Nemeezia Amin vs Dr. Anuradha Kapur

The present Complaint has been filed under Section 21 of the Consumer Protection Act, 1986 by Nemeezia Amin @Zia (hereinafter referred to as the ‘Complainant’) against the opposite parties for  alleged medical negligence during her treatment.

On 03.01.2015 the Complainant, Nemeezia Amin (for short ‘Patient’) consulted Dr. Anuradha Kapur (OP-1) for treatment of polycystic ovarian syndrome (PCOS) at Max Hospital (OP-2). The OP-1 prescribed her tablet "DIANE 35" (one daily) for a duration of 3 months. It was alleged that during subsequent visits on 28.03.2015 and 15.10.2015, the Complainant was again prescribed the same medicine for further 6 months and informed her to continue for a lifetime. It was further alleged that DIANE-35 was prescribed without explaining its side effects as the said drug should not be taken for more than 3 months. The OP-1 did not treat the side effects of the drug. The Complainant further alleged that she suffered stroke/brain clotting and was admitted to Fortis Hospital from 18.01.2016 to 25.01.2016. It became long-term treatment, and she permanently lost her partial eyesight in both the eyes. Being aggrieved the Complainant filed a complaint with the Delhi Medical Council (DMC) on 08.11.2017. She also filed the Consumer Complaint before this Commission on 16.01.2018 and prayed sum of Rs.1,80,00,000/- as a compensation and Rs.30,000/- towards cost of litigation.

The Opposite Parties (OPs) filed their Written Versions and denied allegations of medical negligence. OP-1 stated that the Patient was advised to take Diane-35 for 3 months only, with a break of 7 days after every 21 days of intake. She was instructed to follow up with OP-1 after 15 days, but the patient failed to follow her advice.  During the second visit after 3 months on 28.03.2015, it was observed that her facial hair had not decreased. Based on test reports, OP-1 advised the Complainant to continue Diane-35 for another 3 months, followed by a 3-month break. On 10.10.2015, the Complainant consulted with OP-1 for irregular periods after stopping Diane-35. OP-1 examined her and advised to take Diane-35 for 6 months (21 days intake and 7 days off cycle). OP-1 also recommended laser treatment and blood tests. Patient took follow-up appointment after 1 week, but thereafter she never came for follow-up with OP-1.

The OPs further submitted that the stroke suffered by  the patient was not due to intake of Diane-35. As per the treatment record from Fortis Hospital, it was clearly mentioned that the occipital headache was suspected possibly due to intracranial dissection and the differential diagnosis was vasculitis. The Complainant has deliberately not produced her previous PCOS treatment record.

Heard the arguments at length. The learned Counsel on both the sides reiterated the facts and their evidences. The OP-1 was also present with her counsel. Parties have filed medical literature on the subject and textbook references.

The learned counsel for Complainant argued that the patient was suffering from PCOS.  On 03.01.2015 the OP-1 prescribed DAINE-35 for a period of 3 months without any diagnosis or conducting any tests. Thereafter, the patient visited the OP-1 on 28.03.2015 and again DAINE-35 was advised for 3 more months, for next visit on 15.10.2015 same was prescribed for further 6 months. The drug was prescribed without informing about the side-effects or any alternate treatments. On 18.01.2016, the patient, felt severe headache and partial blurred vision and visited Sharda Hospital in Gr. Noida. Thereafter, on the same day, the Complainant got admitted to Fortis Hospital, Shalimar Bagh.  Dr. Pankaj Aneja advised MRI of brain and MR Angiography of Brain & Neck. The investigations revealed the brain nerves became dead and as a result she suffered partial loss of vision in both the eyes due to thrombophilia as a major side-effect of DAINE 35. The Complainant was discharged from Fortis Hospital on 25.01.2016.

The learned Counsel for complainant further argued that there was no informed consent to the treatment. The OP-1 did not explain the side effects and any alternative treatment.  The Counsel relied upon the judgement of the Hon’ble Supreme Court in Malay Kumar Ganguly v. Dr. Sukumar Mukherjee[2009) 9 SCC 221]. Thus, prescribing Diane -35 for 1 year without clinical examination and/or important investigations  constitute deficiency in service  of the OPs. The Diane-35 medicine was primary cause for  the brain damage and eye-sight impairment. In the present case, there was  no past history of thrombophilia.

