EXTERNAL LIGATION OF INTERNAL EXTERNAL LIGATION OF INTERNAL ILIAC ARTERYILIAC ARTERY
-- E. L. I. I. A. E. L. I. I. A. --
Naira R. Matevosyan, MD, PhD, JSMNaira R. Matevosyan, MD, PhD, JSM
11.04.201511.04.2015
At the CruxAt the Crux:: (I) Incision(I) Incision (II) Ligation (II) Ligation (III) Litigation (III) Litigation
Understanding the Intra-abdominal Hemorrhage – 5 -11 Surgical Anatomy of the Internal Iliac Artery – 12 -16 E.L.I.I.A. – 17 -27 Anastomosis - 28-29 Post-surgical Complications and Care - 30 From Ligation to Litigation: Prima-facie Showing of a
Damage - 31-45
Court Visited Notable Cases – 46 - 50 Disclaimer - 51
CONTENTS:CONTENTS:
FOREWORDFOREWORD
It was the third year of the medical school, when my classmates and I were introduced a commonly practiced technique of ligating the internal iliac artery (IIA) or the hypogastric artery (HA). It was then, when I construed an inquiry of stopping an acute intra-abdominal bleeding without an abdominal entrance (laparotomy or laparoscopy). No more than an inquiry then and now, it assuredly needs empirical support which is a problem in itself. Yet, there is nothing faltering in presenting it.
External ligation of internal iliac artery (ELIIA) or external ligation of hypogastric artery (ELHA) could be a method of sustaining lethal abdominal hemorrhage without opening the abdominal cavity.
4
Causes of an Acute Intra-abdominal BleedingCauses of an Acute Intra-abdominal BleedingBlunt trauma – car/air accident, physical assault and battery, fall, corsage trauma, high-
contact sports (rugby, ice hockey, soccer, horse-riding, boxing, bobsledding, skiing);Penetrating Trauma - gunshot wounds, stabbings, falling onto a sharp object, iatrogenic
(surgical perforation, endoscopy, curettage, embolization, centesis);Spontaneous Perforation - abscess, congenital defects, cancer or metastasis, peptic ulcer,
diverticulitis, ulcerative colitis, Crohn's disease, necrotizing enterocolitis, Kaposi's sarcoma, lactose intolerance, colon polyps, strangulated submucous myoma, rhabdomyoma, glomerulonephritic, ectopic pregnancy, trophoblastic disease;
Hepatic Perfusion (portal hypertension) – cirrhosis, non-cirrhotic portal fibrosis, extra-hepatic portal vein obstruction, ascites, gastric and esophageal varices;
Aneurysms – aortic, omental, gastric,hypogastric, spleen, renal, hepatic, ovarian, etc;Radiation Burns – submucosal edema of intestine, bleeding colon, duodenitis,
proctosigmoiditis;Hemophilia A – X-linked recessive trait - a defect of the clotting factor VIII Intoxication – arsenic, lead, food, other; Rupture of Spleen -trauma, malaria, Epstein Barr virus, Bartonella Henselae;Pregnancy & Labor – rupture of the uterine fundus, corns, lower segment, broad ligaments,
Fallopian tubes; abdominal concept (embryo implanted on the liver, omentum, or spleen);
Helminths & Infections- ascarid, shigella, ebola, anthrax, hookworm, nematode;
Abdominal Compartment Syndrome (ACS) – detailed in the next slide. 5
Abdominal Compartment Syndrome (ACS)
Primary ACS is associated with an organ/tissue injury or disease inside the abdominal cavity; secondary ACS refers to conditions originally not generated in the abdominal cavity. Recurrent ACS is the condition in which ACS redevelops following previous surgical or medical treatment of primary or secondary ACS.
2013 Consensus Definitions of the World Society:2013 Consensus Definitions of the World Society:1. Intermittent intra-abdominal pressure (IAP) is measured via the bladder with a
maximal instillation volume of 25 ml of sterile saline.2. Intra-abdominal pressure (IAP) is measured at end-expiration in the supine
position after ensuring that abdominal muscle contractions are absent and with the transducer zeroed at the level of the mid-axillary line. IAP is nearly 5–7 mmHg in terminally ill adults.
4. Intra-abdominal hypertension (IAH) is a sustained or repeated pathological elevation in IAP ≥ 12 mmHg.
5. ACS is defined as a sustained IAP > 20 mmHg (with or without an APP < 60 mmHg), associated with new organ dysfunction or failure.
6. IAH -grades: Grade I ( IAP 12–15 mmHg), Grade II (IAP 16–20 mmHg), Grade III ( IAP 21–25 mmHg), Grade IV (IAP > 25 mmHg).
7. Abdominal perfusion pressure (APP) = Mean arterial pressure (MAP) – IAPAPP = MAP- IAPAPP = MAP- IAP
6
Spatial AnalysisSpatial AnalysisIntra-abdominal bleeding may be asymptomatic (hidden) and symptomatic (manifested in a pain syndrome, shock, or syncope). In a profuse bleeding, patients may complain of weakness, euphoria, shortness of breath, and other symptoms of shock and hypovolemia. Symptoms depend upon where - in which abdominal quadrant - the bleeding occurs: upper-right, upper-left, lower-right, lower-left.
Topology of the suffered organ/tissue in respect to the peritoneum is crucial to managing an intra-abdominal bleeding (see illustration in the next slide).
Intraperitoneal organs include: stomach, greater omentum, the first ¼ + 5-cm of the duodenum, jejunum, ileum, cecum, appendix, transverse colon, sigmoid colon, the upper 1/3 of the rectum, liver, gallbladder, spleen, and pancreatic tail.
Extraperitoneal (or retroperitoneal) organs include: the rest of the duodenum, ascending colon, descending colon, rectum (the middle 1/3), pancreas (except the tail), kidneys, adrenal glands, proximal ureters, renal vessels, gonadal blood vessels, uterus, Fallopian tubes, inferior vena cava, abdominal aorta (including hypogastric artery).
