DISTRICT CONSUMER DISPUTES REDRESSAL COMMISSION-II
Udyog Sadan, C-22 & 23, Qutub Institutional Area
(Behind Qutub Hotel), New Delhi- 110016
Case No.167/2020
Ms. Mahima Soni
D/o Mr. Vivek Soni
C-536 Defence Colony, 3rd Floor,
New Delhi- 110024
….Complainant
Versus
- Reelabs Stem Cell & Therapy Centre
KK Chambers, 1st Floor, Sir P.T. Road, Fort
Mumbai, Maharashtra 400001
Throguh its Managing Director Mr. Sunil Pophale
- Mr. Jitinder Singh Gill (Vice President Sales)
Reelabs Stem Cell & Therapy Centre
KK Chambers, 1st Floor, Sir P.T. Road, Fort
Mumbai, Maharashtra 400001
- Mr. Ajay Saxena (Senior Adviser)
Doctor at Reelabs Stem Cell & Therapy Centre
KK Chambers, 1st Floor, Sir P.T. Road, Fort
Mumbai, Maharashtra 400001
- M/s Life Care Centre,
11, Gagan Vihar,
Near Karkari Mor Flyover
Delhi-110051.
….Opposite Parties
Date of Institution :05.10.2020
Date of Order :28.11.2024
Coram:
Ms. Monika A Srivastava, President
Ms. Kiran Kaushal, Member
Present: Adv. Sandeep Kapoor for complainant.
None for OP
ORDER
Member: Ms. Kiran Kaushal
1. Facts of the case as pleaded by the complainant are that the complainant was suffering from Multiple Sclerosis (MS) and was recommended Stem Cell Therapy by Reelabs Stem Cell and Therapy Centre (hereinafter referred to as OP-1).Mr. Jitinder Singh Gill and Mr. Ajay Saxena referred to as OP-2 and OP-3 respectively and M/s Life Care Centre is the tie up hospital of OP-1 which is referred to as OP-4.
2. It is stated that complainant was suffering from a disease called Multiple Sclerosis since 2010. This disease caused her to slowly loose control of her body. She was not able to move and had developed a problem of limp while walking. She was not able to walk independently without any support. Due to the negligence of OPs, complainant’s conditions worsened and she has become totally dependent and is permanently on wheel chair. Whereas, prior to taking treatment to OP, complainant was able to walk with support.
3. Complainant in the complaint mentioned about the disease Multiple Sclerosis as under-
Multiple Sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system).
In MS, the immune system attacks the protective sheath (myelin) that covers fibers and causes communications problems between your brain and the rest of your body. Eventually, the disease can cause permanent damage or deterioration of the nerves.
Signs and symptoms of MS vary widely and depend on the amount of nerve damage and which nerves are affected. Some people with severe MS may lose the ability to walk independently or at all, while others may experience long period of remission without any new symptoms.
There’s no cure for multiple sclerosis. However, treatment can help speed recovery from attacks, modify the course of the disease and manage symptoms.
4. It is stated that Dr. Anurag Singh who happened to reside in the same residential colony as the complainant recommended OP-1 which would help to improve the condition of complainant. After meeting the complainant and going through her medical records OP-2 and OP-3 advised Stem Cell Treatment to the complainant which was stated to be the latest advancement in the medical world for the treatment in the therapy of Multiple Sclerosis. It is stated that OP promised to induce stem cells in the spinal cord of the complainant and the newly injected cells would facilitate the healing process and reconstruction of the depleted Myeline Sheet which is the primary cause of the Multiple Sclerosis. It is stated that during the said period complainant could walk without support from anyone.
5. It is next stated that after assessing the condition of complainant OP-2 and OP-3 promised and assured that after the Stem Cell Treatment the complainant would find 25-30% improvement in her walk and gait. Lured by the promises of OP-2 and OP-3, complainant decided to undergo the treatment as suggested by OPs. However, after first course of treatment complainant’s condition worsened, which was intimated to OPs through whats app. She was unable to walk without the support of two persons. After condition of the complainant deteriorated complainant got to know that OP-3 is not a qualified doctor but the same was misrepresented to the complainant.
6. It is further stated that the complainant was not physically examined and diagnosed by any doctor from OP-1 and all the therapies were conducted upon the diagnoses of the non-medico people which is unethical and scrupulous. The treatment was executed in the tie up hospital of OP-1 i.e OP-4. It is stated that OP-4 is not specialized centre for the stem cell treatment rather it is an IVF centre run by a gynecologist and an IVF expert.
