ALJDEC decisions subject to certification as final

07A-26278-MDX · Arizona Medical Board · 2008-05-05

IN THE OFFICE OF ADMINISTRATIVE HEARINGS

HEARING DATES: March 3, 4, and 5, 2008, beginning at 9:00 a.m. on each date; the record was held open until April 14, 2008 to allow the parties to brief the legal issue of the standard in Arizona for “gross negligence” pursuant to A.R.S. § 32-1401(27)(ll); the record was reopened on April 24, 2008 pursuant to the parties’ stipulation regarding Lance S. Burns, M.D.’s status at Midwestern University. APPEARANCES: The Arizona Medical Board appeared through Emma Mamaluy, Esq., Assistant Attorney General; Respondent James W. Schouten, M.D. appeared through Paul J. Giancola, Esq. and Brett W. Johnson, Esq., Snell & Wilmer, L.L.P. ADMINISTRATIVE LAW JUDGE: Diane Mihalsky _____________________________________________________________________

FINDINGS OF FACT Background and Complaint 1. The Arizona Medical Board (“the Board”) is the duly constituted authority for licensing and regulating the practice of allopathic medicine in the State of Arizona. 2. The Board has issued License No. 26278 for the practice of allopathic medicine in the State of Arizona to Respondent James W. Schouten, M.D. 3. On November 20, 2006, the Board received a complaint against Dr. Schouten from Mr. JB, which was dated November 16, 2006, regarding care that Dr. Schouten rendered to Mr. JB’s wife, JB, on March 6-7, 2005, in the Payson Regional Medical Center Emergency Room (“E.R.”). 4. The Board forwarded Mr. JB’s complaint to Dr. Schouten for his response and assigned the complaint to outside medical consultant Lance S. Burns, M.D. to investigate. After allowing Dr. Schouten to review and respond to Dr. Burns’ report and requesting Dr. Burns to consider Dr. Schouten’s response, on March 28, 2007, the Board’s Staff Investigational Review Committee voted that the evidence showed that Dr. Schouten had violated A.R.S. § 32- 1401(27)(e), (q), and (ll) in his treatment of JB. 5. Dr. Schouten requested a hearing on the Board’s proposed findings and the matter was referred to the Office of Administrative Hearings for the scheduling of a hearing in due course under A.R.S. § 41-1092 et seq. 6. On February 27, 2008 the Board issued an amended complaint, which charged that Dr. Schouten had violated A.R.S. § 32- 1401(27)(e), (q), and (ll) by failing to obtain an emergent CT scan of JB, by either not performing or not documenting an appropriate neurologic examination of JB, and by dosing JB with less than 1.5 mg/kg to 2 mg/kg of succinylcholine per kilogram of body weight before attempting to perform rapid sequence intubation (“R.S.I.”) on her. 7. Although the Board alleged that Dr. Schouten’s charged deviations from the standard of care could have harmed JB, it did not provide notice that it would attempt to prove causation in fact. 8. A hearing was held on March 3, 4, and 5, 2007. The parties stipulated to the admission of 38 exhibits. The Board later offered into evidence three additional exhibits, which were admitted over Dr. Schouten’s objections. The Board presented the testimony of Mr. JB, Dr. Burns, and its case manager Vicki Johansen. Dr. Schouten testified on his own behalf and presented the testimony of Mark Robert Solem, M.D., his supervisor at Payson Regional Medical Center E.R. Facts of J.B.’s Case 9. JB was a 68-year-old woman who presented in the Payson Regional Medical Center E.R. at 8:28 p.m. on March 6, 2005, after falling in her bathtub and striking the left side of her forehead, just above her eyebrow, sustaining a laceration. 10. Mr. JB provided to E.R. staff a list of JB’s medications, including Lasix 20 mg once a day, 20 mg Lotensin once a day, 25 mg Plavix once a day, 10 mg Crestor once a day, 20 mg Paxil once a day, 25 mg Coreg twice a day, 250 or 50 mg Advair twice a day, and 81 mg of aspirin once a day. 11. Plavix is an anticoagulate or blood-thinning medication that was prescribed for JB’s vascular disease, for which she had in the past had a stent placed in her heart. Aspirin is also a blood-thinning medication. 12. Mr. JB testified he told personnel at the E.R. that JB was complaining of a headache on the top of her head and nausea from the time that she entered the ER reception area and that he expressed these complaints to the receptionist, to the male nurse, who was later identified as Richard Moreno, R.N., and to Dr. Schouten. He testified that he also informed all three providers that JB had fallen a week earlier and struck her forehead on the sidewalk. 