CMAAO CORONA FACTS and MYTH BUSTER 81

CMAAO CORONA FACTS and MYTH BUSTER 81

Dr K K Aggarwal

President Confederation of Medical Associations of Asia and Oceania, HCFI, Past National President IMA, Chief editor Medtalks

787: Round Table Expert Meet of Medical Liability in COVID Era

May 2, 2020 , 11am- 12 noon

Participants

Dr KK Aggarwal, President CMAAO

Dr Rajan Sharma, National President IMA

Dr RV Asokan

Dr Jayakrishnan Alapet

Dr Girish Tyagi

Dr Ashok Gupta

Dr PN Arora

Dr Narasinga Reddy Toutireddy

Dr Raman Kapur

Dr Marthanda Pillai

Shobha Mishra Ghosh

Prof Mahesh Verma

Dr Omkar Gokhale

Dr Shiv Kumar Utture

Dr Anoop Misra

Dr Ambrish Mithal

Dr Narottam Puri

Dr LK Bharti

Dr NK Pandey

Dr Ashok Gupta

Dr Alok Roy

Dr Harsh Mahajan

Dr Gangadhar Rao

Dr Mohsin Wali

Dr Suneela Garg

Dr AK Agarwal

Dr Sudhanva Kariganoor

Dr Angeli Misra

Dr Alexander Thomas

Dr DR Rai

Dr Arnab Gupta

Dr Gyani Girdhar

Dr JA Jayalal

Dr Naveen Malhotra

Dr Prabhakara GN

Dr Jaya Dhaka

Rachnna

Dr Atul Pandya

Dr Mahima Gupta

Dr NK Pandey

Ashok Grover

Mini Thomas, The Week

Sanjay Prasad

Dr Ganesh K Mani

Dr Maulik Vyas

Dr Apurva IE

Dr Shashank Joshi

Ms Ira Gupta

Dr K Kalra

Naina Aggarwal

Saurabh Aggarwal

Dr Sanchita Sharma

Experts

Justice AK Sikri, Retd. Supreme Court Judge

Mr Mukul Rohatgi, Former Attorney General for India

Excerpts

Acts currently applicable during the Covid pandemic are the Disease Management Act, 2005 at the national level and the Epidemic Diseases Act, 1897 at the state level.

The Epidemic Diseases Act, 1897 has not been revised till date. 

Section 2A of the Epidemic Diseases Act, 1897  states: “When the Central Government is satisfied that India or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease and that the ordinary provisions of the law for the time being in force are insufficient to prevent the outbreak of such disease or the spread thereof, the Central Government may take measures and prescribe regulations for the inspection of any ship or vessel leaving or arriving at any port in the territories to which this Act extends and for such detention thereof, or of any person intending to sail therein, or arriving thereby, as may be necessary.” It uses the words “dangerous epidemic disease”, but the Act does not define either “dangerous” or “epidemic”.

Under Section 4 of Epidemic Act, “no suit or other legal proceeding shall lie against any person for anything done or in good faith intended to be done under this Act”. But it’s not clear if medical professionals are covered under this. Also, the meaning of the words “good faith” needs to be clarified.

The Disaster Management Act, 2005 defines disaster in Section 2(d) as “a catastrophe, mishap, calamity or grave occurrence in any area, arising from natural or man-made causes…”. Covid-19 has been included as a “Notified Disaster” or as a “critical medical condition or pandemic situation”.

Section 74 of the Disaster Management Act provides immunity from legal process, but only to “Officers and employees of the Central Government, National Authority, National Executive Committee, State Government, State Authority, State Executive Committee or District Authority in regard to any warning in respect of any impending disaster communicated or disseminated by them in their official capacity or any action taken or direction issued by them in pursuance of such communication or dissemination”. Again, it does not cover healthcare professionals.

Section52 of the Indian Penal Code (IPC) defines good faith as “nothing is said to be done or believed in “good faith” which is done or believed without due care and attention”.

Section 270 is applicable to Covid, which is “Malignant act likely to spread infection of disease danger­ous to life.—Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.”

The United States has come out with legislations granting immunity to HCPs during Covid-19.

