Benefits outweigh risks, rules the court

  • Posted on: November 07, 2016

It’s become almost fashionable to blame the doctor for patient’s reaction to a drug. He or she is the easiest catch – someone went wrong, who else but the doctor? However, doctors taking appropriate pre-treatment precautions before administering a new drug should not worry, as the following case demonstrates.

Neerja was a diagnosed case of Polyarthralgia and was taking treatment for same for more than two years. She approached Dr. Karlapudi, an orthopaedic surgeon, who prescribed her one month’s dose of a new drug Arava (generic name Leflunomide). The patient reacted adversely to the drug and consulted the surgeon, who in turn advised her to visit a GP. Her consulting GP advised hospitalization for treatment of acute gastroenteritis, the drug’s reaction. Neerja did as told and was hospitaliized for 6 days, but it seemed that fate was catching up with her. She had to be hospitalized again just a few days after being discharged earlier, and she fought hard for twenty-two days before succumbing to Leflunomide Induced Toxic Epidermal Necrolysis (TEN).

Naresh, the patient’s inconsolable husband, wanted to make Dr. Karlapudi pay dearly for his loss. He approached the National Consumer Disputes Redressal Commission praying for justice and compensation while making sharp allegations against the doctor. He alleged that the doctor was not authorized to prescribe Arava and moreover, it was prescribed without diagnosis and proper tests. He further alleged that the doctor neither explained about the drug’s side effects nor took an informed consent from them. Naresh blamed the doctor for failing to administer an antidote to mitigate his wife’s reaction to the drug, and pointed out that instead of referring to a specialist the doctor casually advised them to consult a GP. The doctor should have known that Arava is used to treat Rheumatoid Arthritis and not Polyarthralgia, pointed out Naresh while complaining that Neerja would’ve been with him had the doctor referred her to a Rheumatologist.

Don’t play doctor, Dr. Karlapudi would have thought upon hearing Naresh’s ignorant-to-fact accusations. It was pointed out by the doctor that Neerja was diagnosed with Rheumatoid Arthritis, which is a type of Polyarthralgia, and ample precautions were taken before prescribing Arava – relevant blood tests were conducted and platelet count was taken, but more importantly, Arava was prescribed only after trying initial DMARD (Disease Modifying Anti Rheumatic Drugs). The patient was counselled, Arava was prescribed along with supportive treatment and physiotherapy was advised to avoid joint stiffness, added the doctor. Neerja’s reaction to the drug started after a month, was asked to discontinue them immediately and advised her to consult a GP. Making this concluding statement, Dr. Karlapudi hoped that both, Naresh and the law, saw merit in his defence. He also submitted a membership certificate from Indian Orthopaedic Rheumatology Association (IORA) to further strengthen his credentials.

The Commission, for one, did see weight in the doctor’s stance. It was observed that Neerja was diagnosed case of Polyarthralgia and had admitted to losing her past medical records. It was also observed from medical records that the doctor had indeed conducted tests and taken precautions before prescribing Arava. The patient failed to stop the drug on time as advised, noted the State Commission.

The doctor’s certificate was weighed in by the State Commission and following article from IORA was quoted before ruling the doctor innocent of any medical negligence:

“The arthritis advisory committee to the 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 outweighed any risks. Therefore, in the patient that rheumatoid arthritis, early intervention with DMARD is required to minimize joint damage and retard disease progression”.

While Naresh may have been unable to see beyond his loss and accept the ruling, it was eventually proven that Neerja died not due to doctor’s shortcomings, but because of an unexpected and unfortunate consequence of taking Arava.