The learned counsel for OP-1 vehemently argued that there was no medical negligence or deficiency in service. There was no causal link between suffering of stroke and consuming Diane-35. The Discharge Summary of Fortis Hospital dated 25.01.2016  clearly stated that patient’s  thrombo check profile was normal. Thus, in the instant case, there is no evidence of thrombosis/ blood clotting on the Complainant leading to the alleged stroke. The investigations revealed that the alleged stroke was due to arterial dissection suffered by the patient. Diane 35 very rarely causes Venous Thromboembolism which occurs in veins and not in arteries. The OP-1 during argument submitted that, the side effects of Diane 35 were duly explained to Complainant and preventive measures. She cautioned the patient about weight gain and Deep Vein Thrombosis (DVT).  Also preventive measures were explained to the Complainant and it was mentioned over the prescription for weight gain and deep vein thrombosis (DVT). She was advised for exercises and diet control, which was clearly noted the prescriptions.

I have carefully perused the medical record for chronology of treatment details and the prescriptions. It is evident that after stopping Diane-35 the Complainant came OP-1 for follow–up only on 15.10.2015 with complaints of irregular periods. After clinical examination, she was further advised to take Diane-35 for 6 months (21 days intake and 7 days off cycle). She was advised for laser treatment and to continue regular walk and low carbohydrates in her diet to control weight. The OP-1 in her prescription clearly mentioned about the investigations and about weight gain and DVT.  The patient was called for regular follow up after a week, but she never came for follow up thereafter, thus complainant herself was negligent in treatment.

The DMC in its order dated 05.06.2018 held that the Complainant was treated as per accepted professional practices and Diane 35 was not the cause of complications and patient’s sufferings. The DMC held that prima facie no case of medical negligence was made out.  In my view, relying on the medical literature, there is no chance for losing the vision either partially or in full due to intake of Diane-35. It is pertinent to note that during arguments, the learned Counsel for the OP brought my attention to the LinkedIn profile of the Complainant. Thus, it proves that she was not in such extreme sufferings, otherwise it was impossible for her to pursue her education rigorously. Thus, in my view, the complaint was filed on presumptions and surmises without any scientific basis. The Complainant failed to prove her case by cogent evidence and medical/ scientific literature about the proximate cause of arterial dissection.

I have perused few reference text books on endocrinology and Gynaecology.  Clinical Gynaecological Endocrinology and Infertility (8th Ed.), the treatment of Hirsutism explained that

“No Significant reduction in hair growth may occur for up to 6 months, which approximates the half-life of a hair follicle growth cycle. After 6 months, a change in dose, drug, or the addition of a second drug should be considered, if the patient judges her response inadequate. In general, treatment should be continued indefinitely because the problem rarely goes away and almost always recurs when treatment is discontinued.”

·         OP explained to the Complainant about laser treatment as an additive therapy. The study also shows long term treatment (60 cycles) with the ethinyl oestradiol/cyproterone acetate pill (which is the composition of Diane 35), with no adverse effects and the follow-up after 6 months from cessation, in polycystic ovarian syndrome.

·         Textbook of Gynaecology by Sheila Balakrishnan (2nd ed) the chapter on Polycyctic Ovarian Syndrome documented that Diane-35 is the drug of choice for treating PCOS with irregular periods and hirsutism.

·         South Asian Edition of Clinical Gynaecological Endocrinology and Infertility (8th  Ed) states that:

Diane-35 is the drug most beneficial in PCOS cases in Indian conditions. For treating hirsutism, Diane-35 is recommendation to be given for at least 12 months. Minimum recommended for treating acne is 6 months and 12 months for reviewing treatment of hirsuitism. “After 1-2 years, or when pregnancy becomes goal, treatment can be discontinued and the patient observed for a return of ovulatory cycles, although most again will exhibit chronic anovulation.” According to this, Diane-35 can be prescribed for 1-2 years as a Hormone therapy for treating hirsutism.

·         2016 World Health Organization (WHO) Medical eligibility criteria for Contraceptive Use There was no contra-indication to Diane-35 use. Endocrine Society recommendations[PCOS: Endocrine Society Issues New Guidelines 2013] allow physicians to make the diagnosis of PCOS, if clear symptoms are present without resorting to universal hormone tests or ultrasound screenings.

The Complainant alleged that the patient was advised to take Diane- 35 for life time, however on careful perusal of prescriptions, none of prescription mentioned it. It also evident that discharge slip of the patient or in neurology consultations which the patient took from Fortis, Gangaram, Delhi  and in Srinagar;  no where it was mentioned that  ‘Diane 35’  was a causative agent for stroke.

The complainant alleged that she lost “partial eye sight permanently”  but she has not placed any  proof from the Ophthalmologist  for ‘loss of eyesight permanently’ or that the same has any connection with intake of Diane-35. It is evident from the  AIIMS record that in 2018 the complainant visited  to AIIMS for very special test JAK 2 V617 F MUTATION to detect  cause for cerebral dissection. Thus, AIIMS was also not in support of Diane 35 as a primary cause. The other causes for dissection may be Myeloproliferative disorders.

