27 Video 2 DMU PDM Health Law 2024 Informed Consent & Liability.pdf

Top 10 Lessons: Helping Podiatric Physicians Survive the Health Law Jungle Video 2 DPM Community Health September 2024 Denise M. Hill, JD/MPA Associate Professor, Drake University...

Top 10 Lessons: Helping Podiatric Physicians Survive the Health Law Jungle Video 2 DPM Community Health September 2024 Denise M. Hill, JD/MPA Associate Professor, Drake University Of Counsel Attorney, Whitfield & Eddy, PLC  Learning Objectives: Jurisprudence (2024) Identify the laws that protect patients; including their medical records, protected health information, and their safety. Identify the role of laws that govern corporations and other legal practice entities in protecting patients. Recognize the general legal concepts that govern medical practice. Identify the duties and responsibilities of state medical boards and hospital medical staff. Demonstrate knowledge of the following; Federal Kickback Law, Stark II Law, and False Claims Act as they relate to fraud and abuse. Define and demonstrate knowledge of informed consent liability, batter, and the essential elements of negligence (duty/standard of care, breach of care, damages, and causation) as they relate to health care delivery. Identify strategies for disclosure of adverse outcomes and legal ramifications.  Top Lessons (Part 1) Top Lessons to Survive the Health Law Jungle: 1. Don’t ignore those who set limits & control your destiny. 2. Be clear on the scope of your relationship and don’t abandon your patients. 3. Deal with the elephant in the room—informed consent and disclosure are crucial. 4. Plan ahead and take steps to protect yourself from malpractice. 5. Don’t repeat everything you hear—maintain confidentiality.  Day 1: Patient Relationships Define and demonstrate knowledge of informed consent liability, battery, and the essential elements of negligence (duty/standard of care, breach of care, damages, and causation) as they relate to health care delivery. Identify strategies for disclosure of adverse outcomes and legal ramifications. Demonstrate knowledge of laws that protect patients; including their medical records, protected health information, and their safety. 3. Deal with the Elephant in the Room- provide informed consent & disclose Informed Consent— What is it?  Informed Consent Patient right to UNDERSTAND: Potential Risks; Purpose, Scope & Benefits; and Alternatives  ME 2.0 The doctrine of informed consent is usually defined as a duty to warn a patient of: 1.) possible complications expected; 2.) sequella of the treatment; 3.) unexpected risks of the proposed treatment; 4.) reasonable alternative to the treatment; 5.) risks and comparative benefits of the alternatives; 6.) in most cases, the effects of non-treatment; and, 7.) economic interests that have the potential to influence judgment.  Physician Duty To disclose sufficient information for patient to evaluate before submitting to it. To ensure patient understands what medical procedure/treatment consenting to Not to go beyond the scope of consent 10 For Education Only-Not Legal Advice  Your turn…The Researcher’s Story An investigator wishes to obtain liver cells from healthy donors He offers college students $1500 to ‘insert a needle in the abdomen to obtain a very small number of cells for research on tissue regeneration’. He describes this procedure as being a common medical procedure that has almost no risk. Bryans Larsen, PhD, Research Involving Human Subjects 1, DMU, Feb. 4, 2011.  Special Types of Consent General consent when admitted but may need more specific for procedure. Temporary consent to initiate emergency treatment. i.e. Child injured while on a field trip treat while trying to reach parent for consent. Special consent for unusual risks Human experimentation—drug studies—Two Weeks Pharmaceutical Prescribing Disclosure Inserts  Business Conversation Consent Provide full information Right to information needed to make informed decision – Risks – Benefits Right to have questions – Alternatives answered In terms understand Right to more if requested information Answer Questions Right to say No Two-way discussion  Your turn…Avery’s Story Avery is 55 years old and presents in the ED complaining of severe abdominal pain. After examining and interviewing the patient, Dr. Cole believes the patient has Diverticulitis and wants the patient to have a CT scan to confirm the diagnosis. Dr. Cole tells Avery he wants to order a CT but Avery says adamantly “No way. I don’t want cancer!” When Dr. Cole asks Avery what is going on, Avery explains “ I read in the Des Moines Register about a New England Journal of Medicine article finding that 1 in 80 people who get a CT scan get cancer. My Uncle died of cancer and I don’t want to go there!” 