Trial Magazine

It is rare that a scholarly article serves to establish a standard of care in medical negligence cases, especially when there might be more than one school of thought on a subject. However, research over the last decade supports a new standard of care in the treatment of patients with acute traumatic spinal cord injuries (SCI) of all types. That research has essentially eliminated an argument for delaying surgical treatment of these patients.

The current standard of care in SCI cases is to do surgery as soon as possible after the injury and to not delay decompression of the spinal cord for any reason other than a patient’s medical instability (having unstable blood pressure or difficulty breathing) or critical unsuitability for undergoing anesthesia and surgery.

This new research provides support for medical negligence cases that claim that a delay in surgical treatment—more than 24 hours after the injury occurred—resulted in a predictably worse outcome for a patient with an acute spinal cord injury. Although the studies are most definitive about the differences in outcomes between patients operated on within 24 hours of a spinal cord injury versus those operated on more than 24 hours after suffering one, the data also supports the concepts that “time is spine” and “earlier is better” when it comes to surgery for SCI.

The standard of care has evolved to now require surgeons to operate to decompress the spinal cord as soon as medically reasonable and possible, understanding that the outcome will be predictably worse with delay, especially when the delay exceeds 24 hours after the trauma.

The School of Thought Against Surgical Intervention

Before 2012, tenets of both surgical and nonsurgical treatment of patients with acute spinal cord injuries evolved slowly. Since 1990, several key studies examining proposed medical treatments fell out of favor when increased scrutiny and analyses of outcomes failed to support their conclusions.¹ Even more controversy surrounded surgical care standards for the timing of surgery on patients with acutely injured spinal cords.

Until 2012, there was scant evidence of the benefit of immediate (or emergent) surgical treatment of most patients with an acute traumatic SCI. The neurologic damage associated with such severe injuries was thought to be essentially irreversible. As a result, acute treatments focused mainly on limiting progressive damage to the spinal cord through immobilization or targeting post-injury swelling with steroids. Surgery was often reserved for patients with gross spinal malalignment (or instability) or progressive loss of function due to continued spinal cord compression.²

Surgery for patients with SCI was rarely done in an emergent or “early” fashion. It was also thought that some categories of less-severely injured patients—such as patients with more mild degrees of weakness and no spinal fracture or instability—had more favorable outcomes, regardless of treatment, and therefore less to gain from surgery at any time.

Another common concern was that the surgery itself could worsen the damage to the spinal cord or increase medical complications early in the course of the injury. However, modern medical literature has failed to provide even moderate support for this, and there is simply no effective and ethical way to study the actual cause of damage to a patient’s spinal cord from surgical manipulation.

At best, the issue of when patients with acutely injured spinal cords should undergo surgery has been a controversial matter of academic debate, and several schools of thought have reflected on spinal cord injury specialists’ various opinions about the timing, benefits, and risks of surgical treatment.

The “traditional” standard of care for treatment of patients with SCI allowed for a cautious and usually non-emergent approach. As a result, it was difficult to argue in medical negligence cases focused on an alleged delay in diagnosis or a failure to treat patients with SCI emergently that a deviation from the standard of care had occurred. In essence, if there was no proven benefit to early surgery—and thus patients with quadriplegia or paraplegia had their fates sealed at the time of their injuries—proving both deviation from the standard of care and causation resulting from a delay in diagnosis and treatment was exceptionally challenging.

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Recent studies have confirmed both the efficacy and safety of early surgical intervention for SCI patients, so much so that the neurosurgical standard of care itself has changed.

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Recent studies have confirmed both the efficacy and safety of early surgical intervention for SCI patients, so much so that the neurosurgical standard of care itself has changed, and the current literature now offers strong support for causation arguments related to delay in treatment of SCI.

Evidence Supporting a Shift in the Standard of Care

In 2012, the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS) definitively addressed the outcomes of “early” versus “late” surgery for acute SCI.³ The study assessed outcomes in terms of the American Spinal Injury Association (ASIA) Impairment Scale—known as the AIS—grade of two populations: patients with acute cervical SCI who underwent “early” surgical decompression less than 24 hours after injury, and those who had “late” surgery more than 24 hours after sustaining their spinal cord injury.

The study authors found that “decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome.”⁴ They concluded that the results “appear to validate a growing consensus among spine surgeons favoring early surgical intervention for SCI.”⁵

Central cord syndrome. Although the STASCIS conclusions changed the standard of care for some types of spinal cord injuries, the treatment for one subgroup remained controversial. Patients with central cord syndrome (CCS) have more weakness in the upper extremities than the lower extremities due to more significant damage to the central areas of the spinal cord compared to the peripheral areas of the spinal cord.

