The use of stem cells in the treatment of several diseases such as Thalassemia, Leukaemia, Lymphoma and auto-immune disorders, is being increasingly recognized. Bone-Marrow transplantation is being currently used for treatment of several diseases, including certain malignancies and genetic blood disorders. If it is not possible to get bone marrow donor from a family member, attempt is made to find a suitably HLA matched donor for the patients needing stem cells transplant. It is not always possible to find suitable donors. Moreover, GVHD (Graft- Versus-Host-Disease) occurs in majority of bone-marrows coming from outside the family of the patient. The cord blood which is the left over blood in the umbilical cord and placenta after the birth of a child, is seen as comparable to the bone-marrow in terms of its utility in stem cell transplantation and in fact offers a number of advantages over the bone-marrow. It has also been found that the related samples instead of unrelated samples dramatically increase the survival rate for the patients.
Several parents, particularly those who are well-educated are now keen to store the stem cells of their child at the time of his birth so that the said cells can be stored in a stem cell bank and used in case of an unexpected illness of the child, requiring stem cell transplant in future. Umbilical cord blood therefore is now being recognised as a rich source of blood forming stem cells which, if required, can be used not only to treat dreaded diseases such as blood and bone-marrow cancer but also in regenerative medicines. Even the gelatine tissue in the cord is considered to be a rich source of Mesenchymal stem cells. The stem cells have also been shown to be able to repair damaged heart and nervous tissue besides, treating Type I diabetes and children born with Neurological defects.
2. For the purpose of collecting the cord blood and cord tissue, a sample of the blood is taken immediately after the birth of the child, once the placenta and the umbilical cord are safely delivered. The shorter the time between the birth of the child and cryo-preserver, the better it is for the quality of the cord blood and tissue. Once the stem cells are frozen and are stored in a bank, they can remain stored for upto 25 years, provided that they have been suitably processed and stored. It is therefore, necessary to take the sample of the blood and the cord without any delay once the child is born and an un-expectable delay in drawing such samples is likely to render the sample incapable of being analysed and stored for future.
3. The opposite party, namely Life Cell International Pvt. Ltd., is engaged in collection and preservation of the umbilical cord blood and tissue of a baby and as per the Brochure issued by the opposite party, the collection of umbilical cord stem cell can be done only at the time of birth. On the parents signing up with the opposite party for such collection and preservation, a collection kit is provided to them with necessary tools and instruments in sterile condition for the collection of the umbilical cord blood, cord tissue and maternal blood samples. It is also stated in the Brochure issued by the opposite party that the umbilical cord blood and maternal blood sample are collected just after child birth (emphasis supplied). The sample is transported to the laboratory of the opposite party within 48 hours and the opposite party claims to have enabled online tracking of the sample right from the time it leaves the hospital, in order to allow the parents to track the journey of the stem cells of the baby, right from the umbilical cord, to the cryo-presever. In the laboratory the sample is subjected to various tests to check for the presence of the infectious diseases and also to assess the cell counts, viability and sterility. Several tests on the cord blood are performed. The processing in the laboratory of the opposite party involves separating the stem cells form the cord blood and cord tissue samples. The tissue is minced into small pieces and is incubated. After 28 days, the sample is spun to separate the umbilical cord tissue stem cells. A portion of the native umbilical cord tissue is processed so that future techniques for isolation can be deployed. The harvested stem cells are mixed with cryo-preservation solution for retaining viability during storage and are then transferred to specially designed cryo-bags, in smaller segments, in the form of tubes. The smaller segments are meant for sampling, testing for quality control and future testing. A preservation certificate indicating the cell count and the viability of the stem cells at the time of preservation is sent to the parents for their record.
4. The opposite party claims to have largest network in India and collaboration with Cryo Cell International, which is a private stem cell bank.
5. Should the stored stem cell not be viable on retrieval, the OP provides a guarantee of Rs.20,00,000/- for the baby, siblings and parents, which can be utilized to purchase suitable matching stem cells from any public stem cell bank.
6. The complainant, who is a Doctor by profession was keen to preserve the umbilical stem cells of the child his wife was expecting to deliver and he executed an agreement with the opposite party on 21.9.2016, where-under umbilical cord, blood tissue and maternal blood samples of his wife were to be collected by the Gynaecologist / medical professional / midwife who was to assist in delivering the child. A collection kit was provided to the complainant, which was to be given to the concerned doctor. In terms of Clause 3.1 of the agreement, the complainant was to arrange for collection, preparation and labelling of the maternal blood and umbilical cord for delivery to the laboratory of the opposite party. Clause 8.3 of the agreement however, provided that at the request of the client (the complainant in this case), the opposite party would arrange and pay for the doctor for the collection of the maternal blood and umbilical cord, provided reasonable time for the purpose was given to the opposite party.