Infraperitoneal (or subperitoneal) organs are: the lower 1/3 of the rectum, urinary bladder, distal ureters. 7
Median-cut Topography in a Female
8
ABD
OM
INAL
CAV
ITY
Common SymptomsCommon Symptoms
9
UPPER ABDOMEN:
Ruptured abdominal aortic aneurysm (AAA) presents a triad of (1) pain in the flank or back, (2) hypotension, and (3) pulsatile abdominal mass. The AAA patients may also feel cold, sweat, and faint on standing.
Ruptured omental artery will manifest in a sudden pain, which commonly occurs during the sleep. CT and celiac angiography reveal left subphrenic haematoma with extravasation.
Patients with a bleeding stomach ulcer or polyp may vomit bright red blood. In chronic or old bleeding, the vomit may look like coffee stain. Blood in the stool may be due to bleeding anywhere in the gastrointestinal tract - from the esophagus to the anus. Black tarry stools usually signal of bleeding stomach or duodenum. Black stool may also be due to the intake of iron pills, bismuth (PeptoBismol), and some foods (beets, blueberries, dark chocolate cookies, liquorice, red-colored gelatin).
Common SymptomsCommon Symptoms
Splenic rupture nonspecifically presents a left upper quadrant abdominal tenderness with or without distention, syncope, and a rapid decrease of both systolic and diastolic arterial blood pressure. If severe, shock or subliminal state may also be observed.
Respiratory excursions in left-upper quadrant are limited, painful, stiff, and Schetkin-Bloomberg symptom is positive. Percussion determines a lessening in the left hypochondrium. With a significant congestion of blood in the abdominal cavity zone deadening percussion sound moves with the change of the body position in the patient.
Often, intra-abdominal blood tracks toward the skin and is appreciated on physical examination. Cullen's sign shows the appearance of bruising surrounding the umbilicus. Grey-Turner sign is bruising in the flanks.
Liver laceration follows the same combination of symptoms but in the upper-right quadrant, plus spitting up blood.
Phrenicus symptom is often present if the bleeding is in the upper-right quadrant with diaphragm distortion. 10
Common SymptomsCommon SymptomsLOWER ABDOMEN & PELVIS:Lower gastrointestinal bleeding (LGIB) is distinct from the upper GI bleeding in management and prognosis - mostly because of its retroperitoneal source.
Bleeding of the ascending colon manifests in maroon stools; bleeding of the descending colon may show bright red blood in the stool if the hemorrhage is brisk and massive. Cecal bleeding presents in melena.
Kidneys are well protected by the ribs, abdominal muscles, back muscles, and supporting fascia. Yet, the lower poles of kidneys are inferior to the 12th ribs and are susceptible to trauma. Kidney rupture is presented in haematuria, right or left abdominal pain, muscle guarding, low back pain, abdominal bruising and swelling, common signs of internal bleeding (decreased alertness, dizziness, blurred vision, nausea, vomiting, decreased urine output, fever, shock).
Uterine rupture manifests with symptoms of profuse bleeding, plus fetal distress or death. Amniotic fluid embolism is one of the immediate causes of death.
Due to the retroperitoneal location, the rupture of Fallopian tubes may progress asymptomatic or exhibit a mild clinic.
Blood in the Douglas cul-de-sac manifests in back pain, false signs of bowel movement (rectal irritability), colicky, frequent urination, shoulder pain (phrenicus) if blood accumulates under the diaphragm, and vaginal bleeding due to shedding of the decidua. 11
Surgical Anatomy of Internal Iliac Artery
Internal Iliac Artery (I.I.A.) is the main artery of the pelvis. It is a short- thick vessel, smaller than the external iliac artery, about 3 - 4 cm in length.
Anterior branches: visceral, umbilical, superior vesical, middle hemorrhoidal, uterine, and vaginal arteries.
Posterior branches: parietal, iliolumbar, lateral sacral, superior gluteal, obturator, internal pudendal, and inferior glutea arteries. 12
I.I.A. Topology
I.I.A. arises at bifurcation of the common iliac artery - opposite the lumbosacral articulation and passing downward to the upper margin of the greater sciatic foramen. It is posterior to the ureter, anterior to the internal iliac vein, lumbosacral trunk, and piriformis muscle; close to its origin it is medial to the external iliac vein which lies between it and the psoas major muscle; and it is above the obturator nerve.
13
The I.I.A. divides into anterior and posterior divisions, with the latter giving rise to the superior gluteal, iliolumbar, and lateral sacral arteries.
The artery supplies the pelvic walls and viscera, buttock, reproductive organs, and medial compartment of the thigh. The vesicular branches supply the bladder.
Indications
Indications to the I.I.A. ligation are either prophylactic or therapeutic, and approaches are transabdominal or extrabdominal. Differentiation between the prophylactic and therapeutic purpose of ligation is by no means absolute.
Prophylactic indications: post-abortion and postpartum hemorrhage, abruptio placenta, abdominal pregnancy, placenta accreta, recurrent placenta previa, prior hysterectomy when all conservative measures have failed, groin dissection and vulvovaginectomy,extensive endometriosis, intraligamentous leiomyoma, pelvic inflammatory disease.
Urgent therapeutic indications: bleeding of the broad ligament, uterine rupture, uterine perforation, uterine atony, placenta accreta, ovarian rupture, bleeding of the cervical cancer, conization of cervix, extensive lacerations of cervix, advanced endometrial carcinoma, vaginal sarcoma, vaginal vault bleeding after hysterectomy, bladder perforation.
In elective settings, I.I.A. is either ligated or embolized during the endovascular repair of aorto-iliac arterial aneurysms where the distal end of the endograft has to seal in the aneurysm-free external iliac artery. In this scenario, I.I.A. ligation is essential in preventing a type- 2 endoleak and a potentially non-excluded pressurized aneurysm sac. 14
More Anatomical Considerations
Pelvic vasculature is arranged in such a manner that there is ample collateral circulation.
