Medical Liability: The Current Situation and Patient Safety
Accusations of negligence and harm cannot always be substantially mitigated by compensations for errors. A more realistic approach includes managing expectations and ensuring continuous education systems are in place for healthcare professionals. Typically, the public’s reaction to the term "medical negligence" is: "A qualified doctor made a mistake, and I want financial compensation for that negligence." However, a more accurate interpretation is needed today.
Negligence is sometimes misunderstood as synonymous with malpractice, but in reality, it should be confined to two specific meanings: using outdated knowledge and skills (negligence related to continuous education), and failing to implement safety measures known to be necessary (negligence regarding standard procedures). Both definitions are complex and relative due to the rapid advancements in healthcare professions. Interestingly, most claims of negligence don’t relate to cutting-edge scientific developments but to simple treatments and safety protocols that have long been established in the healthcare sector.
Public attitudes towards healthcare services and professionals used to be generally submissive, but they have thankfully shifted in recent decades. People are now more aware of the real risks of negligence. At times, it seems as though the pendulum has swung from blind trust in the near-divine skills of healthcare workers to the belief that if a treatment or advice does not yield the desired results, someone must have made a mistake, and they should be blamed and financially compensated.
Medical negligence exists in nearly all countries. However, in most places, it remains at such a small scale that it does not impact the quality, cost, or availability of healthcare. In the United States, however, it has reached critical levels. The primary need is to narrow the gap between public expectations and what the healthcare system can realistically deliver. Unfortunately, both sides are resistant to change. The public often believes that their financial contributions to healthcare—whether through insurance, taxes, or service fees—entitle them to high expectations, much like they demand value for money when purchasing other services or consumer goods.
In some healthcare systems, efforts have been made to bridge this gap, but often from a legal standpoint, focusing on unfortunate outcomes. Communication skills, patient education, and health awareness can significantly help reduce this gap, and they need greater emphasis in most healthcare systems today.
The second step is to find better ways to maintain and update the knowledge and skills of healthcare professionals. The most promising solution is to establish a system that combines mandatory ongoing education with numerous voluntary opportunities for further learning.
The purpose of this document is to develop a curriculum centered on patient safety and to discuss the future responsibilities of healthcare providers and organizations. It calls for all involved in healthcare to recognize the harm to patients and the healthcare system and to adopt a culture of safety. Patient safety education and training are just beginning to take hold at various levels. Medical students, future doctors, and healthcare leaders must be prepared to practice safe healthcare.
Although medical curricula are constantly evolving to accommodate the latest discoveries and knowledge, patient safety stands out because it applies to all areas of practice. In recent years, patient safety science has developed, showing that patient harm is not always inevitable and can be prevented. To achieve this, doctors and institutions must learn from past mistakes and understand how to prevent future errors. We must adjust our working methods to make safe healthcare a solid and achievable goal.
Traditionally, medical curricula have focused purely on clinical skills: diagnosing diseases, treating illnesses, and providing post-care follow-up. However, teamwork, quality improvement, and risk management have been overlooked, though they are fundamental to patient safety.
In response, the Women’s Health and Education Center (WHEC), along with its healthcare partners, has developed this curriculum, which will enable and encourage medical schools and healthcare providers to integrate patient safety into their studies. Reducing the harm caused by healthcare is a global priority, and embedding the knowledge of how to achieve this into the medical student curriculum is an urgent necessity. This guide is just the beginning. A plan is already underway to adapt it for use by other healthcare professionals, including nurses and pharmacists.
It is only one step in our efforts to build safer healthcare systems. However, there is no doubt that involving doctors from the earliest stages of their training is critical.
The Cost of Medical Malpractice in the United States and International Approaches
Medical malpractice costs in the United States are estimated at $55.6 billion annually, representing 2.4% of total healthcare spending in 2010 (1). This figure includes $45.6 billion attributed to what is known as "defensive medicine," where doctors order unnecessary tests or treatments to avoid litigation. The true cost of medical liability in the U.S. has long been unclear, but researchers behind this study claim that their analysis is the most comprehensive and reliable estimate to date.
