Medical Liability: A Comprehensive Guide To Fault, Compensation And Legal Protection

Medical liability refers to the responsibility of a healthcare professional for harm suffered by a patient as a result of errors, omissions or breaches of professional duties.

It may be civil in nature, resulting in an obligation to compensate the patient, or criminal, resulting in sanctions linked to the crime, if proven.

It is based on wrongful conduct, damage, and a causal link between the two.

What medical liability is

A doctor has a legal obligation to answer for the harmful consequences arising from negligent or intentional conduct in the exercise of the profession.

More specifically, medical liability concerns the professional conduct of the individual doctor, whereas healthcare liability (or liability of the facility) refers to organisational and structural shortcomings of the hospital or clinic.

The former is non-contractual in nature (with a five-year limitation period) for employed doctors, while the latter is contractual (with a ten-year limitation period) for the facility, which must ensure an overall safe service.

Types of medical liability

As mentioned, medical liability may be divided into two main categories: civil and criminal.

There may also be administrative liability (financial damage to public bodies in the case of public employees) and disciplinary liability (sanctions such as warnings, suspension, or removal from the professional register).

Each type of liability arises from the breach of different rules and entails specific consequences for the healthcare professional.

Civil liability

What it is: it arises from the breach of rules and obliges the liable party to compensate the harm caused to the patient.

When it applies: when the conduct of the doctor or healthcare facility causes damage (for example injuries, death and so on).

Who is liable: both doctors and healthcare facilities.

Types: it may be contractual (when the facility is liable under the hospitalisation contract) or non-contractual (when only the doctor is liable).

Criminal liability

What it is: it applies when the conduct of the doctor constitutes a criminal offence.

When it applies: in cases of negligence, lack of skill or imprudence that cause injury or death to the patient (for example manslaughter or negligent bodily injury).

Sanctions: may include fines or imprisonment.

Administrative liability

What it is: it concerns public employees who cause financial damage to the public administration to which they belong.

When it applies: when the conduct of a healthcare professional employed by a public body causes financial loss to public funds.

Who is liable: doctors employed by a Public Administration.

Disciplinary liability

What it is: it concerns breaches of ethical duties and professional rules.

When it applies: in the event of breach of professional duties or ethical rules.

Sanctions. May include:
– Warning
– Censure
– Suspension from practising
– Removal from the professional register

Who acts: the relevant professional body.

The right to health as a constitutionally protected interest

The significance of the right to health as a constitutionally protected interest lies in its nature as a fundamental right of the individual and, at the same time, a collective interest, safeguarded by Article 32 of the Italian Constitution.

Its importance is such that it ensures free medical care for the indigent, prevents compulsory health treatments unless provided for by law, and forms the basis of the State's obligation to guarantee access to healthcare and to protect public health from threats such as epidemics.

Individual right and collective interest

Individual right: article 32 recognises health as a fundamental right that every person may exercise. This includes the protection of physical and mental health, the right not to be subjected to medical treatment unless provided for by law, and the patient's right to self-determination.

Collective interest: health is also a collective interest, which justifies State intervention to protect the population, for example from infectious diseases. This perspective links individual health to public health and a healthy environment, extending protection even to those without a residence permit.

Role of the State and the National Health Service (SSN)

The Constitution requires the State to safeguard the right to health.

This right is implemented through the National Health Service (SSN), which aims to guarantee access to healthcare for the entire population, according to the principles of universality, equality and fairness.

The Constitution expressly guarantees free care for indigent citizens.

The elements of medical liability

Medical liability may arise where fault, causation and damage are present.

To establish the legal liability of a doctor or healthcare facility, all three elements must be present.

If even one is missing, liability cannot be established.

Fault exists when professional duties are breached through negligence, imprudence or lack of skill, and must be linked to the damage suffered by the patient through a direct causal connection.

Specifically, the elements are as follows:

• Fault (wrongful conduct). This may consist of an act or omission (diagnostic delay, a test not performed and so on) due to negligence, imprudence or lack of skill. It occurs when the doctor does not comply with guidelines, best practices or standard protocols.

Fault may be classified as:

• Generic (minor) fault, arising from negligence (lack of attention or care), imprudence (reckless behaviour) or lack of skill (insufficient professional competence).
• Specific (gross) fault, occurring when the doctor breaches specific rules that he or she was required to know and follow.

