State Consumer Disputes Redressal Commission
R. N. Keshrwani vs S. G. P. G. I. on 20 February, 2023
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. C/1996/72 ( Date of Filing : 15 Feb 1996 ) 1. R. N. Keshrwani a ...........Complainant(s) Versus 1. S. G. P. G. I. a ............Opp.Party(s) BEFORE: HON'BLE MR. Rajendra Singh PRESIDING MEMBER HON'BLE MR. Vikas Saxena JUDICIAL MEMBER PRESENT: Dated : 20 Feb 2023 Final Order / Judgement Reserved State Consumer Disputes Redressal Commission U.P. Lucknow. Complaint Case No. 72 of 1996 Rajendra Nath Keserwani, aged about 48 years, S/o Late Shri Kedar Nath Vaish, R/o 135-136, Sadar Bazar, P.S. Cantt. District Lucknow. ...Complainant. Versus 1- Sanjay Gandhi Post Graduate Institute of Medical Sciences through Director Rai Bareli Road, Lucknow. 2- Dr. Pyali Bhattacharya, Department Pediatric, SGPGI, Lucknow. 3- Dr. Sonia Nityanand, Emonology Deptt., G. Block, SGPGI, Lucknow. 4- Dr. Chandrashekhar, Emonology Deptt., G. Block, SGPGI, Lucknow. 5- Dr. Negi, Emonology Deptt., G. Block, SGPGI, Lucknow. 6- Oriental Insurance Co. Ltd., DO-1, Balmiki Marg, Lalbagh, Lucknow through its Divisional Manager. ...Opposite parties. Present:- 1- Hon'ble Sri Rajendra Singh, Member. 2- Hon'ble Sri Vikas Saxena, Member. Sri Rajendra Nath Keserwani in person. Sri Saroj Kumar Verma, Advocate for OPs. Date : 2.03.2022 JUDGMENT
Per Sri Rajendra Singh, Member- This complainthas been filed by the complainant Mr Rajendra Nath Keserwani under the Consumer Protection Act, 1986 for following reliefs:-
To direct the opposite parties to pay Rs.14 lakhs as compensation of death due to the negligence of the opposite parties responsible for the death of master Harshit Kesarwani.
To direct the opposite parties to pay Rs.5 Lacs for the irreparable loss to the complainant due to death of his son.
Any other relief and order which this Hon'ble commission may deem fit and proper in the circumstances of this case be passed in favour of the complainants.
In brief the facts of the complainant case are that, that the father of the patient visited for the first time to SGPGI on 26.11.1992 along with his son Harshit Kesarwani. The patient was checked up by Dr Pyali Bhattacharya and they started physiological investigation of the patient. Dr Pyali Bhattacharya took the admission of the patient after seeing the report of pathology and advised three years course for treatment of the patient for his recovery. After pathological investigation and seeing Widal test report, Dr Pyali Bhattacharya admitted the patient in general hospital, general ward where bathroom and latrine were common. In due course of treatment he was referred for laboratory test to many other departments, but in spite of this no progress report was achieved ultimately he was sent to G block for further treatment. There the patient was admitted to the special ward by Dr Soniya Nityanand on 09.05.1994 at private room no 3. After admission, Dr Soniya Nityanand and her two colleagues Dr Chandrashakhar and Dr Negi visited regularly to the patient along with his senior Dr RN Mishra and during her visit she always assured the complainant that the patient's condition is improving. During the period of treatment of the patient in the said private room no.3, three junior doctors and the staff of SGPGI compelled him many times to be shifted in isolation room being cheap treatment there in comparison to private rooms but complainant had seen many deaths in the isolation room. The complainant felt nervous shock and fear and made up his mind not to shift even free of cost isolation room be allotted.
The complainant met Dr RN Mishra and requested him not to shift the patient in isolation room. The junior doctors and staff of the private room no 3 forcibly oust his patient who was lying on the bed in the private room and transferred him to isolation room along with his bed on 31.05.1994 . By this act of cruelty the son of the complainant died after 15 minutes. His patient died due to negligence act of Dr S. Nityanand, Dr Chandrashekhar and Dr Negi. The complainant had only one son and his family and his death caused irreparable injury and loss of the complainant. The complainant has three daughters which are highly qualified and as his only son died, he lost his generation according to Hindu mythology.
The opposite parties filed their evidence/affidavit in which they have stated that the registration number allotted to the patient Harshit Kesarwani is of the year 1991. Patient was examined by opposite party-2 and she advised the patient for necessary investigations in order to diagnose the problems. On the basis of investigation reports, the patient was diagnosed as patient of "Acute Lymphoblastic Leukaemia", which is known as Blood Cancer in the children therefore he was hospitalised for necessary treatment. The basic component of the treatment program for such an individual includes induction therapy until the bone marrow no longer shows Leukaemic Cells prophylactic treatment to the central system and a continuation of systemic treatment from 2.5 years to 3 years. The patient was not admitted for Widal Test report but for other necessary investigations like bone marrow etc and for the said purpose, the patient was admitted at Gen Hospital where paediatric patients under the opposite party -2 are hospitalised where no special facilities of private rooms are toilets are provided to paediatric patients.
When investigations finally revealed that the patient was suffering from Lymphoblastic Leukaemia, which requires repeated investigations during the course of induction remission and continuous therapy. It is strongly denied that no relief/progress were achieved. In fact the patient was discharged after initial induction therapy and thereafter made repeated follow-up visits to the patient in OPD during the year 1993 and early 1994, thereafter the patient was attended by the Immunologist. The patient was first presented to the opposite party-3 on 09.05.1994 as a case of " Relapse Acute Lymphoblastic Leukaemia" (Blood Cancer) and it was found that the patient had high-grade fever, leading from his gums, toxic look, generalised lymphadenopathy and hepatosplenomegaly. The blood examination confirmed 44% cancer cells and bone marrow on 10.05.1994 and was packed with 95% of cancer cells (lymphoblastic to record, which confirms a relapse of Acute Lymphoblastic Leukaemia (ALL). It is worth mentioning here that the prognosis/outcome in all patients who relapsed on therapies over all very per, as there is only a small percentage I.E, 10 - 15%, who attain a second remission. Since the complainant wanted to be given his chance to his son, it was decided to treat the said disease again with Chemotherapy.
The patient was treated with antibiotics and thereafter chemotherapy was started on 12.05.1994 and the patient was also given intensive blood and platelet support. By the treatment rendered, the condition of the patient improved and there was no fever by 16.05 94, the society was continued with blood and platelet support. On 24.05.1994 the patient had recurrence of fever and the pain in right upper abdomen. A Gastroenterology reference percent and antibiotics were promptly changed keeping in view the possibility of GI source of infection. A senior resident from gastroenterology care that evaluated the patient, which was followed by consultation with Prof SR Naik, HOD gastroenterology care that and all that advice was properly/ promptly executed by the doctors. However, the patient did not improve on 29.05.1994. He developed abdominal distension, paralytic ileus and his fever was also continuing. He was also examined by the Gastro- Surgery Doctors and their advice was also followed. On 31.05 94 , the condition of the patient deteriorated further and the senior resident on duty Dr Chandrashekar decided to shift the patient from private room -3 two isolated room, which is close to nursing and Dr station. It keeps the things easier to access such serious patient. The patient died due to Lymphoblastic Leukaemia with relapse in spite of regular, timely and prompt treatment.
There is no lapse or negligence on the part of the attending doctors. The complaint has been filed with vague and general assertion and without indicating any lapse on the part of the opposite parties. Needless to mention here that the complainant has failed to demonstrate the illegality/deficiency in service therefore the present case is liable to be dismissed at the threshold. It is submitted that the complainant has utterly failed to demonstrate deficiency of service. He has further failed to establish the negligence on the part of the opposite parties. The complainant has filed the present case in order to grab the compensation on false, vexatious, misleading grounds and facts thus the present complaint is liable to be dismissed with exemplary cost.
It is further submitted that the institution imply the best of medical experts in the relevant field and the experts do their level best to cure the disease but in no way they should be dragged into frivolous litigation, as this will not only lead to harassment and insecurity in the doctors but also create disturbance in the Institute. The doctors will not be able to serve the patients with their hundred percent ability. It is the duty of everybody to provide free atmosphere for the doctor so that they may fully apply themselves. Thus it is expedient in the interest of justice to dismiss such type of frivolous petition/complaint at the admission stage in the interest of justice. In some circumstances the complainant is not entitled to any relief and the complainant is level to be dismissed.
We have heard the the appellant in person and learned counsel for the opposite parties Mr Saroj Kumar Varma on behalf of Mr Praveen Kumar . We have also perused the pleadings, evidence is, documents on record and also opened documents in sealed cover.
The present case is related to Acute Lymphoblastic Leukaemia in short ALL. The patient is Harshit Kesarwani isn't seven years as per dated 31.05.1994. Before going into evidence and documents, we have to understand that what is Acute Lymphoblastic Leukaemia in children.
Childhood acute lymphoblastic leukaemia (ALL) at a glance What is Childhood ALL Childhood ALL is the most common type of childhood cancer. It's a very treatable cancer in children and young adults. Treatment options are similar from one year old up to 24 years old.
The word 'acute' means developing quickly. 'Lymphoblastic' refers to lymphoid blasts, the type of white blood cell affected by the leukaemia.
Normally, lymphoid blasts in the bone marrow develop into white blood cells called lymphocytes, which play a key role in fighting off infection. The body needs new lymphocytes all the time, and usually the bone marrow makes the right amount. In ALL, this process goes wrong. The blast cells multiply too quickly, and don't develop properly.
These abnormal blast cells are leukaemia cells. They overcrowd the bone marrow and spill out into the bloodstream. As more leukaemia cells develop, there's less room in the bone marrow to make healthy blood cells, including white blood cells, red blood cells and platelets. This causes most of the symptoms of ALL.
What causes childhood ALL?
We don't know yet what causes childhood ALL. We do know that changes happen in the genes of cells in the bone marrow. Genes are a set of instructions that tell individual cells how to behave, and errors in these instructions mean cells can't function properly.
There's nothing you could have done to stop your child developing leukaemia. It's not possible to 'catch' leukaemia from someone else and it isn't passed from parent to child.
There are some things that make it more likely to develop childhood ALL:
Sex: Boys are slightly more likely to develop ALL than girls. We don't know why.
Age: ALL can occur at any age in childhood but is most common is children under 4 years old.
Genetic conditions: Children with some genetic conditions (such as Down's syndrome) have a higher risk of developing ALL than other children.
Radiation: High doses of radiation can lead to childhood leukaemia, but it's unlikely to cause many cases in the UK, if any at all.
Symtoms of Childhood ALL A lot of these symptoms can be hard to spot, as they're similar to the symptoms of other more common illnesses. The important thing is to look out for symptoms that last longer than normal or seem out of the ordinary.
ALL affects how your child's blood cells function, which can cause a number of symptoms. It's unlikely they'll get all of the possible symptoms listed here - everyone is different.
The most common symptoms of childhood ALL are:
anaemia (a lack of red blood cells), which can cause constant tiredness, breathlessness, dizziness, pale skin unexplained bruising and unusual bleeding getting infections easily losing weight.
Less common symptoms include:
swollen glands in the neck stomach pain bone pain generally feeling unwell night sweats.
Treatment for Childhood ALL Your child's treatment plan will involve chemotherapy (anti-cancer) drugs, steroids and other medicines. The particular treatment your child has will depend on their individual condition and general health. Doctors will explain their recommendations and you will be able to ask questions and make decisions as the parent or carer of a child under 16.
From 16 years old, young people have the right to make their own treatment choices, although most will want their family closely involved.
We have general information about managing your child's treatment, and looking after your child which you may find helpful.
Treatment planning Your child will normally start treatment soon after being diagnosed. Chemotherapy is the main treatment for ALL and is usually very effective.
Your child will have a combination of chemotherapy drugs according to a treatment plan (your healthcare team may call this a protocol or regimen). We have more information on how chemotherapy works, and how it's given.
Standard treatment is divided into five phases, or 'blocks. Some children and young adults will need more chemotherapy than others, and your healthcare team will adjust your child's treatment based on their test results. Any time there's a change in the treatment plan, your healthcare team will discuss it with you.
