationships between physicians and patients by trying to address the disclosure and communication with appropriate strategies. Disclosure of a medical error can be turned into an opportunity to improve communication skills, providing health-care professionals with renewed motivation to develop and learn from each other’s errors and near misses and strengthening patient trust in the health-care system. Surely many barriers have to be overcome, such as the lack of training of physicians and their fear of litigation, but a system based on secrecy of information is unacceptable today in health care or in any other institution, and leads to a self-defeating strategy in terms of effectiveness and costs.

German legislation is well on the way to achieving a balance between patient expectations and doctors’ freedom of action. On these grounds, Italy could also play a more important role in the debate in which provisions of the recent Legge Gelli-Bianco law, which covers medical responsibility and malpractice, can be integrated with specific regulation. ¹⁴