13. JB was assigned to Room G, which is the furthest room from the nursing station, at 2053, or 8:53 p.m. on March 6, 2005. According to the nursing assessment, Nurse Moreno first assessed JB at 2053 hours. She assessed her pain as on a 1-to-10 scale, with 10 being the worst pain ever. 14. Nurse Moreno described JB’s injury as a “simple laceration.” 15. Nurse Moreno signed a detailed affidavit on February 16, 2007 that stated that JB had “stated that the pain was located in her forehead at the laceration and in her right hand,” but “did not complain of a severe headache [or] nausea . . . .” 16. Dr. Schouten first saw JB at 2115 hours, or 9:15 p.m. on March 6, 2005. Dr. Schouten’s Emergency Physician Record of Facial or Head injury noted that JB provided the history. 17. Mr. JB testified that he provided the history and an account of JB’s symptoms, including a headache on the top of the head and nausea. JB “was not a complainer.” 18. Dr. Schouten described a “goose egg” and laceration on JB’s right temple, above her right eyebrow. Dr. Schouten reported that JB was alert and in no apparent distress (“NAD”), the she had painless range of motion (“ROM”) in her neck. The review of symptoms (“ROS”) on Dr. Schouten’s noted no vomiting, headache, or neck pain. He checked “no” for loss of consciousness (“LOC”). 19. Dr. Schouten also noted that JB’s pupils were equally round and reactive to light (“PERRL”). She was oriented to person, place, and what was going on. Dr. Schouten also checked extra-ocular motion was intact. 20. Dr. Schouten did not note that he had performed a fundoscopic examination. He did not note or rule out nausea. He did not check to indicate that he had examined JB’s sensory, motor, or cranial nerves. 21. Dr. Schouten’s treatment note was negative for past history. 22. Dr. Schouten’s report does not note whether or not JB complained of nausea. He did note that JB was “tender only @ site of swelling.” Dr. Schouten also did not note a history of a recent, similar fall. 23. Dr. Schouten ordered a plain x-ray of JB’s right hand. 24. Nurse Moreno checked on JB at 2150 hours. He noted that she was “alert and oriented.” 25. Kent Cox, MD, an ENT specialist, had been called into the E.R. to help care for another patient. Dr. Schouten requested Dr. Cox’s help to suture JB on March 6, 2005. 26. Dr. Cox’s report notes that, when he sutured JB, she was complaining of increasing nausea and headache. 27. Dr. Cox’s note reflects that he used running stitches to close the laceration and that he instructed JB to return within a week for removal of the stitches. 28. Dr. Cox’s typewritten report, which was dictated on March 8, 2006, described JB’s wound as “extend[ing] full thickness down to the periosteum,” which is the subcutaneous covering of the skull. Dr. Cox also reported that JB’s pupils had changed in size. After Dr. Cox finished suturing JB’s laceration, he reported she was taken for a CT scan and his “attention was then directed to other patients in the [E.R.].” 29. At 2220 hours, or 10:20 p.m. on March 6, 2005, during his rounds, Dr. Schouten heard JB vomiting. He ordered a CT scan and administration of phenergan. The phenergan was administered at 2249 hours but the order for a CT scan was not carried out, apparently because it was overlooked. 30. At 2332 hours, or 11:32 p.m. on March 6, 2005, Dr. Schouten realized that his order for a CT scan of JB had not been carried out. He ordered a second CT scan. 31. The CT scan was performed at 2345 hours and, at 2350 hours, or 11:50 p.m. on March 6, 2005, Dr. Schouten received the results of the CT scan of JB’s brain. It was highly abnormal, showing an “acute subdural hematoma right frontal to temporal convexity” and a “1 cm right to left midline shift.” 32. At 2355 hours, Dr. Schouten began the process of transferring JB to a facility that had neurosurgery capacity. By this time, JB was becoming obtunded and Dr. Schouten moved her to another room where she could be monitored more closely. 33. By 1110 hours, JB was having difficulty breathing and Dr. Schouten ordered an R.S.I. and, in preparation, administration of 7 mg of succinycholine for JB’s body weight of 75.5 kgs, or less than 1 mg for every kg of JB’s body weight. He also ordered administration of lidocaine, which was not immediately available and was not administered at the start of the R.S.I. procedure. 34. Dr. Schouten tried twice without success to intubate JB because her “airway [was] slippery with blood.” 35. Dr. Cox also made two attempts to intubate JB; the second attempt was successful. Dr. Cox reported that intubation “was done without difficulty or any unusual problems.” 36. Mr. JB testified that, after the intubation, JB “blew up like a balloon” and had to have her clothes cut off. He looked in her eyes and her pupil was “very large.” 