Side effects of childhood ALL treatment It's important to understand that all children are different and that although the list of potential side effects may be worrying, they're unlikely to get all of them. Your healthcare team will also have effective treatments to help your child cope with any side effects. This is known as supportive care.
Many cancer drugs cause unwanted effects (side effects) because they damage normal cells as well as killing cancer cells.
Even if two children are having the same treatment, they may have a different experience of side effects. Your child won't get all, and may not even get any, of the potential side effects - try to keep this in mind when you read about them. The side effects are mostly temporary.
Always tell your child's healthcare team if you or your child notice any possible side effects. There may be treatments for particular side effects, or the consultant may be able to change the dose of a drug to lessen its effects.
Side effects from chemotherapy There's a range of side effects your child may have while they're having treatment. These will vary depending on the particular drugs, and on the individual child. Everyone is different.
Here are some of the most common side effects that can happen when a child has treatment with chemotherapy:
hair loss bruising and bleeding infections feeling sick and vomiting a sore mouth or mouth ulcers constipation (difficulty pooing) diarrhoea (frequent watery poos) fatigue (extreme tiredness) rashes an achy flu-like feeling Late effects Chemotherapy can lead to longer term side effects, called late effects. These depend on the type and quantity of drugs used to treat the leukaemia.
It can be hard to work out which drugs are responsible for which late effects, as your child may have a combination of different drugs over time. Your child's consultant or clinical nurse specialist will advise you on possible late effects before treatment begins, and your child will have ongoing follow-up to monitor for these.
Your child's fertility You may be worried about the effect of treatment on your child's ability to have their own children in the future. It's a concern that many parents have, and your consultant will be able to discuss this with you before your child begins their treatment.
It's also natural to worry about the effects of your child's treatment on future grandchildren. Lots of evidence from clinical studies has shown that a parent who's had cancer treatment doesn't pass on a higher risk of cancer or other health problems to their children.
CLIC Sargent has information about sex and fertility for young adults.
Supportive care Supportive care is treatment that isn't directly for the leukaemia but helps with treatment side effects or leukaemia symptoms.
Supportive care for childhood leukaemia might include:
antibiotics to prevent and treat bacterial infections antifungal medicine to prevent and treat fungal infections an antibiotic twice a week to lower the chance of getting a particular type of pneumonia (chest infection) transfusions of red blood cells and platelets (because chemotherapy drugs affect the bone marrow's ability to make new blood cells) steroid eye drops to prevent eye irritation or infections Sometimes children may find it particularly difficult to eat or drink because of the side effects of chemotherapy. Dietitians within your team can help with this.
Some children may need extra help with nutrition and will be fed temporarily by a tube going directly into their stomach (enteral feeding). If this is necessary, your healthcare team will explain how this works.
Your child's healthcare team may also monitor their heart using ultrasound scans as some drugs can affect the heart muscle.
Complementary and alternative therapies Complementary therapies are sometimes used alongside standard medical treatments like chemotherapy. If you're considering complementary therapies like massage or aromatherapy to support your child's general well-being, speak to their healthcare team first to check if it's safe.
Alternative therapies are used instead of mainstream healthcare treatments and we would not recommend using alternative therapies in place of proven medical care.
Prognosis for childhood ALL Based on data from recent clinical trials, most children and young adults with ALL will go into long-term remission (where there's no leukaemia left) at the end of their treatment. Some rare types of childhood ALL are more difficult to treat, so the prognosis may vary. Your child's consultant (their specialist doctor) is the best person to ask about your child's individual prognosis.
Not everyone wants information about their child's prognosis. If you don't want to talk about it, tell your child's healthcare team - you can change your mind at any time. The healthcare team is not allowed to talk to anyone else about it, even family members, without your permission as parent or carer.
Older children will have a say in what they want to know about their prognosis, and who to share that information with.
Tackling childhood leukaemia was the main area of focus for our founders and is where we have some of our biggest research breakthroughs.
The minimal residual disease test: one of the biggest cancer breakthroughs of the last 30 years In the 1990s we funded two researchers who developed a very sensitive method for detecting cancer cells that are left behind in the blood or bone marrow after treatment. This method is called the minimal residual disease (MRD) test. This test is now used worldwide as the gold standard for assessing how someone has responded to their initial treatment and helps doctors to plan whether they should increase or decrease the intensity of subsequent treatment.
Supporting life-saving childhood leukaemia trials We've played a crucial role in improving survival from childhood acute lymphoblastic leukaemia (ALL). We funded the collection of samples from children with ALL and the research that went hand-in-hand with the UK childhood ALL trials, since the 1970s.
The trial aims to further reduce harmful side effects by testing a different dose and timing of steroid treatment, and to prevent leukaemia returning in the brain by using a different, hopefully less toxic, combination of chemotherapy. The MRD test is also used to see if treatment doses can be reduced, making treatment kinder and reducing long-term side effects. This support has improved how children are treated worldwide.
Understanding different types of childhood leukaemia One of the significant contributions we've made to childhood leukaemia is our work to understand how different subtypes of leukaemia can affect how likely someone's disease is to progress. This work has enabled doctors to group children according to their level of risk.
Research to refine chemotherapy In 1994, it was discovered that there can be differences in how the body breaks down chemotherapy drugs, including 6-Mercaptopurine (6-MP), used to treat children with ALL. Some children either get rid of the drug from their body before it can be effective and some don't break it down quickly enough, leading to harmful side effects. To overcome this, researchers funded by us developed a routine diagnostic test, and gave children a personalised chemotherapy dose, based on the understanding of how they would break down the drug. All children now have this test before treatment, which minimises the risk of harmful side effects such as bone marrow failure.
Understanding what goes wrong in the lead-up to childhood leukaemia In the mid-1980s, we invested in several specialist units dedicated to understanding the causes of leukaemia, including the Centre for Molecular and Cellular Biology of Human Leukaemia at The Institute of Cancer Research in London, established in 1983 and led by Professor Sir Mel Greaves. During this time, he has published some of the most important advances in our understanding of the origins and evolution of childhood leukaemia.
We now know far more about the events before and after birth that lead to the development of childhood ALL. The hope is that it might be possible to design a preventative vaccine that mimics the protective effects of natural infections in infancy. If this can be done, it means that some, if not all, forms of childhood ALL could one day become preventable diseases.
Finding the root cause of childhood ALL With our funding, Professor Greaves and his colleague Professor Tariq Enver, were the first to analyse all of the RNA (a type of genetic material) in a single cell. This is now the method of choice for looking at how cancers evolve over time.
The duo continued to delve into how cancers evolve and in 2011, we funded research by Enver and Greaves that showed leukaemia cells evolve constantly by adapting and changing their genetic make-up by gaining new changes in genes over time. This explains why cancers are so difficult to treat: even if you can target a single 'branch' (a particular subclone), this work shows that you need to target multiple branches, and some of them can become dominant and resistant to treatment.
This research has redefined accepted wisdom about cancer biology.
Predicting the risk of AML in babies with Down's syndrome Blood Cancer UK-funded researchers pinpointed a change in a gene called GATA1, that puts babies with Down's syndrome at a higher risk of acute myeloid leukemia (AML).
A study by Professor Paresh Vyas and paediatrician Professor Irene Roberts has given many parents peace of mind, because the majority of babies with Down's syndrome are unlikely to develop leukaemia. It also means that those babies who do have the GATA1 mutation at three months old, and are therefore more likely to develop leukaemia, can be looked after by a specialist team and given treatment as early as possible.
Cancer UK Childhood Leukaemia CellBank The Blood Cancer UK Childhood Leukaemia CellBank collects, stores, and processes samples from children who have been given a diagnosis of leukaemia. It was established in 2004, in response to a need for researchers to access clinical samples. These samples are invaluable to scientists globally who are looking for new ways to diagnose, treat, and prevent the disease.
Over 98,000 samples have been donated by almost 8,000 children and young adults with different types of leukaemia. Every child who is undergoing tests to diagnose leukaemia will be asked to donate a sample to the Blood Cancer UK Childhood Leukaemia Cell Bank. This means that every child with leukaemia is working to benefit other children who will develop leukaemia in the future.
What is leukemia in children?
Leukemia is cancer of the blood. It's the most common form of cancer in childhood. The cancer cells grow in bone marrow and go into the blood. The bone marrow is the soft, spongy center of some bones. It makes blood cells. When a child has leukemia, the bone marrow makes abnormal blood cells that don't mature. The abnormal cells are usually white blood cells (leukocytes). The bone marrow also makes fewer healthy cells. The abnormal cells reproduce very quickly. They don't work the same as healthy cells.
The types of blood cells include:
Red blood cells (erythrocytes). Red blood cells carry oxygen. When a child has a low level of healthy red blood cells, this is called anemia. A child may feel tired, weak, and short of breath.
Platelets (thrombocytes). Platelets help with blood clotting and stop bleeding. When a child has low levels of platelets, he or she bruises and bleeds more easily.
White blood cells (leukocytes). These fight infection and other disease. When a child has low levels of white blood cells, he or she is more likely to have infections.
There are different types of leukemia in children. Most leukemias in children are acute, which means they tend to grow quickly. Some of the types of leukemia that occur in children include:
Acute lymphocytic (lymphoblastic) leukemia (ALL). This is the most common type of leukemia in children.
Acute myelogenous (myeloid, myelocytic, non-lymphocytic) leukemia (AML). This is the second most common type of leukemia in children.
Hybrid or mixed lineage leukemia. This type is rare. It is a mix of ALL and AML.
Chronic myelogenous leukemia (CML). This type is also rare in children.
Chronic lymphocytic leukemia (CLL). This type is extremely rare in children.
Juvenile myelomonocytic leukemia (JMML). This is a rare type of cancer that doesn't grow quickly (acute) or slowly (chronic).
What causes leukemia in children?
The exact cause of leukemia in children is not known. There are certain conditions passed on from parents to children (inherited) that increase the risk for childhood leukemia. But, most childhood leukemia is not inherited. Researchers have found changes (mutations) in genes of the bone marrow cells. These changes may occur early in a child's life or even before birth. But they may occur by chance (sporadic).
Who is at risk for childhood leukemia?
The risk factors for childhood leukemia include:
Exposure to high levels of radiation Having certain inherited syndromes, such as Down syndrome and Li-Fraumeni syndrome Having an inherited condition that affects the body's immune system Having a brother or sister with leukemia What are the symptoms of leukemia in children?
The symptoms depend on many factors. The cancer may be in the bone marrow, blood, and other tissue and organs. These may include the lymph nodes, liver, spleen, thymus, brain, spinal cord, gums, and skin.
Symptoms can occur a bit differently in each child. They can include:
Pale skin Feeling tired, weak, or cold Dizziness Headaches Shortness of breath, trouble breathing Frequent or long-term infections Fever Easy bruising or bleeding, such as nosebleeds or bleeding gums Bone or joint pain Belly (abdominal) swelling Poor appetite Weight loss Swollen lymph glands (nodes) The symptoms of leukemia can be like other health conditions. Make sure your child sees a healthcare provider for a diagnosis.
How is leukemia diagnosed in children?
Your child's healthcare provider will ask many questions about your child's symptoms. He or she will examine your child. Your child's healthcare provider may recommend blood tests and other tests. A complete blood count (CBC) provides the number of red blood cells, different types of white blood cells, and platelets. If the results are abnormal, your child's healthcare provider may recommend that your child see a pediatric cancer specialist (pediatric oncologist). The oncologist may want your child to have additional tests including:
Bone marrow aspiration or biopsy. Bone marrow is found in the center of some bones. It's where blood cells are made. A small amount of bone marrow fluid may be taken. This is called aspiration. Or solid bone marrow tissue may be taken. This is called a core biopsy. Bone marrow is usually taken from the hip bone. This test is done to see if cancer (leukemia) cells are in the bone marrow.
Lab tests of blood and bone marrow samples. Tests like flow cytometry and immunohistochemistry. These tests determine the exact type of leukemia. DNA and chromosome tests may also be done.
X-ray. An X-ray uses a small amount of radiation to take pictures of bones and other body tissues.
