Author(s): Sunil K Jain, MD, Maedot Haymete, BA
Originally published: September 11, 2015 Last updated: June 27, 2024
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Relevance to Clinical Practice

Under Civil law, malpractice cases tend to be assessed under Tort laws that may require intentional acts (which are voluntary acts) or those that do not require intentional acts. Tort laws aim to compensate a wrongfully injured plaintiff while Criminal law punishes defendants and deters similar acts. However, cases relating to patient safety can be assess through Tort laws and Criminal laws individually or simultaneously.1

The most common area of litigation in medicine generally and applicable to rehabilitation medicine is negligence.2

Medical Negligence3

Generally, negligence requires some elements that have to be present and include the following:

  • Duty of Care4 This is a duty owed to foreseeable plaintiffs in the zone of danger as the amount of care expected from a reasonable prudent person under such circumstances. The zone of danger, per the “Cardozo view,”5,6 is the immediate dangerous area created by the negligent behavior of a defendant. Duty of care for physicians is based on national standard of care, and a specialist care, including rehabilitation medicine, will be based on the national standard expected of a board-certified physiatrist. Duties of care are presumed where there is assumption of risk (e.g. as treating physician), statutory obligation (e.g. based on statutory law or regulations), contractual obligation (e.g. concierge medicine), existing relationship (between a patient and a physician even outside the hospital) and creation of a peril (e.g. when a physician tries to help and makes the situation worse). While generally, there is no general duty to come to the aid of another, trying to help and creating more problems leads to duty to care under creation of a peril.
  • Breach of Duty This is defined as when the above duty is not met under the expected circumstance by the defendant. For example, this may involve the expected standard of care falling short of the national standard. This encompasses all acts and omissions that would have been avoided by a reasonable and prudent person under comparable circumstances.
  • Causation The prosecution must prove that the above breach of duty has caused an injury. This is based on two parts of actual causation and proximate causation. The actual causation is based on the “but for” test if it is a single defendant (i.e. “but for” the act of that defendant there will not be harm that ensued). The “substantial factor” test is used in situations where there are possible multiple defendants each performed a breach of duty that may have contributed to the harm the plaintiff sustained. In situations where specific causation by one of the defendants is unascertainable, the “shift of burden of proof” test is used. This shift of burden occurs when multiple physicians were involved in patient care and a mishap occurred with difficulties in finding a substantial individual factor for the mishap. The burden shifts to plaintiff to prove that each defendant individually substantially contributed to patient harm. The proximate causation is the direct or indirect cause of the harm that the patient experienced. A direct cause is a foreseeable cause that is expected when duty of care is breached, and an indirect cause is a consequence that is an intervening cause. An example of such a case would be if an epidural injection by an interventional physiatrist leads to epidural abscess from negligent non-use of aseptic technique, leading to the need for surgical decompression, which leads to spinal cord injury. The interventional physiatrist may still be liable for the spinal cord injury because the surgical decompression is an intervening action. The intervening cause test does not apply if such act is due to an intentional tort or a crime.
  • Damages There has to be harm in the process of the breach of the duty of care for a medical negligence to occur.

Res Ipsa Loquitor7

Under breach of duty with the doctrine of Res Ipsa Loquitor, it is presumed that the very nature of a medical mishap causing patient’s injury suggests negligent conduct if there are not enough facts to define a breach because of unknown circumstances of events leading to the injury. This requires three elements:

  • The harm will not normally occur without negligence.
  • Such harm will normally be caused due to negligence on the part of the defendant, in this case the physician
  • The circumstances under which the harm occurred were in the exclusive control of the defendant (physician).

An example of Res Ipsa Loquitor may be in a circumstance where a patient was able to ambulate on the day of an epidural injection, but after the procedure was found to be paraplegic. The above three elements will be applicable, and this will avoid the plaintiff’s need to prove that there is a breach or no breach of duty of care.

There are defenses to medical negligence that include assumption of risk (i.e. when a patient is fully aware of all the risks through an informed consent and opted to proceed with the treatment plan), contributory negligence (i.e. when a patient’s own action contributes to the harm and may bar recovery in minority jurisdictions) and comparative negligence (for example, if the jury assigns the patient a percentage of faults of 70%, then under the pure comparative fault the patient can recover 30% of their damages. But the partial/modified comparative fault only allows the patient to recover their percentage if it is below 50% and none if it is above 50%).