The distinction is relevant, for instance, in the doctor's liability (under the Gelli Bianco Law), where the professional is directly liable for gross fault, while minor fault results in liability only in exceptional cases; for public employees, gross fault may lead to an action for recourse by the public body.

• Damage. This is the injury to a legally protected interest, such as the patient's right to health. It may take various forms, including physical, psychological and financial harm (medical expenses, loss of income and so on).

Damage must be objectively proved through medical documentation.

• Causal link. This represents the cause and effect connection between the doctor's error and the harm suffered by the patient. In civil cases, the assessment concerns whether the error is the most probable cause of the damage, while in criminal cases the proof must be beyond reasonable doubt.

Medical fault

Medical fault manifests itself through negligence (lack of attention and diligence), imprudence (reckless or careless behaviour) and lack of skill (insufficient technical preparation or professional competence).

These three forms of fault indicate professional conduct that does not comply with rules and standards of care and may cause harm to the patient, leading to civil and criminal liability.

Negligence

Negligence occurs when a doctor fails to take the precautions, attention or diligence required in the exercise of the profession.

For example, a doctor may fail to collect essential information from the patient's medical history, such as a known allergy to a drug, and then administer that drug, causing anaphylactic shock.

Imprudence

Imprudence is shown through reckless behaviour and lack of caution in performing a medical act.

For example, administering a treatment without adequately assessing the risks, or performing surgery without the necessary precautions.

Lack of skill

Lack of skill concerns insufficient technical competence, specific ability or adequate knowledge required to properly perform a medical procedure.

For example, a surgeon performing an operation without the specific training required for that procedure, resulting in negative consequences for the patient.

These different forms of fault often overlap, as negligent behaviour may derive from imprudence or lack of skill.

It is essential to identify the specific form of fault present in order to properly establish the doctor's liability and assess the legal consequences and potential compensation.

Burden of proof

The burden of proof varies depending on whether liability is contractual or non-contractual, as defined by the Gelli Bianco Law (Law 24/2017):

When a healthcare facility is sued, its liability is contractual (the so-called social contract or hospitalisation contract).

The facility must demonstrate that it fulfilled its healthcare obligations correctly in order to be released from liability.

When an individual doctor is sued, the doctor's liability, when practising within a facility, is generally non-contractual (under Article 2043 of the Civil Code).

The patient (claiming compensation) must prove the doctor's fault and the causal link between that conduct and the damage suffered.

Informed consent and the doctor's liability

Informed consent is a fundamental right of the patient and legitimises any medical intervention.

The doctor has a duty to inform the patient about the risks, benefits and alternatives of a treatment, ensuring that consent is properly informed.

A breach of this duty may give rise to civil and criminal liability for the doctor and may weaken the doctor's legal position in the event of errors committed during the intervention.

It is the doctor's responsibility to:

• Duty to inform. The doctor must provide all the information necessary to obtain informed consent, detailing the nature of the treatment, the possible consequences, alternatives and risks.

This duty cannot be delegated to other healthcare professionals.

• Explicit and informed consent. The doctor must ensure that consent is not only expressed but also informed. The professional cannot merely rely on a standard form but must ensure that the patient has understood the information provided.
• Civil liability. The doctor is personally liable for any breach of the informed consent requirement. Such irregularity may result in compensation for the damage suffered by the patient.
• Criminal liability. A doctor who operates without consent or on the basis of invalid consent may be held criminally liable for several offences, including unlawful coercion, negligent bodily injury, or manslaughter, depending on the severity of the harm caused.

Typical cases and examples

Typical disputes arising from improperly obtained informed consent include unauthorised treatments, violations of the right to self-determination and the right to health, and cases where the patient was not placed in a position to understand the risks.

Lack of consent may lead to criminal liability (such as negligent injury or manslaughter) and civil liability, with a resulting obligation to compensate the damage.