37. The Payson Regional Medical Center was not a rated trauma center at the time JB was treated in the E.R. It did not have neurosurgery capacity. Dr. Schouten made arrangements to air-lift JB to Good Samaritan Medical Center in Phoenix, which had neurosurgery facilities. 38. Within several hours after being airlifted to Good Samaritan Medical Center, JB was pronounced dead. 39. The Payson Regional Medical Center E.R. has 10 beds. The E.R. was busy on May 6-7, 2005. However, Dr. Schouten testified that he did not rush his care of JB, but spent the time with her that he felt her symptoms warranted. Evidence on the Standard of Care The Experts Dr. Burns 40. The Board’s outside medical consultant Dr. Burns graduated from the University of Maryland School of Medicine in Baltimore in 1985. He completed a residency at the Baylor College of Medicine in Houston, Texas. Dr. Burns testified that family medicine incorporates some degree of emergency medicine. He took classes in emergency medicine because he wished to practice emergency medicine. 41. Since 1989, Dr. Burns has been a full-time emergency physician at Emergency Physicians’ Professional Association, Inc., which provides coverage for two Level II trauma centers in the Phoenix area, including Arrowhead Hospital. Before that, he moonlighted at various E.R.’s in Arizona, including in rural areas such as Payson, Bullhead City, and Valley View. 42. Dr. Burns has been a Base Station Medical Director since 1990 for the Peoria Fire Department, Glendale Fire Department, and Southwest Ambulance, responsible for providing continuing education, assessment and recertification of approximately 100 prehospital emergency personnel. Since 2003, he has been the Chairman of the Department of Medicine at Arrowhead Hospital. 43. Dr. Burns testified that he does not review the medical literature as part of his initial review. After the physician has responded to his initial report, he reviews the literature. Dr. Schouten 44. Dr. Schouten graduated from the University of Utah School of Medicine in 1995. He was a member of the Family Practice Honors program. Between 1995 and 1998, he completed a family medicine residency at the University of Kansas Medical Center in Kansas City, Kansas. Between 2003 and 2004, he completed a fellowship at the University of Arizona College of Medicine. 45. Dr. Schouten has a family practice in Payson since 1998. He is board-certified in family medicine. 46. Since 1999, Dr. Schouten has also worked he works one shift every other week as emergency physician on duty at Payson Regional Medical Center E.R. between 7 p.m. on Sunday and 7 a.m. on Monday. 47. Dr. Schouten testified that the University of Kansas Medical Center includes a Level 1 trauma center. Family medicine provides care “cradle to grave” and includes treatment of many of the same conditions seen in the emergency room. 48. Dr. Schouten testified that he has a number of certifications in life support. He has been a certified instructor in advanced trauma since 2004 and teaches paramedics about R.S.I. at Flagstaff Medical Center. Dr. Solem 49. Dr. Solem completed a residency in Emergency Medicine at the UCLA Medical Center in Los Angeles in 1982. He completed an internship at Maricopa Medical Center. 50. Dr. Solem testified that he completed the residency at a time when Emergency Medicine was being developed into a separate field of specialization. He has worked in emergency medicine, in Scottsdale and Payson, since completing his residency, 51. Dr. Solem has been the President of the Board of Directors of Payson Emergency Physicians, P.C. and an attending physician in the Payson Regional Medical Center E.R. since 2002. 52. Dr. Solem is Board-certified in emergency medicine. 53. Dr. Solem testified that the “standard of care” is defined by statute to mean a reasonably prudent physician in the same specialty. He would not have employed Dr. Schouten if he were not interchangeable with the other E.R. physicians at Payson Regional Medical Center. He believes Dr. Schouten practice meets the standard of care for a E.R. physician. 54. Dr. Solem testified that he did not review any of the medical literature in preparation for his testimony at hearing. Failure to Order Emergent CT Scan Dr. Burns’ Testimony 55. Dr. Burns testified that a subdural hematoma is bleeding below the dura, the toughest outermost layer around the brain. As people get older, the dura will adhere to the brain, which shrinks. There is more room for the brain to move. In addition, as people age, blood vessels become more fragile. Therefore, an older person may suffer a more severe injury to the brain with a lesser external trauma.