Tort cases requiring intentional acts include Assault, Battery, False imprisonment and intentional infliction of emotional distress.

Assault

Assault is the voluntary/intentional act by a defendant, which causes reasonable apprehension of imminent harmful or offensive contact.8 An example of this could arise when a physician’s actions can be interpreted as sexually inappropriate by the patient.

Assault does not require any physical contact. Threatening a patient can be interpreted as non-physical assault.

The defense to assault is consent, though it is recommended that any potential misunderstandings be avoided by the presence of a witness.

Battery

This is a voluntary/intentional act by a defendant that causes harmful or offensive contact.9

Also, in this instance, consent is a defense.

Both Assault and Battery could occur together where touching the patient is termed offensive or causes harm. This could occur where a procedure was performed without consent, performed on the wrong part of the body from that consented to or when the scope of consent is exceeded.

False Imprisonment10

This is an intentional act or omission whereby the defendant unlawfully confines or restrains a plaintiff to a bounded area against their will without alternative option of escape and plaintiff is aware or harmed by such confinement.

This could occur in a rehabilitation setting if a patient wants a discharge against medical advice or is being physically or chemically restrained from moving around.

Intentional Infliction of Emotional Distress (IIED)11

IIED refers to conduct that is intentional or recklessly extreme/outrageous and leads to severe emotional distress. This could occur in the way a patient is treated or handled. A bystander witnessing the event could sue for IIED if they are a close relative of the patient, were present when the injury occurred, and the defendant was aware of the relative’s presence and close relationship with the patient.

All of the above could plead the defense of consent. Consent could be expressed when written or agreed orally (although it is better to always have a consent in writing), but it could also be implied (e.g. when a patient walks in to an office to see a physician but this has to remain within the reasonable scope of expectation). The reasonable standard is an objective standard based on the expectations of a prudent and reasonable member of the public. Consent also requires legal capacity.

Issue of legal capacity is dependent on age (depending on the jurisdiction in USA, requires being 16 or 18 years and above) and mental capacity in which case consent from a guardian or someone with power of attorney will be required.

There are other tortious acts that could lead to legal actions but in brief include the following:

  • Misrepresentation This could be intentional or negligent, involving false portrayal of material fact that the defendant knows or believes is untrue. The false portrayal induces the plaintiff to justifiably rely on such misrepresentation causing harm.
  • Product Liability This may apply in which a product (e.g., blood products produced by the hospital) leads to harm (e.g., infected with HIV virus or Hepatitis C). Such product liability actions will be analyzed under negligence as stated above.
  • Vicarious Liability Also termed doctrine of Respondeat Superior and makes employers liable for torts committed by employees within the scope of their employment. A frolic is a circumstance where the employee’s actions were not within the scope of employment, and a detour is an action that is not within the scope of employment but is done during the phase of scope of employment. Intentional torts generally are not applicable, except it is within the job description of the employee (e.g., restraining, etc.). Also, independent contractors are not employees, and employers are generally not liable except doing a job that is within the control of the employer (e.g., a credentialed medical staff moonlighting) or when there is negligent hiring (e.g., a medical staff with bad records not properly vetted).

Under Criminal laws, there is also Assault and Battery as defined above under torts. Hence, a physician may be liable for assault and battery under civil and criminal actions.

Other criminal liabilities

Homicide is the killing of another human due to an act or omission. Homicide may occur in the absence of intent or may occur with malice aforethought and without legal justification (i.e. unlawful killing).

Malice aforethought could be intent to kill, intent to cause serious bodily injury, wanton and reckless indifference to life or felony murder (when death occurs during the commission of a felony of battery, arson, robbery, rape and kidnapping).

Murder under intent to cause serious bodily injury may arise if a treatment action could be seen as having potential to cause severe bodily injury or the action could tantamount to reckless and wanton action.

Under homicide, there are first-degree murder, second-degree murder, voluntary manslaughter and involuntary manslaughter.

