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Jagson Pal Pharmaceutical Ltd. v/s A. Selvan & Others

    First Appeal No. 288 of 2007

    Decided On, 28 July 2015

    At, National Consumer Disputes Redressal Commission NCDRC


    For the Appellant: Sindhu Mohan, Advocate. For the Respondents: R1, Died, R2 to R5, TVS Raghavendra Sreyas, R6, Veeranjaneyulu K.L.N.V., Advocates.

Judgment Text

This appeal has been filed by the appellant against the order dated 13.3.2007 passed by the Tamil Nadu State Consumer Disputes Redressal Commission, Chennai (in short, ‘the State Commission’) in OP No. 91/1997 – A. Selvan & Ors. Vs. Jagson Pal Pharmaceutical Ltd. by which, complaint was allowed.

2. Brief facts of the case are that complainant No. 1’s wife and complainant no. 2 to 5/Respondent no. 1 to 4 mother Dhanalakshmi consulted OP No. 1/Respondent No. 5 on 1.5.1996 for her fever. She also complained of pain in her knees. The first complainant (now deceased) went with the deceased to OP-1. OP-1 prescribed Indocap SR manufactured and marketed by OP-2 to relieve her of the pain in her knees. The next day was the general election day and most of the pharmacies in and around the complainants’ residence were closed. The medicines prescribed by OP -1 could be purchased only on 3.5.1996 from M/s. Sri Meena Medicals situated at No. 522, T.H. Road, Madras – 600 021. After dinner the deceased took one tablet of Indocap SR around 9 p.m. and retired for the night. The next morning on 4.5.1996 to the horror and anguish of the complainants, they found the face and the entire body of the deceased covered with rashes and blisters. Her face had swollen to such an extent that it was completely disfigured. She also complained of itching sensation all over her body. By then she was in considerable discomfort. The complainants immediately rushed her to the Government dispensary where OP-1 was working. OP-1 examined her and informed the complainants that Indocap SR capsule which the deceased had consumed under his instructions the previous night had created allergy. He advised the deceased not to take any further capsules and instead prescribed certain anti-allergic drugs. OP No. 1 administered an injection and assured the deceased and the complainants that the rashes, blisters and swelling would subside within a day or two. He also wanted the deceased to be brought to his clinic in the afternoon on that day. In the afternoon OP-1 administered an injection and assured the deceased that her condition would improve over the next two days. However, this did not happen and by 6.5.1996 her condition had not improved. The complainant got must apprehensive and rushed the deceased on 6.5.1996 to a private nursing home namely Ranga Nursing Home. A lady doctor by name Dr. Rajalakshmi examined the deceased. They opined that the problem was due to a reaction by the intake of Indocap SR capsule. The deceased underwent treatment in the said nursing home. Her condition, however, did not improve. The nursing home also did not have the necessary facilities to treat the deceased, who was by then in a highly critical state. She was shifted on 8.5.1996 to Nichani Nursing Home. Her condition by now was worse. Her mouth was ulcerated. She could hardly swallow. She could be fed only intravenously. She was for the most times in a delirious and incoherent state. She had acute pain and discomfort. From 8.5.1996 to 20.5.1996 she underwent treatment at Nichani Nursing Home. Her physical and mental pain during that period was extreme. OP-1 examined the deceased even at that stage. The complainants also called other specialists on 17.5.1996 to examine the deceased. However, the condition grew progressively worse and she finally succumbed due to the above complications on 20.5.1996 directly as a result of the negligence of OP-1 in not following the standard of care while administering the drug Indocap SR and in not treating her when complications set in a result of consuming the said drug. The report furnished at the time of her death also confirmed that the deceased had died directly as a result of the complications and reactions arising on account of the deceased having been administered the tablet 'Indocap SR'. It was further submitted that OP-1 was duty bound to warn the deceased against the risks involved in the intake of the drug Indocap SR. He ought to have given a test dose and only if it did not produce any adverse reaction he should have further instructed the deceased to take the drug. Even after finding out that her problem was due to her taking that drug, OP-1 did not follow the standard of care in effectively treating or hospitalizing the deceased, but assured them that the deceased would recover within a day or two. This was a clear act of negligence on the part of the first opposite party in not advising immediate hospitalization of the deceased. OP-2 as the manufacturer of the said drug failed in not warning the users of the said drug by printing in a prominent manner in the container/receptacle of the said capsules that the consumption of the said drug was likely to cause serious side effects thereby depriving the users of the drug of a choice of not taking a drug which had directly resulted in complications leading to the death of Dhanalakshmi. Alleging deficiency on the part of OPs, complainants filed complaint before State Commission. OP-1 resisted complaint and submitted that Medicine SR Indocap was prescribed to relieve the deceased of her knee pain. It is one of the time tested drugs and was prescribed to the patient suffering from Rheumatic Arthritis. OP-1 had been prescribing the said drug without any report of side effects and based on his experience after examining the deceased, he prescribed the above drug. On 4.5.1996 the deceased consulted him about itches and blisters. When it was found that she had developed allergy, anti-allergic drugs were prescribed and she advised not to take SR Indocap tablets. OP-1 took every precautionary step to prevent the spread of allergic symptoms instructing the deceased to stop taking SR Indocap capsule and then prescribing anti-allergic drugs and only one SR Indocap capsule was taken by the deceased. On 4.5.1996, the deceased was normal, comfortable and her health condition was within the parameters. After 4.5.1996 neither the deceased nor her relatives consulted him. It was further submitted that for prescribing medicine test dose is not administered. It was further submitted that complainants were negligent in not bringing deceased for treatment to OP-1 immediately when they noticed deterioration of health of deceased on 5.5.1996 and prayed for dismissal of complaint. OP-2 resisted complaint and submitted that Indocap SR is not a dangerous drug. It is a product from Indomethacin which had been used in the treatment of rheumatic disorders for almost three decades. It is sold only on a doctor’s prescription. Dosage and warning are printed in the capsule strip. Manufacture of pharmaceutical products is not possible without permission of the drug control authorities. Indocap SR has been manufactured and marketed by OP-2 for over 8 years and till the filing of the complaint no association or individual had made any complaint regarding the drug. There is no defect in the drug manufactured. All reasonable care and precaution has been taken by OP-2 as a pharmaceutical manufacturer before manufacturing and marketing their product. It was further submitted that OP-1 has not administered injection and two nursing homes have not been impleaded as party. It was further submitted that there was no specific allegation that drug manufactured by OP-2 has caused death. It is also not known whether drugs were taken by deceased as per prescription of OP-1 and prayed for dismissal of complaint. Learned State Commission after hearing both the parties allowed complaint and directed OP-1 to pay Rs.3,50,000/- and OP-2 to pay Rs.1,50,000/- to the complainants along with cost of Rs.5,000/- against which this appeal has been filed by OP-2.