Ultrasound (sonography). This test uses sound waves and a computer to create images.
Lymph node biopsy. A sample of tissue is taken from the lymph nodes. It's checked with a microscope for cancer cells.
Lumbar puncture. A special needle is placed into the lower back, into the spinal canal. This is the area around the spinal cord. This is done to check the brain and spinal cord for cancer cells. A small amount of cerebral spinal fluid (CSF) is removed and sent for testing. CSF is the fluid around the brain and spinal cord.
When leukemia is diagnosed, the doctor will find out the exact type of leukemia it is. Leukemia is not assigned a stage number like most other cancers. Instead, it's classified into groups, sub-types, or both.
ALL (acute lymphocytic leukemia) is the most common leukemia in children. It's separated into 2 groups based on the type of lymphocyte the leukemia started in. That would be B cells or T cells. About 8 out of 10 cases of ALL in children are B-cell ALLs. These can be further classified into sub-types. The other 2 out of 10 cases are T-cell ALLs.
AML (acute myelogenous leukemia) is the other kind of leukemia that's common in children. Doctors use 2 different systems to classify AML. The French-American-British (FAB) system divides AML into 8 sub-types based on how the cells look under the microscope. The World Health Organization (WHO) classification system is newer. It groups AML into many groups based on things like the details of the gene changes in the cancer cells as well as the FAB sub-types.
Classifying leukemia is very complex. But it's an important part of making treatment plans and predicting treatment outcomes. Be sure to ask your child's healthcare provider to explain the stage of your child's leukemia to you in a way you can understand.
How is leukemia treated in children?
Your child may first need to be treated for low blood counts, bleeding, or infections. Your child may receive:
Blood transfusion with red blood cells for low blood counts Blood transfusion with platelets to help stop bleeding Antibiotic medicine to treat any infections Treatment will depend on the type of leukemia and other factors. Leukemia can be treated with any of the below:
Chemotherapy. These are medicines that kill cancer cells or stop them from growing. They may be given into the vein (IV) or spinal canal, injected into a muscle, or taken by mouth. Chemotherapy is the main treatment for most leukemias in children. Several medicines are often given at different times. It's usually done in cycles, with rest periods in between. This gives your child time to recover from the side effects.
Radiation therapy. These are high-energy X-rays or other types of radiation. They are used to kill cancer cells or stop them from growing. Radiation may be used in certain cases.
High-dose chemotherapy with a stem cell transplant. Young blood cells (stem cells) are taken from the child or from someone else. This is followed by a large amount of chemotherapy medicine. This causes damage to the bone marrow. After the chemotherapy, the stem cells are replaced.
Targeted therapy. These medicines may work when chemotherapy doesn't. For example, it may be used to treat children with chronic myeloid leukemia (CML). Targeted therapy often has less severe side effects.
Immunotherapy. This is treatment that helps the body's own immune system attack the cancer cells.
Supportive care. Treatment can cause side effects. Medicines and other treatments can be used for pain, fever, infection, and nausea and vomiting.
Clinical trials. Ask your child's healthcare provider if there are any treatments being tested that may work well for your child.
With any cancer, how well a child is expected to recover (prognosis) varies. Keep in mind:
Getting medical treatment right away is important for the best prognosis.
Ongoing follow-up care during and after treatment is needed.
New treatments are being tested to improve outcome and to lessen side effects.
What are possible complications of leukemia in a child?
A child may have complications from the tumor or from treatment. They may also be short-term or long-term.
Treatment may have many side effects. Some side effects may be minor. Some may be serious and even life-threatening. Your child may take medicines to help prevent or lessen side effects. You'll be given instructions about what you can do at home.
Possible complications of leukemia can include:
Serious infections Severe bleeding (hemorrhage) Thickened blood from large numbers of leukemia cells Possible long-term complications from the leukemia or the treatment can include:
Return of the leukemia Growth of other cancers Heart and lung problems Learning problems Slowed growth and development Problems with the ability to have children in the future Bone problems such as thinning of bones (osteoporosis) What can I do to prevent leukemia in my child?
Most childhood cancers, including leukemia, can't be prevented. The risk from X-rays and CT scans is very small. But healthcare providers advise against them in pregnant women and children unless absolutely needed.
How can I help my child live with leukemia?
A child with leukemia needs ongoing care. Your child will be seen by oncologists and other healthcare providers to treat any late effects of treatment and to watch for signs or symptoms of the cancer returning. Your child will be checked with imaging tests and other tests. And your child may see other healthcare providers for problems from the cancer or from treatment.
You can help your child manage his or her treatment in many ways. For example:
Your child may have trouble eating. A dietitian may be able to help.
Your child may be very tired. He or she will need to balance rest and activity. Encourage your child to get some exercise. This is good for overall health. And it may help to lessen tiredness.
Get emotional support for your child. Find a counselor or child support group can help.
Make sure your child attends all follow-up appointments.
When should I call my child's healthcare provider?
Call the healthcare provider if your child has:
Fever Symptoms that get worse New symptoms Side effects from treatment Key points about leukemia in children Leukemia is cancer of the blood. The cancer cells develop in the bone marrow and go into the blood. Other tissue and organs that may be affected include the lymph nodes, liver, spleen, thymus, brain, spinal cord, gums, and skin.
When a child has leukemia, the bone marrow makes abnormal blood cells that do not mature. The abnormal cells are usually white blood cells (leukocytes). And with leukemia, the bone marrow makes fewer healthy cells.
Common symptoms of leukemia in children include feeling tired and weak, easy bruising or bleeding, and frequent or long-term infections.
Leukemia is diagnosed with blood and bone marrow tests. Imaging may be done to look for signs of leukemia in different parts of the body.
Chemotherapy is the main treatment for most leukemias in children.
A child with leukemia may have complications from the leukemia and from the treatment.
Ongoing follow-up care is needed during and after treatment In the present case the complainant has levied serious allegations regarding treatment of his minor son in SGPGI. We have seen the written evidence filed by opposite parties. The opposite parties stated on oath that the patient Harshit Kesarwani was allotted registration number in 1991. It means when the registration number allotted to Master Harshit, he was about four years old. As per evidence of the opposite parties, the patient was diagnosed as a patient of Acute Lymphoblastic Leukaemia (ALL). Commonly it is known as Blood Cancer. The opposite parties further stated on oath that the basic component of the treatment program for such patient includes induction therapy until the bone marrow no longer shows leukaemic cells prophylactic treatment to the central system and a continuation of systematic treatment from 2.5 years to 3 years. The opposite parties further said that the patient was not admitted for Widal Test but for other necessary investigations like bone marrow etc. We have seen the Widal Test report showing Typhoid Fever (?). This report is of 28.11.92. So it is clear that Widal Test was performed on 28.11.92 and on 01.12.92, patient was advised to be admitted in General Hospital. Some medicines were prescribed and it has been written that blood to be arranged and arrange for bone marrow tomorrow. On 02.12.92 as per case sheet, fresh blood transfusion took place but there is no note regarding bone marrow while it has been clearly written on the case sheet of 01.12.92 for the arrangement of bone marrow tomorrow i.e. 02.12.92. Advice for arrangement of bone marrow arrangement clearly shows that the doctor had knowledge about blood cancer, that's why the consent doctor advised for a arrangement of bone marrow but on the next day we did not find the bone marrow arrangement and nothing has been written on the sheet as to why it was not taken in consideration.
The opposite parties in their evidence has further stated that patient was admitted at Gen Hospital for necessary investigations like bone marrow et cetera. In this ward there was no special facilities. So it is clear that the patient was admitted to Gen Hospital although the concerned Dr came to know about leukaemia on 01.12.92. In a RTI, SGPGI has replied that the patients of blood cancer are treated in haematology department and specifically stated that the treatment of patients of acute leukaemia (Blood Cancer) is done under the supervision of Haematology Department. Further in RTI, the SGPGI replied as follows :
There are expert Dr of Blood Cancer Department and Blood Cancer they confirm the patient of acute leukaemia by investigation and after confirmation of blood cancer, their treatment is performed in haematology department.
There is no need of any operation for blood cancer patient but they are treated by way of Chemotherapy. It is necessary to get the signature of the patient before starting chemotherapy.
In reply of another question under RTI, the SGPGI has replied that the investigation of Bone Marrow Requisition and Reporting is done by the doctors of Pathology and Haematology department and the disease is confirmed by the doctors of Haematology Department. The treatment of Acute Lymphoblastic Leukaemia Blood Cancer is done in the Haematology Department of this institution. It has been clearly replied by the SGPGI that the testing procedure regarding Bone Marrow Requisition and Reporting can only be done by the expert doctors of Haematology Department and none others. It is also replied by the SGPGI that the treatment of Acute Lymphoblastic Leukaemia (Blood Cancer) has been started in Haematology Department from June 2003, and before it the treatment was being done at Immunology Department of the Institute.
By these replies, it has become clear that before June 2003, the treatment of the Acute Lymphoblastic Leukaemia (Blood Cancer) was being done in the Immunology Department of the Institute. It has also become clear that Bone Marrow Requisition and Reporting can only be done by the expert doctors of Haematology Department and none others. Now it is clear that in 1992, Acute Lymphoblastic Leukaemia (Blood Cancer) was being treated in the Department of Immunology and not in general ward. From the perusal of the history sheet it is clear that on 28 November 1992, the patient was undergone Widal test confirming typhoid fever. Payment of Rs.1000.00 is of 01.12.92. There is direction of Dr P Bhattacharya to admit the patient in Gen Hospital. Some medicines were prescribed on 01.12.92 and also it has been written "arrange for bone marrow tomorrow". On 02.12.92 the same Dr has written "transfusion of blood one unit start slowly." But nothing has been written about bone marrow for which direction was given one day earlier. For the next two days the patient was under the treatment of paediatrician. We have seen the pathology report of 02.12.92 in which it has been written column of diagnosis/conclusion - Acute Lymphoblastic Leukaemia. So it is clear That the Acute Lymphoblastic Leukaemia has been diagnosed on 02.12.92 and as per version of SGPGI the patient should immediately be transferred to Department of Immunology. After 02.12.92 the patient was still under the treatment of paediatrician. Under what circumstances he was being treated by the petition when pathology report has confirmed Acute Lymphoblastic Leukaemia? Is it not the negligence on the part of the doctor and institute? The complainant has said that his son was being treated at Gen Hospital even after the diagnosis of Acute Lymphoblastic Leukaemia.
In this case documents were summoned from SGPGI . In reply of RTI, the SGPGI had assured that recovery from Acute Lymphoblastic Leukaemia depends on age of the patient, WBC count, different kind of molecular examination, and thereafter the percentage of recovery is from 20 to 80%. It is also clear that bone marrow requisition and reporting cannot be done by any other Dr except the doctors of haematology department or say when this department was not in existence, Department of immunology. But here paediatrician treated the child even after knowing that he was suffering from Acute Lymphoblastic Leukaemia. There is a paper in the record sent by SGPGI showing that the patient was referred for x-ray test by paediatrician Dr P Bhattacharya on 18.12.92 meaning thereby that the patient was under the treatment of Dr P Bhattacharya till 18.12.92 . We have seen other report of Department of pathology dated 19.12.92 in which the Dr name mentioned is of Dr P Bhattacharya. The SGPGI has also stated that the injection to the patient of blood cancer is only given by the specialised doctor of Cancer Department and none other. But in this case it is not so.
During argument when we quarried from the Advocate of opposite parties regarding chemotherapy, he could not answer at all. Except this he was not in a position to clarify all the things and questions related to the treatment of the child.
Cancer in child and its treatment, diagnosis, recovery, and especially when the cancer patient being child is in hospital, it can be curable at a high percent. For this we have see the following article regarding child cancer _ What blood cells are abnormal with cancer?
When cancer occurs in the blood, it's usually the result of an abnormal and excessive reproduction of white blood cells. Blood cancers account for about 10 percent of all diagnosed cancers in the U.S. each year. Blood cancers (including leukemia, lymphoma and myeloma) are more common in men than women.
Cancer blood tests: Lab tests used in cancer diagnosis Cancer blood tests may help your health care provider make a cancer diagnosis. Learn about cancer blood tests and how they're used.
