Judgment:
Dr. S.M. Kantikar, Member
Dr. Charles Clay, who performed the first hysterectomy in year 1843 in Manchester, UK, must be in distress. Today, his remarkable surgical invention, which has given hope and cure to millions of women, has turned in to a scandalous business. Hysterectomy is the most common non“pregnancy-related major surgery performed on women worldwide. The present complaint filed against allegations of medical negligence necessitates to discuss crucial issue of unscrupulous hysterectomies in India and worldwide.
1. The complainant seeks compensation for loss and damage which his wife claims to have sustained as a consequence of the alleged negligence of OPs 1 and 2 , while carrying out a total abdominal hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy , on 17/7/2010. It is also disputed by the complainant that Informed Consent was not taken in the course of this operation.
2. The complainant took his wife, Smt. C. Kusuma Reddy, aged about 36 years to the OP-2 Dr. Padmini in the month of July 2010, for her complaints of abdominal pain and menstrual disturbances and other complaints. Since birth of 1st child, in 2006 she was a known patient of OP, Dr. Padmini, and consults for her menstrual complaints, since the year 2009. The patient, Kusuma, was examined by OP and was diagnosed as a case of fibroid uterus with Endometriosis. She was advised treatment of Tab. Danogen -50 mg and Tab. Pyricontin 10mg for 30 days. Thereafter, on 13.07.2010, during the follow up visit, she was subjected for ultrasound scanning examination and advised the total abdominal Hysterectomy. The complainant contended that the operation was conducted on his wife, without the valid consent of his wife or himself. Due to abdominal pain, fear and disturbed status of mind, she could not give informed consent for the said operation; and the OP hospital took his signatures on the blank form. It was also stated that resistance of the complainant and without any serious problem, the OP “Dr. Padmini, has performed the total abdominal Hysterectomy with Bilateral Salpingo-Opherectomy with Adhesiolysis. The complainant has requested the management to provide information relating to operation theatre documents and copy of case sheet, but OPs turned a deaf ear to it. Even after the operation, Dr. Padmini did not inform anything about the said operation of hysterectomy. OP has removed both the fallopian tubes and ovaries unnecessarily, despite alternative methods to treat such patient, and to remove the fibroids, were available. The complainant had only one child and he wanted to have a second child by IVF or test tube baby method with surrogate mother, but as his wife lost her ovaries after operation by OP, he had to search for an ovum donor and incur heavy expenditure. Therefore, with these allegations and due to negligent attitude of the OP, his young wife lost her reproductive organs, therefore, no chance of second child also. His wife had to suffer lot of serious side effects due to early hysterectomy and removal of ovaries. The complainant contended that he had worked in Nigeria and intended to travel to New Zealand; also he had plans to settle in European or Western Country, in which cost of living and medical expenditure will be higher, hence he is seeking heavy compensation from OP. Therefore, the complainant filed this complaint with different prayers, for directions and relief as stated in the complaint.
The main prayer against OPs 1 and 2 is as under:-
To declare deficiency of service by OP No. 1 and OP No. 2 award compensation Rs. 1,25,00,000/- (one crore twenty five lacs) and for pain and suffering Rs. 25,00,000 (twenty five lacs) and as prayed in the complaint with interest from the date of Notice dated 16-01-2012 with interest at 25% P.A. or pass any other order/s or direction in the interest of justice.?
3. Notice upon OPs was served by registered post, but they have not filed any written version within 45 days. Therefore, as per provision of Section 13 of the Consumer Protection Act 1986 (in short CP Act) OPs right to file the written version is forfeited.
4. Case was called on 5/9/2013; no body appeared on behalf of OPs; they remained absent. The service of notice upon OPs is held sufficient. The complainant appeared in person and argued vehemently. He reiterated the facts of this case, hospitalization details and brought our attention towards several authorities of Honble apex court. Hence, we proceeded for exparte order. The points of our consideration are:-
i) Whether the complainant proved his case of alleged negligence on the part of the doctor?
ii) Whether the doctor acted cautiously in accordance to the standard medical practice?
iii) If there is medical negligence then what is the liability of opposite parties?
5. We have perused the affidavit evidence of complainant and the available medical records of OP hospital. It is clear that Smt. C. Kusuma Reddy, wife of complainant is 36 yrs. old, and was under treatment of OP Dr. Padmini, for menstrual disturbances, from 2009 and in the month of July 2010, after investigations she was diagnosed as a case of uterine fibroid with Endometriosis. She was treated by Tab. Danogen -50 mg and Tab. Pyricontin 10mg for 30 days.
