ISSUES, CHALLENGES & POSSIBLE SOLUTIONS

Dr. R. K. SharmaAssistant Professor

Dept. of Hosp. Admin. PGIMER Chandigarh

Assisted by Dr Jitender Sodhi

Introduction Milestones Brief description of CPA,1986 Consumer dispute redressal system Landmark judgments of honorable Supreme Court of

India CPA cases in which PGI gave expert opinion CPA cases against PGI ;case studies Do’s & Don’ts Take away message Conclusion

Consumer Protection Act, 1986 An important Act in the history of the consumer

movement in the country.

It was drafted to provide the better protection and promotion of consumer rights through the establishment of consumer councils and quasi-judicial machinery.

Mile stone in the history of socio-economic legislation and directed towards public welfare and public benefits

Consumer protection during the Mughal times and especially during the time of Khiljis.

British regime (1765-1947), (‘Colonial Era’), Government’s economic polices in India were concerned more with protecting and promoting the British interests than with advancing the welfare of the native population.

Prominent among these were: the Indian Penal code, 1860, the sale of Goods act, 1930, the dangerous drugs act, 1930 and the drugs and cosmetics act, 1940

J.N.Sarkar (1952): Mughal Administration, Calcutta.

J.N.Pandey (1992): Constitutional Law of India, Allahabad: Central Law Agency, pp.1-16.

During post independence period, enactment of a number of laws to safeguard the interests of the consumers from various angles such as:

Banking Companies Act,1949 (later called The Banking Regulation Act) to amend and consolidate the Law related to banking matters

Industries (Development and Regulation)Act,1951 to implement the Industrial Policy Resolution of 1948

These were among earlier steps taken by National Government in India in the direction of consumer protection.

“Thou shalt not injure thy neighbor

“Neighbor principle”- Lord Atkins (1932)

Liability for negligence is based on a general public sentiment of moral wrong doing for which the offender must pay

Neighbour : Persons who are so closely and directly affected by my act, that I ought to have them in my mind while performing those acts (Donoghue Vs Stevenson‘ 32)

Various provisions providing protection to the consumer against adulterated and substandard articles were made available, like

Indian Penal Code 1860

Criminal Procedure Code, 1908

Sales of Goods Act, 1930

Indian Contract Act, 1972

Cont…….

Prevention of Food Adulteration Act, 1954

Monopolies and Restrictive Trade Practices Act, 1969

Standard of Weights and Measures Act, 1976

Motor Vehicle Act,1988

But very little could be achieved in the area of consumer protection

Contd..

In order to achieve these objectives, the Consumer Protection Bill, 1986 was introduced in the Lok Sabha on December 5th 1986.

The motive of CPA 1986 was to ensure the better protection of the interest of consumers from exploitation and for the purpose to make provisions for the establishment of Consumers Councils and other authorities for the settlement of consumer’s dispute and for matters connected therewith.

Industrialization

Urbanization

Malpractice such as Adulteration

Shortage or Non availability of essential goods at reasonable price.

Lack of control on the quality of the consumer goods.

Global markets and open economie

CPA(1986) was enacted for the promotion and prevention of the consumers-

Right of redressal

Right to information

Right to choose

Right to be heard

Right to safety

A doctor, when consulted by a patient owes to him:

Duty of care

Duty of administration of most appropriate treatment. A breach of any of these duties gives the right of action for medical negligence to the patient.

Contd...

The main relief provided under the Consumer Protection Act is compensation for the damage caused due to deficiency in service, which in the case of medical services is negligence

Three elements for obtaining compensation:

That there was a legal duty of providing care.

Violation of that duty

That this breach resulted in damage, injury/death

Means a failure on the part of the doctor by not acting in accordance with medical standards in vogue which are being practiced by a prudent doctor practicing in the same profession.

Unexpected developments, complications and risks can not be considered as negligence, if these have been explained to the patient.