56. Dr. Burns testified that a person who takes anticoagulates like JB have an additional risk factor. Although many older people may have some bleeding after head trauma, brain injury may not result because the bleeding stops. A person who takes anticoagulates will have a tendency to keep bleeding because blood does not clot, causing pressure and injury to the brain. In addition, a person with a significant vascular history like JB may have more fragile blood vessels. A person’s anticoagulated status, including daily doses of Plavix and aspirin, which work on different receptors in the blood, puts them at significant risk for bleeds. 57. Dr. Burns testified that Plavix is a recent anticoagulate which the FDA approved in 2002. It was not widely used until recently. An older, more traditional anticoagulate is Coumadin or Warfarin. There is no test to determine how Plavix affects a person’s ability to clot. 58. Dr. Burns testified that the standard of care for a patient who is older than 65 years, who suffers an injury above the clavicle, and who is anticoagulated is to have a CT scan performed within 30 minutes of presentation because of the increased risk of intracranial bleeding in such a patient.

59. Dr. Burns testified that symptoms such as a headache on the top of the head and nausea indicate than an intracranial process may already be underway. An anticoagulated patient over 65 years who suffered trauma above the clavicle requires a CT scan even without additional symptoms. In any event, an E.R. physician must identify intracranial bleeding as soon as possible so that the patient may if necessary be referred to or transported to a neurosurgeon for a craniotomy to relieve pressure caused by intracranial bleeding. Because there is nowhere for the blood to go, the more time that passes, the less likely a full recovery. 60. Dr. Burns testified that, for younger patients, an emergent CT scan is not required for all trauma above the clavicle. 61. Dr. Burns testified that Mr. JB’s description of JB’s symptoms and events were consistent with a subdural hematoma. Within 30 minutes, the patient would experience nausea and pain on the top of her head. Mr. JB’s description of a “blown eyeball” after JB had become nonresponsive is a sign of neurological damage caused by a subdural hematoma. 62. Dr. Burns testified that no loss of consciousness means that a patient may have suffered minimal head trauma. However, it is not a definitive requirement if other factors, such as a patient’s age or anticoagulated status, indicated that a CT scan was warranted. 63. Dr. Burns testified that JB’s alleged lack of nausea was a significant negative that Dr. Schouten should have noted. He believes Mr. JB that JB reported a headache and nausea from the time she entered the E.R. He does not believe that JB’s condition went from no nausea at 8:28 p.m. to intractable vomiting at 10:20 p.m. on March 6, 2005. 64. Dr. Burns testified that a nurse’s note provides a starting point for the physician, but he still must make his own assessment. JB did not have a simple laceration, which means there was not more than one layer to close. 65. Dr. Burns testified that, if a laceration goes to the bone, as it did in JB’s case, the mechanism of injury is more severe. 66. Dr. Burns testified that he has seen at least 10 or 20 subdural hematomas in his years full-time E.R. practice. He realizes that the injury can be devastating and that time is of the essence in treating such patients. Dr. Schouten’s Testimony 67. Dr. Schouten testified that his examination of JB revealed no findings suggestive of intracranial bleeding, brain injury, or concussion. The only evidence of injury was a laceration over JB’s right eye, which he might have suggested could have been glued. Dr. Schouten testified that JB’s injury was mild or minimal. 68. Dr. Schouten testified that he would have asked JB whether an episode of dizziness caused her to fall. He also would have asked whether she had experienced blurred vision, numbness, or weakness. 69. Dr. Schouten testified that he specifically remembered asking JB whether she had a headache other than pain at the laceration site and that she denied having a headache. If she had not denied having a headache or had reported nausea, he would have ordered a CT scan. 70. Dr. Schouten denied that JB or Mr. JB had told him that JB had fallen in the past two weeks. 71. Dr. Schouten testified that his thought process was that he would reevaluate JB’s neurological status after Dr. Cox finished sewing up her laceration. While he was reviewing films, he heard JB vomiting. 72. Dr. Schouten testified that, at first, he believed that JB had a simple laceration. He did not remember putting on a glove to palpate the injury. He did not know that her laceration was a full thickness laceration to the periosteum. 73. Dr. Schouten testified that he has seen more than one subdural hematoma in the E.R. He did not know exactly how many; he estimated that he had seen 10-20 subdural hematomas. Dr. Solem’s Testimony 74. Dr. Solem wrote a letter in support of Dr. Schouten, which was admitted into evidence. The guidelines to help differentiate high-risk from low-risk intracranial injury include the patient’s age, mechanism of injury, historical information, presenting symptoms, physician exam findings and the Glasgow Coma scale value. JB had been injured in a ground level fall, which caused a laceration above her eyebrow. JB reported no headache, vomiting, neck pain, or loss of consciousness. She had no worrisome symptoms. 75. Dr. Solem testified that the only risk JB had was taking Plavix and aspirin. But many patients, especially those who are elderly, take aspirin or Plavix due to the advertisements of drug companies. If taking Plavix and aspirin were a criteria, a CT scan would be required for even young asymptomatic patients. 