Medical Legal Aspects of Hospital Medicine: A Systematic and Case- Based Approach

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1 Medical Legal Aspects of Hospital Medicine: A Systematic and Case- Based Approach Shahed Brown, MD Atlanta VA Medical Center Emory University School of Medicine 1

2 Review medical malpractice concepts and legal aspects of inpatient care Using a case-based approach, identify high risk situations in hospital medicine Discuss strategies to reduce risk in hospital medicine 2

3 Tried in civil court (*not criminal court) Penalty for losing is financial Rather than prove something beyond a reasonable doubt, the plaintiff has to show that it is more likely than not to have occurred Decided by a jury of your peers The plaintiff has to prove 4 things: Duty *Patient- Physician Relationship Breach of Duty *Physician did not provide standard of care Harm *Physical or emotional Causation *Harm or damage was a result of the physician s breach of duty 3

4 What is Standard of Care? Clinical Guidelines Consensus Statements UpToDate What we usually do?!? Many variables: State laws Regional practices Care setting Specialty Level of training Scope of practice How you represent yourself 4

5 Most courts consider the standard of care to be what a minimally competent physician in the same field would do in the same situation, with the same resources West J Emerg Med. 2011;12(1): ] 1985: Hall vs Hillburn A post-operative patient did not have appropriate monitoring and died from respiratory failure The Chief Justice in that trial stated When a physician undertakes to treat a patient, he takes on an obligation enforceable at law to use minimally sound medical judgment and render minimally competent care A physician does not guarantee recovery A competent physician is not liable per se for a mere error of judgment, mistaken diagnosis or the occurrence of an undesirable result. Hall v. Hilburn, 466 So. 2d 856 (Miss. 1985). 5

6 Expert witness testimony 97% of cases Average of 5 witnesses/trial Clinical Guidelines May still require an expert to testify that the guidelines apply I typed Clinical Practice Guidelines in PubMed on 3/1/ ,186 results 6

7 Mr. W is admitted for respiratory distress; he was intubated in the ER and admitted to MICU ICU nurse places an NG tube for medications and you order a portable CXR to confirm placement Quickly look at the X-ray on your smartphone and you think the tube is in proper position but don t have the official read You write the order that the NG tube can be used for medications Hours later, the radiologist tells you the tube in in the lung. The patient develops pneumonitis and has a subsequent prolonged ICU stay. Did malpractice occur? Duty? Breach of duty? Did harm occur? Did the harm occur because of the breach of duty? 7

8 radiopaedia.org Breach of duty? Is it standard of care for a hospitalist to interpret an X-ray? Theoretically, any physician that interprets a radiographs may be held to the same standard of care To provide care as would a reasonable physician under the same or. similar circumstances X-ray is still the gold standard to confirm NG tube placement - Physical exam for confirmation of placement: 20% false positive - ph meter, capnography American Journal of Roentgenology. 2012;199: W523-W523 Harm occurred Was it inevitable? Prospective study: 740 NG tube insertions in ICU patients, there was a 2% incidence of tracheopulmonary complications with a mortality of 0.3%, with pneumothoraces being the most frequent complication. Other thoracic complications include erroneous bronchial placement, leading to atelectasis, pneumonia, and lung abscess. Rassias et al. Crit Care (1):

9 Why do you think that patient brought a lawsuit? When things go wrong in healthcare, do they always lead to lawsuits? 30,195 discharges from 51 hospitals in New York in ,133 adverse events 280 adverse events due to negligence Chart Review for adverse events and evidence of negligent care; malpractice claims data for same time period Linked the charts with adverse events to malpractice claims Ratio of negligence to malpractice claims of 7.6:1 98% percent of all adverse events due to negligence did not result in malpractice claim 8 filed malpractice claims Localio AR et al. N Engl J Med 1991; 325:

10 Claims with Error involved: 29% were missed or delayed diagnosis, 18% were related to medications Error in 889 (63%) 1406 (97%) involved injury 1452 claim files reviewed No error in 515 (37%) No payment in 31 (84%) 37 (3%) did not involve injury Payment in 6 (16%) No payment in 236 (27%) Payment in 653 (73%) No payment in 370 (72%) Payment in 145 (28%) Top 3 specialties involved: 1. Obstetrics 2. Surgery 3. Primary Care 57% were inpatient Studdert DM, NEJM, 2006;354: major themes: 1. Concerns with standards of care, desire to prevent similar incidents from occurring to others in the future 2. Need for an explanation 3. Compensation for actual losses, pain, suffering; to provide care in the future for an injured person 4. Accountability: belief that the staff/organization should have to account for their actions Vincent C. Lancet Jun 25;343(8913):