Section 3215 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act establishes a specific limitation on liability for "volunteer" health care providers during the COVID-19 emergency declaration. With certain exceptions, it provides that such providers "shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services" during the COVID-19 public health emergency. In addition to volunteer status, the services being rendered must be within the scope of the provider's license (including applicable state law emergency expansions of scope of practice).  Providers are not protected from liability for harm resulting from the provider's willful or criminal misconduct, gross negligence, reckless misconduct, or "conscious flagrant indifference" to the patient's rights or safety. Further, providers are not protected from claims resulting from care given while the provider is under the influence of drugs or alcohol.

Another law in the US, the Public Readiness and Emergency Preparedness (PREP) Act provides that a "covered person," including a qualified person who prescribes, administers, or dispenses "pandemic countermeasures," "shall be immune from suit and liability under Federal and State law with respect to all claims for loss covered by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure" during a declared disease-related public health emergency.

Besides these two Federal laws, various states in the US may have provisions that limit or immunize providers from liability.

Following queries and concerns of doctors were highlighted during the discussion

1.    Definition of “good faith” mentioned in the Epidemic Disease Act (Section 4), Disaster Management Act (Section 73) and its implication.

2.    Immunity from legal process”: Disaster Management Act (Section 74) and its implication

3.    Are healthcare professionals covered under Epidemic Act, 1897 and Disaster Management Act, 2005? If yes, can they take defence of work done under good faith?

4.    Are healthcare professionals who are not treating COVID-19 patients covered under Epidemic Act, 1897 and Disaster Management Act, 2005? ? If yes, can they take defence of work done under good faith? E.g. doctors are not able to attend to their non-Covid-19 patients properly due to lockdown limitations as many clinics are closed, patients are afraid to come to hospitals.

5.    If answers to Queries 3 and 4 are “no”, then what are the available remedies and defences for HCPs? Can the government include HCPs under these two acts by passing some order or clarification?

6.    Can a separate legislation be enacted by Government of India just like USA giving immunity to healthcare professionals during COVID period? If yes, then what is the procedure?

7.    What are the immunities available to healthcare professionals under Epidemic Act, 1897 and Disaster Management Act, 2005 during lockdown period and after that?

8.    Can healthcare professionals be included under Section 74 of the Disaster Management Act, 2005 and get complete immunity from any liability for any act during COVID period? If yes, then what is the procedure?

9.    Are the Epidemic Act, 1897 and Disaster Management Act, 2005 applicable till the lockdown period or till the eradication of COVID-19 from the country?

10. What law will prevail once Epidemic Act, 1897 and Disaster Management Act, 2005 are lifted from the country?

11. Will the Epidemic Disease Act be applicable in Green Zones?

12. Testing: Doctors have the right to ask for Covid test for patients scheduled for chemotherapy or non-elective surgery or for non-Covid illness. But, the government says that hospitals cannot insist on Covid-19 testing as it will be considered a crime. Doctors themselves need to be tested for Covid-19. Italy has made it compulsory for all doctors to undergo weekly Covid test and state their positive or negative status.

Expert Opinion

·        Disaster Management act does not provide immunity to the medical profession. It provides immunity only to the officials of the authority mentioned in the section. Likewise, the Epidemic Disease Act also does not protect the private doctors.. The question of “good faith” and other questions will arise only when doctors are covered by these Acts.

·        Justice AK Sikri expressed his “pain and anguish” that doctors themselves are struggling to find ways out to not be harassed or persecuted by their patients. Under the existing environment today, doctors need all kinds of protection.

·        Once a case is filed against a doctor, under ordinary law, he/she will have to defend the complaint and establish that the action was in good faith and he/she was not negligent. If the doctor has acted in a certain manner as per the government instructions, this may become a clear defense.

·        The American laws, not only the Central Act but also the state acts (Louisiana, Georgia, Maryland, and Tennessee) provide immunity to doctors from civil and criminal negligence unless they have wantonly or negligently treated their patients.

·        Just as the government has added a section in the Epidemic Diseases Act, 1897 by an Ordinance providing for punishment, if there is an act of violence against doctors and paramedical workers, in the same way, Section 74 can be amended or a new section can be added at the time when the Disaster Management Act is in operation by a notification.

·        Just as the issue of violence has been addressed, this issue has to be addressed. But for that it has to be shown that unnecessary willful, malicious threats or complaints have been initiated against doctors during the pandemic.

