1. 1 Todd R. Bartos, Esquire Healthcare Litigation Group Rewarding excellence and protecting your Bariatric Surgery Practice New Informed Consent for Bariatric Surgeons and a Fresh Look at Post-Adverse Event Communication STEVENS & LEE Health Care Litigation and Risk Management Group

2. 2 Agenda  The Liability Landscape…  Impacting Risk in Bariatrics  Five Star Components  Second Generation Informed Consent  Post-Adverse Event Communication  A Case Study…NOVUS STEVENS & LEE Health Care Litigation and Risk Management Group

3. 3 The Liability Landscape in 2010-2011 What you know you can better control... STEVENS & LEE Health Care Litigation and Risk Management Group

4. 4 New Data – Frequency Increasing From the Press Release... STEVENS & LEE Health Care Litigation and Risk Management Group Personal and Confidential

5. 5 Severity  Severity continues to be on the rise!  Why isn’t it going down?  Psychologists/ Jury consultants help us understand How it is… How it should be… And for some...how it is! STEVENS & LEE Health Care Litigation and Risk Management Group National Median Medical Malpractice Verdict Trends Source - Jury Verdict Research $0 $200,000 $400,000 $600,000 $800,000 $1,000,000 $1,200,000 $1,400,000 $1,600,000 2001200220032004 Year Verdict Amount

6. 6  Selective cases being pursued  Consolidation of counsel  Psychodrama  Still in 2010... Complications coupled with a “plus” STEVENS & LEE Health Care Litigation and Risk Management Group Severity Drivers

7. 7 STEVENS & LEE Health Care Litigation and Risk Management Group Psychodrama to the next level

8. 8 Changing Environment Never Events “Never events cause serious injury or death to beneficiaries and result in unnecessary costs to Medicare and Medicaid due to the need to treat the consequences of the errors,” said CMS Acting Administrator Kerry Weems. “The steps taken today reflect our strong conviction that these events, in fact, should be prevented, and our commitment to protecting Medicare and Medicaid patients from them.” STEVENS & LEE Health Care Litigation and Risk Management Group Surgical site infection following bariatric surgery for obesity

9. 9 Benchmarking and Ratings STEVENS & LEE Health Care Litigation and Risk Management Group

10. 10 What’s being said on the web? STEVENS & LEE Health Care Litigation and Risk Management Group

11. 11 Zagat Surveying in Healthcare Hospitals & Health Networks, December 2007 STEVENS & LEE Health Care Litigation and Risk Management Group

12. 12 The Environment Keeps Evolving...

13. 13 It’s Getting Louder!  Healthcare reform  Continued focus on quality and cost STEVENS & LEE Health Care Litigation and Risk Management Group

14. 14 The combination POWERFUL RESULTS Continue to Change the Liability Equation Being aggressive- using the evidence $$ Risk Mitigation Risk Event Management Event Control of the Process Claim A Different Defense Lawsuit $$ Infrastructure Baseline assessments Create positive evidence Build the foundation STEVENS & LEE Health Care Litigation and Risk Management Group

15. 15 Understanding Cause of Our Bariatric Risk STEVENS & LEE Health Care Litigation and Risk Management Group Post-operative leaks Pulmonary embolism Vitamin deficiency Pre-surgery education (true/false test) Bariatric informed consent Post-surgery compliance Leak Guidelines Clinical Clusters Professional Liability

16. 16 So Why Are Bariatric Claims Filed?  In the first instance...a clinical cluster  Post-op leaks (esophageal, anastomatic, and stomach pouch)  Failure to recognize sx  Staple misfire  Delay in diagnosis  Delay in surgery to fix leak  Left shift  PE  Failure to recognize symptoms  Delay in diagnosis  Delay in or failure to treat  Fail to take preventive measures  Vitamin deficiencies  Failure to detect and treat thiamine deficiency  Untreated vitamin deficiency  Coupled with a professional liability plus factor  Lack of service excellence/communication  Lack of service recovery/post- adverse event management  Lack of relationship  Unmanaged patient expectations

