This complaint filed under sec.12 of the Consumer Protection Act 1986, relates to loss of  vision of left eye of the complainant after conducting   operation of cataract surgery on his left eye by Dr.Vijil C.H(1^st OP) at Ashoka Hospital(2^nd OP).  Complainant alleged medical negligence, professional misconduct and deficiency of service by administering  injection “Dexa ford” on the complainant during surgery, which was contaminated with bacteria, that caused complications of  Exdophanitis on his left eye resulted loss of vision of left eye.

       Brief  fact of the case are that  on 24/2/2016 complainant  approached 1^st OP with complaint of blurred  vision on his left eye and the complainant was referred to 2^nd OP from where 1^st OP examined and on 5/3/2016 1^st OP had conducted cataract surgery  on complainant’s left eye. On the very  next day  on 6/3/2016 complainant , there was a severe complications to his left eye and he left great pain  and  blindness to the left eye.  The OPs had given wrong medicines and treatment resulting in this situation and there is professional negligence on  his part. After two days of the operation,  the complainant could not see anything with his left eye   , 1^st OP referred the  complainant to Dr.B.V.Bhat the  Ophthalmic surgeon  at 2^nd OP hospital from where it was realized that  were severe deficiencies in the operation  done and referred the complainant to Dr.Sripathi Kamath  at Mangalore for what he diagnosed as Post OP Endopthalmitis  and complaints of H/o Diminution of vision in his left eye and  he  was an inpatient  at  Father Muller Hospital at Managalore   from 7/3/2016 to 12/3/2016 and from 29/4/2016 to 3/5/2016.Periodic review is also being done.  But even now the vision is not rectified and the complainant is having diminished vision which is sure to lead to blindness. The complainant had hired OPs service by paying consideration for consultation, treatment and surgery.  The complainant has got reliable information that the OPs had used defective medicines on him and thereby virtually put his eye sight at risk and danger. The OPs have committed deficiency of service and unfair trade practice, the complainant had to incur great financial expenses for getting further treatment  at Mangalore, which is still continuing.  The  complainant is a senior  citizen had to get the help of other people for all his day to day activities for several months.  All this caused severe mental agony financial loss and hardship. For this  all the OPs are liable to compensate the complainant. Hence the complaint.

