|SYMPOSIUM: COMPLICATIONS IN SPINE SURGERY
|Year : 2023 | Volume
| Issue : 1 | Page : 48-53
Managing complications: Communication and medicolegal aspects
Krishnendu Mukherjee1, Rik Mukherjee2, Jayanta Das1
1 AMRI Hospitals, Salt Lake, Kolkata, India
2 University of Birmingham, Medical School, Birmingham, UK
|Date of Submission||29-Jul-2022|
|Date of Decision||27-Oct-2022|
|Date of Acceptance||25-Nov-2022|
|Date of Web Publication||11-Feb-2023|
AMRI Hospitals, Salt Lake, Kolkata
Source of Support: None, Conflict of Interest: None
Complications are neither entirely predictable nor preventable in the practice of spinal surgery. Communications, particularly the pre-operative consent, play an important role in the management of complications. Patient dissatisfaction leading to complaints and legal proceedings are common and expected sequelae to complications. This article is an overview of important aspects of doctor–patient communication and the relevant legal issues including the principles followed by the judicial system in India while adjudicating on alleged medical negligence.
Keywords: Compensation, complications, consent, lawsuits, malpractice, National Medical Commission, negligence, spinal surgery
|How to cite this article:|
Mukherjee K, Mukherjee R, Das J. Managing complications: Communication and medicolegal aspects. Indian Spine J 2023;6:48-53
| Introduction|| |
In the practice of clinical medicine, particularly in the interventional specialities, complications and adverse events are not always preventable. It is therefore crucially important that clinicians remain constantly aware and updated about detection and management of complications. The communication of an adverse event or outcome to a patient and their family is a formidable challenge and needs to be handled with empathy. While wisdom and experience enhance this skill, formal training is also of great importance. There is evidence that training and tutorship improve communication skills. Physicians should also possess the basic knowledge about the handling of sensitive issues of grievances and litigations, which often follow surgical complications. Spinal surgery carries a high risk of evoking litigations, and both experience as well as systematic reviews suggest that awareness of medicolegal implications tends to be lower in the early phase of a surgeon’s career.
| Pre-operative Communication|| |
While enumerating the complications of spinal surgery is beyond the ambit of this review, it does need mention that every patient undergoing a surgical procedure on the spine be adequately counselled about the possibilities. Although injuries to nerve roots and spinal cord remain the commonest serious adverse outcomes, some complications like an inadvertent dural tear are not particularly uncommon and often thought to be usually benign; experience shows that this commonly leads to dissatisfaction and complaints. In contrast, rare but devastating complications like a ureteric injury or pancreatic laceration are often not discussed pre-operatively. This dilemma of complications of which the patient must be informed about before undertaking a procedure has plagued surgeons for a long time.
It is important to appreciate that in India the laws guiding the resolution of medical malpractice suits are more in line with the British as opposed to the American system. In the latter, every conceivable adverse outcome must be informed to the patient beforehand. However, clinicians in India generally limit themselves to information about relatively common and foreseeable complications and the ones which are unique and/or specific to the procedure they are supposed to perform. For example, before a thyroid surgery, implications of injuries to the laryngeal nerves or effects of hypocalcemia are almost always informed, but a stroke from a carotid plaque in an elderly patient is rarely discussed. The most prudent approach to this dilemma is to view the problem in the professional spirit of good clinical practice rather than from a defensive angle of avoiding litigations. Hence, although common general and specific complications should be discussed and documented (consent, vide infra), it is good practice to encourage patients and their families to read about the procedure in well-informed articles and websites. It is equally imperative that we concomitantly reassure the patient and emphasize on the indication of the procedure.
Consent for a surgical operation is neither a simple matter nor a piece of signed document; it is a process in itself. As the practice of medicine progressively evolves into a shared decision-making model, consent will continue to pose newer challenges. Most experts believe this to be the purest form of doctor–patient relationship with a mutual exchange of information and preferences with both agreeing on the decision before implementing it.
To aid our understanding and recall of the crucial aspects of the process of consenting, it is helpful to follow an algorithm. When should we document it? What details should be included? Who listens, understands, and signs it? What should we do under difficult and special circumstances?