11 Other factors that led to the decision to take legal action: Original injury Insensitive handling and poor communication after the incident Unsatisfactory explanations by physicians Patients who took legal action wanted: Honesty Appreciation for the severity of the trauma they experienced Assurance that lessons were learned Vincent C. Lancet Jun 25;343(8913): So it wouldn t happen to anyone else Vincent C. Lancet Jun 25;343(8913):

12 Cause Suing Patients Sued Physicians Physician Error 96 % 20 % 66 % Physician Negligence 97 % 10 % 51 % Non-Sued Physicians Unavoidable consequence of medical treatment 34 % 39 % 66 % Physician s directions were not followed 0 23 % 44 % Patient s desire for financial compensation 22 % 83 % 85 % Need to place responsibility for injury 41 % 66 % 85 % P< Arch Intern Med. 1989; 149: The risk of facing medical malpractice is not predicted by the patient, the complexity of the illness, or the skills of the physician But by the patients dissatisfaction with their physician, the inability of the doctor to establish rapport and to communicate effectively especially in the face of an adverse event. Sage WM. JAMA. 2002;287(22):

13 Specialty Previous malpractice claims, patient complaints, investigations (risk management) Behaviors/Bedside Manner Gender N Engl J Med 2011; 365:

14 Analysis of over 66,000 malpractice claims from % of all physicians accounted for 32% of paid claims Risk of recurrence increased with the number of previous paid claims Specialty dependent: risk among neurosurgeons was 4x the risk among psychiatrists 87% were male, most were US trained, most practiced in a metropolitan area Studdert DM et al. N Engl J Med 2016;374: Retrospective longitudinal cohort study of 645 general practice and specialty physicians (surgeons and non-surgeons) between Examined the association between physicians patient complaint records and their risk management experiences Risk management activity and lawsuits were significantly related to total number of patient complaints Hickson GB, JAMA.2002;287(22):

15 Physicians who never faced a malpractice claim Used more statements of orientation, what to expect Laughed and used humor Used facilitation (soliciting patient s preferences, checking understanding, and encouraging patients to talk) Asked patients their opinions about their medical problems or treatment Spent longer in routine visits *length of the visit had an independent effect in predicting claims status Levinson et al. JAMA 1997; 277: Doug Bell 15

16 Dr. A is on the Swing Shift admitting and crosscovering Mrs. Z is a patient who is supposed to be discharged Mrs. Z s son is a radiologist and is concerned about her being discharged and wants to speak with the doctor Dr. A speaks with the son, who voices his concerns about his mother s condition and asks Dr. A s opinion on whether or not she should spend another night in the hospital Dr. A replies that he doesn t know anything about the patient and it was his understanding that the patient was ready for discharge. He stated that he trusts his colleagues judgments and if they felt she was ready for discharge, he would concur The patient s son felt that his mother did not sound very good and he spoke with a nurse earlier who said that his mother looked uncomfortable. The son asked if Dr. A would take a look at his mother and assess if there has been a change in her condition Dr. A again responded that he was the doctor on call and did not want to make alterations in established discharge plans for patients he was unfamiliar with The son again voiced his concerns about his mother going home alone and asked Dr. A if he thought it was a good idea to keep her another night. Dr. A responded, I m sorry. There is nothing I can do. Your mother is being discharged and I trust my colleague s medical judgment. 16

17 The patient was discharged that evening around 8pm to the care of a close friend and a different family member. Sadly, the patient had an episode of massive emesis at home that evening and subsequently had respiratory distress and died later that day The patient s family alleged Dr. A breached the standard of care when he did not re-evaluate the patient based on her son s request and that the patient died of a condition that should have been detected before she was discharged Duty?????????? Breach of duty? Did harm occur? Did the harm occur because of the breach of duty? 17

18 (Dis)continuous Care No longitudinal relationship with patients Sick patients Co-management Consultations Supervision of trainees, other providers Coordination of care Retrospective observational analysis using claims data from a liability insurer of over 52,000 malpractice claims No. of claims Physician coverage years Claims per 100 physician coverage years Hospitalists (Internal Medicine only) All Other Internal Medicine Physicians Emergency Room Physicians General Surgeons Obstetricians- Gynecologists ,060 20,787 2,571 4,062 4, (95% CI) ( ) ( ) ( ) ( ) ( ) P<0.001 compared to hospitalists for these specialties Journal of Hospital Medicine. 2014; 9:

19 Contributing Factor No. of Cases % of Cases (95% CI) Clinical Judgment % ( %) - Failure or delay in ordering a diagnostic test % (9.4%-17.8%) - Failure or delay in obtaining a consult or referral % (9.1%-17.4%) - Having too narrow a diagnostic focus % (8.8%-17.0%) Communication % (30.7%-42.4%) -Inadequate communication among providers regarding the patient s condition -Poor rapport with/lack of sympathy toward patient and/or family -Insufficient education of the patient and/or family regarding the risks of medications % (17.6%-27.9%) % (3.1%-8.9%) 9 3.3% (1.5%-6.2%) Documentation % (14.9%-24.7%) Journal of Hospital Medicine. 2014; 9: There was no significant difference by speciality in the percentage of cases that resulted in payments In cases against hospitalist physicians, 1/3 resulted in payment to plaintiffs Median payment: $240,000 Journal of Hospital Medicine. 2014; 9:

20 Mrs. K is a 80 y/o female admitted for a femur fracture after a slip and fall. She did well periand postoperatively with the hospitalist service as the primary and ortho consultation On hospital day #7 she was transferred to subacute rehab (SAR), attached to the main hospital 10 days later, she developed respiratory distress and came back to acute care hospital She had a cardiac arrest on hospital day #2 and was resuscitated She was initiated on amiodarone drip and she was stabilized and transferred back to telemetry floor and transitioned to all po meds 20

21 Cardiology was consulted after her cardiac arrest and followed her daily The hospitalist deferred the dosing regimen of amiodarone to cardiology Cardiology saw the patient for the first 3 days after her transfer to the telemetry floor and then signed off in the chart. In the last progress note, they recommended a tapering schedule of amiodarone She was discharged to home with home health a few days later The hospitalist wrote a discharge order for Amiodarone 400 mg TID Approximately 29 days after discharge, Mrs. K became ill, had a fall at home and returned to the hospital. She died 19 days later. The family filed suit against the hospitalist and the hospital. They alleged that the hospitalist breached the standard of care by overdosing Mrs. K with amiodarone which caused pulmonary toxicity and death. 21

22 Provider-Provider 57% communication cases Provider-Patient 55% communication cases Overlap (12% of cases) Copyrighted by and used with permission of The Risk Management Foundation of the Harvard Medical Institutions, Inc., all rights reserved. Provider-Patient Communication Breakdown Inadequate informed consent (13%) Unsympathetic response to patient complaint (11%) Inadequate education about medications (5%) Incomplete follow-up instructions (4%) No/wrong results given to patient (4%) Miscommunication due to language barrier (4%) Provider-Provider Communication Breakdown Miscommunication about the patient s condition (26%) Poor documentation (12%) Failure to read the medical record (7%) 22

23 Health-IT related problems CRICO claims database, , 285 cases involved health IT Errors involving medications, diagnosis, or complications of treatment User-related issues (156 cases): incorrect information (pre-population by templates, copy/paste), training and education, overriding or ignoring alerts Graber, M. J Patient Saf Volume 00, Number 00,

24 Show genuine concern Active listening Allow patients to vent their complaints, fears, and frustrations Sit down! Perception that you spent more time at bedside Provide explanations Keep your promises Phone calls, family updates, stopping by again Process of managing expectations and involving the patient in shared decision making Providing information about risks, benefits, expected outcomes and alternatives for a given treatment so the patient can make a decision and give permission Assigning responsibility to patient Replacing anxiety and uncertainty with information and a sense of control 24

25 Help patients understand what to expect and keep their expectations realistic Be reassuring, but avoid making promises Discussion of daily care plan Frequent updates, discussion of results Patient education tools: brochures, videos Patients can refuse treatment Refusal of medications leaving the hospital Discuss consequences of not receiving treatment (risks, benefits, outcomes, alternatives) Must be documented in the medical record Critically important that you make a note of the patient s capacity to make an informed refusal 25

26 Adverse events and errors are not always negligence Several organizations advocate disclosure of errors, considering it to be an ethical requirement (SHM, AMA, ACP) Joint Commission on the Accreditation of Healthcare Organizations: Requires institutions to have a process to inform patients and their families of unanticipated outcomes Patients want an explanation No information assumption that there is a cover-up Disclosure should occur as soon as possible following the event Requires open, honest discussion of all of the details that resulted in the unanticipated event along with genuine concern and even an apology 26

27 Inform Risk Manager Provide facts: what occurred and why Avoid assigning blame Express empathy, concern, regret I m sorry that this happened Discuss next steps, implications (longer hospital stay? More tests or new medications?) Explain what will be done to prevent this from happening again From What You May Not Have Learned in Your Internal Medicine Residency A guide to malpractice liability, risk management, and patient safety. From ACP and the Doctors Company Guidelines have legal relevance Can be used to allege negligence when physicians deviate from them Can be used as a defense to show that standard of care was delivered Lawsuits occur more frequently when physicians deviate from clinical guidelines Plaintiffs attorneys rely heavily on guidelines to determine whether to file suit or settle J Health Polit Policy Law. 1996;21:

28 Defensive medicine is care provided to patients only to reduce the risk of being sued rather than add to diagnostic capability or treatment Study from BMJ in 2015 reviewed admissions to acute care hospitals in Florida from and malpractice history Greater average spending by physicians was associated with reduced risk of facing a malpractice claim Jena A, BMJ 2015;351:h5516 Write your notes as if the patient will read it If you didn t document it, it did not happen What you write is memorialized permanently What you don t write is questioned forever Document significant events immediately Document discussions with family, consultants, telephone encounters 28

