DOCTORS SHOULD REPORT MALFUNCTIONING OF IMPLANT TO DRUG REGULATOR TO PROTECT LITIGATION AS J & J FINED 74.5 LACS
DOCTORS SHOULD REPORT MALFUNCTIONING OF IMPLANT TO DRUG REGULATOR TO PROTECT LITIGATION AS J & J FINED 74.5 LACS
All doctors should report any malfunction of any device or disposable in the interest of the profession otherwise all it's implication will come on treating Doctors.
J&J’s Articular Surface Replacement (ASR) hip implant had failed in certain patients, allegedly leading to leaching of metals in the patients’ blood, causing the hip joint to deteriorate. In 2010, the company had announced a voluntary recall of 93,000 ASR hip implant systems across the world, saying 12% of them had failed over five years.
The company has announced plans to pay at least $2.47 billion, and has since settled many lawsuits while others remain stuck in litigation at various levels. Of the over 4,000 patients fitted with the ASR implant in India, just about 844 have been traced by the company till date.
We all need to inform the patients about the possibility of device failure or malfunction so that the fault does not come on the doctors, in case this happens as it did in this case.
And, in this case if the fault had not been traced to the implant itself, then consumer complaints would have been filed against doctors for medical negligence.
The Central drug regulator, DCGI, has instructed Johnson and Johnson (J&J) to pay a compensation of over Rs 74.5 lakh to the first patient from Maharashtra affected by the company’s faulty hip implants.
The State-level committee, headed by Dr RK Arya Director Sports Injury Centre at Safdarjung hospital looked into the patient’s issue and forwarded its recommendation to the central expert committee along with various documents including the disability certificate issued by a medical authority in Mumbai. The compensation amount was arrived at by a committee through a formula that was devised to calculate the expenses in each patient’s case.
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