       After receiving notices opposite parties 1&2 entered appearance and filed version jointly.  The Ops admitted  that the complainant approached the 1^st OP with the complaint of blurred vision. On examination it was diagnosed as a matured cataract and after taking consent  from the complainant the OP had conducted  cataract operation for the  complainant’s left eye on 5/3/2016 and even before  fixing the operation, 1^st OP had advised the  complainant to control and minimize the diabetes and cholesterol by taking treatment from a physician and also advised him to get a fitness certificate from a competent doctor in order to  rule out of the complication that  may arise for a diabetes patient during or after the operations.  The cataract surgery was successful and after  an hour the complainant left the hospital without any complaints.  The Ops  also admitted that the complainant approached the 1^st OP on 6/3/2016 owing to pain  on his left eye  and for  better management  1^st OP referred the complainant  to senior specialist Dr.Bhat working as an ophthalmic surgeon  at 2^nd OP hospital.  On 7/3/2016 the complainant came to Dr.B.V Bhat at 2^nd OP hospital and on examination, it was found that the complainant  is having endophthalmitis, ie  the  infection and inflammation in the anterior chamber and posterial segment of  his left eye, which was confirmed by B scan test for which an urgent vitectomy surgery was needed to be done by a vitreo-retinal  surgeon  at a higher centre and hence Dr.Bhat  had given an intraocular injection of antibiotics and cephatazine injection for containing the inflammation and infection as an emergency measures till the time the complainant reaches at the higher centre.  The 2^nd OP never demanded or collected any fees from the complainant on that day.  Accordingly Dr.Bhat  referred  the complainant to Dr.Sripathi Kamath, the competent Vitero-retinal surgeon, working at Fr.Muller Hospital,Mangalore.  The allegation of the complainant that the OPs had given wrong medicines and treatment is utter false and there is no professional negligence on the part of the OPs in giving the treatment and the medicines as alleged.  It is also false that the complainant could not see anything with his left eye after two days of operation.  The OPs states that  as the complainant had reported pain on the very next day and as there was infection seen on the very next day the 1^st OP verified the  sterilizing method  in the OT  and checked  whether there is any chance of getting infection from the operation theater  due to any unforeseen reasons, as the way in which he performed the operation and the medicines prescribed post operatively are of standard ones usually given for preventing the infection and speedy recovery.  Accordingly the 1^st OP  informed the same to the 2^nd OP  and they had also  checked the sterility of the equipments in the operation theater.   Accordingly  the infection  control department of  2^nd OP took samples of all consumables used by the patient during the surgery for cultural and sensitive test at the  microbiology department of Dhanalakshmi Hospital Kannur, one which  is accredited to NABH  There after the microbiology department  gave report and on going through the report fortunately the result of all cultures were negative except  the result  on injection Dexaford Batch No.HL 1521 E showed bacterial growth  and it was affirmed by culturing two more vials of the same batch from the stock separately and as per their report it shows there is growth of  pseudomonas aeruginosa and Klebsilla species which is resistant to most of the antibiotics.  The said injection was used during the surgery as a standard medicine used by all surgeons.  Immediately 1^st OP  intimated the same to the  OPs 3 to 5  the manufacturers and distributors of the said injection and the medicine was purchased by 2^nd OP from them.  The injection purchased by 2^nd OP are contaminated with bacteria, hence  the OPs bonafidely  believes that the unfortunate  complication of Endophamitis was caused to the above said injection  and it is quiet unfortunate  and  it is beyond the control of 1^st OP.  It is submitted that  1^st OP being  an eye specialist and  have enough experience in the field treated complainant in accordance with his diagnosis and the operation was conducted up to his skills and standard and it performed  with at most care and precision.  None of the OPs had ever done  any  unfair trade practice and never promoted or administering any wrong medicine as alleged by the complainant .  There is no negligence or deficiency in service on their side .  Hence prayed for the dismissal  of complaint.

      Based on the contention of  OPs 1&2, complainant has filed impleading petition to  implead the manufacturer and distributors of Dexford medicine which has been allowed and impleaded as Addl. Opposite parties 3 to 5.  On receiving notices, addl. OPs 3 to 5 were entered appearance and  4^th OP filed written version.  It is submitted by  4^th OP that he is not  the service provider to the complainant and the complainant has no relation with the 4^th OP  4^th OP states that without the government laboratory report there cannot be any  allegations whatsoever  about the defective medicine and therefore the 4^th OP puts the complainant  to strict proof to prove the same.  The 4^th OP states that they are only manufacturer and distributor f the medicine and all the  medicine are of quality tested prior to its dispatch to various locations across India. 4^th further stated that  he is not aware about the 1^st OP is the eye specialist and hence denies the same .  4^th P is also not aware of  that the complainant was referred  by the 1^st OP to the 2^nd OP and therefore denies the  same  and  further states that he is not aware of the performance of the cataract operation on the left eye on 5/3/2016 and therefore denies the same. 4^th OP further denies the  severe complication  to the left eye of complainant and  the OPs prescribed wrong medicine whatsoever for which  the 4^th OP cannot be held liable for negligence  whatsoever. The 4^th OP denies that the injection Dexaford administered on the complainant was contaminated with bacteria which cause the complications of exdophanitis.  4^th OP states that the 1^st OP in order to shield his negligence and also there was severe deficiencies in the operation done  and therefore the same cannot be attributed to the medicine without cogent proof of the same.  Hence prayed for the dismissal of the complaint against them.

       On behalf of the complainant, two PWs including the complainant have been examined and  they were subjected to cross- examination by the OPs 1 to 5.  On behalf of the  OPs, 3 witness including OP.NO.1& OP.NO.5 have examined  as DWs 1 to 3 and DWs  1 to 3 were subjected to cross-examination by the rival parties.  After that  the learned counsels of parties in the case have filed  their respective written argument notes.