CCS is an “incomplete” spinal cord injury, meaning there is some preservation of function below the level of the injury, rather than a “complete” loss of function below the injured area. Patients with CCS, by definition, are classified as either “ASIA C” or “ASIA D.” (See chart below.)

American Spinal Injury Association Impairment Scale

Adapted from ASIA—ISCOS International Worksheet 2019.

Most ASIA D patients are able to walk. Both patient populations, however, exhibit weakness in the upper extremities, most commonly affecting hand strength and function, even in the less-severely impaired ASIA D patients.

Many CCS patients’ spinal cord injuries do not involve cervical spine fractures or dislocations. Often, these patients have an underlying narrow spinal canal (stenosis) and even preexisting compression of the spinal cord that relatively minor trauma worsened. The trauma did not cause a fracture or dislocation of the joints of the spine, but it results in an SCI.

Such patients often have initially unremarkable X-rays and CT scans, at least to the extent that radiologists detect no bony abnormality (such as a fracture). As such, the injuries often go undiagnosed. Cursory and imprecise neurologic exams (“Move your arms! Wiggle your toes!”) can easily miss critical findings of weakness or even paralysis. However, MRI findings in such cases often reveal not only compression of the spinal cord but also signs of acute edema (swelling of the cord), consistent with the recent trauma and concurrent neurologic deficits, which indicate an acute spinal cord injury.

Traditionally, treatment of CCS called for a cooling-off period after the initial trauma. Surgeons did not rush patients into acute (early) surgery, with the thinking that there was a reasonable likelihood of some neurologic recovery without surgery and that early intervention risked worsening the patient’s spinal cord damage. Doctors often treated patients with acute traumatic CCS with only steroids and sent them promptly to inpatient rehabilitation. They would reassess the patient for signs of improvement several weeks later.

Delayed surgical treatment was reserved for patients whose neurologic condition was worsening, or perhaps, who showed an absence of improvement. But early surgery was the exception, not the norm. It is reasonable even now that “the dogma that central cord syndrome carries a more favorable prognosis leads to a higher likelihood to delay surgical decompression in clinical practice.”⁶

The 2017 literature review. In 2017, a review of the existing literature on surgical outcomes for patients with acute traumatic SCI concluded that “existing evidence supports improved neurologic recovery among cervical SCI patients undergoing early surgery.”⁷ In essence, the authors of this review confirmed that the literature existing as of 2017 supported the conclusions of the STASCIS. However, the authors also noted “inconsistent” evidence regarding clinical outcomes in certain subpopulations of SCI patients, including those with acute traumatic central cord syndrome.⁸

While there was an on-point study reporting the superior results of early surgery in patients with acute CCS without instability,⁹ other studies had failed to prove the benefit of early surgery in that specific pattern of injury. Thus, although there appeared to be mounting evidence supporting the value of early surgery in acute traumatic SCI in general, as of 2017, no obvious standard of care had yet emerged for treatment of patients with CCS.

The Badhiwala study. That all changed in 2022 with the landmark Badhiwala study.¹⁰ This study collected data from 1991 through 2017 and included patients classified as either ASIA C or ASIA D with a cervical level of injury who had undergone decompression surgery for traumatic CCS.¹¹ The researchers compared the results of early surgery to those of patients who had surgery more than 24 hours after their injuries. Outcome measures included assessment of motor recovery and functional independence (for example, eating, grooming, toileting, and walking).

The authors found that early surgical decompression in patients with CCS resulted in improved recovery in upper and lower extremity motor function in ASIA C patients, while those patients who were classified as ASIA D (and, therefore, initially less impaired) experienced improved recovery in upper extremities only.¹² Additionally, “a higher proportion of patients in the early-surgery group appeared to achieve complete independence in various functional activities, particularly those involving upper limb function.”¹³

The authors commented that “the concept of time is spine, or earlier is better, is increasingly recognized.”¹⁴ They emphasized that “recent literature has validated this concept, with a large-scale pooled analysis demonstrating progressively improved neurologic recovery with progressively shorter time to decompression after acute SCI.”¹⁵ They concluded that “it should be recognized that any potential benefit to early surgical decompression may be greater with time thresholds even shorter than 24 hours.”¹⁶

They said their study results “suggest that early surgical decompression, within 24 hours of injury, was associated with improved recovery in upper limb motor function” and that “in patients with [an] ASIA grade C injury, early surgery was associated with a parallel improvement in lower extremity motor function, resulting in superior overall motor score.”¹⁷

They offered a final conclusion of perhaps the most importance for purposes of both medical and legal analysis: “Treatment paradigms and clinical care pathways for CCS may need to be redefined to encompass early surgical decompression as a neuroprotective therapy.”¹⁸

Commentary following the 2022 Badhiwala publication stated, “The evidence is overwhelming that time is spine for all patients with SCI, including traumatic central cord syndrome.”¹⁹ It concluded that “the possible gain to be made from early decompression is too great to ignore clinically,” and “we believe that modern trauma centers should not delay spinal surgical decompression” for spinal cord injuries.²⁰

Lessons From Two Case Studies

For trial lawyers handling SCI medical negligence cases, two case examples show how the evolving standard of care affected plaintiffs’ claims.

