|
 
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| REVIEW ARTICLE |
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| Year : 2020 | Volume
: 8
| Issue : 1 | Page : 83-87 |
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Medicolegal challenges in the COVID era
George C Vilanilam1, Praveen Kumar John2
1 Department of Neurosurgery, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India
2 Department of Radiodiagnosis, AJ Institute of Medical Sciences, Mangalore, Karnataka, India
| Date of Submission | 20-May-2020 |
| Date of Decision | 08-Jun-2020 |
| Date of Acceptance | 09-Jun-2020 |
| Date of Web Publication | 20-Jun-2020 |
Correspondence Address:
Prof. Dr. George C Vilanilam
Additional Professor (Neurosurgery), Sree Chitra Tirunal Institute for Medical Science and Technology, Thiruvanathapuram, Kerala
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/amhs.amhs_109_20
Unprecedented times created by the COVID-19 pandemic have challenged medicolegal limits to unimaginable levels. The traditional Hippocratic Oath, provision of medical care, informed consent, and research ethics have all been put to the immense test. Concepts on medical negligence, malpractice, and standards of care are all being redefined in this era, based on epidemiological concerns and priorities. Basic concepts in public health ethics, bioethics, human rights, and epidemiology need to be adapted and restructured to these times. Medical negligence laws would be viewed through the lens of the epidemic diseases act in COVID times. We examine the challenging scenarios wherein ethical, moral, and medicolegal rights have been stretched in these pandemic times. We also aim to examine the vulnerable clinical and research scenarios during pandemic times, with an intent to offer the most ethically, morally, and legally appropriate solutions.
Keywords: Bioethics, COVID times, informed consent, medicolegal, patient rights
How to cite this article:
Vilanilam GC, John PK. Medicolegal challenges in the COVID era. Arch Med Health Sci 2020;8:83-7 |
| Introduction | |  |
”Extraordinary times require extraordinary measures.
We should not let people die with their rights on.”
– Dennis Culhane.
Fear, uncertainty, and distrust characterize epidemic outbreaks. The most crippled by pandemics are often resource limited, developing nations. In these nations, vulnerable patients and research subjects may compromise their rights for prioritized access to care services and resources. Potentially competing ethical concerns add to the public health pandemic woes.[1],[2]
Never before has humankind faced such an overwhelmingly extraordinary challenge, as posed by the present Covid times. As on May 17, 2020, 4,799,266 people have tested positive for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 319,965 people have succumbed to the illness.[3] About 210 countries worldwide had patients afflicted by the disease.[3] Preserving lives and preventing the pandemic spread, while upholding ethical standards is a daunting task. One may justify a dilution of medicolegal rights for the greater gain of protecting human lives. However, it is impending on medical practitioners and researchers to uphold the highest medicolegal standards of care despite the pandemic urgencies that tempt to lower the bar.[4]
Unprecedented and unique medicolegal scenarios have been the hallmark of medical care in the Covid times. In the urgency to provide optimum care while protecting caregivers' health and elevating research gains, medicolegal compromises have almost become an acceptable norm. We examine the distinctive and unexpected situations posed by clinical care and research in these times, wherein moral, ethical, and legal standards are challenged to their limits.[4],[5]
| Medicolegally Vulnerable Situations in COVID Era | | |
Medical care in times of a pandemic is often compromised and constrained. In usual nonpandemic times, the principles of justice, equality, beneficence, utility, respect, liberty, reciprocity, and solidarity govern all acts of medical care done in good faith. Maintaining high ethical standards without compromising public health principles is crucial.[4],[5],[6]
| Some Vulnerable Situations | | |
Constrained clinical circumstances
Every patient or health-care worker (HCW) could be a source of infection, and therefore, clinical care is greatly compromised.[4],[5],[6],[7],[8],[9] The viral load and infectivity being more in health-care scenarios adds further insult to the existing injury [Table 1].
Examples
- A surgeon using personal protective equipment (PPE) for an emergency brain tumor surgery under the operating microscope in a COVID patient may be restricted in his/her surgical skills and the flow of the operation due to the bulky equipment and added protocols. Potentially, this carries an enhanced risk of adverse events
- Physical examination of outpatients may be compromised and thus bedside clinical diagnosis, greatly impaired [10]
- The doctor is often put in a situation where he/she has to decide whether a patient needs to go for COVID testing and further treatment. There can be errors of judgment in these, and the doctor cannot be made liable when he/she has offered the best available treatment in good faith.