    Here the admitted facts by complainant and OPs 1&2 are that 1^st OP is a qualified and experienced ophthalmologist and on 24/2/2016 complainant  approached 1^st OP with complaint of blurred  vision on his left eye and the complainant was referred to 2^nd OP from where 1^st OP examined and on 5/3/2016 1^st OP had conducted cataract surgery  on complainant’s left eye.  It is also admitted that on the very  next day  on 6/3/2016 complainant  felt pain on left eye and  diminution of eye vision and 1^st OP referred the  patient to Dr.Bhat working as an ophthalmic surgeon  at 2^nd OP hospital.  It is further admitted that complainant had paid  fee for the treatment.   Further admitted that on examination by Dr.Bhat, it was found that the complainant is having  endophthalmitis on his left eye.  Accordingly the patient was referred to Dr.Sripathi Kamath  vitreo  –retinal surgeon working at Fr.Muller Hospital Mangalore with reference letter.  Further admitted fact that the complainant was treated at Fr.Muller Hospital at Managalore as inpatient from  7/3/2016  to  12/3/2016 and from  29/4/2016  to  3/5/2016.

    Complainant alleged that OPs 1&2 had used defective medicine(Dexaford) on him and  thereby put his eye sight at risk and damages.  According to complainant the above said action of OPs 1&2 amount to medical negligence for this  OPs are liable to compensate him for the mental  agony , financial loss and hardship.

   OPs 1&2 contended that even before fixing the cataract operation, 1^st OP had advised the  complainant to control and minimize the diabetics and cholesterol by taking treatment from a physician and also advised him to get a fitness certificate from a competent doctor in order to  rule out of the complication that  may arise for a diabetics patient during and after the operations.  Further stated that the cataract surgery was successful and after  an hour the complainant left the hospital without any complaints.  Further stated that after the surgery when he came with  the complaint of pain of the eye on the next day, he was referred to senior specialist Dr.B.V.Bhat at 2^nd OP hospital and on 7/3/2016 the patient came to Dr.Bhat and on examination, it was found that the patient is having infection and inflammation of his left eye, which was confirmed by B scan test and hence referred to Dr.Sripathi Kamath, the competent Vitero-retinal surgeon, after given an intraocular injection of antibiotics and cephatazine injection for containing the inflammation and infection as an emergency measures till the time the complainant reaches at the higher centre.  Further submitted that the infection  control department of  2^nd OP took samples of all consumables used by the patient during the surgery for cultural and sensitive test at the microbiology department of Dhanalakshmi Hospital Kannur,  which  is accredited to NABH and on going through the report revealed that on injection Dexaford Batch No.HL 1521 E showed bacterial growth  ie pseudomonas acruginosa and Klebsilla species which is resistant to most of the antibiotics.  According to Ops 1&2 the said injection was used during the surgery as a standard medicine used by all surgeries .  Hence they immediately intimated the same to the  OPs 3 to 5 as they are the manufacturers and distributors of the said injection and the medicine was purchased by 2^nd OP from them.  OPs 1&2 contended that the injection purchased by 2^nd OP are contaminated with bacteria, so the  complication of Endophamitis was caused to the  complainant .  According to Ops 1&2, it is beyond the control of 1^st OP hence there is no negligence or deficiency in service on their side as alleged by the complainant.  The learned counsel of OPs 1&2 submitted that even if complainant’s allegations of loss of vision and disfiguration of his left eye is true, the same was not due to the acts of OPs 1&2.  The diminution of vision  to the  complainant’s left eye is caused due to the contaminated medicine Dexaford injection supplied by  5^th OP,manufactured and distributed by  OPs 3&4 and they are responsible to pay compensation to the complainant for the grievance sustained to him. 