A jet ski crash injured a 42-year-old man. He arrived immediately at a community medical center ER, where the ER physician recognized that the patient had an abnormal neurologic exam, consistent with a likely spinal cord injury. After a trauma surgery consult, the attending trauma surgeon confirmed the abnormal exam findings, including lower extremity weakness and numbness from the upper chest down, consistent with an acute injury to the spinal cord.

The patient then had an immediate consult with the on-call neurosurgical physician’s assistant (PA). Unfortunately, the PA failed to perform a complete neurological examination of the patient’s spinal cord function and failed to recognize ligamentous injury with instability and acute traumatic disc herniation with cord compression on the MRI scans.²¹

Although the PA discussed his findings with the supervising neurosurgeon, the patient had no in-person neurosurgical consultation with a physician until almost 24 hours later. At that time, the physician’s neurological exam showed “incomplete” impairment (and ASIA B). The neurosurgeon proposed a continued nonsurgical course of care, describing the need for “the swelling to go down before operating.”

The recommendations did not sit well with the patient’s family, and they insisted that he be transferred to another facility more experienced with SCI care. Upon arrival at the second facility, the patient underwent immediate surgery to decompress the injured spinal cord and surgically stabilize his spine. Unfortunately, the surgery—done more than 48 hours after the injury—resulted in no meaningful return of neurologic function.

The plaintiffs claimed that the neurosurgeon deviated from the standard of care by not personally evaluating, diagnosing, and treating the patient emergently, resulting in a delay of several days in providing the necessary surgery for the patient’s incomplete spinal cord injury. Had the patient had earlier diagnosis and surgery, especially within 24 hours of the injury, the plaintiffs argued, a full recovery was possible, and meaningful neurologic improvement would have been expected.

The defense arguments in this case centered almost entirely around their experts’ claims that the neurosurgeon’s plan to delay surgical treatment was a reasonable alternative based on an accepted school of thought allowing for late surgery in SCI cases. The defendant neurosurgeon claimed that, since he and the PA had discussed the patient’s condition at the time of the PA’s consult, there was no delay and no deviation from the standard of care when he failed to personally respond to the ER physician’s request for emergent neurosurgical evaluation.

However, the neurosurgeon did admit that he was “not sure” about the type or degree of severity of the patient’s spinal cord injury or whether he would have been stable for surgery upon presentation. The defense claimed there was no causation because the traditional concept that delayed surgery was safer for the patient, with no demonstrated difference in neurologic outcome.

At deposition, the plaintiff’s expert testified that STASCIS demonstrated that not only was early surgery safe, the outcomes of virtually all spinal cord injuries were superior when patients had surgery within 24 hours of injury. After this deposition, the parties reached a favorable settlement. The expert’s knowledge of the most recent literature on the subject, especially the literature related to differences in outcomes with earlier surgery for patients with spinal cord injury, was critical to supporting the argument about standard of care deviations and causation. It proved critical that the expert was properly prepared in how to handle the defense’s efforts at restating “old” dogma as a currently acceptable school of thought.

For the plaintiff attorneys, understanding the current medicine in the context of older theories and concepts allowed us to predict where the defense’s arguments would focus and prepare the expert to avoid inadvertent agreement with, or acknowledgment of, the defense’s outdated medical claims.

In another case, a 28-year-old woman with a genetic condition that caused significant cognitive dysfunction arrived at the local ER after an unwitnessed fall at home. She complained of neck pain, but the ER notes said she was “uncooperative with examination.” A CT scan of the patient’s neck revealed only “degenerative changes” and no acute fracture or instability.

The day after admission, the consulting neurologist described the patient as “able to move her arms with distraction, but refusing to move legs or walk.”²² However, the physical therapist found “significant deficits in strength testing of both hands and both lower extremities.” The admitting physicians ultimately concluded that the patient’s “deficit was psychological, and not neurological at all.”

The hospital discharged the patient four days later. She visited her usual neurologist two weeks later for a routine outpatient follow-up. That neurologist, who knew the patient’s baseline neurologic function well, immediately recognized that the patient, who had not gotten out of bed or walked since the fall, had significant neurologic deficits in strength and coordination entirely different from her known baseline.