7. It is further stated that OP did not explain the procedure, its outcome, it complications and even without written informed consent OP performed three procedures at OP-4’s centre which caused remarkable deterioration in the condition of the complainant.
8. It is stated that before getting treatment from OPs complainant had got the MRI of her brain done and the lesions in her brain had decreased. As the condition of the complainant deteriorated after the second session, complainant again consulted HOD Neurology at BLK Hospital, New Delhi who advised her to get an MRI done. MRI of her brain dated 04.08.2018 showed more lesions than before. Same resulted in significant deterioration of her walk and gait. The doctor at BLK Hospital immediately prescribed steroids to the complainant after looking at the reports of her MRI. It is stated that the complainant paid sum of Rs.20,000/- for the said consultation and MRI. The third and final session taken from the OP left the complainant feeling even worse.
9. It is stated that OP experimented upon the patient by performing the procedure not medically prescribed or authorized. The said therapy of stem cell is not medically required or recommended at all for treating the condition akin to the patient. The patient was treated like a guinea pig.
10. Alleging deficiency of service and unfair trade practice, complainant prays for direction to OP to refund the entire amount of Rs.4,50,000/- paid by the complainant to OP and Rs.20,000/- paid by the complainant to the HOD of BLK Hospital; Rs.50,000/- paid for the subsequent treatment; Rs.90,00,000/- with interest @ 18% p.a towards compensation to the complainant in lieu of loss of health, loss of value of money, harassment, mental pain and agony and Rs.1,00,000/- towards cost of litigation.
11. OP resisted the complaint stating inter alia that OPs advised the complainant for stem cell which is believed to be the latest advancement in the medical world. Complainant’s father sent a video of the condition of the complainant to confirm the process for Stem Cell Therapy. It is stated that the core team of OPs met the complainant to discuss further course of action. The sales and marketing representatives visited the complainant in order to counsel her and to evaluate and note down her signs and symptoms, also collect her history, pathological investigation and personal details. Since, the representatives are from sales and not medical practitioners therefore, they are not authorized to give assurance to any patient as to how much improvement and recovery will be there after the therapy. It is stated that OP-1 through the representatives collects the reports, history and records the short video for a nominal fee of Rs.2,500/-.
12. It is further stated that the data collected is sent to the companies stem cell expert team of doctors to confirm the eligibility, chances of improvement, prognosis and treatment protocol. OP has denied giving any assurance of 25%-30% improvement and has stated that as per the experts’ opinion which the complainant had been apprised of, the chances of a long lasting impact was virtually impossible.
13. It is next stated that the complainant had been clearly informed that due to her medical condition i.e multiple sclerosis , it would be very hard to treat this disorder as whatever good work is done by stem cells, will be reversed by any relapse and OPs endeavor is only to stop and arrest the progression of the disorder. The complainant after having been fully satisfied with the written opinion paid the therapy fees to the extent of Rs.3,00,000/- plus Rs.1,50,000/- to OPs toward bone marrow aspiration, transport of bone marrow and doses from Delhi to Mumbai and vice versa through Air cargo, Hospitalization, Room charges, OT Charges, Anesthetic fees, Doctor and attendants fee, Stem cell expansion, Stem cell specialist fee and Medicine used in the procedure. Photocopy of the informed consent for therapy is annexed as Annexure 1.
14. It is further stated that M/s Life Care Centre (OP-4) is the tie up centre and the doctor attached is responsible for bone marrow aspiration providing OT, Room nursing staff and implant of stem cells as per protocol of stem cell specialist. OPs confirm that that the doctor under whose supervision the therapy was done is a seasoned one and had been doing such therapy for a very long time.
15. It is next stated that the claim made by the complainant that stem cell therapy is not approved by M/o Health and Welfare is a vague statement as in the Gazette notification of FDA of Government of India, auto logons/stem cells is termed as medicines. Copy of Gazette notification and Government’s letters is annexed as Annexure 2.
16. In light of the facts stated above, OP prays for dismissal of the complaint and for direction to complainant to pay the compensation for harming their reputation.
17. In the rejoinder filed by the complainant to the written statement of OP, it is stated that that as per Annexure 1 of the written statement the percentage of patients showing improvement in different body parts is mentioned in the clinical evaluation of MS patients but not a single thing is mentioned about the deterioration in the condition of the patients. In the instant case complainant’s condition deteriorated due to negligence and deficiency in service on part of OPs.
18. It is next stated that the doctor who treated the complainant is a Russian doctor, it is not clear whether the doctor was competent to practice in India as per the restrictions of National Medical Commission, India. It is next stated that the said doctor never examined the complainant and without physical examination and evaluation how can a treating doctor confirm the diagnoses.