       Here we can see that OPs 3 to 5 has taken a different contention.  The learned counsel of OPs 4&5 submitted that OPs 4&5 are not liable  for the  negligence of OPs 1&2  at the time of operation cataract.  According to OPs 4&5, they are unaware of the treatment received  by the complainant from OPs 1&2 and from Dr.B.V.Bhatt and then from Dr.Sripathi Kamath.  These OPs further submitted that the complainant has not rendered any service from OPs 4&5 and there is any professional negligence and also unfair trade practice.  The contentions of OPs 4&5 are that the laboratory report of the consumables in the operation theatre and  sterility of the equipments  of the  operation theatre was not produced by the  OPs 1&2.  Further Ext.X1 report is not legally acceptable because the medical Board has not conducted investigation or examination to prove that the complainant has loss of vision and has not verified the mode of treatment given to the complainant.  Further submitted that DW1 adduced evidence that the damages caused to Retina due to health problem  cannot be reversed and  the macular  degeneration can be  caused due to Retina disease.  Then complainant has to adduce evidence to prove that his eye sight has lost due to Dexaford injection.  According to OPs 4&5 complainant has  not produced clinical test, laboratory test or ultra sound test.  Further DW2 stated that complainant was a chronic diabetic patient at the time of surgery.  Diabetic may cause weak in sensing  light.  Further he added that diabetic will cause weak signals  in optic nerve to the brain to generate image and that will cause  loss of central and peripheral vision leads to blindness.  The doctor says that due to chronic diabetics loss of vision is caused. 

       The next contention of OPs 4&5  is whether the lab report by Dhanalakshmi Hospital and Pariyaram Medical college Exts.X3 & X4 are acceptable.  The samples are not  sent to a Govt. analyst.  Further contended that according to the Drugs and Cosmetics amendment Act 2008 action against spurious and adulterated drugs can be initiated only on the  basis of test  report of Govt. Analysts declaring that the drug samples are as not of standard quality.  Under Rule 46 of Drugs and Cosmetics Rules the patient proprietary formulations should be tested by the Govt. Analyst.  In this case the reports produced before this commission is not from a Govt. Analyst.  The Klebsiella bacteria spread by  contamination in the environment and health care infections via the contaminated hands of health care workers. Therefore the report does not  contain  any substance to prove that complications caused in the eye of the complainant was due to the application of eye drops.  The oral evidence alone does not prove that the complainant had a deficiency of 10% eye sight.   OPs 4&5 submitted that complainant and OPs 1&2 have not proved by cogent medical evidence or report that the loss of eye sight was due to infection caused by the medicine supplied by OPs 4&5.  Hence according to OPs 4&5 they are not liable to pay any compensation to the complainant.

   In this case the 1^st point is required to be find out that whether complainant has succeeded in proving his allegation that after the cataract surgery done by 1^st Op on his left eye , at 2^nd OP hospital, has lost his vision of left eye.

  Ext.A1 is the consultation prescription of 1^st OP dtd.24/2/2016 issued in favour of complainant Mr.Abdul Majeed aged 66 years.  On perusal  reveals that “Report at Ashoka Hospital (OP.NO.2) on 5/3/2016 at 7.A.M for cataract surgery (LE) .  Ext.A2 is also a consultation prescription of 1^st OP dtd7/3/16 ,shows  complaint of cornea edema, endophthalmitis .  Ext.A3 is the referral letter to Dr.Sripathi Kamath at Fr.Muller Hospital.  Thus through Exts.A1 to A3 ,complainant has proved that the  cataract surgery on his Left eye was done by 1^st OP at 2^nd OP hospital on 5/3/2016 and he  was referred to  Dr.Sripathi Kamath, Fr. Muller Hospital ,Mangalore with a request “urgent intervention of suspected postodendophthalonitis” which makes it clear that complainant has proved the above said point.  Moreover OPs 1&2 voluntarily admitted the said point of fact.

