National Consumer Disputes Redressal
Y. Naresh & Anr. vs Dr. Vasu Karlapudi on 29 January, 2016
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL NO. 673 OF 2015 (Against the Order dated 28/10/2014 in Complaint No. 66/2010 of the State Commission Andhra Pradesh) 1. Y. NARESH & ANR. SON OF SRI Y. MRUTHYUNJAL, R/O. FLAT NO. 105, UMA ENCLAVE, ROAD NO. 4, KAKATIYANAGAR, NEW ASHOK NAGAR, RAMACHNASRAPURAM, HYDERABAD-500032 TELANGANA 2. DR. Y. MRUNALINI (BPT) WIFE OF SRI N. PRAMOD GOUD, R/O. FLAT NO. 303, LAKSHM DURGA ESTATES, LANE IPP, VIJETHA SUPRE MARKET, MADINAGUDA, HYDERABAD-500050 TELANGANA STATE ...........Appellant(s) Versus 1. DR. VASU KARLAPUDI M.S. (ORTHO.), PROP.: M/S. PUJITHA HOSPITAL, NTR CIRCLE, BESIDE SWEET MAGIC, OPPOSITE DONKA ROAD, PATAMATA, VIJAYWADA-520010 ANDHRA PRADESH ...........Respondent(s)
BEFORE: HON'BLE MR. JUSTICE J.M. MALIK, PRESIDING MEMBER HON'BLE DR. S.M. KANTIKAR, MEMBER For the Appellant : Mr. Sanjeev Kumar Sharma, Advocate For the Respondent : Mr. D. Bharat Kumar, Advocate Dated : 29 Jan 2016 ORDER ORDER DR. S.M. KANTIKAR, MEMBER
1. The patient, Ms. Neerja, about 40 years was suffering from knee joint pain from 2005-07. She approached Pujitha Hospital with her husband, Mr. Y. Naresh and consulted Dr. Vasu Karlapudi, an Orthopedic Surgeon. In August 2007, the OP diagnosed her as a case of Polyarthralgia , he prescribed a new drug 'Arava', its generic name is 'Leflunomide' in the dose, 20 mg. He also advised few blood tests and physiotherapy. The complainant used this drug from 04-09-2007, for a period of one month. Then,she developed skin allergy and diarrhea. It was informed to OP, who assured, 'nothing serious', but advised to contact general physician. Therefore, the patient contacted physician Dr. B. Guruprasad of Global Hospital, Vijaywada, on 16.10.2007. Thereafter, she was admitted in Jagdamba Hospital at Gandhinagar from 19.10.2007 to 25.10.2007. Again, she consulted Dr. A.N. Roy, on 30-10-2007, who advised immediate hospitalization, as the patient suffered serious reaction like skin allergy, diarrhea and health complications due to consumption of 'Arava'. Further, she suffered abdominal pain, fatigue and peeling of the skin. She was hospitalized in Yashododha Hospital, Hyderabad, on 30.10.2007, but despite all efforts, she died on 21-11-2007 in Yashoda Hospital. The death summary revealed that, she was suffering from Leflunomide Induced Toxic Epidermal Necrolysis (TEN), Therefore, the complainant filed a complaint before the Andhra Pradesh State Consumer Disputes Redressal Commission at Hyderabad, against the OP and 15 others, including manufacturing unit and marketing division of the drug Arava. Another complaint also was filed before the Additional Chief Metropolitan Magistrate.
2. The State Commission held the OP negligent to some extent and passed the following order:
"The only negligence on the part of the opposite party found is in referring the patient to a Physician without examining her in person and advising the first complainant to take the patient to a Rheumatologist while the patient was under the treatment of other doctors in Jagadamba hospital, Hyderabad. All these mitigating factors are considered in assessing the compensation payable by the opposite party and accordingly this Commission is inclined to award an amount of Rs.1,00,000/- with interest @9% per annum thereon."
3. Aggrieved by the order of the State Commission, the appellants (the complainant and the daughter of the deceased) filed this appeal for enhanced compensation.
4. We have heard the learned counsel for the parties. The counsel for complainant, Mr. Sanjiv Kumar Sharma, vehemently argued that, the OP was not authorized to prescribe Arava, he treated patient negligently, the drug was prescribed without proper standards, without diagnosis and proper tests. The OP failed to take informed consent of the patient prior to prescribing the said drug which had side effects. The same is evident from the expert committee reply to the interrogatories. The counsel further submitted that despite repeated intimation of drug reaction, the OP did not bother to treat the patient with proper antidote. OP failed to refer the patient to specialist centre, but casually advised to contact general physician. Thus, it was professional misconduct as per the Indian Medical Counsel (Professional) Conduct, Etiquette and Ethics) Regulations 2002. The drug Arava was negligently prescribed for Polyarthralgia, but, it is used for treatment of Rheumatoid Arthritis. At initial stage only, the OP should have referred the patient to Rheumatologist, for proper treatment. Therefore, the complainants deserve for higher compensation.