·        The court does not have the power to direct the government to pass a law; this is the preserve of the government or the Parliament. But the Court can make a recommendation to the government to urgently look into this matter and address/redress the issue. This will be useful not only in this pandemic but also in future such pandemics or epidemics.

·        Doctors can and should insist on Covid test as the result of the test may have an impact on the treatment protocol. For instance, the surgery, if not an emergency, can be postponed. Also, persons in contact with the patient need to be quarantined.

·        There should be en masse testing of medical professionals/paramedical workers for Covid, as they are the ones treating the patient and so can be carrier themselves. The medical council can forward a protocol in this regard to ICMR or the government (State or Central).

Further course of action

Immunity for medical professionals is the need of the hour in this time of Covid-19. This is a difficult time. There are going to be mistakes, which are beyond the control of doctors, since it is a totally new disease. Doctors and other healthcare workers are at the forefront of this battle to fight Covid-19. Private healthcare takes care of about 75% of health needs of the country. Doctors and support staff are facing difficulties on account of contradictory orders of the government. Guidelines are not clear.

·        In view of this, it was decided to file a representation to the Prime Minister/Health Minister in this regard citing all instances of complaints or malicious actions against HCPs along with list of apparent contradictions and inconsistencies in government directives.

·        If the Government does not respond, then the petition would be filed in the Supreme Court of India.

·        The draft petition would be first vetted by Mr Mukul Rohatgi.

·        Consent of all associations and organizations to be taken individually.

·        Copy of the petition to be marked to the Board of Governors and all State Medical Councils.

4^th May

One US national plaintiff attorney malpractice firm has been advising the public to be on the lookout for certain types of medical negligence that could occur during this crisis and that might be grounds for making a claim:

Alleged failures of hospitals to prepare for and respond appropriately and timely to coronavirus patients;

The negligent failure of hospitals and other healthcare providers to timely diagnose the coronavirus in patients;

The negligent failure to take appropriate precautions to prevent or limit the exposure to and spread of coronavirus among patients not infected;

The negligent failure to timely and appropriately treat coronavirus patients; and

Negligent failures that result in the delay of unrelated treatments and procedures that cause harm to patients.

Acts as applicable to COVID 19

Acts as applicable to COVID 19

Dr KK Aggarwal

President CMAAO, HCFI and Past national President IMA

The legislative section is divided into three lists: Union List, State List and Concurrent List. It is true that public health is a state subject.  But the Concurrent List or List-III] (Seventh Schedule) is a list of 52 items  given in the Seventh Schedule to the Constitution of India. It includes the power to be considered by both the central and state government.

The State list: 6, includes Public health and sanitation; hospitals and dispensaries.

However the concurrent list 26 covers Legal, medical and other professions and 29 covers: Prevention of the extension from one State to another of infectious or contagious diseases or pests affecting men, animals or plants. Concurrent list.

Also, an epidemic is also covered under disaster management act.

Powers executed by the Union home secretary under the disaster management Act were "delegated" to health ministry to enhance preparedness against the coronavirus outbreak. The Union home ministry order said the powers are exercised by the Union home secretary under section 10 of the Act and he being the Chairman of the National Executive Committee (NEC).

Other acts Applicable to COVID 19

Indian Public Health system

India has a constitutional division of legislative responsibilities between the central government and the states.  Both the central government and the state governments are constitutionally empowered to legislate on matters of public health. 

Central Acts

1.  Epidemic Diseases Act 1897

The preamble states that its objective is to provide for better prevention of the spread of dangerous epidemic diseases.

It empowers the state governments and the central government to take measures as may be warranted or necessary to control the further spread of disease. 

Thus, any state government, when satisfied that any part of its territory is threatened with an outbreak of a dangerous disease, may adopt or authorize all measures, including quarantine, to prevent the outbreak of the disease.

Similarly, the central government, when satisfied that there is an imminent threat of an outbreak of an epidemic disease and that the provisions of the law at that time are insufficient to prevent such an outbreak, may take measures and prescribe regulations allowing for the inspection of any ship or vessel leaving or arriving at any port and for the detention of any person arriving or intending to sail.

