169

Journal of Health & Biomedical Law, XVII (2021): 169-208 © 2021 Journal of Health & Biomedical Law Suffolk University Law School

A Medical-Legal Guide to Spinal

By Samuel D. Hodge, Jr.*

“You only really discover the strength of your spine when your back is against the wall.” ---James Geary

Patricia Jones, a 56-year-old payroll manager, suffered from neck discomfort and radiating because of a herniated disc. She underwent a laminectomy but complications arose during the procedure. A small fragment of the vertebra broke off and became embedded in the protective covering surrounding the spinal cord.1 The neurosurgeon forged ahead despite the complication and wrote in the post-operative note that no adverse events had occurred during the surgery.

The patient’s pressure plummeted the next day and she developed . A computed tomography scan (“CT scan”) was not ordered until three hours later and it revealed an epidural .2 The neurosurgeon dismissed this finding and said that no accumulation of blood was present that was pressing on the spinal cord. If a proper diagnosis had been made, the hematoma could have been promptly evacuated. Instead, the mistake rendered Ms. Jones a quadriplegic.3

At trial, the defense argued that the patient suffered a spinal cord , nothing could have been done to prevent it, and the informed consent document covered the problem.4 Following a five-month jury trial, Mrs. Jones and her husband were awarded $55.9 million in damages.5

I. Introduction

Many legal and insurance professionals do not understand the indications and limitations of spinal surgery. For instance, the mere finding of a herniated disc or other

* Samuel D. Hodge, Jr. is an award-winning professor at Temple University where he teaches law, , and forensics. He is also a member of the Dispute Resolution Institute where he serves as a mediator and neutral arbitrator. He has authored more than 185 articles in medical or legal journals and has written ten books including co-authoring the text, The Spine For Lawyers, American Bar Association. Professor Hodge enjoys an AV preeminent rating and has been named a top lawyer in Pennsylvania on multiple occasions. 1 Robert Brum, She Became a Quadriplegic After Spinal Surgery. A Jury Awarded her $56M Malpractice Verdict, USA Today (Aug. 12, 2019), https://www.usatoday.com/story/news/nation/2019/08/12/woman-wins-56-million- malpractice-verdict-after-botched-spinal-surgery/1994020001/. 2 Id. 3 Id. 4 Id. 5 Id.

170 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 abnormality on magnetic resonance imaging (“MRI”) may not be clinically significant especially when such a large percentage of asymptomatic people have these findings.6 Spinal are also not created equal and one must understand the differences to properly present or defend a back surgery claim. Damage awards must also be considered as a possible reason that can influence claims for severity and duration of symptoms regardless of the method of treatment employed.7

This article will provide an anatomic overview of the spine with a discussion of the parts that make up this structure, the cushions that permit the spine to bend, and the tissues that hold the together.8 A description of spinal and surgical interventions is also presented along with a discussion of the risks and limitations of these procedures.9 This will be followed by an examination of the malpractice implications of spinal surgery and a representative sample of court cases involving the different surgical approaches involving the spine.

a. Statistics

The spine consists of an array of vertebrae, intervertebral discs, nerves, a spinal cord, and soft tissues. It is a common assumption that this structure is frail or vulnerable and that people must be cautious not to hurt it is wrong.10 The spine is a very sturdy and robust configuration crafted to do its job. Yet, it is a great generator of pain11 and one of the most common medical ailments that affects eighty percent of the population at some time during their life. This discomfort can be a dull ache or an excruciating pain.12 Acute spinal discomfort typically persists from a few days to a few weeks but if it becomes chronic, the pain can continue for months.13

Back pain is the foremost reason for disability around the world, prohibiting countless individuals from working or engaging in everyday activities. It is also one of the most common reasons for lost time from work and fifty percent of employees acknowledge having back pain symptoms annually.14 Age is not a determining factor and most causes of back discomfort are mechanical or non-organic, meaning they are not produced by a serious problem, such as inflammatory , , fracture, or .15 Statistically, it exacts a huge financial toll costing the economy more than $215

6 See JMS Pearce, Aspects of the Failed Back Syndrome: Role of Litigation, 38 SPINAL CORD 63, 66 (2000), https://www.nature.com/articles/3100947 (“[C]onsiderable radiological ‘abnormalities’ commonly exist in people devoid of symptoms and complaints.”). 7 Id. 8 SAMUEL D. HODGE, JR. & JACK E, HUBBARD, THE SPINE FOR LAWYERS: ABA MEDICAL- LEGAL GUIDES 409 (2013). 9 Id. 10 See HODGE & HUBBARD, supra note 8, at 409. 11 See HODGE & HUBBARD, supra note 8, at 409; see also Back Pain, MEDLINE PLUS, https://medlineplus.gov/backpain.html (last visited Mar. 25, 2021). 12 Id. 13 Id. 14 Back Pain Facts and Statistics, AM. CHIROPRACTIC ASS’N, https://www.acatoday.org/Patients/What-is-Chiropractic/Back-Pain-Facts-and-Statistics (last visited Mar. 22, 2021). 15 Id.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 171 billion annually.16 Back pain is also the most common cause of disability in those under forty-five years of age.17

b. Treatment Options

The necessity for care of these individuals, combined with the poor comprehension of the basic foundations of back discomfort, has generated an ever- expanding selection of treatment options, including medications, and manipulative care.18 Occasionally, the pain will not abate, and it may cause neurological issues or instability requiring surgical intervention. There has been a recent increase in the number of techniques available and a marked increase in the number of surgical procedures performed.19 Percutaneous approaches such as epidural steroid injections, facet blocks, spinal cord stimulation, intradiscal methods, and interventions meant to excise discs or other materials in the spinal canal or to fuse the vertebrae have been employed.

Spinal surgeries vary from traditional methods involving discectomies and spinal canal decompression to diverse ways of tackling segmental fusions using different approaches, materials, instruments, and indications.20 Back surgery alters a person’s anatomy so surgical intervention should only be pursued as a last resort. If a or spinal abnormality has not been identified, surgical intervention is improper, nor should back surgery be done to explore possible reasons for the pain. These interventions will transform the routine soft claim into one fraught with possible complications and legal repercussions. The value of the case will also dramatically increase depending upon the type of surgery performed and the patient’s prognosis.21

II. Anatomy of the Spine

This anatomic region is one of the most important parts of the body. Without it, one would be unable to stand; it also provides the body with flexibility, structure, and support. The backbone also protects the spinal cord which passes through the center of the vertebrae.22

The spine runs from the bottom of the skull to the pelvis and is made up of moveable bones called vertebrae. These bones are stacked on top of each other and separated above and below by cushion-like pads dubbed discs.23 Altogether these weight-bearing bones consist of

16 See HODGE & HUBBARD, supra note 8, at 409. 17 See HODGE & HUBBARD, supra note 8, at 409. 18 See Janna Friedly et al., Epidemiology of Spine Care: The Back Pain Dilemma, 21 PHYSICAL MED. AND REHAB. OF N. AM. 659, 659–77 (2010). 19 Id. 20 Id. Fusions are done because of intractable pain instability, herniated discs, and spinal deformities. 21 Id. 22 See A Patient's Guide to Anatomy and Function of the Spine, THE U. OF MD. MED. CTR., https://www.umms.org/ummc/health-services/orthopedics/services/spine/patient- guides/anatomy- function#:~:text=The%20spine%20is%20one%20of,to%20protect%20your%20spinal%20cord (last visited on November 12, 2020). 23 See HODGE & HUBBARD, supra note 8, at 409.

172 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 thirty-four vertebrae but only twenty-four are independent and not fused.24 The vertebrae are also not identical in size and generally become bigger in a downward order because of their weight-bearing obligations.25

a. Regions of the Spine

The vertebral column consists of five major regions; cervical, thoracic, lumbar, sacrum, and coccyx.26 The cervical spine or neck is made up of seven small bones which are tightly stacked upon one another. They are numbered C1 to C7, support the head and allow the neck to rotate as well as flex and extend. The most mobile portion of this segment occurs between the C5-C6 and C6-C7 levels making them the most susceptible to injury.27 The top two bones, however, are uniquely shaped. The C1 vertebra, known as the Atlas bone, holds up the globe of the head. The second vertebra is the Axis and the embryologic body of the C1 bone. It plays a significant role in the rotation of the head28 and is susceptible to a - type injury.29

The thoracic spine is the largest portion of the spine and the most complex. It runs from the base of the neck to the . These 12 vertebrae attach to the ribs, form a fairly rigid unit, and are labeled T1 through T12. Most levels have restricted forward, backward, and side-bending movements.30 Anatomically, the first thoracic vertebra, or T1, is situated parallel to the clavicle, and T12, the last thoracic vertebra ends at the last rib. Due to their anatomic positioning, the thoracic vertebrae and rib cage protect many of the vital organs such as the , , and .31

The lumbar spine is considered the lower back and is made up of five moveable bones which are bigger and thicker than the other vertebrae.32 The first lumbar vertebra, or L1, is located just below the last rib and the L5 bone is situated around the waist. Some people will occasionally have a sixth vertebra which is an anatomic variant.33 This portion of the spine has much flexibility and is subject to the greatest number of back injuries because of their weight-bearing load and mobility.34

24 See J.D. Mitchell, The Engineering Marvel of Our Spine, THE CREATION CLUB, https://thecreationclub.com/the-engineering-marvel-of-our-spine/ (last visited Mar. 25, 2021). 25 See SAMUEL D. HODGE, JR., ANATOMY FOR LITIGATORS 96 (2006). 26See HODGE & HUBBARD, supra note 8, at 410. 27 See HODGE & HUBBARD, supra note 8, at 410, 412. 28 See Axis (C2), RADIOPAEDIA, https://radiopaedia.org/articles/axis-c2?lang=us (last visited Mar. 13, 2021). 29 See HODGE, supra note 25, at 96. 30 See Mark Yezak, DC, Thoracic Spine Anatomy and Upper Back Pain, Spine Health, April 3, 2018, https://www.spine-health.com/conditions/spine-anatomy/thoracic-spine-anatomy-and-upper-back- pain#:~:text=The%20thoracic%20spine%20is%20the,attached%20to%20the%20rib%20cage. 31 See HODGE, supra note 25, at 96. 32 See Stuart Eidelson, Lumbar Spine, SPINE UNIVERSE, https://www.spineuniverse.com/anatomy/lumbar-spine (last visited November 13, 2020). 33 Id. 34 See HODGE, supra note 25, at 97.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 173

The sacrum consists of five fused bones that resemble an inverted triangle with a concave shape.35 It forms the base of the spinal column where it interconnects with the hip to create the pelvis.36 Developmentally, the individual bones of the sacrum start to fuse during late puberty and early adulthood to create a single structure.37 This area forms the back of the pelvis and at the bones of the hip, called the sacroiliac joints, which are main weight- bearing areas. The sacrum has four holes on each side for the nerves and blood vessels to exist. These structures support muscles that perform important roles, such as the pelvic floor, bladder, and anal sphincter.38

The coccyx or tail bone is the final region or termination point of the spine and is made up of four bones that have fused over millions of years.39 It is the skeletal remnant of the caudal eminence that exists from weeks four to eight of gestation. This structure is reabsorbed in the womb, but a small tailbone survives.40 This region supports the body when a person is seated to make sure that the weight is evenly distributed. The coccyx is also the attachment point of the pelvic muscles, which assist in a variety of movements such as jogging and walking.41

b. Ligaments of the Spine

A ligament is a strong fibrous strip of collagenous fibers that hold the bones of the spine together and stabilize the vertebrae and discs.42 There are three major ligaments in the spine. The ligamentum flavum are fibrous bands that run the length of the spine in both the front and back of the stacked vertebral bodies.43 The tissue in the front is the anterior longitudinal ligament and resembles a piece of tape that has been placed on the front of the vertebral bodies to hold them in place and prevent unnecessary movement. The long fibers on the back aspect of the vertebrae make up the posterior longitudinal ligament. This structure assists in keeping the intervertebral discs in an anatomic position and provides stability to the spinal column.44

The ligamentum flavum or yellow ligaments are paired segmental structures that constrict naturally and run between the laminae of adjacent vertebrae. They are located

35 See The Sacrum, TEACH ME ANATOMY, https://teachmeanatomy.info/pelvis/bones/sacrum/ (last visited November 13, 2020). 36 See Tim Taylor, Sacrum, INNER BODY RES., https://www.innerbody.com/image_skel05/skel14_spine.html (last visited November 13, 2020). 37 Id. 38 Eren, How the Spinal Column Supports the Body, FACTY HEALTH, https://facty.com/anatomy/skeletal-system/how-the-spinal-column-supports-the-body/4/ (last visited Mar. 25, 2021). 39 The Coccyx, TEACH ME ANATOMY, https://teachmeanatomy.info/pelvis/bones/coccyx/ (last visited Feb. 22, 2021). 40 Id. 41 Eren, supra note 38. 42 Ligament, BRITANNICA, https://www.britannica.com/science/ligament (last visited Feb. 22, 2021). 43 Anatomy of the Spine, MAYFIELD BRAIN AND SPINE, https://mayfieldclinic.com/pe- anatspine.htm (last visited Feb. 22, 2021). 44 HODGE & HUBBARD, supra note 8, at 415.

