Professional Liability Today: Understanding Medical Malpractice, Standards of Care and Physicians’ Rights and Responsib

1. Professional Liability Today: Understanding Medical Malpractice, Standards of Care and Physicians’ Rights and Responsibilities GME Grand Rounds April 15, 2008 Susan L. Penney, JD, UCSF Director of Risk Management

2. Course Objectives • Understand functions of Risk Management • Learn the law related to commonly presented medical legal issues • Learn the elements of a professional liability action & how liability is determined • Understand adverse event disclosure obligation • Be familiar with reporting mandates to the California Medical Board relative to settlements and adverse trial verdicts • Review informed consent processes • Discuss documentation issues

3. Risk Management Functions • Enhance patient safety and the quality of patient care we provide by review of adverse clinical outcomes • Reduce the University’s financial exposure arising from the provision of medical care • Oversee the professional liability program for faculty and staff—work with Third Party Administrator: Sedgwick • Ensure compliance w/ Medical Center policies, bylaws, rules & regulations • Respond to concerns regarding management of clinical care

4. Risk Management Consultation • In connection with any concerning clinical situation or adverse event • Receipt of any legal notice, such as a claim, complaint or subpoena • California Medical Board inquiry • Policy & procedure clarification/assistance • Request for information by legal counsel (verbal or written) • Patient’s written request for compensation • Receipt of notice of taking deposition

5. UCSF Structure for Management of Adverse Event/Litigation

6. UCSF Structure for Management of Litigation • Administrative Committee • Allocation Committee: Recommends allocation as between care providers for reporting/credentialing purposes; Ultimate decision lies with UC Office of the President; No appeal available • Medical Staff Committees: • The Clinical Event Oversight Committee: Meets once per week to review adverse events, conduct root cause analysis and monitor the effectiveness of risk reduction strategies—deals with systems issues • Risk Management Committee: Meets once per month to review cases in litigation, settlements and new complaints; conducts internal reviews of cases in litigation re standard of care • Credentials Committee: Receives medical malpractice and other performance information for re-credentialing

7. UCSF Structure for Management of Adverse Event/Litigation • Litigation Process • Patient Complaint/service of lawsuit • Factual investigation • Determination of course and scope • Transfer of claim to Sedgwick (third party administer) • Assignment of attorney • Coordination Meeting with involved parties, Risk Management, Third Party Administrator • Discovery—litigation • Consideration of settlement/Defense • Risk Management Committee Review • Review by UCOP, Risk Management & Sedgwick • Settlement or trial.

8. UCSF Structure for Management of Adverse Event/Litigation • Litigation Process-Case Resolution • Review of Case with involved health care practitioners • Technically, consent of health care provider not required for settlement of case • Duty to cooperate with litigation process

9. Professional Liability Coverage • Coverage extended for approved activities within the course and scope of training program • Excludes “moonlighting” • Excludes intentional acts, such as assault, battery or other criminal behavior

10. ANATOMY OF A LAWSUIT

11. Elements of Malpractice Claim • Health care providers owe fiduciary and ethical duties to their patients to provide appropriate levels of care • Breach of duty by failing to comply with applicable standards of care • Act or omission to act fell below applicable standard of care as established by expert testimony • Causation (act/omission to act resulted in injury) • Injuries & damages according to proof

12. Determining Standard of Care • Established by expert testimony • State and federal laws and regulations • Accreditation standards • Professional journals, association standards & guidelines • Facility bylaws, policies and procedures • “Reasonably prudent practitioner under same or similar circumstances”

13. Common Reasons for Suits • Poor communication between patients & health care providers • Care inconsistent with expectations-failure to manage patient expectations • Failure to obtain full informed consent • Perception of “cover up” of adverse clinical outcomes—no communication with patient after adverse event

14. Common Reasons for Suits • Poor communication among healthcare team • Failure to follow-up on abnormal findings • Lack of understanding of clinical plan • Not knowing who is doing what • Not treating patient as a whole • Not considering patients wishes/advance health care directive • Oral designation and documenting on admission • Effort to locate surrogate

15. Common Reasons for Suits • Pain Management--Inadequate • Medication errors • Delay in diagnosis & treatment • Surgical issues • Intraoperative injury • Postoperative infection • Retained foreign body • Postoperative monitoring

16. Case Examples • Pediatric Cardiology-Post Operate communication between ICU attending and residents • “Curbside” vs Real Cardiac Consulation • Attending supervision of Resident in VBAC delivery • Recognizing Compartment Syndrome • Failure to diagnose Colon Cancer