Doctors are the primary targets of malpractice lawsuits. In 2006, malpractice payment records revealed that 79% of payments were made in lawsuits against physicians, while dentists accounted for 10.3%, and other healthcare professionals made up the remaining 10.7% (2). Interestingly, poor quality of care does not appear to be the main cause of most malpractice claims, as no significant differences in care quality were found between doctors who had been sued and those who had not. The risk of malpractice varies by medical specialty, often increasing with the frequency of procedures and the likelihood of catastrophic outcomes. A 2005 study found that obstetricians and gynecologists in the U.S. face a malpractice claim every 11 years on average, with a trial occurring approximately every 69 years. A more recent survey conducted in 2009 by the American College of Obstetricians and Gynecologists (ACOG) revealed that 90.5% of respondents had faced at least one malpractice claim, with an average of 2.69 claims per physician (3). The study also found that 62.1% of claims involved obstetric care, while 37.9% were related to gynecological care.
According to the 2000 landmark report from the Institute of Medicine, To Err is Human: Building a Safer Health System, between 44,000 and 98,000 deaths occur each year in U.S. hospitals due to medical errors, with over 7,000 of these deaths attributed to medication errors (4). The key objectives of the U.S. medical malpractice system are to compensate individuals harmed by medical negligence, hold individuals accountable for unsafe practices or errors, and deter future unsafe medical practices. However, many patients who suffer injuries due to medical negligence do not file lawsuits, and a large number of claims do not involve negligence. This disconnect leaves the primary goals of the malpractice system unmet, prompting calls for reform.
In the United Kingdom, doctors have faced litigation for over 100 years. Most early lawsuits involved allegations of "quackery" or breach of contract. In response, the first medical defense organization, the Medical Defence Union, was founded in 1885, followed by the Medical Protection Society in 1892 and the Medical and Dental Defence Union of Scotland in 1902. As in the U.S., the cost of litigation in the UK's National Health Service (NHS) has risen significantly. In 1995, the NHS Litigation Authority was established with the mission to "manage clinical negligence claims and promote high standards of risk management in the NHS." During 2008-2009, 6,080 clinical negligence claims were filed against NHS bodies, up from 5,470 claims in 2007-2008, and the total payouts for clinical negligence in 2008-2009 reached £769 million, compared to £633 million the previous year (5). Awards in the U.S. are generally higher because damages there are punitive, whereas in the UK they are compensatory.
Several countries, including Sweden, Norway, Australia, Canada, and New Zealand, have established well-functioning administrative compensation systems for medical injuries. In Sweden, compensable events are defined as preventable injuries—those that a doctor (whether general practitioner or specialist) could have avoided. For an internal injury, the determination is whether the procedure was carried out correctly and if another approach could have satisfied the medical needs in a less risky way. In Denmark, compensable events include all avoidable injuries and some unavoidable injuries. Importantly, these systems do not require proof of fault or negligence to obtain compensation.
It is noteworthy that these programs are not absolute liability systems, nor are they purely no-fault schemes. They are concerned only with injuries caused by treatment, examination, or care. While these systems are no-fault, they do not guarantee compensation in every case. Patient Injury Compensation Boards assess whether an injury or adverse event qualifies for compensation under the program's terms. In Sweden and Denmark, more patients receive compensation, and the criteria for eligibility are more objective and liberal. Additionally, there is no financial risk for patients, the time to process claims is shorter, and administrative costs are lower. Perhaps most importantly, these systems foster better relationships between doctors and patients, as doctors can assist patients without fearing punitive consequences. Patients are less likely to file complaints with regulatory bodies if they are supported by their doctors in seeking compensation, allowing doctors to focus on their medical duties.
The history of Sweden's and Denmark's patient injury compensation systems illustrates that it is possible to identify negative medical outcomes that deserve compensation. The authors of this study believe that practical pilot programs will convince patients, doctors, insurance experts, insurers, and policymakers that patients can be fairly and swiftly compensated through sound financial and administrative mechanisms. There would no longer be a need to rely on the tort system to determine whether or not an event is compensable
Key Concepts in Medical Malpractice
Medical errors are often addressed within the civil court system or through tort law in the United States. Generally, the civil court system provides a mechanism for individuals or groups to seek compensation when harm (derived from the French word meaning "wrong") is inflicted on a person or property. Such harm is categorized as either intentional or negligent. Several types of intentional harm may be committed by healthcare providers, including assault and battery (such as performing surgery without prior consent), false imprisonment (for instance, forcing a patient to remain in the hospital until a bill is paid), and fraud (such as a doctor claiming a treatment will work when they know it will not).