3. Respondent No.1 died during proceedings.

4. Heard learned Counsel for the parties and perused record.

5. Learned Counsel for the appellant submitted that inspite of no evidence against appellant, learned State Commission has committed error in granting compensation to the complainants; hence, appeal be allowed and impugned order be set aside qua appellant. On the other hand, learned Counsel for Respondent No. 2 to 5 submitted that order passed by learned State Commission is in accordance with law; hence, appeal be dismissed. Learned Counsel for the Respondent No. 6 supported appellant and further apprised that under compulsion payment of Rs.3,50,000/- has already been made by Respondent No. 6 to Respondent No. 2 to 5 so no appeal has been filed.

6. It is not disputed that Respondent No. 6 has already made payment of compensation as awarded by State Commission and has not preferred any appeal.

7. The core question to be decided in this appeal is whether there was any deficiency on the part of appellant.

8. Learned State Commission while fastening liability on appellant observed as under 'that so far as OP-2 is concerned, there is justification in the stand of the complainants that they cannot contend that Indomethacin is not a dangerous drug and does not cause Steven Johson Syndome merely on the basis of what the first opposite party had stated. Medical literature furnished by the complainants clearly establishes that the second opposite has failed to warn the users of the drug, Indocap SR of the contra indications in a prominent manner on the container/receptacle of the said capsules. OP-2 is also liable to compensate the complainants'.

9. Learned Counsel for the appellant submitted that Indomethacin is not a dangerous drug and has drawn my attention towards the material published in Nonsteroidal Anti-Inflammatory Drugs (Systemic) in which it has been mentioned that Steven Johnson Syndrome is rarely caused by Indomethacin. There is no iota of evidence on record to substantiate that Indomethacin has caused Steven Johnson Syndrome to the deceased on account of which she died.

10. Learned State Commission observed that medical literature furnished by complainant clearly established that the second OP has failed to warn the users of the drugs in a prominent manner on the container / receptacle of the said capsules taken by the deceased. Learned Counsel for the appellant submitted

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that necessary warning as provided by the Drug Controller and under the Act are always mentioned on the container/receptacle/strip of capsules. State Commission has not observed in the order that at which place necessary warning was printed and at which place it should have been printed. Learned Counsel for the Respondent No. 2 to 5 also could not apprise under which law and under which direction of Drug Controller, necessary warning was to be printed on particular part of the container/receptacle/strip. In such circumstances, there was no occasion for learned State Commission to fasten liability on appellant on account of failure to warn users of the Drugs in a prominent manner on the container/receptacle/strip when OP No. 2 pleaded that dosage and warning were printed in the capsule strip and appeal is to be allowed. 11. Consequently, appeal filed by the appellant is allowed and impugned order dated 13.3.2007 passed by learned State Commission in OP No. 91/1997 – A. Selvan & Ors. Vs. Jagson Pal Pharmaceutical Ltd. is partly modified and order awarding compensation against appellant is set aside.