Legal Vignettes- Risks in Ambulatory Anesthesia

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1 Legal Vignettes- Risks in Ambulatory Anesthesia Christopher M. Burkle, M.D., J.D. Professor of Anesthesiology and Perioperative Medicine Mayo Clinic Rochester, MN 2017 MFMER slide-1

2 No conflicts of interest Nothing to disclose 2017 MFMER slide-2

3 Lawyer disclosure Every lawyer thinks that they re saying the most interesting thing anybody could ever hear. From time immemorial, jurors having been falling asleep because from time immemorial, lawyers have been boring. We re the dullest people in the world, for Christ s sake John Gleeson, former Brooklyn federal judge Wall Street Journal Dec 8, MFMER slide-3

4 Outline and objectives Background information on litigation and risk Sample litigation cases Importance of causation (the all important third element) Joint and Several Liability Laws Arbitration agreements Agency law 2017 MFMER slide-4

5 Settlement Reached in Joan Rivers Malpractice Case Melissa Rivers and her lawyers,.,said they did not want the focus to be solely on what happened to the famous entertainer. They said that the case highlighted the lax oversight at outpatient surgical centers, and that they would be working to advance legislation in Albany to ensure that these clinics operate under the same minimum safety standards as hospitals do. Profit cannot be placed above patient safety, the plaintiff s attorney said MFMER slide-5

6 Ambulatory Surgery in the News (for all the wrong reasons!) Similar news accounts adding to public interest: Paralyzed Castle Rock Woman Receives $14.9 Million in Lawsuit Against Surgery Center, Joe Dahlke, Fox 31 Denver, Apr. 6, 2017 Jury Awards $543k in Lawsuit Against Pismo Beach Outpatient Surgery Center, Cynthia Lambert, Telegraph News, Dec. 21, 2013 Paralyzed Colorado Woman Wins $14.9 Million Malpractice Verdict, Monica Mendoza, Denver Bus. J., Apr. 6, 2017 Suit Raises Concern About Outpatient Clinics, Amanda Cuda, The News- Times, Apr. 20, MFMER slide-6

7 How a push to cut costs and boost profits at surgery centers led to a trail of death Christina Jewett, Kaiser Health News Mark Alesia, IndyStar March 2, MFMER slide-7

8 What goes wrong? ASC closed claims data from : Surgical treatment (68%) Anesthesia related treatment (14%) Patient environment (5%) Medical treatment (5%) Diagnosis related (3%) Medication related (2%) Other (4%) MedPro Group claims, closed dates MFMER slide-8

9 What goes wrong? Anesthesia related closed claims: Improper performance (41%) Improper management of patient (21%) Dental damage (15%) Positioning (8%) Improper choice of anesthesia (2%) Other (14%) MedPro Group claims, closed dates MFMER slide-9

10 Between 2007 and 2014, a total of 944 anesthesiology claims and lawsuits were closed for anesthesia care. HOR 528 (56%) ASC 290 (30.7%) HOR setting, there were 299 closed claims made against anesthesiologists and 10 made against CRNAs. ASC setting, there were 259 closed claims made against anesthesiologists and 11 made against CRNAs. Mean closed claim value was significantly lower for ASC than HOR claims, averaging US $87,888 versus $107,325. Ranum D J Patient Saf MFMER slide-10

11 Analysis of ACS-NSQIP data for adult patients undergoing outpatient surgical procedures from ,600 total cases 232 cases experiencing an event: 21 mortalities 234 perioperative morbidities (multiple morbidities in some cases) within 72 h postoperatively. Incidence of 0.095%, or approximately 1 in 1,053 cases 1 death related to an intraoperative anesthetic complication (propofol, midazolam, and fentanyl sedation supervised by a surgeon without the assistance of an anesthesiologist or nurse anesthetist) Mathis MR Anesthesiology. 2013;119: MFMER slide-11

12 Case 1 The Importance of Proving Causation 2017 MFMER slide-12

13 The elements of negligence 1) Standard of care must be established 2) Standard of care was breached 3) Breach was a proximate cause of the injury 2017 MFMER slide-13