Prudent: exercising good judgment or common sense.

Medical services provided at Government/Non-Government hospitals, where fees are required to be paid by some and others are provided free service.

When the employer or insurance company bears the expenses of medical treatment.

ESI hospitals/SAIL or any other hospital/clinic run by an industrial house or company for the benefit of their employees and members of their families.

Non Government hospitals/ Government hospitals where all patients are given free service.

The question about excessive fee of doctor.

For violation of medical ethics.

When there is no evidence, documents, receipts etc and no affidavits to support your complaint.

Where case has already been filed / decided in a civil court for the same cause of action.

Services provided by CGHS dispensaries /hospitals etc where some token charges, such as membership fee/registration fee is charged but treatment and medicines are provided free .

When anyone feels or is able to prove :

That the patient has been made to pay the fees for a service not actually provided

When there has been a deficiency in the medical service provided as breach of duty described above.

ALLEGED EXCESSIVE FEES REGARDING CONSULTATION,OPERATION,DIAGNOSTIC TEST,BED CHARGES ETC,AND FOR ANY OTHER CHARGES FOR SERVICES ACTUALLY PROVIDED

A consumer for himself and/or for his beneficiary including parents, guardians for minor wards and children etc.

No fees.

The complaints can be either hand written legibly or typed, but preferably typed. It may be in a local language.

The complaint can be submitted in person, through agent/lawyers, or by registered post. documentary support is a must

Total Three members Retired District Judge –president One lady Compensation up to 20 lacs

Total Three members Retired High Court Judge -president One lady Compensation > 20 lakh to 1 crore Appeal against district forum of state

DISTRICT LEVEL

STATE LEVEL

Total Five members

Retired Supreme Court Judge –president One lady Compensation > 1crore Appeal against state forum Revision orders

NATIONAL LEVEL

The complaint needs to be lodged with in two yrs from the day of cause of action

Exception can be made but valid reason to be documented

With in 30 days Certain amount of compensation awarded is required to

be deposited

APPEAL AGAINST THE DECISION

LIMITATION PERIOD

1. Refund of the charges paid.

2. To award compensation for any loss or injury suffered due to the negligence of the opposite party / Nursing home.

3. To rectify the deficiency in services, and

4. To compensate the financial losses occurring to the affected party (e.g; lawyer fees, loss of wages in case of earning member and potential future earning)

The deficiency of service as described

CPA(original)1986Deficiency means any fault,

imperfection, shortcoming in quality, nature and manner of performance which is required by or under any law for time being in force or has been undertaken to be performed by person in pursuance of contract or otherwise in relation of any service.

8

The deficiency of service as described

CPA(original)1986Deficiency means any fault,

imperfection, shortcoming in quality, nature and manner of performance which is required by or under any law for time being in force or has been undertaken to be performed by person in pursuance of contract or otherwise in relation of any service.

8

Any act of Omission or commission which causes any damage to the consumer on account of negligence or consciously withholding of relevant information to the consumer.

Any act of Omission or commission which causes any damage to the consumer on account of negligence or consciously withholding of relevant information to the consumer.

PLUS

LANDMARK JUDGMENTS OF SUPREME COURT OF INDIA

 Issues Raised

Whether the services provided by a doctor to a patient fall under the ambit of ‘service’ as defined under section 2(1)(0) of this act.

Contd….

Judgment of Supreme Court

The Honorable court directed that services provided to a patient by a doctor by way of consultation, diagnosis and treatment, both medicinal and surgical, would fall within the ambit of 'service' as defined in Section 2(1) (o) of the Act.

The detailed inclusion and exclusion criteria's framed in this judgment are discussed earlier(slide no- 11&12)

Issues Involved

The patient died due to the carelessness of doctors and nurses and non availability of oxygen cylinder and the empty cylinder was fixed on the patient.

An FIR was registered under Section 304A/34 IPC, against the two doctors.