17. Case Examples • Informed Consent for Research • Approval for New Procedures/approaches • Monitoring of Gestational Diabetes • Monitoring potential complications/side effects from treatment and medication

18. ELDER ABUSE LITIGATION “In this day and age, almost all pain can be treated. Physicians must be responsible for learning about modern pain care practices and must be attentive to their patients’ pain, especially in the context of terminal illness.” Kathryn Tucker, Director of Legal Affairs Compassion in Dying

19. ELDER ABUSE LITIGATION • Pain management theories will be included in claims brought under Elder and Dependent Adult Abuse Act • Who can bring Elder and Dependent Adult Abuse actions? - Patients over 65 - Dependent Adults—very broadly defined, e.g., women in labor. 44-year old liver biopsy patient Marron v. Superior Court - Family of above • Physicians can be liable

20. ELDER ABUSE LITIGATION • Available Remedies: - If negligence claimed—MICRA cap - If plaintiff shows by “clear and convincing evidence” that defendant was “reckless” plaintiff may recover: * Attorney's fees and costs * Post-mortem pain and suffering - If plaintiff shows by “clear and convincing evidence” “oppression, fraud or malice,” plaintiff may recover: * Punitive damages

21. PAIN MANAGEMENT TEST CASE—FACTS Factual Background • 4.5 day hospitalization of 85-year old man • Medical history: 1-year history of pain, compression fractures, chronic obstructive pulmonary disease • 40-60 year smoking history • Unclear / disputed as to Dx of lung cancer; patient declined diagnostic tests • On admission, patient received morphine, valium and phenergan followed by 15-second period of apnea 42

22. PAIN MANAGEMENT TEST CASE—FACTS (cont.) Factual Background (cont.) • Physician testified morphine not used due to “allergic reaction”—issue as to documentation • Thereafter: Demerol, 25-50 milligrams “q” 3 hours, PRN, for pain • Intermittent physician chart entries as to pain level or pain free • Some nursing notes as to pain level; some inconsistent with physician note / charting by exception • No bowel movement for entire hospitalization—patient c/o severe abdominal pain on day 3 43

23. PAIN MANAGEMENT TEST CASE—FACTS (cont.) Factual Background (cont.) • On date of discharge: - 8:00am pain 10/10 – 25 mg shot of Demerol - 11:00am pain10/10 – 25 mg Demerol - 2:00pm (discharge) pain 10/10 – 25 mg Demerol • Discharge Medication: original order—Vicadin; after objection by family physician ordered—75 microgram Durgasic (Fentanyl) patch • Patient Died 2-3 days later at home—primary care physician wrote death certificate—no autopsy or coroner's report 44

24. Pain Management: Risk Reduction Strategies: Discharge Planning • Work as an interdisciplinary team • Decide who is going to manage medications after discharge—communicate with the patient and family • Comply with law on written discharge instructions • Follow UCSF policy (newly updated Discharge Planning policy)-Adult Patient Discharge Plan and Discharge Prescription Form • Patient/family Education 4

25. Why Is Allegation Of Inadequate Pain Management Hard to Manage From A Legal Perspective? • Pain: • Is an untestable hypothesis • Has many meanings • - No two patients are the same • - It’s all in your head • Definition: “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage” 49

26. Risk Management GuidelinesFor Pain Management • Know when to obtain a consultation • Communicate with nursing staff and other disciplines: Ensure everyone (nurses and physicians) are using the same pain management assessment tool, the same way • Ensure everyone is using the same terminology for pain management orders, to mean the same thing • Communicate with the patient and those closest to the patient 63

27. RISK MANAGEMENT GUIDELINES (cont.) • Ensure physicians are reviewing the pain assessments and taking appropriate steps to control pain • Know your institution’s policies and procedures • Chart appropriately: Ensure pain is charted every time vital signs are charted—no charting “by exception” • Maintain continuity of pain management 64

28. Professional Liability Damages .

29. Professional Liability Damages • General Damages • Non-Economic Damages-- MICRA law in California limits maximum recovery to $250,000 • Pain, suffering, loss of consortium (loss of spouse), grief, fear, etc. • Intangible value

30. Professional Liability Damages • Special or Economic Damages • Loss of past, present, future wages • Past, present, future medical expenses • Burial/Funeral expenses • Tangible, objective monetary value • Unlimited recovery based upon proof

31. “Medical Injury Compensation Reform Act of 1975” MICRA PROVISIONS • $250,000 CAP ON NON-ECONOMIC DAMAGES • LIMIT ON PLAINTIFFS’ ATTORNEY’S FEES • PERIODIC PAYMENTS FOR FUTURE DAMAGES • COLLATERAL SOURCE DISCLOSURE • STATUTE OF LIMITATIONS • ARBITRATION (by prior legal agreement)

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33. UCSF’s Allocation Committee and Reporting Process

34. Business & Professions Code • Section 801 (b): “Every insurer providing professional liability insurance to a physician and surgeon . . . shall report to the MBC as to any settlement over $30,000 . . . of a claim for damages for death or personal injury caused by that person’s negligence, error, or omission in practice or his or her rendering of unauthorized professional services . . . .”