14 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) The patient arrived to the ambulatory surgery center for a scheduled outpatient surgical removal of a ganglion cyst from her left wrist. A Bier Block under sedation was planned. The tourniquet cuff was inflated to 250 mmhg at 11:31 a.m. Circulating nurse did not recall noticing anything wrong with the tourniquet cuff at the time it was placed on the patient's arm. The anesthesiologist administered 0.5% lidocaine for a Bier Block in the amount of 30 ml. The anesthesiologist provided propofol, fentanyl, and midazolam remained near the head of the patient throughout the case and had full view of the monitors MFMER slide-14

15 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) Circulating nurse was seated at a desk in the operating room, but in a position where she could observe the patient as she was working on charting the notes of the surgery. At the end of the 15 minute surgery, the circulating nurse noted the patient s face to be colored a dusky blue. She came around the patient to look at the patient, the monitor, and to speak to the anesthesiologist. She observed that the anesthesiologist was looking at an electronic device in his hand. She mentioned that the patient did not look good MFMER slide-15

16 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) At that point, the anesthesiologist looked up at the monitor and watched the patient's heart rate drop from the 50s to 18 to 20 and then to zero (occurred at approximately 11:45 a.m.) No alarms from the monitors sounded. When the event happened, the blood pressure cuff was inflated and the oxygen saturation monitor had gone down correspondingly because it was on the same arm. When the blood pressure cuff deflated, the oxygen saturation tone did not return back, alerting the anesthesiologist that the patient was in distress MFMER slide-16

17 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) At the time of the asystolic event, neither the anesthesiologist or circulating nurse observed the status of the tourniquet cuff to determine if it was inflated or deflated. After the asystolic event, the tourniquet cuff was observed to be deflated. The anesthesiologist had not deflated the tourniquet cuff or instructed the circulating nurse to deflate the tourniquet cuff. The anesthesiologist stated he believed it was inflated at the time of the asystolic event because the surgeon's field was bloodless throughout the procedure and the bandages were being placed on the patient when she became asystolic MFMER slide-17

18 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) The circulating nurse did not believe the cuff prematurely deflated because she did not recall hearing noises indicating that it prematurely deflated. After the asystolic event and before the patient was transferred the circulating nurse went to the tourniquet machine and noted the monitor reported the cuff was inflated for 15 minutes. The patient ultimately was diagnosed as suffering an anoxic brain injury with long term memory and speech deficits. A claim was filed a medical negligence claim against the surgery center, the circulating nurse and the anesthesiologist alleging that the defendants failed to meet the standard of care MFMER slide-18

19 Medical negligence The treatment provided did not meet the prevailing standard of care and the failure to meet the standard of care caused the patient's injury MFMER slide-19

20 Burk v. Fairfield Ambulatory Surgery Ctr., Ltd., 2014 Ohio 4062 (Ohio App. 2014) Plaintiff s expert testified it was his opinion the tourniquet cuff deflated prematurely and the lidocaine entered patient's system as a single bolus, yet could not identify which party committed the negligent act. He stated, "[s]o the first deviation from the standard of care, I cannot ascribe to an individual or an entity of any kind. I will let the jury decide that. But I believe beyond a reasonable degree of medical certainty that the tourniquet deflated prematurely in this case. Plaintiff's expert testimony gave only limited opinions on causation. The trial court found for the defendant anesthesiologist, circulating nurse, and outpatient surgical center 2017 MFMER slide-20

21 Case 2 Joint and Several Liability Laws 2017 MFMER slide-21

22 Kimble v. Laser Spine Institute, et al., No March 28, 2018 West Chester, PA The patient arrived to the Laser Spine Institute ambulatory surgery center for a scheduled outpatient minimally invasive spine surgery for chronic lumbar back pain. The patient had a history of chronic narcotic and other medication use (MS-Contin, Oxycodone, Baclofen, Xanax, Valium). Her maximum MS-Contin use was 200 mg morphine equivalents per day two years prior to her spine surgery and decreased to 60 mg morphine equivalents at the time of surgery MFMER slide-22

23 Kimble v. Laser Spine Institute, et al., No March 28, 2018 West Chester, PA A local under MAC was planned. Surgical case went as expected. However, postoperatively she was complaining of a lot of pain. A standard order for 0.5 mg of Dilaudid up to 2 mg was ordered by the anesthesiologist. Continuing to complain of pain, this was repeated until the patient received a total of 12 mg of Diluadid over a 90 minute PACU stay. At 4 hours after surgery the patient was complaining of 4-5/10 pain and discharged to a local hotel escorted with her husband after meeting formal discharge criteria MFMER slide-23