Both of them filed a revision in the Court of Sessions Judge and subsequently in High Court for quashing of the FIR but the revision was dismissed.

Contd….

The investigating officer before proceeding against the

doctor accused of negligence needs to obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical discipline

A doctor accused of negligence, may not be arrested in a routine manner (simply because a charge has been leveled against him).

A doctor may be liable in a civil case for negligence.

Issues Involved Patient filed a case in National Commission that he was

suffering from renal failure and the doctor was negligent in prescribing Amikacin (Contraindicated) which resulted in hearing impairment.

Patient alleged that it was wrong to prescribe Amikacin .

Patient was awarded Rs 4 lacs compensation by the commission.

The respondent went to Supreme court on appeal against this decision.

Whenever a complaint is received against a doctor or hospital by the Consumer Forum (whether District, State or National) or by the Criminal Court then before issuing notice to the doctor or hospital the matter must be referred to a competent doctor or committee of doctors, and if prima facie a case of medical negligence is established ,only then the notice be issued.

Contd…

The police officials were warned not to arrest or

harass doctors except as per the criteria laid down in Jacob Mathew case, otherwise they will have to face legal action.

Issues Involved

Patient counsel alleged that their patient died due to negligent treatment

Patient was treated for typhoid fever despite the fact that

she was suffering from malaria.

Contd….

Appellant won the case in Distt. Forum and they were awarded compensation of Rs 2 lacs.

Respondents approached state and national commission which quashed the orders of Distt. Forums as no expert opinion was taken to prima facie establish the medical negligence(Ref: Martin .F.D’Souza Judgment)

Contd…..

Modified the decision given in Martin.F. Dsouza case

Directed that the decision of sending cases for prima facie evaluation are to be judged on the facts of each case and there cannot be a mechanical or strait jacket approach that each and every case must be referred to experts for evidence.

CPA cases in which PGIMER has given

expert opinion

CPA cases in which PGIMER has given

expert opinion

The case files are received at Establishment branch of Medical Superintendent Office from various consumer forums

The case is processed and a committee of the concerned specialists is constituted to give expert opinion pertaining to case in a stipulated period.

When the comments are ready the same are sent back to the respective consumer forums.

Total fifty one case files received over a period of time from different consumer forums were studied (Nov’09-Dce’10)

It was observed that there is increase number of cases being referred to PGI after the judgment of Martin.F.D’Souza case

