Legal Risks and Policy Issues: Inflammatory Bowel Disease

Transcription

1 Legal Risks and Policy Issues: Inflammatory Bowel Disease Virginia Mason IBD Course 3/20/15 Lauren D. Feld Mt Sinai School of Medicine Benjamin Byers UW School of Law Andrew D. Feld MD JD Program Chief, Gastroenterology Group Health Cooperative Clinical Professor, University of Washington

2 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 offlabel/investigative use or application of a product or device.

3 Proportion of Physicians Facing a Malpractice Claim Annually, According to Specialty Jena AB et al. N Engl J Med. 2011;365:

4 Basic Legal Concepts What 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

5 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., postprocedure or decades later)

6 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?

7 Implications of a Lawsuit Reporting MQAC Federal Databank Credentialing/Hiring Repeated explanations Financial Settle within policy limits? Personal Years of stress, depositions, increased rate divorce Feld AD Moses RM Most Doctors Win: What To Do If Sued for Malpractice Am J Gastro 2009

8 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

9 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: , 2004

10 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

11 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

12 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)

13 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

14 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!

15 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

16 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

17 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

18 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

19 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

20 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?

21 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?

22 Wickline v State ofcalifornia 239 Cal.Rptr 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

23 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

24 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

25 Policy Issue: Disability On 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

26 Policy Issue: ADA On 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

27 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

28 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.

29 Thank you Comments? Concerns? Questions?