14 For Education Only-Not Legal Advice Level of Information Required Information that would: ordinarily be provided to a patient under like circumstances by similar health care providers (Standard of Care=Experts) 15 For Education Only-Not Legal Advice  Never Guarantee the Result of your Treatment of a Patient With Medical Procedures there is always a chance of complications without fault—even if the procedure was perfectly performed. There is no guarantee of result, but patient should know what they are getting in to. Mississippi jury trial, a patient said podiatrist guaranteed she would be pain free 4-6 weeks after bunionectomy. Patient alleged she would have declined surgery if she knew she would be in pain for 9 months after surgery. 16 For Education Only-Not Legal Advice Consent in Writing (Iowa Code 147.137) Iowa Code 147.137 A consent in writing to a medical or surgical procedure/course of procedures in patient care which meets the requirements of this section shall create a presumption that informed consent was given. A consent in writing meets the requirements if it: – Sets forth general terms the nature and purpose of the procedure(s), known risks, probability each risk if reasonably determinable. – Acknowledges that the disclosure of that information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner. – Is signed by the patient or person who has legal authority to consent on behalf of that patient  What if Patient Refuses to sign? Is it the signing of the form or the care that is the issue? If the form-explain the treatment plan and role of the form. If the care-more discussion is necessary (C-B-A). Document all discussions whether or not proceed! (Retrieved Feb. 23, 2009) at http://www.rmf.harvard.edu/patient-safety-strategies/informed- consent/faqs/index.aspx 18 For Education Only-Not Legal Advice  Comprehension is Crucial Not liability waiver—explanation of the scope of the procedure=must understand If patient tough time understanding take more care documenting in chart (not just form) questions, risks, benefits etc. discuss If real question about capacity may seek substitute decision maker. 19 For Education Only-Not Legal Advice  ME 2.0 Informed Consent The doctrine of informed consent is premised upon the right of the patient to exercise control over his or her body by deciding whether or not to undergo a proposed treatment regimen. The duty of the podiatrist is always to disclose relevant information to the patient and obtain the consent of a competent patient or someone legally authorized to give consent on behalf of the patient before initiating treatment. (See interpretive guideline.) ME2.1 What a Patient Needs to Know About the Proposed Treatment ME2.11 The podiatrist strives to ensure that the patient is cognizant of the nature of the illness or condition, the treatment proposal or its alternatives with reasonable explanations of expected outcomes, potential complications, and length of recovery. ME2.2 Disclosure of Experience and Outcomes ME2.21 The podiatrist provides truthful representations of the his/her experience and outcomes. How many do you take?  Special Issues in Securing Informed Consent Mental Capacity (See following slides) Health Literacy Cultural Competency Minority Health—Trust & Disparate Impact Disability Limited English Proficiency Minors (See following slides)  Who Consents? Patients themselves when competent Someone else: – Guardianship/Durable Power (144B) – Parental consent for minors – Whoever authorizes for another person must have sufficient information to make an intelligent judgment on behalf of the patient.  