Legal Aspects in the Surgical Treatment of Lumbar Degenerative Disk Disease




© Springer-Verlag Berlin Heidelberg 2016
João Luiz Pinheiro-Franco, Alexander R. Vaccaro, Edward C. Benzel and H. Michael Mayer (eds.)Advanced Concepts in Lumbar Degenerative Disk Disease10.1007/978-3-662-47756-4_12


12. Legal Aspects in the Surgical Treatment of Lumbar Degenerative Disk Disease



Vincent C. Traynelis  and Ricardo B. V. Fontes 


(1)
Department of Neurosurgery, Rush University Medical Center, 1725 W Harrison, Suite 855, Chicago, IL 60610, USA

 



 

Vincent C. Traynelis



 

Ricardo B. V. Fontes (Corresponding author)



Keywords
Degenerative disk diseaseLitigationWorker’s compensationWrong-site surgeryWrong-level surgeryInformed consent


Legal issues and the practice of medicine are intrinsically intertwined. This is especially true in terms of the management of symptomatic lumbar degenerative disk disease (DDD). This chapter will focus on some of the legal aspects as they relate to lumbar DDD with particular emphasis on the surgically treated patient. Medicolegal issues, as they relate to the preoperative, intraoperative, and postoperative periods, will be individually addressed. Additionally perspectives on the management of worker’s compensation cases and injuries which are being litigated will be included.

Lumbar surgery is indicated for those patients who experience symptoms due to a surgically treatable lesion despite appropriate nonoperative therapy. Once these conditions are met, a candid discussion should be held with the patient. The purpose of this discussion is to inform the patient of the numerous facts and, in essence, begin the process of obtaining informed consent. Within the USA, the legal concept of informed consent relative to health law began about 50 years ago. The first court records addressing a physician’s duty to discuss the details and information concerning a proposed procedure appeared in 1957 [1, 2]. Since then, there have been numerous rulings and judgments related to informed consent, and this concept has been embraced almost universally by patients. Over 90 % of patients want the proper information to allow them to actively participate in their medical decision-making process. This is not always fully appreciated by physicians, and, in fact, many surgeons not only underestimate patients’ desire for information but also overestimate how much time they spend obtaining consent [3].

In the USA, informed consent is formed from both civil law (tort law) and constitutional law (codified law). The foundations of US civil law are rooted in decisions regarding injuries inflicted upon one individual by another formulated by the medieval English courts of law. Civil law may be codified into state or federal laws and/or statutes if legislative bodies perceive that such an action is in the best interest of the society. Overall, the law of informed consent is based predominantly on civil law with constitutional laws codifying some essential elements. Informed consent is not a document and does not have to be written but rather a process which begins with a dialogue between the surgeon and the patient. The discussion should establish the expectations of both the patient and surgeon with regard to the procedure. The written documentation serves as a record that the discussion took place, but such notations usually do not completely describe the entire exchange of information between the patient and physician. It is important to record the key features of the discussion, and certainly the more detailed the written documentation, the greater its benefit should there be some question at a later date as to what transpired during the informed consent process.

The surgeon has many obligations in the informed consent process. The primary duty is to inform the patient and obtain the patient’s consent to proceed with a treatment plan in a respectful manner. The information exchange should include the results of pertinent diagnostic studies, explanation of the surgical procedure, and probable outcome of surgery. Alternative management strategies need to be listed, and the risks, benefits, outcomes, and potential complications of these options are reviewed. This portion of the discussion is critical; intentional suppression of such information has been judged by the courts to invalidate consent. Many surgeons do not discuss their specific surgical outcomes but, rather, rely on what is published in selected articles; this practice places the surgeon at great legal risk [4].

Providing reliable information on the outcome and benefits of surgery for degenerative lumbar disk disease is not easy. There are many conflicting opinions regarding the management of symptomatic lumbar spondylosis, and often even experts do not agree on the best treatment. For these reasons, a great effort to present an honest appraisal of the proposed procedure is necessary. It may be reasonable in many instances to explain that surgical treatment of degenerative disk disease is not an exact science, and there are many differing opinions. On the other hand, it is important that the surgeon adheres to the procedure for which the consent was obtained. Failure to do constitutes breach of contract, and battery may also be charged [5].

Spinal surgery dominates neurosurgical malpractice claims in the USA accounting for over 40 % of all claims. A widely publicized study from the New England Journal of Medicine revealed that neurosurgeons are the physicians most prone to face a malpractice claim – the yearly risk may be as high as 19.1 % [6]. Orthopedic surgeons followed closely in fourth place [6]. Most claims faced by neurosurgeons are related to elective lumbar surgery [7, 8]. While the reasons for these claims are many, a few of these complications require mention, particularly the infrequent and catastrophic ones. Introduction of sharp instruments such as rongeurs and curettes into the abdominal cavity may occur if the anterior annulus is violated. These instruments may harm the major blood vessels, ureters, or bowel. Such injuries are potentially life-threatening, and the lumbar surgeon should be aware of their various signs and symptoms and act promptly to diagnosis and treat the problem. Though frequently overlooked when obtaining consent due to its presumed rarity, symptomatic injury of intra-abdominal contents is estimated to occur in around 100 cases per year in the USA [9]. A 1998 study focusing on the medicolegal aspects of this potentially catastrophic injury demonstrates that it can be successfully defended, especially if immediately recognized and treated, but it still resulted in a verdict for the plaintiff or a settlement in 48 % of the time [9].