76. Dr. Solem testified that he took Coumadin. If he followed the advice that required a CT scan for an anticoagulated patient every time the patient “bumped his head,” he would have had 30-40 CT scans by now. That is far too much radiation for the brain. There was no need to obtain a CT scan immediately in JB’s case. 77. Dr. Solem testified that Dr. Schouten appropriately ordered a CT scan when JB’s condition worsened and she began vomiting. 78. Dr. Solem admitted on cross-examination that he is younger that 65 years old. He also admitted that a person older than 65 years is more likely to sustain a brain injury from a head trauma. The Medical Literature 79. The parties included the article, “Clinical Policy: Neuroimaging and Decisionmaking in Adult Mild Traumatic Brain Injury in Acute Setting,” Neurology/ Clinical Policy (American College of Emergency Physicians 2002) (“Clinical Policy: Neuroimaging”). 80. Dr. Schouten pointed out that the “Clinical Policy: Neuroimaging” article required the one of the following criteria for an emergent CT scan after a mild traumatic head injury: LOC, amnesia, and mental impairment. JB did not meet any of these criteria. 81. Dr. Burns pointed out that the “Clinical Policy: Neuroimaging” article excluded from application the presence of a bleeding disorder. JB’s anticoagulated status was the equivalent of a bleeding disorder. 82. Dr. Schouten disagreed that someone like JB who took Plavix and aspirin had the equivalent of a bleeding disorder. 83. The “Clinical Policy: Neuroimaging” article also concluded that a CT scan was indicated only for patients who met criteria or for those patients with one of five high-risk factors, including age greater than 64 years. 84. The parties also had admitted into evidence “Head injury: Which patients need imaging? Which test is best,” in CMA, by Jonathan Glauser, MD. The review discussed the New Orleans criteria and the Canadian criteria for CT scans after head trauma. Among the high risk factors for patients with an injury above the clavicle were aged greater than 65 years and more than two episodes of vomiting. Other indications for a CT scan included patients with coagulopathies or who are taking Warfarin. 85. The parties also had admitted into evidence “Comparison of the Canadian CT Head Rule and the New Orleans Criteria in Patients with Minor Head Injury,” reprinted in the Journal of the American Medical Association, September 28, 2005. The study reported that the hospital ethics boards excluded from the study patients who had a bleeding disorder or used oral anticoagulants. The Canadian Head Rule was that patients who were 65 years or older were at high risk of neurosurgical intervention. 86. Dr. Schouten testified that Warfarin and Coumadin operated differently than Plavix and presented a far greater risk of intracranial bleeding. Alleged Inadequate or Inadequately Documented Neurological Examination Dr. Burns’ Testimony 87. Dr. Burns testified that the standard of care after a head trauma to an elderly patient requires a focused neurological examination by the E.R. physician, including a top-down quick check of the cranial nerves, including motor and sensory. The physician should palpate the patient’s neck. 88. Dr. Burns testified that the neurological examination should include a fundoscopic examination, which requires the physician to look into the patient’s retina to see the optic nerve and blood vessels. Usually the lights are turned down for the fundoscopic examination to cause the patient’s eyes to dilate. 89. Dr. Burns testified that traumatic injury to the optic nerve and blood vessels may be difficult to see in a fundoscopic examination. Although the availability, reliability, and quickness of CT scans have lessened the importance of a fundoscopic examination, it is still the standard of care because such an examination is allows the physician to see the status of the cranial nerves. 90. Dr. Burns testified that a physician who treats a head injury should also perform Romberg’s test and look for Babinsky’s sign. Babinsky’s sign requires the patient to take her shoes off and the physician to stroke the bottom of her feet. Almost everyone’s great toe goes down; if the patient’s toe goes up, it could be a sign of brain injury. 91. Dr. Burns testified that the standard of care requires the physician to document all the tests performed during his neurological examination. 92. Dr. Burns testified that the standard of care for a 65-year- old anticoagulated patient with an injury above the clavicle requires a focused neurological examination and a CT scan. According to Dr. Schouten’s report of his examination of JB, he did not perform the full focused neurological exam. 93. Dr. Burns testified that the standard of care required Dr. Schouten to perform a motor and sensory examination of JB. According to the patient record, this was not done. Dr. Schouten’s Testimony 94. Dr. Schouten testified that, from the time he enters the examination room, he is observing the patient. 95. Dr. Schouten testified that he would have checked JB’s face. If she had reported a headache on the top of her head, he would have noted the context, that is, whether she had experienced a direct blow to her head. 96. Dr. Schouten testified that he asked JB whether she was nauseous. Because he did not note her response, it must have been negative. 97. Dr. Schouten testified that he would have looked at JB’s laceration. He would not have unpacked a laceration that had stopped bleeding. He would have felt the area around the laceration to check for broken bones and would have looked for a black mark under JB’s eye or swelling behind her ear. He also would have checked her neck to see if anything were swollen and whether she could move normally. JB did not have meningitis or stiffness in her neck. She did not show pain with movement of her head. 98. Dr. Schouten testified that, his note of “PERRL” on JB’s chart indicates that he examined her cranial nerve. If JB’s eyes were tracking, it showed there was no fracture of her facial bones. If she could see an object, it showed no brain injury. 