Friday, 5 August 2022

Malpractice litigation in orthopaedic surgery

 

Malpractice litigation in orthopaedic surgery



                              DR KS Dhillon


Introduction

The Macmillan dictionary defines medical malpractice as “carelessness or improper treatment by a health care worker that results in injury or death”.

Negligence is defined by the Oxford English Dictionary as ‘a want of attention to what ought to be done or looked after’, and ‘a failure to match up to required standards of performance’ [1]. Essentially negligence is the failure to provide the standard of health care resulting in medical injuries.

In the law of negligence, there is a three-stage test, the first that the doctor owed the patient a duty of care, the second that the duty was breached, and the third that the doctor caused the breach. The case will fail if any of these cannot be proved [1]. The plaintiff has to prove that the standard of care has fallen below what is acceptable. 

A recent judgment in Chester vs Afshar (2004) [2] has raised the threshold for what is deemed acceptable. Patients are also becoming more informed of their right to redress.


Chester v Afshar [2004] 3 WLR 927

In Chester v Afshar, the claimant Chester had suffered back pain for about 6 years. She was treated conservatively by Dr. Wright, a consultant rheumatologist. An MRI of the spine showed disc protrusions. The pain got worse, and she developed severe pain with reduced bladder control. A repeat scan showed marked disc protrusions into the spinal canal. 

She was referred to a distinguished consultant neurosurgeon, Mr. Afshar for surgery. Mr. Afshar became subject to a legal and professional duty to take reasonable care and skill in examining her, assessing her case, and advising her on the need for surgery to treat her condition. He was also obliged to take reasonable care and skill in doing the operation and looking after her. 

The surgery which was needed to treat her condition carried a 1-2% risk of making her condition worse, even if it was performed without negligence.  Mr. Afshar however did not warn her of this risk. The claimant underwent the surgery and postoperatively developed a cauda equina syndrome leading to a serious adverse outcome. Mr. Afshar took reasonable care to examine, assess her condition, and carry out the surgery in compliance with his legal duty.

Miss Chester, however, contended at her trial that Mr. Afshar had performed the operation negligently but the judge, however, rejected this complaint and stated that the surgeon was not negligent in performing the operation. The trial judge found that the failure to warn the patient of this small unavoidable risk was a breach of duty.

Miss Chester argued that had she been warned of the risk she would not have had the operation straight away but would have taken time to consider other options and discuss the risks of surgery with her family.  She did not, however, say that she would never have had the operation.

The judge was of the opinion that if she had the operation on another occasion it may have been successful and the complication may not have materialized. Hence, the judge found for the claimant. The defendant then appealed but the Court of Appeal dismissed the appeal. The defendant then appealed to the House of Lords on the grounds of causation. The defendant said that she was likely to have consented to the operation. He also said that even if the operation had been carried out on a different occasion it carried the same risk.

With a 3:2 decision at the House of Lords, with Lord Bingham & Lord Hoffman dissenting, the appeal was dismissed. Lord Hope summed up his decision as follows:

"To leave the patient who would find the decision difficult without a remedy, as the normal approach to causation would indicate, would render the duty useless in the cases where it may be needed most. This would discriminate against those who cannot honestly say that they would have declined the operation once and for all if they had been warned. I would find that result unacceptable. The function of the law is to enable rights to be vindicated and to provide remedies when duties have been breached. Unless this is done the duty is a hollow one, stripped of all practical force and devoid of all content. It will have lost its ability to protect the patient and thus to fulfill the only purpose which brought it into existence. On policy grounds therefore I would hold that the test of causation is satisfied in this case. The injury was intimately involved with the duty to warn. The duty was owed by the doctor who performed the surgery that Miss Chester consented to. It was the product of the very risk that she should have been warned about when she gave her consent. So I would hold that it can be regarded as having been caused, in the legal sense, by the breach of that duty" [2].

In essence, what the decision means is that the doctor owes a duty to the patient, to warn of risks of surgery, however small the risk is, and even if the risk is unavoidable.


Litigations and orthopaedic surgery

Medical malpractice claims are relatively common. One study reported that 7.4% of physicians have a claim filed against them each year [3]. In the USA, the medical malpractice system accounts for about 2.4% of the health care spending at an estimated cost of $55.6 billion dollars yearly [4].

In the USA, more than 50% of orthopedic surgeons have been named as a defendant in at least 1 medical malpractice lawsuit [5]. Up to 90% of medical lawsuits do not go to trial but litigation has a significant impact on the cost and practice of medicine besides its contribution to physician burnout and depression [5]. Malpractice is definitely a reality in orthopedics.  The payouts for plaintiff-favorable decisions are substantial, with a reported median payout of $132,915 [6]. Others have reported a median payout in plaintiff-verdict cases of between $440,000 to $500,000 [5,7].

From 2003 to 2008 the medical liability lawsuits involving orthopaedic surgeons in the USA increased by 13%. It is thought to be related to the aging population. Orthopaedic surgery has the 7th highest number of lawsuits as compared to other specialties. About 33% of all orthopaedic surgery claims result in payment to plaintiffs. The average cost of defending orthopaedic surgery claims is about $47,000 in the USA.