The common iliac artery bifurcates into two main branches – external iliac artery (which, at the inguinal ligament, becomes the femoral artery) and internal iliac (hypogastric) artery which descends into the pelvis.
In the pelvis, I.I.A. divides into the anterior and posterior branches.
1515
More ConsiderationsThe level of bifurcation of the common iliac artery is quite constant. There are two easily identifiable guides:(1) the sacral promontory, and (2) the line drawn between both anterior superior iliac spines. Both I.I.A. branches are not always of similar diameter along the entire length and a visual observation alone is misleading. Likewise, there may be difference in the length and diameter of the right and left I.I.A. 16
Surgeons should therefore be aware that subdivision of the main internal Iliac trunk may be into branches that are not significantly narrower than the main trunk. Also, it's crucial to appreciate that the I.I.A. is entirely retroperitoneal.
Ligation
Transabdominal method with median or transverse incision is commonplace for the I.I.A. unilateral or bilateral ligation.
However, in “street-emergencies,” there is a last-resort external method of approaching the I.I.A. through the greater sciatic foramen , using the superior gluteal artery, lateral sacralis artery, obturator artery, and piriformis muscle as guides. 17
The PassageGreater sciatic foramen is bounded anteriorly and superiorly by the posterior border of the hip bone (greater sciatic notch), posteriorly by the sacrotuberal ligament, and inferiorly by the sacrospinal ligament.
Piriformis (“pear-shape”) muscle takes origin from the anterior surfaces of S2 to S4, both between and lateral to the sacral foramina. It exits the pelvis via the greater sciatic foramen, inserting on the greater trochanter of the femur in order to rotate the thigh laterally. It passes through the foramen, as do the accompanied corresponding nerves and vessels:
superior to piriformis muscle // superior gluteal vessels and nerve
inferior to piriformis muscle // inferior gluteal vessels and nerve, sciatic nerve, posterior femoral cutaneous nerve, the nerve to the quadratus femoris muscle. Note: internal pudendal vessels and nerve and the nerve to the obturator internus muscle leave the pelvis via this opening, but enter the perineum through the lesser sciatic foramen.
Superior gluteal artery originates from the posterior branch of the I.A.A. and supplies to the gluteus maximus muscle, gluteus medius muscle, gluteus minimus muscle, and hip joint. 18
Superior Gluteal Artery
Superficial branch of the superior gluteal artery supplies maximus.
Deep branch enters deep surface of medius in intermuscular plane between the medius, gluteus minimus, and tensor fasciae lata. This attachment tethers muscle limiting amount of upward retraction of muscle and prevents one from reaching the iliac crest.
19
Arterial branches reach as far as the anterior superior iliac spine. Terminal branches anastomose with the ascending branch of the lateral circumflex femoral artery.
Entering Greater Sciatic ForamenNote: piriformis is an external rotator
of the hip. When flexed, it pulls-inward or abducts the thigh. When extended, it rotates the thigh. Therefore, surgery must be performed in an extended leg, with an outward rotated hip position.
Superior gluteal artery and nerve leave the greater sciatic notch superior to the piriformis. The sciatic nerve lies on the ischium, gemelli and obturator internus, and quadratus femoris. Piriformis too, is close to the sciatic nerve, the largest nerve in the human body.
Seven nerves and two arteries emerge inferior to the piriformis, and two nerves and an artery regain the pelvis through the lesser sciatic foramen.
20
If general anesthesia is unavailable, the lumbar blockage is perhaps the second-best method of anesthesia. The 4th and 5th lumbar spinal nerves form the lumbosacral trunk. The sacral plexus runs down on the posterior pelvic wall anterior to the piriformis muscle. See details in the next slide.
The Sacral PlexusThe lumbosacral trunk goes on to join the 1st through 4th sacral nerves as they exit the sacrum to form the sacral plexus. The plexus runs down on the posterior pelvic wall anterior to the piriformis muscle. Nerves that stem from this plexus include:
Sciatic nerve: The largest nerve in the body, it leaves the pelvis through the greater sciatic foramen to enter the gluteal area.
Pudendal nerve: Exits the pelvis through the greater sciatic foramen and enters the perineum through the lesser sciatic foramen to innervate the muscles and skin of the perineum.
Superior gluteal nerve: Leaves the greater sciatic foramen to innervate gluteal muscles.
Inferior gluteal nerve: Runs through the greater sciatic foramen to innervate gluteal muscles.
Nerve to the quadratus femoris muscle: Leaves the greater sciatic foramen to innervate hip muscles.
Nerve to the obturator internus muscle: Leaves the greater sciatic foramen to innervate hip muscles.
Nerve to the piriformis muscle: Innervates the piriformis muscle.
Perforating cutaneous nerve: Innervates the skin over the lower and medial portion of the buttock.Posterior femoral cutaneous nerve: Innervates the skin of the perineum and the back surface of the thigh and leg.Pelvic splanchnic nerves: Provide the parasympathtetic innervation to the pelvic organs.
21
Surgery: Skin Incision
The following landmarks are used for orientation: Posterior superior iliac spine (PSIS) Iliac crest Anterior superior iliac spine (ASIS) Lateral margin of the kneeIncision on the skin must be in form of an inverted “J,”starting from the PSIS and following the iliac crest to the ASIS. Reaching the ASIS, continue along the anterolateral surface of the thigh for a length of 20-30 cm and halfway down the thigh. Proceeding distally, aim a bit posteriorly, to allow posterior retraction of the musculocutaneous flap.
22
Expose the iliac crest from the ASIS towards the PSIS using a standard scalpel. The gluteal muscles will be mobilized, and the abdominal muscles left attached to the iliac crest. Complete the dissection of gluteal muscles from the top of the iliac crest. Dissect subperiosteally along the external surface of the iliac wing, from anterior to posterior and from proximal to distal. Proceed further from the lateral aspect of the crest down to the superior border of the greater sciatic notch and posteriorly until the posterior inferior iliac spine are exposed. Take care to protect the superior gluteal vessels which emerge from the greater sciatic notch and lie on the deep surface of the muscles.
