Wherever people work, there will be mistakes – even in the medical field. If patients are harmed in the process, medical liability applies under certain conditions. Radiology finds itself in a special position here: Although its field of activity is mostly limited to diagnostics, errors can nevertheless have serious medical and legal consequences – for example, if a medically necessary treatment is omitted or delayed due to a diagnostic error. This article clarifies where the main sources of errors in radiology lie, what exactly happens when allegations are made, and how radiology practices can protect themselves from claims for compensation.
What is medical liability?
Anyone seeking medical care is entitled to treatment that meets current professional standards. This basic entitlement applies throughout the U.S., even though the details of medical liability law are the responsibility of the individual states and thus differ from state to state.
In the United States, medical liability law is generally governed by tort law, which deals with non-contractual liability between private parties. Contrary to many European legal systems, there is no general liability clause here, only individual liability constellations that have arisen through case law. Medical liability is generally based on a specific subset of torts, namely negligence.
Since U.S. tort law is originally derived from British common law, the basic features of British and U.S. medical liability law are comparable. In other European countries such as Italy or Germany, however, medical liability is governed by civil law and is based on contract and/or tort law.
In which circumstances does medical liability apply in radiology?
Not every medical error automatically has consequences in terms of liability law. Four basic conditions must be met for a patient’s allegation to actually result in medical malpractice liability based on negligence:
- Duty: The physician was legally obligated to treat the patient. This duty arises as soon as a doctor-patient relationship exists.
- Breach: The physician committed a breach of duty by failing to meet his or her duty of care and falling below the minimum professional standards. A specific treatment outcome is not owed.
- Causation: The violation of duty has caused an injury to the patient.
- Damages: The violation has caused damage to the patient.
Proof of these four aspects is the linchpin of every medical liability case.
In medical liability proceedings, the burden of proof is usually on the injured party, but it is less demanding than in many criminal proceedings:
During a trial for medical malpractice, the plaintiff’s lawyer must prove every aspect of the case to convince the jury that it’s more probable than not that the physician was negligent. This standard of legal proof is known as the “preponderance of evidence” standard, which is less demanding than the “beyond reasonable doubt” standard for criminal cases.
This means that for the jury to find the physician guilty after considering the evidence presented by both sides, they must be convinced it is more probable than not that the physician was negligent.
Which types of malpractice can occur in radiology?
The field of radiology occupies a special position in medicine, since radiologists generally perform examinations and make diagnoses, but only plan and perform limited therapeutic measures themselves. Possible treatment errors are therefore mostly limited to diagnostics. In legal terms, however, the concept of a treatment error includes all aspects of medical care – from examination and diagnosis to information, therapy and documentation.
Medical malpractice is therefore also possible in radiology and can give rise to medical liability. The main sources of error include so-called diagnostic errors, diagnostic findings errors, and documentation and educational errors.
A diagnosis is understood to be the conclusion drawn from findings to a specific disease. A diagnostic error occurs when radiologists grossly misjudge a correct diagnosis – for example, when a bone fracture is overlooked on an X-ray.
The courts do not consider every incorrect evaluation of findings in radiology to be a treatment error. As a result, the courts recognize that radiological imaging does not always permit unambiguous conclusions due to the clinical overlap of clinical pictures and that diagnoses are therefore fundamentally fraught with uncertainty. As long as the medical procedure appears to be justifiable according to general professional standards, no gross deficiencies are demonstrable and further findings are obtained in the event of uncertainty, a mere diagnostic error does not automatically constitute a treatment error.
Diagnostic assessment errors
In contrast to a diagnostic error, false findings occur when medically necessary findings are not obtained in the first place. An example would be the omission of a mammography in the case of palpable lumps or other abnormalities of the female breast. By no means is it implied that radiologists must use every possible diagnostic procedure in order to avoid possible medical liability – especially since the examinations themselves also involve risks due to radiation exposure. According to the courts, a diagnostic error only applies if the omitted examination would have resulted in a positive finding “with sufficient probability”.
Documentation and information errors
Treatment errors can also occur when dealing and communicating with patients. In principle, patients must be fully informed about the opportunities, risks and possible dangers of medical interventions or examinations. Another risk of medical liability is incomplete documentation, because in case of doubt, undocumented treatment or information can be interpreted in court as a service not rendered.
Collaborative treatment: Which party bears medical liability?