99. Dr. Schouten testified that he also performed an ENT examination of JB. If she had clear liquid coming out her nose, it could be spinal fluid, which would warrant further examination. 100. Dr. Schouten testified that a complete motor-sensory examination would take an hour. He generally did an abbreviated or focused examination. 101. Dr. Schouten testified that a fundoscopic examination could be very valuable for a patient who complained of headache rather than trauma. Since JB’s injury was traumatic, a fundoscopic examination would not have provided useful information. 102. Dr. Schouten testified that he would have had a hard time performing a fundoscopic examination of JB in the E.R. because elderly people’s eyes do not dilate easily. He would have had to put drops in JB’s eyes to dilate them. If the physician suspects a possible eye injury, it makes no sense to paralyze a patient’s eyeballs for 6-8 hours. Dr. Solem’s Testimony 103. Dr. Solem report stated that Dr. Schouten’s practice is to perform a full neurological exam of patients who present in the E.R. after suffering head trauma. Although Dr. Schouten did not fully document the neurological exam, he met the standard of care in performing it. The demands upon E.R. physicians’ time frequently prevents them from fully documenting all the examinations they perform. 104. Dr. Solem testified that the standard of care does not require a fundoscopic examination because the value of such an examination is so limited. Unless there is an injury to the eye, there is not much a physician can do without dilating the pupil. 105. Dr. Solem admitted that, although he is rarely successful in performing a fundoscopic examination, he does attempt such examination during a neurological examination. 106. Dr. Solem admitted that nausea is a pertinent negative. Dr. Schouten should have noted the presence or absence of nausea. Alleged Inadequate Succinylcholine Dosage Dr. Burns’ Testimony 107. Dr. Burns testified that an R.S.I. procedure involves passing a tube through a patient’s vocal cords to the branches of her lungs to allow her to breath. R.S.I. should be performed with as little trauma to the patient as possible. 108. Dr. Burns testified that, before an R.S.I. procedure is performed, a sedative is administered to the patient to relax her. After that, Succinylcholine is administered to paralyze the patient for approximately 5-7 minutes to allow the tube to be inserted. The Succinylcholine must be sufficient. 109. Dr. Burns testified that the usual Succinylcholine dose is 1.5 mg per kg of patient weight. A typical dose is 100 mg. 110. Dr. Burns characterized an R.S.I. that is accomplished after 4 attempts as a difficult intubation. Most R.S.I.s are accomplished after 1 or 2 attempts. 111. Dr. Burns testified that a difficult intubation could cause a perforation of the retropharynx, which would allow air to enter the subcutaneous tissues. He has seen such patients “blow up like a balloon,” as Mr. JB described JB after the R.S.I. The perforation would likely be small and likely would not be noted on an autopsy report. 112. Dr. Burns’ response to Dr. Schouten’s response to the initial report notes that, “[w]hile ATLS does allow the low end for dosage at 1mg/kg, it also states that the average dose is 100 mg.” He trains paramedics to administer 1.5 to mg succinylcholine per kg of body weight and to err on the side of 2 mg/kg for R.S.I. Dr. Schouten’s Testimony 113. Dr. Schouten’s written response to Dr. Burns’ initial report characterized the R.S.I. of JB as “difficult.” His testimony at hearing was consistent. 114. Dr. Schouten testified that succinylcholine does not last long and has a long list of adverse effects. A physician should use only enough succinylcholine as is necessary. If the patient is not sufficiently relaxed 60 seconds after the initial dose, the physician may administer more. 115. Dr. Schouten testified that he did not give JB a second dose of succinylcholine, because the initial dose lasted at least 5 minutes. 116. Dr. Schouten testified that the Advanced Trauma Life Support for Doctors (“ATLS”) Program for Doctors recommends between 1 and 2 mg/kg of body weight of succinycholine. Various authorities recommend various doses. 117. Dr. Schouten testified that he had studied JB’s autopsy report. It did not indicate a perforation of her retropharnyx. 118. Dr. Schouten admitted that his statement in his initial response to the Board’s complaint that he intubated JB was false. In fact, Dr. Cox had intubated JB. Dr. Solem’s Testimony 119. Dr. Solem testified that he uses 1-2 mg of succinycholine per kg of patient body weight. That is the correct dose and what he uses. The Medical Literature 120. Dr. Schouten uses Epocrates, which is a small, hand-held reference source. Dr. Schouten pointed to the Epocrates online dosing information for succinylcholine, which provides a dosage of 0.5 to 1 mg/kg of body weight. 121. Dr. Burns testified that Epocrates dosage was not for R.S.I. procedures. Anesthesiologists may order a lower dosage of succinylcholine for procedures other than R.S.I. because they use succinylcholine in combination with other drugs. APPLICABLE LAW 1. A.R.S. § 32-1451(M) provides in relevant part: Any doctor of medicine who after a formal hearing is found by the board to be guilty of unprofessional conduct . . . is subject to censure, probation as provided in this section, suspension of license or revocation of license or any combination of these, including a stay of action, and for a period of time or permanently and under conditions as the board deems appropriate for the protection of the public health and safety and just in the circumstance. The board may charge the costs of formal hearings to the licensee who it finds in violation of this chapter.

