National Consumer Disputes Redressal
Smt. Swarna Kataru, vs M/S Life Cell Inernational Pvt. Ltd., on 8 July, 2021
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 77 OF 2013 1. Smt. SWARNA KATARU, W/o Shri Kiran Reddy Kataru, R/o Flat No. 403, D.No. 6-3-787, Royal Pavilion, Shaili Estates, Next to RBI Quarters, Ameerpet, HYDERABAD - 500016. ...........Complainant(s) Versus 1. M/s LIFE CELL INERNATIONAL PVT. LTD., 26, Vandalur, Kelambakkam Road, Keelkottaiyur, CHENNAI - 600048. ...........Opp.Party(s)
BEFORE: HON'BLE MR. C. VISWANATH,PRESIDING MEMBER HON'BLE MR. JUSTICE RAM SURAT RAM MAURYA,MEMBER
For the Complainant : Mr. Sanjeev Kumar, Advocate For the Opp.Party : Mr. Harish Vaidyanathan Shankar, Advocate
Dated : 08 Jul 2021 ORDER
1. Heard Mr. Sanjeev Kumar, Advocate, for the complainant and Mr. Harish Vaidyanathan Shankar, Advocate, for the opposite party.
2. Smt. Swarna Kataru (the complainant) has filed this complaint, for a compensation of Rs.10,00,00,000/- (Rupees Ten Crores only) together with refund of proportionate charges of the Cord Tissue Preservation. The complainant stated that Life Cell International Pvt. Ltd. (the opposite party) had propagated to be the India's first and largest private stem cell bank and stem cell solution provider to bring the revolutionary concept of umbilical cord stem cell banking (Cord Tissue Preservation) to India; It started its operation in 2004, in Chennai with cryogenic preservation of umbilical cord blood and stem cell in its advance facilities. It had technical collaboration and exclusive licence agreement with CRYO-CELL International Inc., U.S.A., who was a world's first and largest stem cell bank; Pursuant to its technological partnership with CRYO-CELL, they preserve the new-born's umbilical cord blood for its potential use in many deceases, viz Chronic Obstructive Pulmonary decease, Cardiac Arrhythmia, Crohn's decease, Graft vs Host decease, Osteoarthritis, Critical Limb Ischemia, Multiple Sclerosis and Diabetes. Believing upon the aforesaid advertisement, the complainant, who was at that time, in advance stage of pregnancy, got herself enrolled with the opposite party on 16.04.2010 and was allotted CRM No. 103901010. The complainant opted for Standard Plan "Baby Cord Duo 1 M", in its One Time Plan (which included enrolment, processing and storage fee for 21 years of Rs.79,900/-). Under this plan, complainant's baby's (i) Cord Blood Stem cells and (ii) one million Cord Tissue Stem cells had to be harvested and preserved. One H Jawahar Razee, the representative of the opposite party filled up various printed forms and an agreement (which run in so many pages) and obtained signatures of the complainant, her parent and the witnesses. After her delivery on 10.05.2010, at Konda Reddy Nursing Home, Manda Peta city, the samples of complainant's baby Cord Blood Stem cells and Cord Tissue Stem cells were collected as per instructions of the opposite party, for which they had provided a complete kit, on which Sample Lab ID; CES/PN/7825 was marked. For the aforesaid purposes, the complainant paid Rs. 70100/- through account payee cheque, which was encashed by the opposite party on 22.05.2010. The complainant also received a Preservative Certificate on 01.07.2010, and believed throughout that Cord Blood Stem cells and Cord Tissue Stem cells were successfully harvested and preserved. The complainant received an email communication on 23.12.2011 that sample of her baby's Cord Tissue was found to be contaminated and consent was sought for discarding it. The father of the complainant made a protest and required the reasons for contamination and delay in communication on email on 23.12.2011. Then an email letter was sent on 28.12.2011, mentioning therein that bacterial colony in the sample was found on 18.05.2010; Then the sample was stored at -196'0C in liquid nitrogen for 3-6 months, considering that at this very low temperature, the bacteria would be killed; Second time, the sample was put to culture on 18.03.2011, then again similar bacterial colonies were detected. Aggrieved by irresponsible and negligent handing and preservation of cord tissue sample by the opposite party and withholding information of its contamination for a long time, the complainant gave a legal notice dated 16.07.2012, claiming compensation of rupees Ten crores. The opposite party gave his reply through notice dated 10.08.2012 and denied any negligence on his part and alleged that the negligence was committed at the time of collecting sample for which the opposite party was not responsible under the agreement. The complainant then gave another legal notice dated 07.09.2012 and demanded copy of the agreement. The opposite party supplied copy of the agreement, through letter dated 24.09.2012. Then this complaint was filed on 01.04.2013.