Sr No Consumer forum

No of Cases

1 District 42

2 State 9

3 National 0

4 Total 51

05

1015202530354045

Cases

Distt State NationalConsumer Forum Involved

SR NO STATE NO OF CASES

1 PUNJAB 45

2 HARYANA 3

3 CHANDIGARH 2

4 U.P 1

5 TOTAL 51

0

5

10

15

20

25

30

35

40

45

cases

Chd Pb Hry UPState

Sr. No. Age Group No. of Male

No. of Female

Total

1 >14 3 1 4

2 15-30 6 6 12

3 30-45 3 5 8

4 45-60 5 3 8

5 >60 6 2 8

6 Not Known 2 9 11

6 Total 25 26 51

Type of Negligence No. of Cases

Surgical Procedures 22

Wrong Diagnosis 11

Delay/Lack in Care 4

Dental Procedure 2

Operation Failure 5

Miscellaneous 5

Total 51

Department No. ofCases

General Surgery 8

Gyane & Obst 10

Neurosurgery 2

Medicine 5

Orthopaedics 12

Cardiology/CTVS 3

Dental Surgery 2

Ophthalmology 3

Miscellaneous 6

Total 51

Sr. No TYPE OF NEGLIGENCE

NO OF CASES

1 Death 8

2 Permanent handicap

9

3 Reoperation 14

4 Prolongation of medication

2

5 Miscellaneous 18

6 TOTAL 51

Compensation(Rs in Lacs) No of cases

LESS THAN 1 LACS 1

5 LACS 12

5-10 LACS 7

10-20 LACS 17

MORE THAN 20 LACS 1

NOT KNOWN 13

TOTAL 51

Sr no. Type of Inst No of Cases

1 Private Instt 16

2 Nursing Home 19

3 Govt. Instt 6

4 Charitable Instt 3

5 Corporate Instt 5

6 Not known 2

7 Total 51

Sr. No

Decision of Expert

Committee

No. of cases

Remarks

1 In Favor of Doctors

30

2 Against the Doctors

-

3 Undecided 21 Due to incomplete documents

4 Total 51

CPA cases in which PGIMER has been made

a respondent

CPA cases in which PGIMER has been made

a respondent

Sr. No

Total No of cases

In favor of PGIMER

Against PGIMER

Pending cases

1 100 53 7 40

Mrs. Harjit Kaur Versus PGIMERIssues involved

Mrs. Harjit Kaur was admitted to the PGIMER on 19-04-1996 for treatment of burn injuries. As part of her treatment, she was transfused with A+ blood, which was her blood group.

It was alleged that during a second blood transfusion on 20-05-1996, she was transfused with B+ blood instead of A+.

It was alleged that as a result of the wrong transfusion, her kidney and liver got damaged and she died on 01-07-1996 Cont..

DECISION:

State consumer dispute redressal forum awarded a compensation of Rs 2 lacs to the complainant.

This was contested by PGIMER in the National Commission & National Commission upheld the State Commission’s award

PGIMER appealed to the Supreme Court against the Commission’s Order.

The appellant contended that the patient died of Septicemia and not due to mismatched blood transfusion as the patient had survived for about 40 days after the blood transfusion.

The Supreme Court Bench dismissed the appeal on

the ground that wrong blood transfusion is an error which no hospital/doctor exercising ordinary care would have made.

Vinay Kumar& others Versus PGIMER

Issues Involved:- Patient was operated for laparoscopic

cholecystectomy on 13-4-07

It was alleged that there is negligence of operating surgeon as patient developed post operative pain abdomen (due to pancreatic injury)

It was further alleged that patient was in comma on 14-04-07 and subsequently shifted to ICU and ultimately died on 15-4-07. Cont..

Consumer Forum Involved:- State Consumer Dispute Redressal Forum,

Chandigarh

Defense of PGI in Consumer Forum:- Autopsy had been conducted which did not prove

the cause of death as Pancreatitis Decision:-

Court dismissed the appeal on the ground mentioned above and gave decision in favor of PGIMER

Parmaeshwari Sharma Versus PGIMER

Issues Involved:-

Patient met with an accident in Pinjore and she was transfused 12 units of blood in PGI

The patient alleged that she developed transfusion induced Hepatitis –C due to negligence on the part of doctors.

Consumer Forum Involved

District Consumer Dispute Redressal Forum, Chandigarh

Allegations of Patient Patient alleged that blood was not screened before transfusion

Defense of PGI PGI defended that the patient was transfused 12 units of blood

(Though no donor from her family was available) to save her life and the blood was screened properly.

DECISION

Consumer forum awarded compensation to the tune of Rs 12 lacs as well as charges incurred on future treatment.

PGI went on appeal against this decision in State Commission ,National Commission and finally in Supreme court of India

They upheld the decision of Distt. Forum and PGI paid the compensation to the tune of Rs15,34,699/-

Smt. Bimla Devi Versus PGIMER

Issue Involved:- Petitioner alleged that patient was suffering from

Heart disease and he was suggested surgery(as per decision after coronary angiography)

Patient was given an estimate of Rs.1.75 lacs by treating consultant and a cheque of Rs. 157500/- was deposited with the PGI by his department.

The petitioner alleged that the patient died due to alleged delay and negligence on the part of PGI Doctor. Contd..