2. A.R.S. § 32-1401(27) defines “unprofessional conduct” to include: (e) Failing or refusing to maintain adequate records on a patient. . . . .

(q) Any conduct or practice that is or might be harmful or dangerous to the health of the patient or the public. . . . .

(ll) Conduct that the board determines is gross negligence, repeated negligence or negligence resulting in harm to or the death of the patient.

3. A.A.C. R4-16-603 provides in relevant part as follows: A physician commits an act of unprofessional conduct when the physician violates one or more subparagraphs of A.R.S. § 32- 1401(27). These statutory violations are referenced under the categories that follow:

(10) “Medical Records Issues” includes those actions or omissions that violate A.R.S. § 32-1401(27)(e), or (rr).

a. A one-time occurrence of a minor nature that does not depart from the standard of care may be issued an Advisory Letter.

b. Repetitive, egregious, or non-remediable offenses may result in a minimum penalty of Letter of Reprimand. . . . .

(18) “Departures from the Standard of Care” includes those actions or omissions that violate A.R.S. § 32-1407(27)(l), (q), or (ll).

a. Technical Errors:

i. When there has been a technical error, the Board may consider the following factors:

(1) Whether the procedure was otherwise performed within the standard of care;

(2) Whether the complication that occurred is a complication that is documented to occur when the procedure is otherwise competently performed;

(3) Whether the complication was recognized in a timely fashion and then treated appropriately;

(4) Whether the patient and/or the patient’s family was informed of the complication/ error in a timely fashion; and

(5) Whether the proper informed consent was obtained from the patient prior to the procedure or surgery. ii. A one-time technical error that answers the above questions in the affirmative may be adjudicated with an Advisory Letter to trend the specific error.

iii. A one-time technical error that does not answer the above questions in the affirmative may result in a letter of Reprimand or a Decree of Censure.

iv. Repetitive or egregious technical errors may result in a Letter of Reprimand, Decree of Censure, Probation, Suspension, or Revocation, or any combination, depending on severity, frequency, the potential for remediation, and other aggravating circumstances. . . .

4. A.A.C. R4-16-604 includes among the aggravating factors considered in disciplinary actions the following: 5. Submission of false evidence, false statements, or other deceptive practices during the investigative or disciplinary process;

6. Refusal to acknowledge the wrongful nature of the conduct.

5. The Arizona Court of Appeals has defined “negligence” and “gross negligence” as follows: “Negligence” is defined by our legislature as “a want of such attention to the nature or probable consequences of the act or omission as a prudent man ordinarily bestows in acting in his own concerns.” . . . “Gross negligence” has been equated by our supreme court with “wanton negligence.” . . . Wanton negligence is defined as:

A person is wantonly negligent if he willfully does an act or fails to do an act which it is his duty to do, knowing or having reason to know of facts which would lead a reasonable man to realize that the actor’s conduct not only creates an unreasonable risk of bodily harm to the plaintiff but also involves a high degree of probability that substantial harm will result. . . .

As far as “gross incompetence,” [allopathic physicians] are well advised by the terms of [A.R.S. § 32-1401(27)(ll)][1] that their professional behavior will be judged against recognized standards of ethics and that no practice which endangers the health or safety of the public will be tolerated. The term “gross” relates solely to the matter of degree. . . .