After retraction of the gluteus minimus muscle, the trochanteric insertion and the distal part of the gluteus medius muscle become visible. A curved forceps, placed underneath the gluteus medius tendon will help to define its insertion. The tendon of the piriformis muscle will be found just proximal and anterior to the medial border of medius gluteus tendon.
2323
Protect the sciatic nerve with care, and avoid prolonged retraction of the nerve.
Once the sciatic nerve and piriformis are uncovered, the superios gluteal nerve and artery above will guide to the greater sciatic foramen (see the next slide).
24
Since the posterior division is given off within 3 cm from the bifurcation, most of the times what is ligated beyond 3 cm from bifurcation is the anterior division of internal iliac artery. Selective arterial embolization is an option in managing hemorrhage if the patient is hemodynamically stable.
After reaching the spot and removing the areolar tissue, the bifurcation can be located through digital palpation of the bounding pulse. The vein is visualized posteriorly.
Ideally, the I.I.A. should be ligated distal to the posterior division to get optimum decrease in pulse pressure in the circulation it covers. Yet, in emergency, it is not advisable to try locating the posterior division, as such efforts are time consuming and may injure the internal iliac vein.
25
26
Ligation
The bifurcation feels like an inverted Y. The branch coming off at right angles is the hypogastric (IIA) artery. It courses medially and inferiorly to the palpating finger. The continuing branch is the external iliac artery. It courses laterally and superiorly out over the psoas muscles to the leg, where it becomes the femoral artery. The surgeon must accurately identify these two branches. There is no room for error. This approach comes with many risks. The superior gluteal artery and its accompanying veins lie on the deep surface of the gluteal muscles. During elevation and posterior reflection of the glutei, the vessels may be torn and may retract into the pelvis. Bleeding from the superior gluteal vessels may be difficult to control. Packing the notch may help. The sciatic nerve is also at the risk of injury, typically from retractors or prolonged stretching. The ureters cross the common iliac artery at the level of its bifurcation.
Ligation Pitfalls
If the external iliac artery is ligated, the leg of that side will become cold, numb, and pale. Loss of the limb can follow. Note: if the artery is transected, repair is difficult .
In order to avoid the external iliac artery ligation, after the spot identification, the I.I.A. is elevated from the vein by Mixter forceps or Reich forceps. The artery often is firmly adherent to the underlying vein; caution is advised. The point of the instrument should be directed toward the midline and placed at the border of the artery, and the forceps tips should be spread open gently. At the same time, the forceps should be “nudged” medially. When the artery is lifted off the vein, the external branch should be reexamined and reidentified. After confirmation, ligatures should be passed beneath the artery and tied gently but firmly. The artery should not be transected.
Another pitfall associated with ligation of the I.I.A. is poor timing (the delay). When hemorrhagic shock is irreversible, this operation will not overcome it. Inadequate transfusion is another error in managing a severe hemorrhage and blood loss is often seriously underestimated. Also, trauma to the sciatic nerve is a severe complication.
Failure to remember that the vaginal artery is a separate branch of the I.I.A. rather than a branch of the uterine artery may disorientate the surgeon to an unnecessary hysterectomy for bleeding control. Injury to the external iliac artery from retractors or mistaken ligation of this vessel can lead to loss of the entire lower limb.
27
AnastomosesPelvis is distinctly rich in collateral circulation. Post-surgical anastomoses occur in each hemipelvis -- horizontally and vertically. The vertical system functions to a greater extent than the horizontal, especially after bilateral ligation.
Three major vertical anastomoses are: (1) lumbar-iliolumbar, (2) middle sacral, and (3) superior hemorrhoidal-middle hemorrhoidal. Bilateral ovarian-uterine anastomoses are another important vertical link.
Other vertical anastomoses occur between: Ovarian artery (branch of aorta) || uterine artery; Superior hemorrhoidal a. (branch of inferior mesenteric) || middle hemorrhoidal artery; Middle hemorrhoidal a. || inferior hemorrhoidal (branch of internal pudendal from IIA); Obturator artery || inferior epigastric artery (branch of external iliac); Inferior gluteal artery || circumflex and perforating branches of deep femoral artery; Superior gluteal artery || lateral sacral artery (posterior branches); Lumbar arteries || iliolumbar artery and last lumbar artery (from the aorta); Middle rectal artery || superior rectal artery (a branch of the inferior mesenteric artery); Lateral sacral arteries || median sacral artery (from the aorta). 28
Anastomoses also occur between the:
inferior epigastric arteries || medial circumflex femoral arteries; circumflex & perforating branches of the deep femoral artery || inferior
gluteal artery; superior gluteal artery || posterior branches of the lateral sacral artery.
Horizontal anastomoses include:
Branches of vesical arteries from each side; Pubic branches of obturator from each side.
Anastomoses
29
Post-surgical Complications & CareLarge hematomas or collections of
serosanguineous fluid can be drained through separate wounds or stab- wounds.
Antibiotics are not indicated after ligation of the arteries. Their use is dictated only by the presence of infection.
An indwelling catheter may be necessary to facilitate adequate assessment of urinary output in women who are at risk of serious morbidity.
Occasionally, ligation of the hypogastric arteries fails to stem pelvic hemorrhage. The reason is unclear. Yet, there are some suggestions:
(1) Massive necrosis after infection with destruction of the vessels;
(2) Presence of large, aberrant branches feeding blood to the area;(3) Dislodgement of clots when blood pressure rises;
(4) Rarely, concomitant severe venous bleeding;
(5) Coagulopathy with deranged hematological indices.30
From Ligation to Litigation
31
We often hear that there is no such a thing as 'minor' or 'non-invasive' surgery. Whether you are having your appendix removed or a quadruple bypass, any surgical procedure is a serious and invasive matter. The last thing you want to learn aftermath, is that an error occurred. Yet, it does not automatically mean that the surgeon committed malpractice.