Any person who disobeys any regulation or order made under the 1897 Act may be charged with an offense under section 188 of the Indian Penal Code.

188. Disobedience to order duly promulgated by public servant.—Whoever, knowing that, by an order promulgated by a public serv­ant lawfully empowered to promulgate such order, he is directed to abstain from a certain act, or to take certain order with certain property in his possession or under his management, disobeys such direction, shall, if such disobedience causes or tends to cause obstruction, annoyance or injury, or risk of obstruction, annoyance or injury, to any person lawfully employed, be punished with simple impris­onment for a term which may extend to one month or with fine which may extend to two hundred rupees, or with both; and if such disobedience causes or trends to cause danger to human life, health or safety, or causes or tends to cause a riot or affray, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both. Explanation. —It is not necessary that the offender should intend to produce harm or contemplate his disobedience as likely to produce harm. It is enough that he knows of the order which he disobeys, and that his disobedience produces, or is likely to produce, harm. Illustration An order is promulgated by a public servant lawfully empowered to promulgate such order, directing that a religious procession shall not pass down a certain street. A knowingly disobeys the order, and thereby causes danger of riot. A has committed the offence defined in this section.

Such offense, at the discretion of the trial magistrate, may be tried summarily.  No suit or legal proceeding lies against any person or authority for anything done, or in good faith intended to be done, under this Act. 

Some of the issues that require revisiting, the act is the “definition of epidemic disease, territorial boundaries, ethics and human rights principles, empowerment of officials, [and] punishment.” National Centre for Disease Control is developing a “Public Health Emergencies Act,”.

2. Indian penal Code: Section 270: Malignant act likely to spread infection of disease danger­ous to life.—Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.

3. MCI Ethics Regulations: 2.2 Patience, Delicacy and Secrecy: Patience and delicacy should characterize the physician. Confidences concerning individual or domestic life entrusted by patients to a physician and defects in the disposition or character of patients observed during medical attendance should never be revealed unless their revelation is required by the laws of the State. Sometimes, however, a physician must determine whether his duty to society requires him to employ knowledge, obtained through confidence as a physician, to protect a healthy person against a communicable disease to which he is about to be exposed. In such instance, the physician should act as he would wish another to act toward one of his own family in like circumstances.

4. MCI Ethics Regulation 7.14:  The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his / her profession except – i) in a court of law under orders of the Presiding Judge; ii) in circumstances where there is a serious and identified risk to a specific person and / or community; and iii) notifiable diseases. In case of communicable / notifiable diseases, concerned public health authorities should be informed immediately.

5. Quarantine of Visitors: For people entering India from abroad, a health officer appointed by the central government is posted and empowered at the port of entry.

The health officer may demand to see the aircraft journey logbook, which shows the places the aircraft visited. He may also inspect the aircraft, its passengers, and its crew, and subject them to medical examinations after their arrival.

The officer must follow specific precautions about communicable diseases that require a period of quarantine (such as yellow fever, plague, cholera, smallpox, typhus, and relapsing fever) and other infectious diseases that do not require a period of quarantine.

He may prohibit the embarkation on any aircraft of any person showing symptoms of any quarantinable disease and any person whom the health officer considers likely to transmit infection.

Regulations require that airline staff report any suspected cases or passengers who in their opinion, from observations made in flight, may be suffering from symptoms of a quarantinable disease. 

With respect to Ebola, in early August 2014, the Health Ministry announced that “mandatory self-reporting is required at immigration.”

6. Right to move free

Quarantine affects the fundamental right “to move freely throughout the territory of India.” However, this right is subject to reasonable restrictions that the state may impose in the interest of public health.

7. Right to privacy

The Supreme Court of India has found that the right of privacy is an essential component of the right to life, but that it is not absolute and may be restricted to prevent crime or disorder, or to protect health, morals, or the rights and freedom of others.

State acts

Punjab Vaccination Act makes primary vaccination and revaccination of children compulsory throughout the state. 

Epidemic Diseases Act gives wide ranging powers to the states.

The states, in such emergencies, delegate some of these powers to the deputy commissioners in the districts typically through state health acts or municipal corporation acts. 

State and Municipal Governments  

A state government may also take measures and prescribe regulations for the inspection, vaccination, and inoculation of persons traveling by road or rail, including their segregation in a hospital, temporary accommodation, or otherwise, if such persons are suspected by the inspecting officer of being infected with any such disease.