In reality, the process begins with the primary consultation, and it is a good practice to document it initially in the clinic (in elective surgeries) and repeat it, doubts cleared, and signed again shortly (few hours to a day) before the procedure. There is no consensus as to the timeframe of validity of a consent, but it makes better sense to document it closer to the day or time of the procedure. In a busy hospital setting, this may not be possible for the primary surgeon to do. Hence, the value of an initial consent taken at consultation allows the patient to learn more about it.
Fundamental to the process are informing and discussing with the patient four cardinal pieces of information.
- What operation is being proposed? Who will perform it? [The National Medical Commission (NMC) which has replaced the Medical Council of India has made this mandatory. Specifying the name of the surgeon(s) will deter “ghost” surgeons where another surgeon, unknown to the patient, performs the procedure; vide Draft Regulations.]
- Why? (What is the aim/what are we hoping to achieve?)
- What are the risks? (Complications and adverse outcomes)
- What are the alternatives?
The name of the surgery should be mentioned in full avoiding abbreviations. It is salutary to mention the same in as much lay language as possible, in addition.
The aim should be clarified. Is relief of symptoms the only aim or are other forms of palliation or cure expected? Important and relatively common complications and unique or specific complications should be mentioned. Chances of recurrence, if any, should be clarified. Alternatives, to the best of our knowledge, should be mentioned. Complementary alternatives need not be discussed (NMC guidelines have clarified that only one system of medicine can be practiced at any given time). The consent must be signed by the patient themselves. If the patient is less than eighteen in completed years, the parents or guardians should sign alongside but the patient should also be encouraged to sign unless they are less than eight in completed years.
A consent should be “witnessed” (a step often missed or ignored) and particularly so in unusual circumstances. A child of seventeen lives with an uncle while their parents are working abroad, a specially abled individual who is an adult but has some articulation deficits, an adult on regular doses of opioids for chronic pain; these are situations in which a witnessed consent is essential.
Clinicians often worry about consenting in emergencies. If the patient is unable to sign or provide a valid consent and/or the next of kin or other family relatives are not available, it is perfectly acceptable to document the circumstances, signed by another doctor and witnessed by a colleague (such as a nurse, technician, or ward attendant) and proceed with the surgery. As we globalize, we are more likely to face situations in which either the patient is abroad and away from their family or vice versa. Here, telephonic recorded consent and/or electronic communication will be accepted as an appropriate surrogate. One golden rule to remember when faced with a difficult situation is that the audiovisual recording of the process, if facilities are available, is the best solution. In fact, for organ transplantation, the NMC has made it mandatory. The same form of video-consenting may be used for patients who do not understand English if local vernacular cannot be used in the consent form.
| Post-operative Communication|| |
Communications with the patient and their family after a surgery, usually in and around the wards or in the clinic, are almost always verbal and never recorded. It is good medical practice to send brief electronic messages (text messages or e-mails) from the hospital/department to the patient’s family either as routine updates or in the event of a complication. This initial information need not be exhaustive in details; however, as soon as an unexpected incident occurs or is discovered, it is prudent to inform the family that an incident has occurred which was not as per expectation and request them to meet the treating physician at early convenience. Alternatively, if the family members are present during ward rounds, they may be requested to countersign in case files in which the salient aspects of daily progress of the patient are documented. It is crucial for the treating physicians to appreciate that regular and detailed communication with the patient and the family should act as positive feedback to perform thorough clinical assessment of the patient who is recovering from surgery. Timely detection of complications and their appropriate treatment can thus be achieved. It has been suggested in a large review of complications in spinal surgery that psychological factors of the treating team are often responsible for the delay in the diagnosis of complications. Denial and abandonment are powerful abettors of such pitfalls. Spoliation, the phenomenon of allowing inaccurate clinical notes or falsification, is indefensible and must be avoided with proactive attention because it often happens as a subconscious act (e.g. while ticking through a checklist of symptoms and signs).
In a recent incident, the National Consumer Dispute Redressal Commission (NCDRC) has found an opthalmologist deficient in service following a complication of a cataract surgery. This verdict was predictably based on the opinion of an expert panel under the aegis of the Medical Council of India. The panel had observed that the occurrence of the complication was not communicated to the patient in proper time. This alone amounted to deficiency of service. Early, honest, and candid discussion with the patient and family members about post-operative complications remains extremely important. The salient points must be documented. Second opinions should be both welcomed and encouraged and the subsequent plan of action discussed at frequent intervals.