To better understand the context of missing or invalid consent, consider the following examples:

• Lack of consent to a surgical operation. A patient agrees to surgery but is not properly informed of the specific risks. If foreseeable complications arise that were not disclosed, the patient may claim compensation, arguing that they would not have consented had they been adequately informed. Case law has established that in such situations, the violation concerns not only the right to health but also the right to self-determination (Civil Supreme Court, Third Chamber, Judgment no. 27268/2021).
• Unnecessary treatments. A patient agrees to a treatment but later discovers that it was not necessary for their condition, for example because the procedure was performed without adequate medical indication. The dispute arises because the patient consented to a treatment that was not essential. In such cases, liability may arise for having caused unnecessary harm, even though formal consent had been given.
• Consent based on generic information. A patient signs a pre-printed form that lacks specific and detailed information on risks, benefits, alternatives and possible consequences of the treatment. Such consent may be considered invalid because it does not represent a genuine informed choice. This can render the medical act unlawful and lead to litigation.
• Omitted consent in emergency situations. When a patient requires emergency treatment but is not informed, consent cannot be considered valid. For example, in the case of an accident where the doctor must intervene without the patient's consent.
• Failure to inform about an adverse event. A doctor fails to inform the patient of an adverse event that occurred during the treatment, even if it did not result in material harm. This may still constitute a violation of the patient's right to self-determination, as patients have the right to be informed even about minor adverse events.

Cases in which consent is not required

Informed consent is not required in the case of compulsory medical treatment or serious necessity that endangers the patient's life.

Refusal of treatment. The doctor must respect the patient's refusal, informing them of the consequences of their decision and limiting intervention to necessary palliative care.

Key facts about consent

• Consent may be withdrawn at any time.
• Informed consent does not release the doctor from professional liability for any errors.
• Liability may be shared between the doctor and the healthcare facility, depending on the circumstances provided for by law.

The doctor's liability after the Gelli Bianco reform

The Gelli Bianco Law (Law No. 24 of 2017) introduced significant changes, including the civil liability of healthcare facilities for damage caused by affiliated doctors and the requirement of an attempt at conciliation or mediation before initiating legal action.

The law reformed the doctor's liability by distinguishing between criminal and civil liability.

In criminal matters, it excludes liability for manslaughter or negligent injury when the damage occurs in compliance with appropriate guidelines.

In civil matters, the liability of employed doctors becomes non-contractual (five-year limitation period), with a heavier burden of proof on the patient, while that of self-employed doctors and healthcare facilities remains contractual (ten-year limitation period).

The reform also introduced obligatory insurance for both doctors and healthcare facilities, to guarantee compensation.

Assessment of damage in medical liability

The assessment of damage in medical liability cases is based on the evaluation of both pecuniary and non-pecuniary losses, which may include medical expenses, loss of income, biological damage (harm to physical and psychological integrity), moral damage (suffering) and existential damage.

The quantification is carried out with the involvement of forensic medical experts, who assess the severity of the impairment (minor or major permanent disability), and through the use of legal compensation tables, such as those issued by the Milan Court for more serious injuries.

Types of compensable damage

• Pecuniary damage: covers direct financial losses.
  – Actual losses (danno emergente): medical, pharmaceutical, rehabilitation and assistance expenses incurred.
  – Loss of earnings (lucro cessante): loss of income due to temporary or permanent incapacity to work.
• Non-pecuniary damage: concerns harm to the person and their emotional sphere.
  – Biological damage: injury to physical and psychological integrity, quantified in percentage points of disability.
  – Moral damage: inner suffering, pain and emotional distress.
  – Existential damage: deterioration of quality of life and daily habits.
  – Damage from loss or harm to family relationships: compensation to family members for the death or severe disability of a relative.

How the assessment Is carried out

A forensic medical specialist evaluates the damage, assigning a percentage score on the basis of official medico-legal tables.

The evaluation distinguishes between:

• Minor permanent disabilities: impairments resulting in nine percent disability or less.
• Major permanent disabilities: impairments resulting in ten percent disability or more.

The quantification of compensation takes into account the medical evaluation of the damage and the relevant official tables.

The Milan Tables generally quantify major permanent disability, while the National Single Table quantifies non-pecuniary biological damage above ten percent due to road accidents or cases of medical malpractice.

For minor permanent disabilities, the provisions of the Private Insurance Code apply.

In certain specific cases, the judge may personalise the compensation, awarding an amount different from that suggested by the tables, while still relying on the expert report and reference criteria.