3. The opposite party filed its written statement/reply after expiry of statutory period as such its defence was struck off by order dated 11.11.2013. However, by a subsequent order dated 12.11.2014, his written statement was directed to be read. The opposite party has stated that the agreement between the parties contained a clause for arbitration as such the complaint was not maintainable. The complainant has arbitrarily claimed compensation of rupees ten crores with a view to file the complaint before this Commission while total value of the agreement was Rs.79,900/- out of which Rs.20,000/- was for preservation of Cord Tissue; The parties have agreed for exclusive jurisdiction of the Court in Chennai under the agreement; The complaint was residing in Hyderabad and it was easy for her to contest the case in Chennai. The terms and conditions of the agreement and other transactions were explained to the complainant and her parents before obtaining their signatures on it. The opposite party used to adopt full transparency and the format of the agreement and other documents are available on its official website, which can be examined by any one at any time. The opposite party did not undertake the process of collection of samples, under clause 2 (b) of the agreement, rather the complainant had to authorise the staff of hospital/nursing home, where delivery had taken place, to collect the samples of the baby's Cord Blood Stem cells and Cord Tissue Stem cells and transport it to the opposite party. The complainant authorised Dr K. Swarnalatha, for collection. It has been denied that the samples were collected by the employees/representative of the opposite party or contamination in the sample had occurred in his lab. It has been denied that the opposite party had committed any negligence in handling the sample or there was any deficiency in service on his part. The contamination of the bacteria, being Elizabethkingia meningoseptica, was found in the sample, which is a Gram negative rod shaped bacteria, widely distributed in nature (e.g. fresh water, salt water or soil). It is generally reported to cause outbreaks of meningitis predominantly in premature new born and infants in neonatal intensive care unit of developing/ under-developed countries. Some of the outbreaks have been linked to sources, like contaminated lipid stock bottles, venous catheter lines, nutritional solution and tap water. The opposite party performs cells culture work in Class 10,000 classified clean rooms and Class 100 bio-safety cabinets, which are basic requirements of pharmaceutical industries. The opposite party implements strict clean room practice, regular fumigation of clean rooms, complete clean room attire, including a primary sterile gown supplemented with secondary bunny suit, according to ISO & WHO Standard. The opposite party has employed the trained and qualified staffs. Regular weekly monitoring of the rooms, attires and employees used to be done to ensure best international practices in all their process. These facilities are accredited by AABB, CAP, NABL, WHO ISO certification bodies in addition to DCGI. During whole year of 2010, this particular bacteria was not found in the rooms and chambers of the opposite party. The opposite party received 27 cord tissue samples on 13.05.2010, when the complainant's sample was received. In May, 2010, total 803 samples were processed. Out of which, only one sample of the complainant was found contaminated, which proves that the contamination had not occurred at the lab of the opposite party. A gynaecologist cannot adopt such a standard precaution while collecting samples of cord blood and cord tissue as they gave first priority to the safety of the mother and baby. Internationally, all cord blood banks encounter this challenge on day to day basis and about 5.7% cord blood collections