If the faulty device had not been found, then
the entire blame would have gone to the doctors
Dr KK Aggarwal
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.
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.
All doctors should report any malfunction of
any device or disposable in the interest of the profession.
Dr KK Aggarwal
Padma Shri
Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group
Editor-in-Chief IJCP Publications
President Heart
Care Foundation of India
Past National President
IMA
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