6. We find that before filing this complaint the complainant had approached several authorities like NHRC, SHRC, Medical Council of India, Secretary, H and FW, and Government of India for redressal of his grievances against OPs. Thereafter, complainant served legal notice upon the OP 1 and 2, on 16/1/2012 and reminder on 29/02/2012; but the OPs turned deaf ears to legal notices on both occasions.
7. We have perused the medical record like Follow-up visit slip of OP hospital written by Dr. Padmini on 13/7/2010, which reads as follows:
Provisional Diagnosis : Degenerating Fibroid with ?Endometriosis.
She was investigated by TVS Scan (Trans vaginal scan); blood for CA-125 and other routine investigations.
œwill require TAH/BSOPH and urgent admission? .
8. As per advise of OP-2, a High Resolution Real Time Ultrasonography (USG) of Pelvis was performed at Nitya Diagnostic Centre, on 14/7/2010; the report is reproduced as follows;
Trans-vaginal Scan:
Uterus:134 x 91 x 85mm “ Increase in size. Antevert
Evidence of large anterior wall fibroid of 87 x 62mm
Endometrial echo 12.5mm, thick.
Rt. Ovary: 41 x 82mm - Increase in size with altered echotexture.
Lt Ovary:107 x 82mm “ Increase in size with mixed echoic lesion showing cystic
andsolid area measure 61 x 45mm.
Color Dopplershow increase in vascularity in both ovaries.
Free fluid in pouch of Douglas.
Conclusion:U S findings are suggestive of Anteverted bulky uterus with large anterior wall fibroid and thick endometrium.
Bulky Rt ovary with altered echo texture, enlarged Lt ovary with mixed echoic lesion showing cystic and solid areas and increased vascularity in both ovaries on color Doppler-----? Neoplastic
9. Observations on Discharge Summary of Mrs. Kusuma Reddy C/111046 dated 23/7/2010 issued by Department of Gynecology of OP hospital, reads as follows:
The Final Diagnosis as œ Adenomyosis with Polyp with DUB with left ovarian cyst.?
On 19/7/2010 œTotal Abdominal Hysterectomy+ Bilateral Salpino-oopheraectomy+ Adhesiolysis surgery was performed under Spinal anesthesia. ?It also mentions several blood investigations of Pre “operative profile and Thyroid profile which are within normal limits . The specific assay of CA-125 vale is 339.5 U/ml. Ovarian fluid cytology was insignificant.
10. We have carefully examined the hospital record on file, under the heading title as œThe Summery of Hospital Course?, the relevant portion, of which reads as follows:
Details of surgery:œTotal Abdominal Hysterectomy + Bilateral Salpino-oopheraectomy+ Adhesiolysis done under Spinal anesthesia.
O.T. Findings:(Operation Theatre )
Uterus bulky with multiple fibroids “ 25 x 15 cms
Cervix “ Normal
Ovaries “Left “ large chocolate cyst “ 20 x 20 cms., Right “ Normal
Fallopian tubes and Adnexa “ Normal
11. The main crux of this case is the opinion of pathologist i.e. final diagnosis; who has examined the surgical specimen grossly and microscopically. Hence, the Surgical Pathology report 3501/HP/2010 (in short HPE report), dated 24/7/2010 play a vital role in deciding this complaint. The HPE is reported by Pathologist of Department of Laboratory medicine of OP-1 hospital, which runs as follows:
Lab No. 3501/HP/2010 (in short HPE report) dated 24/7/2010
NATURE OF SPECIMEN :
Total abdominal hysterectomy with Bilateral salphingo-oopherectomy.
GROSS:
Received a specimen of Total abdominal hysterectomy with Bilateral salphingo “oopherectomy. Uterus with cervix measures 15 x 9 x 8 cm in size. External surface shows bosselated areas. On cutting open endometrial cavity is fleshy. The endometrium and myometrium measures 0.7 and 2 cm, in thickness,respectively. Myometriumshows gross evidence of Adenomyosis. Myometrium also shows two cystically dilated congested areas.
Right ovary measures 4 x 3 x 2 cm in size. On cut section shows a corpus luteal cyst .Right fallopian tube measures 7 cm in length. Cut section is grossly unremarkable.
Left ovarymeasures 7.5 x 4 x 2 cm in size. External surface is congested and shows focal haemorrhagic areas. On cutting open, it shows a large cyst, measuring 6 x 4 cm, in size. Inner wall shows haemorrhagic and congested areas.
Sections:
I. Endomyometrium.
II. Cervix and isthmus.
III. Right Ovary with right fallopian tube.
IV. Left ovary with left fallopian tube.
MICROSCOPIC EXAMINATION:
Multiple sections studied from the uterus shows endometrium with secretory changes.
Extensive foci of Adenomyosis are noted in the myometrium.
Cervix and isthmus are unremarkable.