  The next contention raised by the OPs 4&5 that OPs 1&2 has not proved  the hygienic condition of the operation theatre and also Ext.X1,Medical Board Report, Ext.X2 the Microbiology report issued  by Dhanalakshmi Hospital Kannur and Ext.X3 the Microbiology report issued by Pariyaram Medical College Hospital Kannur  cannot be accepted with regard to this contention, we can see that first of all complainant does not have an allegation that his infection of left eye after the cataract  surgery leading to loss of vision  was not caused due to the unhygienic condition of the operation theatre of 2^nd OP hospital.  Hence there is no element of consideration about the sterility of the equipments of the  operation theatre of 2^nd OP hospital.  With regard to Ext.X1, it is the Medical Board report submitted by the  Medical Board at District Hospital Kannur consisted  by Superintendent of Dhanalakshmi Hospital Kannur,Medical consultant (Ophthalmologist),Medical consultant Dhanalakshmi Hospital Kannur, on 29/8/2018, as per the direction of this Commission.  The said report was marked by the complainant through Dr.Anita.S one of the Member of the Medical Board PW2.  PW2 deposed that there is loss of vision in the left eye of the complainant and the percentage  of disability noted was 10%.  In Ext.X1 percentage of vision stated  as 6/60P(LE).  PW2 categorically deposed that disability on the left eye  can be  occurred due to administration of injection dexaford which is contaminated with bacteria.  PW2 also deposed that after examination and verification of previous treatments we came in to the conclusion as stated in Ext.X1.  PW2 has been subjected to cross-examination by OPs 3 to 5.  The learned counsel of OPs 3 to 5 put forward a question  that “Did you notice that the patient was suffering from diabetics?(A) not noticed. Which clears that the  patient was not suffering from chronic diabetic.  It is to be noted that OPs 1&2 in their version stated that before conducting cataract surgery the patient  was advised to control and minimize the diabetics to rule out of the complication  that may arise for a diabetes patient.   Hence the contention  raised by OPs that the complication  was developed due to diabetics can be ignored.  Further during cross-examination PW2 deposed that if Dexaford contaminated with bacteria, loss of vision will cause and also deposed that she has not  seen any lab report regarding contamination of Dexaford.  Here Ext.B1 is the microbiology report prepared by Dhanalakshmi Hospital,Kannur.  Ext.X4 shows the certificate of  Accreditation issued by NABH to the said hospital valid for a  period from 12/3/2014 to 11/3/2017. Hence Ext.B1 the Microbiology Report issued from Dhanalakshmi Hospital can be accepted as a valid report.  On perusal of Ext.B1 report , it is seen that out of the administration of medicine to complainant during surgery culture and sensitivity  of Dexa ford ,specimen ,  Batch No.HLI 521E,result shows  pseudomonas Aeruginosa Grown in culture after 24 hrs of incubation.  Though OPs 2&3 has taken steps to microbiologist, as witness, the summons to witness were not returned.  Hence they  were exempted from examining.  Since through Ext.X4, it is proved that Dhanalakshmi Hospital Kannur has Accreditation Certificate, during the relevant  period, there is no reason to discard Ext.B1 report.  Further Ext.X3 investigation reports from Microbiology Department of Pariyaram MCH submitted as per the direction of this  commission also reveals that  on culture and sensitivity report of the Dexaford injection, Klebsiella pneumoniac isolated from 2 out of 4 vials received for culture.  Thus Ext.B1 as well as in Ext.X3 microbiology report it is evident that the Dexaford Batch No.HLI 521E was contaminated with pseudomouas Aeruginosa bacteria .  It is  also proved that the  said medicine was supplied by OP.NO.5, and manufactured by OP.NO.4.  OPs 4&5 raised  a contention that since Ext.B1 and Ext.X3 were not prepared by Government Lab for cultural and without conducting sensitive test, those document cannot be accepted.  Here it is pertinent to be noted that while complainant has taken steps to send the sample to Pariyaram Medical College Hospital, OPs 3 to 5 has not given any suggestion  to send the sample to Govt.Lab.  Here we can  see that  both the  microbiology Departments in Dhanalakshmi Hospital and Pariyaram Medical College hospital are recognized Lab by the government.  Hence there is no meaning to raise objection by OPs 3 to 5 at the  fag end of this case.   We are of the view that there is no reason to disbelieve the culture result stated in Ext.X3 & Ext.B1.  Thus through Exts.X3 &Ext.B1, it is proved that the medicine Dexa ford supplied by OP.No.5,manufactured by OP.NO.4 to 2^nd OP hospital was contaminated with psuedomouas Acruginosa Bacteria which  resulted endopthalmitis  of the left eye of complainant.

   The next point to be decided is which opposite parties are held liable for the grievance occurred to the complainant?