Procedural aspects of medical liability

The procedural aspects of medical liability focus on three main areas:

1. Condition of admissibility
2. Mediation process
3. Legal action

Before initiating court proceedings, a Preventive Technical Assessment (ATP) or mediation procedure must be undertaken, with the aim of reaching an out-of-court settlement.

If no agreement is reached, civil proceedings may begin, during which the patient must prove the damage and the causal link, whereas the burden of proving diligence falls on the doctor or the healthcare facility.

Preliminary procedure

The law requires the initiation of a Preventive Technical Assessment procedure (under Article 696 bis of the Code of Civil Procedure) as a condition of admissibility before filing a lawsuit.

The ATP, also known as preliminary expert assessment for the purpose of resolving the dispute, constitutes a mandatory form of mediation.

The purpose is to reach an agreement between the parties.

If an agreement is reached, it is formalised in a record that has the effect of an enforceable title.

Legal action in case of failed mediation

If mediation fails, within 90 days from the conclusion of the ATP (or from the expiry of six months if it does not conclude), a claim on the merits must be filed, usually by application under Article 702 bis of the Code of Civil Procedure.

According to a recent Supreme Court ruling, the patient must prove the causal link between the healthcare professional's conduct and the harm suffered, but does not need to prove the violation of the leges artis, that is, the failure to comply with written or unwritten technical and scientific rules governing the medical profession.

This burden lies with the healthcare facility or the professional, who must demonstrate the absence of fault or the presence of non-imputable causes.

The patient may also bring an action directly against the insurance company of the healthcare facility.

Territorial jurisdiction is determined according to specific rules, which may vary.

Limitation periods: the contractual liability of the healthcare facility is subject to a ten-year limitation period, whereas the doctor's liability may be subject to a shorter period.

Prevention and management of medical risk

The prevention and management of medical risk aim to improve patient safety and the quality of care through a systematic process of identifying, assessing and mitigating risks.

Risk management in healthcare facilities is the strategic function that coordinates this process, focusing on the prevention of errors (both clinical and organisational) and the management of adverse outcomes.

Its role includes the implementation of procedures, staff training and the analysis of incidents in order to create a safer environment for both patients and healthcare workers.

Healthcare risk management, through the adoption of guidelines and best practices, reduces medical errors, improves patient safety and may limit the use of defensive medicine.

Guidelines and best practices help standardise processes, identify risks and intervene appropriately, thereby creating a safer system of care and reducing the need for defensive practices, which often lead to unnecessary tests and procedures.

How risk management and guidelines reduce medical errors

Risk management is responsible for:

• Identifying and assessing risks. The risk management team analyses clinical and organisational processes to identify potential weaknesses in the care pathway that may lead to errors. Best practices and clinical guidelines provide a framework for identifying and assessing these risks.
• Standardising care. Adopting standardised clinical guidelines ensures that all patients receive appropriate care, reducing variations in treatment and decreasing the likelihood of errors arising from non-standard procedures.
• Reducing the need for defensive medicine. A system based on solid risk management and standardised procedures makes doctors less inclined to resort to unnecessary tests or procedures solely to protect themselves from potential legal claims.
• Encouraging compliance with correct procedures. When professionals follow evidence-based guidelines, they are better protected from legal disputes because their actions reflect the highest available standards of care.
• Promoting training and awareness. Risk management is responsible for training healthcare staff on how to prevent and handle risks, fostering a safety culture that involves all members of the organisation.
• Analysing incidents. It manages the analysis of adverse events and near misses, using these as learning opportunities to improve systems and processes.
• Monitoring and reporting. It monitors the effectiveness of implemented measures and produces periodic reports on adverse events, their causes and the corrective actions taken. This contributes to the dissemination of best practices and compliance with legal obligations.
• Managing claims. It provides strategic support to the organisation and handles claims, working with lawyers and insurers to ensure efficient case management and to protect the institution and its reputation.

These are the objectives and benefits associated with risk management:

• Patient safety. The primary objective is to ensure patient safety by reducing adverse events such as diagnostic or treatment errors, healthcare-associated infections and avoidable surgical complications.
• Protection of the facility. It helps protect the institution from negative legal and financial consequences, safeguarding its reputation and sustainability.
• Continuous improvement. It promotes a continuous improvement process based on learning from errors, contributing to an overall increase in the quality of healthcare services.