Right ovary shows a haemorrhagic corpus luteal cyst.
Multiple sections studied from the left ovarian cyst is lined by a single layer of columnar epithelium. Underlying strauma is fibrous and shows areas of haemmorhage and hemosiderin laden macrophages. Few foci of endometriosis are also noted.
Both fallopian tubes are unremarkable.
IMPRESSION:
Adenomyosisof the uterus.
Benign ovarian cyst, Endometriotic type, Left ovary. ??.
12. On careful analysis of reports in paras 8,9 and 10 above , we have noticed gross of discrepancies in the USG report, Operation Theatre(OT) findings and the Gross Findings of specimen in Surgical Pathology (HPE) report. The USG report mentions about anterior wall fibroid measuring 87x62 mm, while the OT findings mentioned as œBulky uterus with multiple Fibroids of size 25x15 cm?, i.e 250x150 mm..! but in HPE report , the Gross specimen did not mention single word about presence of any fibroid and also microscopically, there was no evidence of leiomyoma i.e. fibroid. Hence, there is no correlation between their clinical, diagnostic and operative findings.
13. Also it very pertinent to note that the provisional diagnosis of OP was degenerating fibroid with Endometriosis. The USG findings confirms œthe Right ovary normal; only single fibroid? . Therefore, we are in doubt that why OP has not tried the alternative line of conservative treatment in this patient? What necessitated the OP to perform pan hysterectomy ( Removal of uterus with both ovaries)? Instead of removing one ovary OP would have preserved one ovary, at least. It tantamount the deliberate attempt and therapeutic misadventure in this young woman of 36 yrs of age, who suffers from early menopausal symptoms and need lifelong hormonal therapy.
14. To know the adverse effects hysterectomy with removal of both the ovaries before age of 40 yrs;we have referred the standard medical text books namely TeLindes Operative Gynecology 10th edition, JeffcotsText bookof Gynaecology, Shawss Text book of Gynaecology 15th edition, SabistonTextbook Of Surgery. Also perused research articles on this subject published in National and International medical journals.
15. Even after viewing the evidence in a light most favorable to complainant, the OP, Dr. Padmini, not only lacked consent, but removed both the ovaries and tubes in circumstances that were neither pathologically necessary nor reasonably incidental to the surgery contemplated. An ovary is of distinct value to the female patient”one that cannot be determined by a physician without, at a minimum, an express dialogue with that patient regarding the possibility of its removal and its side effects.
The starting point is of course, the well-known dictum of Lord?President Clyde in Hunter v Hanley 1955 SC?200 at?206. Since the present case is based upon an allegation of deviation from ordinary professional practice, it is worth quoting the relevant passage:
"To establish liability by a doctor where deviation from normal practice is alleged, three facts require to be established. First of all it must be proved that there is a usual and normal practice; secondly it must be proved that the defender has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course, the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care. There is clearly a heavy onus on the pursuer to establish these three facts, and without all three, his case will fail."
16. We feel necessary to discuss about œWhat is the valid consent ??
Consent is œnot a one-off event of signatures on paper?and not a submission of the patient to a particular treatment but rather a process of communication. It is then perceived as a proactive process empowering the patient to consciously decide on what s/he considers best. Thus, consent is œa process of communication requiring the fulfilment of certain established elements, like competence, sufficient disclosure, understanding and volunteering?.
The ICMR guidelines acknowledge the patients consent as a necessary prerequisite to the medical process. However, consent is not systematically required as it is formulated in the case of redesign of treatment, though, with the existing formulation, the achievement of the written consent is misguiding and may ultimately allow the practitioner to override the patients opinion.
The doctrine of informed consent finds its common law roots in the landmark decision of Justice Cardozo in Schloendorffv. Society of New York Hospital,211 N.Y. 125, 105 N.E. 92 (1914),in which he wrote:
Every human being of adult years and sound mind has a right to determine what shall be done with his own body and a surgeon who performs an operation without his patients consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.
17. MEDICAL ETHICS - NEED FOR HYSTERECTOMY?.
In our country, few studies were conducted which showed;
A significant percentage of women
had been referred to the private hospitals by the RMPs who will receive a œhonorarium? as payment for their referral services
limited dialogue regarding their illness and different options were not offered to them
Undergone hysterectomies with no proper procedures and protocols without proper medical records and follow up.
Operated without valid consent as most of women were from the lower income group and illiterate also such patients had to incur debts in order to meet the surgery expenses.