   PW2 the doctor  Sripathi Kamath, Opthalmoligist who treated the complainant  working as Vitreo retina surgeon at higher centre Father Muller Medical College Hospital ,Mangalore was examined as expert witness from the side of OPs 1&2.  On analysis of the evidence of DW2, revealed that he  has deposed that the patient was appropriately referred with immediate effect, not found any lapses by the 1^st Op doctor as per the records and further medicines were given as per the standard norms following cataract surgery .  Further stated that as per records post operative medicines were given by 1^st OP are standard medicine and Dexa ford injection is a standard one.  He has also deposed that if the Dexaford injection in contaminated endopthalmetic will be the sudden result, and it is not treated properly at right time it can result in loss of vision.  During cross-examination by OPs 4&5, the learned counsel put certain questions ie Endopthalmetis is caused Macular degeneration? Answer No.  Also DW2 deposed that at the time of examination previous hospital records were seen and the patient was not  a chronic diabetic at the time of surgery. During cross-examination by the learned counsel of complainant asked a question to DW2 ‘Had the complainant not reached yours Hospital in Mangalore in time the patient would have lost his eye sight? Ans: Yes.

      From the evidence of DW2 revealed that there is no medical negligence on the part of 1^st OP Dr.vijil.C.H.  But DW2 deposed that if the endopthalmetis is not treated at the right time, it can result in loss of vision.  Further deposed that the eye sight of the patient would not have been  lost  if the patient had reached in right time at higher centre.  Hence from the above said  evidence of DW2, expert  doctor, there is some latches happened from the side of 1^st OP in referring the patient to higher center.  Further OPs 1&2 contended that  OPs 4&5 have not produced any document to show that the Dexaford injection was properly tested before supplied to 2^nd OP hospital to certify that the medicine was not contaminated and  there is no bacterial growth.  Here 2^nd OP admitted that the disputed medicine was purchased from Ops 4&5.  Then the hospital  OP.NO.2 also have a  bounden duty to rule out the fact that the medicine purchased by them are not contaminated.  Here 2^nd OP has not submitted such a certificate obtained from OPs 4&5 before us.  Hence we are of the view that along with OPs 3 to 5, 2^nd OP is also responsible for administering contaminated Dexaford injection to the complainant.  The negligent act of OPs 1&2  in sending the patient at proper time to higher center resulted, loss of vision 6/60 on the left eye of the complainant(senior citizen).

      Considering all the facts stated above, we are of the view that there is negligence on the part of all opposite parties.

     In the result complaint is allowed in part.  Opposite parties 1 to 5 are directed to pay Rs.1,50,000/- to the complainant as compensation.  Out of which opposite parties 1&2 will have to pay Rs.50,000/- and opposite parties 3 to 5  have to pay Rs.1,00,000/- to  the complainant within one month from the date of receipt of this order.  Failing which the awarded amount carries interest @9% per annum from the date of order till realization.  Complainant is at liberty to file execution application against opposite parties 1 to 5 for realization of the amount as per provision of Consumer Protection Act 2019. 

Exts:

Exts.A1 to A3- prescriptions dtd.24/2/16,7/3/16,7/3/16

A4&A5-Discharge summary  of Fr.Muller Medical college Hospital Mangalore 7/3/16 to 12/3/16 &nd 29/4/16 to  3/5/16

A6-prescription dt.17/3/16

A7-lawyer notice dtd.7/6/16

A8- reply notice

A9- registered   cover

A10 series-Medical  bills  from Fr.Muller Hospital (1 to29 Nos.)

A11- Railway ticket 1/5/16

A12series-Railway ticket ( 43 document )

X1- Medical Board  Report  from District hospital Kannur.

B1- Microbiology report

B2-Cash bill dtd.13/4/16 Dhanalakshmi Hospital Kannur

B3- copy of letter issued from 2^nd OP dtd.1/5/16

B4-copy of lawyer notice

B5-copy of letter send by 2^nd OP

X2- case sheet and treatment records  from Fr.Muller Hospital

X3- Microbiology report issued  fro Pariyaram  Medical College Hospital

X4- certificate of Accreditation  issued by NABH

PW1-Abdul Majeed- complainant

PW2- Dr.Anita.S- witness of PW1

 DW1- Vijil.C.H- 1^st OP

DW2- Dr.Sripathi Kamath- witness of OP

DW3-Manoharan-OP.No.5

Sd/                                                                             Sd/                                                                         Sd/

PRESIDENT                                         MEMBER                                                 MEMBER

Ravi Susha                                    Molykutty Mathew                                     Sajeesh K.P

eva                                                                      /forwarded by Order/

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