5. We have perused the medical record filed along with the first appeal, the expert's reply to the interrogatories and relevant medical literature. It is an admitted fact that, the patient was diagnosed to be a 'Polyarthralgia' case, who was under regular treatment for more than two years, since 2005. On 25-08-2007, the OP advised blood test likes HB, TC, DC, ESR, SGOT, SGPT, Platelet Count and thereafter he planned to start her on Arava. The Arava drug is manufactured by Avantis Pharma Ltd. The complainant filed the literature extract, which clearly mentioned about the warning that;
"Schedule H Drug: Warning: To be sold by retail on the prescription of a Rheumatologist only. Caution: It is dangerous to take this preparation except under medical supervision."
6. The counsel for OP submitted that, after one month of treatment, the patient suffered acute gastroenteritis, it was alleged to be due to drug reaction. She was treated at Jagdamba Hospital and managed conservatively. The OP diagnosed the case as Polyarticular Rheumatoid Arthritis which is one of the types of Polyarthralgia. As the patient was under treatment for more than two years, admittedly, patient misplaced old record. Over a period of two years, the OP prescribed Arava only after trying initial DMARD's (Disease Modifying Anti Rheumatic Drugs). Before starting the drug, the opposite party counselled the patient and the first complainant and only after making her to promise to visit regularly, every month, the opposite party prescribed the drug along with supportive treatment, i.e., Analgesic and P.P.I.'s (antacid) and physiotherapy, then started with the loading dose of 100 mg for three days. Also counseling was done with regard to beneficial effect and contra-indications by the representatives of the manufacturer of the drug. The patient was advised physiotherapy in order to avoid progress of joint stiffness.
7. We have gone through several medical literatures on Rheumatology regarding treatment of Polyarthralgia. We have perused the prescription dated 25-08-2007, the OP clearly mentioned that the patient was suffering from 'Polyarthralgia' and she lost her medical record. OP planned to start her with medicine 'Leflunomide' and it is further mentioned in the prescription dated 25-08-2007, that 'Arava' has to be used after administration of loading dose. Before medication, OP advised the patient to undergo various tests such as Hb, TC, DC, ESR, SGOT, SGPT, Platelet count as also he advised for physiotherapy. As seen from the cash receipt dated 27-08-2007, the patient purchased Pronax, Razo and Rejoint-RA from Sri Sai Medical & Fancy Stores, Vijaywada. After gastroenteritis, the OP informed the complainant to stop patient's all the drugs, including Arava and take her to nearby physician but complainant failed to do so.
8. As per death summary of patient issued by Yashoda Hospital, the patient was diagnosed as TEN, Rheumatoid Arthritis, Hypothyroidism and UTI. There, she was administered with antihistamines, IV steroids, antibiotics, antispasmodics, anti-diarrheal, IV fluids and antipyretics. Also, for the purpose of removal of Leflunomoide from her body, the patient was administered with Activated Charcoal.
9. We have perused the supportive documents submitted by the counsel for OP regarding the practice of prescribing DMARDs by the orthopedic surgeon. He produced a certificate from Indian Orthopaedic Rheumatology Association (IORA) which is reproduced as below:
"CERTIFICATE This is to certify that Dr. Vasu Karlapudi M.S. (Ortho), Consultant Orthopaedic Surgeon is a life member of Indian Orthopaedic Rheumatology Association (I.O.R.A.) and actively participates in all I.O.R.A annual conferences and Continuing Medical Education (C.M.E.) programmes and gets abreast of the recent developments in Rheumatology nationally and internationally which is one of the aim of our association.
He is professionally competent and experienced to treat all Rheumatology cases, related with joint problems and prescribe DMARDs (Disease Modifying Anti Rheumatic Drugs) such as Leflunomide, Methotrexate, Hyroxychloroquine, Sulfasalazine, etc. as Rheumatoid Arthritis (Rheumatology) is a part of Orthopaedics dealing with diseases of joints and its manifestations.
Dr. Manish Khanna Secretary General"
10. In the instant case, the OP is a qualified orthopedician, who attended and actively participated in several IORA conferences in the Country. The rheumatology is also one of the specialties included under orthopedics. The article "Rheumatoid Arthritis Drug Not Withdrawn Despite Safety Concerns" reads:
"The arthritis Advisory Committee to the Food and Drug Administration (FDA) recently rejected a petition to remove a rheumatoid arthritis drug from the market due to severe liver toxicity. The committee decided that the benefits of Arava (generic name: leflunomide) outweighed any risks. Therefore, in the patient that Rheumatoid arthritis (RA), early intervention with disease-modifying antirheumatic drugs (DMARDs) is required to minimize joing damage and retard disease progression (1). Therefore, on the basis of forgoing discussions, we do not find any negligence upon the OP who treated the patient with drug Arava. He is competent to treat patient with Rheumatoid arthritis.
11. On the basis of forgoing discussion, we do not find any merit in this first appeal. Also, there is inordinate and unexplainable delay of 250 days' in filing this appeal. Therefore, this first appeal is hereby dismissed, on merit as well as on delay.
......................J J.M. MALIK PRESIDING MEMBER ...................... DR. S.M. KANTIKAR MEMBER