18. Hysterectomy is the partial or full removal of uterus. Sometimes ovaries and fallopian tubes are also removed. Ethically doctor should suggest this operation, in case certain medical conditions or when all other treatment options fail. Scandalous hysterectomies, for petty monetary gains are well known and can cause disastrous consequences. Few years back, there was a report on increasing number of young women (some as young as 25 years), from Chennai ,undergoing hysterectomies in order to raise insurance claims (The Times of India, Nov 12, 2009). Indications for hysterectomies had been as frivolous as small fibroids causing excessive bleeding. The unfortunate story of a group of Lambada women in Kannaram village of Medak district, Andhra Pradesh is well known (The Times of India, July 31, 2010). Most women, even as young as 20 years in this village of 125 households have undergone hysterectomies for complaints of abdominal pain and whitish discharge. These women now suffer from results of surgical menopause. Few days back, National Press reported over 16,000 hysterectomies most of them œunnecessary?, done at private hospitals across Bihar during the last one year allegedly to œavail insurance benefit? under the Rashtriya Swasthya Bima Yojna (RSBY) (The Indian Express August 27, 2012). Under the RSBY, a BPL family can avail Rs.30,000/-, in case of hospitalization. Private hospitals in turn claimed reimbursement of Rs.12 crores, over last one year. 89% of hysterectomies were conducted, in private hospitals. Also, in Chhattisgarh about 7,000 uterus removal surgeries performed, over a period of 30 months, while a total of 11,000 hysterectomies were performed in Andhra Pradesh in two years.
19. Unnecessary hysterectomy results inability to have future conceptions, pregnanciesand children. This can have disastrous medical, social and psychological consequences of those couples, who desire to have children. Removal of both ovaries, in young and middle aged women (below 40 yr.), leads to loss of female sex hormones, resulting in premature surgical menopause. Medical studies have established that itcan lead to menopausal hot flushes, emotional labiality and osteoporosis (bone softening and propensity to bone fractures on minor trauma), heart diseases. Such women need long term follow up and hormone replacement therapy (HRT). They are also more likely to become depressed.
20. Uterus worth if it's valued as a hormone responsive sex organ that supports the bladder and bowel, and provides cardiovascular protection. Hysterectomy is rarely, a life saving surgery, and it is almost always performed on women, who were not given information about the consequences of the surgery. In law, this is considered lack of informed consent, a case that is almost impossible to win, because, women had no idea of the damaging effects of hysterectomy, when they signed the consent form. In fact, even women ask queries about the consequences of hysterectomy, and they are routinely lied to, by gynecologists. Of course, no amount of money can fix the damage that is done to a woman, when she is hysterectomized and castrated. However, dont think that hysterectomized women don't deserve any compensation.
21. Such doctors are shrinking their Hippocratic Oath for money and removing the very essence of womanhood. Standard protocol demands that women have to be informed about the after-effects of such a surgery. Instead of following the normal protocols while examining women with complaints of abdominal pain, bleeding or vaginal discharge the doctors advice hysterectomies. However, experts believe that with advances in medical science, the operation need not be a necessity. Women can opt for oral remedies, hormonal injections, intra-uterine devices and endometrial ablation to get rid of problems like heavy bleeding and fibroids. Experts also suggest that doctors should resort to this operation only when all other treatment options fail.
RashtriyaSwastha Bima Yojana (National Health Insurance Scheme) has become such a craze among private nursing homes and several thousand nursing homes in India took advantage of RSBY and cheated the women by carrying out hysterectomies where they were not required. The Ministry of Health and Family Welfare, Govt of India and statutory body like MCI should initiate stringent action against such doctors. Data of hysterectomy surgeries should be made mandatory for each private and Govt Hospitals in the country. There is need to protect the innocent women in our country and stop such rampant unscrupulous hysterectomies. We believe that unless there is an effective, efficient and accountability of public health system such unethical practices will continue.
22. On the basis of foregoing discussions we are of considered view that OP 1 and 2 are negligent in all points of diagnosis and treatment. Further OPs did not bother to reply to the complainants legal notice and did not appear before this Commission, even after due service of notice. Hence, OP 1 and 2 are liable for deficiency in service and medical negligence. At this point, we do not want to consider the issue of complainants desire to settle in European country and have second child through surrogate mother etc., such submissions appear to be purely hypothetical and are meritless. But, it is important that the wife of complainant who anticipate lifelong unforeseen complications of hysterectomy and removal of her both ovaries; she deserves for just and proper compensation. Also she lost the chance of second baby.
Therefore, we pass the following order as ;
OP 1 and 2 are directed to pay Rs.10, 00,000/- (Ten lacs) jointly and severally to the complainant, along with interest @9% pa from the date of operation i.e., 17/07/2010. The entire amount should be paid, within three months otherwise it will carry further interest @ 9% pa, till its realization.
The copy of this order to be sent to the Secretary, Ministry of Health and Family welfare, Govt of India and Medical Council of India, New Delhi for the necessary steps to protect innocent women.