The evidence of the OP-1 revealed that the Complainant did not disclose that she had been taking Metformin and Aldactone more than two years before consulting her first time on 03.01.2015. Therefore, it was clear that she took treatment for PCOS before, elsewhere. However, there was no relief in her symptoms of irregular cycles, acne and increased facial hair.  On 03.01.2015 at first consultation, the OP-1 recorded the history and examined the complainant issued the prescription for blood tests.  As per the Endocrine society’s new guidelines 2013 allows physicians to make diagnosis of PCOS if clear symptoms are present without resorting to universal hormone tests or ultrasound screening. In January 2016, at Fortis Hospital, the patient was diagnosed as arterial dissection based on the report of cerebral angiography. The differential diagnosis of reversible vasoconstriction syndrome was made.  In the discharge summary of Fortis Hospital it was stated that her thrombocheck profile was normal. The MR venography report that “no significant venous abnormality.” Thus it was not a case of venous thromboembolism also.

It is pertinent to note that, nowhere in any of its records, reveal that the cause of stroke in the patient was due to intake of Diane-35. The MR Venography of Brain done on 18.01.2016, reported as “MRV revels no significant venous abnormality.”. Moreover, the Discharge summary of Fortis Hospital Dated 25.01.2016 clearly stated that “her (Complainant) thrombo check profile and vasculitis were normal”. Thus, there was no thrombosis/blood clotting leading to the alleged stroke. The Cerebral Angiography Reported by  Dr. Ashwin Grag on 20.01.2016 states that, “in view of patient being young and classical history of occipital headache at the onset of symptoms, most likely these findings represent the features of intracranial dissection. - Other differential diagnosis is vasculitis.”

Several text books and literature on PCOS and its treatment documented that DIANE-35 is being used in over 126 countries for the same purpose. It is a drug of choice in India for patients suffering from PCOS with  symptoms like acne, hirsuitism and irregular cycles. In the  instant case, the complainant was suffering from the symptoms of PCOS and Diane-35  is an accepted standard treatment. The prescriptions clearly show that the OP-1 prescribed in correct dose and advised for follow-up, but the Complainant did not follow the instructions. The literature also specify that  Diane-35 should be given for 1 year, then break of 3 months to prevent DVT. The DMC has clearly opined that the complications suffered by the complainant were not attributable to the drug Diane 35. The DMC held that Ms. Nemeezia Amin was treated as per accepted professional practices by Dr. Anuradha Kapur. There was no causal link between patient’s cerebral dissections with Diane 35.

To bring successful claim (complaint) in medical negligence case the victim or victim’s family bringing the action must prove the four D’s against the erring doctor/hospital. The 4 D’s of medical negligence stand for ‘Duty’, ‘Deviation’, ‘Direct Cause’ and ‘Damages’. In the instant case the Complainant failed to established any deviation of standard of practice from the OP-1 which was the direct cause of her complications. She suffered intracranial dissection / vasculitis which was not due to consumption of DIANE-35.

The Hon’ble Supreme Court laid down certain duties of the doctor.  In the cases of Dr. Laxman Balkrishna Joshi v Dr. Trimbak Bapu Godbole[(1996) 1 SCR 206] and A.S. Mittal vs. State of U.P[(1989) 3 SCC 223], it was observed that the doctor owes to his patient certain duties which are:

(a) a duty of care in deciding whether to undertake the case;

(b) a duty of care in deciding what treatment to give; and

(c) a duty of care in the administration of that treatment.

It further held that if a doctor adopted a practice that is considered “proper” by a reasonable body of medical professionals who are skilled in that particular field, he or she will not be held negligent only because something went wrong. Doctors must exercise an ordinary degree of skill.

In the instant case, the OP-1 followed the reasonable standards.

In my view, the complaint was filed on presumption and surmises. I would like to rely upon the decision of the Hon’ble Supreme Court in C.P. Sreekumar (Dr.), MS (Ortho) vs. S. Ramanujam[(2009) 7 SCC 130], wherein it was held that the Commission ought not to presume that the allegations in the complaint are inviolable truth even though they remained unsupported by any evidence.

Considering the entirety and based on the foregoing discussion, I conclude that the Complainant failed to prove ‘4 Ds’, the essential ingredients of medical negligence against the OP-1. There was neither failure of duty of care towards the patient nor any deficiency in the treatment by the OP-1. It was the reasonable standard of care and practice. The primary cause (causa causens) of arterial dissection was not due to the consumption of Diane-35. I do not find any merit in the instant complaint. Accordingly, the Complaint stands dismissed.

The Parties to bear their own costs.