First-degree murder is the deliberate, willful and premeditated and enumerated murder as stated above. Such a circumstance could arise in rehabilitation medicine in the case of euthanasia of terminally ill persons.

Second-degree murder is differentiated from first-degree murder by the lack of premeditation. This describes murders with the specific intent to kill or inflict bodily harm, unlawful distribution of dangerous controlled substances to either the victim or to an individual who subsequently distributes controlled substances unlawfully to the victim.

Voluntary Manslaughter arises in a murder with adequate provocation in the heat of passion without time to cool off and there was no cool off period.

Involuntary Manslaughter describes murder caused by criminal negligence (reckless disregard for others,5 battery or misdemeanor. This also could arise with negligent action that leads to death including prescription of opioid analgesics, failing in duty of care as the treating physician.

Defenses for homicide applicable in medicine will often be based on lack of the necessary intent to bring a case from first or second-degree murder or voluntary manslaughter to a lesser charge of involuntary manslaughter.

There are certain laws and regulations that a physiatrist could be liable if breached that include:

Civil False Claims Act Knowingly presenting or causing the presentation of false or fraudulent claims to the US government for payments. This could occur in sending false claims to Medicare for a patient that was never treated, upcoding, falsifying certificates of medical necessity, unbundling, etc. Most physicians have been prosecuted based on reckless disregard for the truth in conduct when such conduct is out of line with normal business conduct. The penalty for this includes a $10,000 fine plus inflation adjustment (additional $3,946 as of Feb 2024) for each false claim (U.S.C citation 31 U.S.C 3802(a)(1)), exclusion from participation in a Federal healthcare program (like Medicare, Medicaid, etc.) and a fine of triple damages in any civil suit.

Under the Qui Tam Relator doctrine, a whistleblower as a private party can bring an action under this act on behalf of the US government and will be entitled to 15%-30% of the amount recovered by the government along with the legal fees sometimes.

Criminal False Claims Act This describes the act of making a false claim knowingly with the intention to defraud the government (U.S.C citation 31 U.S. Code § 3729). The penalty for this is a felony punishable by imprisonment for up to 5 years with possible fine of $250,000 for individuals and $500,000 for institutions.

Anti-Kickback Law This law was created in 1972 and is administered by the office of the Inspector General (OIG). It describes knowingly or willfully inducing, soliciting or accepting remuneration, offer, payment, etc. in return for the purchase order of items etc. paid for through a Federal program. Penalties include imprisonment of up to 5 years for each violation, fine of up to $25,000 plus inflation adjustment (additional $2,894 as of Feb 2024) per violation (U.S.C citation 41 U.S.C 8706(a)(1)(B)) and exclusion from Federal programs if through criminal prosecution and if through the OIG, it could be civil penalty of up to $50,000 per violation along with assessment up to thrice the amount of the illegal payment.

Stark Law5 This law is similar to the anti-kickback law and prohibits physician self-referral. Originally enacted in 1989, the law aims to prohibit healthcare providers from referring or providing unnecessary services due to their own financial interest. Penalties towards the health service entity include repayment of all claims made in the self-referral, thrice the payment amount if payment was from Medicare and exclusion from federal programs. Penalties towards healthcare providers include a fine of $15,000 per prohibited service and exclusion from federal programs. There is an exception to EMR adoption and cooperation. A recent update to the Stark Law in 2020 supports the CMS “Patients Over Paperwork” initiatives enabling coordination of care between physicians and other healthcare providers towards providing high quality healthcare across different settings. This allows entering into value-based arrangements when such will improve coordination and quality of care while lowering costs while also preventing overutilization and other harms in healthcare delivery. Other arrangements under the updated Stark Law include exceptions like donations of cybersecurity technology, physician wellness programs etc.

Obstruction of Criminal Investigation of Healthcare Offenses This describes willfully obstructing, misleading, delaying or engaging in any action that makes it difficult for a criminal investigator to access any records necessary for the investigation of a violation of a federal healthcare offense. This tends to occur when requests for records are denied or records are destroyed in the process of avoiding such criminal investigation. Responsible individuals can be fined up to $250,000 or imprisoned up to 5 years, or both (18 U.S. Code 1518).