By Mayo Clinic Staff If your health care provider is worried you might have cancer, you might need more tests to be sure. Cancer blood tests are often part of this process.
Samples taken for cancer blood tests are tested in a lab for signs of cancer. When viewed under a microscope, the samples may show the actual cancer cells. Other blood tests might find proteins or other substances made by the cancer. Blood tests can also tell your provider how well your organs are working.
Most blood tests aren't used on their own to diagnose cancer. But they can provide clues that may lead your health care team to make the diagnosis. For most types of cancer, a procedure to remove a sample of cells for testing is often needed to be sure.
Some blood tests used to diagnose cancer include:
A test to count your blood cells. A complete blood count (CBC) measures the amount of each type of blood cell in a sample of your blood. Blood cancers may be found using this test.
A test that looks at the blood proteins. An electrophoresis blood test looks at the various proteins in your blood to find the ones made by your body's germ-fighting immune system. This test is helpful in diagnosing multiple myeloma.
Tests to find chemicals made by cancer cells. Tumor marker tests use a sample of blood to look for chemicals made by cancer cells.
These tests don't always help with diagnosing cancer because many healthy cells also make these chemicals. And some conditions that aren't cancer can cause high levels of tumor markers. Instead, tumor marker tests are mostly used after your cancer diagnosis to see if treatment is working.
Examples of tumor markers include prostate-specific antigen (PSA) for prostate cancer and cancer antigen 125 (CA 125) for ovarian cancer. Other examples include carcinoembryonic antigen (CEA) for colon cancer and alpha-fetoprotein for testicular cancer.
Tests to look for cancer cells. Circulating tumor cell tests detect cancer cells in your blood. The cells might be in the blood if they've broken away from where they started and are spreading to other parts of the body. Circulating tumor cell tests are mostly used after a cancer diagnosis.
Not every person with cancer needs a circulating tumor cell test. These tests are sometimes used for a few types of cancer, including breast cancer, colon cancer and prostate cancer. Researchers are looking at how these tests might help people with other types of cancer.
Tests to look for cancer cells' genetic material. These tests use a blood sample to look for small pieces of cancer cells' genetic material, called DNA. Healthy cells and cancer cells discard pieces or break apart as part of the natural process of growing and dying. These pieces of cells make their way into the blood so that the body can dispose of them. Special tests look for these cell pieces in a sample of blood.
In people with cancer, these tests are sometimes used to understand the DNA changes present in the cancer cells. A health care provider uses the results to select the best treatment.
One day providers might use these tests to detect signs of cancer in healthy people with no symptoms. This is an active area of research.
If your blood test shows a result that's not expected, you might need other tests and procedures to find the cause.
Polycythemia vera (pol-e-sy-THEE-me-uh VEER-uh) is a type of blood cancer. It causes your bone marrow to make too many red blood cells. These excess cells thicken your blood, slowing its flow, which may cause serious problems, such as blood clots.
Polycythemia vera is rare. It usually develops slowly, and you might have it for years without knowing. Often the condition is found during a blood test done for another reason.
Without treatment, polycythemia vera can be life-threatening. But proper medical care can help ease signs, symptoms and complications of this disease.
Can blood work detect cancer in kids?
In addition to a physical examination, the following tests may be used to diagnose childhood cancer: Blood tests. Routine blood tests measure the number of different types of cells in a person's blood. Levels of certain cells that are too high or too low can indicate the presence of certain types of cancer.
Is high platelet count cancer?
An elevated platelet count has been shown to be associated with short-term risk of cancer in the general population. Prospective studies evaluating platelet count and survival among patients with newly diagnosed cancer have also noted a high proportion of patients who presented with thrombocytosis.
Does cancer affect WBC or RBC?
Some cancer treatments, mainly chemotherapy, can lower your white blood cell count. Cancers that affect the blood can also lower white blood cell count. These types of cancers include leukemia, lymphoma, and multiple myeloma. High and low results in the white blood cell differential.
Does cancer affect RBC count?
Cancer can infiltrate bone marrow - the blood cell factory - which can lead to a decrease in the production of red blood cells. Cancer sometimes triggers an autoimmune response that destroys the body's normal red blood cells.
Can CBC detect leukemia?
Your doctor will conduct a complete blood count (CBC) to determine if you have leukemia. This test may reveal if you have leukemic cells. Abnormal levels of white blood cells and abnormally low red blood cell or platelet counts can also indicate leukemia.
What test confirms leukemia?
How is leukemia diagnosed? A diagnosis of leukemia is usually made by analyzing a patient's blood sample through a complete blood count (CBC) or microscopic evaluation of the blood, or by using flow cytometry.
How do you know if your child has leukemia?
Common symptoms of leukemia in children include feeling tired and weak, easy bruising or bleeding, and frequent or long-term infections. Leukemia is diagnosed with blood and bone marrow tests. Imaging may be done to look for signs of leukemia in different parts of the body.
What is normal CBC for leukemia?
These ranges are based on the cell counts of healthy people of similar age and sex. According to the Leukemia & Lymphoma Society, the "normal" range of white blood cells per microliter of blood is: 5,000 to 10,000 for men. 4,500 to 11,000 for women.
Is leukemia curable in child?
With the proper treatment, the outlook for kids and teens with leukemia is quite good. Most childhood leukemias have very high remission rates, with some up to 90%. Remission means that doctors see no cancer cells in the body. Most kids are cured of the disease.
A case report of pediatric acute lymphoblastic leukemia with e8a2 BCR/ABL1 fusion transcript Aleksandra Mroczkowska, Bożena Jaźwiec, Justyna Urbańska-Rakus, Sylwia Szymanowska, Anna Tessmann, Sonia Pająk, Katarzyna Machnik, Olga Haus & Tomasz Wróbel BMC Medical Genomics volume 15, Article number: 20 (2022) Cite this article Abstract Background Acute lymphoblastic leukemia is the most common type of cancer in children. Most often it affects the age group between 2 and 5 years of age. Studies have shown an improvement in general survivability, more than 90% 5-year overall survival (OS). Current treatment protocols for acute lymphoblastic leukemia require verification of the presence of favorable and unfavorable genetic abnormalities, which help qualify patients to the appropriate risk group and select a more suitable treatment. The presence of the BCR/ABL1 fusion gene stratifies the patient into a high-risk group and requires special treatment with tyrosine kinase inhibitors (TKI). The three dominant mRNA transcripts are e1a2, e13a2, and e14a2. Nevertheless, cases of atypical BCR/ABL1 transcripts have also been reported.
Case presentation This paper presents the case of a pediatric patient with Ph + B-cell precursor acute lymphoblastic leukemia with rare atypical e8a2 BCR/ABL1 fusion transcript. Our patient achieved complete remission after 33 days of treatment. Molecular and cytogenetic studies in TP1 did not reveal the presence of the BCR/ABL1 transcript. The PCR-MRD test in TP1b was negative, the patient did not require hematopoietic stem cell transplantation.
Conclusion Genetic evaluation of the bone marrow sample is crucial in the initial stage of the diagnosis. Fluorescent in situ hybridization and reverse transcriptase polymerase chain reaction with Sanger sequencing are the appropriate methods used in the detection of rare variants of BCR/ABL1 transcripts.
Peer Review reports Background Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy. ALL is a heterogeneous neoplasm derived from the precursors of the lymphoid lineage. About 80-85% of cases are B-cell precursor leukemias, while T-lineage leukemias are about 15-20%. The ALL diagnoses are based on certain criteria including clinical presentation, laboratory tests, a bone marrow biopsy, immunophenotypic analysis and genetic tests. Currently, cytogenetic and molecular tests play a very important role in determining prognosis and stratification for suitable treatment of pediatric ALL [1, 2]. The typical recurrent translocations occurring in ALL are t(12;21)(p13;q22) causing ETV6/RUNX1, t(1;19)(q23;p13) causing TCF3/PBX1, t(9;22)(q34;q11.2) causing BCR/ABL1, and the most common rearrangement of KMT2A gene, t(4;11)(q21;q23) causing KMT2A/AFF1. ETV6/RUNX1 is associated with a favorable prognosis and the last three genetic abnormalities have unfavorable outcomes [3, 4].
BCR/ABL1 fusion transcripts occur approximately in 2-5% cases of childhood ALL and the frequency of BCR/ABL1(+)ALL increases with the patient's age [5]. ALL cases with this genetic abnormality are associated with poor outcome and are qualified to the high risk group. Due to the introduction of tyrosine kinase inhibitors to the therapy, the prognosis of Ph + patients has improved.
The most common mRNA transcripts of BCR/ABL1: e1a2, e13a2, e14a2, occur in about 99% of Ph + cases. Approximately 70% of Ph + ALL patients have an e1a2 transcript and more than 25% e13a2 or e14a2. 1% of patients with Ph + shows atypical transcripts like e19a2, e6a2, e1a3, e13a3, e14a3 and e8a2 [6].
We present here a case of a pediatric patient with Ph + BCP-ALL (B cell precursor ALL) with an e8a2 BCR/ABL1 transcript.
Case presentation An 11-year-old boy was admitted to the Unit of Pediatric Hematology and Oncology, City Hospital, Chorzów, Poland due to a suspicion of acute leukemia. Five days before admission to the hospital, he developed a severe and difficult to stop nosebleed. Since then, the boy was experienced weakness, lethargy, lack of appetite. Additionally he developed abdominal pain, a headache and nausea. Physical examination revealed pale skin with petechiae, inflammation of the gingiva, tooth decay and splenomegaly. Lymphadenopathy, hepatomegaly and the presence of a Central Nervous System (CNS) disease/leukemia were not observed. Family Health History has no indication of any genetic, hematologic or cancerous diseases. Patient was not exposed to any physical (i.e. ionic radiation) or chemical factors (organic solvents, pesticides, herbicides, paints, lacquers) during childhood nor fetal period. He was born out of second pregnancy, first childbirth (first pregnancy ended due to spontaneous miscarriage around eighth week). Weight at birth 2400 g. Mother's age at birth: 19, father: 21. Patient has younger step-sister (same mother, different father), showing no symptoms of ALL or any other hematological disorders.
By the time of diagnosis of ALL, the patient had been sick sporadically and had no routine blood tests--including morphology. The patient has not taken any medications on a permanent basis.
The laboratory results showed: white blood cell 206,900/µl, platelet count 142,000/µl and hemoglobin level 10.2 g/dl. The bone marrow was highly cellular, represented by a homogeneous population of small blasts with lymphoid morphology (88.5%). Flow cytometric analysis showed BCP-ALL phenotype: CD45dim + , CD38 + , CD34(+), CD81(+), CD24(+), CD19(+), CD79a(+), TdT(+), CD10(+), CDdim33(+), CD20dim(+), CD22dim(+), CD15(-), CD117(-). The boy was diagnosed with common B-cell precursor ALL and qualified for treatment according to the AIEOP-BFM ALL 2017 protocol.
The cytogenetic and molecular examinations of the patient's bone marrow were performed by the Laboratory of Molecular Biology and Cytogenetics at the University Clinical Hospital in Wroclaw. Karyotype analysis and fluorescence in situ hybridization (FISH) was performed on the bone marrow sample according to the AIEOP-BFM ALL 2017 protocol. According to the protocol, tests for genetic diagnostics were performed. By day 6, a FISH test was performed to obtain a result for the presence of the Philadelphia chromosome. Up to day 33, the FISH test was performed for the frequent genetic aberrations: ETV6/RUNX1 translocation and rearrangements in the KMT2A and TCF3 genes. At the same time, molecular tests were carried out using the RT-PCR method for the presence of the BCR/ABL1 and KMT2A/AFF1 fusion gene. G-banded chromosome analysis revealed an abnormal male karyotype 46,XY,t(9;22)(q34;q11) [11]/46,XY [9] (Fig. 1A). The FISH study showed no rearrangements in ETV6/RUNX1, TCF3 (MetaSystems Probes, Germany) or KMT2A (Vysis, Abbott Molecular, Illinois, USA). The FISH study performed with the BCR/ABL1 dual color, dual fusion translocation probe (Vysis, Abbott Molecular, Illinois, USA) disclosed a typical translocation pattern 2 green/orange BCR/ABL1 fusion signals, 1 green BCR signal, and one orange ABL1 signal in 90% of the interphase cells (Fig. 1B). Reverse transcription-polymerase chain reaction (RT-PCR) was performed to detect the presence or absence of the KMT2A /AFF1 and BCR/ABL1 fusion gene using primers as per JJM van Dongen et al. [7]. The test was negative in both cases. Due to the positive result of the FISH test for BCR/ABL1, another RT-PCR was performed in order to search for atypical BCR/ABL1 transcripts. New RT-PCR analysis was performed based on primers BCR-6 and ABL-3 published by T. Burmeister and R. Reinhardt [6]. Electrophoresis showed a band of ~ 489 bp (Fig. 2A). Sanger sequencing confirmed the direct junction between exon 8 of BCR (NM_004327.4) and exon 2 of ABL1 (NM_005157.6) (Fig. 2B). The Sanger sequencing was important because this method determined the type of transcript by analyzing the direct junction between exons. Transcript type information is crucial for monitoring the presence of BCR/ABL1 transcript by RT-PCR method.