19. Evidence and written arguments have been filed on behalf of complainant. OP was proceeded exparte vide order dated 13.09.2023. Submissions made are heard. Material placed on record is perused.
20. Complainant in support of the case has filed report of ultrasound conducted at OP-4. Three discharged slips for the three sessions of the stem cell treatment, whats app chat between the parties, the photographs of the patient in question and MRI of the brain and screening of the whole spine dated 27.02.2017 and 04.08.2018 is filed by the complainant.
21. It is noted that complainant was aware that Multiple Sclerosis has no cure. However, from the MRI reports of the brain and screening of whole spine, it is noticed that the patient’s condition deteriorated from February, 2017 to August, 2018. In the MRI reports dated August, 2018 fresh lesions in the right pons without abnormal enhancement or restricted diffusion were found. The period between the two MRIs is the time when the complainant had opted for Stem Cell Therapy.
22. Complainant’s contention that OP promised or assured 25 to 30% of improvement has not been evidenced. The informed consent for therapy annexed as Annexure-1 of the WS, which is duly signed by the father of the patient clearly mentions that OPs do not guarantee cure of the disease. Relevant portion of the consent form is reproduced as under-
- I fully understand and agree that the stem cell science is new and innovative. ReeLabs DOES NOT guarantee the cure of your disease.
- I understand and agree that as with all medications, there may be additional, unanticipated side effects, which have not yet been identified. I understand and agree that if I have any side effect during my visit,I should immediately notify the on-site treating physician. I understand and agree that if the side effect continue to persist that I should contact my treating physician.
- I understand and agree that deterioration of my diseased condition during the therapy is not attributive to stem cell therapy. Outcome after the stem cell treatment may vary from patient to patient. Stem Cell may help achieve significant improvement or no further deterioration of the condition or they may help in slowing down the rate of deterioration in the condition or in some cases there won’t be any improvement at all.
23. As per the complainant after the first dose/session of the therapy complainant’s condition had deteriorated . Complainant had an option to withdraw or stop the treatment but the complainant chose not to rather complainant took all three sessions. From the photographs placed on record and the report of the MRI, it is seen that the condition of the complainant had deteriorated but complainant has not provided substantial evidence to prove the fact that the deterioration was due to the wrong, negligent or deficient treatment of OP. Complainant has not filed any expert opinion to prove that the treatment provided by OP was the cause of complainant’s deterioration.
24. Deterioration of the complainant’s condition cannot be attributed to OPs as human body reacts/responds differently to different therapies and medicines. OP cannot be held negligent solely because the treatment did not produce the expected results.
25. Hon’ble Supreme Court of India in Bombay Hospital And Medical Research vs Asha Jaiswal on 30 November, 2021 in Civil Appeal No. 1658 OF 2010 has held as under-
“ In case of medical negligence, this Court in a celebrated judgment reported as Jacob Mathew v. State of Punjab and Anr. held that simple lack of care, an error of judgment or an accident, is not a proof of negligence on the part of a medical professionals.”
“………….Recently, this Court in a judgment reported as Dr. Harish Kumar Khurana v. Joginder Singh & Others14 held that hospital and the doctors are required to exercise sufficient care in treating the pa- tient in all circumstances. However, in an unfortunate case, death may occur. It is necessary that sufficient material or medical evidence should be available before the adjudicating authority to arrive at the conclusion that death is due to medical negligence. Every death of a patient cannot on the face of it be considered to be medical negligence
“. …….. Ordinarily an accident means an unintended and unforeseen injurious occurrence, something that does not occur in the usual course of events or that could not be reasonably anticipated. The learned counsel has also referred to the decision in Martin F.D'Souza v. Mohd. Ishfaq, (2009) 3 SCC 1 wherein it is stated that simply because the patient has not favourably responded to a treatment given by doctor or a surgery has failed, the doctor cannot be held straight away liable for medical negligence by applying the doctrine of Res Ipsa Loquitor. It is further observed therein that sometimes despite best efforts the treatment of a doctor fails and the same does not mean that the doctor or the surgeon must be held guilty of medical negligence unless there is some strong evidence to suggest that the doctor is negligent.”
26. Complainant has failed to establish that OP had faltered in its duty of due care and attention towards the patient and complainant’s condition deteriorated on account of negligence or deficiency of OP.
27. In light of the discussion above and the judgment supra complainant has failed to establish her case consequently, the complaint fails and is dismissed.
Parties be provided copy of the judgment as per rules. File be consigned to the record room. Order be uploaded on the website.