Although an error of clinical judgment per se does not amount to medical negligence, it is to be noted that lack of communication is considered outside any defense shields.
| Elements of Medical Laws in Relation to Medical Negligence|| |
Medical law is best defined as “a discrete autonomous discipline that governs rights and responsibilities of medical professionals and their patients. It tends to revolve around a set of central concerns such as confidentiality, negligence, ethics and other torts related to medical treatment.”
A common medicolegal question has been: what surgical operation can be performed by a medical graduate independently? Can a clinician with an MBBS and adequate experience in a spinal surgery unit perform a traditional operation for a prolapsed disc? Here too, the recent NMC guidelines have clarified the situation. Specialist qualification is essential to perform operations under a speciality. A recognized qualification in Neurosurgery or Orthopedics is thus required. Several diplomas are not recognized anymore; however, many post-graduate fellowships are accredited and recognized. It is prudent to go through the relevant Annexure of the NMC as soon as they are published in the Gazette.
In a landmark judgment, the NCDRC had suggested that spinal surgery may evolve as a “speciality in its own right” in the future. The litigation arose after a young lady became paraplegic after attempted surgical correction of kyphoscoliosis. Though the complaint was dismissed, it is interesting to note the observation of the learned members of the NCDRC: “from medical literature from the standard textbooks on spinal surgery it is apparent that in any surgical procedure complications are inherent. Moreover, in spinal surgeries, the serious complications are seen due to the proximity of nerves and spinal cord to the spine.” Implants (rods, pedicular screws, etc.) are commonly used in spinal surgery. This Case Law also shows that adjudicating bodies consider contemporary medical literature in detail, e.g. movement of screws in relation to positional change of the spine.
Patient dissatisfaction often leads to complaints which may range from a verbal or written complaint to the physician/hospital to more serious forms including complaints to the regulatory bodies (State Medical Council, Clinical Establishment Regulatory Authority), criminal or civil lawsuits, or compensation claims in the Consumer Fora.
The grievance redressal mechanism against real or perceived deficiency of medical service is rather flawed in our country. Prolonged delays in the proceedings are common which frustrate every stakeholder; doctors often face the same charges about the same patient in multiple fora simultaneously. There is no provision of technical screening of allegations; hence, many frivolous charges are often filed. Hence, it is difficult to find any dataset to ascertain the exact number of lawsuits against spine surgeons over a given timeframe. However, experience and available data suggest (the authors having examined a series of complaints against spinal surgeons in the consumer fora) that the most common causes of litigations remain:
- New onset neurodeficits occurring after the surgery;
- Persistent pain and morbidity;
- Inadequacy of pre-operative consent (which overlaps with the first two causes);
- Missed diagnosis and erroneous treatment.
There are no separate medical malpractice laws in India; hence, proceedings will continue to draw on the rules enunciated by the NMC, law of contracts and tort, and precedents of judgments of the Apex court. “Deficiency of service” and “medical negligence” are used interchangeably in the Indian judicial system, implying that they are synonymous.
Legal proof of negligence therefore depends on the nature of the allegation. A retained swab at surgery is “res ipsa loquitur” (obvious, speaks for itself), whereas a rare but recognized complication or the lack of a special equipment at surgery is a difficult issue. These will be judged as per the professional literature and expert opinions. This is further elaborated upon in the next section.
The criminal liability of doctors in alleged medical negligence has been adequately clarified by the Hon’ble Supreme Court of India (Jacob Matthew vs. State of Punjab, August 2005).
The court has cautioned that adequate safeguards be in place to prevent undue harassment, in particular police arrests, of medical practitioners. For an act of omission or commission to amount to a rash and negligent act (IPC 304A) during the treatment of a patient, the act must be of a very gross nature. For example, a wrong-site surgery during an operation on the spine, despite pre-operative radiological confirmation, will very likely lead to a lawsuit but not in a criminal court.