174 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 throughout the spine starting with C1-C2 and ending at L5-S1.45 Each is 5 millimeters thick from the front to the back. Structurally, they are the thinnest in the cervical vertebra and largest in the lumbar area.46 Their purpose is to maintain the body’s upright position, to assist in maintaining the normal curvature of the back, and to straighten the spine after it has been flexed.47

Additional tissues that offer stability in the spine are the interspinous ligaments which interconnect the back portion of the vertebra, primarily in the thoracic and lumbar areas, and the intertransverse ligaments which attach adjoining vertebral transverse processes.48 Their purpose is to restrict lateral flexion of the spine.49

c. Curves of the Spine

The spine is anatomically balanced for peak flexibility and support of the body’s mass.50 One would assume that the vertical spine is straight, but this presumption is only correct when the structure is viewed from the front. Looking at the spine from the side, however, reveals several curves that loosely form an “S” shape.51 These gentle bends permit the spine to function as a spring or absorber for the micro-traumas of daily life and they develop as people age since they are not present at birth when the spine has a gentle “C” curve.52 These curves also act in unison to maintain the body’s center of gravity centered over the hips and pelvis.53

The cervical and lumbar regions both have a lordotic curve which represents a mild bending of the spine in an inward direction. When the curve in the cervical spine becomes exaggerated, the person is said to have a swayback.54 A or outward bending curve is observed in the thoracic and sacral areas. These curves help dispense stress while the body is at rest and during movement.55 is an abnormal curvature to the lateral side of the spine that happens most frequently during the growth spurt before puberty.56 This condition can cause a mild cosmetic deformity to life-threatening

45 See generally GREGORY D. CRAMER, CLINICAL ANATOMY OF THE SPINE, SPINAL CORD, AND ANS 135-209 (3d ed. 2014). 46 Id. 47 MARC FISICARO ET. AL., Basic Anatomy of the Cervical, Thoracic, Lumbar, and Sacral Spine, CORE KNOWLEDGE IN ORTHOPAEDICS: SPINE (2005). 48 HODGE & HUBBARD, supra note 8, at 417. 49 Veridiana Tschepe, What is the Role of the Intertransverse Ligaments?, FIND ANY ANSWER, https://findanyanswer.com/what-is-the-role-of-the-intertransverse-ligaments (last visited Feb. 22, 2021). 50 Spinal Deformities, THE SPINE , https://www.columbiaspine.org/condition/spinal- deformities/ (last visited Feb. 22, 2021). 51 Stewart Eidelson, Normal Curves of Your Spine, SPINE UNIVERSE, https://www.spineuniverse.com/anatomy/normal-curves-your-spine (last visited Feb. 22, 2021). 52 HODGE & HUBBARD, supra note 8, at 417. 53 Spinal Deformities, supra note 50. 54 HODGE & HUBBARD, supra note 8, at 99. 55 Eidelson, supra note 51. 56 Scoliosis, MAYO , https://www.mayoclinic.org/diseases-conditions/scoliosis/symptoms- causes/syc-20350716 (last visited Feb. 22, 2021).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 175 breathing disruptions.57 If the problem accelerates, the spine will rotate or twist to its sideways curve. This forces the ribs on one side to project further out than the ones on the opposite side. Scoliosis can be triggered by problems such as and , but in most instances the cause is unknown.58

d. The Vertebrae

The spinal column consists of vertebrae that vary in size and shape based upon their location and function but follow a comparable structural pattern. A typical vertebra will consist of a body, a vertebral arch, and several processes.59 The vertebrae in the neck are the smallest when compared to those in the low back which are the biggest because of their weight-bearing responsibilities.

A vertebra has two main components. The solid and largest portion of the structure situated in front of the middle hole is the vertebral body and the posterior aspect of the bone is the arch. The projection that protrudes backward from the vertebrae for a few inches and can be felt directly below the surface of the is the spinous process.60 This anatomic part provides the attachment point for the soft tissues of the back.61 The vertebra then bends similarly to a wishbone to surround and protect the spinal cord.62 This flattened or arched portion is the laminae which means “plate,” and forms the posterior wall of the bone that covers the spinal cord and nerves.63

The spinal cord travels down the middle of the vertebrae and the nerve roots exit from the sides of the bone for their journey across the body. This is accomplished by natural holes or openings in the bone; the foramina.64 The spinal column also has a series of joints known as facets that allow for movement between the two vertebrae.65 These joints, which are also known as zygapophyseal or apophyseal joints, connect the vertebrae, giving them the needed flexibility to glide against each other. These small, cartilage-lined points of contact66 look like bony knobs that overlap with the vertebrae

57 See Jason Highsmith & Pam Moore, Scoliosis Causes, Symptoms, Diagnosis and Treatment, SPINE UNIVERSE, https://www.spineuniverse.com/conditions/scoliosis (last visited November 13, 2020). 58See Scoliosis, supra note 56. 59 See The Vertebral Column, LUMEN LEARNING, https://courses.lumenlearning.com/suny- ap1/chapter/the-vertebral-column/ (last visited November 13, 2020). 60 See HODGE & HUBBARD, supra note 8, at 411. 61 See Spinous Process Definition, SPINE-HEALTH, https://www.spine-health.com/glossary/spinous- process (last visited November 12, 2020). 62 See Lamina Definition, SPINE-HEALTH https://www.spine-health.com/glossary/lamina (last visited November 12, 2020). 63 See id. 64 See HODGE & HUBBARD, supra note 8, at 491. 65 See Joseph Bernstein, Anatomy, in MUSCULOSKELETAL 253 (Joseph Bernstein ed., 2003). 66 See 6 Clues That Your Back Pain Is From Facet Joint Problems, SPERLING MED. GROUP, http://sperlingmedicalgroup.com/6-clues-that-your-back-pain-is-from-facet-joint- problems/#:~:text=The%20facet%20joints%20are%20small,limit%20its%20range%20of%20m otion (last visited November 12, 2020).

176 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 above and below a joint to provide the spine with maneuverability.67 The facets wear out over time and degenerative such as can eventually be found, especially if there has been a traumatic event.68 Facet joint pain takes places when the joints fail to move smoothly. The resultant changes in the spine can alter the distribution of the body’s weight unevenly over the facet joints resulting in the loss of mobility and irritation. This condition can also irritate the medial branch of the sensory nerve casing the adjacent muscles to spasm and stiffen.69

e. Muscles of the Back

Soft tissues surrounding the backbone play an important part in the fitness of the structure. These large muscles work in tandem to support the trunk and keep the body erect. They also permit the trunk to move, twist and bend.70 These soft tissues are called the extrinsic and intrinsic muscles. The extrinsic muscles attach the spinal column to the extremities and assist in the movement of the shoulder and upper limbs.71 They include the trapezius, latissimus dorsi, rhomboid major and minor, levator scapulae, and the serratus posterior, superior, and inferior muscles.72

The intrinsic muscles are the deep muscles of the back and help the spine move in different directions. Since there is little movement at each vertebral level, spinal motion is achieved by gliding movements over the bony segments.73 These muscles interface with the vertebral column and consist of the erector spinae, the transverse-spinalis, and the deepest muscles whose names are interspinous and intertransverse.74

f. The Discs

The intervertebral discs are fibrocartilaginous cushions acting as the back's shock absorbers, thereby protecting the vertebrae, nerves, and other structures.75 They account for twenty-five percent of the height of the spinal column76 and consists of twenty-three

67 See Apophyseal Joint Definition, SPINE-HEALTH, https://www.spine- health.com/glossary/apophyseal-joint (last visited April 14, 2021). 68 See Facet Joint Anatomy Video, ARTHRITIS – HEALTH, https://www.arthritis- health.com/video/facet-joint-anatomy-video (last visited November 13, 2020). 69 See Overcoming Pain from Facet Joint Syndrome, SPINE ONE, www.spineone.com. (last visited November 22, 2020). 70 See Back Muscles, CEDAR SINAI, https://www.cedars-sinai.org/health-library/diseases-and- conditions/b/back-muscles.html (last visited November 13, 2020). 71 See Extrinsic Muscles of the Back, CIZ ANATOMY ZONE, http://anatomyzone.com/tutorials/musculoskeletal/extrinsic-muscles-of-the- back/#:~:text=The%20extrinsic%20muscles%20of%20the%20back%20are%20those%20muscl es%20which,of%20the%20spine%20and%20head (last visited November 13, 2020). 72 See Brittney Mitchell et al., Anatomy, Back, Extrinsic Muscles, STATPEARLS, https://www.ncbi.nlm.nih.gov/books/NBK537216/#:~:text=The%20extrinsic%20muscles%2 0include%20the,of%20the%20scapula%20and%20humerus (last visited Nov. 13, 2020). 73 See HODGE & HUBBARD, supra note 8, at 450-51. 74 See id. 75 See Keith Bridgewell, Intervertebral Discs, SPINE UNIVERSE, https://www.spineuniverse.com/anatomy/intervertebral-discs (last visited Nov. 13, 2020). 76 Id.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 177 cushions that separate the vertebrae in the cervical, thoracic, and lumbar areas.77 Discs are typically labeled based upon the vertebrae above and below them. Accordingly, the L4- L5 disc is located between the fourth and fifth lumbar vertebrae.78

Discs differ in depth and permit the back to move, bend, and twist. Each has a soft gel-like center, the nucleus pulposus, and a tough outer edge, or annulus , made up of ten to twenty concentric rings of collagen fibers.79 The annulus fibrosis resembles a steel-belted radial tire and is orientated at various angles. In turn, the annulus surrounds and protects the soft inner core.80 The annulus is thicker in its front aspect, which may explain why a disc will most often herniate posteriorly.81

Since the nucleus pulposus provides the main support for the central part of the body, it depends upon its liquid content to provide strength and flexibility.82 As people age, however, the spine starts to display evidence of wear and tear as the discs dry out and shrink making them less pliable. This degenerative process can cause arthritis, disc herniation, , and pain.83

The discs lack a blood supply so they must absorb their nutrients from the surrounding tissue through movement. This reduced blood flow makes discs susceptible to harm and slow to improve from an insult which can result from acute trauma or chronic degeneration.84 A disc herniation occurs when the gelatinous center escapes through a rip or defect in the annulus, just as that which might occur when a grape is squeezed so that the inner pulp escapes through the skin of the grape.85 Discs generally herniate backward in the middle and are known as a central or midline disc or to the left or right sides dubbed a lateral disc which may compress the exiting nerve root.86 When this occurs, surgical

77 See HODGE & HUBBARD, supra note 8, at 100. 78 See Jack Hubbard & Samuel D. Hodge, Jr., “Show Me The Pain”: Limitations and Pitfalls of of the Low Back, 14 MICH. ST. U. J. MED. & L. 129, 138 (2010). 79 See HODGE & HUBBARD, supra note 8, at 100. 80 See Bridgewell, supra note 75. 81 See Bernstein, supra note 65. 82 See HODGE & HUBBARD, supra note 8, at 100. 83 See Degenerative Disc , MAYFIELD BRAIN AND SPINE, https://mayfieldclinic.com/pe- ddd.htm#:~:text=Degenerative%20disc%20disease%20(DDD)%20affects,and%20nerves%20m ay%20cause%20pain (last visited Nov. 13, 2020). 84 See Understanding Anatomy: Intervertebral Discs, AINSWORTH INSTITUTE OF , https://ainsworthinstitute.com/patient-information/anatomy/intervertebral-discs/ (last visited Nov. 13, 2020). 85 See Why Does a Herniated Disk Happen & Will It Go Away?, CLEVELAND CLINIC, https://health.clevelandclinic.org/why-does-a-herniated-disk-happen-will-it-go-away/ (last visited Feb. 27, 2021). 86 See Royal Indemnity Co. v. Jones, 201 S.W.2d 129, 132 (Tex. Civ. App. 1947). The plaintiff’s expert noted:

When you part the membrane that keeps the disc material between the vertebrae, the material of the discs shoots through the break [.] [W]hen an intervertebral disc collapses, it can only collapse in one direction, the material has to go somewhere, it can't go laterally, because the ligaments on each side are too strong[.] [I]t doesn't break forward for the same reason, those ligaments are intensely tough, so it can only bulge backwards into the area where the spinal cord goes down.