Competent v. Capacity Competency=legal (Judges) Decision making Capacity (dmc)=clinical (Healthcare providers) Total, partial, or even transient  Your turn…Mrs. Ray’s Story What to do… Emma, a home health nurse, is treating Mrs. Ray, an 80-year-old woman. She is living independently but her family has told Emma that they are concerned that her behavior is deteriorating and she often appears confused. During her assessment, Emma asked Mrs. Ray about her health history and learned she was supposed to be taking medications for hypertension and thyroid pills on a daily basis. Mrs. Ray shared that she had consulted with the local curandero who conducted several rituals and advised Mrs. Ray to stop taking all of her medicines because they were “poisoning her system” and instead she should drink a mint herbal tea and wear a magnetic bracelet to balance her energies. Mrs. Ray believes strongly in this healer and wants to follow her advice. Emma talks to Mrs. Ray about the fact that failing to take her medication is endangering her safety and her life. Mrs. Ray got irate and accused Emma of not respecting her beliefs and being “on the side of the doctor and her family.” » Adapted from: Morrison, E.E. Ethics in Health Administration: A Practical Approach for Decision Makers, Sudbury , MA: Jones and Bartlett, 2006: 128. 26 For Education Only-Not Legal Advice  Consent to Treat Minors (Under 18) The authorization of a parent or legal guardian is usually necessary before rendering medical care to a minor. Exceptions to Parental Consent: Emergency Emancipated Minor Substance Abuse (125.33(1)) HIV/AIDS (141A.7)—test is positive=tell parents! Sexual Health (139A.35) Abortion (135L.3)  Emergency Exception Any condition that requires prompt treatment/urgent attention or is causing a person pain or fear and No parent “reasonably available” (Immunity under 147A.10 (2) regardless of age!)  AMA Ethical Opinion E-5.055 Confidential Care for minors: Protect autonomy involve in decisions Encourage parent involvement Look at the law—permit child to consent for care w/out parent if legal Pregnancy, STD, Substance Abuse or mental illness—parents may be counter productive Balancing disclosure to parents  Your turn…Mary’s Story Mary, age 11 is left temporarily with her two sisters, Jane age 18 and Margie age 21, while her parents are away shopping in the neighboring city for the weekend. Margie, a registered nurse takes Mary to the physician because of a persistent sore throat. The physician recommended a tonsillectomy-adenoidectomy. Margie agrees and Mary is admitted for the procedure. Mary dies in the course of being anesthetized for the operation. Garrett et. al. Health Care Ethics: Principles And Problems, Upper Saddle, N.J.: Prentice Hall, 3rd Edition, 1998:52. 30 For Education Only-Not Legal Advice  Your turn…John’s Story John, 17-years-old, is seriously injured while jumping from a train on which he had been hitching a ride. Taken to a nearby hospital, he is given emergency treatment by Dr. Lycanthropus, who judges that the boy’s leg will have to amputated below the knee because it had been crushed beyond repair. Two other physicians are consulted and agree that the amputation should be done immediately to protect John’s life. John is unconscious as a result of an anesthetic administered to allow the suturing of a head wound that was bleeding profusely. Attempts to contact the boy’s parents in a neighboring town are unsuccessful and Dr. Lycanthropus assists a surgeon who amputates the leg as recommended. Adapted from Garrett et. al. Health Care Ethics: Principles And Problems, Upper Saddle, N.J.: Prentice Hall, 3rd Edition, 1998:52. 31 For Education Only-Not Legal Advice The 1-2 Punch of Liability: INFORMED CONSENT  Elements: Non-Disclosure 1. Medical procedure carried a specific risk that was not disclosed. 2. Provider violated the applicable standard of disclosure in her jurisdiction by not disclosing. 3. The Undisclosed risk actually happened and 4. The failure to disclose caused the plaintiff’s injury (was both the factual and proximate/legal cause). Informed Consent LIABILITY Go to: https://www.apma.org/PracticingDPMs/content.cfm?ItemNumber=27285&navItemNumber=24162  Your Turn…Side Effects Jerry, age 15, is diabetic and has a foot infection. His podiatrist Dr. Link prescribes Cleocin Oral off label as she has had several other patients have success with this approach and in the past Jerry has been resistant to several more common generic antibiotics. Dr. Link gives the prescription to Jerry’s parents and tells them she wants to see him back if his foot is not healing well in two weeks or if he develops any diabetes-related complications. Several weeks later Jerry’s foot is healing well. But he keeps complaining to his mother that he has severe stomach pain and is having diarrhea