DISTRICT CONSUMER DISPUTES REDRESSAL FORUM,

PATIALA.

                                      Complaint No. CC/15/148 of 16.7.2015

                                      Decided on:        28.6.2016

Veena Kumari aged about 67 years W/o Sh.Jai Kishan R/o Gilzian Mohalla, Bassi Pathana, Tehsil Bassi Pathana, District Fatehgarh Sahib.

                                                                   …………...Complainant

                                      Versus

1.      Columbia Asia Hospital through its Incharge/Medical Superintendent/Authorized Official, Bhupindra Road, 22 Number Fatak, Patiala, District Patiala.

2.      Dr.Jiwan Kumar, Columbia Asia Hospital, Bhupindra Road, 22 Number Fatak, Patiala, District Patiala.

                                                                   …………….Ops

                                      Complaint under Section 12 of the

                                      Consumer Protection Act.

                                      QUORUM

                                      Sh. A.P.S.Rajput, President

                                      Smt.Neelam Gupta, Member        

Present:

For the complainant:   Sh.Manpreet Singh , Advocate

For Ops:                       Sh.H.P.S.Verma,Advocate           

                                         ORDER

A.P.S.Rajput, PRESIDENT

1. Complainant Veena Kumari w/o Sh.Jai Kishan R/o Gilzian Mohalla, Bassi Pathana, District Fatehgarh Sahib has filed this complaint against the Opposite Parties ( hereinafter referred to as the Ops) under  Section 12 of the Consumer Protection Act,1986 ( for short the Act). The brief facts of the complaint are as under:-
2. It is averred in the complaint that the complainant approached the Ops for seeking medical attention for which the Ops got conducted various medical tests upon the complainant on 25.10.2014 and after discussing the case, Op no.2 decided to put stent in the heart of the complainant. Coronary angioplasty  was also done by Op no.2 under the supervision of Op no.1. As per cardiology report prepared by Op no.2 , Lesion was made and thereafter a proximal LAD (xienc 2.75x23mm) and mid LAD(xienc 2.5x18mm) ie. Two stents of the size of 2.75 and 2.5 were put in the heart of the complainant on 25.10.2014. Regular checkup was got by the complainant from the Ops during which she complained about the pain in her heart but the Ops failed to adhere to the request of the complainant.
3. On 28.1.2015, due to severe pain in the heart of the complainant she was taken to PGI, Chandigarh, where she was admitted on 5.2.2015. After  conducting various tests upon the complainant, it was transpired by the doctors of the PGI that the stents deployed by the Ops were of under size and therefore, new stents were required to be placed in the heart of the complainant.
4. After got conducted various tests upon the complainant by the doctors of PGI, Chandigarh, two new stents of the dimension of 3.00x38 and 3.50x20 were deployed in the heart of the complainant whereby the complainant spent Rs.2,00,000/- more on her treatment.
5. It is alleged in the complaint that the Ops have not taken care while deploying the stents of the proper size in the heart of the complainant, which lead to the reoccurrence of the problem of heart. Thus, there is negligence on the part of the Ops for which the complainant has suffered monetarily as well as physically. Hence this complaint with a prayer for a direction to the ops to pay Rs.8,00,000/- on account of the financial, physical loss suffered by the complainant and Rs.1,00,000/- as compensation on account of the harassment and mental pain suffered by the complainant.
6. On notice , the Ops appeared through their counsel and filed the written version. It is submitted that on 25.10.2014, patient Veena Kumari reported on Columbia Asia Hospital, Patiala with the complaint of chest pain radiating to left arm, jaw and back on exertion from the last two months. The ECG of the complainant showed T wave Inversion in VI to V6 with ST depression and she was on Tab Ecosprin Gold, Betaloc 100mg OD and Tab Ismo 20mg BD. In the Echocardiography got done by the Ops, it showed Regional wall motion abnormality in LAD territory with LVEF=50%,Mild TR with RVSP=28mmHg. The trop 1 test of the patient was 0.12 and she was a known case of diabetic. In this way the complainant was diagnosed a case of acute coronary syndrome with non ST elevation myocardial infarction. The coronary angiography report showed significant stenosis in proximal and mid LAD. The video recording of the coronary angiography was shown and discussed with the companions of the complainant. The patient was advised coronary angioplasty with use of two Drug eluting stents. During the procedure, it was found that the patient had calcified coronary artery (LAD). After taking the decision, proper sized stents were used as per condition of the patient. It is denied that under sized stents were deployed by the Ops. It is stated that the patient was asymptomatic at the time of discharge from the hospital and was advised to report back in case of pain or breathlessness. After the discharge from the hospital, the complainant came for follow up on 3.11.2014, 2.12.2014 and on 2.1.2015.It is averred that the complainant again visited the hospital on 27.1.2015 with the complaint of chest pain on exertion for which Tread Mill Test was advised which was positive and the complainant was advised coronary angiography but the complainant did not report back.
