legal risks and policy issues: inflammatory bowel disease · 2017. 9. 7. · legal risks and policy...
TRANSCRIPT
![Page 1: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/1.jpg)
Legal Risks and Policy Issues:Inflammatory Bowel Disease
Virginia Mason IBD Course 3/20/15
Lauren D. Feld Mt Sinai School of Medicine
Benjamin ByersUW School of Law
Andrew D. Feld MD JDProgram Chief, Gastroenterology Group Health Cooperative
Clinical Professor, University of Washington
![Page 2: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/2.jpg)
““Your Honor, my client pleads guilty to having been mislead by his advisors….”
This lecture is for educational purposes only, and does not constitute specific legal advice.
I have nothing to disclose and my presentation will have no discussion of off-label/investigative use or application of a product or device.
![Page 3: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/3.jpg)
Proportion of Physicians Facing a Malpractice Claim Annually,
According to Specialty
Jena AB et al. N Engl J Med. 2011;365:629-636.
![Page 4: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/4.jpg)
Basic Legal ConceptsWhat Does it Take to make a Lawsuit Successful?
• Tort of Negligence• Duty• Breach• Proximate Cause• Harm
• Vicarious Liability• Sympathetic Plaintiff• Policy Issues: ADA ( disability)• Duty to Warn ?
• Genetic factors
![Page 5: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/5.jpg)
Managing Risk
• What can you do to manage risk?• Understand risk
• the nature of the risk• the magnitude of the risk
(seriousness)• the probability that the risk may occur• the imminence of the risk (i.e., post-
procedure or decades later)
![Page 6: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/6.jpg)
Basic Risk Review
• Risk Areas• Vicarious Liability
• Informed Consent• Dangerous drugs
• Screening for cancer
• Plan of care
• Informed Refusal• Risks associate with disease progression
• Medical error
• What does risk mean for you?
![Page 7: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/7.jpg)
Implications of a Lawsuit
• Reporting• MQAC• Federal Databank
• Credentialing/Hiring• Repeated explanations
• Financial• Settle within policy limits?
• Personal• Years of stress, depositions, increased rate divorceFeld AD Moses RM “ Most Doctors Win: What To Do If Sued for
Malpractice” Am J Gastro 2009
![Page 8: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/8.jpg)
Malpractice and IBD
• Medical Malpractice issues that arise• Cognitive/Management Errors ”Misdiagnoses/Failure to
diagnose”• Medications: dangerous drugs• Top down/bottom up• Cancer screening• Quality measures ignored• Guidelines ignored• Labs overlooked• Vicarious Liability: staff errors
• Procedural Errors • Complication• Missed lesion
![Page 9: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/9.jpg)
Why is Malpractice Of particular Concern in IBD?
• IBD occurs in young people, so long period of disability following mistake• Relatively young age of plaintiff means damage awards are
larger
• Larger damages makes lawsuit worth plaintiff attorney time
• Means lawyers will take more IBD cases relative to other medical cases
• Example : missed rectal abscess leads to incontinence. How much is that worth? What is a jury award?
Feld AD “Malpractice Risks Associated with Colon Cancer and IBD”Am J Gastroenterol 99:1641-44, 2004
![Page 10: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/10.jpg)
Malpractice Examples:Medications
• FACT PATTERN: 30 yo on steroids get fem head ischemic necrosis
• Effective but Dangerous Drugs• Steroids• Immunosuppressive, Anti TNF• ? Antibiotics ( C Diff )
• Risk management tip:• Provide written information materials
• Cover major risks• Understandable• Don’t have to it make too scary
• Document provision
![Page 11: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/11.jpg)
Malpractice Examples:Top Down/Bottom Up
• FACT PATTERN: 26 yo on Top Down Therapy gets Lymphoma; or, on Bottom up Therapy gets fistulae and short gut
• Effective Therapy to Prevent Disease Complication,
• OR, Safest Therapy to Avoid Adverse Medication• With 2 options, must pick the “wrong one “
sometimes ( plaintiff attorney delight)
• Risk Management Tip:• Informed Consent and Documentation• Educational Materials to Review at Home
![Page 12: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/12.jpg)
Malpractice Examples: Cancer Screening
• Cancer Screening well established in IBD
• Risk Management Tip• Reminder File• System Issue: make sure system works,
and your people support you (vicarious liability)
![Page 13: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/13.jpg)
Malpractice Examples: Clinical Guidelines
Q: Is there a legal mandate that one follow CG?
• A: No
Q: Can CG be used to define SoC, and thus one’s violation of a guideline may result in adverse finding in a lawsuit
• A: Yes
• Feld “Legal Risks of Clinical Guidelines” Clinical Guideline Committee Symposium, DDW 2015
![Page 14: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/14.jpg)
Malpractice Examples: Clinical Guidelines
Q: But can you defend deviation from the CG, even if it purports to be SoC
• A: yes
Q: As long as the authors and the CG says “ this CG is not intended to represent SoC”, it can’t be sued to represent, right?
• A: Wrong
Q: Will understanding the basic legal theory about CG and SoC help me navigate these treacherous waters, and stay out of trouble?
• A: Yes!