several times a day. His mom keeps giving him over the counter antidiarrhea pills but it is getting worse. One day she comes into his room to find him lethargic and almost unresponsive. Jerry’s parents rush him to the local urgent care center where it is determined that he is severely dihydrated from the severe diarrhea. Jerry was later diagnosed as having clostridum difficile diatthea. When the attending physician asks what medications Jerry has been s on his mother mentions that he recently finished his prescription of Cleocin Oral. The doctor looks it up on WebMed and reads the following warning for this drug: “This medication may cause a severe (rarely fatal) intestinal condition (Clostridium difficile- associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor immediately if you develop persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.” Jerry’s parents are furious that Dr. Link never told tem about this danger as they would never have given Jerry this prescription—particularly given that there were so many other antibiotic options available. 36 For Education Only-Not Legal Advice  Treat Against Will? Constitutional right to control medical care for our own bodies (competent adult) Generally, no statutory right to hold an individual against their will—(false imprisonment, criminal or civil battery) Exceptions – Public health (i.e. emergency) – civil commitment – 72 hour hold  Assault & Battery Medical Malpractice – Negligent Podiatric Surgery: $750,000 Recovery during trial A 38 year-old janitor visited a podiatrist in Lodi California for painful calluses on the bottoms of her feet. The podiatrist performed multiple surgeries to the toes on both of her feet but performed unnecessary surgery on her. Sued the podiatrist for negligence, misrepresentation, fraud, emotional distress and assault and battery. During cross-examination at trial, the podiatrist admitted he told three falsehoods in the medical records regarding the client’s medical condition. The Defendant settled for $750,000 the day before closing arguments at trial. 4. Plan ahead and take steps to protect yourself from malpractice and disclose errors Don’t Hide in your shell—use it to protect yourself! Unacceptable!  No Denying it… This Applies to YOU!!!!! Most Physicians Sued During their Careers http://lawyerinformation4u.com/lawyer-information/medical-malpractice-lawyer- harvard-study-finds-most-doctors-will-be-sued-for-malpractice-during-their-careers/ The Healthcare Provider View Image from Top 10 Things Doctors can do to Save Themselves from being Sued for Malpractice, available at http://www.financephysician.com/2007/06/22  Impact on Providers Liability Insurance Premiums Change Practice/Move/Retire=shortage Defensive Medicine Regulatory Burden – Joint commission – state regulators – Medicare Conditions of Participation – Healthcare Quality/Patient Safety Laws/Legislation Toll on those involved in lawsuits – Emotional – Financial – Loss of productivity  “patients are the first and obvious victims of medical mistakes, doctors are wounded by the same errors: they are the second victims.” Albert Wu, MD Mistakes are possible, providers are human. Many times brought into the lawsuit if any contact with the patient at all—may include residents! Difficult to deal with rationally…feels like a personally personal & professional attack.  Don’t Lose Sight of Patient Perspective Physical Harm, injury or death Emotional Harm Financial ruin Families destroyed – Linda’s Story http://www.youtube.com/watch?v=-fWOmfpa3n8&feature=related – Josie King (Sorrel King at IHI) http://www.josieking.org/page.cfm?pageID=10 --Patient Safety Day http://www.youtube.com/watch?v=cfm5bXOj-KA  Liability Tort—“a civil wrong” Element of Fault—”Standard of Care” Intent is not Required Worrisome Trend? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638762/ This Photo by Unknown Author is licensed under CC BY Patient Outcomes & Negligence Improper management of surgical patient (41%) MOST Infections Pain Malunion COMMON Fracture Nerve Damage ALLEGATIONS Improper performance of Surgery (26%) Often failure to manage the patient’s Contributing Factors: expectations Patient Injuries Delayed/Limited Recovery & Surgical Repair Was there negligence?  