Allegations against Doctor for wrong use of Schedule H drug turned down by Court
In the judgment dated 29/01/2016, in the case of Y. NARESH & ANR V/s. DR. VASU KARLAPUDI, FIRST APPEAL NO. 673 OF 2015, the National Commission rejected the appeal of the Compliant !
The Factual matrix in nutshell !!
Ms.Neeraja, 40, the (since deceased) the mother of the complainant was suffering from knee pains!! The opponent Doctor diagnosed her case as a Polyarthralgia, & he prescribed a new drug ‘Arava’, its generic name is ‘Leflunomide’. After taking the medicine for 1 month, the patient developed skin allergy and diarrhoea and ultimately she succumbed to death in another hospital and the cause of death was she suffering from Leflunomide Induced Toxic Epidermal Necrolysis (TEN). Therefore the Complaint of Negligence was filed against Doctors including Drug Manufacturers!!
Allegations against Doctor for wrong use of Schedule H drug turned down by Court
The national commission held that:
After perusing the medical record and after listening to arguments, 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. The drug ARAVA was prescribed after various tests like Hb, TC, DC, ESR, SGOT, SGPT, Platelet count & after trying initial DMARD’s (Disease Modifying Anti Rheumatic Drugs)!!
Allegations against Doctor for wrong use of Schedule H drug turned down by Court
The Arava drug is manufactured by Avantis Pharma Ltd, which is a Schedule H Drug and it had a 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.” After gastroenteritis, the Doctor informed the complainant to stop patient’s all the drugs, including Arava and take her to nearby physician but complainant failed to do so. It was also observed by the commission that the Doctor is a qualified orthopedician, who attended and actively participated in several Indian Orthopaedic Rheumatology Association (IORA) conferences in the Country. The rheumatology is also one of the specialties included under orthopaedics. The commission observed that the Doctor is competent to treat patient with Rheumatoid arthritis after relying upon the Article “Rheumatoid Arthritis Drug Not Withdrawn Despite Safety Concerns” which stated that the benefits of Arava (generic name: leflunomide) outweighed any risks.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 joint damage and retard disease progression (which the Doctor did)
Allegations against Doctor for wrong use of Schedule H drug turned down by Court
An article by Adv. Rohit Erande,Pune