Patient confidentiality
Example
Ensuring the confidentiality of identity and medical records may not be conformable to public health regulations during pandemic times
Resource crunches and rights/obligations of health-care workers (frontline and non-frontline)
Training, tools, and resources necessary to minimize the HCWs risks to the most reasonable possible extent are desired but less often achieved.[4],[5] Frontline health workers cannot be expected to expose themselves to risks that are out of proportion to the public health benefits, and their efforts are likely to achieve.
Example
HCWs in nonfrontline care may not have sufficient protective gear while treating “suspect cases,” thereby increasing exposure risks.
Health-care systems have a duty to ensure the following:[6]
- Minimize the risk of infection of personnel and patients
- Priority access to health care for infected HCWs
- Appropriate remuneration, incentives, and “hardship allowance”
- Support for reintegrating into the community after the pandemic times
- Assistance to family members of HCWs
- Reciprocal obligations for the service rendered
- Equity and transparency in task and resource allocations
- Fair consequences for nonparticipation-exigent circumstances and health frailties may restrict an HCW from offering services in a pandemic. These situations need to be viewed humanely by the authorities with restricted penalties.
Informed consent
Complete autonomy with the patient having sound decision making capacity and full information about the procedure, are the cornerstones of informed consent.[7] These could be clouded in pandemic times due to several exigencies as follows:
- Risk of cross-infection with SARS-CoV2 during treatment/surgery of the patient and caregivers
- Compromised clinical care reduced outpatient and surgical services for nonemergent care, less frequent imaging, and postoperative review consultations
- Elevated cost of care
A medicolegally sound “model consent form” has been proposed for these Covid pandemic times [Table 2].
Working outside fields of specialization
As pandemic health-care requires supportive and general measures, specialists may be called upon for frontline care outside their areas of expertise. Retired doctors may also be called into meet the requirements. A restricted number of working hands and quarantined fellow workers further stretch this need.
Example
When orthopedic surgeons may be expected to man intensive care unit ventilators, their liabilities for less than optimum performance need to be reduced.
Enhanced positions and temporary registrations
To meet urgent workforce needs in a pandemic, medical students and resident doctors may need to be urgently recruited for clinical services before completing their qualifying examinations. They would be expected to provide professional services, but their liabilities could be limited in these exigent situations.[4]
Remote consultations and telemedicine
Telemedicine services are invaluable in pandemic times despite the few limitations. Without the clinician's diagnostic and caring touch, several gaps remain in optimum clinical services. Misdiagnosis and consequent liabilities could be delayed fallout of this care rendered in good faith. In addition, data breach and confidentiality issues may become more likely in these circumstances.
Research in Pandemic times
The urgency to find treatment intervention benefits in a pandemic could often trample upon basic rights of research subjects.[1],[2] These subjects could be the layman in the community, the infected patient, HCW, or people having non-Covid ailments. The basic principles of pandemic research should be centered on scientific validity, social value, risk–benefit ratios, fair and voluntary participation, and equal moral respect for participants and cleared by independent fair reviews. A basic checklist of questions to guide ethical benchmarks in pandemic research would be useful [Table 3].
Enhanced cost of medical care
The judicious use of PPE, tests, and additional precautions to protect the patient/HCW from cross-infections add significantly to the cost of care. The costs would be borne by state-sponsored health-care systems, insurance companies, or by individuals are per the norms in different nations.[4]
Example
Hospital bills for both Covid care and non-Covid ailments are enhanced by 30%–400% of the pre-pandemic times, thus making medical care outrageously expensive.
| Medical Negligence and Culpabilities in Pandemic Times | | |
The Epidemic act with its legal measures to control the pandemic may often cross paths with medical malpractice laws and concepts of medical negligence in these pandemic times.[4],[5] The Epidemic Diseases Act of 1897 was put in place due to the mass spread of the bubonic plague outbreak in Bombay. The Epidemic act is centered around enforcement of public health measures for epidemic control. On the other hand, medical negligence laws are centered on standards of care, rights of the patient, and the doctors' duties.