17. 17 It’s Turning Out to Be So...  Medicolegal analysis of 100 malpractice claims against bariatric surgeons 1  69% of events occurred on day of surgery  Co-morbidities  Diabetes – 31%  Obstructive Sleep Apnea – 38%  Death occurred – 53%  Post-operative leaks – 53%  Bowel obstruction – 18%  42% involved surgeon < one years experience in bariatrics BACKGROUND: Very few studies have addressed malpractice litigation specific to bariatric surgery. This study was designed to analyze litigation trends in bariatric surgery to prevent further lawsuits and improve patient care. METHODS: A total of 100 consecutive bariatric lawsuits were reviewed by a consortium of experienced bariatric surgeons and an attorney specializing in medical malpractice. RESULTS: Of the 100 lawsuits, 45% were reviewed for defense attorneys. The mean patient age was 40 years (range 18-65), 75% were women, 81% had a body mass index of <60, 31% were diabetic, and 38% had sleep apnea.... 1 Cottam D., Lord J., Dallam RM, Wolfe B., Higa K., McCauley K., and Schauer P. “Medicolegal analysis of 100 malpractice claims against bariatric surgeons.” Surg. Obes. Relat. Dis. 2007 Jan-Feb;3(1):60-6. Epub 2006 Dec 27.

18. 18 An Element of Five Star: New Informed Consent STEVENS & LEE Health Care Litigation and Risk Management Group

19. 19 Second Generation Informed Consent u Patient accountability too!  Use in pre-event discussions  Use a procedure-specific form  Enhance patient education  Expectation management  Documents patient understanding  Then use it in post-adverse event discussion  Additional Strategies  Spousal consent  Copy of form to the patient STEVENS & LEE Health Care Litigation and Risk Management Group

20. 20 Introductory language INFORMED CONSENT TO SURGICAL PROCEDURE It is very important to [insert physician, practice name] that you understand and consent to the treatment your physician is rendering and any procedure your physician may perform. You should be involved in any and all decisions concerning surgical procedures your physician has recommended. Sign this form only after you understand the procedure, the risks, the alternatives, the risks associated with the alternatives and all of your questions have been answered. Please initial and date directly below this paragraph indicating your understanding of this paragraph. _________________________________ Patient's Initials or Authorized Representative STEVENS & LEE Health Care Litigation and Risk Management Group

21. 21 For Example, Informed ConsentWitness attestation STEVENS & LEE Health Care Litigation and Risk Management Group

22. 22 In Your Informed Consent Form? “In the unlikely event that one or more of the above inherent complications may occur, my physician(s) will take appropriate and reasonable steps to help manage the clinical situation and be available to me and my family to address our concerns and questions.” STEVENS & LEE Health Care Litigation and Risk Management Group

23. 23 Where the Rubber Hits the Road: Post-Adverse Event Communication STEVENS & LEE Health Care Litigation and Risk Management Group

24. 24 Prevent the Ultimate Plus Factor  Emotions running high  High during adverse events  For Patients, Family and You!  Perceived cold demeanor  Conclude you are uncaring  Or worse...covering it up!  Must have set the table (that’s why…5 Star!) STEVENS & LEE Health Care Litigation and Risk Management Group

25. 25 Creating The Relationship  Event management  Creating appropriate and favorable evidence  QA opportunity  Platform for disclosure  Disclosure of adverse events to promote patient safety and reduce liability risk STEVENS & LEE Health Care Litigation and Risk Management Group

26. 26 Effective Post-Adverse Event Communication  The key to getting comfortable is:  Understanding what “it” is  Understanding empathy v. responsibility  An adverse event can be  A complication – a known risk of the procedure  A medical error – generally, a preventable adverse outcome STEVENS & LEE Health Care Litigation and Risk Management Group

27. 27  First and foremost empathize!  Objective facts – what is known  What happened, why  If not yet known, say so...but follow up  Discuss what is being done to reduce further harm  If not clear about what caused injury, say so  Extension of informed consent discussion*  Answer questions you know they must have When It Is a Complication STEVENS & LEE Health Care Litigation and Risk Management Group