24 Kimble v. Laser Spine Institute, et al., No March 28, 2018 West Chester, PA Her husband had been instructed and signed a form describing instructions for post discharge care including ensuring his wife remained with ice packs to her back while resting in the supine position in bed. At one point, his wife took a 10 mg tablet of Oxycodone along with some pills from a bag she had that contained prescriptions for 12 different medications that she had been taking prior to surgery. According to court records, the patient s husband periodically left his wife unattended to gather ice from the machine in the hotel hallway. Approximately 5 hours following discharge, the husband found his wife lying prone and unresponsive and called MFMER slide-24

25 Kimble v. Laser Spine Institute, et al., No March 28, 2018 West Chester, PA Paramedics arrived and were unable to resuscitate the patient. According to autopsy reports, there were no medications on the toxicology report that exceeded either sub-therapeutic or therapeutic levels. A lawsuit was filed against the Laser Spine Institute and their employed anesthesiologist arguing that the 12 mg total dose of Diluadid provided the patient in the PACU was a violation of the medical standard of care. Jury found the Laser Spine Institute was 65% at fault and the anesthesiologist was 35% at fault for the death of the patient. $20 million damage award 2017 MFMER slide-25

26 Joint and Several Liability Laws (1) Pure Joint and Several Liability: Each defendant is responsible for the entire amount of damages regardless of the amount of responsibility. 8 states (Alabama, Delaware, Maryland, Massachusetts, North Carolina, Pennsylvania, Rhode Island, and Virginia). (2) Modified Joint and Several Liability: A defendant is responsible for the entire verdict only if they are found to be at or above a specified percentage of fault. 28 states (California, Colorado, Hawaii, Idaho, Illinois, Iowa, Louisiana, Maine, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Texas, Washington, West Virginia, and Wisconsin). (3) Pure Several Liability: Each Defendant is only liable for their assigned portion of damages based on their percentage of responsibility. 14 states (Alaska, Arizona, Arkansas, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Tennessee, Utah, Vermont, and Wyoming) MFMER slide-26

27 Case 3 Arbitration Agreements 2017 MFMER slide-27

28 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) A front desk employee at a surgical center provided the patient with several intake forms to complete and sign while he waited to meet a physician for an outpatient hernia repair The initial intake forms included questions about his medical history along with an arbitration agreement to sign. Patient denied having received the arbitration agreement on the day that it was signed and asserted that the contents of the agreement were not clear to him even after he had read it. He contended that, "[i]f the agreement had been brought to my attention and I had been told signing it was optional, I would not have signed it MFMER slide-28

29 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) In the course of the performance of the hernia repair procedure, the surgeon injured the patient s distal abdominal aorta, resulting in abdominal bleeding. Remedial procedures led to occlusion of an artery, a thromboembolism to the patient's right lower leg, and acute ischemia in his right foot. As a result of the injury that he sustained during the hernia repair procedure, the patient incurred unexpected medical expenses, abdominal scarring, lost wages, numbness, and a limited ability to use his right leg and foot MFMER slide-29

30 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) The plaintiffs filed a complaint against defendants in the Superior Court seeking damages for medical malpractice. The defendants filed a motion seeking to have further litigation in this action stayed and the arbitration agreement that had been entered into enforced MFMER slide-30

31 Arbitration Law The Federal Arbitration Act (FAA) provides that an agreement to settle a controversy by arbitration shall be valid, irrevocable, and enforceable, save upon such grounds as exist at law or in equity for the revocation of any contract. 9 U.S.C. 2. SCOTUS has held that arbitration agreements are enforced according to their terms, in the same manner as other contracts. SCOTUS decided the Kindred Nursing Centers v. Clark case in May 2017 confirming that state law on contract formation is also subject to preemption by the Federal Arbitration Act MFMER slide-31

32 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) The North Carolina trial court refused to compel arbitration based on its finding that the apparent agreement was only an agreement to agree and not an enforceable contract. The Court of Appeals reversed on that point and remanded, directing the trial court to consider the facts through the lens of the North Carolina law that fiduciary relationships create a rebuttable presumption that the plaintiff put his trust and confidence in the defendant as a matter of law MFMER slide-32