The mere fact that a surgical error has occurred does not mean a negligence. The medical procedure in question has to adhere to a reasonably accepted medical standard of care, and the sub-standard treatment must result in provable harm to the client or patient.
Intent or scienter theory are often irrelevant in surgical negligence actions and depending on the structure of the claim or complaint, the harmful act is often interpreted as a battery or strict liability.
However, in order to pursue malpractice action, plaintiff has to show standing. Article 1 of the U.S. Constitution reads: "The judicial power shall extend to cases and controversies.” Put simply, standing refers to a factual showing of a conflict or controversy.
Standing
General requirements of standing:
1) injury-in-fact - the plaintiff has suffered a realistic or measurable harm;
2) invasion of legally-protected interest which is concrete and particularized, actual or imminent (non-speculative), not conjectural and not hypothetical;
3) causation - injury proximately caused by defendant's conduct (injury must be shown, but injury alone is not enough);
4) redressability (a prove that the injury caused by defendant to plaintiff was likely to be avoided).
However, where plaintiff has a good standing, she still needs to address all minimum requirements of malpractice action to avoid a summary judgment for defendant.
As early as 1897, Circuit Judge William H. Taft (later Chief Justice of the U.S. Supreme Court) interpreted the Ohio law on malpractice in the matter of Ewing v. Goode ( 1897), 78 F. 442-444:
"Before the plaintiff can recover, she must show by affirmative evidence - first, that the defendant was unskillful or negligent; and, second, that his want of skill or care caused injury to the plaintiff. If either element is lacking in her proof, she has presented no case for the jury's consideration.”
32
Prima-facie Showing of a Damage
In Anglo-American jurisprudence, in order to establish a surgical malpractice it must be shown by preponderance of the evidence (in civil suits), or beyond the reasonable doubt (in criminal complaints), that the injury in question was caused by doing some particular thing(s) that a surgeon of ordinary skill, care and diligence would not have done under similar conditions or circumstances, or by the failure or omission to do some particular thing(s) that such a surgeon would have done under similar conditions and circumstances, and that the injury complained of was the direct result of such doing or failing to do particular thing(s).
In order to recover on a theory of negligence, the injured party (plaintiff) carries the burden of proving that:
(1) defendant had a duty to conform his conduct to a standard of care;
(2) defendant failed to conform his conduct to the requisite standard of care required by the relationship;
(3) defendant's negligent act was the proximate cause of the injury, and
(4) the damage was transferred.
33
Elements of prima-facie case: DUTY & DUE CAREThere are two key aspects of physician-patient relationship: voluntary agreement (where there is no obligation without consent), once created, such a relationship raises obligations that cannot be waived.
Under the Anti-Discrimination Law [1] and Emergency Medical Treatment & Active Labor Act ( EMTALA),[2] the following facilities (known as 'non-participating hospitals') have no obligations and can exercise the voluntary relationship doctrine:
1. hospital-based outpatient clinics not equipped to handle medical emergencies, 2. Shriners' Hospital for Disabled Children, 3. private clinics not designed for surgical or non-surgical emergencies, 4. restaurants, shops, or bookstores inside the campus, 5. in-campus rooms for education, recreation, praying, or grievance.
The 250-yard rule: After the Chicago incidence of 1998, the 42 CFR 489.24 reads: “A person who presents anywhere on the hospital campus and requests emergency services, must be handled under EMTALA. Other presentations outside the emergency room do not invoke EMTALA.
EMTALA does not apply to any off-campus facility, regardless of its provider-based status, unless it independently qualifies as a dedicated emergency department. Under 42 CFR 413.65; a “campus” means the physical area immediately adjacent to the provider’s main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the HCFA regional office, to be part of the provider’s campus.”
(1) Title VI of the Civil Rights Act 1964, 42 U.S.C. 2000; (2) 42 U.S.C. §1395dd34
DUTY & DUE CARE – continued
The voluntary relationship doctrine has sprung from Hurley v. Eddingfield. [3] The issues were: (1) whether the licensed doctors were obligated to help patients in dire need of medical attention; and (2) whether there was an affirmative duty to be a good citizen and help others in peril if one had not caused their predicament?
The Montgomery Circuit Court of Indiana ruled that:
the physician had no duty to enter into relationships with the patient;
the license permitted, but did no require provision of medical services;
a physician cannot be forced to practice at all or on other terms than he may choose to accept.
By holding “the Act is a preventive, not a compulsive measure,” the Court reasoned that in “obtaining the state's license to practice medicine, the state does not require, and the licensee does not engage, that he will practice at all or on other terms than he may choose to accept.” Thus, in the absence of a heightened relationship, there is no affirmative duty that a person give help to a stranger (Good Samaritan Laws).
Inevitably, this doctrine is in conflict with medical ethics: under the Hippocratic oath a physician has to respond to the medical needs of any person in imminent need. [4]
(3) 156 Ind. 416, 59 N.E. 1058, 1901 Ind
(4) Blake, V (2012). When Is a Patient-Physician Relationship Established? The AMA Journal of Ethics; 14(5): 403-406 35
Elements of prima-facie case: STANDARD OF CARE
A general definition of standard of care is "...the type and level of care an ordinary, prudent health care professional with the same training and experience would provide under similar circumstances and in the same community." [5]
Under EMTALA, there are two minimum standards of emergency care: duty to screen, and duty to stabilize.
EMTALA defines “to stabilize” as to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility, or, with respect to [a pregnant woman having contractions], to deliver (including the placenta).
Under the same law, provision of appropriate treatment means medical screening examination or intervention within the capability of the hospital's emergency department, including ancillary services routinely available to the emergency medical condition.
(5) Ewing v. Goode, 78 Fed. 442 (W.D. Ohio 1897); 442, 443-444
36
STANDARD OF CARE - continued
A standard of care is determined from the testimony of medical experts or witness-scientists. Commonly, three types of experts are summoned to the trial: reporting, educating, and interpreting. To be admitted by the Court, the procedure in question has to be in the sub-field to which the expert-witness belongs. The locality rule concerns to the specialty, the geographical location, and the accrediting school of the witness.