He referred her to the hospital for immediate care. There, a neurosurgical consultant diagnosed a hyperextension injury of the cervical spine with ASIA C central cord syndrome. An MRI showed several herniated discs compressing the patient’s spinal cord, and the neurosurgeon ordered immediate surgery. Unfortunately, the surgery offered no meaningful recovery, and the patient later passed away due to complications of quadriplegia.

In this case, the plaintiff’s claims focused mainly on the ER physician’s failure to recognize the severity of the patient’s neurologic condition when she was first seen in the ER, resulting in a failure to diagnose her spinal cord injury. That failure to diagnose led to her discharge without emergent surgical treatment, which was a deviation from the standard of care. That deviation deprived the patient of the opportunity to experience meaningful (or even full) neurologic recovery.

The defense first attempted to argue that the patient hadn’t sustained an acute traumatic injury to the spinal cord. The plaintiff’s expert report and deposition testimony, however, showed that a patient can have an acute traumatic injury to the spinal cord without a fracture (as was the case here) and that the absence of a documented neurologic deficit when doctors did not perform a complete neurologic exam does not mean the patient had normal neurologic function.

The defense then claimed that any delay in diagnosis was harmless because there was no demonstrated advantage to earlier surgery for the type of spinal cord injury the patient had sustained. With the Badhiwala study not yet published, the plaintiff’s argument focused specifically on the results of STASCIS regarding ASIA C injuries: In that study group, only patients operated on early had any chance of regaining normal motor and sensory function—that is, experiencing a complete recovery from their SCI—and no ASIA C patient operated on more than 24 hours after injury had returned to their pre-injury condition. The plaintiff argued that the missed diagnosis and delay in surgery deprived the patient of a meaningful recovery and the only chance to regain neurologic function. The parties reached a favorable pretrial settlement.

Classic defense arguments rely on expert claims that the patient’s outcome would not have been any different with earlier surgery and often cite old and now-disproven science that the damage is already done at the time of injury. Both STASCIS and the Badhiwala study demonstrate that these defense arguments are no longer within the standard of care. Nor can defendants resort to claims of “no harm, no foul,” as we now know that delays in surgical treatment adversely affect patients with all types of spinal cord injuries.

Plaintiff attorneys must stay up to date with the current literature and science related to spinal cord injuries and the timing of surgery. You’ll be able to refute predictable defense arguments and strongly support your client’s claims about delays in treatment.

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James Lowe is a doctor and an attorney at James Lowe, MD Law in Philadelphia and can be reached at jim@lowemdlaw.com.

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Notes

1. Michael Bracken et al., A Randomized, Controlled Trial of Methylprednisolone or Naloxone in the Treatment of Acute Spinal-Cord Injury. Results of the Second National Acute Spinal Cord Injury Study, 322(20) New Engl. J. Med. 1405 (1990).
2. “Spinal malalignment” and “instability” occur when the anatomy is disrupted such that there is no longer normal position and function of the bones and joints of the spine and the spine cannot adequately support and protect the spinal cord.
3. Michael Fehlings et al., Early vs Delayed Decompression for Traumatic Cervical Spinal Cord Injury: Results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS), 7(2) PLoS One 7:e32037 (2012).
4. Id. at 1.
5. Id. at 6.
6. David Okonkwo & Harry Mushlin, Invited Commentary: Central Cord Syndrome is Likewise a Surgical Emergency—Time Is Spine, 157(11) JAMA Surg. 1032 (2022).
7. Jefferson Wilson et al., Timing of Decompression in Patients With Acute Spinal Cord Injury: A Systematic Review, 7(3S) Global Spine J. 95S (2017).
8. Id.
9. Id. at 103(S).
10. Jetan Badhiwala et al., Early vs Late Surgical Decompression for Central Cord Syndrome, 157(11) JAMA Surg. 1024 (2022); Brian Lenehan et al., The Urgency of Surgical Decompression in Acute Central Cord Injuries With Spondylosis and Without Instability, 35(21 suppl.) Spine S180 (2010).
11. Badhiwala, supra note 10 at 1025.
12. Id. at 1026.
13. Id. (emphasis added).
14. Id. at 1029 (emphasis added).
15. Id.
16. Id.
17. Id. at 1030.
18. Id.
19. Okonkwo, supra note 5.
20. Id.
21. “Disc herniation” is another term for “ruptured disc” or other disruption of the normal disc anatomy. “Cord compression” is when the spinal cord is deformed or compressed by an abnormal bone and/or disc or malalignment of the bones of the spine, such as occurs with a fracture or dislocation of the spine.
22. This is a direct quote from the chart, so it was not entirely clear until deposition what was meant by “with distraction.” However, “with distraction” in the context of a neurologic exam refers to techniques used to divert the patient’s attention (especially children or patients with mental disabilities) while examining their strength. In this case, the neurologist described in the deposition shaking the patient’s stuffed animal to get her to not focus on the strength testing.