HIPAA/HITECH The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 and states that a covered entity may not use or disclose protected health information (PHI) except as permitted or required for treatment, payment, healthcare operations, operation of the law, patient authorization or waiver of that patient authorization. HIPAA does not cover PHI that has been de-identified.

The Health Information Technology for Economic and clinical Health (HITECH) is part of the American Recovery & Reinvestment Act (ARRA) (also called the “Stimulus Package”) and provides expanded and strengthened enforcement for HIPAA with increased penalties, expanded security breach notifications, HIPAA extended to business associates, etc.

Penalties for HIPAA violations includes minimum $100 per violation and maximum of $25,000 per calendar year for cases in which offender was not aware that the act was violated, (i.e. not intentional) minimum of $1000 per violation and maximum of $50,000 per calendar year for violations due to reasonable cause but not to willful neglect, minimum, $10,000 per violation and maximum $250,000 per calendar year for an infringement corrected by the organization once detected and not due to willful neglect, and minimum $50,000 per violation and maximum $1.5 million per calendar year for violations due to willful neglect not corrected by the organization.

CMS-1135 and Public Health Emergency (PHE) Rules:13,14,15 These rules describe unexpected disasters and public health emergencies which may call for temporary waivers or modifications of Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements through section 1135 of the Social Security Act. 

For example, with the advent of the recent COVID-19 pandemic, the role of CMS was to ensure that Medicare beneficiaries are able to get safe and effective care during the COVID-19 Public Health Emergency (PHE) and also ensure that Medicare payment/coverage policies during this period do not “impede providers to expand capacity to treat patients. This was to ensure that during the pandemic, providers “may be reimbursed for such items and services and exempted from sanctions for such non-compliance, absent any determination of fraud or abuse.”13

These exceptions allowed CMS to enable significant flexibility in the provision of healthcare services by waivers and regulatory flexibility including waiving some pre-approval requirements, federal licensing requirements, Emergency Medical Treatment and Labor Act (EMTALA), Stark law and “certain deadlines and timetables for performance of required activities” that would have made such activities illegal as discussed earlier.

Such waivers allow hospitals, facilities and providers to expand into other related services, go into partnership with third-parties/entities in providing services and also offer services that are not within clinical care like childcare, free meals or laundry to healthcare workers without the expected sanctions under the Stark law. Sanctions and penalties are also waived arising from noncompliance with HIPAA privacy regulations.14

Under the flexible regulatory framework during the pandemic, services that could be offered without legal consequence were expanded. This included telehealth services, broadening types of physicians that can provide telehealth, and removing sanctions for hospital outpatients who temporarily relocated due to PHE, ensuring they did not receive lower payments. Additionally, services reclassified as new hospital level care under FEMA/DOED/State regulation (such as those in convention centers, tents, or hotels) were covered without incurring any legal liability.

There are also state regulations allowing emergency issuance of state medical licenses by medical boards and also cross-border practice of medicine through telehealth without the need for medical licensing. Some of these waivers are limited to allowing continued care for previous patients and can be limited to only neighboring states. Importantly, healthcare providers and entities may face legal liabilities such as negligence (as defined above) during public health emergencies such as the COVID-19 pandemic. However, certain protections can be enacted in defense of this. The Secretary of the Department of Health and Human Services declared on March 10, 2020 (using the authority of the Public Readiness and Emergency preparedness Act of 2005) that certain providers and entities would be immune from legal liability for claims associated with actions taken to treat and curtail the spread of COVID-19 pandemic.  Some states followed suit and granted the same level of liability immunity to healthcare workers. For employees, such legal liability is not well defined but will be very difficult to prove in a pandemic condition based on recent case laws because of difficulty in proving that source of infection was at work and not elsewhere.15

Cutting Edge/Unique Concepts/Emerging Issues

Risk management in a rehabilitation setting involves taking steps to avert an actual or potential calamity through the provision of a safe and effective environment. This entails having a dedicated risk management department staffed with people experienced in taking appropriate steps in preventing or mitigating such risks. State and national regulatory bodies such as Joint Commission for Accreditation of Healthcare Organization (JCAHO) and Commission on Accreditation of Rehabilitation Facilities (CARF) also require this and are recognized by payors and the Center for Medical Services (CMS) as evidence of set standard of care.