Fig. 1 A--Conventional G-banding karyotype analysis showing typical translocation between chromosome 9 and 22. B--FISH analysis on interphase and metaphase with LSI BCR/ABL1 Dual Color, Dual Fusion Translocation Probe Fig. 2 A--Detection of e8a2 BCR/ABL1 transcript by RT-PCR. Lane 1: size marker; lane 2: patient sample; lane 3: negative control, lane 4: internal reference gene--ABL1. B--Sanger sequencing demonstrating the direct junction between BCR exon e8 and ABL1 exon a2 The patient's induction therapy started according to the protocol IA-Pred. On the 8th day of treatment, the patient had a poor response to prednisone. Due to the presence of the BCR /ABL1 fusion gene, further treatment was performed according to the EsPhALL 2009 protocol (European intergroup study of post-induction treatment of Philadelphia-chromosome-positive ALL). Imatinib at a dose of 300 mg/m2 daily was started on day 15 of treatment, but on day 28 was withheld due to hepatotoxicity (WHO grade III). Evolution of peripheral blood cell counts during therapy is presented in Table 1. In accordance to protocol, the patient's bone marrow was collected on days 15 and 33 of treatment. Examination of the bone marrow sample on day 15 revealed 15.4% blast cells in bone marrow morphology. Flow cytometry (FCM) revealed 23.48% of blasts. On day 33 (TP1), the bone marrow was already aplastic. Nevertheless, a PCR-MRD (Minimal Residual Disease) result was obtained. MRD in TP1 was low-positive (< 10−4). Bone marrow smear revealed a total of 2.6% of blasts. Despite the poor quality of the material in TP1, it was also possible to perform a FISH study (Fig. 3A) and RT-PCR test (Fig. 3B). Both molecular and cytogenetic tests were negative. According to the EsPhALL 2009 protocol the boy should have been classified as poor risk Ph(+) ALL group because of PPR (prednisone poor responder) on the 8th day, but due to complete remission on day 33 (LBL 1.2%, PC-MRD < 10-4) he was classified as good risk Ph(+) ALL group. From about day 32 of treatment, the patient reported abdominal pain, constipation, nausea and vomiting. Physical examinations showed hepatomegaly and lazy intestinal peristalsis. The symptoms were most likely caused by paralytic intestinal obstruction after chemotherapy. Additionally, the patient developed a fungal infection of the bladder.
Table 1 Evolution of peripheral blood cell counts during therapy Full size table Fig. 3 A--FISH study on day 33 of treatment, B--RT-PCR test on day 33 of treatment. Lane 1: size marker; lane 2: positive control; lane 3: patient; lane 4: negative control, lane 5: internal reference gene--ABL1 Due to the general condition of the patient, consolidation treatment was delayed by 25 days. After this time, according to the EsPhALL 2009 protocol the IB protocol was started and Imatinib was resumed. Another PCR-MRD test was performed on day 17 of treatment (TP1b) of the IB protocol. PCR-MRD in TP1b was negative. Therefore the patient continued chemotherapy without qualification for HSCT (Hematopoietic Stem Cell Transplantation). The patient after consolidation therapy was in haematological remission of ALL. The patient remains without a transplant for 8 months after diagnosis.
Discussion and conclusions The very rare e8a2 transcript (about 8% from 1% of non-typical BCR/ABL1 transcripts) has been reported mainly in cases of chronic myeloid leukemia (CML) [8,9,10,11,12,13, 18]. Two cases have been reported in adult ALL [14, 15]. The e8a2 BCR/ABL1 transcript could be associated with worse prognosis than the e13a2 or the e14a2 transcripts in CML patients. However, there were cases of good response to treatment with imatinib with an achievement of a major molecular response [8, 10, 12]. CML cases with this transcript that have been reported so far, additionally had insertions from ABL1 intron 1b or 1a, from BCR intron 8 or another gene such as PRDM12, MAST2 [11, 16, 17]. Only one patient with CML and e8a2 BCR/ABL1 transcript had no additional insertions and after treatment with imatinib achieved a complete cytogenetic response [12]. In adult acute lymphoblastic leukemia one case was reported with insertion of 2 nucleotides from ABL1 intron 1a [14]. One adult ALL woman that had RALGPS1 exon 8 inserted into the fusion, was treated with FLAG-Ida (fludarabine, cytarabine, granulocyte-colony stimulating factor [G-CSF], idarubicin) and dasatinib and after re-induction therapy achieved hematological, cytogenetic and molecular remission [15]. Unfortunately, the e8a2 variant in adult ALL patients is so rare, that its impact on outcome remains unknown. To the best of our knowledge, our patient is the first pediatric ALL case with e8a2 BCR/ABL1 transcript. Our case sequencing analysis revealed e8a2 BCR/ABL1 transcript without any insertion. Creation of the e8a2 transcript by the exact fusion of BCR exon e8 to ABL1 exon a2 could encode an oncogenic protein, therefore our patient was qualified for treatment with the EsPhALL 2009 protocol. Our patient achieved complete remission after 33 days of treatment. Molecular and cytogenetic studies in TP1 did not reveal the presence of the BCR/ABL1 transcript. The PCR-MRD test in TP1b was negative, the patient did not require hematopoietic stem cell transplantation.
The presence of the BCR/ABL1 fusion gene is considered an unfavorable genetic abnormality and is associated with poor prognosis but survival has improved with the development of TKI. Our case shows that atypical transcripts of BCR/ABL1 also occur in cases other than CML or adult ALL. RT-PCR and sequencing are appropriate methods for identifying these atypical transcripts. Using both conventional cytogenetics and molecular methods, we are able to detect many genetic changes occurring in leukemias. It is important to identify them accurately and use this information to monitor the patient's treatments. The monitoring of the presence and quantity of the BCR/ABL1 transcript using the RT-qPCR method is a gold standard in monitoring of Ph + patients with chronic myeloid leukemia. This method can also be used in monitoring of Ph + ALL patients to assess treatment efficiency. For proper patient monitoring it is important to evaluate the type of transcript at the time of diagnosis. Detection of a rare atypical transcript may affect the patient's treatment and may be associated with a worse prognosis.
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When we went through the article it is clear that by pathology test, cancer may be detected and recovery rate in children is very high say about 90%. Why in this case the opposite parties failed to recover a child aged about five years at the time of admission. The medical profession is a noble profession and Dr takes a oath when enters into this noble profession.As per guidelines of MCI , Every member should get it framed in his or her office It should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confined in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain by all means in my power, the honour and noble traditions of medical profession.
I will treat my colleagues with all respect and dignity.
I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional status and reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient , the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient .
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ? It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III(1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC 513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence. The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995) In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent.This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent.
This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
Essentials of Res Ipsa Loquitur Maxim The injury caused to the plaintiff shall be a result of an act of negligence.
There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
The defendant owes a duty of care towards the plaintiff, which he has breached.
There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In Achutrao Haribhau Khodwa and Others vs State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn't exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:
The event doesn't normally occur unless someone has acted negligently;
The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.
Top of Form Bottom of Form The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat , the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. { Mark Luney and Ken Opliphant , Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 } In A.S. Mittal & Anr Vs State Of UP & Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth ₹ 12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not have occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligence leads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest.
Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. Trimbak Bapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
"Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%."
"Smt. Anuradha Saha ( in short Anuradha), aged about 36 years wife of Dr.Kunal Saha ( complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998."
"Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary."
"The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr.Sukumar Mukherjee, Dr.B.Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr.Kaushik Nandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC."
"The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment."
"Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs."
"Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No. 1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Honble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos. 1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Honble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.Kaushik Nandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation."
"We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others."
"The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission."
"Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity."
" The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court."
"There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals."
"On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- ( rounded of to Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr.Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them."
" In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no. 1 to 4 to the complainant in the following manner:
(i). Dr.Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation] .
(ii) Dr. B.Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation]
(iii) AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation]
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default."
Now we see, the authorisation for operation or special procedure is document which has been submitted by SGPGI. This is on a printed pro forma having blank spaces to be filled by the concerned Dr. It is dated 30.08 (or 09).94. It is better to paste a scanned copy of this document. On this printed form there is no signature of witness or guardian, name of the patient has been written as Harshit Kesarwani, address and date has been mentioned on this printed pro forma but there is neither the signature of patient nor the signature of the Guardian on this form. We know that before operation or chemotherapy consent of the patient is necessary and it should be according to prescribed consent form. Now the special consent has also been obtained for anaesthesia. SGPGI is a reputed institute not only of Uttar Pradesh but of India. Their doctors are well qualified and master of their field. How can one imagine that such consent form has been kept by this institute without any signature of the patient or his Guardian. When there is no consent how can operation or chemotherapy has been performed on the child? This clearly indicates the level of negligence and the degree of carelessness on the part of the institute and concerned Dr. This consent form is reproduced here.
It is the story of negligence and carelessness on its own. As far as consent is concerned we have to see the articles and guidelines regarding consent.
Consent and the Indian medical practitioner Consent is a legal requirement of medical practice and not a procedural formality. Getting a mere signature on a form is no consent. If a patient is rushed into signing consent, without giving sufficient information, the consent may be invalid, despite the signature. Often medical professionals either ignore or are ignorant of the requirements of a valid consent and its legal implications. Instances where either consent was not taken or when an invalid consent was obtained have been a subject matter of judicial scrutiny in several medical malpractice cases. This article highlights the essential principles of consent and the Indian law related to it along with some citations, so that medical practitioners are not only able to safeguard themselves against litigations and unnecessary harassment but can act rightfully.
INTRODUCTION Legally, two or more persons are said to consent when they agree upon the same thing in the same sense.[1] Consent must be obtained prior to conducting any medical procedure on a patient. It may be expressed or implied by patient's demeanour. A patient who comes to a doctor for treatment implies that he is agreeable to general physical (not intimate) examination.[2] Express consent (verbal/written) is specifically stated by the patient. Express verbal consent may be obtained for relatively minor examinations or procedures, in the presence of a witness.[3] Express written consent must be obtained for all major diagnostic, anaesthesia and surgical procedures as it is the most undisputable form of consent.
ESSENTIAL PRINCIPLES OF A VALID CONSENT AND THE INDIAN LAW A doctor must take the consent of the patient before commencing a treatment/procedure except in emergencies, informed consent should be obtained sometime prior to the procedure so that the patient does not feel pressurised or rushed to sign. On the day of surgery, the patient may be under extreme mental stress or under influence of pre-medicant drugs which may hamper his decision-making ability. Consent remains valid for an indefinite period, provided there is no change in patient condition or proposed intervention.[4] It should be confirmed at the time of surgery.[4] Consent must be taken from the patient himself.