Common Examples of Medical Negligence Failure to timely diagnose and treat an infection, including osteomyelitis Failure to diagnose and treat nerve injuries, including Reflex Sympathetic Dystrophy (RSD) also known as Complex Regional Pain Syndrome (CRPS) Failure to adequately perform surgery Malpractice in treatment of bone spurs Malpractice in treatment of heel pain Negligence in treatment of diabetics with foot or skin problems Failure to provide adequate follow-up care Failure to timely refer the patient Providing medical treatment that was not needed Improper Treatment — 70.45 % Improper Surgical Technique — 56.17 % Lack of Informed Consent — 24.03% Postsurgical Infection — 20.13 % Pain — 19.81% Misdiagnosis — 13.31 % Unnecessary Surgery — 12.01 % Poor Result — 6.49 % “We're just going to scrape some bone.”  What do you think? https://drive.google.com/file/d/1CMToZnPzGpboCubFzOoqZ-Mq52rIh44a/view  U.S. Court in Kentucky Finds Podiatrist Potentially Liable for Punitive Damages for Wrong Foot Surgery A podiatrist must face punitive damages claims after performing surgery on the wrong foot of one of his patients, the U.S. District Court for the Western District of Kentucky held June 22. The court declined, however, to grant the patient summary judgment on her claim of willful/wanton negligence, saying that although there is a genuine issue of fact whether the podiatrist acted with gross negligence, "it is far from certain that he actually did so.“ Plaintiff Sherrie Griffey sought treatment from podiatrist William Adams, II for pain in her left foot. Griffey eventually underwent surgery performed by Adams at defendant Lourdes Ambulatory Surgery Center, LLC. In the operating room, Adams began operating on Griffey's right foot until other attendants in the room realized that the surgery was supposed to take place on her left foot. In her complaint, Griffey alleges that, as a result of the operation and the erroneous incision made by Adams into her right foot, she was rendered immobile. Griffey v. Adams, No. 5:16-CV-00143-TBR (W.D. Ky. June 22, 2018). https://www.hortyspringer.com/documents/griffey-v-adams-june-2018-pdf/ 6 Claims against Adams & Lourdes: (1) negligence against Adams; (2) willful and wanton negligence against Adams; (3) battery against Adams; (4) negligence against Lourdes; (5) willful and wanton negligence against Lourdes; and (6) battery against Lourdes. ✓ Duty-obligation to conform to a recognized reasonable care under circumstances (Look at standard of care and use experts to establish) ✓ Breach-Breached duty by failing to meet the standard of care. (Experts) ✓ Damages-Compensatory and intangible losses ✓ Causation-Cause of injuries/damages not occurred any way or for different reason—foreseeable Negligence: Elements to Prove  Negligence Liability Institution/Organization 1. Respondeat superior/vicarious liability—responsible for acts of employees or agents acting with the scope of authority 2. Ostensible agency/apparent authority—Held out to patient/public as having authority 3. Corporate negligence—Short comings of institution contributed. i.e. Nursing shortage, under staffing, credentialing  Res Ipsa Loquitur “The thing speaks for itself” Establishes duty without direct evidence of causation Injury does not ordinarily occur unless negligent Conduct is under the exclusive control of the defendant.  Comparative Contributory Statute of Good Fault Negligence Limitations Samaritan P’s negligence No liability if P Time Frame to File Affirmative Defense-- reduces D’s contributed in after discovery Immunity if you liability any way render aid without Recover? compensation. If after S of L = No Recover? Recover? If within S of L = Yes Immunity = can still 50% ≥ =Yes P 1% ≤ fault = No be sued but shields 51%≤ =No D 100% fault= Yes State law e.g. Iowa- from liability statute of repose State law e.g. State law e.g. Once you take on can’t abandon Iowa Washington, DC Doesn’t protect against recklessness, bad faith or gross negligence Defenses Iowa Cap on Noneconomic Damages May 2017  Professional Liability Insurance (PLI) Public Policy rationale— – Limit personal liability – Adequately protect patients NOT required under Iowa law. Check your state. Generally required in credentialing for hospital privileges and insurers. How much is enough? Decide on a case-by-case basis.  