7. In reply to para no.5 of the complaint, it has been observed by the Ops that the complainant  suffered severe pain in her heart on 28.1.2015, for which the complainant was taken to PGI Chandigarh but was admitted on 5.2.2015. It is also submitted that Coronary angiography with stenting is a technique to open the blocked coronary artery and has its limitations. It is denied by the Ops that the problem had occurred on the deployment of the stents by the Ops. There is no negligence on the part of the ops in treating the complainant. The complaint filed by the complainant is false, frivolous, vexatious and fabricated and is filed in order to extract money from the Ops. After denouncing all other averments made in the complaint, it is prayed to dismiss the complaint.
8. In order to prove her case, the complainant tendered in evidence Ex.CA her sworn affidavit, Ex.C1 copy of cardiology report, Ex.C2, copy of cardiology report dated 25.10.2014, Ex.C3 copy of colour Doppler echocardiography report, Ex.C4 copy of laboratory report, Ex.C5 copy of laboratory report, Ex.C6 copy of laboratory report, copy of laboratory report,Ex.C7 copy of laboratory report, Ex.C8 copy of laboratory report, (all dated 25.10.2014), Ex.C9 copy of discharge summary,Ex.C10 copy of discharge summary, Ex.C11 copy of patient advice, Ex.C12 copy of patient advice,Ex.C13 copy of receipt,Ex.C14 copy of patient advice, Ex.C15 copy of patient advice,Ex.C16 copy of TMT positive,Ex.C17 copy of selected Medians report,Exs.C18 and C19, copies bills, Exs.C20 to C23 copies of official receipts, Ex.C24 copy of out patient card, Exs.C25 to C28 copies of discharge and follow up card, Ex.C29 copy of progress sheet, Ex.C30 copy of bill/receipt no.505247 regarding medicine  of PGIMER, Chandigarh, Ex.C31 copy of record of medicine of PGIMER,Chandigarh,Ex.C32 copy of Drug and Treatment,Ex.C33 copy of Graphic record of observations,Ex.C34 copy of B.P.Chart, Ex.C35 copy of progress sheet,Ex.C36 copy of progress sheet, Ex.C37 copy of  prescription, Ex.C38 copy of haemotology requisition, Ex.C39 to Ex.C43 copies of retail invoices, Ex.C44 copy of final adjustment bill,Ex.C45 to C46 copies of retail invoices, Ex.C46 , Ex.C47 to Ex.C49 copies of IPD services, Ex.C50 copy of retail invoice, Ex.C51copy of admission record of Nehru Hospital and her counsel closed the evidence.
9. On  behalf of the Ops, their counsel tendered in evidence Ex.OPA the sworn affidavit of Dr.Jiwan Kumar, Ex.OP1 copy of consent for cardiac procedure, Ex.OP2 CD, Ex.OP3, copy of consent for cardiac procedures, Ex.OP4 copy of Drug-eluting intracoronary stents: General Principles,Ex.OP5 CD, Ex.OP6 copy of discharge summary, Ex.OP7 copy of progress note, Ex.OP8 copy of summary of findings, Ex.OP9 copy of progress note, Ex.OP10 copy of literature on Coronary Heart Disease, Ex.OP11 copy of consent for hospitalization and conditions of service, Ex.OP12 copy of discharge summary, Ex.OP13 copy of progress note,  Ex.OP14 copy of echocardiography report, Ex.OP15 copy of progress note, Ex.OP16 copy of case report, (literature) Ex/OP17 copy of observation chart, Ex.OP18 copy of cardiac CATH flowsheet, Ex.OP19 copy of cardiac CATH Flowsheet, Ex.OP20 copy of PRE CATH CHECKLIST, Ex.OP21 copy of discharge hand over form,  Ex.OP22 copy of Coronary Artery Disease (literature), Ex.OP23 to OP25 copies of  reports, and closed the evidence.
10. The ld. counsel for the complainant has submitted that the main controversy involved in the present case is, that the OP No.2 had implanted two stents on 25/10/2014 and thereafter the complainant had to again get the stent implanted on 5/02/2015 in the same artery from PGI, Chandigarh. The ld. counsel stated that it is established from the documents placed on record that the complainant had to undergo  Angioplasty from the OPs and thereafter from the PGI, Chandigarh. He pleaded that in case the OP no.2, had intimated the complainant that complications can re-occur then the complainant would have got herself treated from the PGI, Chandigarh. He pleaded that, as per cardiology report prepared by OP no.2 , Lesion was made and thereafter a proximal LAD (xienc 2.75x23mm) and mid LAD(xienc 2.5x18mm) ie. Two stents of the size of 2.75 and 2.5 were implanted in the artery of the complainant on 25.10.2014.He also pleaded that regular checkup’s were got by the complainant from the OPs during which she complained about the pain in her chest and heart but the OPs failed to adhere to the request of the complainant. The ld. counsel further pleaded that due to negligent act of  OP no.2 the complainant had to suffer mental as well as physical harassment and deserves to be compensated for the same.