There are 3 broad categories that lead to medical litigation. These include improper performance, inappropriate or negligent surgery, and patient dissatisfaction. Improper performance can include postoperative complications or technical errors such as inadequate fracture reduction. Negligent or inappropriate surgery may involve wrong diagnosis, delayed diagnosis, or failed diagnosis and wrong-site surgery. Patient dissatisfaction is defined as a patient’s perception of how successful a surgery was. It commonly involves patients claiming potential complications were not adequately explained or informed consent was not properly obtained [8]. Success rates in defending malpractice claims vary based on the reason for the litigation [8].

Improper performance involving technical error has the highest number of plaintiff verdicts at about 30%. Most orthopedic claims stem from

intraoperative events [9]. 

Thirty percent of lawsuits for patient dissatisfaction are focused on informed consent. The doctrine of acceptable informed consent usually focuses on the risks, benefits, alternatives, and expected outcomes of the surgery or procedure [10].

Most patients report being satisfied with the consent process. However, fewer than half may remember the potential complications of surgery [11]. In trauma patients, this number falls to less than 25% [12]. More than 70% of filed suits are reportedly related to poor physician communication skills [13]. To reduce the likelihood of informed consent claims the focus should be on adequately informing patients of potential complications and outcomes.

The plaintiff-favorable verdicts are higher in patients receiving paediatric orthopaedic care [14]. The average payout is also higher. The rates

of plaintiff-favorable verdicts were higher at about 49% with a higher indemnity payment at about $2.6 million in this group of patients.

Past literature suggests that closed reduction of forearm fractures accounted for the highest number of claims. 

Spine surgery is a high-risk subspecialty, with both high claim numbers and high average indemnity payments [3,15]. This is partly due to the potential for catastrophic outcomes relatively unique to spinal surgery, such as quadriplegia [16]. About 45% of spine claims center around death or permanent injury [17].


Physician errors

There are several types of physician errors.


1. Communication errors  

Communication errors are the leading cause of wrong-side surgeries, medication errors, diagnostic delays, and loss of patients to follow-up [18]. This results in increased treatment costs, treatment delays, and complications.     

Crew resource management has been shown to improve communication and team dynamics [19,20]. This leads to an improvement in patient safety and team morale.


2. Wrong site surgery     

There are several ways to prevent wrong-site surgery. The surgeon should get the patient involved in identifying the correct site and side prior to the induction of anesthesia. The pertinent imaging should be displayed in the operating room. The correct site must be marked with the surgeon's initials visibly in the area to be operated. Prior to making the incision, a time-out must be carried out with the operating room team [21].

When wrong site surgery has been performed the error must be acknowledged with immediate discussions with the family. The surgeon must apologize and accept responsibility.  

  

3. Surgical errors

Surgical errors can be prevented by having a surgical "time-out".

According to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), it should include identifying the correct patient, site, side, and verifying the correct procedure. All members of the team should be present for the time out. Alternatively, it can be repeated. 

In 2009 WHO started implementing the surgical safety checklist (fig 1).  The implementation resulted in measurable improvements in surgical mortality and in-hospital complications [22]. The surgeon is the most effective operating room team member at reducing complications when using a surgical checklist and "time-out".


Fig 1.


4. Medication prescribing errors

In the hospital setting prescribing errors are common. While computerized prescriber order entry (CPOE) systems can improve practitioner prescribing, the design and implementation of a CPOE system should focus on errors with the greatest potential for patient harm. Pharmacist involvement, in addition to a CPOE system, is vital for achieving maximum medication safety [23].    



5. Medical documentation errors

It is illegal to alter the medical records for any reason. No person has the authority to authorize a physician to alter the medical records. The errors can be noted and addendums can be added to the records.


6. Second opinions

A second opinion surgeon is ethically required to disclose the effect of medical errors on patient clinical outcome. Only the patient can unilaterally decide to transfer his/her medical care to a second surgeon. The surgeon is not allowed to seek out transfer of care of a patient [24].


What are the outcomes of Litigation?

The likelihood of malpractice suits across specialties varies substantially. The size of indemnity payments also varies. The risk of facing a malpractice claim is high, especially in spine surgery. Most claims, however, do not lead to payments to plaintiffs [25]. 

Many malpractice claims do not end up in court or in a settlement. When cases do end up in the court, most result in a favorable outcome for the defense [25]. 

Jena et al [26] reviewed 10,056 claims against doctors, from all medical specialties in the USA, who were covered by a large professional liability insurer with a nationwide client base. During their study period, they found that each year 7.4% of all doctors had a malpractice claim. They also found that 1.6% of the claims lead to a payment. Seventy-eight percent of all claims did not result in payments to the claimants. 

The proportion of doctors facing a claim each year varied from 19.1% in neurosurgery to 2.6% in psychiatry. In thoracic–cardiovascular surgery it was 18.9%, general surgery 15.3%, and orthopaedic surgery slightly below 15%.