Professional Liability Policies generally covers up to a set amount of: costs of a liability defense legal fees negotiated settlements Liability for damages May cover only court proceedings or may include administrative hearings (i.e. Licensing Boards)  Key Types of Professional Liability Insurance Coverage Occurrence Policy—Insured has coverage for claims made and damages awarded as long as liability results from an “occurrence” WITHIN THE STATED TIME LIMITS in the policy—focus is on the time of the incident and not the time of losses (claims or verdicts) are actually sustained. When did the negligence occur? Claims Made Policy— Coverage is limited to actions which are known during the coverage period because and actual “claim is made during that time. Premiums are generally lower but exposure to risk is higher for the physician if the claim comes in after the stated coverage period ends. When was the claim made? Tail Coverage—Includes a “Reporting Endorsement” that confers on the policy holder, after nonrenewable or cancellation of the policy the right to purchase coverage for additional claims or disputes. Most often comes in to play when leaving one occurrence policy to go to a non-occurrence policy situation (I.e. changing practice setting or employer). Do you need “Gap” coverage?  Self-Insurance Definition: When a company, or group of companies, pays part of its own insurance losses and also assumes the role of an insurer by establishing systems to pay those claims. Regulation: Insurance is generally regulated by the Iowa Division of Insurance--many states regulate the companies that elect to self-insure but in Iowa only regulated for workers comp—not professional liability. Caution: Issues of conflict of interest in representation and settlement may exist.  Best Defense is a Good Offense Disclosure Process Initial Disclosure Investigation Resolution  Why Apologize/Disclose? Proponents of apology theorize: – “[I]f patients were treated with openness and sympathy-and offered prompt compensation- when doctors make mistakes….they would be less likely to sue.” “Doc’s Humble Apology Could be Saving Grace,” Chicago Sun Times Editorial (February 25, 2005).  What Should an Apology or Disclosure Include? A clear and understandable explanation of the outcome, free of conjecture or innuendo The details of the how and why the negative outcome occurred should wait until all the facts are known and the response to this information is addressed  Admission of Liability or Blame is Not Required Disclosure does not require an outright admission of liability or fault. Nor is naming of the responsible party required. An expression of concern without an admission of responsibility is appropriate. Many disclosure policies outline this approach by providing , “the intent of disclosure is to provide necessary medical information, not to provide the basis for legal liability.” Apology Statutes States enacted “Apology” or “I’m Sorry” statutes. Rule of Evidence: Professional’s statement of apology, sorrow, regret after adverse outcome is non-discoverable/not admissible. Encourage apologies and open communication on errors/adverse outcomes by placing limitations on admissibility. Iowa’s Candor Law  When You Do Not Know, Say… “___, this was terrible what happened and what makes it even worse is that we don’t know why it happened. But I want you to know that we are investigating what’s going on and when we’re confident we know what occurred we’ll certainly be telling you.” http://www.gha.org/pha/video/index.asp  If a Patient Suffers an Adverse Outcome Do be honest. If you don't tell a patient about an error, someone else—possibly an attorney—certainly will. Covering up a mistake may result in lengthening the statute of limitations or inflating the damage claim. Do act quickly to correct treatment errors, and to change policies and procedures to lessen the chance that an error will happen again. Do plan your conversation with the patient or family to ensure the information conveyed is factual, objective, complete, and free of medical jargon. Remember, anything you say can be used as evidence in a lawsuit. Do contact your malpractice insurer, but don't assume a bad outcome is malpractice. Don't make off-the-cuff statements or guess about causes. Don't assign blame or point fingers. Source: Midwest Medical Insurance Co. Mark Crane. What to say if you made a mistake. Medical Economics 2001;16:26.  Record Keeping Non-existent Documentation Sloppy/Disorganized = Vulnerable to Litigation Incomplete  Patient Relationship https://www.podiatrytoday.com/essential-keys-preventing-malpractice-lawsuits