178 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 intervention may be required to excise the extruded nucleus pulposus thereby freeing up the nerve root. In addition to the resultant discomfort by direct compression on the adjacent nerve roots, a herniated disc can also generate pain by secreting inflammatory proteins located inside the nucleus pulposus which inflame nearby tissues.87 However, “the term herniated disc does not imply any knowledge of etiology, relation to symptoms, prognosis or need for treatment.”88

Most herniated discs are caused by the natural aging process known as degeneration. However, a traumatic event can also cause a disc to rupture. In a majority of cases, a herniated disc has an excellent prognosis and will improve over several days or weeks. Overall, the disc fragment will be reabsorbed and people will become asymptomatic in three to four months. Treatment usually focuses on pain relief and only a small percentage of those with herniated discs proceed to surgery.89

g. Spinal Cord and Nerves

The spinal cord is part of the which consists of the brain and spinal cord. The cord is a long, fragile tube-like structure90 that starts at the base of the brain, in an area known as the medulla oblongata, and ends around L1, as it narrows to form a cone labeled the conus medullaris.91 The spinal cord contains multiple nerves that transmit incoming and outgoing signals between the brain and the remainder of the body. These bilateral pairs of nerves for each cervical, thoracic, lumbar, and sacral vertebrae make up the peripheral nervous system.92

The spinal cord is protected by the meninges which consist of the dura, arachnoid, and pia. The spinal cord and meninges are contained within the spinal canal.93 Nerves branch off the spinal cord and exit through the holes on the lateral sides of the vertebrae. They are known as the spinal nerves and are divided into five main parts: cervical, thoracic, lumbar, sacral, and coccygeal.94 These nerves are critical for the control

Id. 87 See Hubbard & Hodge, Jr., supra note 78, at 138. 88 See id. 89 See Herniated Disc in the Lower Back, ORTHOINFO, https://orthoinfo.aaos.org/en/diseases-- conditions/herniated-disk-in-the- lowerback/#:~:text=A%20herniated%20disk%20is%20a,leg%20pain%20or%20%E2%80%9Cs ciatica.%E2%80%9D (last visited Feb. 27, 2021). 90 See Steven Goldman, Spinal Cord, MERCK MANUALS, https://www.merckmanuals.com/home/brain,-spinal-cord,-and-nerve-disorders/biology-of-the- nervous-system/spinal- cord#:~:text=The%20spinal%20cord%20is%20a,the%20rest%20of%20the%20body (last modified Apr. 2018). 91 See Anatomy of the Spine and Peripheral Nervous System, AM. ASS’N OF NEUROLOGICAL , https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Anatomy-of-the- Spine-and-Peripheral-Nervous-System (last visited Feb. 27, 2021). 92 See Eren, supra note 38. 93 See Goldman, supra note 90. 94 See How Does the Spinal Cord Work, U. OF IOWA HOSP. AND CLINICS, https://uihc.org/health-topics/how-does-spinal-cord-work (last visited Feb. 27, 2021).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 179 of the different parts of the body. If a spinal nerve is injured, compressed, or subject to a disease process, the parts of the body innervated by that nerve can be compromised.95

There are 31 sets of nerves that transverse the body in predetermined pathways after they exit the foramen on both sides of the vertebra. There are 8 pairs in the cervical spine, 12 sets that exit from the thoracic segments, five pairs of lumbar nerves, five sacral nerves, and one coccygeal nerve.96 These nerve roots then become a component of the peripheral nervous systems and dispatch motor and sensory signals throughout the body.97

Each spinal nerve is made up of two roots, an anterior or ventral root and a posterior or dorsal root. The anterior root contains the motor fibers that transmit information away from the spinal cord.98 The posterior root consists of sensory or afferent fibers and carries information from the environment back to the brain. Both of these spinal nerves split off from the spinal cord before they exit the vertebrae and merge back together to form a single spinal nerve that transverses the body in a predetermined pathway.99

The spinal cord has a sausage-like covering named the thecal sac. This waterproof casing works as a buffer so that the spinal cord does not contact the vertebrae. The sac also houses the spinal fluid which bathes the cord with nourishment.100

Spinal stenosis is a term often employed by radiologists when reviewing imaging of the spine. It means “narrowing,” so this phrase can signify a disc herniation or bony overgrowth that may decrease the size of the spinal canal so that the opening must be enlarged to reduce pressure on the nerves.101 The condition is most frequently related to wear-and-tear alterations of the spine caused by osteoarthritis. In others, the narrowing may be congenital in that they are born with a narrowed spinal canal. The majority of those with spinal stenosis are over the age of 50 although the condition can occur in younger individuals as the result of trauma, a congenital abnormality, or a genetic disease.102

h. Limitation of Diagnostic Imaging

The number of patients who visit for back pain in recent years has dramatically increased. There have also been great strides in diagnostic imaging to diagnosis these problems from the traditional X-ray to the sophisticated MRI which relies

95 Spinal Nerves, BRAIN MADE SIMPLE (Feb. 14, 2020), https://brainmadesimple.com/spinal- nerves/#:~:text=Spinal%20nerves%20are%20bundles%20of,the%20head%20and%20neck%20r egion (last visited Mar. 30, 2021). 96 Id. 97 Id. 98 Id. 99 Id. 100 Samuel D. Hodge, Jr., Chapter 7, The Back Injury Claim, supra note 8 at 100. 101 Jack Hubbard & Samuel D. Hodge, Jr., “Show Me The Pain”: Limitations and Pitfalls of Medical Imaging of the Low Back, 14 MICH. ST. U. J. MED. & L. 129, 139 (2010). 102 Spinal Stenosis, Mayo Clinic, www.mayoclinic.org (last visited November 22, 2020).

180 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 on magnetics and radio waves to generate images so sophisticated that they resemble an artist’s rendition of the anatomy.103

The task of a and counsel would be simple if one could point to an abnormality on an x-ray, CT scan or MRI and confidentially report that the abnormality is causing the pain. The problem is that imaging abnormalities are often discovered in the spine without attendant back pain.104 No imaging modality is exempt from this problem. Simply stated, many positive findings on diagnostic imaging are related to the asymptomatic aging processes.105

Multiple studies confirm this problem. For instance, research related to x-rays of the low back of over one thousand healthy young adults without revealed meaningful abnormalities in fifty-eight percent of those imaged.106 Likewise, an investigation of military parachute instructors whose spines were subject to huge vertical forces revealed “[n]o correlation [between] the severity of radiographic changes and either the prevalence [or] the severity of low back pain.”107 CT scans are plagued by similar findings. For example, twenty-four percent of a test population who were asymptomatic were discovered to have many abnormalities of the lumbar spine on CT imaging.108

A study involving MRI scans, the gold standard for diagnostic imaging of the spine, of a group of people without low back pain was reported in the New England Journal of Medicine. The authors found that “52% of the subjects had a [lumbar disc] bulge at least one level, 27% had a [disc] protrusion, and 1% had a [disc] extrusion.”109 A second study of asymptomatic individuals discovered a seventy-six percent occurrence of disc herniations110 while other research involving those without a history of back or leg pain demonstrated that 33.3% of the volunteers had substantial abnormalities.111 In a paper discussing females between sixteen and eighty years of age without low back pain, over a third of them between twenty-one and forty years of age had degenerative disc disease shown in MRI scans.112 By age seventy, eighty percent of those imaged had major disc

103 Mohamed Nouh, Imaging of The Spine: Where Do We Stand?, 11 WORLD J. 55–61 (2019). 104 Hubbard & Hodge, supra note 78, at 139. 105 Id. 106 Id. 107 See John Korber & Bernard Bloch, The “Normal” Lumbar Spine, 140 MED. J. AUSTL. 70, 70 (1984). 108 Sam W. Wiesel et al., A Study of Computer-Assisted Tomography: The Incidence of Positive CAT Scans in an Asymptomatic Group of Patients, 9 SPINE 549 (1984). 109 Maureen C. Jensen et al., Magnetic Resonance Imaging of the Lumbar Spine in People Without Back Pain, 331 NEW ENG. J. MED. 69, 69 (1994); see, e.g., Stevens v. Homiak Transp., Inc., 21 A.D.3d 300, 302 (N.Y. App. Div. 2005); Pierce v. La. Maint. Serv., Inc., No. 95-747 (La. App. 5 Cir. 01/30/96); 668 So.2d 1232, 1237. 110 Norbert Boos et al., The Diagnostic Accuracy of Magnetic Resonance Imaging, Work , and Psychosocial Factors in Identifying Symptomatic Disc Herniations, 20 SPINE 2613, 2613 (1995). 111 Scott D. Boden et al., Abnormal Magnetic-Resonance Scans of the Lumbar Spine in Asymptomatic Subjects, 72-A J. BONE JOINT SURGERY AM. 403 (1990). 112 M. C. Powell et al., Prevalence of Lumbar Disc Degeneration Observed by Magnetic Resonance in Symptomless Women, 2 LANCET 1366, 1366 (1986).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 181 abnormalities.113 In yet a different study involving age-related asymptomatic patients, thirty-one percent of those viewed were said to have a disc or spinal canal irregularities.114 Repeat imaging seven years later found no connection between the duration or severity of subsequent low back pain and the degree of seen on the original images.115

Thus, the shows that no matter which imaging method is employed, significant pathology is present in the spines of those without a current or past history of back pain.116 Consequently, the important question that must be answered is “[w]hat separates individuals with dramatic morphologic findings who have no symptoms from individuals with identical alterations who do?”117 Counsel must, therefore, recognize that an abnormality discovered on diagnostic imaging should not be considered diagnostic “unless it conforms to the clinical syndrome.”118 In other words, an abnormality discovered on imaging must correspond to the clinical picture and findings to be medically relevant. This demonstrates why counsel must conduct a diligent search for past incidents of trauma or complaints and earlier diagnostic studies involving the spine.

III. Spinal Surgery

Spinal surgery is not performed merely because a person has back discomfort, nor is the presence of a herniated disc a prerequisite for surgical intervention. Research demonstrates that patients with herniated discs and have a seventy-eight percent rate of disc reduction with conservative care.119 Instead, surgery is focused on those with intractable pain, spinal instability, or neurological compromise such as leg or loss of bladder or bowel control.120 The critical consideration for operative intervention is whether the pain compromises the patient’s enjoyment of life and whether

113 Id. 114 See David G. Borenstein et al., The Value of Magnetic Resonance Imaging of the Lumbar Spine to Predict Low-Back Pain in Asymptomatic Subjects: A Seven-Year Follow-up Study, 83 J. BONE & JOINT SURGERY 1306, 1306 (2001). 115 See id. at 1310. 116 See Hubbard & Hodge, supra note 78, at 151; see also Korber & Bloch, supra note 107, at 70-72 (finding significant abnormalities in 58% of 1,172 x-rays from young adults without low back pain).

The work of physicians and lawyers would be rather easy if one could point to an abnormality on an x-ray or scan and unequivocally state that the pathology is the cause of the pain. The problem is that radiographic abnormalities frequently occur in the spine without concomitant back pain. No imaging procedure is immune to this conundrum.

Hubbard & Hodge, supra note 78, at 150. 117 Michael T. Modic & Jeffrey S. Ross, Lumbar Degenerative Disk Disease, 245 RADIOLOGY 43, 57 (2007). 118 John W. Frymoyer, Back Pain and , 318 NEW ENG. J. OF MED. 291, 294 (1988); see Hubbard & Hodge, supra note 78, at 152 (arguing medically relevant imaging abnormalities should correspond to the clinical findings). 119 See HODGE & HUBBARD, supra note 8, at 435 (1st ed. 2014). 120 See id.

182 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 the problem, if left unchecked, will deteriorate into a much more serious problem, including a progressive neurological impairment.121

Approximately one-half million Americans have low back surgery each year, and they spend more than $11 billion annually on operations to alleviate back discomfort.122 Statistically, the average back surgery patient is between forty and forty-five years; men have twice the number of procedures than women, and more than ninety-five percent of low back interventions involve the L4 and L5 vertebrae.123 The kind of surgery is based upon the reason for the intervention and includes a laminectomy, discectomy, spinal fusion, corpectomy, and foraminotomy. Each operation is different and can be performed in a variety of ways.124

a. Anatomic Abnormalities

If an intervertebral disc is damaged to the extent that it intrudes into the spinal canal in the cervical or thoracic areas, it may impinge on the spinal cord and cause damage or dysfunction to the structure, in addition to potentially impinging on the associated nerve roots at the level of herniation.125 is the term coined to refer to spinal cord damage, and related clinical dysfunction. This condition is evidenced by abnormal findings upon examination, which demonstrate long tract signs.126 These findings can include pain in the spine and extremities, , decreased motor skills, balance and coordination, abnormal reflexes, difficulty walking, and loss of bowel or bladder control.127 Additional findings of myelopathy include gait dysfunction that results in

121 See id. 122 See Chris Woolston, Back Surgery, HEALTHDAY (Dec. 31, 2019), https://consumer.healthday.com/encyclopedia/back-care-6/backache-news-53/back-surgery- 645795.html; see also Victoria M. Taylor et al., Low Back Pain Hospitalization: Recent United States Trends and Regional Variations, 19 SPINE J. 1207, 1207-13 (1994) (noting low back operation rates in the United States increased substantially); Atul T. Patel & Abna A. Ogle, Diagnosis and Management of Acute Low Back Pain, AM. FAM. PHYSICIAN (Mar. 15, 2000), https://www.aafp.org/afp/2000/0315/p1779.html (“Of all industrialized nations, the United States has the highest rate of spinal surgery”). 123 See William C. Shiel, Lumbar Laminectomy, EMEDICINEHEALTH (Aug. 21, 2020), https://www.emedicinehealth.com/lumbar_laminectomy/article_em.html. 124 HODGE & HUBBARD, supra note 8, at 435. 125 See Herniated Disc (Cervical, Thoracic, Lumbar), THE SPINE HOSPITAL, https://www.columbiaspine.org/condition/herniated- disc/#:~:text=A%20large%20disc%20herniation%20in,level%20of%20the%20disc%20herniatio n (last visited Feb. 24, 2021); Back pain – Disc Problems, BETTER HEALTH CHANNEL, https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/back-pain-disc-problems (discussing symptoms and risk factors of disc problems). 126 See Myelopathy, PENN MEDICINE, https://www.pennmedicine.org/for-patients-and- visitors/patient-information/conditions-treated-a-to- z/myelopathy#:~:text=Myelopathy%20is%20an%20injury%20to,autoimmune%20disorders%20 or%20other%20trauma (last visited Feb. 24, 2021) (defining myelopathy). 127 See id.; Myelopathy, JOHNS HOPKINS MEDICINE, https://www.hopkinsmedicine.org/health/conditions-and-diseases/myelopathy (last visited Feb. 25, 2021); see also ANTHONY WOODWARD, ATTORNEYS TEXTBOOK OF MEDICINE § 11.08 (3d ed. 2021) (mentioning the initial symptoms and progression of myelopathy under the spinal stenosis umbrella).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 183 significant imbalance and the presence of Lhermitte’s phenomena, which is diagnosed by having the patient flex their chin to the chest.128