11.    On the other hand, the ld. counsel for the OPs has objected to the submissions made by the ld. counsel for the complainant. He stated that the OP no.2 after conducting all the requisite tests duly explained the entire procedure, limitations and complications and thereafter got the consent forms i.e Ex.OP-1and Ex.OP-3, signed from the complainant and her accompanying relations. The ld. counsel submitted that the PGI as per the Ex.C-24 to C-29, has no where stated that the procedure or the stents implanted by the OP no.2 were an act of negligence. He pleaded that the PGI had only recommended the appropriate size of the stent and have not given any comments or opinion against the OPs. The ld. counsel also pleaded that the complainant being a diabetic person was advised to take proper care as it is evident from the observation chart i.e Ex-OP-17 and follow up chart i.e Ex-OP-18 but complainant seems to have not followed the advice of the OP no.2, therefore she had to again undergo angioplasty from the PGI. The ld. counsel further pleaded that as per the medical theory and literature i.e Ex.OP-2(colly), complainant developed restrenosis,

“Restenosis occurs when the treated vessel becomes blocked again. It usually occurs within 6 months after the initial procedure. Compared with balloon angioplasty alone, where the chance of restenosis is 40%, stents reduce the chance of restenosis to 25%.Therefore, the majority of patients having angioplasty today are treated with stents. Restenosis can occur after the use of stents, and physicians refer to this as “in-stent restenosis.”

12.    The ld. counsel argued that as per the medical literature the patients suffering from high level of diabetics are more prone to in-stent restenosis. He further argued that the complainant has failed to prove medical negligence against the OPs.

