Kokilaben Dhirubhai Ambani Hospital — doctor negligence and not informing / counselling on serious effect and infection risks of the biologic injections

Address:

400097

I have sent the below complaint to the kokilaben hospital management.
This is regarding my nephew deepak chandrani (18 years old) who died in kokilaben hospital due to dr. Gaurav mehta's negligence and does not informing / counselling the serious side effects and infection risks of the exemptia (Injections) before prescribing the biologic or immunosuppresant injection to deepak who was very weak suffering from severe malnutrition.

Please find below the detail history.

Deepak was suffering from ulcerative colitis, severe mal-nutrition and back pain. Initially deepak was under dr. Shankaran treatment as he was very weak and had back pain, he referred dr. Gaurav mehta for the second opinion. On first visit, dr. Gaurav told that he will cure deepak with medical treatment. Deepak was admitted thrice in the kokilaben hospital.

On first admission and treatment, he was discharged after 4 days. He had follow-up with the doctor next week, but in between deepak again had a stomach pain, so he was admitted second time to the hospital again. He was under medical treatment, the doctor informed that the medical treatment is not working we have to go for the biological injection and told that each injection will cost rs 40000 and 4 injections will be given on 1st day, 2 on15th days and 1 on 29th day, and thereafter it has been to given 1-2 times every month depending on the condition. We asked the doctor whether this injection will cure the ulcer. He told that this injection will suppress the ulcer pain. We told if it not cure the ulcer and the injections are very expensive it is not affordable to us in the hospital so we asked the doctor for discharge. He agreed for the discharge and told that still he has to be given the injection so he prescribed the injection and gave the contact of zydus dealer named visha and told that he will given you the injections on discount and you can give the injection at home to deepak.

We trusted the doctor and gave the injection to deepak at home through nurse. After injection he starting breathing rapidly, his heart was beating fast and he was unable to move from the bed, and his stomach was rigid and was paining. I called dr. Mehta and told him of deepak's condition. He told to admit him to the nearby hospital. We admitted him in agrawal's hospital. Doctor gave him the injection then he got some relief from the pain. We told dr j agrawal that we have given 4 exemptia (Adalimumab) injections as per dr. Mehta's prescription. He and dr. Jay kotecha did deepak's check-up and found that the infection has increased and the ulcer had further deteriorated and there is a sign of mega toxic colon and his x-ray report said the ulcerative colitis going into intestinal obstruction and (Pct), serum showed report showed 46.76.. Dr. J agarawal advice us that he needs to be admitted to big hospital either at kokilaben where his treatment was going or seven hills hospital, where he and his team will do his treatment there.

Agrawal discharge reports said: ulcerative colitis going into intestinal obstruction, toxic colon with adalimumab and procalcitonin (Pct), serum of 46.76.

As initial treatment was done on kokilaben, we admitted deepak there on 13th jun at night 11:00 p. M, his blood testing and ct scan was done. Next day morning at about 10 a. M, dr. Mehta told that injection also didn't worked and there is punctured in the intestine and emergency surgery needs to be done. Dr. Manoj mulchandani also told that his intestine is ruptured and emergency surgery in 4 hours, but the surgery was done in the evening at about 7 p. M. After surgery, dr. Mulchandani informed that the operation was successfully and the team removed about 2-3 liters of pus and there was no ulcer in the intestine.

Next day in the morning after surgery, dr. Mehta called me in the icu, and told that deepak is ok, he will be moved from icu to general ward in 1-2 days. But when i met deepak, he was not able to identify anyone, hee was not well. When i asked the dr. Mehta why he is unable to identify anyone? He said nothing wrong, he will be moved to nearby window bed and everything will be ok and informed me that he will on leave for 3 days. Looking at deepak's condition, i started feeling that there is something major wrong after surgery and dr. Mehta didn't gave the correct information and left for holiday for 3 days. Next day dr. Rupa informed that deepak is in critical condition and was put on sedation, i told her there something wrong with the diagnosis, injections and surgery. How come simple ulcer brought deepak into critical codition. Dr. Manoj mulchandani took charge for 3 days in dr. Mehta's absence, and he also informed that deepak is in serious condition and his infection was increasing. Dr. Mulchandani asked me whether deepak was also suffering from liver problem. I said no as per my understanding. I also told we have admitted him thrice and the ct scan was done three times, if there was a liver problem then the doctor would have been identified there itself. Dr. Mulchandani told that his blood was also thin (Blood disorder) and antibiotics are not working. He was also not sure why antibiotics were not working. Icu head, dr. Prashant borade informed us that he had a multi-organ failure (Liver and brain) and need liver transplant we had a meeting thereafter with the team of doctors (You were also involved), and the doctors informed that deepak has only 5% chance of survival and dr. Mulchandani justified that due to blood transfusion deepak's was delayed. (Blood testing was done at 11 p. M report normally comes at 7 a. M next morning, how come then it took 12 hours for blood tranfusion?). Dr. Mehta told about 7 single donor platelets would be needed, i also advised to coordinate with the team of doctors and get the best antibiotics to cure deepak. Dr. Mulchandani gave new antibiotics (Fhosfomycin and reinvexin) and that too didn't worked. His condition was becoming worst and there was no improvement. Dr. Mehta informed that deepak was having new infection day-by-day and there was no antibiotics for this new infection, and deepaks condition was not improving. We are not aware what happening. I asked dr. Mehta what next now, he told that there are 3 options 1) we follow the same aggressive treatment 2) we give the required treatment and stop taking report / ct scan, 3) we reduce the dose and let deepak die as comfort care. He expired on 28th june.