If a disc herniates or otherwise impinges on the nerve roots, it can cause radiculopathy, a focal dysfunction of a nerve root distinct from myelopathy, although they can occur together.129 Dysfunction of a specific nerve root can result in focal complaints of pain radiating along the nerve root distribution in the extremity. It can also be associated with subjective complaints of loss of sensation and loss of motor function if the radiculopathy is significant enough to cause damage to the motor components of the nerve root.130 Findings on examination include focal loss of sensation, deep tendon reflex loss, and potentially motor loss. However, radiculopathy often presents with only partial, subjective findings and a variety of objective findings; having abnormal results in all of the above-noted nerve function areas is not a requirement to diagnose radiculopathy.131

Anatomic abnormalities in the spine or other structures in the area can involve disease processes or traumatic injury resulting in concern for the . This includes the arthritic deterioration of both discs and the posterior-positioned facet joints.132 The facet joints are different from the shock-absorbing type intervertebral discs and are more properly referred to as apophyseal joints.133 These structures are described as small, cartilage-lined points of contact where each individual vertebra contacts the one above and below it.134 More mild forms of injury to those joints can result in purely axial (non- radiating) spinal pain in the injured facet joint area. More significant deterioration of the facet joint can occur with degeneration and deterioration of the joint, causing cartilaginous overgrowth, hypertrophy of the joint, painful dysfunction, and even impingement on adjacent structures such as nerve roots or the spinal cord. Traumatic injury to the facet joints can result in instability, requiring surgical correction and stabilization.135

128See Supreet Khare & Deeksha Seth, Lhermitte's Sign: The Current Status, ANNALS OF INDIAN ACAD. OF ,154, 154–156 (2015) (reviewing the etiopathophysiology of Lhermitte's sign); MYELOPATHY.ORG, Lhermitte's Sign - Definition, https://myelopathy.org/lhermittes-sign- definition/#:~:text=Lhermitte's%20sign%2C%20the%20phenomenon%20of,your%20chin%20t o%20your%20chest). (last visited Feb. 25, 2021). 129 See JOHN HOPKINS MEDICINE, Radiculopathy, https://www.hopkinsmedicine.org/health/conditions-and- diseases/radiculopathy#:~:text=Radiculopathy%20describes%20a%20range%20of,%2C%20wea kness%2C%20numbness%20and%20tingling (last visited Feb. 25, 2021); see also MARY JEANNE KROB & LAURA BRASSEUR, ATTORNEYS TEXTBOOK OF MEDICINE § 15.04 (3d ed. 2021) (discussing lumbar disc protrusions in the lawyer’s context). 130 See Telephone Interview with James G. Lowe, Neurosurgeon, Chief of the Div. of Spinal Surgery at AtlantiCare Reg’l (January 2021). 131 See id. 132 See Telephone Interview with James G. Lowe, supra note 130. 133 Apophyseal Joint Definition, supra note 67. 134 6 Clues That Your Back Pain is From Joint Problems, SPERLING MEDICAL GROUP, http://sperlingmedicalgroup.com/6-clues-that-your-back-pain-is-from-facet-joint- problems/#:~:text=The%20facet%20joints%20are%20small,wears%20thin%2C%20pain%20ca n%20occur (last visited Jan 28, 2021). 135 See Telephone Interview with James G. Lowe, supra note 130.

184 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

Additional structures of pathologic concern in the spine include the interlaminar ligaments, otherwise referred to as the ligamentum flavum, that run through the spinal canal’s posterior aspect.136 Hypertrophy of these ligaments can occur with chronic degenerative processes and can cause stenosis, a narrowing of the spinal canal’s caliber or area where the nerve roots exit laterally, the foramina.137 Stenosis related to ligamentum flavum hypertrophy is often associated with bulging discs and facet hypertrophy as part of an overall degenerative process.138 When stenosis from these processes – in an isolated fashion or combined from all structures – is significant enough to cause neural compression, impingement can result in radiculopathy or myelopathy, depending upon the involved neural structures.139

b. Considerations for Surgery

Surgical indications in patients with spinal problems depend significantly upon the extent of damage to any or all of the spinal structures, the acuity of such damage, and the insult or disruption’s neurologic results.140 Common indications for surgery include:

1. A herniated disc causing severe, intractable discomfort and/or neurological compromise; 2. Fractures of the spine or dislocations; 3. Symptomatic ; or 4. Neurological deficits resulting from nerve root compression or instability.141

A traumatic stems from an insult causing harm to the spinal cord that may produce short-term or permanent neurological impairment such as paralysis.142 In the case of an acute traumatic spinal fracture with or without injury to the spinal cord, the indication for surgery is a complex concern that involves assessment of whether the spine is stable – able to move and function properly in support of the associated spinal cord and nerves – and whether there is a spinal cord injury or .143 This variability occurs because spinal fractures are not created equal and can vary from uncomfortable compression fractures, frequently detected after subtle trauma in those with , to more significant injuries such as burst fractures and fracture-dislocations that happen after motor vehicle collisions or falls from height.144 Those severe injuries often produce an unstable spine, with a high risk of spinal cord

136 HODGE & HUBBARD, supra note 8 at 440, 484. 137 Jianwei Chen et al., Hypertrophy of Ligamentum Flavum in Lumbar Spine Stenosis Is Associated with Increased miR-155 Level, HINDAWI (May 18, 2014), https://www.hindawi.com/journals/dm/2014/786543/. 138 Id. 139 See Teruaki Okuda et al., Morphological Changes of the Ligamentum Flavum As A Cause Of Nerve Root Compression, 3 EUR. SPINE J. 277, 277–86 (2005). 140 See Telephone Interview with James G. Lowe, supra note 130. 141 Id. 142Traumatic Spinal Cord Injury, TEACH ME SURGERY (Oct. 1, 2020), https://teachmesurgery.com/neurosurgery/traumatic-injuries/traumatic-spinal-cord-injury/. 143 See Telephone Interview with James G. Lowe, supra note 130. 144 Spinal Fractures, CLEVELAND CLINIC, https://my.clevelandclinic.org/health/diseases/17498- spinal-fractures (last visited Jan. 29, 2021).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 185 trauma and pain. These factors, and the patient’s overall medical condition, will be assessed to determine the need for spinal intervention.145

In the more routine situation of patients who present with pain or subjective complaints of sensory or motor dysfunction in the extremities, the practitioner’s challenge is to determine the structure generating the pain and/or the neurologic dysfunction.146 In the cervical or thoracic region, the physician must consider whether spinal cord dysfunction is involved.147 In the lumbar region, typically, the issue of spinal cord dysfunction is not a concern, although impingement of one or more of the structures of the nerve roots of the cauda equina can be worrisome.148 Additionally, impingement of nerve roots at the neural foraminal level can occur at any region in the spine and classically result in significant symptomatology referred to the corresponding extremity, including pain, numbness, and weakness.149

In non-acute spinal diagnoses such as disc degeneration, stenosis, or traumatic disc disruption, surgery indications usually depend on the course and results of prior attempted non-surgical treatment. Most patients with radiculopathy from nerve root compression, whether from stenosis, disc degeneration, or disc herniation, do not require emergent surgical intervention.150 Pain relief is usually first tried through medication, pain injections, and physical .151 However, surgery may be indicated in a patient who has continued difficulty with activities of daily living, or develops an acute weakness of an extremity, such as a from a lumbar disc herniation.152 When patients exhibit signs and symptoms of damage to the nerves in the cauda equina, such as the loss of bladder or bowel control, emergent intervention is usually indicated.153

c. Surgical Intervention

If patients are identified as having significant ongoing or increasing pain or neurologic findings despite appropriate non-surgical treatment, surgery may be indicated.

145 Id. 146 See Telephone Interview with James G. Lowe, supra note 130. 147 See Peter Ullrich, Spinal Cord Compression and Dysfunction from Cervical Stenosis, SPINE HEALTH (Oct. 1, 2009), https://www.spine-health.com/conditions/spinal-stenosis/spinal-cord-compression-and- dysfunction-cervical-stenosis. 148 Peter Ullrich, , AMERICAN ASS’N OF NEUROLOGIC SURGEONS (Oct. 1, 2009), https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Cauda- Equina- Syndrome#:~:text=Cauda%20equina%20syndrome%20(CES)%20occurs,incontinence%20and %20even%20permanent%20paralysis. 149 See Fact Sheet, Cauda Equina or Lower Motor Neuron Injuries, QUEENSLAND SPINAL CORD INJURIES SERV., https://www.health.qld.gov.au/__data/assets/pdf_file/0025/426571/lmn- injuries.pdf (last visited Jan. 29, 2021). 150 Anne Asher, Should You Have Surgery for Cervical Radiculopathy?, VERYWELL HEALTH (May 10, 2020), https://www.verywellhealth.com/neck-surgery-for-cervical-radiculopathy-297091. 151 Do I Need Surgery for Spinal Stenosis?, WEBMD, https://www.webmd.com/back-pain/surgery-for- spinal-stenosis#1 (last visited Jan. 29, 2021). 152 Id. 153 Cauda Equina Syndrome, THE SPINE HOSPITAL, https://www.columbiaspine.org/condition/cauda-equina-syndrome/ (last visited Jan. 29, 2021).

186 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

However, surgery would be suggested only if the physician feels reasonably comfortable that the pain generator has been identified.154 Interventions to address non-symptomatic anatomic findings, such as ongoing asymptomatic arthritic abnormalities in the aging patient, should not be performed.155

The urgency of surgery may vary based upon the extent of the symptomatology and the degree of concern about continued or worsening neurologic function in the absence of surgical correction.156 The preoperative patient should be clearly advised of their diagnosis, the surgeon’s opinion about the pain generator, and the types of surgery available to address the anatomic or clinical problem.157 The surgeon is often faced with several treatment options, and the patient should be advised of the risks, possible benefits, and drawbacks of each option.158 Whichever surgical procedure is recommended, the patient must be educated about the risks and potential complications associated with that option and the perioperative course expected. The patient should also be advised about the desired surgical outcome and the expected result of non-surgical treatment choices.159

d. Surgical Procedures

The type of surgical procedure is primarily driven by the anatomic structure involved and the spine’s region. Because of the spinal cord’s presence in the cervical and thoracic areas, certain forms of surgery are more technically limited.160 For example, traditional posterior approaches for disc surgery, such as is commonly done in the lumbar spine, are limited in the cervical and thoracic regions due to the spinal cord’s presence within the spinal canal, which obscures a significant portion of the disc structure. In these two areas, the surgery is often performed from an anterior (cervical) or anterolateral (thoracic) approach.161

Perhaps the most common surgical procedure for a cervical disc herniation is an anterior cervical microdiscectomy and fusion. The suffix “ectomy” refers to the “removal of,” so a laminectomy is removing that part of the vertebra dubbed the lamina. Conversely, “otomy” deals with making an opening, so a is a procedure that creates an opening in the lamina.162 These interventions permit access to the spinal cord or nerve roots surrounded by bone, and allow the physician to remove a herniated disc, free up nerve root compression resulting from degenerative changes, or access a spinal

154 Top 3 Reasons to Have Spine Surgery, VIRGINIA SPINE INSTITUTE (Jan. 17, 2017), https://www.spinemd.com/top-3-reasons-to-have-spine-surgery/. 155 Jordan Cloyd, Frank. Acosta, Jr. & Christopher Ames, Complications and Outcomes of Lumbar Spine Surgery in Elderly People: A Review of the Literature, Progress in , July 2008–Vol. 56, No. 7, at 1320 - 21. 156 Three Signs You Need Back Surgery, UNIVERSITY ORTHOPEDIC ASSOCIATES (Oct. 16, 2019), https://www.uoanj.com/three-signs-you-need-back-surgery/. 157 See Telephone Interview with James G. Lowe, supra note 130. 158 Id. 159 See Brian Murray, Informed Consent: What Must a Physician Disclose to a Patient?, AMA JOURNAL OF ETHICS, https://journalofethics.ama-assn.org/article/informed-consent-what-must-physician- disclose-patient/2012-07 (last visited Jan. 29, 2021). 160 See Telephone Interview with James G. Lowe, supra note 130. 161 Id. 162 See HODGE & HUBBARD, supra note 8, at 435-36.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 187 tumor.163 With an open laminectomy, an incision is made that extends several inches down the center of the spine and the exposed soft tissues are moved to the side. Part of the lamina is then cut away to reduce the pressure on the appropriate nerve root or spinal cord segment.164

A laminectomy results in the expansion of the cross-sectional volume of the spinal canal. This technique is a standard and effective procedure for relieving stenosis affecting the spinal cord or nerve roots of the cervical, thoracic, or lumbar spine.165 The laminectomy is often accompanied by a foraminotomy, which involves the surgeon’s removal of ligaments and bone that compresses the nerves as they exit through the neural foramina.166 This procedure, which is often combined with a discectomy in the lumbar spine, can effectively treat patients with radiculopathy and nerve root compression.167

A discectomy involves removing part or all of the herniated disc’s protruding aspect, the nucleus pulposus. Surgical advances permit less invasive ways to remove the offending disc material, such as a microdiscectomy, endoscopic discectomy, and laser discectomy.168

Disc surgery involving the neck usually requires making an incision in the front of the structure and dissection through the anterior neck, past the carotid artery, trachea, and esophagus, to access the front portions of the cervical disc. The disc is removed through curettage (scraping with a tool called a curette), typically removing the entire disc and releasing any pressure on the spinal cord or nerve roots.169 Commonly, the intervertebral space vacated by the removed disc is fused. A fusion requires the insertion of bone or other prosthetic or cadaveric material capable of healing to the point where the bones join together into a single unit.170 The advantage of a fusion is eliminating damaged, painful, and dysfunctional joint or joints following complete decompression of the nerves or spinal cord.171

A fusion can be done at any level of the spine and can remedy several issues:

163 Id. 164 Id. at 436. 165 Id. 166 Lali Sekhon, Foraminotomy: Taking Pressure off Spinal Nerves, SPINE UNIVERSE, https://www.spineuniverse.com/treatments/surgery/foraminotomy-taking-pressure-spinal- nerves (last visited Jan. 30, 2021). 167 Laminectomy and Discectomy, MedStar Health, https://www.medstarunionortho.org/treatments/back/lumbar-laminectomy-and-discectomy/ (last visited Jan. 29, 2021). 168 See HODGE & HUBBARD, supra note 8, at 436. 169 Derek Moore, Anterior Approach to Cervical Spine, ORTHO BULLETS, https://www.orthobullets.com/approaches/12001/anterior-approach-to-cervical-spine (last visited Jan. 29, 2021). 170 Anterior Cervical Fusion, UNIV. OF MD. MED. CTR., https://www.umms.org/ummc/health- services/orthopedics/services/spine/patient-guides/anterior-cervical-fusion (last visited Jan. 29, 2021). 171 HODGE & HUBBARD, supra note 8, at 438.