are found contaminated. Samples of the complainant were collected by Dr. K. Swarnalatha on 10.05.2010 at 19:35 hours at Konda Reddy Nursing Home, Manda Peta City. The sealed samples were dispatched to the opposite party, where it was received on 13.05.2010. Part of the sample was chopped and cord tissue pieces were stored in 6 vials in liquid nitrogen. No culture work or other kind of manipulation was done. Second part of sample was processed and put in culture for stem cell expansion. Contamination was detected in minced cord tissue pieces as well as in the 6 well plate put for expansion of stem cells and in pre-sample i.e collection tube. Report showing contamination was prepared on 18.05.2010. Contamination in both pre-processed and post processed samples indicate contamination from source i.e. at the time of collection. Subsequently, contaminated 6-well plates were discorded. Other 6 vials of minced tissue kept in liquid nitrogen were preserved, for conducting of the decontamination process, in anticipation of some superior technology that can effectively eliminate bacteria and salvage stem cells as new and better technology is evolving every day. The opposite party used to conduct own experiments for developing superior technology. The opposite party also developed technology of freeze-thaw protocol involving alcohol wash. Experiment was completed and successful in August, 2010. From December, 2010 onwards, the opposite party retrieving contaminated samples, using advanced decontamination process and successfully decontaminated about 50% samples. One out of the six vials of the complainant was retrieved on 17.03.2011 and put in culture. The sample was subjected to the advanced freeze thaw protocol for de-contamination but it did not respond and again in the report dated 24.03.2011, Elizabethkingia Meningoseptika were identified. Rejection report was sent to the complainant on 22.12.2011. The opposite party is still hopeful that advance technology will be evolved, giving 100% result of de-contamination. The complaint is liable to be dismissed with costs.
4. The complainant has filed her Rejoinder Affidavit on 05.11.2015, in reply to the written statement, in which the facts stated in the complaint have been reiterated. Along with the complaint, the complainant has filed copy of the registration form and agreement dated 16.04.2010, copy of sample collection report dated 10.05.2010 (but it is not available on the record), copy of email communication dated 23.12.2011 of the opposite party, copy of email reply of the complainant dated 23.12.2011, copy of email communication of the opposite party relating to technical queries dated 28.12.2011, copy of legal notice dated 16.07.2012, copy of reply of the opposite party dated 10.08.2012, copy of the legal notice of the complainant dated 07.09.2012 and copy of the reply of the opposite party dated 24.09.2012. The complainant has filed her affidavit in evidence on 27.11.2013, in which she has proved the facts stated in the complaint and the documentary evidence filed by her.
5. The opposite party has filed copy of Standard Operating Procedure, prepared by it, for collection of cord blood and cord tissue, effective from 01.06.2009 to 31.05.2010, copy of Standard Operating Procedure, prepared by it, for process and cryopreserve the umbilical cord tissue, effective from 25.02.2010 to 24.02.2011, copy of Standard Operating Procedure, prepared by it, for generation, verification and dispatch of final report (Preservation Certificate), effective from 10.11.2010, copy of Environmental Monitoring Record dated 21.03.2010, copy of Environmental Monitoring Record dated 18.03.2010, copies of Cord Tissue Testing Reports dated 18.05.2010 and 18.03.2011 and Resolution of Board of Director Dated 10.06.2016. Affidavit of Dr. Chirag dated 19.09.2016 was filed in evidence.