28. 28 When It Is a Medical Error  Investigation reveals responsibility...  The hardest  Takes planning, coordination, preparation  Involve legal counsel  Same advice as complications...  Empathy  Objective, known facts  What happened and why  Discuss what is being done to reduce further harm ...and  Accept responsibility STEVENS & LEE Health Care Litigation and Risk Management Group

29. 29 A Real Case Study… Disclosure First 30 Seconds Sets the Tone Creates Relationship or Not Procedure Specific Informed Consent Unfortunate Event STEVENS & LEE Health Care Litigation and Risk Management Group

30. 30 NOVUS – Putting it all together  Understanding and evaluating bariatric surgery  Researched specific root cause of frequency and severity with an Ethicon grant  Formal endorsement from ASMBS – August 2005  Comprehensive loss control program infrastructure which has been accepted!  Bariatric surgeons across the country ARE changing the way they practice STEVENS & LEE Health Care Litigation and Risk Management Group

31. 31 ASMBS  Endorses NOVUS (since 2005)  Vision: Improve public health and well-being by lessoning the burden of the obesity disease and related diseases.  Founded in 1983, the purpose of the society is to encourage its members to:  Improve care and treatment of the obese and related diseases  Advance the science and understanding of metabolic surgery  Foster communication among healthcare professionals  Be the recognized authority and resource on metabolic and bariatric surgery  Advocate for health care policy that ensures patient access to high quality prevention and treatment of obesity  Be a highly valued specialty society that serves the educational and professional needs of our diverse membership STEVENS & LEE Health Care Litigation and Risk Management Group

32. 32 Surgical Excellence, LLC  To help general and bariatric programs, surgeons, hospitals, and centers enhance quality of care and patient safety while reducing professional liability risk  To respond to the growing need for supporting bariatric and general surgeons, and their programs from both a clinical and risk management perspective  A complimentary program to NOVUS  Helping doctors become COE  Insurance proficiency evaluations STEVENS & LEE Health Care Litigation and Risk Management Group

33. 33 What is Surgical Excellence?  Surgical Excellence’s goals include  Moving more bariatric surgeons and bariatric programs to full Center of Excellence status  Increasing quality of care and safety  Reducing liability risk  Providing peer review services specific to the needs of bariatric and general surgery programs  Helping the start-up of new bariatric surgery programs  Reducing morbidity and mortality in bariatrics STEVENS & LEE Health Care Litigation and Risk Management Group

34. 34 Centers of Excellence  To survive in today’s environment, it is a must have  Eligibility is a comprehensive process that includes  Documented comprehensive program  Emphasis on results of safety  Process is  Time-consuming  Benefit from our experience  SE provides support  Becoming a COE  Mock COE site visit  SE provides a program for COE The Advisory Board Company – Horizon Scan, February 2009 STEVENS & LEE Health Care Litigation and Risk Management Group

35. 35 Take Home Points  The Liability Landscape keeps evolving  You can impact your risk in Bariatric Surgery  Simple, tested techniques have already worked  Second Generation Informed Consent  Post-Adverse Event Communication  And...the data supports it  NOVUS  SRC  Surgical Excellence STEVENS & LEE Health Care Litigation and Risk Management Group

36. 36 Stevens & Lee’s 225 lawyer and non-lawyer professionals assist health care providers and organizations meet the challenges they face in a changing and consolidating industry. Our Health Care Department is comprised of approximately 31 professionals – including 25 attorneys whose exclusive practice is in health care – who serve as general counsel to acute care and specialty health care organizations, health systems, long-term care providers and physician practices and regularly litigate cases in state and federal court. Stevens & Lee’s health care litigation and risk management team has designed customized risk reduction programs focused on both risk reduction and economics. Some of those programs include “Five-Star Service Excellence”, Disclosure Training, Risk Assessments, as well as the new EMR risk reduction program. Specialty specific programs are available as well. All programs combine education, training, communication, as well as documentation services. STEVENS & LEE 51 South Duke Street P.O. Box 1594 Lancaster, PA 17608-1594 717-399-1723 trba@stevenslee.com For more information, please contact Todd R. Bartos: STEVENS & LEE Health Care Litigation and Risk Management Group