188 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

1. To decrease the areas between two or more bones such as with spondylolisthesis; 2. To stabilize an unsound fracture of the spine; 3. To readjust or straighten the bone; 4. To repair an insult to the vertebrae; and 5. To stabilize the spine due to a tumor.172

In patients who have mechanical pain in the lumbar region related to dysfunction or damage of the lumbar discs, or pathologic malalignment of the joints in the lumbar spine, fusion is a procedure performed under carefully considered indications.173 These reasons typically require identifying the pain generator, that is, the spinal level contributing to the patient’s painful mechanical dysfunction. Once that pain generator is determined, a fusion of the area, combined with decompression, is often an effective means of treating the problem.174 Fusions in the lumbar spine usually consist of the removal of discs followed by the placement of bone graft material, or prostheses designed to knit the two segments together permanently.175 Spinal fusion is generally a successful option for fractures, deformities or instability in the back. However, some studies provide mixed results when the reason for spinal pain is undetermined. In those instances, a fusion is as effective as non-surgical treatments for non-specific spinal discomfort.176

Most current forms of fusion are supplemented by spinal instrumentation, which is essentially an internal fixation to immobilize the graft area.177 Internal fixation in the cervical spine consists of the use of plates in the anterior portions of the spine or screws and rods affixed to the cervical spine’s posterior aspect.178 Typically, the thoracic and lumbar spine’s fixation will consist of screws connected to rods, implanted across the areas to be fused. The screws themselves are usually inserted into structures known as the pedicles of the vertebral segments. Each segment has paired columns of bone (“pedicles”) that connect the vertebral body to the posterior elements – the lamina, facet joints, and spinous processes. The pedicles are strong cylinder-shaped projections located near nerve roots at the margins of the spinal canal.179 The anatomic locations of the nerves, spinal cord, and pedicles need to be considered when assessing the risk of injury to nearby neural structures when placing screws in the pedicles.180 Nonetheless, the pedicles are common sites for the placement of instrumentation in the spine, essential for the insertion of an internal bracing system that optimizes the likelihood of bony fusion healing.181

172 Id. 173 See Telephone Interview with James G. Lowe, supra note 130. 174 Id. 175 Preparing for Lumbar Spinal Fusion, MAYFIELD BRAIN AND SPINE, http://www.mayfieldclinic.com/pe-fusionpreparing.html (last visited Jan. 28, 2021). 176 Spinal Fusion, MAYO CLINIC, https://www.mayoclinic.org/tests-procedures/spinal- fusion/about/pac-20384523 (last visited Jan. 29, 2021). 177 Ali Araghi & Peter Ullrich, Elements of a Spinal Fusion, SPINE-HEALTH.COM, November 27, 2006, https://www.spine-health.com/treatment/spinal-fusion/elements-a-spine-fusion (last visited Feb. 26, 2021). 178 Anterior Cervical Fusion, UNIV. OF MD. MED. CNT., supra note 170. 179 Vertebrae of the Spine, CEDARS SINAI, https://www.cedars-sinai.org/health-library/diseases- and-conditions/v/vertebrae-of-the-spine.html (last visited Feb. 26, 2021). 180 See Telephone Interview with James G. Lowe, supra note 130. 181 See id.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 189

An alternative to a fusion is a prosthetic disc replacement ( or “artificial disc”) in the cervical or lumbar spine. The Food & Drug Administration (“FDA”) approved the procedure in 2004 to treat degenerative disc disease,182 but the endurance of artificial discs is unknown at present.183

Degenerative changes in the spine can frequently place undue pressure on the spinal cord. This problem can be corrected by removing the degenerative vertebrae and replacing them with a bone graft. This procedure is known as a corpectomy and strut graft.184

e. Risks of Surgery

All surgeries have risk, but the resultant complications can be serious when surgery is done around the spine and spinal cord.185 One must also understand back surgery isn't always effective. Spinal fusion is successful up to eighty percent of the time, and intervention involving a disc abnormality will eradicate discomfort and sciatica in about seventy percent of cases.186 Paradoxically, spinal surgery has offered many patients a new lease on life, but it has also caused others to suffer continued pain and aggravation.187

These risks and complications can occur despite the utilization of the best care and skill. Factors that may affect the surgical outcome include:

1. A person’s general health; 2. Age; 3. Prior operative experience; 4. Underlying medical conditions such as ; 5. Smoking; and, 6. Osteoporosis.188 More specific complications include , blood clots, and infection. Anesthetic risks must also be considered, and these concerns include a heart attack, , , and death caused by drug reactions or issues arising from other medical problems.189

182 Spine Surgeons Speak Out About Artificial Disc Replacement, SPINE UNIVERSE, https://www.spineuniverse.com/treatments/emerging/artificial-discs/spine-surgeons-speak-out-about- artificial-disc-replacement (last visited Feb. 26, 2021). 183 Id. 184 HODGE & HUBBARD, supra note 8, at 438. 185 Jennifer Whitlock, Understanding the Risks Involved When Having Surgery, VERYWELL HEALTH, November 1, 2019, https://www.verywellhealth.com/understanding-the-risks-involved-when- having-surgery-3156959 (last visited Feb. 26, 2021). 186 Woolston, supra note 122. 187 Id. 188 Todd Albert, Spine Surgery Risks and Potential Complications, SPINE UNIVERSE, https://www.spineuniverse.com/treatments/surgery/spine-surgery-risks-potential-complications (last visited Feb. 26, 2021). 189 Id.

190 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

Spinal surgery candidates also face a unique risk related to their positioning, which usually requires them to lie face down on the surgical table. This placement alters how the blood moves throughout the body and restricts the physician’s access to the patient’s airway.190 Therefore, it is important to have an anesthesiologist present in the operative arena to ensure that the equipment and patient are properly placed and the medical team can respond immediately if anything goes awry.191

According to Dr. James Lowe, a neurosurgeon who specialize in surgery of the spine, patients should be advised about the hazards specific to certain procedures, such as the risk of swallowing dysfunction or laryngeal nerve palsy when performing anterior cervical surgeries. Other risks include injury to the nerves or the spinal cord, in the case of cervical or thoracic surgeries.192 Peripheral and visual loss are also occasional outcomes correlated to patient positioning during spinal surgery that causes considerable disability and functional impairment.193 Complications can arise despite “successful” and good surgical technique that results in decompression of the neural elements and/or stabilization of the spinal segments, which are the operation’s subject.194 Therefore, it is critical to understand that, because surgeons are operating on spinal structures of significant neurologic concern, those structures are at risk for injury intraoperatively.195 Patients should be aware that meaningful clinical improvement is not always achievable despite perfect execution and healing of the intended surgical intervention.196 Unfortunately, in the realm of spinal surgery, procedures appropriately performed and which go on to heal in an expected fashion do not always equal clinical success as recognized by patient satisfaction. This issue should be carefully discussed with patients to set appropriate expectations of the surgical outcome before consenting to a spinal procedure.197

IV. Surgical Considerations in a Compensation Setting

The stakes involving back surgery claims are high. Factfinders are generally impressed by those who undergo surgical intervention and are more likely to find those spinal injuries permanent. This is especially true when a spinal fusion involves more than one level.198 According to one lawyer, the average pain and suffering value for a single level fusion in Florida is between $250,000 and $400,000 unless the case is from a rural

190 Ihab Kamel & Rodger Barnette, Positioning Patients for Spine Surgery: Avoiding Uncommon Position- Related Complications, 5 WORLD J. ORTHOPEDICS 425, 425-443 (2014). 191 Back Surgery, American Society of Anesthesiologists, https://www.asahq.org/madeforthismoment/preparing-for-surgery/procedures/back-surgery/ (last visited January 28, 2021). 192 See Telephone Interview with James G. Lowe, supra note 130. 193 Ihab Kamel & Rodger Barnette, supra note 190, at *1. 194 Id. 195 See Telephone Interview with James G. Lowe, supra note 130. 196 Id. 197 Id. 198 Justin Ziegler, Spinal Fusion Settlements and Lawsuits (Cervical and Lumbar), JZ HELPS (May 11, 2020), https://www.justinziegler.net/fusion- settlements/#:~:text=For%20settlement%20purposes%2C%20in%20most,likely%20between% 20%24250%2C000%20to%20%24400%2C000.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 191 county where the value will be less.199 Another source placed the national average at between $300,000 and $600,000.200 The worth of the claim will increase if the spinal surgery was not successful or if the person was treated for more than 10 months.201 However, if the claimant has prior issues at the level fused, or if there are liability or causation questions, the value will be diminished.202

Jury Verdicts and Settlements statistics involving back surgery lawsuits revealed seventy-seven reported cases in which the plaintiff received more than $5 million and 356 matters that yielded compensation of between $1 million and $5 million.203 Spinal surgery by itself, however, is no guarantee of success. The largest number of back surgery claims reported by Jury Verdicts and Settlements involved plaintiffs that received nothing. The reported lawsuits in this category numbered 1,360.204

a. Practice Tips

There are several factors to keep in mind when advancing a spinal injury claim. Back pain is common and most people will suffer from the malady at some point in their lives without it being related to trauma. This makes it critical to conduct a proper investigation of the claimant’s past medical history including obtaining the necessary medical records to check for previous incidents of back or . In this regard, counsel must stress to the client the need to be upfront about all previous injuries or disorders that may have some connection to the claimant’s current back complaints.205 When an accurate medical history is disclosed to counsel and treating physicians before a legal proceeding, the case can then be presented in the best manner.206 Experience, however, demonstrates that many claimants are hesitant to divulge this information. Therefore, counsel must impress upon the client the importance of revealing these facts at the beginning, rather than having the information come as a surprise at the hearing, especially when the law recognizes an aggravation of a preexisting condition as a compensable event.207 On the other hand, defense counsel should at a minimum obtain the claimant’s records from the family , health insurance carrier, and . These records will provide a blueprint of the person’s medical history and disclose information about prior back problems.

Injuries to the spine, especially those involving the soft tissues, present problematic diagnostic and treatment challenges for the physician, and these difficulties are demonstrated in the problems of advancing or disputing such injuries and their

199 Id. 200 Average Settlement for Spain Fusion Personal Injury Claims, NOVA LEGAL FUNDING, https://fundmylawsuitnow.com/average-settlement-for-spinal-fusion/ (last visited Nov. 15, 2020). 201 Ziegler, supra note 198. 202 Id. 203 These statistics are based upon a Jury Verdict and Settlement search done by the author via Westlaw on November 14, 2020. 204 Id. 205 Mary Leary, Obtaining Workers Compensation for Back Injuries, 79 AM. JUR. Trials 231 §4, October 2020 Update. 206 Id. 207 Id.