33 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) On remand, the trial court again declined to enforce the arbitration agreement, this time finding that the surgeon had breached his fiduciary duty to his patient by effectively hiding the arbitration agreement among routine paperwork the patient had signed on his first visit to the surgeon s office. The Court of Appeals affirmed, noting that while the FAA applied, the arbitration agreement was procedurally and substantively unconscionable under state contract law, and thus void, given defendants failure to take any active steps, in accordance with their fiduciary duty, to make a full, open disclosure of material facts to [the patient] before he signed the arbitration agreement MFMER slide-33

34 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) On further appeal, the North Carolina Supreme Court ultimately affirmed the decision of the Court of Appeals, holding (i) that the physician owed a fiduciary duty to the patient under state law; and (ii) that he breached this duty by failing to make full disclosure of the nature and import of the arbitration agreement to [the patient] at or before the time that it was presented for [the patient s] signature MFMER slide-34

35 King v. Bryant, 795 S.E.2d 340 (N.C. 2017) Apparently anticipating an argument that its holding was discriminatory toward arbitration agreements, the court noted: [S]ince the breach of fiduciary duty defense to enforcement of the agreement that we uphold in this case does not apply only to arbitration,., a refusal to enforce an arbitration agreement on that basis does not stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress MFMER slide-35

36 Case 4 Agency Liability 2017 MFMER slide-36

37 Kristensen-Kepler v. Cooney, 39 So. 3d 518 (Fla. App 2010) Patient alleged that an anesthesiologist negligently caused an infection to the patient's spine while treating him at an ambulatory surgical center for chronic back pain. Patient also asserted that surgical center was liable for the anesthesiologist s negligence because it had a statutorilycreated, non-delegable duty to provide the patient with nonnegligent anesthesiology services under Wax v. Tenet Health System Hospitals, Inc., 955 So.2d 1, 11 (Fla. 4th DCA 2007) MFMER slide-37

38 Wax theory If a treating physician directs a patient to a hospital for a particular procedure, that patient has little, if any, control over who administers the anesthesia. Therefore the hospital has a statutory duty to provide that service and therefore bears a non-delegable duty to provide the service in a non-negligent manner. However, in this case the court did not hold that a hospital likewise has a non-delegable duty to supervise the physician a patient has chosen to perform an elective procedure. It is this latter circumstance the facts of this case that make it distinguishable from Wax MFMER slide-38

39 Agency theory Apparent agency liability: Where it can be shown that a hospital, by its actions, has held out a particular physician as its agent and/or employee and that a patient has accepted treatment from that physician in the reasonable belief that it is being rendered in behalf of the hospital, then the hospital will be liable for the physician's negligence. To establish apparent authority, the plaintiff would have to show that: (1) Surgical center made a representation to the patient; (2) The patient relied on the representation; and (3) The patient changed his position as a result of that reliance MFMER slide-39

40 Kristensen-Kepler v. Cooney, 39 So. 3d 518 (Fla. App 2010) The patient did not come to surgical center seeking pain treatment; he went to see the pain medicine anesthesiologist. Surgical center did not pay salaries to the doctors. The doctors did not have offices at the surgical center. There were no signs posted stating that the doctors were agents, employees, or servants of the surgical center. Surgical center made no representation to the patient that the doctors were its agents. The patient did not rely on the surgical center's reputation for the treatment of pain in choosing the pain medicine anesthesiologist. Court affirmed the final summary judgment and remand to the circuit court for further proceedings MFMER slide-40

41 Thank you!!!! 2017 MFMER slide-41

TABLE 3c: Congressional Districts with Number and Percent of Hispanics* Living in Hard-to-Count (HTC) Census Tracts**

TABLE 3c: Congressional Districts with Number and Percent of Hispanics* Living in Hard-to-Count (HTC) Census Tracts** living Alaska 00 47,808 21,213 44.4 Alabama 01 20,661 3,288 15.9 Alabama 02 23,949 6,614 27.6 Alabama 03 20,225 3,247 16.1 Alabama 04 41,412 7,933 19.2 Alabama 05 34,388 11,863 34.5 Alabama 06 34,849 4,074