Risk management tends to involve the identification, analysis, treatment and evaluation of all possible hazards.

A dedicated risk manager will have the competence and responsibilities to ensure the prevention and reduction of losses, manage claims, oversee financial risks and maintain compliance with risk regulations and accrediatations.13

There are various protocols and steps that should be in place as part of risk management and these include:

  • Adequate documentation of every patient encounter. The EMR helps in this regard.
  • Policies, procedures and enforcement of treatment protocols as these form part of the operational steps and standards of care.
  • Incidence and Occurrence reporting especially at the time of the incident by those directly involved. This could help in preventing such mishap in future by instituting new policies, training, etc. It could be also be the basis for evidence of events as part of the business record doctrine.

Gaps In Knowledge/Evidence Base

N/A

References

  1. Ramanthan, T. (2014). Law as a tool to promote healthcare safety. Clin Gov., 19(2), 172-180. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741097/
  2. Studdert, D et al. Medical Malpractice. New England Journal of Medicine 2004;350:283
  3. Preskorn, S. H. MD. Clinical Psychopharmacology and Medical Malpractice: The Four Ds. Journal of Psychiatric Practice 20(5):p 363-368, September 2014. | DOI: 10.1097/01.pra.0000454781.67482.ad. https://journals.lww.com/practicalpsychiatry/fulltext/2014/09000/clinical_psychopharmacology_and_medical.6.aspx
  4. Lesnik, M et al. Legal Aspects of Nursing. Lippincort, Philadelphia, PA. 1947 p. 258.
  5. “Long Island R. Co. v. Palsgraf.” New York State Court Reports. Accessed May 27, 2024). https://www.nycourts.gov/reporter/archives/palsgraf_lirr.htm
  6. Lawshelf Educational Media. ‘Duty of Care, Part 2.’ Lawshelf Accessed May 27, 2024.. https://www.lawshelf.com/coursewarecontentview/duty-of-care-part-2
  7. Sewick, J et al. the Health care Risk Management Professional: Carroll, R (Ed): Risk Management Handbook for Health Care Organizations, 3rd ed. 2001. p. 3-4 Jossey-Bass. San Francisco
  8. Cornell Law School, ‘Assault.’ Legal Information Institute. Accessed May 27, 2024.. https://www.law.cornell.edu/wex/assault
  9. Cornell Law School. ‘Battery.’ Legal Information Institute. Accessed May 27,2024.. https://www.law.cornell.edu/wex/battery
  10. Cornell Law School. ‘False Imprisonment.’ Legal Information Institute. Accessed May 27, 20204.. https://www.law.cornell.edu/wex/false_imprisonment
  11. Cornell Law School. Intentional Infliction of Emotional Distress.’ Legal Information Institute. Accessed May 27, 2024.. https://www.law.cornell.edu/wex/intentional_infliction_of_emotional_distress
  12. Modernizing and Clarifying the Physician Self-Referral Regulations Final Rule (CMS-1720-F) https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-final-rule-cms-1720-f accessed January 25. 2021 (accessed on January 25, 2021).
  13. Medicare 1135 Waivers, May 2020; https://www.cms.gov/files/document/covid-19-regulations-waivers-enable-health-system-expansion.pdf (accessed November 15, 2020).
  14. Waiver or Modification of Requirements under section 1135 of the Social Security Act , March 13, 2020; https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx (accessed November 15, 2020).
  15. Immunity from liability in the age of COVID-19: A New reality for Trial Lawyers? https://www.americanbar.org/groups/litigation/committees/trial-practice/articles/2020/immunity-from-liability-covid-19-trial-lawyers/ (accessed on November 16, 2020).

Original Version of the Topic

Segun Dawodu, MD. Medico-Legal Considerations/Risk Management in Rehabilitation. 9/11/2015

Previous Revision of the Topic

Segun Dawodu, MD. Medico-Legal Considerations/Risk Management in Rehabilitation. 2/23/2021

Author Disclosures

Sunil K Jain, MD
Nothing to Disclose

Maedot Haymete, BA
Nothing to Disclose