The level of requisite expertise is relative to the subtlety and complexity of the subject matter of proposed testimony. The educating witness testifies at a higher plane of abstraction about the validity of an underlying scientific theory and the reliability of an instrument implementing the theory. Consequently, this witness usually needs heavy academic credentials (H-index, number of publications, profess, referrals, etc).
There are exceptions to expert testimony requirement. Where the propriety of the treatment is such that the lack of skill or care of the surgeon is so apparent as to be within the comprehension of laymen and requires only common knowledge to understand or judge it, expert testimony is not necessary.[6-8] Such cases are: accidental injuries, crude mistakes (like wrong blood transfusion), “sponge-cases”, and “imaging cases.” Under the Canterbury jurisdiction, the doctrine of res ipsa loquitur is applied. [9, 10]
If scientific evidence falls within 901(b)(9), 901 (a), it governs and imposes the normal standard for authentication. If a scientific theory qualifies as a 'readily verifiable certainty,' the judge can judicially notice the theory of validity. Under the Federal Rule of Evidence 104 (a), the judge's decision is final.
(6) Garfield Memorial Hosp. v. Marshall, 204 F.2d 721 (D.C. Cir. 1953); (7) Dean v. Dyer, 64 Cal. App. 2d 646, 149 P.2d 288 (1944); (8) Covington v. James, 214 N.C. 71, 197 S.E. 701 (1938); (9) Hubach v. Cole, 133 Ohio St. 137 (1938); (10) Morgan v. Sheppard , 91 Ohio Law Abs. 579 (1963)
37
ErrorSurgical errors go beyond the known risks of surgery. Put simply, surgical error is a preventable mistake or an omission of reasonable aid on timely manner. Patients may suffer damages from a single surgical error, or a combination of several errors:
38
ANALYTIC TECHNICAL misdiagnosis abandonment of the patient wrong surgery drug administration errors timing errors failure to assess preexisting medical, mental,
dental conditions lack of professional vigor overconfidence or lack of confidence "imaging cases" commercial or competitive interests surgeon's mental illness that obscures ad hoc
decisions poor rapport poor postoperative care poor choice of anesthesia method breach of patient's privacy mispresenting the informed consent form other
wrong-site surgery operating the wrong patient fatigue or burnout of the surgeon or surgical
team poor venue capacity deficient blood bank or code blue package health insurance constraints poor presurgical order, including failure to
empty the urine bladder, large intestine, or instruct NPO prior the surgery
anesthesia accidents contaminated or off-label surgical tools or
equipment “sponge cases” contagious respiratory or skin diseases in the
surgeon failure to measure the blood loss before,
during and after surgery other
Elements of prima-facie case: CAUSATION
Where defendant had a legal duty to act under the circumstances within a reasonable standard of care, and plaintiff successfully proved that defendant acted negligently, plaintiff still needs to demonstrate that her damages were caused by defendant's failure to provide a reasonable care.
The issue of actual causation (“causation -in- fact”) requires application of the but-for test. But-for surgeon's breach of duty, would the patient's injury still have occurred?
The proximate cause is applied to those more or less undefined considerations which limit liability even where the fact of causation is clearly established.
The proximate cause is a part of the actual cause. It's like the 'yolk in the egg.' The actual cause can be remote or proximate. There can be multiple proximate causes, each one of them serving as the basis for liability.
In actual cause, the issue is whether a particular causal factor is “sufficiently close" or "proximate" to the injury to justify the imposition of liability?
In proximate cause, the issue is whether defendant's liability directly reasons the foreseeable consequence?
At the risk of oversimplifying their difference, one can suggest that:
✔ In actual cause, but for defendant's negligence accident would not have occurred.
✔ In proximate cause, the causal contributions are not too remote to justify imposition of liability. 39
Contributory v. Comparative Negligence
Tort law has two aims: (1) to deter negligence, and (2) to enforce those who acted negligently pay for the damages.
The defense has the burden to reasonably explain why the plaintiff's proposed amount of recovery must be barred or adjusted. In other words, in tort actions the defense is stemmed of: (1) plaintiff's negligence, and (2) assumption of risk. Based on the first doctrine (negligence), tort jurisdiction of the U.S. has contributory and comparative fault systems.
CONTRIBUTORY FAULT is any amount of negligence by the plaintiff which is a complete bar to recovery in most of the cases. In pure contributory negligence systems, defendant's liability is reduced by percentage of injury is attributable to negligence (as determined by jury). If even plaintiff contributed to the 90% of the damage and only 10% was imposed by defendant, plaintiff still can recover for that 10%. Thirteen states use this system.
COMPARATIVE FAULT ensures that plaintiff fully or partially recovers for damages, even if plaintiff too, was negligent.
The difference between these two systems is that in comparative fault, negligence in part of plaintiff does not constitute an absolute bar to recovery. Instead, the monetary award is reduced (adjusted). 40
Comparative Fault
Comparative fault systems fall into one of two basic types:
• Pure comparative fault: negligent plaintiff can recover from negligent defendant only when his share of the fault is less than 50%. If plaintiff's contributory fault is 40% and defendant's is 60%, plaintiff recovers at 60%. Twenty-one states follow the 51% Bar Rule under which a damaged party cannot recover if it's 51 % or more at fault: CT, DE, HI, IL, IN, IA, MA, MI, MN, MT, NV, NH, NJ, OH, OK, OR, PA, TX, VT, WI, WY.
• Modified comparative fault (“proportionate responsibility”) is the 50% bar rule. If there is a 50%/50% negligence, plaintiff gets 50% recovery. Twelve states follow the 50 % Bar Rule, meaning a damaged party cannot recover if it's 50% or more at fault, but if it is 49 % or less at fault, it can recover. Those states include: AR, CO, GA, ID, KS, ME, NE, ND, SC, TN, UT, WV.