| Defending Litigations|| |
Although it is not possible to provide very elaborate guidelines in defending medical negligence lawsuits because technical details vary abundantly, it is nevertheless important to formulate the general principles. A very important change should be noted. As per a new rule of the NMC, the defending physician(s) must reply within 14 days following the first intimation of a complaint with every available document, investigation reports, and medical literature. No further evidence can be adduced to later; the same applies to the complainant. Thus far, an initial reply from the defendant(s) was asked for within 2 weeks while further evidence was produced during subsequent depositions. It remains to be seen whether the time period of 15 days is extended by the NMC; nevertheless, physicians should be doubly careful upon receipt of the first notification of a complaint. A copy of the case file should be obtained as soon as possible and every scientific evidence in defense of the allegations must be collated simultaneously. Adequate documentation and following established evidence-based treatment guidelines remain the most important cornerstones of both good medical practice and precaution against complaints. The occurrence of a complication in itself is not medical negligence. Whether it was informed to the patient and the family and steps taken to identify and treat the problem remain the deciding factors.
The second important issue is to conceptualize the basic approach of the judicial system in India to a medical malpractice litigation. Every doctor owes the following duties of care toward their patients:
- (a) Duty of care in deciding whether to undertake the case;
- (b) Duty of care in deciding what treatment to give;
- (c) Duty of care in administration of that treatment.
A breach of any of the aforementioned duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor. Breach of this duty of care is a fundamental aspect of “deficiency of service” or “negligence.” The automatic corollary therefore will be to define what is “standard of care.” The standard expected is that of the ordinary skill of an ordinary competent professional exercising the art. The highest standard of care is not expected but the standard should match the reasonably average standards of other equivalent professionals. This is referred to as the “Bolam test” (Bolam vs. Friern Hospital Management Committee, UK). One must appreciate that the interpretation of “standard” in the Bolam test is an evolving phenomenon. However, in the recent past, a more stringent yardstick is often applied in India, also after another judgment in the UK (Bolitho vs. City and Hackney Health Authority), referred to as the “Bolitho test.” It emphasizes that the steps of a “reasonable” standard of care must withstand logical analysis by the Courts. As spinal surgery involves the use of sophisticated equipment and specialized instruments, surgeons should familiarize themselves with them and ensure they are in proper order before commencing a surgery. The doctor/hospital could be held liable in the event of complications arising out of dysfunctional equipment and instruments. Choice of equipment and specifications remain entirely with the treating physicians, e.g. the use of intra-operative neuromonitoring which may not be available in smaller hospitals. However, in the event of a lawsuit, contemporary medical literature, expert opinions, and the Bolam and Bolitho tests will be perused.
It is also imperative to remember a few additional points. No matter how absurd an allegation appears, clinicians should never misbehave with any representative of the patient. The media and the public at large often get involved in these issues and avoiding their queries does not help. Issuing a written statement in electronic format is a commendable practice; it also protects against distortion of facts to a reasonable extent. It is not enough to inform the medical defense and indemnity company retained by the physician, and the insurance company should also be kept in the loop. One must exercise one’s right to speak to and choose one’s lawyer before the proceedings begin. In the consumer fora, if initially an adverse verdict is proclaimed, the physician will not be able to appeal to the higher forum without first making a deposit of 50% of the compensation amount pronounced in the initial verdict.
| Compensations|| |
Compensation for deficiency of service may be awarded by the consumer fora and/or the Courts. NMC shall, henceforth, be also authorized to decide on financial penalties. Compensation amount is calculated by taking into account the age and occupation of the patient, the nature and duration of disability, and other variables. A “multiplier method” is often used for the claim by the complainant’s lawyers. [Table 1] shows a list of some important cases and judgements in litigations related to spinal surgery.
Inadequate or missed diagnosis was the cause of the lawsuits in the second case in the table. Though error of judgment may be the actual cause of an inadequate diagnosis and the same can be used in defense in some cases, good training and caution remain the best prevention of such mishaps. The fourth case in the table is another landmark judgment. Here, the Hon’ble Supreme Court of India emphasized on the need of a balanced approach while calculating compensation. While the judgment of deficiency of service was upheld and a large compensation granted (INR 1 crore/10 million), the Apex Court did not entertain the “multiplier method” as claimed by the complainants’ counsel.
| Conclusion|| |
Adequate pre-operative consent, early detection of complications, and appropriate management coupled with regular honest communication with the patients and their family and accurate documentation remain the most important issues.
Financial support and sponsorship
Ethical policy and institutional review board statement
Conflicts of interest
There are no conflicts of interest.
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