The doctor before performing any procedure must obtain patient's consent.[5] No one can consent on behalf of a competent adult. In Dr. Ramcharan Thiagarajan Facs versus Medical Council of India case,[6] disciplinary action was awarded to the surgeon for not taking a proper informed consent for the entire procedure of kidney and pancreas transplant surgery from the patient. In some situations, beside patient consent, it is desirable to take additional consent of spouse. In sterilisation procedures, according to the Ministry of Health and Family Welfare, Government of India guidelines, consent of spouse is not required.[7] The Medical Council of India (clause 7.16) however states that in case an operation carries the risk of sterility, the consent of both husband and wife is needed.[8] It is advisable to take consent of spouse when the treatment or procedure may adversely affect or limit sex functions, or result in death of an unborn child.[9] In case of minor, consent of person with parental responsibility should be taken.[10] In an emergency, the person in charge of the child at that time can consent in absence of parents or guardians (loco parentis).[11] In a medical emergency, life-saving treatment can be given even in absence of consent.
Refusing treatment in life-threatening situations due to non-availability of consent may hold the doctor guilty, unless there is a documented refusal to treatment by the patient. In Dr. TT Thomas versus Smt. Elisa and Orscase,[12] the doctor was held guilty of negligence for not operating on a patient with life-threatening emergency condition, as there was no documented refusal to treatment.
The patient should have the capacity and competence to consent.
A person is competent to contract[13] if (i) he has attained the age of majority,[14] (ii) is of sound mind[15] and (iii) is not disqualified from contracting by any law to which he is subject. The legal age for giving a valid consent in India is 18 years.[14] A child >12 years can give a valid consent for physical/medical examination (Indian Penal Code, section 89).[3] Prior to performing any procedure on a child <18 years, it is advisable to take consent of a person with parental responsibility so that its validity is not questioned. If patient is incompetent, then consent can be taken from a surrogate/proxy decision maker who is the next of kin (spouse/adult child/parent/sibling/lawful guardian).[11] Consent should be free and voluntary.
Consent is said to be free[16] when it is not caused by coercion,[17] undue influence,[18] fraud,[19] misrepresentation,[20] or mistake.[21,22,23] Consent should be informed.
Consent should be on the basis of adequate information concerning the nature of the treatment procedure.[5] Consent should be informed and based on intelligent understanding. The doctor must disclose information regarding patient condition, prognosis, treatment benefits, adverse effects, available alternatives, risk of refusing treatment and the approximate treatment cost. He should encourage questions and answer all queries.[2] If the possibility of a risk, including the risk of death, due to performance of a procedure or its refusal is remote or only theoretical, it need not be explained.[5] Exceptions to physician's duty to disclose include[24] : (i) Patient refusal to be informed; this should be documented. (ii) If the doctor feels that providing information to a patient who is anxious or disturbed would not be processed rationally by him and is likely to psychologically harm him, the information may be withheld from him (therapeutic privilege); he should then communicate with patient's close relative, family doctor or both.
The "adequate information" must be furnished by the doctor (or a member of his team) who treats the patient.[5] Information imparted should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not.[5] Consent should be procedure specific.
Consent given only for a diagnostic procedure, cannot be considered as consent for the therapeutic treatment.[5] Consent given for a specific treatment procedure will not be valid for conducting some other procedure.[5] In Samira Kohli versus Dr. Prabha Manchanda and Anr case,[5] the doctor was held negligent for performing an additional procedure on the patient without taking her prior consent. An additional procedure may be performed without consent only if it is necessary to save the life or preserve the health of the patient and it would be unreasonable to delay, until patient regains consciousness and takes a decision.[5] A common consent for diagnostic and operative procedures may be taken where they are contemplated.[5] Consent obtained during the course of surgery is not acceptable.
In Dr. Janaki S. Kumar and Anr. versus Mrs. Sarafunnisa case, [25] in an allegation of performing sterilisation without consent, it was contended that consent was obtained during the course of surgery. The commission held that the patient under anaesthesia could neither understand the risk involved nor could she give a valid consent.
Consent for blood transfusion.
When blood transfusion is anticipated, a specific written consent should be taken,[24] exception being an emergency situation where blood transfusion is needed to save life and consent cannot be attempted.[26] In M. Chinnaiyan versus Sri. Gokulam Hospital and Anrcase,[27] court awarded compensation as patient was transfused blood in the absence of specific consent for blood transfusion.
Consent for examining or observing a patient for educational purpose Prior to examining or observing patients for educational purpose, their consent must be taken.[28] Blanket consent is not valid.
Consent should be procedure specific. An all-encompassing consent to the effect 'I authorize so and so to carry out any test/procedure/surgery in the course of my treatment' is not valid.[29] Fresh consent should be taken for a repeat procedure.
A fresh written informed consent must be obtained prior to every surgical procedure that includes re-exploration procedure. In Dr. Shailesh Shah versus Aphraim Jayanand Rathod case,[30] the surgeon was found deficient in service and was liable for compensation as he had performed a re-exploration surgery without a written consent from the patient.
Surgical consent is not sufficient to cover anaesthesia care.
The surgeons are incapable to discuss the risks associated with anaesthesia. Informed consent for anaesthesia must be taken by the anaesthesia provider as only he can impart anaesthesia related necessary information and explain the risks involved. It may be documented by the anaesthesiologist on the surgical consent form by a handwritten note, or on a separate anaesthesia consent form.[31] Patient has the right to refuse treatment.
Competent patients have the legal and moral right to refuse treatment, even in life-threatening emergency situations.[31] In such cases informed refusal must be obtained and documented, over the patient's witnessed signature.[32] It may be advisable that two doctors document the reason for non-performance of life-saving surgery or treatment as express refusal by the patient or the authorised representative and inform the hospital administrator about the same.
To detain an adult patient against his will in a hospital is unlawful.[9] If a patient demands discharge from hospital against medical advice, this should be recorded, and his signature obtained.[9] Unilaterally executed consents are void.
Consent signed only by the patient and not by the doctor is not valid.[33] Witnessed consents are legally more dependable.
The role of a witness is even more important in instances when the patient is illiterate, and one needs to take his/her thumb impression.[34] Consent should be properly documented Video-recording of the informed consent process may also be done but with a prior consent for the same. This should be documented. It is commonly done for organ transplant procedures. If consent form is not signed by the patient or is amended without his signed authorisation, it can be claimed that the procedure was not consented to.[10] Patient is free to withdraw his consent anytime.
When consent is withdrawn during the performance of a procedure, the procedure should be stopped. The doctor may address to patient's concerns and may continue the treatment only if the patient agrees. If stopping a procedure at that point puts patient's life in danger, the doctor may continue with the procedure till such a risk no longer exists.[10] Consent for illegal procedures is invalid.
There can be no valid consent for operations or procedures which are illegal.[24] Consent for an illegal act such as criminal abortion is invalid.[9] Consent is no defence in cases of professional negligence.[9] HOW TO OBTAIN A VALID CONSENT AND CONSENT FORMAT.
Always maintain good communication with your patient and provide adequate information to enable him make a rational decision.[35] It is preferable to take consent in patient's vernacular language. It may be better to make him write down his consent in the presence of a witness.[34] It is desirable to use short and simple sentences and non-medical terminology that is written/typed legibly.[36] Patient information sheets (PIS) depicting procedure related information, including pre-operative and post-operative pre-cautions in patient's understandable local language with pictorial representation may facilitate the informed consent process. These may help in providing consistently accurate information to the patients.[35] PIS should be handed over to the patients after explaining the contents. Even videos may be used as an aid in increasing patient understanding.[37] Though there is no standard consent format, it may include the following [e.g., Figure 1]:[38] Figure 1 Anaesthesia informed consent form Document the fact that patient and relatives were allowed to ask questions, and their queries were answered to their satisfaction.
Date and time Patient related: Name, age and signature of the patient/proxy decision maker Doctor related: Name, registration number and signature of the doctor Witness: Name and signature of witness Disease-related: Diagnosis along with co-morbidities if any Surgical procedure related: Type of surgery (elective/emergency), nature of surgery with antecedent risks and benefits, alternative treatment available, adverse consequences of refusing treatment Anaesthesia related: Type of anaesthesia (general and/or regional, local anaesthesia, sedation) including risks Blood transfusion: Requirement and related risks Special risks: Need for post-operative ventilation, intensive care, etc CONSENT IN RELATION TO PUBLICATION.
A registered medical practitioner is not permitted to publish photographs or case reports of his/her patients without their consent, in any medical or another journal in a manner by which their identity could be revealed. However, in case the identity is not disclosed, consent is not needed (clause 7.17).[8] CONSENT IN RELATION TO MEDICAL RESEARCH Consent taken from the patient for the drug trial or research should be as per the Indian Council of Medical Research guidelines[39]; otherwise it shall be construed as misconduct (clause 7.22).[8] COMMON FALLACIES IN THE CONSENT PROCESS.
The anaesthesiologist must ensure that consent is given maximum importance, and all the legal formalities are followed before agreeing to provide the services. Following are some frequent mistakes and omissions that can cost him/her dearly in the event of a mishap: Procedure is considered trivial, and consent is not taken.
Consent of relative is taken instead of the patient, even when patient is a competent adult.
Consenting person is minor, intoxicated or of unsound mind Blanket consent is taken.
Alterations or additions are made in the consent form without patient's signed authorisation.
It is not procedure specific Consent for blood transfusion is not obtained.
Fresh consent is not taken for a repeat procedure Procedure related necessary information is not given Even if the information given, it is not documented Consent lacks the signature of the treating doctor Consent is not witnessed SUMMARY It is not only ethical to impart correct and necessary information to a patient prior to conducting any medical procedure, but it is also important legally. This communication should be documented. Even professional indemnity insurance may not cover for lapses in obtaining a valid consent, considering it to be an intentional assault.
ACKNOWLEDGMENTS We gratefully acknowledge the invaluable contribution and irreplaceable advice extended to us during the preparation of this article by Mr. M Wadhwani, Advocate.
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39. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Published by: Director General Indian Council of Medical Research; 2006. [Accessed on 2014 Mar 3]. eral Ethical Issues; pp. 21-33. ] Now we discuss a little about consent form filed by the opposite parties as annexure -2 with his written statement. First there is no signature of the concerned Dr on this consent form. There is no separate consent form for anaesthesia. This pro forma is not in accordance with the pro forma prescribed for taking the consent. There is no separate consent to use the body for post-mortem examination for the purpose of study. There is nothing in this consent form which show that the doctor has specifically mentioned all the risks to the patient or his family members regarding operation or any other tests which may be performed. So this consent form is not a proper consent form as per the guidelines. It also shows deficiency and negligence on the part of the opposite parties.
Now we come to discuss the safety point of view of the patient. Whenever any patient is admitted in the hospital the first and foremost duty of the doctor and paramedical staff, is to look after the patient in all respect, to work for his safety so that he may not feel otherwise. In this case the patient was suffering from Acute Lymphoblastic Leukaemia, being a child of tender age, proper care should be given to him and he should be kept in a homely atmosphere. Precautions and safety are also necessary.
Committee on Patient Safety and Quality Improvement This document reflects emerging concepts on patient safety and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.
ABSTRACT: Ensuring patient safety in the operating room begins before the patient enters the operative suite and includes attention to all applicable types of preventable medical errors (including, for example, medication errors), but surgical errors are unique to this environment. Steps to prevent wrong-site, wrong-person, wrong-procedure errors, or retained foreign objects have been recommended, starting with structured communication between the patient, the surgeon(s), and other members of the health care team. Prevention of surgical errors requires the attention of all personnel involved in the patient's care.
Potentially preventable surgical errors have received increasing attention in recent years, although they appear to occur relatively infrequently compared with other types of medical errors. The Joint Commission has collected data on reported sentinel events since 1995 with wrong-site surgery consistently ranked as the most frequently cited reason 1. In 2008, the year for which most recent data are available, there were 116 wrong-site surgery sentinel events reviewed. Although specialty specific statistics are not included on the Joint Commission's web site, no surgical specialty is immune from surgical errors 1. Classic examples in the specialty of obstetrics and gynecology include wrong procedures, such as tubal ligation without consent.
Terminology The term wrong-site surgery is used to refer to any surgical procedure performed on the wrong patient, wrong body part, wrong side of the body, or at the wrong level of the correctly identified anatomic site 2. The following terms can be used to describe the various specific errors:
Wrong-patient surgery describes a surgical procedure performed on a different patient than the one intended to receive the operation.