7. It is alleged in the consumer complaint that as per the Standard Operative Procedure explained to the complainant, he was to inform the opposite party on its toll free number, 12 hours before the expected time of delivery. The opposite party was to provide the contact details of its employee who had to collect the samples from the place where the expecting mother would be at that time. The complainant contacted the opposite party at 7.30 pm on 21.10.2016 and provided the requisite details, including the date and time of expected delivery as well as the name of the doctor and the hospital. He was assured that a paramedic namely Imran Khan will arrive before time to collect the stem cell. However, despite advance intimation of the expected time of delivery having been given to the opposite party, namely Mr. Imran Khan nor any other employee / representative of the opposite party was present in the hospital at the time the child was delivered at 9-53 a.m. on 22.10.2016. When the complainant contacted Mr. Imran Khan, he told the complainant that the job had not been assigned to him. On repeated calls, an employee of the opposite party finally turned up at the hospital but by that time, the umbilical cord had already been discarded and therefore stem cell preservation was impossible. Alleging deficiency on the part of the opposite party in rendering services to him by not collecting the stem cells of his newly born child, the complainant is before this Commission seeking compensation quantified at Rs.1.5 crores, besides refund of amount of Rs.55,990/- which he had paid to the opposite party.
8. The complaint has been resisted by the opposite party which has admitted the agreement with the complainant as well as the payment received from him. It is stated in the written version that as per Clause 3.1 of the agreement, it was for the complainant to arrange for the collection of the maternal blood and umbilical cord. It is further alleged that the child of the complainant was born between 9.15 am to 9.30 am on 22.10.2016 and the cord tissue was collected at about 9.40 am to 10.00 a.m. on the same day by the paramedic arranged by the opposite party on the request of the complainant at 10.00 am. A confirmation message as well as an email was then sent by the opposite party to the complainant on 24.10.2016. Thus, according to the opposite party, the paramedic had not only reached the hospital in time but he had also collected the sample. It is also stated in the written version that the paramedic had collected umbilical tissue sample secured by the attending doctor in the kit box at about 10.00 a.m. on 22.10.2016 and booked the kit for transit at about 4.00 pm on the same day. The sample was shipped from Delhi to Chennai in the evening of 23.10.2016 and reached Chennai Facility of the opposite party at 00.55 a.m. on 24.10.2016, within 40 hours of the collection of the sample. It is also alleged that unfortunately, the cord tissue sample showed signs of no growth and intimation in this regard was given to the complainant on 10.3.2017.
9. Though, in terms of Clause 3.1 of the agreement it was for the complainant to provide the kit to the doctor and arrange for collection, preparation and labelling of the maternal blood and umbilical cord, Clause 8.3 of the said agreement also provided for the opposite party arranging for the collection of the maternal blood and umbilical cord, if so requested by the complainant. This is not the case of the opposite party that advance intimation of the expected delivery of the child was not given to it by the complainant and therefore it did not get reasonable time to arrange for the collection of the maternal blood and umbilical cord. A perusal of the message sent by the opposite party to the complainant on his phone confirms that the opposite party was contacted in the evening of 21.10.2016 and the complainant was informed that Mr. Imran Khan would be collecting the said samples. Mobile number of Mr. Imran Khan was also sent to the complainant through the said message. Therefore, the opposite party had undertaken the responsibility to collect the samples, on the request of the complainant in terms of Clause 8.3 of the agreement executed between the parties, by deputing Mr. Imran Khan for the said purpose. Therefore, if Mr. Imran Khan did not collect the sample or did not collect the same in time, it would be an act of deficiency in rendering services to the complainant and being the service provider, the opposite party would be responsible for the said deficiency.