Postoperative vision loss (POVL) is another infrequent but potentially catastrophic complication of surgery for lumbar degenerative disk disease. POVL can happen due to ischemic optic neuropathy, central retinal artery occlusion, cortical blindness, or another unexplained mechanism [10]. Long associated with prone positioning, other risk factors include elevated blood loss, duration of surgery longer than 6 h, patient comorbidities (particularly diabetes), and systemic hypotension during surgery [11]. Its estimated incidence is 0.2 % of all prone lumbar surgeries, thus making it a very infrequent complication, though with life-altering consequences. Unfortunately, POVL is often not discussed by surgeons during informed consent. The American Society of Anesthesiologists issued an advisory suggesting that a physician “consider” disclosing the risk of POVL to high-risk patients; it does not address who (anesthesiologist versus surgeon), how, or when to do it. A possible reason for surgeons refraining from discussing this complication is a belief that patients would not accept surgery if told of the risk for POVL; however, Corda et al. have recently shown that a vast majority of patients would prefer to be informed of POVL in a face-to-face discussion with the surgeon, and it would still not affect their decision to undergo surgery [12].

Cauda equina syndrome (CES) is also one of the main diagnoses quoted in legal claims related to spine surgery. Despite a low incidence (1–6 % of all disk herniations), it possesses a disproportionately high medicolegal profile [13]. It is a classical neurosurgical teaching that decompression should be achieved on an emergent basis, particularly if the syndrome is incomplete and either residual motor or urinary function is present [14]. Despite a number of meta-analyses published in recent years claiming benefit for decompression within 24 or 48 h, in reality the available evidence is of very low quality. Between 50 % and 70 % of cases have a very quick onset and progress to a complete syndrome rapidly; it may be argued that these patients already have their outcome set by the time they present to the hospital [14]. Ultimately, 75 % of CES patients will recover acceptable urinary function; this number may be higher in patients presenting with an incomplete injury. Most legal claims made over CES cases involve a delay in diagnosis and/or treatment; therefore, not only physicians of other specialties may be involved as well but actually be the main target of the claim. Gardner et al. reported on 63 claims made in the UK that 48 were directed to a general practitioner or an emergency physician, 2 against radiologists, and 13 to the spine surgeon [14]. Daniels et al. also found a significant correlation between verdict for the plaintiff and time to surgery >48 h [13]. Significant, persistent disability, on the other hand, has not been always associated with increased claims or verdicts for the plaintiff [1315].

Considerable controversy is found in the recent medical literature over wrong-site and wrong-level surgeries. Wrong-site surgery not only fails to improve the patient’s symptoms, but has major medical, legal, social, and emotional implications. An American Academy of Orthopedic Surgeons (AAOS) bulletin report stated, “A successful legal defense to surgery performed on the incorrect limb is almost impossible” [16]. In 2012, wrong-patient, wrong-site, wrong-procedure-type events were reported to be the second most common sentinel event (12 %) by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) [17]. Preoperative marking of the surgical site, “time-out” verification routines, and intraoperative radiographic verification are some interventions designed to minimize the occurrence of this serious problem [18]. Utilization of intraoperative imaging is believed to be one of the most effective measures to reduce wrong-level surgery – Ammerman et al. demonstrated that incorrect identification of a lumbar disk level by an experienced surgeon without intraoperative imaging may happen in up to 15 % of cases. Despite having been designated a “never event” by the National Quality Forum, there is controversy in grouping wrong-level surgery in the same category as wrong-site, wrong-patient, or wrong-procedure errors [19]. While laterality or identification can be easily determined by anybody without medical training, identification of a specific thoracic or lumbar vertebral level is dependent on variable anatomy and interpretation of radiological studies, and therefore wrong-level errors should not be grouped in the “never event” category [20]. This may explain why over 90 % of spine surgeons report a “close call” of wrong-level error during surgery, and over 50 % admit to having performed a wrong-level procedure at least once; in two thirds of these cases, the error was identified and corrected still during the index procedure [21]. It may also contribute to a perception that while self-verification (i.e., by the patient) and “time-out” procedures have effectively contributed to decrease the number of wrong-site procedures, they may be ineffective to prevent wrong-level errors [20, 21]. In contrast to the fact that wrong-site surgery is virtually indefensible, Goodkin and Laska reviewed 68 cases of wrong-level surgery taken to court up until 2004 and found that in 13 of them a verdict in favor of the surgeon was achieved [9]. Perhaps their most important finding was that there was only one case in which the surgeon identified the wrong-level error during the index procedure and corrected it and was ever taken to court; in that specific instance, settlement was based on the occurrence of an aortic laceration and death and not the wrong-level surgery [9]. In contrast, failure to identify the error, delays in addressing it, and alteration of medical records have all been associated with higher payments [9, 22].

Only gold members can continue reading. Log In or Register to continue

Stay updated, free articles. Join our Telegram channel

May 4, 2017 | Posted by in ORTHOPEDIC | Comments Off on Legal Aspects in the Surgical Treatment of Lumbar Degenerative Disk Disease

Full access? Get Clinical Tree

Get Clinical Tree app for offline access