Wrong-side surgery indicates a surgical procedure performed on the wrong extremity or side of the patient's body (eg, the left ovary rather than the right ovary).
Wrong-level surgery and wrong-part surgery are used to indicate surgical procedures that are performed at the correct operative site, but at the wrong level or part of the operative field or patient's anatomy.
Systems Approach Particularly because of the potential for serious harm from surgical errors, vigorous efforts are required to eliminate or reduce their frequency. Preventing a surgical error appears to be amenable to a systems approach involving a team effort by all individuals participating in the surgical process. Although all members of the surgical team share this responsibility, the primary surgeon should oversee these efforts. The Joint Commission has identified the following factors that may contribute to an increased risk of wrong-site surgery:
Multiple surgeons involved in the case Multiple procedures during a single surgical visit Unusual time pressures to start or complete the procedure Unusual physical characteristics, including morbid obesity or physical deformity A common theme in cases of wrong-site surgery involves failed communication between the surgeon(s), the other members of the health care team, and the patient. Communication is crucial throughout the surgical process, particularly during the preoperative assessment of the patient and the procedures used to verify the operative site. Effective preoperative patient assessment includes a review of the medical record or imaging studies immediately before starting surgery. To facilitate this step, all relevant information sources, verified by a predetermined checklist, should be available in the operating room and rechecked by the entire surgical team before the operation begins. A briefing is important for assigning essential roles and establishing expectations. Introduction of each person in the operating room by name and role, even if team members are familiar, is recommended for improved communication. Whenever possible, the patient (or the patient's designee) should be involved in the process of identifying the correct surgical site, both during the informed consent process and in the physical act of marking the intended surgical site in the preoperative area. A formal procedure for final confirmation of the correct patient and surgical site (a "time out") that requires the participation of all members of the surgical team may be helpful. Time outs may include not only verification of the patient and the surgical site, but also relevant medical history, allergies, administration of appropriate preoperative antibiotics, and deep vein thrombosis prophylaxis.
Improving Patient Safety in the Surgical Environment The Universal Protocol In 2003, the Joint Commission published "Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery" 2. The universal protocol, now included in the chapter on national patient safety goals in the Joint Commission's accreditation manual, involves the completion of three principal components before initiation of any surgical procedure 3:
1. Preprocedure verification process The health care team ensures that all relevant documents and related information or equipment are available before the start of the procedure;
correctly identified, labeled, and matched to the patient's identifiers; and reviewed and are consistent with the patient's expectations and with the team's understanding of the intended patient, procedure, and site.
The team must address missing information or discrepancies before starting the procedure.
2. Marking the operative site Procedures that require marking of the incision or insertion site include those where there is more than one possible location for the procedure or when performing the procedure would negatively affect quality or safety. According to the Joint Commission, the site does not need to be marked in cases where bilateral structures (such as ovaries) are removed 3. Although the Joint Commission does not require a specific site marking method, each facility should be consistent in the method it uses ensuring that the mark is unambiguous. Only the correct site should be marked; an "X" or "No" should never be used on the wrong site.
3. Performing a "time out" before the procedure The operative team conducts a final assessment that the correct patient, site, and procedure are identified, recognizing that this is problematic in emergency situations, such as an emergency cesarean delivery.
World Health Organization Surgical Safety Checklist Another useful tool to promote patient safety in the surgical setting is the surgical safety checklist published by the World Health Organization. The checklist is based on the successful international program "Safe Surgery Saves Lives," which incorporates validated checklists to be reviewed by the surgical team before induction of anesthesia, before skin incision, and before the patient leaves the operating room 4. It is inappropriate to place total reliance on the surgeon to identify the correct surgical site or to assume that the surgeon should never be questioned. The risk of error may be reduced by involving the entire surgical team in the site verification process and encouraging any member of that team to point out a possible error without fear of ridicule or reprimand.
Patient Involvement A relatively new but essential element of the overall process is the formal enlistment of the patient in the effort to avert errors in the operative arena. Involving the patient in this manner requires personal effort by the surgeon to educate the patient during the preoperative evaluation process. The patient, who has the greatest stake in avoiding errors, thus becomes integrally involved in helping ensure that errors are avoided.
Granting Privileges for New Procedures New techniques and new equipment are important components for developing and delivering the best quality care in the operating room, but they also represent sources of potential surgical error. Whenever possible, a surgeon who is incorporating a new surgical technique should be proctored or supervised by a colleague more experienced in the technique until competency has been satisfactorily demonstrated. In some circumstances, however, a technique may be so innovative that no other surgeon at that facility has more experience. In such situations, it may be necessary to require reciprocal proctoring at another hospital or grant temporary privileges to someone from another hospital to supervise the applicant. The surgeon performing the procedure should have already documented skills and experience in the related surgical arena.
When new equipment is introduced, all members of the surgical team must be trained on and practice with the new equipment as appropriate for the extent of their involvement, and all personnel involved must be aware of all safety features, warnings, and alarms of the device. Whenever possible, the institution's medical engineering department should inspect the equipment and verify that it is functioning properly before the equipment is put into clinical use. Any informational material (eg, user manuals, operating instructions) provided by the manufacturer of the equipment should be carefully reviewed by the principal users and should be familiar to anyone using the equipment. Labels attached to the device or plastic cards summarizing instructions for proper use may be helpful until everyone involved is comfortable with the new equipment. All necessary adaptors, attachments, and supplies should be in the room or readily available before beginning surgery with the new equipment. Any recommended protective devices, such as eye shields or special draping material, should be used for the safety of all concerned. The lead surgeon using the new equipment should have demonstrated competency in the use of the device, resulting in the granting of privileges. Leaders of each surgically oriented department will determine the specific requirements for granting privileges to their members for the use of new techniques or equipment. It is never appropriate for nonmedical, noncredentialed individuals, such as industry representatives, to perform the actual surgery. Such individuals should be excluded from the operating room if their presence would present a distraction or discomfort for any member of the essential operating room team. Additional information on requests for new privileges can be found in Quality and Safety in Women's Health Care, 2nd edition.
Stress and Fatigue A well-recognized source of human error is excessive stress and fatigue. According to the Health and Safety Laboratory, Britain's leading industrial health and safety facility and an agency of the British Health and Safety Executive, disrupted sleep patterns and inadequate sleep can result in fatigue and reduced levels of cognitive performance thus increasing the risk of an accident. Human error arising from fatigue may have catastrophic results in safety critical environments 5. Sleep deprivation can cause errors in performing even the most familiar tasks; for example, the National Highway Traffic Safety Administration reports that sleepy drivers cause at least 100,000 automobile accidents annually in the United States, resulting in approximately 40,000 injuries and 1,500 deaths 6. For this reason, many industries have already imposed strict limitations on working hours for individuals in vulnerable occupations, such as truck drivers, airline pilots and crew members, air traffic controllers, and power plant personnel. The Accreditation Council on Graduate Medical Education has enacted restrictions on resident work hours to prevent sleep deprivation, stress, and fatigue that might increase the risk of error 7 8. Although no legal restrictions have yet been imposed on the work hours of physicians in clinical practice, common sense dictates that the surgeon and the surgical team should be alert and well rested when initiating major surgical procedures. Emergency situations may be particularly hazardous as an environment for error, especially if the surgical team is stressed and fatigued already. A recent study that examined the risk of complications by attending physicians after performing nighttime procedures found an increased rate of surgical complications when physicians had slept less than 6 hours 9. Adequate backup personnel should be available to relieve individuals who detect diminished performance in themselves or others due to fatigue, so that the risk of error is not increased.
Medication Errors The surgical environment deserves heightened vigilance to prevent medication errors because medication orders often are given verbally rather than in writing, making such orders particularly vulnerable to misinterpretation or misapplication. Increased stress or confusion during urgent situations in the operating room may increase the possibility of error in prescribing, administering, or monitoring medications. For these reasons, medication error in the surgical arena may not be addressed by the safety measures (eg, electronic order entry) proved effective in other environments. It may be wise for the surgical team to agree on protocols for administering commonly used medications or treatments and to practice their implementation. Timely and effective communication between the surgical and anesthesia teams, including read backs as necessary, during the entire procedure may help avoid errors that could result from misunderstanding.
Retained Foreign Objects The Joint Commission includes unintended retention of a foreign object in a patient after surgery or other procedure as a reviewable sentinel event 10. In its statement on the prevention of retained foreign objects after surgery, the American College of Surgeons recommends consistent application and adherence to standardized counting procedures and documentation of the surgical counts, instruments or items intentionally left as packing, and actions taken if count discrepancies occur 11. Other protocols to prevent unintentional retention of foreign objects during surgery and vaginal delivery have been developed. For example, the Institute for Clinical Systems Improvement's protocol suggests that sponges, needles, and sharp instruments are counted before and after surgery and vaginal delivery. Only radiopaque sponges and soft goods should be placed on surgical trays or delivery fields. If the counts at the end of the case are either incorrect or compromised, then an abdominal or vaginal examination must be performed. If the counts are still not reconciled, radiographic imaging for retained foreign objects will need to be obtained 12.
Teaching Trainees, such as obstetric-gynecologic residents, surgical residents, anesthesiology residents, medical students, nursing students, and operating room technician students, may be part of the surgical environment in the operating room or labor and delivery suite. The education process in these environments presents special challenges in protecting patient safety. It is a fundamental principle that all trainees must be meticulously supervised and assisted when participating in surgery. Both the trainee and the supervisor should be alert, well rested, and well prepared in advance for the surgical procedure being performed. Because patient safety depends on effective communication among all members of the health care team, trainees should be conversant in the pertinent terminology before starting the procedure. The presence of noninvolved individuals as observers in the operating room or delivery suite may be a distraction to the surgical team and, therefore, should receive careful consideration before they are admitted. The current development of virtual surgery training techniques may become useful for students to learn and practice surgical skills before attempting procedures in the operating room.
Obstetric Surgery Operating on pregnant patients creates unique responsibilities in ensuring patient safety because two or more patients are involved simultaneously--the woman and the fetus(es)--each with different needs. Adequate personnel who will ensure proper attention to the condition of each patient must be present. Particular attention is needed to address administration of the different medications appropriate for the pregnant patient and her fetus(es) or the newborn patient(s), such as dosage and timing of antibiotics or analgesics for mother or newborn(s) or both. The obstetric surgeon also needs to communicate with a pediatrics team in a timely and effective manner to reduce the possibility of error in care of the neonate. The occasional use of blood transfusion opens another potential avenue for introduction of error because calling for the administration of blood products may take place under especially stressful and hectic conditions. Checklists and protocols for massive transfusion in the event of significant obstetric hemorrhage are recommended for labor and delivery units. Much obstetric surgery is by nature unplanned as the course of the delivery unfolds, and obstetric emergencies can progress rapidly, increasing the possibility of error if protocols and standardized procedures are skipped or abbreviated.
Freestanding Surgical Units In recent years, many surgical procedures traditionally performed only in hospitals or similar institutions have increasingly been performed in physicians' offices or freestanding surgical facilities. This trend has produced cost savings and convenience for patients as well as health care providers and will likely continue. However, because these facilities may not be subject to the same level of scrutiny or administrative oversight as hospitals, surgeons who use these facilities must be particularly vigilant against inadequate training of personnel, inappropriate or poorly maintained equipment and instruments, and ineffective protocols or practices, all of which may increase the likelihood of medical error and jeopardy to patient safety. According to the American College of Obstetricians and Gynecologists' Presidential Task Force on Patient Safety in the Office Setting, patients have the right to expect the same level of safety regardless of where they seek treatment 13. This task force also notes that accreditation is something more practices may seek in the future. Many states already require it if certain levels of anesthesia are used in the office or surgical center--typically moderate sedation or deeper anesthesia will trigger this requirement 13. Such requirements will likely improve the quality and safety of care provided in these settings.
Distractions Beepers, radios, telephone calls, and other potential nonessential activities and distractions in the surgical environment should be kept to a minimum, if allowed at all, especially during critical stages of the operation. Just as pilots maintain "sterile cockpits," a Federal Aviation Administration regulation requiring pilots to refrain from nonessential activities during critical parts of a flight, all members of the operating room team also should postpone nonessential conversation until surgery is finished 14. Similarly, it may be preferable to ask nonessential personnel to remain outside the operating room while surgery is being performed. Everyone on the team is mutually accountable for minimizing distractions.