29 Avoid chart wars - makes you look unprofessional Be mindful of copying/pasting inaccurate, outdated data Be careful with templates Read the nurses notes DO NOT IGNORE A SUBPOENA OR SUMMONS Before responding or talking to any attorney: Inform the Risk Manager/Legal Department at your facility supervisor 29

30 KINDNESS & ERROR DISCLOSURE WON T PREVENT EVERY MALPRACTICE SUIT Act Compassionately Be Competent Communicate Documentation in the chart 30

31 Thank you! Questions? 1. Al Saif N, Hammodi A, Al-Azem MA, Al-Hubail R. Case Rep Crit Care. 2015;2015: Berlin L, When Interpreting Radiologic Studies, Is the Standard of Care the Same for Board-Certified Radiologists, Radiology Residents, and Nonradiology Physicians? Amer J of Roent. 2012;199: W523- W /AJR Berlin L, Standard of Care for Non-Radiologic Interpretations. American Journal of Roentgenology. 2011;197: W358-W /AJR Boothman R, Blackwell A. A Better Approach to Malpractice Claims? The University of Michigan Experience. Journal of Health & Life Sciences Law. Vol 2, No. 1, January Brennan T. Incidence of Adverse Events and Negligence in Hospitalized Patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: Brennan T. Hospital Peer Review and Clinical Privileges Action. JAMA. July 28, Vol. 281, No Carter L, Williams, Evidence-Based Medicine in the Law Beyond Clinical Practice Guidelines: What Effect Will EBM Have on Standard of Care?, 61 WASH & LEE L. REV. 479, 488 (2004). 8. Confirming Feeding Tube Placement: Old Habits Die Hard. PA PSRS Patient Saf Advis 2006 Dec;3(4): Correia N. Adverse Events: Reducing the Risk of Litigation. Cleveland Clinic Journal of Medicine. Vol 69. No. 1. January Graber M, Electronic Health Record Related Events in Medical Malpractice Claims. J Patient Saf 2015: Hall v. Hilburn, 466 So. 2d 856 (Miss. 1985). 12. Hickson et al. Patient Complaints and Malpractice Risk. JAMA. 2002; 287(22): Jena A. et al. Physician Spending and Subsequent Risk of Malpractice Claims. BMJ 2015;351:h Jena A, Outcomes of Medical Malpractice Litigation Against US Physicians. Arch Intern Med/Vol. 172 (No.11). June 11, Jena A, Malpractice Risk According to Specialty. N Engl J Med 2011; 365: Leape L. The Nature of Adverse Events in Hospitalized Patients. Result of the Harvard Medical Practice Study II. N Engl J Med 1991; 324:

32 17. Levinson W. The Relationship With Malpractice Claims Among Primary Care Physicians and Surgeons. JAMA. Feb Vol 277, No Localio A. Relation Between Malpractice Claims and Adverse Events due to Negligence. Results of the Harvard Medical Practice Study III. N Engl J Med 1991; 325: Moffett et al. Standard of Care Legal History. West J Emerg Med. 2011;12(1): Rassias et al. A Prospective Study of Tracheopulmonary Complications Associated with the Placement of Narrow-Bore Enteral Feeding Tubes. Crit Care. 1998; 2(1) Rindsberg v. Neacsu, 730 S.E.2d 525 (Ga. Ct. App. 2012) 22. Sage WM. Putting the Patient in Patient Safety: Linking Patient Complaints and Malpractice Risk. JAMA. 2002;287(22): doi: /jama Schaffer A. Liability Impact of the Hospitalist Model of Care. Journal of Hospital Medicine. 2014; 9: Seabury et al. On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim. Health Affairs, 32, no.1 (2013): Shapiro R, eta al. A Survey of Sued and Nonsued Physicians and Suing Patients. Arch Intern Med Vol 149, October Studdert D, et al. Claims, Errors and Compensation Payments in Medical Malpractice Litigation. N Engl J Med 2006;354: Studdert D, et al. Prevalence and Characteristics of Physicians Prone to Malpractice Claims. N Engl J Med Jan 28; 374(4): Swidler R, et al. Difficult Hospital Inpatient Discharge Decisions: Ethical, Legal and Clinical Practice Issues, The American Journal of Bioethics, 7:3, Taylor C. The Use of Clinical Practice Guidelines in Determining Standard of Care. Journal of Legal Medicine, 35: Vincent C. Lancet Jun 25;343(8913): Casetext.com/case/roth-v-mercy-health-center-inc 32. Malpractice Risks in Communication Failures.2015 Annual Benchmark Report. Crico Strategies. Accessed 2/19/ Accessed 2/28/

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