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

““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.

Proportion of Physicians Facing a Malpractice Claim Annually,

According to Specialty

Jena AB et al. N Engl J Med. 2011;365:629-636.

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

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)

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?

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

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

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

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

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

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)

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

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!

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

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

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

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

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

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?

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?

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

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

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

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

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

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

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.

Thank you

• Comments?

• Concerns?

• Questions?