Another peculiarity of radiology is that patients are usually referred to the radiology facility by their attending physicians with a specific examination order. In cases of liability, therefore, the question arises as to how the areas of responsibility are to be defined: When is the ordering party liable, and when is the medical liability transferred to the radiology facility?
Essentially, the responsibility of the radiology facility extends to the radiological service specifically requested in the referral. It is up to the ordering party to decide on further necessary examinations or treatments. However, radiologists are obligated to critically review the order given and to consult with the client in case of doubts or discrepancies – for example, if the suspected diagnosis and the requested examination do not match.
Medical liability and artificial intelligence (AI): What to watch out for
The increasing use of artificial intelligence (AI) poses new challenges for medical law. Radiology is playing a pioneering role here. AI can ultimately help to improve the reliability of diagnoses and thus minimize potential medical liability risks. But who is liable should errors occur when self-learning systems are used?
As it currently stands, AI systems do not act autonomously, but are supervised by qualified medical staff and only assist them in making diagnostic decisions. Leading North American and European radiology societies have issued a joint statement advocating that ultimate responsibility for the use of AI systems should remain with medical staff. The U.S. Food & Drug Administration (FDA) also currently considers AI systems to be medical devices. Thus, there is no fundamental difference in the use of AI systems compared to other medical devices with regard to potential liability risks.
It should be noted that radiological facilities should educate their patients about the use of AI systems. Otherwise, the radiological facility could possibly be accused of a violation of the physician’s duty to inform.
What happens in the event of medical malpractice?
In the event of proven treatment errors, medical liability applies and injured patients are entitled to compensation. This includes
- pecuniary damages such as additional treatment costs, care costs, reduction in earning capacity or loss of livelihood
- non-pecuniary damages (“compensation for pain and suffering”)
- under certain circumstances, punitive damages.
The legal construct of punitive damages is unknown in most European legal systems. This is one of the main reasons why claims for damages in the USA are usually much higher than in Europe and are more likely to threaten the existence of a company.
In many cases, however, the parties to the dispute seek an out-of-court settlement.
In the United States, the legal system encourages efficient self-resolution of civil disputes through adversarial representation by respective attorneys and the utilization of legal tools such as the Discovery process. This involves exchanging facts and underlying information between disputing parties, which can result in mutual understanding and a settlement prior to trial. Depositions, which are part of the Discovery process, involve a witness testifying under oath and recorded for later use in court. Typically, attorneys for both parties and a representative from the insurance company attend depositions, which can be held at a convenient location, such as the doctor’s office. Many medical malpractice lawsuits settle out of court with payment of damages by the physician’s insurance company, with the physician often having input into the settlement decision.
Checklist: How to minimize medical liability risks in radiology
Physician liability cases can result in serious economic damages, as well as reputational damage. Here’s what radiology facilities can do to minimize medical liability risks:
- Practice according to guidelines: Radiological facilities should follow the guidelines of recognized professional societies such as the European Society of Radiology (ESR), Radiological Society of North America (RSNA) or the American College of Radiology (ACR) in their diagnostic procedures without exception. This is because these guidelines define the generally accepted “specialist standard” that physicians are obligated to follow.
- Standardization of processes: Treatment errors often result from a concatenation of factors that could be avoided by seamless standardization of all medical and organizational processes. Communication at key intersections, such as between medical staff and radiographers or between radiology practices and their referring physicians, should also be standardized.
- Complete documentation: Although it means a certain amount of extra work in daily routine, consistent documentation of all treatment steps minimizes the risk of liability if allegations are made. This also includes patient education or a waiver of the educational interview requested by patients.
- Critical review of the examination assignment: If there are doubts or obvious discrepancies in the examination assignment, contact should always be sought with the referring institution. This also applies to any incidental findings.
- Regular staff training: Operators of radiology practices are also liable for errors made by their staff. Regular training and continuing education should therefore be a matter of course.
- Open error culture: Intra- or inter-facility error reporting systems can help to objectively analyze critical events and errors in order to avoid them in the future.
- Peer review process: To err is human. Peer review concepts represent an effective means of quality assurance and thus of avoiding medical liability risks, but they naturally involve increased personnel costs. An alternative could be self-learning AI-based systems that assist radiologists as “sparring partners” during diagnosis and point out possible errors or incidental findings.
Medical liability in radiology: Do not underestimate the risk
Avoiding medical liability risks is an enormous challenge – especially in radiology, since examinations require a high level of documentation and are often performed under time and personnel constraints. Radiological practices should therefore take a critical look at their processes and identify neuralgic liability risks in order to subsequently take targeted precautions.