Conclusion Although medical errors can occur in any aspect of medicine, the surgical environment presents additional, special challenges to safeguarding patient safety. Because these injuries can be serious, particular care is appropriate in creating checklists, systems, and routines that reduce the likelihood of wrong-patient, wrong-side, wrong-part surgical errors, and retained foreign objects. Along with these tools, communication among members of the surgical team is crucial throughout the surgical process, particularly during the preoperative phase. The wide variety of techniques, instruments, and technology used for surgical procedures makes granting privileges of surgeons critically important. Freestanding surgical units may need to be particularly vigilant in ensuring that personnel and equipment are in good condition for surgery. Protocols and procedures to identify and manage stress and fatigue in surgical personnel may help to avoid surgical errors and patient injuries. The operating room is an appropriate educational environment, but the presence of observers at any level must not be allowed to compromise patient safety. Patient safety in surgery demands the full attention of skilled individuals using well-functioning equipment under adequate supervision.
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Now we come to the present case which has been handled poorly by the doctors and Institute. The patient was sent to special ward on 09.05.94 by Dr Sonia Nityanand. After admission, Dr S Nityanand and Dr Chandrashekhar and Dr Negi visited regularly to the patient along with senior Dr RN Mishra and they used to console the complainant that the patient's condition is improving. As per complainant, during this period of treatment in private room-3, the patient was compelled many times to be shifted in isolation room being cheap treatment there in comparison to private rooms. We have seen the death certificate in which Dr S Nityanand has written that on 31 May 1994 at 1.4 5 PM patient developed hypotension and he was then shifted to Iso-2 (after informing mother of patient) as Iso-2 is next to the nursing station were all emergency equipments are available and from where intensive monitoring of patient is better. The patient expired at 2:20 PM. Here the question arises when the patient was in immunology ward, there was no need to shift him to isolation ward /room. This report is given later on when the court directed the institute to file the documents. It is the duty of every hospital, nursing home to provide all the case history sheet, BHT to the patient or his ward at the time of discharge on in case of sad demise of the patient. But they did not do it and ultimately the court, to the rescue.
The Department of Clinical Immunology and Rheumatology was established in 1987 and was the first department of its kind in the country. At the time of admission of the patient there was immunology department in SGPGI and inspite of it, the patient was admitted in general hospital/general ward. The qualified doctor even after detecting the need of bone marrow, could not transfer the patient to the Department of immunology. When once they came to know that it is not a case of paediatrician, why did she not direct that patient be immediately shifted to Department of immunology and the expert doctors dealing with cancer should go for further management. The Department of Radiotherapy was there. So they were responsible for the treatment of the patient. In spite of it various doctors including paediatrician treated the patient for a long time knowing that it is a known case of ALL. It is negligence on the part of Dr and also on the part of the institute. When we know that the cancer patient may be treated at an early stage and could be saved, in spite of it they did not pay proper attention and care as demanded by cancer patient. The consent paper is blank meaning thereby that it has been prepared later on when the court asked the institute to file all the papers related to the treatment of the patient. In reply of RTI so many facts revealed that established the fact that such type of patient cannot be admitted to general hospital and it should have been admitted to Department of immunology. In this case the ultimate negligence was shown by Dr Pyali Bhattacharya who being a paediatrician treated the patient for a long time though she knew that it is a case of Department of immunology. The institute was also negligent in not seeing that a paediatrician is treating the cancer patient. Other doctors were also negligent towards the treatment of the patient. The patient was shifted from one ward to another ward for no reason. Opposite parties no.3 to 5 also did not pay attention towards the proper treatment of the patient. When the document dated 18 December 1992, the patient was referred to Department of radiology by Dr P Bhattacharya, the paediatrician, for the first time for chest x-ray and in the column of clinical finding/provisional diagnosis it is written "Acute Leukaemia on Chemotherapy." There is no document showing the permission taken for chemotherapy. We are unable to understand that why paediatrician was involved in the treatment of a ALL patient. While did she not refer the patient to Department of immunology in the beginning.
Now we have see the bone transplantation. For bone marrow, it is necessary to give anaesthesia but we did not find any paper regarding taking of consent for the bone marrow transplantation or sending bone marrow for biopsy or for giving anaesthesia. When they did not take consent and submitted a blank consent form without the signature of either the doctor or the patient or the Guardian of the patient what to sayabout bone marrow .
Bone marrow aspiration and bone marrow biopsy are procedures to collect and examine bone marrow -- the spongy tissue inside some of your larger bones.
Bone marrow aspiration and bone marrow biopsy can show whether your bone marrow is healthy and making normal amounts of blood cells. Doctors use these procedures to diagnose and monitor blood and marrow diseases, including some cancers, as well as fevers of unknown origin.
Bone marrow has a fluid portion and a more solid portion. In bone marrow aspiration, a needle is used to withdraw a sample of the fluid portion. In bone marrow biopsy, a needle is used to withdraw a sample of the solid portion.
Bone marrow aspiration can be performed alone, but it's usually combined with bone marrow biopsy. Together, these procedures may be called a bone marrow exam.
A bone marrow exam offers detailed information about the condition of your bone marrow and blood cells.
Your doctor may order a bone marrow exam if blood tests are abnormal or don't provide enough information about a suspected problem.
Your doctor may perform a bone marrow exam to:
Diagnose a disease or condition involving the bone marrow or blood cells Determine the stage or progression of a disease Determine whether iron levels are adequate Monitor treatment of a disease Investigate a fever of unknown origin A bone marrow exam may be used for many conditions. These include:
Anemia Blood cell conditions in which too few or too many of certain types of blood cells are produced, such as leukopenia, leukocytosis, thrombocytopenia, thrombocytosis, pancytopenia and polycythemia Cancers of the blood or bone marrow, including leukemias, lymphomas and multiple myeloma Cancers that have spread from another area, such as the breast, into the bone marrow Hemochromatosis Fevers of unknown origin Your blood pressure and heart rate will be checked, and you'll be given some form of anesthesia to keep you comfortable.
A bone marrow examination can be done with only local anesthesia to numb the area where the needles will be inserted. With local anesthesia, bone marrow aspiration, in particular, can cause brief, but sharp, pain. Many people choose to also have light sedation for additional pain relief.
If you're anxious about pain, you may be given an IV medication so that you're either completely or partially sedated during the bone marrow exam.
The area where the biopsy needles will be inserted is marked and cleaned with an antiseptic. The bone marrow fluid (aspirate) and tissue sample (biopsy) are usually collected from the top ridge of the back of a hipbone (posterior iliac crest). Sometimes, the front of the hip may be used.
You'll be asked to lie on your abdomen or side, and your body will be draped with cloth so that only the exam site is showing.
Rarely, bone marrow aspiration -- but not biopsy -- is collected from the breastbone or, in children under the age of 12 to 18 months, from the lower leg bone.
Bone marrow aspiration The bone marrow aspiration is usually done first. The doctor or nurse makes a small incision in the skin, then inserts a hollow needle through the bone and into the bone marrow.
Using a syringe attached to the needle, a sample of the liquid portion of the bone marrow is withdrawn. You may feel a brief sharp pain or stinging. The aspiration takes only a few minutes. Several samples may be taken.
The health care team checks the sample to make sure it's adequate. Rarely, fluid can't be withdrawn and the needle is moved for another attempt.
Bone marrow biopsy The doctor or nurse uses a larger needle to withdraw a sample of solid bone marrow tissue. The biopsy needle is specially designed to collect a core (cylindrical sample) of bone marrow.
After the procedure Pressure will be applied to the area where the needle was inserted to stop the bleeding. Then a bandage will be placed on the site.
If you had local anesthesia, you'll be asked to lie on your back for 10 to 15 minutes and apply pressure to the biopsy site. You can then leave and go about your day, returning to normal activity as soon as you feel up to it.
If you had IV sedation, you'll be taken to a recovery area. Plan to have someone drive you home, and take it easy for 24 hours.
You may feel some tenderness for a week or more after your bone marrow exam. Ask your doctor about taking a pain reliever, such as acetaminophen (Tylenol, others).
Site care Wear the bandage and keep it dry for 24 hours. Don't shower, bathe, swim or use a hot tub. After 24 hours you can get the area wet.
Contact your doctor if you have:
Bleeding that soaks through the bandage or doesn't stop with direct pressure A persistent fever Worsening pain or discomfort Swelling at the procedure site Increasing redness or drainage at the procedure site To help minimize bleeding and discomfort, avoid rigorous activity or exercise for a day or two.
Results The bone marrow samples are sent to a laboratory for analysis. Your doctor generally gives you the results within a few days, but it may take longer.
At the laboratory, a specialist in analyzing biopsies (pathologist or hematopathologist) will evaluate the samples to determine if your bone marrow is making enough healthy blood cells and to look for abnormal cells.
The information can help your doctor:
Confirm or rule out a diagnosis Determine how advanced a disease is Evaluate whether treatment is working It shows that there is negligence on the part of the doctors and institute at each and every step regarding the treatment of a ALL patient, specifically a child of a tender age who can be saved by immediate and proper treatment but he could not be saved. There was lack of post-operative care which should have been of the highest level but in this case we do not find any effective post-operative care by the Institute or by the concerned Dr treating the patient. All these show the ultimate degree of carelessness and negligence on the part of the Institute and also on the part of concerned doctors. After considering all the facts and circumstances of this case we are of the constant view that there is negligence, deficiency of service and carelessness on the part of the opposite parties.
Opposite party-6 is Oriental Insurance Company who will indemnify the doctor against any compensation to the maximum limit for which they are insured. For this the negligent person can file a suit against the Oriental insurance Co to indemnify themselves.
The complainant has prayed Rs.14 lakhs as compensation for the death of his son, Rs.5 Lacs towards irreparable loss and also prayed for the reliefs and order which this Hon'ble commission may deem fit and proper in the circumstances of this case. So for this prayer of clause (c) of the complainant we are of the opinion that the complainant is entitled to Rs.30 lakhs towards mental harassment, mental torture, depression, special compensation. The death of his only child in such a tender age cannot be compensated by means of money but this may be a consolation for the bereaved father. So we come to the following conclusion regarding reliefs:
ORDER 1- The opposite parties no.1 to 5 are jointly and severally directed to pay Rs.14 lakhs to the complainant towards compensation within 45 days from the date of judgment of this complaint case with interest at a rate of 10% from 01.06.94 and if not paid within 45 days, the rate of interest shall be 15% per annum from 01.06.94 the date of actual payment.
2- The opposite parties no.1 to 5 are jointly and severally directed to pay Rs.05 lakhs to the complainant towards death and a irreparable loss of the child of the complainant within 45 days from the date of judgment of this complaint case with interest at a rate of 10% from 01.06.94 and if not paid within 45 days, the rate of interest shall be 15% per annum from 01.06.94 the date of actual payment.
3- The opposite parties no.1 to 5 are jointly and severally directed to pay Rs.30 lakhs to the complainant towards mental agony, torture, depression, cost of the suit within 45 days from the date of judgment of this complaint case with interest at a rate of 10% from 01.06.94 and if not paid within 45 days, the rate of interest shall be 15% per annum from 01.06.94 the date of actual payment.
If the order is not complied with, within the stipulated time, the complainant will be free to file execution case against the opposite parties at their cost. The opposite parties may go to the insurance company to indemnify themselves to the extent, they are insured.
The stenographer is requested to upload this order on the Website of this Commission today itself.
Certified copy of this judgment be provided to the parties as per rules.
(Vikas Saxena) (Rajendra Singh) Member Presiding Member Judgment dated/typed signed by us and pronounced in the open court. Consign to the Record Room. (Vikas Saxena) (Rajendra Singh) Member Presiding Member Dated : March 2, 2023 JafRi, PA I Court 2 [HON'BLE MR. Rajendra Singh] PRESIDING MEMBER [HON'BLE MR. Vikas Saxena] JUDICIAL MEMBER