192 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 consequences.208 These repercussions are often not immediately obvious and both physician and counsel must chiefly depend upon the patient’s subjective complaints in evaluating the claim. These injuries may also be long-term or periodic so that issues of proof concerning future medical costs, disability, and pain must be satisfied.209

b. Patient Dissatisfaction Following Surgery

Studies have been conducted on those who have had a disappointing result after back surgery. It was found that failure occurs after multiple decompressions and fusions as compared to disc removals.210 The most common cause of dissatisfaction is the failure of the physician to spot abnormal patent pain behavior before the procedure. The majority of those with poor outcomes had active workers’ compensation claims or were at “psychological risk for surgery” thereby focusing the attention on the role of litigation on back pain.211

Those who sustain spinal injuries as the result of trauma such as a car accident, slip and fall, or lifting of a heavy weight develop pain almost immediately, which may worsen over the next seventy-two hours. They do not acquire “de nova” pain after two days as is occasionally asserted.212 The capacity to walk away from the scene of the accident, the continuation of work, and the capacity to drive to another location are indications that reflect upon the severity and nature of the injury.213 Proof that a claimant may be exaggerating is the assertion that the pain is unrelenting and constant twenty-four hours a day. Severe pain is rarely present all of the time. Acute back symptoms will usually moderate after a day or two as the person finds comfortable positions that help the discomfort until they move and the pain returns after a few seconds or minutes.214

It is important to remember that most people with pain in the spine make a good recovery, with sixty percent of this population becoming asymptomatic within six weeks and the vast number of all back pain sufferers feeling pain-free within three months.215 Separating those who have a noteworthy non-organic element to their back pain and those who do not is difficult. This is muddied by the statistics which show that individuals with chronic back pain who no longer have active compensation claims are inclined to have significantly better treatment results than claimants in active litigation.216 It has even been noted that about one-quarter of compensation claimants who have a valid injury demonstrate some degree of “lack of effort” or exaggeration of their symptoms. Financial gain may also play a role in illness and disability.217 In this regard,

208 Carl Drechsler, Excessiveness or Adequacy of Damages Awarded For Injuries To Back, Neck, or Spine, §2(b) Practice Pointers—The Special Difficulties in Back, Neck, and Spine Injuries, 15 A.L.R.4th 294. 209 Id. 210 Pearce, supra note 6, at 64. 211 See Pearce, supra note 6, at 64. 212 Id. at 66. 213 Id. 214 Id. 215 Samuel D. Hodge, Jr. & Nicole Saitta, What Does It Mean When A Physician Reports That A Patient Exhibits Waddell's Signs?, 16 MICH. ST. U. J. MED. & L. 143, 145 (2012). 216 Id. 217 Id. at 145-46.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 193 some tests have been created to identify nonorganic causes of low back pain, and Waddell's signs are the most well-known.218

To help in differentiating between normal and nonorganic responses, a progression of physical signs were identified by Dr. Waddell that provide a simple way to help spot those who need a more detailed evaluation. Consisting of five different categories, these nonorganic signs are used to ascertain whether low-back pain is physical or has psychological overtones.219 Waddell’s signs, however, have been criticized as to their accuracy in showing nonorganic pain and secondary gain and must be applied with care, particularly if the aim is to demonstrate malingering. After all, Waddell’s findings may be present in medically-based disorders, such as complex regional pain syndrome.220 Studies also demonstrate the lack of association between positive Waddell signs and secondary gain and malingering.221

V. Spinal Surgery and Malpractice

Surgery involving the spine has the highest number of malpractice claims among all surgical specialties and the greatest number of cases are filed in California, New York, Pennsylvania, and Texas.222 Spinal surgery, however, is unlike other operative procedures because its main goal is not to fix or remove a diseased body part or anatomical structure but to remediate and hopefully alleviate unremitting pain.223 Whether the procedure is done to reduce the discomfort from spinal stenosis or a herniated disc, a traumatic insult to the structure, or a congenital irregularity, the procedure cannot restore the structure to its normal state. Instead, it is designed to improve the symptoms, but not to cure the underlying problem.224 The nervous system is also extremely unpredictable following trauma. There is still much to learn about injuries to these structures, and nerve damage is frequently a wait-and-see process.225

Litigation involving spinal surgery is a significant problem, which generates a high number of malpractice claims, substantial financial exposure, and a heavy emotional toll, that threatens the future of this form of surgery.226 The surgery involves a variety of complex procedures with associated risks and inherent complications that do not always arise from a medical mistake, surgical error, or misconduct. This form of surgery is often the last option for a patient and the physician cannot reestablish a pristine spine.

218 Id. at 146. 219 Id. at 156. 220 Hodge & Saitta, supra note 215 at 159. 221 Id. 222 Jennifer Grauberger et al., Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims, 152 JAMA SURGERY, (2017), https://jamanetwork.com/journals/jamasurgery/fullarticle/2622648. 223 Daniel Pendofsky, Litigating Spinal Surgery Malpractice Cases, 119 AM. JUR. Trials 1 § 6 (Originally published in 2011). 224 Id. 225 Spine Surgery Litigation, AM. MED. FORENSIC SPECIALISTS, (June 25, 2019), https://www.amfs.com/spine-surgery-litigation/. 226 Gabriel Iacob & Alexandru Vlad Ciurea, Assessment of Malpractice Litigation Following Spine Surgery, 34 ROMANIAN 179-188 (2020) https://www.journals.lapub.co.uk/index.php/roneurosurgery/article/view/1473/1207.

194 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

Therefore, counsel and insurance professionals need to comprehend the realistic expectations related to spinal surgery to better understand the merits of a claim.227

Medical malpractice litigation is filled with competing interests between doctors who believe they are being confronted by a malpractice crisis that mandates defensive medicine and counsel who maintain that lawsuits protect patients from medical mistakes in a scheme impervious to regulations.228 Practicing defensive medicine, however, only drives up the cost of medical care to the tune of $46 billion annually and it is estimated that about eighty-five percent of providers order needless laboratory tests to protect themselves from medical negligence claims.229 This practice does not inure to anyone’s benefit.230

a. The Orthopedic and Neurosurgeons Experience

Orthopedic and neurosurgeons are two of the specialties with the greatest number of malpractice claims. Spinal surgery, usually at the lumbar level, has the greatest number of lawsuits, and lack of informed consent is a common allegation in these matters.231 An article in the New England Journal of Medicine reviewed fourteen years of malpractice litigation and ascertained that 19.1% of neurosurgeons and fifteen percent of orthopedists were defendants in lawsuits annually. This represents some of the highest percentages for any specialty group analyzed even though they are among the smallest associations in the United States.232 Spinal surgery made up sixty-five percent of all of the litigation concerning neurosurgeons and most of the operations were elective. Allegations varied from lack of professionalism to improper informed consent, as factors increasing the likelihood of being sued.233 Other things that influenced the decision to file suit included failing to properly explain the risks and advantages linked to a procedure, the failure to diagnose or treat, not ordering the proper diagnostic tests, needless procedures, unwarranted medications, the nature of the case, procedural mistakes, and patient deaths.234

These facts are compounded by the dramatic increase in spinal fusions. Surgical complications are infrequent, but they consist of myelopathic difficulties secondary to spinal cord injuries and non-myelopathic problems like radicular injuries, peripheral nerve palsies, and .235 Because of the morbidity associated with these complications, it is certainly foreseeable that patients will advance malpractice claims.236 This is supported by

227 Spine Surgery Litigation, American Association of Forensic Specialists, supra note 225. 228 Jennifer Grauberger et al., supra note 222, at 2. 229 Nitin Agarwal et al., Descriptive Analysis of State and Federal Spine Surgery Malpractices Litigation in the United States, 43 SPINE 984, 984–90 (2018). 230 Id. at 4. 231 Id. at 7. 232 Id. at 5. 233 Id. at 5. 234 Id. at 2. 235 Nishant Ganesh Kumar et al., Letter: Malpractice Litigation in Spinal Fusion Surgeries, 86 NEUROSURGERY 234, 234-235 (2020). 236 Id. at 234.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 195 a Westlaw search that reveals 3,371 reported cases involving the search terms “back surgery” and “malpractice.”237

A statistical analysis of spinal surgery malpractice cases from 1988 through 2015 reveals that 54.2% of the verdicts favored the defendants, 26.1% resulted in a finding for the plaintiffs and 19.6% of the cases were settled.238 The verdicts for successful plaintiffs ranged between $134,000 and $38,323,196, and settlements varied from $125,000 to $9,000,000. Litigation involving delays in the diagnosis and treatment of a surgical complication favored the patient and catastrophic complications generated large awards for the plaintiffs.239 Matters dealing with the wrong level of spinal surgery were associated with lower malpractice payouts240 and named in lawsuits tended to result in awards for the plaintiffs as opposed to those matters where the facility was not a party.241 Factors that were a precursor to a worse patient outcome included being older, previous spinal surgery, availability of workers’ compensation, and consultation with counsel before the operation.242

b. The International Experience

Medical malpractice lawsuits involving spinal surgery are a worldwide phenomenon. This type of surgery carries the highest risk of litigation in the United Kingdom compared to cranial and peripheral nerve operations and improper spinal procedures at forty-three percent, are the leading cause followed by a late diagnosis or improper diagnosis at seventeen percent, lack of sufficient information at fourteen percent, and operative infection.243 The median payment involving faulty surgical techniques was $304,382 and a delayed or improper diagnosis yielded an average payment of $281,422.244

Spinal surgery in is at a high-risk for generating malpractice claims. The alleged rate of error in these types of procedures was 40.7%, surgical indications and preoperative workups accounted for 28.4% of the claims, postoperative treatment lawsuits were pegged at 25.9%, and lack of informed consent constituted 4.9% of the cases.245 The German analysis found that most malpractice claims are pursued out of court

237 These numbers are based upon a database search using Westlaw by the author on November 10, 2020, employing the search terms “back surgery” and “malpractice.” 238 Alan Daniels et al., Malpractice Litigation Following Spine Surgery, 27 J. OF NEUROSURGERY: SPINE 470, 470-75 (2017), https://thejns.org/spine/view/journals/j-neurosurg-spine/27/4/article- p470.xml. 239 Id. at 471. 240 Laura Dyrda, 7 Trends in Spine Surgery Malpractice cases - 75% Found in Favor of Surgeons, BECKER’S SPINE REVIEW (July 5, 2017), https://www.beckersspine.com/spine/item/37340-7-trends-in- spine-surgery-malpractice-cases-75-found-in-favor-of-surgeons.html. 241 Id. 242 Victoria Taylor et al., Patient-Oriented Outcomes from Low Back Surgery: A Community – Based Study, 25 Spine 2445, 2445-52 (2000). 243 S. Mukherjee et al., A Nine-Year Review of Medicolegal Claims in Neurosurgery, 96 Ann. R. Coll. Surg. Engl. 266, 266-270 (2014). 244 Id. at 266. Amounts have been converted into U.S. dollars. 245 Sebastian Ahmadi et al., Malpractice Claims in Spine Surgery in Germany: A 5-Year Analysis, 19 THE SPINE JOURNAL 1221-1231, at 1221 (2019).

196 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 by way of a review board and the plaintiffs were successful in 29.5% of filings.246 Spinal surgery accounted for four percent of all claims with most of the treatment rendered in an inpatient setting. Looking at the distribution of malpractice claims 48.5% involved neurosurgeons and 37.6% were against orthopedic surgeons.247 Most of those who advanced claims involving spinal surgery believed their treatment was inappropriate or erroneous and seventy-five percent of all matters were due to new postoperative neurological deficits, , or insufficient postoperative symptom relief.248 Regardless of the surgical care rendered, the majority of treatment-associated damages happened before or after the procedure.249 Data from the largest malpractice carrier in Germany demonstrated that claimants obtained significantly lower awards for cases resolved out-of-court with the average settlement being $41,000.250

Canada has witnessed an increase in back surgeries and an examination of their malpractice claims involving the spine shows that eighty percent of the procedures were elective and about fifty percent of them involved chronic pain.251 Most of the operations dealt with the low back and poor patient outcomes that resulted from inherent risks or were unrelated to the back surgery.252 In about forty percent of the cases, patients maintained that critical information was not offered during the informed consent process. The most common adverse surgical outcomes involved dural tears, spinal cord injuries, and lacerated iliac arteries or veins.253 The patients were successful in fifty percent of their malpractice claims which were based upon performing surgery that was not indicated, improper informed consent, inappropriate utilization of a high-speed drill, misreading of intraoperative imaging, the failure to explore postoperative complaints, and the inadequate disclosure of an injury to the patient.254

Unlike the physician experience in the United States, sixty percent of Canadian physicians indicated that they seldom perceived the need to engage in defensive medicine. The majority further related that the medico-legal risk atmosphere has no impact on their preferred practice location.255 Part of this phenomenon may be due to the cap limit in the country that restricts noneconomic financial compensation to $300,000.256 The average award for a successful claimant is $117,000 and the losing party is required to pay the opponent‘s attorney fees which acts as a deterrent in initiating a malpractice claim.257

246 Id. at 1222. 247 Id. at 1224. 248 Id. at 1225. 249 Id. at 1225. 250 Id. at 1229. 251 Medical-Legal Cases in Spinal Surgery: 3 Essential Lessons, CMPA (June 2019), https://www.cmpa- acpm.ca/en/advice-publications/browse-articles/2019/medical-legal-cases-in-spinal-surgery-3- essential-lessons (last visited Mar. 30, 2021). 252 Id. 253 Id. 254 Id. 255 Timothy Smith et al., Defensive Medicine in Neurosurgery: The Canadian Experience, 124 J. OF NEUROSURGERY 1524, 1524-30 (2016). 256 Id. 257 How Canadian Law Discourages Patients from Suing Physicians for Medical Malpractice, DIAMOND AND DIAMOND (July 10, 2017), https://diamondlaw.ca/blog/how-canadian-law- discourages-patients-from-suing-physicians-for-medical-malpractice.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 197

VI. Court Cases

Litigation involving the spine is common and covers a variety of issues from third party actions to medical malpractice. Surgical intervention is an undertaking in which patients and surgeons have a joint objective; improving the person’s spinal condition, but unfavorable results can still occur.258 After all, surgical intervention is a mutual enterprise, necessitating both the patient’s compliance and the physician’s expertise. This makes discussions about surgical outcomes an important element of the process. As the cases demonstrate, counsel on both sides of medico-legal matters must comprehend what realistic expectations should be expected following a spinal intervention to better evaluate the merits of a claim.259 The following cases present a representative sample of the disputes that have arisen in a variety of contexts.

A. Fusion

In Lantier v. Caskey, the passenger’s mother was operating a motor vehicle on a two-lane highway when it was involved in an accident with the defendant’s vehicle which attempted to make a left-hand turn from the shoulder of the road.260 The passenger injured her neck and was given an epidural steroid injection and a subsequent facet injection.261 When the pain did not abate, was performed which was expected to provide relief for twelve to eighteen months.262 At that point, the plaintiff could either continue with injections, which would only give temporary relief, or she could undergo a two-level neck fusion. The physician testified that, in his opinion, Ms. Walsh, the passenger, would require a two-level neck fusion within the next ten years.263 He described that procedure in the following manner:

We make an incision on the front of the neck because the disc[s] are in the front of the spine, and we don't want to have to move the spinal cord if we don't need to. So we make an incision on the front, pull the tissues to the side, we would take out the majority of the disc at C5-C-6. We would take out the majority of the disc at C6-C7. By removing the disc, we remove those tears, the fissures, the annular fissures. We're also able to take the pressure off of the nerve root. We then put in a spacer at each level and then put in some bone graft at each level and then we put a plate on the front. The plate holds it still just so the bones have a chance to heal. Similar to a broken bone or a

258 Spine Surgery Litigation, AM. FORENSIC EXPERT SPECIALISTS (June 25, 2019), https://www.amfs.com/spine-surgery-litigation/. 259 Id. 260 Lantier v. Caskey, 308 So.3d 758 (La. App. 3 Cir. 2020). 261 Id. at 767. 262 Id. at 767-68. 263 Id.