Jena et al [26] also found that by the age of 65 years, about 75% of doctors in low-risk specialties had faced a malpractice claim, and about 99% of doctors in high-risk specialties would have faced a claim.

When the cases go to court, fifty-four to seventy-five percent of the cases end in favour of the surgeon (defendant) [25].

Daniels et al [27] reviewed 234 medicolegal cases following spinal surgery and they found that 54.2% of cases were ruled in favour of the defense, 26.1% in favour of the plaintiffs, and 19.6% ended in a settlement. 

Higher rates of plaintiffs’ decisions were seen in cases with catastrophic complications, delays in the diagnosis of complications, and delays in treatment [27]. 

Daniels et al [27] found that the awards given for plaintiff rulings ranged from $134,000 to $38,323,196 (mean $4,045,205 ± $6,804,647). In cases where settlements were reached, the awards ranged from $125,000 to $9,000,000 (mean $1,930,278 ± $2,113,593). The awards for settlements were significantly less than those for plaintiff rulings.

Generally, cases with catastrophic complications and delays in diagnosis or treatment are difficult to defend in litigation proceedings.


Cost of the Malpractice Litigation System

The costs of spine surgery litigation are very high. The magnitude of indemnity payments and associated legal expenses are high.

A study of neurosurgical litigation cases by Rovit et al [28] showed that the

mean indemnity payments for cervical spine cases was $457,453 and for lumbar spine cases was $485,182. These indemnity averages exceed the mean payment of all other specialties.

The defendants’ legal costs remain high even after successful claims. The study by Rovit et al [28] found that the average legal fee for cases not proceeding to trial was $28,440 and for cases that went to trial was $73,000. The high indemnity payouts and high defense expenditures lead to higher malpractice premiums for the surgeons.

A national survey of neurosurgeons in the USA by Nahed et al [29] found that 70% of neurosurgeons spend more than 10% of their gross annual revenue on malpractice premiums. 

In another survey, Din et al [30] found that surgeons who mainly performed spine procedures spent an average of $104,480.52 yearly for professional liability insurance. 

Mello et al [31]  estimated that in the USA, the overall annual medical liability system costs about $55.6 billion in 2008, or 2.4 percent of the total health care spending. The indemnity payments were $5.72 billion and the administrative expenditures were $4.13 billion. The defensive medicine costs were much higher at $45.59 billion.

Defensive medicine comes into play “when doctors order tests, procedures, or visits, or avoid certain high-risk patients or procedures, primarily (but not solely) because of concern about malpractice liability” [32].

The spine surgeons are three times more likely to practice defensive medicine as compared to non-spine neurosurgeons [30].


Is the malpractice litigation system a just system?

There are two principal objectives of the medical malpractice liability system. One is to compensate patients who are injured through the negligence of healthcare providers and two is to deter providers from practicing negligently [33]. The system, however, is slow and very costly to administer. Unfortunately, it sometimes fails to compensate patients who have suffered from poor medical care, and it compensates those who haven’t suffered [33].

Some patients who have legitimate claims are turned away because of the high costs of litigation and in many of these cases, the potential monetary award is simply too small to justify the time, resources, and risk of an unfavorable outcome [28]. 

In some cases, the outcome of litigation does not match the strength of

the evidence presented at the trial. Several studies, where independent physicians were asked to grade the strength of adjudicated malpractice claims, found that the defendants won 80% to 90% of cases where experts deemed that the doctors had provided good medical care and about 70% of cases where medical care was uncertain [34-39].

Epstein [40] in a review of 36 cervical spine cases, believed that only 66.6% of patients who received indemnity had legitimate claims. On the other hand, 23.8% of patients with legitimate claims did not receive any indemnity.

The current medicolegal malpractice system is far from perfect. It is doing a poor job in providing indemnity to patients who are harmed due to negligence and at the same time, it punishes a number of doctors who are providing good medical care [25].


Conclusion

The judgment in Chester vs Afshar has raised the threshold for what is deemed acceptable in the medical malpractice arena. Patients are now becoming more informed of their right to redress.

In the USA, spine surgery represents one of the most litigious medical specialties. The most common reasons for spine litigation involves complications following surgery, lack of informed consent, and failure to diagnose or treat the patient in a timely manner. 

The likelihood of malpractice suits across specialties varies considerably. The size of indemnity payments also varies. The risk of facing a malpractice claim is high, especially in spine surgery. Many of these claims, however, do not lead to payments to plaintiffs

The current malpractice system is far from perfect. Unfortunately, it is doing a poor job in providing indemnity to patients who are harmed due to negligence while at the same time it punishes a number of doctors who are providing good medical care for the patients.

The cost of defensive medicine is also very high and defensive practice patterns negatively affect patient care.

By recognizing and understanding the common pitfalls leading to malpractice claims, orthopaedic surgeons can adapt their responses to potentially lower their risk of litigation. 


References

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