10. The opposite party has not filed any affidavit of Mr. Imran Khan to prove that the sample was actually collected by him as also to prove the time the sample was allegedly collected by him. No attempt was made by the opposite party to summon Mr. Imran Khan as a witness through the process of this Commission. In my opinion, considering the denial by the complainant, it was obligatory for the opposite party to produce Mr. Imran Khan as a witness or to file his affidavit to prove the alleged collection as well as time the sample was collected by him. The learned senior counsel for the opposite party has drawn my attention to the messages and emails purporting to be sent to the complainant and acknowledging the receipt of the samples. Attention is also drawn to the email sent to the complainant on December 12, 2016 whereby he was informed that the sample was still in process and the final conclusion could be derived only after completion of the process. The attention was also drawn to the subsequent email of the opposite party dated 10.3.2017 whereby the complainant was informed that the isolation and expansion of the stem cells was unsuccessful primarily due to no growth. Relying upon the aforesaid messages and emails, it was contended by the learned senior counsel for the opposite party that had the samples not been actually taken, the complainant in the normal course of human conduct would immediately have controverted the above referred messages and emails and would have written to the opposite party that no sample had actually been collected on the birth of his child. However, I need no go into the question as to whether the sample was actually collected or not since there is no credible evidence to prove that the sample was collected soon after the birth of the child. It is stated in the Brochure of the opposite party itself that the umbilical cord blood and maternal blood sample are collected just after child birth (emphasis supplied). The Brochure issued by the opposite party itself shows that the collection of the stem cell can be done only at the time the child is born. If the sample is not collected soon after the birth of the child, it is likely to show no growth and will not serve the purpose for which the sample is obtained. In fact, this is not the case even of the opposite party that the sample could be collected even hours and hours after the birth of the child. Though, the opposite party has placed on record the photocopy of what purports to be a Purple Card filled by the paramedic at the time the sample was allegedly collected and the said Purple Card does bear the name of the wife of the complainant as well as her CRM number and mobile phone number, it shows that the sample was collected after 9.25 p.m. after placenta delivery. The person who filled this purple card has ticked against the p.m. and not against the a.m. after writing 9.25, against the time of the delivery. Since the sample is shown to have been collected after placenta delivery and the time of delivery is shown to be 9.25 p.m., the sample could not possibly have been collected before 9.25 p.m. on 22.10.2016. Though, it was contended by the learned senior counsel for the opposite party that a mistake was committed by the paramedic when he ticked against p.m. instead of ticking against a.m., the said contention cannot be accepted in the absence of the affidavit of Mr. Imran Khan, paramedic, who allegedly collected the said sample. In fact, this is not even the case of the opposite party in its written version that a mistake had been committed by Mr. Imran Khan, paramedic while filling up the purple card. The paramedic Mr. Imran Khan has not ticked either against a.m. or against p.m. in the column meant for writing the time of sample collection. Again, there is no explanation as to why Paramedic, Mr. Imran Khan did not tick against the a.m. if the sample was collected in the morning of 22.10.2016.
11. Had the sample been collected soon after the birth of the child, the doctor who delivered the child could not have been unaware of it. In fact, it was not possible to draw the samples without the knowledge and permission of the attending doctor unless the sample was taken from an unknown source or it was taken from the umbilical cord of the wife of the complainant after the said cord had been discarded by the doctor. The complainant has filed an affidavit of Dr. Adarsh Bhargava, who delivered the child, in addition to his own affidavit and the affidavit of his wife. The name of Dr. Adarsh Bhargava also finds mention on the purple card filed by the opposite party. In her affidavit Dr. Adarsh Bhargava has clearly stated that neither she had consented nor collected umbilical cord blood and cord tissue. Considering the affidavit of Dr. Adarsh Bhargava and the failure of the opposite party to produce Mr. Imran Khan in the witness box or even file his affidavit by way of evidence, I have no hesitation in holding that the sample was not collected soon after the birth of the child, as a result of which the complainant lost a precious opportunity to preserve the stem cells of his child, which could prove to be of a vital use in case the child was to develop an illness, requiring stem cell transplant in future.
12. The next question which arises for consideration is as to what amount, the complainant is entitled as compensation. Though, the complainant has claimed compensation amounting to Rs.1.5 crore, the said claim would far exceed a fair and reasonable compensation. The complainant lost a lifetime opportunity to preserve the stem cells of his child. Had the samples been taken in
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time, it would have been possible to preserve the stem cells of the child and if he, his parents or his sibling, if any, was to need them in future, for the purpose of stem cell transplant, the stem cell so preserved and stored could have helped in saving the life of the child or his biological parents or his siblings. If anyone of them requires stem cell in future, the suitable stem cell may not be available with a private stem cell bank and even if they are available, the said bank may demand charges, which may be beyond the financial capacity of the complainant to pay. As per Clause 8.2 of the agreement, if the child, his biological parents or siblings are diagnosed for any condition treatable by stem cell transplantation using the stored specimen and in the opinion of the transplant physician, the specimen of retrieval does not meet the prevailing viability criterial, the opposite party would provide suitable matching stem cells and if the same is found at any public stem cell bank, failing which it will pay Rs.20.00 lacs to the client. Thus, even the opposite party recognises that the matching stem cells, even if available with a stem cell bank, will cost atleast Rs.20.00 lacs. Since the sample was not collected in time and the stem cell could not be preserved, the opposite party, in my opinion, should pay a compensation amounting to Rs.20.00 lacs to the complainant. 13. For the reasons stated hereinabove, the opposite party Life Cell International Pvt. Ltd. is directed to pay a sum of Rs.20.00 lacs as compensation to the complainant within three months form today, failing which the said amount shall carry interest @ 9% per annum from the date of this order, till the date of payment. The complainant shall also be entitled to the cost of litigation quantified at Rs.25,000/-.