6. We have considered the oral and written submissions of the counsel for the parties and examined the record. The facts that the opposite party was engaged in profession of cryogenic preservation of umbilical cord blood and stem cell, in technical collaboration with CRYO-CELL International Inc., U.S.A., the representative of the opposite party enrolled the complainant on 16.04.2010 for Standard Plan "Baby Cord Duo 1 M", collection, sealing and dispatching of the samples of complainant's baby Cord Blood Stem cells and Cord Tissue Stem cells were done on 10.05.2010 at 19:35 hours at Konda Reddy Nursing Home, Manda Peta city and it were received to the lab of the opposite party on 13.05.2010 at 19:30 hours, have not been denied. However, the opposite party took the plea that on pathological examination of the samples in its lab, the sample of Cord Blood Stem cells was found all right while sample of Cord Tissue Stem cells was found contaminated of the bacteria, being Elizabethkingia meningoseptica, on 16.05.2010, of which, the concerned section had submitted its report on 18.05.2010. Contamination was detected in minced cord tissue pieces as well as in the 6 well plate put for expansion of stem cells and in pre-sample i.e collection tube, from which it is proved that the contamination had occurred at the source i.e at the time of collection of sample at Konda Reddy Nursing Home and not in the lab of the opposite party.
7. The opposite party submitted that under clause 2 (b) of the agreement, it was responsibility of the complainant to select a qualified personal for the collecting the sample. The complainant and her parents authorised Dr. K. Swarnlatha of Konda Reddy Nursing Home, for collecting the sample and signed authorisation document on 16.04.2010. The opposite party has not committed any negligence in handling and processing the sample rather contamination had occurred at the time of collection of sample at Konda Reddy Nursing Home and the opposite party is not responsible for the negligence of collection centre. According to the complainant, one H. Jawahar Razee, the representative of the opposite party filled up various printed forms relating to enrolment, authorisation document and the agreement (which run in so many pages) and obtained signatures of the complainant, her parent and the witnesses on it on 16.04.2010, without explaining anything to them. After her delivery of child on 10.05.2010, at Konda Reddy Nursing Home, Manda Peta city, Dr. K. Swarnalatha collected the samples of complainant's baby Cord Blood Stem cells and Cord Tissue Stem cells as per instructions of the opposite party, for which they had provided a complete kit, on which Sample Lab ID: CES/PN/7825 was marked. Dr. Swarnlatha did not commit any mistake in collecting, sealing and dispatching the samples. The sample of Cord Blood Stem cells was collected at the same time by same person and found all right. It is improbable that contamination in the sample of Cord Tissue Stem cells had occurred at the time of collection. In any case, Dr. Swarnlatha acted as an agent of the opposite party, who is bound by her act. The copy of the agreement was not provided to the complainant on 16.04.2010. It was provided along with letter dated 24.09.2012, for the first time. Then she came to know that the opposite party had surreptitiously shifted the responsibility of the collection of sample on the complainant.
8. The collection of the sample is integral and important part of its preservation. The opposite party has framed Standard Operating Procedure for collection of Cord Blood and Cord Tissue, which was effective from 01.06.2009 up to 31.05.2010 (filed as Annexure-B of the application dated 14.09.2016). A perusal of Standard Operating Procedure for collection of the samples shows that it has provided various strict rules to be followed at the time of collection, sealing and dispatch of the samples and was a most technical work and required to be performed by a qualified person with proper care and caution. Under Clause-6, responsibility of nurses/paramedics-trained in cord blood collection procedure, logistic personnel at collection, who were trained and authorised to dispatch umbilical cord blood unit was fixed. This Standard Operating Procedure for collection of the samples was not provided to the complainant at any time nor is it expected that a man of ordinary prudent would follow these rules, particularly by a lady, just after delivery of the child. If the opposite party has framed Standard Operating Procedure for collection of Cord Blood and Cord Tissue, effective from 01.06.2009 up to 31.05.2010, in which it has fixed responsibility of paramedical staff involved in collection, sealing and dispatching then it might have been demonstrated to the personals, which were authorised for the collection of the samples at the time of registration of the complainant. Without demonstration of the rules, fixing responsibility of the complainant for collection of the sample was meaningless. In any case, the collection, sealing and dispatch of the samples are integral part of preservation and have important role for the profession of the opposite party. The opposite party cannot shirk its responsibility in this respect upon the customers which is contrary to Standard Operating Procedure.