13.   After hearing the ld. counsel for the parties and going through the pleadings, evidence produced by the parties and the oral arguments and written submissions, in our opinion, it is evident from Ex.OP1 copy of consent for cardiac procedure, Ex.OP2 CD, Ex.OP3, copy of consent for cardiac procedures, Ex.OP4 copy of Drug-eluting intracoronary stents: General Principles, Ex.OP5 CD, Ex.OP6 copy of discharge summary, Ex.OP7 copy of progress note, Ex.OP8 copy of summary of findings, Ex.OP9 copy of progress note, Ex.OP10 copy of literature on Coronary Heart Disease, Ex.OP11 copy of consent for hospitalization and conditions of service, Ex.OP12 copy of discharge summary, Ex.OP13 copy of progress note,  Ex.OP14 copy of echocardiography report, Ex.OP15 copy of progress note, Ex.OP16 copy of case report, (literature) Ex/OP17 copy of observation chart, Ex.OP18 copy of cardiac CATH flow sheet, Ex.OP19 copy of cardiac CATH Flowsheet, Ex.OP20 copy of PRE CATH CHECKLIST, Ex.OP21 copy of discharge hand over form,  Ex.OP22 copy of Coronary Artery Disease (literature), Ex.OP23, that the accompanying relatives of the complainant were informed in detail about the procedure, tests and the complications that can occur after the implanting of the stent. It is also evident from the material placed on record that the complainant is a patient of diabetics. We have also examined documents issued by PGI, Chandigarh i.e  Ex.C17 copy of selected Medians report,Exs.C18 and C19, copies bills, Exs.C20 to C23 copies of official receipts, Ex.C24 copy of outpatient card, Exs.C25 to C28 copies of discharge and follow up card, Ex.C29 copy of progress sheet, from the perusal of the aforesaid documents, we find that the doctors of the PGI had no where expressed that the treatment, procedure and tests conducted by the OPs were not correct, rather the PGI has only recommended the size of the stent that was implanted by the PGI doctor. We have also noted that the PGI has not given any opinion with regard to the OPs.

14.   The relevant part of the medical literature states; 

“Restenosis occurs when the treated vessel becomes blocked again. It usually occurs within 6 months after the initial procedure. Compared with balloon angioplasty alone, where the chance of restenosis is 40%, stents reduce the chance of restenosis to 25%. Therefore, the majority of patients having angioplasty today are treated with stents. Restenosis can occur after the use of stents, and physicians refer to this as “in-stent restenosis.”

“When a stent is placed in a blood vessel, new tissue grows inside the stent, covering the struts of the stent. Initially, this new tissue consists of healthy cells from the lining of the arterial wall (endothelium). This is a favorable effect because development of normal lining over the stent allows blood to flow smoothly over the stented area without clotting. Later, scar tissue may form underneath the new healthy lining. In about 25% of patients, the growth of scar tissue underneath the lining of the artery may be so thick that it can obstruct the blood flow and produce an important blockage. In-stent restenosis is typically seen 3 to 6 months after the procedure; after 12 months have passed uneventfully, it is rare.”

“Patients with diabetes are at increased risk for in-stent restenosis. Further important risk factors relate to the properties of the blocked artery and the pattern of scar tissue growth inside the artery; the more extensive the scar tissue growth, the worse the prognosis.”

“In-stent restenosis may produce symptoms that are very similar to the symptoms that initially brought the patient to the interventional cardiologist, such as chest pain triggered by exertion. Diabetic patients, however, may have fewer symptoms, atypical and unusual symptoms, or even no symptoms at all. Fortunately, a heart attack does not usually occur even if in-stent restenosis develops.”

15.    Accordingly in view of our aforesaid discussion and the medical literature, we are of the view that the arteries can again get blocked, even if a stent had been implanted keeping in view the medical condition of the complainant. We find that the OPs had not committed any deficiency of service and medical negligence while implanting the stent. Hence the present complaint is hereby dismissed.  

16.    The arguments on the complaint were heard on 16.6.2016  and the order was reserved. Now the order be communicated to the parties. Copy of the order be sent to the parties free of cost and thereafter the file be consigned to the record room.

Pronounced

Dated:28.6.2016

                                      Neelam Gupta                        A.P.S.Rajput

                                 Member                                  President