There is also joint liability, when multiple defendants (surgeons) are involved. Plaintiff can recover any portion of total damages from any of defendants (until 100% of damages are recovered). In some states, this type applies only to cases where defendants "acted in concert." In some states, it only applies to defendants whose negligence exceeds minimum threshold of responsibility.
41
Measuring the Fault Prominent legal scholars [11] empirically discriminate such rules, by developing testable predictions concerning the effects of contributory and comparative negligence. For example, in the common traffic accident cases drivers do not know in advance whether they would injure or get injured. Suppose a driver is considering a care level (x) in driving. The second driver, who would be involved in the accident, uses a care level (y). The cost of the first driver’s care is C(x), and the cost of the second driver’s care is C(y). The expected value of damage that the first and second drivers sustain in accidents is D1(x, y) and D2(x, y), respectively. The social cost of the accident will be:
C(x) + C(y) + D1(x, y) + D2(x, y). Under the comparative negligence rule, the particular driver’s private cost is:
C(x) + λ(x)s(x)D ̄ (x2) + [1 − μr(x)]D ̄ (x1)Thus, the socially efficient care level x occurs where the social cost of accidents is minimized. Under the contributory negligence rule, the particular driver’s private cost is:
C(x) + λ (x)s (y)D ̄ (x2) + [1 − μ (x)r(x)]D ̄ (x1)Under this rule, the second driver is liable qua injurer only if the first driver is non-negligent, and the probability μ that the second driver is liable depends positively on the first driver’s care level x.(11) Adapted from White, MJ (1993). Empirical Comparisons of the Contributory versus Comparative Negligence Rules. Palgrave - Negligence Rules 42
Assumption of Risk
The defense is also given an opportunity to develop its argument based on the assumption of risk doctrine. The risk of damage can be EXPRESS or IMPLIED.
Express risk acknowledgment is a written waiver of liability, an agreement to release a party providing services from liability for any negligence on their part. Such releases are outside the context of the informed consent and are uncommon in medical practice. However, often the hospitals (not the physicians) ask the patient to release liability in the event the patient falls and gets injured in the premises or contracts an airborne infection in the hospital. Whether such a waiver will be enforced depends largely on the jurisdiction and the circumstances surrounding the case.
In denying a release of liability(waiver), the Courts reason that the waiver is contrary to the public policy.
Implied liability has to types:• primary assumption of risk - the person in full awareness of danger cannot recover
damages under this theory. The defense only arise after showing that plaintiff acted negligently.
• secondary assumption of risk - when plaintiff was hesitant of danger, yet did not avoid it when there was an alternative. 43
Elements of prima-facie case: DAMAGE
Any surgery may result in several outcomes: the patient’s condition can improve, can stay the same, or can deteriorate. A negative outcome alone is not sufficient to indicate professional negligence. The trier of the case must understand that negligence cannot be inferred solely from any of the following: an unexpected result, a bad result, failure to cure, failure to recover, or any other circumstance showing merely a lack of success.
"But-for " rule in surgical damage:
Even if defendant (surgeon) has committed actus reus, the prosecution must still show that his act caused a particular sort of harmful result. To make that showing, the prosecution must typically exhibit two things: (1) that defendant's act was the "cause in fact" (actual cause) of the harm; (2) that the act was "proximate" or (legal cause) of the harm.
What is a proximate harm in surgery?
A causal connection exists when, but only when, disclosure of significant risks incidental to treatment would have resulted in a decision against it. The more difficult question is whether the factual issue on causality calls for an objective or a subjective determination? Viewed from the point at which he had to decide, “would the patient have decided differently had he known something he did not know?" The answer which the patient supplies hardly represents more than a guess. The subjective method of dealing with causation theory comes in second- best. By contrast, the objective test calls, “what a prudent and reasonable person in the patient's position would have decided if suitably informed of all perils bearing significance?” 44
Pure Economic Loss Rule Scenarios:
(a) A patient is admitted to the hospital for pre-surgical screening. His inpatient bed-days are prolonged (and billed accordingly) due to the unexpected absence of the surgeon.
(b) A patient signs informed consent for a certain type and volume of surgery, and after demands another surgical procedure. This deviation from consent may put the provider or the facility under unexpected expenses that were not discussed and approved before the procedural engagement. In this case, the hospital or provider may sue the patient.
Pure economic loss rule applies by showing privity. In order to succeed in pure economic loss doctrine, plaintiff (either the patient, or the surgeon, or the hospital) will have to prove a much closer relationship with the defendant than she would have to prove in a claim for physical damage. The level of proximity differs from one situation to another, because certain types of damage or conduct require a more direct connection between the plaintiff and the defendant.
Where there has only been pure economic loss, recovery incurred through the tort of negligence is very limited. If there is a contract between the parties, then damages can be claimed for ‘pure economic loss,' but where there is no contract and no physical injury, the law does not impose a duty of care, although there are some exceptions (like EMTALA) or cases with a special relationship between the parties.[12]
(12) Chapter 11. The Tort of Negligence (2010). Oxford University Press 45
Court -visited Notable Cases
Note:
Cases presented in the next slides solely concern to the traditional (transabdominal) internal iliac artery ligation, and are shared for the conceptual view.
To the author's knowledge, there are no published clinical cases or adjudicated cases of the external ligation of internal iliac artery (ELIIA).
46
Hoeke v. Mercy Hospital of Pittsburgh [13]
FACTUAL SUMMARY: In 1971 plaintiff - age 28, a citizen of the Netherlands and a U.S. resident for fourteen years, underwent a hysterectomy. Due to the profuse bleeding in the operative area, the operating gynecologist was aided by a cardiovascular surgeon. Both ligated the right internal iliac artery during which time the right ureter and kidney were damaged. In post-surgical intensive care unit, the diminished blood supply to plaintiff's right leg was not attended on timely manner. Subsequently, the leg was amputated. The kidney, which appeared to be perforated, was removed at a later date. (Author's note: the diminished blood supply to the leg was likely due to the erroneous ligation of the external iliac artery).