The necessary components for establishing professional negligence (as proposed by Percy and Charlesworth)[8],[9] are
- Existence of a duty to take care which is owed by the defendant to the complainant
- Failure to attain the standard of care prescribed by the law, thus committing a breach of duty
- Damage suffered by the complainant caused by this breach of duty and recognized by law.
Thus, a medical practitioner could have the following liabilities in his/her usual duties of providing medical care,
- Tortious liability (civil)
- Contractual liability
- Criminal liability – For gross criminal negligence.
However, in pandemic times, several exigencies exist and these laws have to viewed in the right context and penalties modified accordingly.
| Penalties in Pandemic Times | | |
Regulatory orders in pandemic times need laws to enforce them.[4],[5],[6] The Indian Section 188, Indian Penal Code (IPC), imposes punishment for disobeying an order promulgated by a public servant, and this is often used to enforce the Epidemic Act violations. Section 269 of the IPC prescribes punishment for negligent actions which may spread infection of any disease, and Section 270 is a more serious offence than the one listed under Section 269.
During usual non-pandemic times, acts of alleged medical negligence, doctors could incite liability under IPC Section 304 A (rash or negligent act causing death not amounting to culpable homicide), IPC 336,337,338 respectively (rash or negligent act endangering life, safety of others, causing grievous hurt). Besides this, violation of a contract under the consumer protection act or civil right violations(falling short of reasonable standards in clinical care) could attract medical negligence charges. However, these laws need to be interpreted through the prism of the alarmist and constrained medical care during the pandemic.
| Doctor's Defense Against Claims and Charges | | |
A medical practitioner works under immense pressures and compromises during a pandemic, often stretching beyond the call of duty. Whether this could be reason enough to lower the medicolegal bar of standards is a matter of debate.[2] However, in medicolegally vulnerable situations, the defense of a doctor could be based on the following,
Exigent circumstances
Resource crunches, crisis urgencies, and health risks to self and extreme hardships may mitigate the liabilities of a doctor charged with medical negligence in pandemic settings.
Good Samaritan cover
When care is rendered to individuals to whom the practitioner does not owe a duty, then his liabilities are reduced. Hence, rendering voluntary service outside one's specialization or after retirement may be considered a Good Samaritan's service in difficult times.
Limitations of the present review
Concepts of bioethical propriety, medicolegal rights, and ethical practices are undergoing rapid modifications based on epidemiological principles and regulations. Thus, these contemporary views are subject to frequent fluctuations in these fluidic times.[1],[2]
| Conclusion | | |
Vulnerable medicolegal situations of an unprecedented nature are faced by health-care personnel and researchers in the Covid pandemic era. In public health crisis situations, medical practitioners are expected to go beyond the call of duty. All HCWs strive to abide by the highest ethical and moral standards despite difficult circumstances posed by the pandemic crisis. Yet, when these times pass and past practices are reviewed by future generations, one must not be caught off guard. Containing the pandemic and preserving patient rights, both should have equal priority despite moments of conflict.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Rosenbaum L. Facing covid-19 in Italy-Ethics, logistics, and therapeutics on the epidemic's front line. New England J Med 2020;382:1873-5. doi:10.1056/nejmp2005492.  |
| 2. | London AJ, Kimmelman J. Against pandemic research exceptionalism. Science 2020;368:476-7. |
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| 7. | Bernat JL, Peterson LM. Patient-centered informed consent in surgical practice. Arch Surg 2006;141:86-92. |
| 8. | Zhang ZY, Yao Y, Zhou LF. To err is human-medicolegal issues and safe care in neurosurgery. World Neurosurg 2014;81:244-6. |
| 9. | Vilanilam GC, Sasidharan GM. Informed refusal-A gray area in informed consent. Neurol India 2016;64:1393-5. [ PUBMED] [Full text] |
| 10. | Iype B, Vilanilam GC. Patellar jerks in the 3-Tesla era: No knee-jerk excitement anymore! Neurol India 2017;65:1445-7. |
[Table 1], [Table 2], [Table 3]
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