9. The sample of Cord Blood Stem cells was also collected by Dr. K. Swarnlatha at the same time when Cord Tissue Stem cells were collected. Admittedly on pathological examination, the sample of Cord Blood Stem cells was found all right from which possibility of contamination in Cord Tissue Stem cells at the time of collection of its sample, is ruled out.
10. The opposite party has framed Standard Operating Procedure for generation, verification and dispatch of final report (Preservation Certificate) to the client. It is alleged that sample of Cord Tissue Stem cells was found contaminated of the bacteria, being Elizabethkingia meningoseptica, on 16.05.2010, of which, the concerned section had submitted its report on 18.05.2010. But no information, in this respect was given to the complainant at that time. In the written statement, it has been stated that in May, 2010, total 803 samples were processed, out of which, only one sample of the complainant was found contaminated. But Dr. Chirag, in paragraph-15 of his Affidavit of Evidence has admitted that in one other sample processed on 10.05.2010, in his lab, also contamination was found as such possibility of cross contamination of the sample of the complainant in the lab of the opposite party cannot be ruled out. The complainant was informed on 23.12.2011, which raises a serious doubt that contamination of bacteria was detected on 16.05.2010. If contamination was detected on 16.05.2010 and the sample was discarded on 18.05.2010, there was no reason for the opposite party to withhold information in this respect from the complainant, particularly when Preservation Certificate of cord blood was given on 10.07.2010. From these facts also it is proved that the opposite party had committed negligence in preserving the sample.
11. Counsel for the opposite party has relied upon the judgment of Hon'ble Supreme Court in Branch Manager, Indigo Airlines, Kolkata and another Vs. Kalpana Rani Debbarma and others, (2020) 9 SCC 424 in which the Supreme Court has held that the material fact which constituted deficiency in service, ought to have been pleaded in the complaint and substantiated by adducing the evidence in this respect. In the absence of any pleading and proof in this respect, the respondent cannot be held liable for deficiency in service. The civil aviation regulations are only executive instructions and have no force of law, but have been issued for guidance of duty-holders to implement the scheme of Aircraft Act, 1934. In the present case, we have already held that the opposite party has committed negligence in not demonstrating its standard operating procedure to the personnel who had been actually given responsibility for collection, sealing and despatch. Therefore, there was deficiency in service on the part of the opposite party and this judgment does not help the opposite party in any manner.
12. The opposite party took plea that part of the sample cord tissue cell was chopped and cord tissue pieces were stored in 6 vials in liquid nitrogen. No culture work or other kind of manipulation was done. Second part of sample was processed and put in culture for stem cell expansion. Contamination was detected in minced cord tissue pieces as well as in the 6 well plate put for expansion of stem cells and in pre-sample i.e collection tube. Subsequently, contaminated 6-well plates were discorded. Other 6 vials of minced tissue kept in liquid nitrogen were preserved, for conducting of the decontamination process, in anticipation of some superior technology that can effectively eliminate bacteria and salvage stem cells as new and better technology is evolving every day. The opposite party used to conduct own experiments for developing superior technology. The opposite party also developed technology of freeze-thaw protocol involving alcohol wash. Experiment was completed and successful in August, 2010. From December, 2010 onwards, the opposite party retrieving contaminated samples, using advanced decontamination process and successfully decontaminated about 50% samples. One out of the six vials of the complainant was retrieved on 17.03.2011 and put in culture. The sample was subjected to the advanced freeze thaw protocol for decontamination but it did not respond and again in the report dated 24.03.2011, Elizabethkingia Meningoseptika were identified. Rejection report was sent to the complainant on 22.12.2011. Thus there was unreasonable delay in dispatch of the report to the complainant. When the opposite party has framed Standard Operating Procedure for prompt information to the client, then there could have no reason for not following this procedure by them in the case of the complainant.