PROCEDURAL HISTORY: During the trial, expert witnesses (anesthesiologist of the disputed surgery, orthopedic surgeon who amputated plaintiff's leg, another ob/gyn, and vascular surgeon) testified that damage to the ureter and the kidney were related to the operative procedure. Both surgical and post-surgical errors were established. Judgment was entered for the plaintiff. Defendants appealed relying on Restatement, Second, Torts,[14] that reads: “one who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other's person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking, if (a) his failure to exercise such care increases the risk of such harm.”
ISSUE: Whether the Trial Court erred in instructing the jury as to the proximate cause of harm and whether the poor post-surgical care increased the risk of the damage.
(13) 445 A. 2d 140 - Pa: Superior Court 1982 (14) Restatement, Second, Torts, § 323(a): Negligent Performance of Undertaking to Render Services
47
Hoeke v. Mercy Hospital of Pittsburgh - continued
RULE OF LAW: In determining whether or not a statement of law given in a charge is erroneous, the charge of the court must be considered in its entirety.
JURISPRUDENCE: Schneider v. Albert Einstein Medical Center; Voitasefski v. Pittsburgh Rys. Co; Jones v. Montefiore Hospital.
DISPOSITION: Judgment of the Trial Court was affirmed.REASONING: The issue wasn't about primary versus secondary responsibility. It was whether
defendants fell below the standard of care in their duties owed to the patent. In this case, the respective duties and standards of care were submitted to the jury based upon the expert- testimony presented at the Trial. Accordingly, the jury found that both doctors (the operating ob/gyn and the attending doctor in post-surgical intensive unit) were responsible for the loss of the patient's right leg and right kidney.
Defendants erroneously relied on the Trial Court's language on the issue of causation. Taken verbatim from Hamil v. Bashline [15] it reads : “If a physician's negligent action or inaction has effectively terminated his patient's chances of avoiding injuries, he may not raise conjectures as to the measure of chances that he has put beyond the possibility of realization.” The issue in Bashline was the degree of certainty of the required proof. The Supreme Court resolved this issue by adopting Section 323(a) of the Restatement of Torts, Second, holding that evidence would be sufficient to support a finding of proximate causation if the defendant's negligence increased the risk of harm to his patient and that the increased risk was in turn a substantial factor in bringing about the injuries to the plaintiff. Bashline did not deal with defendant's right to present expert testimony on the issue of causation. It rather dealt with plaintiff's burden of proof on causation in a medical negligence case.
(15) Hamil v. Bashline, 481 Pa. 256, 271-72, 392 A.2d 1280, 1288 (1978)48
Reinke v. Kordisch [16]
FACTUAL NARRATIVE: In 2010 plaintiff, age 22, underwent a laparoscopic hysterectomy with an evaluation of the ovaries. Formerly, she had three cesarean sections with live births, tubal ligation, gallbladder surgery, and laparoscopy of a right hemorrhagic ovarian cyst.
Prior the surgery, plaintiff signed an informed consent form pertaining the following risks of supracervical hysterectomy and bilateral salpingo-oophorectomy: infection, injury to nearby structures, puncture of the bowel or blood vessel requiring abdominal irrigation, an operation to correct injury, severe hemorrhage, and the need for transfusions. During the surgery there was "immediate significant bleeding" in the abdominal lower left quadrant, which was controlled and stabilized. In early post-surgical period, the patient was infused several packs of red blood cells (PRBC) due to the continuous, but not significant, blood loss. The next day, due to the severe anemia and pelvic haematoma (detected by the CT scan), the second surgery was performed with the aid of a general surgeon, at which time fresh blood was uncovered in the left lower quadrant. Several drains were sutured and the bleeding was stopped. The next morning, due to the sharp and stable decrease of blood pressure and alleged internal bleeding, the patient underwent two more “observational” laparotomies. An aiding vascular surgeon ligated the left internal iliac artery, recording that "the oozing was much less." Aftermath, the patient continued receiving PRBC infusions. She was discharged with improved condition on the 10th day from the initial surgery.
(16) Reinke v. Kordisch, 134 So. 3d 176 - La: Court of Appeals, 3rd Circuit 2014 49
Reinke v. Kordisch - continuedPROCEDURAL HISTORY: In 2011, plaintiff filed a malpractice complaint against the
operating doctor and the hospital under the La.R.S. 40:1299.47 . The surgeon requested a medical review panel (MRP). Composed of three physicians, the MRP issued an unanimous opinion, contending that neither the surgeon nor the hospital had breached the standard of care to plaintiff. In 2012, plaintiff timely filed suit with identical claim. In 2013, defendants (the surgeon and the hospital) filed motions for summary judgment on the grounds that plaintiff had no expert testimony to support her claim as required by La.R.S. 9:2794(A). The Trial Court entered summary judgment for defendants. Plaintiff timely appealed.
ISSUE: Whether the Trial Court erred in granting the motion for summary judgment.RULE OF LAW: If the mover has made a prima facie showing that the motion for summary
judgment should be granted, the burden shifts to the non-moving party to present evidence demonstrating that a genuine material factual issue remains.
JURISPRUDENCE: Smith v. Our Lady of the Lake Hosp.; La.C.Civ.P. art. 966(C)(2); id 967(B)DISPOSITION: Judgment of the Trial Court was affirmed.REASONING: Plaintiff had the burden to present evidence to establish a breach of the
applicable standard of care with a causal connection to her injury. Plaintiff argued by relying on the application of res ispa loquitor as in Pfiffner.[17] Her sole opposition was an affidavit, which was never properly filed in the record before the Appeal. Also, the Trial Court specifically addressed the application of res ispa loquitor to this case, finding it as not falling into the category of cases as envisioned by Pfiffner.
(17) Pfiffner, 643 So.2d 1228.50
51
DISCLAIMER
This presentation is rather observational and ancillary.
It shan't be used as a medical or legal advice.
The author declares no commercial or strategic interest with the names of
entities - either used or omitted.