How this ulcer colitis which was easily treatable become serious and took deepak's life. What went wrong?

Below are the finding after doing thorough investigations:

1) dr. Gaurav mehta should not have prescribed the exemptia (Adalimumab injection) to deepak as he was very weak and couldn't tolerate it. This injection deteriorated the ulcer and increased the infection and as per the x-ray report saying, obstruction "ulcerative colitis going into intestinal obstruction"

Please go through this q & a "preparing for biologic or immunosuppressant therapy" link http://europepmc.org/articles/PMC3264940.

Extract from the link "
G&h what factors should clinicians consider before initiating biologic or immunosuppressant therapy?

Svk first, clinicians should consider whether the patients disease warrants such treatment: is the patient sick enough that he or she needs biologic or immunosuppressant therapy? Also, is the patient healthy enough to tolerate these drugs?

If a patient feels a therapy is too dangerous, he or she is likely to be non-compliant with the prescribed regimen, even if he or she does not directly express any objections to the therapy. Finally, the patient's economic status should be taken into consideration, as immunosuppressants and especially biologic agents can be very expensive."

Deepak was severely malnutrition, he was very weak, and he couldn't tolerate these injections this injection suppressed his immune system and the infection increased [procalcitonin (Pct), serum of 46.76 as per the report]
2) dr. Gaurav mehta didn't informed / counseled us of the serious side effects and infection risks before prescribing this injection. It is the duty and responsibility of the doctor to inform the patient which was not done in this case.

After surgery, deepak had sepsis, multi organ failure (Liver + brain) and fatal blood disorders and new viral, fungal and bacterial infections
Side effects : https://en.wikipedia.org/wiki/Adalimumab#Side_effects
Because adalimumab suppresses tnf, which is part of the immune system, latent infections such as tuberculosis can be reactivated, and the immune system may be unable to fight new infections. This has led to fatal infections in some patients. After a number of studies and reports of adverse events in patients receiving adalimumab — including serious and sometimes fatal blood disorders; serious infections, including tuberculosis and infections caused by viruses, fungi, or bacteria; rare reports of lymphoma[15] and solid tissue cancers; rare reports of serious liver injury; rare reports of demyelinating central nervous system disorders; and rare reports of cardiac failure.

Adalimumab side effects : https://en.wikipedia.org/wiki/Adalimumab#Side_effects

Antibiotics didn't worked on deepak after surgery because this injection suppressed his immune system (~ for 15 days) and infection was increased and he had sepsis, blood disorder and multi organ failure (Liver and brain) because of infection
Inline image 2

Open this link : http://reference.medscape.com/drug/remicade-inflectra-infliximab-343202#3 and click adalimumab, you will see below.
Serious - use alternative (68)

Adalimumab
Adalimumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or use alternate drug.
From above, it clearly shows adalimumab injection must not be used still dr. Gaurav mehta prescribed it.
Extract from this q and a link:http://europepmc.org/articles/PMC3264940. "the risks involved with these therapies should be discussed. Risks of biologic and immunomodulator therapy include infection, an immune-allergic phenomenon, anaphylaxis, and lymphoma. When discussing the risk of lymphoma, clinicians should mention that this risk is equal for all agents in a particular class, and that while all of these agents are associated with an increased risk for lymphoma, this risk is not as high as the risk of complications from untreated ibd. Finally, although the risk of lymphoma is 4 times greater for patients receiving these agents than for someone who is not taking these medicines, the absolute risk of lymphoma remains low in most patients.
One important point to note is that there is a much higher risk for certain kinds of lymphomas in males under the age of 30 years, and this risk seems to be even higher when these patients are receiving combination therapy."

If dr. Metha would have informed us about the side effects and infections risks we would definitely not have given this injection to deepak.

3) pre testing guidelines were not followed before preparing for biologic therapy as per the standard.

Deepak was not tested for hepatitis b virus (Hbv) and hepatis c virus (Hcv). These tests needs to be done as per the standard guidelines

Below extract from q & a "preparing for biologic or immunosuppressant therapy" link http://europepmc.org/articles/PMC3264940.

G&h do patients need to be screened for latent infections prior to starting biologic therapy or immunosuppressants?

Svk testing for tb and hbv is standard and should be performed in all patients who are preparing to start biologic therapy.

To summarize:

1) firstly, the doctor must not have prescribed this biological injection to weak and serve malnutrition patient who cannot tolerate it.

2) secondly, it is the responsibility and duty of the doctor to inform / do counselling of the serious side effects and infection risks of the biological or suppressant as described above. It was not done in this case. Antibiotics didn't worked on deepak because this injections suppressed deepak's immunity, and the infection went on increasing. Because of the infection he had blood disorder and multi-organ failure (Liver and brain) and new infections like leposprisis. If dr. Gaurar mehta had informed us this serious side effects and infection risk before prescribing this biological injections we would definitely not have taken this injection.

3) thirdly, the doctor didn't followed or advice us the proper pretesting guidelines (Like hbv, hbc etc. Test) before prescribing the injection.

There are many other important points which i cannot describe in this email. We will discuss it in the meeting. As described above in the detail, we like to have claim for the pain and suffering that we have undergone. Keeping yourself in deepak father's place, you think of the pain we have gone through.

I would request you to look into this matter seriously on high priority and take appropriate action.

I hope the hospital transparency and ethics will be followed and maintained.