13. In Jacob Mathew Vs. State of Punjab, (2005) 6 SCC 1, Nizam Institute of Medical Sciences Vs. Prashanth S Dhananka, (2009) 6 SCC 1 and Kusum Sharma Vs. Batra Hospital, (2010) 3 SCC 480, Supreme Court has laid down broad principles to adjudge the medical negligence. One of the such principles is that a professional may be held liable for negligence on one of the two findings i.e. either he had not possessed the requisite skill, which he professed to have possessed or he did not exercise with reasonable competence in a given case, the skill, which did he possess.
14. In the present case, we found that although the opposite party has framed Standard Operating Procedure for collection of Cord Blood and Cord Tissue, effective from 01.06.2009 up to 31.05.2010, realizing that the collection of the sample was an important and integral part of preservation but there is nothing on record that these procedures were demonstrated to the doctor, who had collected the samples. In most cursory manner, contrary to the provisions of Standard Operating Procedure, the opposite party shifted the liability of collection of the sample on the complainant, for whom it was not possible to follow these strict procedures at the time of her delivery of child. Standard Operating Procedure for generation, verification and dispatch of final report (Preservation Certificate) to the client was framed for prompt information but the opposite party took about 19 months in informing the complainant about contamination in the samples which shows that there was no contamination when the sample was initially examined on 13.05.2010 and the contamination was developed in the lab of the opposite party, during preservation of the sample. The opposite party has committed negligence in handling and preserving the samples.
15. Now the question arises for determination of the compensation. In the literature published on the website, the opposite party propagated that umbilical cord blood and cord tissue had its potential use in many deceases, viz Chronic Obstructive Pulmonary decease, Cardiac Arrhythmia, Crohn's decease, Graft vs Host decease, Osteoarthritis, Critical Limb Ischemia, Multiple Sclerosis and Diabetes. The opposite party has further mentioned that it is important to preserve both the cord blood and cord tissue stem cells to ensure that your child gets a complete cover from most of the ailments what the future may promise. Preserving your baby's umbilical cord tissue stem cells is a once in a lifetime opportunity to secure your child future. Other articles in this respect claimed that umbilical cord fluid can treat cancer, blood deceases like animia and some immune system disorder. The complainant has stated that due to negligence committed by the opposite party, her baby has been deprived from the aforesaid benefits as such the compensation of Rs.10,00,00,000/- was claimed. The opposite party stated that earlier, the umbilical cord blood and umbilical cord tissue were waste and never preserved earlier as such even if it is found that the opposite party had committed any negligence in preserving cord tissue stem cells, the complainant is not entitled for any compensation as till today the complainant had not suffer any loss except return of Rs. 20,000/- i.e charges realized for it. The complainant has nowhere stated that her child was suffering from any of the aforementioned ailments. Under the plan total period of preservation was 21 years. Now 11 years have expired and during this period no such ailment was detected in the child of the complainant. The compensation has been claimed for imaginary future occurrence. At present, treatments of the ailments mentioned above are available in the country. In these circumstances, we determine a token compensation of Rs.2,00,000/-. Apart from it, the opposite party had collected Rs.70,100/- as charges for preservation and will return half of it, along with interest at the rate of 9% per annum, from the date of deposit.
O R D E R In view of the aforesaid discussion, the complaint is partly allowed. The opposite party is directed to pay compensation of Rs.2,00,000/- (Rupees two lakhs only) and Rs.35,050/- (Rupees thirty five thousand fifty only) along with interest at the rate of 9% per annum, from the date of deposit ,as the charges collected by it. The opposite party will also pay Rs.1,00,000/- (Rupees one lakh only) as cost of the litigation. Aforementioned amounts will be paid within two months from the date of pronouncement of this judgement.
...................... C. VISWANATH PRESIDING MEMBER ......................J RAM SURAT RAM MAURYA MEMBER