Negligence occurs when a healthcare professional either fails to act or takes an action that a reasonably prudent person would or would not have taken under the same circumstances. The statute of limitations for filing a medical malpractice claim varies by state, with many states having laws that differ depending on the nature of the case, especially for minors. In general, a medical malpractice claim must be filed within one to five years of the incident or, in cases where the injury was not immediately apparent, within a set time after the injury was discovered.
Standard of Medical Care and Negligence
In cases of medical malpractice, the burden falls on the plaintiff to establish the appropriate standard of care and demonstrate that this standard was breached. The standard of care is primarily defined by practitioners with similar qualifications, who provide expert testimony on how a reasonable professional would have acted under similar circumstances. Typically, expert testimony is based on the physician's knowledge, skills, experience, and training, which can be supplemented by published literature, practice guidelines, and surveys of practitioners. The key focus is whether the physician's actions met or violated the standard of care, and if the latter, whether the plaintiff was harmed as a result of that breach.
Several healthcare systems have attempted to establish standardized guidelines for obstetric care, with varying degrees of success. The main advantage of a guideline-based system is that it theoretically allows for more consistent approaches to medical care among healthcare workers and support staff within a single system or hospital. In many leading healthcare systems and academic institutions in the United States, there is a growing trend toward creating unified clinical guidelines to improve patient safety and clinical outcomes.
Various strategies aim to standardize clinical guidelines, including care algorithms, electronic medical record templates, surgical checklists, and other protocols designed to enhance patient care. However, successful implementation of these methods requires more than just educational efforts directed at healthcare team members.
Under tort law, four essential elements must be established to determine a case of malpractice:
Duty of Care: The healthcare provider must have a legal obligation to provide care to the patient. This duty arises from the professional relationship between the provider and the patient.
Breach of Duty: The healthcare provider fails to meet the standard of care expected in the situation. This breach can occur through action or inaction that a competent professional would not have taken under similar circumstances.
Causation: There must be a direct link between the provider’s breach of duty and the harm suffered by the patient. In other words, the patient’s injury must be a result of the provider's negligence.
Damages: The patient must have suffered actual harm or injury as a result of the breach of duty. This could include physical, emotional, or financial damages.
All four elements must be proven for a malpractice claim to be successful.
These elements must be proven by a "preponderance of the evidence," which means it is more than 50% likely that the claim is true. This standard is lower than the "beyond a reasonable doubt" threshold used in criminal law. In malpractice cases in the United States, decisions are made based on what "a jury is likely to believe is the truth" rather than the actual truth itself.
Informed Consent
The Legal Basis of Informed Consent in Medicine
In medical law, the concept of consent was initially derived from the idea of battery, an intentional tort. The primary goal of informed consent is to protect patients by requiring physicians to provide a balanced discussion of the proposed procedure or treatment, as well as alternative options, so that patients can make informed decisions. Originally, informed consent was only required for invasive procedures, but its scope has expanded to include more complex treatments (such as radiation therapy and chemotherapy). In some states, separate written consent is also required for the use of anesthesia (whether general, spinal/epidural, or regional).
Informed consent is an ethical concept that has become deeply integrated into contemporary medical ethics and clinical practice. As an ethical doctrine, informed consent is a communication process that empowers the patient to make an informed and voluntary decision about whether to accept or refuse medical care. Recognizing the ethical importance of informed consent, the Ethics Committee of ACOG (American College of Obstetricians and Gynecologists) emphasizes the following eight key principles:
1- The process of obtaining consent for medical treatment, participation in medical research, and involvement in teaching activities is an ethical obligation that is partially reflected in legal theories and requirements. This includes situations where students and residents are involved in procedures, underscoring the ethical need for transparency and respect for patient autonomy.