Consumer Forum Involved:District Consumer Dispute Redressal Forum,Chandigarh

Allegations : Petitioner alleged that despite deposition of required

money the patient was not given timely treatment and as a result he died in want of treatment.

Petitioner showed stamps on OPD card at regular intervals to prove that the patient was on regular follow up.

Defense of PGI:-

PGI pleaded that the patient did not come for regular follow up despite being advised and there was no lapse on part of treating Doctors

PGI pleaded that the stamps on patient’s OPD card was not of our Institute and this is CGHS dispensary stamp.

PGI pleaded that there was no postmortem of the patient after death, so it showed that he was not on treatment.

Contd…

Decision of Consumer Forum:

The forum was not satisfied with PGI defense and fined the institute to the tune of Rs. 5,80000/- +Rs.2100/- on 25-09-07

Appeal by PGI

PGI appealed in State Consumer Dispute Redressal Forum, National Forum & Supreme court of India but they all upheld the decision of Distt. Forum and the PGI paid the compensation awarded.

YEAR NO. OF MED. RECORD

2010 210

2011 195

2012 211

Ayurvedic doctor fined Rs 7 lakh for prescribing allopathic medicines that led to a patient’s deathMonday, May 28, 2012

Mumbai: The National Consumer Disputes Redressal Commission (NCDRC) has directed Dr R R Singh, an ayurveda practitioner, to pay Rs 7 lakh as compensation to the petitioner Pratibha Gamre, widow of Pandurang Gamre, who died after Dr Singh administered allopathic medicines on him.

Chennai’s CSI Rainy Hospital directed to pay Rs. 1 lakh compensation for medical negligence

Wrong side (L) opened to operate (R) inguinal hernia

Wednesday, February 6, 2013,Aala Times

Judgment delivered on 31st Jan,2013

Wrong side Inguinal Hernia Surgery

The patient presented with an apparent Benign growth in Rt. lower limb.

He was operated, mass removed, he recovered and discharged, on pain killers and dressing.

But pain continued; was advised another surgery. He preferred to seek 2nd opinion from a private hospital,

where he was diagnosed as having Malignant growth, underwent AK amputation, but unfortunately died during the course of treatment.

PGI contested that this is mis-diagnosis, not negligence, which was not accepted by the Dist. Cons. Forum and a compensation of Rs. 10.Lakhs awarded.

NUMBER OF COPRA CASES IS RISING

HOW TO PREVENT COPRA CASES IN

YOUR HOSPITAL

Mention your qualifications/experience/ designation on the prescription.

Qualifications mean recognized degrees/ diplomas .

Mention of scholarships/ membership/ awards which are no qualifications should be avoided

Always mention date and timing of the consultation.

Contd…

Mention age and sex of the patient. In a pediatric prescription weight of the patient must be mentioned.

Always put your hand on the part that the patient/ attendant says is painful. Apply your stethoscope on him, even if for cosmetic reasons.

Listen attentively. Look carefully. Ask questions intelligently.

If, after completing the examination, the patient/ attendant feels that something has been left out or wants further examination, do it. Contd….

Always face the patient. Do not stare. Some patients tolerate very little eye contact. Learn to observe out of the corner of your eyes.

In case you have been distracted/ inattentive during the history taking, ask the patient/ attendant to start all over again. He will never mind it. As far as possible consultations should not be interrupted for non-urgent calls.

Ask the patient to come back for review the next day, in case you have examined him hurriedly or if you are not sure about the diagnosis/ treatment.

Contd..

Mention “diagnosis under review” until the diagnosis is finally settled.

In complicated cases record precisely history of illness and substantial physical findings about the patient on your prescription.

If the patient/ attendants are erring on any account (history not reliable, refusing investigations, refusing admission) make a note of it or seek written refusal preferably in local language with proper witness.

Mention the condition of patient in specific/objective terms. Avoid vague terms.

Demonstrate AFB in the sputum before starting ATT

Go for tissue diagnosis whenever possible.