198 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

fracture, that bone will heal and become one solid piece of bone.264

There was also evidence that the plaintiff would need shoulder surgery in the future.265 The jury accepted this testimony and awarded the plaintiff $675,000 in damages, which was upheld on appeal.

Merely having back surgery, however, is not a guarantee that the person will be successful in the presentation of a claim. There are different standards and burdens of proof in a worker’s compensation, Social Security, disability, and third-party context. For instance, in Reilly v. Commissioner of Social Security, the plaintiff applied for disability benefits after not having worked for several years as the alleged result of a severe impairment caused by a cervical discectomy and fusion, left shoulder pain, and arm weakness.266 The Administrative Law Judge (ALJ) found that she was not capable of performing her past work as the director of food services but that jobs were available that suited her background. Therefore, her claim was denied.267

The ALJ determined that she was able to engage in light work, carry ten pounds regularly, stand, and walk up to three hours, and sit for a six-hour shift. Concluding that she could be employed as a cashier, office helper, and information clerk.268 On appeal, she argued that the ALJ did not give substantial weight to the testimony of her treating physician who stated that the plaintiff was limited to occasional lifting and standing of no more than two hours, and had to use a neck brace if standing for more than one hour. He also noted that she had to be recumbent six to seven hours a day because it was the only way to relieve her pain.269

The court was not impressed and upheld the denial of benefits. The treating physician’s records were not consistent with his testimony. The plaintiff had been in a car accident and experienced pain in her neck and shoulders. Diagnostic imaging was negative for fracture or dislocation. An MRI revealed multilevel facet in the neck. At that time, the physician noted that she was able to perform all activities of daily living,

264 Id. at 767-68. Dr. Sledge informed the court that the patient would need the spinal surgery as the current treatment she had of epidurals and facet blocks could not be done indefinitely as they would become less effective. 308 So.3d at 767-68. 265 See id. at 768. After doing an MRI, Dr. Sledge discovered that the plaintiff had tendinosis in her shoulder which is damage to the tendons, and that treatments such as lidocaine and were not effective so the plaintiff would likely need surgery. Id. 266 Reilly v. Commissioner of Social Security, No. 18-CV-1269-FPG, 2020 WL 6507327, at *2 (W.D. N. Y. Nov. 19, 2020). The time between when the plaintiff had worked and then filed for disability was roughly six years. Id. 267 See id. The ALJ determined that the Plaintiffs severity of impairment did not meet or equal any criteria of any Listing and thus was not impaired enough. Id. 268 See id. The ALJ stated that while the Plaintiff could not return to her previous employment, there was employment opportunities in the national economy for someone of her age and educational background that she could do. Id. 269 See Reilly, 2020 WL 6507327 at *5. Even though the doctor had stated this in the record to the court, the court determined this course of treatment was not consistent with the doctors own medical records. Id.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 199 except for heavy lifting.270 Six months after the accident, the plaintiff underwent a spinal fusion and the records indicate that the procedure was unnecessary because there was no indication of a neurological deficit, , or severe sensory deficits.271 Post- surgery, a doctor noted that there was no need for physical therapy and she could return to her job and perform her activities as she had done before the accident. Other health care providers noted that her physical exam was unremarkable and without musculoskeletal complaints.272

This case demonstrates an important point that counsel needs to remember. Lawyers may misinterpret the consent of a client to undergo surgery or frequent invasive procedures, such as pain injections, as proof of the legitimate nature of the complaints.273 This type of reaction is common in other types of pain syndromes and can be a reflection of a person seeking sympathy or notice because the individual is unhappy with her station in life or because of an unpleasant work environment.274 When one then adds the prospect of financial compensation to this mix, the motivation to undergo a surgical procedure makes sense.275

b. Corpectomy

A corpectomy has been defined by the court as “the surgical removal of a vertebral body due to or bone spurs that are compressing the spinal cord. After removal of the vertebral body, a bone graft is placed in the space to obtain a fusion of the remaining vertebrae.” 276 The fact that there are only 221 reported cases involving this procedure is reflective that this form of surgery is not commonplace but lawsuits run the gamut from malpractice to product liability claims.277 For instance, Paulino v. QHG of Springdale, Inc. involved a novel lawsuit against a hospital for the negligent credentialing and retention of a physician who performed back surgeries.278 The facts reveal that Dr. Cyril Raben completed a discectomy and fusion on the patient’s neck which resulted in a failed union of the bones and displacement of screws. Following diagnostic

270 See id. The independent physician noted that there was no significant fractures or spinal narrowing that was medically treatable. Id. 271 See id. at *6. The court noted that the plaintiff chose to undergo the surgery and that an independent review of the plaintiff’s medical records found no need for her to have the surgery. Id. 272 See Reilly, 2020 WL 6507327, at *6. The various other doctors that treated the plaintiff noted that her range of motion and MRIs were normal for someone that had undergone a spinal fusion. Id. 273 Pearce, supra note 6 at 67. Often times there can be psychological reasons for the pain that may not be healed by surgery or these constant treatments. Id. 274 See id. Also, if there is a possibility of financial compensation for an injury, clients may be more likely to accept surgical or invasive treatment. Id. 275 See id. Often times people will play up their medical complaints during a medical examination to have the medical examiner think the issue is more severe than it actually is. Id. 276 State ex rel. Morton International, Inc. v. Indus. Comm., No. 06AP-382., 2007 WL 944005, at *8 (Ct. App. Ohio Mar. 3 2007) (defining corpectomy). 277 See, e.g., Howard v. University of Medicine and of New Jersey, 800 A.2d 73 (2002); Carr v. Brezel, 2006 WL 6573801 (Mar. 16, 2006). 278 See Paulino v. QHG of Springdale, Inc., 386 S.W.3d 462, 463 (Ark. 2012) (stating that the patient’s condition became worse after surgeries by this doctor).

200 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 imaging, the surgeon performed additional surgery to remedy the problem but it resulted in extreme neck pain and the lack of feeling below the chest.279 A CT scan revealed that part of the hardware was pressing into the spinal canal causing impingement of the spinal cord. A third operation only made things worse and the plaintiff was unable to walk, had very little movement in her arms, and pain in the neck.280

A lawsuit was filed against a variety of entities for the devastating outcome and an amended complaint including a count against the hospital for negligent credentialing claiming that the surgeon was never credentialed to perform corpectomies and that they knew the physician was incompetent to perform those procedures.281 The hospital filed a motion for summary judgment asserting that no such cause of action existed. The plaintiff countered that negligent credentialing was recognized under the state’s Medical Malpractice Act since it constituted a “medical injury” and the theory was allowed under “direct negligence” against a hospital for breaching a duty owed to a patient.282

A summary judgment was granted in favor of the defendant and the appellate court upheld that ruling.283 The court noted that a “medical injury” can only occur as the result of professional services, a doctor’s treatment, or a matter of . The court rejected the plaintiff’s novel theory since the injury did not originate with a doctor’s order.284 The decision to credential the surgeon was not done “to pursue a method of treatment, care, or course of medical action relating to a specific patient[,]” and it was not a medical injury. Credentialing decisions do not constitute a professional service, treatment, order, or medical science.285

Lyles v. Medtronic Sofamor Danek, USA, Inc. involved a patient who underwent a corpectomy and a vertebral replacement device was used in the plaintiff’s cervical spine.286 A cervical plate system was employed to stabilize the area and to stimulate fusion. However, that plate either broke or became displaced sometime after the operation so a product liability claim was filed against the manufacturer.287

An investigation revealed that the plaintiff had fallen on two occasions following the operation and repeat imaging showed that the device had broken since the films were taken right after surgery.288 The plaintiff’s symptoms did not improve and the bones failed to fuse so a second surgery was performed and rods were inserted into her neck. A suit

279 See id. (following surgery the patient informed the nurse she was in extreme pain and lacked feeling). 280 See id. At the time of filling the lawsuit, the plaintiff was still in extreme pain and unable to walk. Id. 281 See id. at 464. The plaintiffs alleged that NMC had given Dr. Rabin credentials and privileges to provide orthopedic surgeries, never cervical corpectomies. Id. 282 See Paulino, 386 S.W.3d at 462, 468. The appellate court said that credentialing someone doesn’t mean a direct overseeing of their treatment or operations they perform so the hospital could not be directly negligent in this regard. Id. 283 Id. at 465-66. 284 Id. 285 Id. 286 Lyles v. Medtronic Sofamor Danek, USA, Inc., 871 F.3d 305 (Ct App. Fifth Cir. 2017). 287 Id. at 308. 288 Id. at 309.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 201 was filed against the manufacturer of the device under a defective design and construction theory.289 The defendant argued that the claimant could not prove that an alternative design would have prevented the damage or that the design was unreasonably dangerous.290 The plaintiff countered that res ipsa loquitur created a presumption that the device was defectively manufactured. The court dismissed this allegation and the case was appealed.291

This ruling was upheld on appeal. The court noted that res ipsa loquitur is limited to those matters that “are of such an unusual character as to justify, in the absence of other evidence bearing on the subject, the inference that the accident was due to the negligence of the one having control of the thing which caused the injury.”292 The plaintiff failed to meet his burden of proof by excluding “all other reasonable explanations for his injuries.”293 For instance, the plaintiff failed to identify or exclude any other reason for his injuries nor did he establish that the plate was defective when it left the manufacturer. No evidence was offered as to how the plate was stored at the hospital or who had access to the device.294

c. Intradiscal Electrothermal Treatment

In Turner v. Colvin, the court noted that “intradiscal electrothermal annulopasty [(IDET)] is a minimally invasive alternative treatment for lower back pain due to disc problems.”295 Because it is a relatively new procedure, several reported decisions discuss whether the treatment is reimbursable. In Sneed v. RTA/TMSE, a claimant’s employer refused to pay for the procedure in a worker’s compensation context.296 The plaintiff was a streetcar operator who was in an accident with a garbage truck. She had conservative treatment and was seen by a neurosurgeon who recommended surgery.297 The claimant’s employer had her undergo independent medical examinations which doctors noted that she should continue with physical therapy so her request for surgery was denied.298 Her physician then recommended IDET as a compromise which was done without the employer’s knowledge.299 The claimant’s doctor explained, “In the IDET or intradiscal electrothermal annuloplasty surgery procedure, an electrode was threaded into the disc's annulus and the disc was heated to ninety degrees for about fifteen minutes to repair the disc's annular tear at the L5-S1 level.”300 He also produced several articles that discussed the merits of IDET as an alternate procedure for treating annular tears and segmental lumbar instability.301

289 Id. at 310. 290 Id. at 310. 291 Id. at 310. 292 Lyles, 871 F.3d at 312. 293 Id. at 313. 294 Id. at 314. 295 Turner v. Colvin, 964 F.Supp.2d 21 (D. Kansas 2013). 296 Sneed v. RTA/TMSE, 869 So.2d 254 (Ct. App. La. 2004). 297 Id. at 256. 298 Id. at 256. 299 Id. at 260. 300 Id. at 261. 301 Id. at 261.

202 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

The IME doctor admitted that he was not familiar with the procedure but professed that it “has no effect on the stability of the spine and no effect on the rest of the pathology either mechanical and/or functional. Therefore, the success rate on this procedure... is quite questionable.”302 The court found that the procedure was medically necessary. The employee’s pain required her to have an epidural block. Two years after the accident, the IDET procedure was performed after much conservative treatment. The physician did not rush to have the claimant undergo this surgery, but he desired to ease her back pain.303 Therefore, the procedure was medically necessary and the defendant was ordered to pay for it.304

In a different case, payment for the procedure was denied in Ramsteck v. Aetna Life Ins. Co.305 The facts reveal that the plaintiff underwent laser spinal surgery and had physical therapy without first obtaining preliminary approval through her health insurance plan.306 That contract had a provision on IDET procedures that provided:

Percutaneous lumbar discectomy, manual or automated, is considered medically necessary for [the] treatment of herniated lumbar discs when all of the following are met:

A. Member is otherwise a candidate for open laminectomy; and B. Member has failed 6 months of conservative management; and C. Diagnostic studies show that the nuclear bulge of the disc is contained within the annulus (i.e., the herniated disc is contained); and D. Member has no previous surgery or chemonucleolysis of the disc to be treated; and E. Member must have typical clinical symptoms of radicular pain correspondence to the level of disc involvement.

Percutaneous lumbar discectomy is considered experimental and investigational for all other indications.307

The defendant proclaimed that the plaintiff's procedure was “experimental and investigational” because there was insufficient proof of the safety and usefulness of

302 See Sneed, 869 So.2d at 262 (noting successful outcomes of the procedure are questionable). 303 See id. at 262 (emphasizing that in 1999 Ms. Sneed had severe pain requiring an epidural). 304 See id. (describing surgery performed two years after Ms. Sneed’s accident). 305 See id. (observing Dr. Vogel wanted to alleviate patient’s back pain, not rush surgery). 306 See id. (demonstrating surgery was medically necessary and Ms. Sneed was entitled to expenses incurred). 307 See Ramsteck v. Aetna Life Ins. Co., No. 08–CV–0012 (JFB)(ETB), 2009 WL 1796999, at 1 (E.D. N.Y. 2009) (concluding defendant provided fair review of claim and acted in accordance with plan’s terms).