![Page 15: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/15.jpg)
Malpractice Examples:Quality Measures
• Now well established in IBD
• Risk Management Tip:• Incorporate into your practice and
follow up• Can delegate (ARNP, PA, RN,
population management)
• Use of clinical guidelines
![Page 16: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/16.jpg)
Malpractice Examples: Vicarious Liability
• You are responsible for errors of your peeps (subordinates)
• Risk Management• Train and Monitor• Calls into clinic with problem? Urgent
• How Contact you or covering colleague• Delay in making appointments
Moses & Feld “Physician Liability for Errors of Non Physician Clinicians” Am J Gastroenterol 102:6-7, 2007
![Page 17: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/17.jpg)
Malpractice Examples: Pregnancy
• Pregnancy can change test results
• Chance of passing disease on to child
• Some treatments can cause infertility in men, but not shown to be an issue in women
• Raised caution for medications during pregnancy- Work with OB• NB Statute of Limitations for Mother may be 3 years,
but for Infant 18 years plus 3 years=21 years
![Page 18: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/18.jpg)
Malpractice Examples:Complex Patient
• Pregnant patients just one example of complex patients
• Complex Patients have
• Higher risk of adverse outcome
• Higher risk of error
• Risk Management Tips:
• Careful Follow Up and Monitoring
• Documentation/ Consent
• Second Opinion ***
• Shifts assessment from error to adverse outcome
![Page 19: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/19.jpg)
Malpractice Example: Procedure Complication
• Bad Outcome or Error ?• Less likely than cognitive error to give you
trouble
• Risk management • Pre procedure informed consent and
indication• Thorough post procedure care• A little help from your friends• Regular contact with patient and family
![Page 20: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/20.jpg)
Malpractice Examples:System Issues
• Hand offs• Who is responsible for the patient?
• Who is checking compliance?
• Overlooked Lab tests• How are lab tests logged?
• What is the chain of custody?
• Delay in scheduling/response• Who schedules a patient?
• What are they trained to listen for?
![Page 21: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/21.jpg)
Policy Malpractice Example
• You want to prescribe a new drug treatment• Better for the patient• More Expensive
• Insurance company refuses, suggests alternate drug:• Not as good in your opinion
• What do you do?
![Page 22: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/22.jpg)
Wickline v State ofCalifornia239 Cal.Rptr 810 1986
Facts: RN reviewer/discharge planner for Medical recommends discharge of hospitalized patient; MD requests 8 additional days; planner grants 4 days; pt discharged after 4 days. Gangrene, Amputation, Suit
eldCourt: 1. Patient... can recover from all responsible• 2. Third Party payors can be legally responsible when
medically inappropriate decisions result..from defects in cost containment mechanisms
• 3. Physician who complies without protest with limitations imposed by third party payor cannot avoid ultimate responsibility for patient care
• 4. Medi-Cal not liable for discharge decision
![Page 23: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/23.jpg)
Wickline Policy
• Wickline• Physician is responsible for his or her
decisions, not the third party payor!• Physician has a fiduciary duty to patient• Physician must be willing to go through a
grievance process for patient• Responsibilities go beyond individual
patient—broader public health responsibilities
![Page 24: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/24.jpg)
Policy Malpractice Example
• You want to prescribe a new drug treatment• Better for the patient
• More Expensive
• Insurance company refuses, suggests alternate drug:• Not as good in your opinion
• What do you do?• Inform patient of your opinion
• Submit appeal or assist patient appeal
• DOCUMENT CAREFULLY
![Page 25: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/25.jpg)
Policy Issue: DisabilityOn one Hand….
• Fact Pattern: Saks dismissed a make up artist with UC; EEOC ( Equal Employment Opportunity Commission) files suit under ADA
• Take away points: • IBD may qualify (Waste elimination )• Complex Issue, best referred to attorney
• Mental And Physical Disability Law Reporter 34:1, Jan –Feb 2010 p 91 BUT…..
• Rosenthal LD Can’t Stomach the Americans With Disabilities Act? How the federal Courts Have gutted disability Discrimination legistation in cases involving Individuals With gastrointestinal Disorders and Other Hidden Illnesses . Catholic University Law Review: 53.2 ( Winter 2004) p 449-498
![Page 26: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/26.jpg)
Policy Issue: ADAOn the Other Hand…
• Is IBD a disability under the ADA? (Don’t Confuse ADA with FMLA)
• Problematic• Issue of “not sick enough” v. “too sick”
• The ADA and the Rehabilitation Act have not resulted in many successful outcomes for plaintiffs• Why?
• Plaintiffs cannot prove that they suffer from a "disability,” or
• Plaintiff cannot demonstrate that they can perform the essential functions of their jobs with a reasonable accommodation
![Page 27: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/27.jpg)
Policy Issue:Medical Marijuana
• What are the implications of prescribing marijuana?
• How do you discuss risk?
• Is a doctor responsible for informing a patient about non-medical risks?• Could lose job
• Can’t drive while using
• Potential of social stigma
![Page 28: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/28.jpg)
Staying informed:Advocacy
• Crohn’s and Colitis Foundation of America
• IBD Support Foundation
• Private foundations that support research and provide information to patients about treatment options.
• Be aware of what patients may be using as external resources.
![Page 29: Legal Risks and Policy Issues: Inflammatory Bowel Disease · 2017. 9. 7. · Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D](https://reader034.vdocuments.net/reader034/viewer/2022052019/6032582b607acf3b322a8375/html5/thumbnails/29.jpg)
Thank you
• Comments?
• Concerns?
• Questions?