Liability of the doctor and role of healthcare facilities

The main difference between individual medical liability and facility liability lies in the nature of the liability: the healthcare facility bears contractual liability towards the patient, while the doctor practising within the facility bears non-contractual liability (or contractual liability if there is a direct agreement with the patient).

This means that the patient may act directly against the facility under the healthcare contract (with a lighter burden of proof), whereas to act against the doctor, the patient must prove fault in more detail.

Once the facility compensates the patient, it may seek reimbursement from the doctor through a recourse action.

Liability of the healthcare facility

• Nature: contractual
• Legal basis: the contract between the patient and the facility for healthcare services
• Burden of proof on the patient: the patient must prove the contract and the breach (the harmful event)
• Limitation period: ten years

Liability of the doctor

• Nature: non-contractual (tort liability under Article 2043 of the Civil Code)
• Legal basis: general rules of civil liability
• Burden of proof on the patient: the patient must prove the harmful event, the causal link between the conduct and the harm, and the doctor's fault
• Limitation period: five years

Exception: if there is a direct contract between doctor and patient, liability becomes contractual and the ten-year limitation period applies.

Possibility for the patient to act directly against the facility

• Principle: the patient may bring an action directly against the hospital or clinic.
• Reason: the facility is liable for damage caused by its doctors and staff as a result of the healthcare contract. This is an example of liability deriving from the patient's reliance on the facility.

Facility's right of recourse against the doctor

• Principle: once the facility has compensated the patient, it may take action against the doctor to recover the amount paid.
• Reason: the facility is held liable for the error committed by its employee.
• Recourse action: the action brought by the facility against the doctor is a form of recourse liability for the error committed.

Legal assistance in cases of medical liability

Legal assistance in medical liability cases begins with the assessment of the case by a lawyer and may require a medico-legal expert opinion to determine whether an error occurred and whether a causal link exists between that error and the harm suffered.

A lawyer's task is to assess the strength of the case by analysing documents and facts to determine whether legal action is justified.

If the analysis confirms the basis for a claim, an obligatory mediation phase follows before any potential court action.

Mediation phase

Before filing a lawsuit, an attempt at conciliation through a mediator is mandatory.

The aim is to reach an out-of-court settlement for compensation, avoiding the time and expense of judicial proceedings.

Litigation phase

If no agreement is reached during mediation, court proceedings may be initiated to obtain appropriate compensation for the harm suffered.

Targeted legal advice in cases of medical malpractice can be decisive in obtaining justice and fair compensation.

The death of a foreign national in Italy due to medical malpractice gives their family members the right to claim compensation.

Do not hesitate to contact the lawyers of the Personal Injury Department at Boccadutri Law Firm for guidance and assistance.

FAQ on Medical Liability

What is meant by medical liability?

It refers to the liability of the doctor or healthcare facility for harm caused to the patient through errors, omissions or breaches of professional duties.

What is the difference between a doctor's liability and that of a healthcare facility?

Doctors are generally liable under non-contractual liability, while facilities are liable under contractual liability, with limitation periods of five and ten years respectively.

When does medical fault arise?

When the professional acts with negligence, imprudence or lack of skill, causing harm connected to their conduct.

What is the role of informed consent?

The doctor must properly inform the patient of risks, benefits and alternatives. Incomplete or absent consent may give rise to liability and the right to compensation.

What types of damages may be compensated?

Pecuniary damages (expenses, loss of income) and non-pecuniary damages (biological, moral, existential and family-related).

How is medical liability proven?

The patient must prove the damage and the causal link. The facility must prove that it complied with its obligations.

Can a doctor be criminally liable?

Yes, in cases of negligent injury or manslaughter arising from negligence, imprudence or lack of skill, especially in serious cases.

What does the Gelli Bianco Law provide?

Exemption from liability for minor fault when guidelines are followed, mandatory insurance, and a clearer distinction between the liability of the doctor and that of the facility.

How long do I have to file a compensation claim?

Ten years against the healthcare facility and five years against the doctor, unless a direct contract exists.

Is mediation mandatory before filing a lawsuit?

Yes, mediation or preventive technical assessment is required before initiating civil proceedings.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.