Don't go by assumptions/speculations/gut feeling.

Go for FNAC/ Biopsy/ definitive Serology/PCR

Take 2nd or 3rd opinion, if need be.

No hit & trial treatment

Update yourself by subscribing to Journals/ Conf./CME

Don’t prescribe without examining the patient, even if he is a close friend or relative (Telephone advice is an exception).

Never examine a female patient without presence of female nurse/ attendant, especially during genital and breast examinations.

Don’t insist on the patient to tell the history of illness or be examined in presence of others. He has right to privacy and confidentiality.

Do not permit considerations of religion, nationality, race, party, politics or social standing to intervene between you and your patient.

It may not be reasonable for a doctor to assume what the patient is saying is truthful where what the patient/ attendant says is clearly contradicted by the symptoms.

Don’t smoke while examining a patient, Avoid distractions; mobile phone

Don’t examine a patient when you are sick, exhausted, or under influence of alcohol or any intoxicated substance.

Don’t be overconfident. Don’t look overconfident.

Don’t’ prescribe a drug or indulge in a procedure for which you cannot justify its indication.

Don't over-prescribe/administer: too much of the drug, too large a dose, for too long

Don’t under-prescribe.

Don’t prescribe multiple drugs (inability to form a correct diagnosis). Possibilities of drug interactions increase with polypharmacy.

Don’t write instructions on a separate slip. Write: diet,rest,avoindence of alcohol, next visit

Don’t allow substitutions.

Strong Defence for Doctors / Hospitals

Meticulous documentation ; ensure proper maintenance & safety of medical record.

Audit Medical Record from time to time

No Overwriting/ cutting/ abbreviations

Informed consent including one for Blood transfusion

Explain the procedure, what you aim to do, likely outcome, possible risks & complications

No false claims or promises

No loose talk

Explain and document the prognosis in seriously ill patients

Keep yourself updated

Seek expert opinion –whenever required

Investigate if needed, Evidence based medicine

Refuse to treat if you are unwell / intoxicated

Ensure compliance to all the measures of patient safety in your hospital

Get CCTV’s installed at strategic locations

No verbal orders

Address all the queries, concerns of the patient

Be polite, courteous, show concern and have empathy

AT HOSPITAL LEVEL

A-AVAILABILITY; FIX A TIME TO MEET THE GENERAL PUBLIC AND HONOR THAT

B- BEHAVIOUR; BE POLITE , COURTEOUS , LISTEN TO THE GRIEVANENCES

C- CONCERN, COMMITTEE- Medical Grievances,Control HAI

D- DEVELOP SOP’s DRESS THE WOUNDS BY HEALING WORDS, DIRECT INTERVENTION,

E- EXIT INTERVIEW

FEED BACK -FREQUENT AUDIT OF MEDICAL RECORD……….list continues

Strengthen your systems to strengthen the PATIENT SAFETY in your Hospital because it is bad (poorly designed) system, not the bad people that leads to most errors which otherwise are preventable

We are living in an era of information technology

leading to increased awareness.

A vast ocean of knowledge and information is available just at a click of mouse.

Our society has been empowered with RTI Act 2005.

Mutual faith, trust and respect is fast evaporating and the social fabric is weakening rapidly.

Contd....

Young India (Youngistan) is assertive, aggressive demanding and intolerant. Doctors are no more seen as“ Demy-Gods “,but a service provider.

The tendency of taking law in hand is on rise.

Public interest litigations (PIL) are being filed left , right and centre.

Factor Anna Hazare

The Hon’ble courts are taking sue motto notices.

The media has become hyperactive/media trials/string operations

We are THUS turning into a Law driven society

The medical fraternity therefore needs to be more careful, alert and vigilant, as it is a soft target.

The need of the hour is to follow the golden rule that a stitch in time saves nine and it is always better to stay out of the problem than to get out of the problem.