2- Seeking prior consent respects the patient as an individual and specifically honors their moral right to bodily integrity, self-determination regarding sexual and reproductive abilities, and supports their freedom to make decisions within the context of care relationships.
3- Informed consent not only safeguards the patient from unwanted medical treatments, but also enables their active involvement in planning their ongoing and future medical care.
4- Effective communication is essential for informed consent to be achieved. Physicians can support this process by finding ways to facilitate communication not only in their individual relationships with patients but also within the structured environment of healthcare institutions.
5- Informed consent should be viewed as an ongoing process rather than a mere form-signing event. This process involves the continuous exchange and sharing of information between the physician and the patient over time, aimed at supporting the patient’s autonomy in making informed decisions throughout their care journey.
6- The ethical requirement to obtain informed consent does not conflict with the general ethical obligation of physicians to act beneficently. Physicians should make every effort to integrate the commitment to informed consent within their duty to provide medical benefits to patients, thereby respecting them as whole and embodied individuals.
7- When obtaining prior consent from the patient is impossible, an alternative decision-maker should be identified to represent the patient’s wishes or best interests. In emergency situations, healthcare professionals may act based on their perception of the patient's best interests. In rare cases, they may have to forego obtaining consent due to a higher ethical obligation, such as protecting public health.
8- Since ethical requirements cannot be equated with legal obligations, physicians must also familiarize themselves with federal and state legal requirements for obtaining consent. Additionally, doctors should be aware of the policies within their practices, as these may vary from one institution to another.
Relevant Malpractice Laws
Several laws have been established to provide healthcare professionals with specific protections against legal liability. These laws, which include Good Samaritan laws, charitable immunity laws, and apology laws, vary from state to state. The American Medical Association (AMA) has developed a resource that outlines the details of these protections in each state.
Good Samaritan Laws: These laws are designed to protect individuals who voluntarily provide emergency assistance to those in need. "Good Samaritans" can assist an injured person based on implied consent; however, if the person is conscious and responsive, it is advisable to first ask for permission before providing help. In most states, individuals are not legally obligated to administer first aid unless it is part of their job description. However, once assistance is offered, the individual providing help is expected to act with reasonable caution. Good Samaritan laws shield volunteers from legal liability in the event that they make a mistake while providing emergency care. Generally, two conditions must be met: the assistance must be given at the scene of the emergency, and the volunteer should not have any ulterior motives, such as a desire for payment.
Charitable Immunity Laws: These laws are designed to protect physicians and other healthcare professionals who volunteer their services free of charge to uninsured individuals. The specifics of these laws vary from state to state, but they generally raise the threshold for negligence claims (from ordinary negligence to gross negligence) or provide liability protection to volunteer healthcare professionals as if they were government employees. Some state laws incorporate elements from both approaches. They often require proof of gross negligence (defined as "willful," "outrageous," or "reckless" neglect), which can make it challenging to establish medical negligence.
In states where volunteers receive compensation, there are legal defense funds available to cover defense costs and monetary damages; in some instances, there is a cap on the total amount of compensation that can be awarded. Thus, these laws, known as state damage compensation laws, help mitigate financial losses. Charitable immunity legislation exists in all states (including Washington, D.C.) except for Alaska, California, Massachusetts, Nebraska, New Mexico, New York, and Vermont.
Specifically, retired physicians are referenced in legislation in 12 states, while three states (Pennsylvania, Washington, and West Virginia) have laws that apply only to retired physicians. In addition to state laws, federal legislation also protects healthcare professionals who provide free medical care. The Volunteer Protection Act of 1997 provides immunity from liability for volunteer physicians "acting within the scope of their duties in a nonprofit organization." This law also limits punitive damages in cases where there is clear and convincing evidence of intentional misconduct, criminal behavior, or willful disregard for the rights and safety of individuals at risk of harm.
While neither state nor federal charitable immunity laws guarantee that malpractice claims will not be filed, they appear to limit the number of claims for compensation, and volunteer physicians in these settings are rarely targeted by malpractice lawsuits.
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