Caldwell v. Arizona State Board of Dental Examiners, 137 Ariz. 396, 400, 670 P.2d 1220, 1224 (App. 1983) (citations omitted; footnote added). CONCLUSIONS OF LAW 1. This matter lies within the Board’s jurisdiction.[2] 2. The Board bears the burden of proof and must establish cause to discipline Dr. Schouten’s license to practice allopathic medicine under applicable statute by a preponderance of the evidence.[3] “A preponderance of the evidence is such proof as convinces the trier of fact that the contention is more probably true than not.”[4] A preponderance of the evidence is “[t]he greater weight of the evidence, not necessarily established by the greater number of witnesses testifying to a fact but by evidence that has the most convincing force; superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other.”[5] 3. The issue of “gross negligence” is a question of fact: If the care that Dr. Schouten rendered to JB fell below the applicable standard of care in any respect, the Administrative Law Judge and, ultimately, the Board must determine the degree of the departure. The issue of whether Dr. Schouten committed unprofessional misconduct as defined by A.R.S. § 32-1401(27)(ll) must be determined based on the evidence that the Administrative Law Judge and the Board determine to be more credible. Failure to Order Emergent CT Scan 4. Nurse Moreno and Dr. Schouten had no reason not to note JB’s alleged early complaints of a headache on the top of her head and nausea. The Administrative Law Judge does not believe that she made these complaints upon presenting at the E.R. 5. Nonetheless, Dr. Burns’ testimony and the peer-reviewed literature that was admitted into evidence establish that, since JB was 68 years old, anticoagulated with Plavix, and had an injury above the clavicle, the applicable standard of care required that she be given an emergent CT scan to diagnose a possible brain injury. 6. The Administrative Law Judge believes it is a close question whether Dr. Schouten’s failure to order an emergent CT scan for JB constitutes gross negligence, given the unanimous concern in the literature that such a scan be ordered and the potentially disastrous consequences of a failure to order such scan. Nonetheless, she does not believe that Dr. Schouten’s failure rose to the level of gross negligence under A.R.S. § 32-1401(27)(ll). 7. The Board has established, that in failing to order an emergent CT scan of JB, Dr. Schouten committed unprofessional conduct as defined by A.R.S. § 32-1401(27)(q). Inadequate or Inadequately Documented Neurological Examination 8. Dr. Schouten admitted that he did not fully document the neurological examination that he claims to have performed of JB and the importance of documenting such examination. The Board has therefore established a violation of A.R.S. § 32- 1401(27)(e). 9. The Board has also established that Dr. Schouten in fact departed from the standard of care by failing to perform a complete neurological examination of JB that included reflex and muscle strength testing, visual field testing, a fundoscopic examination, evaluation of balance and a Babinski’s test. 10. The degree of Dr. Schouten’s departure from the standard of care is exacerbated by his failure to order an emergent CT scan and the severity of JB’s full-thickness laceration. 11. The Board therefore has established that Dr. Schouten committed unprofessional conduct as defined by A.R.S. § 32- 1401(27)(q) and (ll) by failing to perform an adequate neurological examination of JB. Inadequate Succinylcholine Dosage 12. With the exception of Epocrates, all authorities, including Dr. Solem’s testimony, indicate that the appropriate dose for Succinylcholine is between 1 and 2 mg/kg of body weight. The recommended dose in Epocrates does not appear to be for an emergency R.S.I. procedure. Dr. Schouten administered less than 1 mg/kg of body weight to JB. The resulting difficult intubation may have resulted in a perforation of her retropharnyx. 13. The Board therefore has established that Dr. Schouten committed unprofessional conduct as defined by A.R.S. § 32- 1401(27)(q) when he administered an inadequate dose of succinylcholine to JB. Factors in Mitigation and Aggravation 14. Dr. Schouten has no prior disciplinary history. The five questions set forth in A.A.C. R4-16-602(18)(a)(i) must be answered in the affirmative. 15. Dr. Schouten falsely claimed to have completed the R.S.I. of JB in his initial response to the Board. His care of JB included performance of three distinct procedures that fell below the standard of care. RECOMMENDED ORDER Based on the foregoing, it is recommended that the Board issue a decree of censure against License No. 26278, previously issued to James W. Schouten, M.D. It is further recommended that Dr. Schouten be prohibited from practicing emergency medicine until he has demonstrated his competence to do so to the Board’s satisfaction. Done this day, May 5, 2008.

______________________________________ Diane Mihalsky Administrative Law Judge

Original transmitted by mail this ____ day of May, 2008, to:

Arizona Medical Board Lisa Wynn, Executive Director ATTN: Susan Ahn, Legal Coordinator 9545 East Doubletree Ranch Road Scottsdale, AZ 85258

By ___________________________ ----------------------- [1] This authority concerned denturists regulated by A.R.S. § 32- 1201.12(n). The parties’ attorneys agreed that it is equally applicable to allopathic physicians under A.R.S. § 32-1401(27)(ll). [2] See A.R.S. § 32-1401et seq. [3] See A.R.S. § 41-1092.07(G)(1); A.A.C. R2-19-119; see also Vazanno v. Superior Court, 74 Ariz. 369, 372, 249 P.2d 837 (1952). [4] Morris K. Udall, Arizona Law of Evidence § 5 (1960). [5] Black’s Law Dictionary at page 1220 (8th ed. 1999).

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