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 203 that treatment modality.308 The court upheld this denial of payment and noted that the claimant must demonstrate that a benefit is covered, while the insurer is required to show that an exclusion applies.309 In this case, the policy language indicated that the IDET procedure is only medically necessary for the treatment of a herniated lumbar disc when specific conditions are satisfied. Otherwise, it must be found “experimental and investigational for all other conditions.”310 It was uncontested that the carrier gave the insured notice of its reason for the denial of benefits when she was told that the use in question was considered “experimental and investigational.”311 Therefore, the denial was based upon a fair review and the policy language was employed in a reasonable manner.312

d. Foraminotomy

A foraminotomy was explained in Wagner v. Georgetown University Medical Center as “a surgical operation for the enlargement of an intervertebral foramen (a normal opening between two vertebrae of the spine). It is done to relieve pressure on the root of a spinal nerve, a nerve passing through an intervertebral foramen.”313 The procedure is part of a laminectomy and entails decompression of the spinal cord and nerve roots. Nerve root damage and paralysis are inherent risks of the procedure.314

The issue in Arnold v. Johnson is whether the plaintiff had to use an expert to prove his case involving a foraminotomy and pedicle screw placement.315 Arnold developed burning pain and numbness following back surgery as the result of an allegedly misplaced pedicle screw. He eventually developed a dropped foot. The defendant’s physician assistant reviewed a post-surgical MRI and said that it was normal but the plaintiff noticed that the screws placed in the vertebra were crooked.316 He then consulted other physicians who recommended additional surgery which only partially relieved his symptoms.317

Based on the evidence, the plaintiff argued that the facts were sufficient to allow the factfinder to decide the case without an expert’s medical guidance. The court disagreed. It found that a layperson could reasonably conclude that the plaintiff developed new symptoms in the leg following the first surgery, the MRI revealed a misplaced screw,

308 See id. at 8 (remarking defendant submitted claims for reimbursement without seeking preliminary approval). 309 See id. at 6 (detailing intricacies of the contract). 310 See id. at 6 (noting plaintiff’s procedure was amongst procedures considered experimental and investigational). 311 See id. at 28 (stating insurance law places the burden of proving a claim is covered on the insured). 312 See id. at 29 (indicating plaintiff’s procedure is considered experimental and investigational unless certain criteria are met). 313 Wagner v. Georgetown University Medical Center, 768 A.2d 546, fn. 3 (D.C. Ct. App. 2001), quoting J.E. Schmidt, Attorneys' Dictionary of Medicine and Word Finder F–100 (Matthew Bender ed., 1992); See Ramsteck, 2009 WL 1796999, at 29 (concluding non-specified procedures are experimental). 314 See id. at 34 (declaring plaintiff’s claim she was not afforded full and fair review of claim lacked merit). 315 See Arnold v. Johnson, No. 6:07-CV-00170-BB, 2008 WL 11412089, at *1 (D. N.M. 2008). 316 Id. at *2. 317 Id. at *3.

204 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 and that a CT scan showed the screw was “attending” across the “left lateral recess.”318 However, a jury would not understand the significance of the screw’s intrusion into the spinal canal and whether the plaintiff’s pain relief resulting from the screw’s removal or by the foraminotomy procedure. A layperson would have to guess which of the surgeries relieved the plaintiff’s symptoms and that was unacceptable.319

e. Artificial Disc Replacement Surgery

In Hill v. United Healthcare Insurance Company, the plaintiff was insured under a health insurance policy issued by the defendant.320 She had degenerative lumbar disc disease which caused “severe and debilitating pain” in her middle to lower back.321 Her physician suggested that she undergo artificial disc replacement surgery (ADR) with an FDA-sanctioned medical device. The defendant rejected this request claiming that her insurance plan only pays for surgery that is effective. “The surgery your doctor plans has not been shown to be effective for your condition.”322 The plaintiff proceeded with the surgery anyway and appealed the carrier’s determination. The carrier responded by issuing two justifications for its rejection on appeal: “(1) the ADR procedure was not medically necessary…, and (2) the ADR procedure was an ‘Experimental or Investigational and Unproven Service.’ The letter went on to note that the denial ‘[was] based on medical policy Total Artificial Disc Replacement for the Spine,’ that ‘states that lumbar ADR is considered not safe and effective, i.e., ‘investigational’ by UHIC in all circumstances.’”323

The plaintiff countered by claiming that this form of surgery is an “often recommended procedure that has successfully treated the symptoms of lumbar disc disease” and that the FDA has sanctioned at least two such devices for lumbar ADR surgeries.324 She further argued that “the single-level ADR surgery has been an accepted form of treatment for close to a decade and the two approved implant devices have been used in ‘thousands of spinal arthroplasties.’”325

The court denied the defendant’s motion to dismiss the complaint and opined that the complaint demonstrated sufficient facts to show the medical necessity of the procedure. The plaintiff’s physician noted that a single-level ADR has been an accepted medical procedure for more than a decade and that the device “ha[s] been proven to be safe and effective in the treatment of degenerative disc disease.326 The language of the insurance plan notes that Unproven Services are those “that are determined not to be effective for treatment of the medical condition and/or not to have a beneficial effect on health outcomes due to insufficient and inadequate clinical evidence from well-conducted

318 Id. at *3. 319 See Duncan v. McCormack, No. A138211, 2015 WL 1094749 (Cal. Ct. App. 2015) (indicating nerve root damage and paralysis are risks of a foraminotomy). 320 Hill v. United Healthcare Insurance Company, No. SA CV 15-0526-DOC (RNBx), 2016 WL 11523589, at *1 (D. Cal. 2016). 321 Id. at *1. 322 Id. at *1. 323 Id. 324 Id. 325 Id. 326 Hill, 2016 WL 11523589, at *1.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 205 randomized controlled trials or cohort studies in the prevailing published peer-reviewed .”327 The plaintiff’s expert has asserted that lumbar ADR surgery is successful for the management of her medical problem and that single-level ADR is widely used across the United States as a useful remedy for degenerative disc disease.328 Accepting the plaintiff's allegations as true for purpose of this motion, and deciding all factual conclusions in the light most beneficial to the insured, the court concluded the plaintiff had sufficiently asserted that the procedure is safe, reliable, and proven.329 A similar ruling was rendered several years later in the class action lawsuit of Hendricks v. Aetna Life Insurance Company.330

f. Medical Malpractice

Mistakes during spinal surgery can have devastating consequences with resultant multi-million-dollar verdicts or settlements. An adverse consequence, however, does not always mean that the physician committed malpractice. For example, a $22.4 million award was rendered against a neurosurgeon for spinal fusion surgery that was unnecessary and improperly performed in Calli v. Alemo.331 The plaintiff suffered from a condition that caused one vertebra to slip against another thereby producing nerve root compression. The defendant suggested a lumbar fusion as a remedy to correct the improper positioning of the bones and to relieve the pain.332 It turns out the physician had never previously performed the procedure which spinal fusion required the insertion of rods and wires to reposition the vertebrae. During the first procedure, the metal rods were left unsecured and several wires snapped puncturing the protective covering around the spinal cord.333 This mandated a second surgery by the defendant which only exacerbated the problem. The glue utilized in the procedure then prevented the vertebrae from fusing which was the initial goal of the procedure.334 The outcome was that the plaintiff had to undergo a 23-hour operation at another hospital but the pain never disappeared and the patient was unable to return to work.335

A defense verdict was rendered in Haskins. v. Georgia Neurosurgical Institute, P.C., as the result of an injury that had occurred thirteen years earlier and which symptoms had progressively worsened.336 An MRI and CT scans both revealed a protruding lumbar disc so the plaintiff elected to undergo a discectomy to excise the protruding disc that was abutting the nerve roots. A short time after the patient regained consciousness from the surgery, he was unable to move his feet and was diagnosed with cauda equine syndrome.

327 Id. 328 Id. 329 Id. 330 Hendricks v. Aetna Life Insurance Company, No. CV 19-06840-CJC(MRWx), 2019 WL 9054861 (D. Cal. 2019). 331 $22.4 Million Verdict for Botched Spine Surgery, FELDMAN SHEPPARD, https://feldmanshepherd.com/results/22-4-million-verdict-for-botched-spine-surgery/ (last visited Nov. 18, 2020). 332 Id. 333 Id. 334 Id. 335 Id. 336 Haskins. v. Georgia Neurosurgical Institute, P.C., 845 S.E.2d 770, 770 (Ga. Ct. App. 2020).

206 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2

A post-operative MRI failed to show a hematoma or herniated disc but the patient did have stenosis of the spinal canal.337 The surgeon then performed an emergency laminectomy to make more room for the spinal nerves but it was to no avail. The patient was left with permanent neurological problems.338

A malpractice lawsuit asserted that the surgeon negligently caused the nerve damage and that he breached the standard of care by over-retracting the nerves during the procedure.339 The defendant’s expert opined that the surgeon could not have over- extended the nerves because the space in which he worked was too limited. It was also the opinion of the defendant’s expert that the plaintiff had suffered an unavoidable spinal cord stroke during the discectomy. 340 The jury returned with a defense verdict and that finding was upheld on appeal. The plaintiff alleged that the doctor had failed to provide proper informed consent because he had claimed that the surgery was “simple” and “easy.” On cross-examination, it was demonstrated that the plaintiff had signed the informed consent document which explained the surgery and its risks.341

Knight v. Clark involved a malpractice claim against a neurosurgeon for a four- level transforaminal lumbar interbody fusion at L4 and L5.342 This operation attempts to fuse the vertebrae to stabilize a patient's spine by use of a rod. This device is held in place by “pedicle screws.” Anatomically, this part of the vertebra consists of bony projections that extend from the posterior aspect of the vertebra. The pedicles assist in shielding the spinal canal and the spinal nerves.343 The goal is to insert the pedicle screws into the bone at an angle “to get as much bony purchase as you can without traversing the area where the nerves are.”344 After the surgery, the plaintiff continued to complain of pain so she was prescribed medicine and physical therapy. She eventually returned to full-time work and claimed that her back and right leg were eighty-five percent better.345 The defendant then told her it would take two years before she would fully recover. The plaintiff eventually relocated and started to see new physicians and a new MRI revealed that one of the screws was improperly angled into or near the spinal canal. 346 Additional surgery was performed to remove the pedicle screws and hardware from her back and it was determined that her fusion was stable and nothing else had to be done.347

A suit was filed against the original surgeon who denied that he had misplaced the pedicle screw or that any breach of the spinal canal happened during the initial procedure.348 The defendant noted that after he had placed the pedicle screws into the vertebra, he used a “ball probe” to check their placement which provided “tactile

337 Id. at 782. 338 Id. at 782. 339 Id. 340 Id. 341 Id. at 774. 342 Knight v. Clark, 283 So.3d 1111, 1111 (Miss. Ct. App. 2019). 343 Id. at 1114. 344 Id. 345 Id. at 1115. 346 Id. at 1115. 347 Id. at 1115. 348 Knight, 283 So.3d at 1115.

2021 JOURNAL OF HEALTH & BIOMEDICAL LAW 207 feedback” to see “if the screw…ha[d] penetrated into the canal or an open space.” The ball probe confirmed that the screw had not breached the spinal canal.349 Rather, he maintained that the screw must have “moved” after the plaintiff left his care.350 The defendant’s expert opined that the plaintiff’s pain was caused by a failure of the vertebrae to fuse which did not represent a breach of the standard of care.351 The expert for the plaintiff admitted that “a certain percentage of screws ... are misplaced” without fault but that the defendant was negligent in failing to identify and correct the misplaced screw during the operation.352 The jury returned with a defense verdict and that decision was upheld on appeal. The court ruled that it was within the jury’s province to decide which expert to believe.353

VII. Conclusion

The spine is an engineering marvel that is robust in construction but a significant generator of pain. The need to treat these individuals, combined with a poor comprehension of the basic foundations of back discomfort, has caused an expansion of treatment options from taking medication to surgical intervention. These operations vary from traditional methods involving discectomies and decompressions to techniques involving segmental fusions applying different approaches, materials, and instrumentation.

Most people with acute back pain caused by a herniated discs will recover with conservative care. However, in a compensation context, the desire to seek money affects the severity and duration of symptoms regardless of the treatment method. Spinal surgery should be pursued only as a last resort and should never be done merely to ascertain the cause of back pain. After all, surgical intervention is not a cure but a remedial measure to allow patients to perform daily living activities with less discomfort or alleviate a neurological compromise. Nevertheless, surgical intervention transforms a routine soft tissue injury into one fraught with possible complications and legal repercussions.

All operations have risk, but the resultant complications can be significant when the surgery is performed around the spine and spinal cord. Paradoxically, spinal surgery has provided many people with a new lease on life, but it has also caused others to suffer continued pain and disability. Complications can also occur despite proper surgical technique so patients must be aware that meaningful clinical improvement is not always achievable. In spinal surgery, procedures appropriately performed and which go on to heal in an expected fashion do not always equal clinical success as recognized by patient satisfaction.

A back surgery claim is not one that should be handled by counsel in a cavalier fashion. There are many reasons for abnormal diagnostic and clinical findings unrelated to trauma. Ascertaining the proximate cause of a spinal problem requires an understanding of the spine’s anatomy, a proper investigation into the claimant’s past

349 Id. 350 Id. at 1116. 351 Id. 352 Id. 353 Id.

208 JOURNAL OF HEALTH & BIOMEDICAL LAW VOL. XVII NO. 2 medical history, and the difference among the various treatment options. Hopefully, this article will provide the legal professional with a better comprehension of a spinal issue.