35. Business & Professions Code • Section 800: “Every insurer providing professional liability insurance to a person who holds a license . . . shall report to the Board of Registered Nursing as to any judgment or settlement over $3,000 . . . of a claim for damages for death or personal injury caused by that person’s negligence, error, or omission in practice or his or her rendering of unauthorized professional services . . . .”

36. National Practitioner Data Bank Reporting • Mandates reporting of all settlements and judgments –there is no dollar minimum • Report must be made within 30 days of payment • www.npdb.org

37. California Board Reporting • Mandates reporting of settlements in excess of $30,000 arising from physician liability; $3,000 arising from nursing liability • Allocation of settlement required among responsible providers and/or systems issues • Allocation is NOT dependent on being named as a defendant • Patients may file their own complaints with the CMB or Nursing Board in addition or as an alternative to filing a civil suit

38. UCSF Allocation Process • Initiated following settlement or adverse trial verdict exceeding $30,000 for physicians or $3,000 for nurses • Case Referred to “Allocation Committee” • All providers notified in writing of Allocation Committee deliberations • Invitation to attend and/or provide written statement • If trainee, may request attendance by Program Director or other faculty • No legal representation permitted • Allocation is not for disciplinary purposes

39. UCSF Allocation Process • Committee reviews all relevant information • Medical record • Case summary, including allegations, expert reviews obtain on behalf of all parties, defense counsel evaluations • Oral and/or written statements from providers

40. UCSF Allocation Process • Committee Allocates Responsibility • Degree of responsibility of each provider • Financial apportionment of responsibility • Allocation may include systems issues (i.e., equipment malfunctions, lack of institutional protocols/processes to effectively respond to or handle clinical issue) • Exception to Allocation • Circumstances where there is a settlement for reasons other than standard of care

41. Special Considerations re: Allocation • Allocation to residents is rare • Allocation to residents only under following circumstances: • Actions inconsistent with what one would reasonably expect of a comparable trainee with similar education and experience • Inappropriate care provided without the knowledge of the attending physician • Actions in direct opposition to instructions from an attending physician

42. CMB – Public Disclosure (website) Medical specialties deemed “high risk” or “low risk” • “Low risk” – 3 settlements reported w/in 10 years • “High risk” – 4 settlements reported w/in 10 years • Disclaimers on information posted on website regarding settlements

43. What Do I Do When Things Go Wrong? Adverse Event Reporting to DHS

44. Risk Management ConsultationAdverse Event Reporting to DHS • Effective July 1: Notice of unexpected or adverse clinical outcomes—SB 1301 Reporting to DHS • Medical Center must report to DHS no later than 5 days after detection of event • Report should be made to Risk Management and Incident report completed • Patient or surrogate must be notified of the nature of adverse event no later than time reported to DHS—attending physician and patient care manager decide timing and manner

45. Disclosure of Unanticipated Outcomes • Why Disclose? • It’s the Law • It’s the right thing to do • It can help maintain the physician-patient relationship* • (source: “Why Do Patients Sue Doctors? A Study of Patients and Relatives Taking Action” Lancet 1994: 343: 1609-13)

46. Disclosure of Unanticipated Outcomes • How to Disclose • Talk about how the patient’s care will be managed • Arrange for appropriate consultants • Advise family of identity of contact person • Inform Risk Management and preserve equipment/relevant information • Ensure following—disclosure may be an ongoing process

47. Disclosure of Unanticipated Outcomes • How to Disclose • Decide time and place to disclose • Decide who should disclose (attending physician or designee) • Obtain permission from patient to speak to the family as needed • Consider patient/family’s emotional state/need for privacy

48. Disclosure of Unanticipated Outcomes • How to Disclose—The meeting • Empathize • Verify patient’s/family’s understanding of the outcome and prognosis • Discuss objective information contained in medical record • Do not discuss confidential protected discussions with Risk Management

49. Disclosure of Unanticipated Outcomes • How to Disclose—Do Not Communicate the following: • Subjective information • Conjecture or beliefs • Confidential information (peer review, Incident reports, risk management) • Speculation or blame

50. INFORMED CONSENT