A state government, by general or special order, may also empower a deputy commissioner to exercise, in relation to his district, all the powers under section 2 of the 1897 Act that are exercisable by the state government in relation to the state, other than to determine the manner in which and by whom any expenses are to be defrayed. 

Many of these powers are prescribed in Municipal Corporation Acts governing “major municipal areas,” or Public Health Acts that also provide municipal-level commissioners or collectors with quarantine or other powers. These can be in relation to removal of a person to separate premises for medical treatment, Cleansing or disinfecting any building or part of any building or any articles, taking special measures in case of the outbreak of dangerous or epidemic diseases.

Civil Rights 

The ambit of section 2 of the Epidemic Diseases Act is wide enough to allow a state or a lower functionary in the administration, in dealing with an emergency caused by the outbreak of a dangerous disease, to seek or require the cooperation of the public or corporate bodies in the public or private sectors.  If the desired cooperation is not forthcoming, a regulation may be imposed.  Failure to obey or comply with restrictions imposed by such a regulation constitutes a punishable violation.

Judiciary

The judiciary in India ensures transparency in government actions and executive orders.  One can seek judicial review of executive orders and regulations.  The Parliament of India has also enacted a Freedom of Information Act, requiring transparency in government actions.

International Regulations

PHEIC: mandates reporting to WHO about disease in question

The epidemic Act

2. Power to take special measures and prescribe regulations as to dangerous epidemic disease] is satisfied that [the State] or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease, the  [State Government], if [it] thinks that the ordinary provisions of the law for the time being in force are insufficient for the purpose, may take, or require or empower any person to take, such measures and, by public notice, prescribe such temporary regulations to be observed by the public or by any person or class of persons as  [it] shall deem necessary to prevent the outbreak of such disease or the spread thereof, .

(1) When at any time the [State Government and may determine in what manner and by whom any expenses incurred (including compensation if any) shall be defrayed.

 (2) In particular and without prejudice to the generality of the foregoing provisions, the  [State Government] may take measures and prescribe regulations for— (b) the inspection of persons travelling by railway or otherwise, and the segregation, in hospital, temporary accommodation or otherwise, of persons suspected by the inspecting officer of being infected with any such disease.

[2A. Powers of Central Government.—When the Central Government is satisfied that India or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease and that the ordinary provisions of the law for the time being in force are insufficient to prevent the outbreak of such disease or the spread thereof, the Central Government may take measures and prescribe regulations for the inspection of any ship or vessel leaving or arriving at any port in [the territories to which this Act extends] and for such detention thereof, or of any person intending to sail therein, or arriving thereby, as may be necessary.]

3. Penalty. —Any person disobeying any regulation or order made under this Act shall be deemed to have committed an offence punishable under section 188 of the Indian Penal Code (45 of 1860).

4. Protection to persons acting under Act. —No suit or other legal proceeding shall lie against any person for anything done or in good faith intended to be done under this Act.

COVID 19

• Despite CDC protest, 14 Americans infected with coronavirus on the Diamond Princess cruise ship shared a plane back to the US with healthy passengers, separated by plastic sheeting. (New York Post)
• A US court temporarily blocked government from sending up to 50 people infected with a new virus from China to a Southern California city for quarantine after local officials argued that the plan lacked details about how the community would be protected from the outbreak.
• Hong Kong police: nabbed a part-time security guard at a shopping mall for allegedly writing on social media that multiple staff members had caught a fever and gone on sick leave. The messages "caused panic" and helped "breed paranoia".
• Singapore: Severe penalties for non-compliance of the quarantine order, including fines or jail time.
• Saudi Arabia will impose a fine of up to 500,000 riyals ($133,000) on people who do not disclose their health-related information and travel details at entry points  
• Italy PM puts citizens on lock down and threatens them with a fine (206 euros; around £178) or jail (3 months) if they leave quarantine zones (Daily Mail UK)
• IPC: Section 270: Malignant act likely to spread infection of disease danger­ous to life.—Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
• Epidemic Disease Act, Essential Commodities Act, NLEM, Municipal corporation acts, state public health acts
• My rights to be tested