FDA approves compensation of Rs.25 lakh each to 48 patients

Maharashtra FDA approves compensation of Rs.25 lakh each to 48 patients who affected by J&J faulty hip implant

Food and Drugs Administration FDA Maharashtra
FDA Maharashtra

Last Updated on January 20, 2024 by The Health Master

Maharashtra FDA approves compensation of Rs.25 lakh each to 48 patients who affected by J&J faulty hip implant

The Maharashtra Food and Drug Administration (FDA)’s state level committee on Johnson & Johnson’s (J&J’s) faulty hip implant compensation cases has recently approved Rs.25 lakh each to the 48 affected patients from Mumbai.

This comes close on the heels of Centre’s directive to expedite compensation related cases of J&J faulty hip implants.

Also read: J&J faces criminal charges in faulty hip implants case

On 29 November, 2018, Centre had approved a formula devised by the Arya committee on the quantum of compensation based on the percentage of disability, age factor and risk factor. T

he compensation, however, is between the range of Rs.30 lakh and Rs.1.2 crore.

Out of total 68 applications received by the Maharashtra FDA committee in 2019, 57 were related to J&J faulty metal-on-metal ASR XL Acetabular Hip Replacement System (ASR) in India.

Also read: New tests show no asbestos in Johnson’s Baby Powder: J&J

Maharashtra FDA state level committee is currently scrutinizing 8 applications received in the subject matter.

The scrutinized applications will then be forwarded to the Central Government for recommendations and action.

Around 4,700 hip replacement surgeries were carried out in India between 2004 and 2010.

However, only 1,080 affected patients could be traced through the dedicated helpline set up to trace these patients.

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In 2017, Central Drug Standards Control Organisation (CDSCO) had formed a panel headed by Dr. Arun Agarwal, former dean of Maulana Azad Medical College, which suggested compensation for each patient.

Viewing that revision surgeries were necessitated due to the faulty ASR implants, the committee had recommended that J&J be made liable to pay adequate compensation commensurate with severity of the pain, the resultant disability, sufferings (both mental and physical) and with loss of wages of each patient who received faulty ASR hip implant.

The Maharashtra FDA’s action comes at a time when the Delhi High Court (HC) asked J&J to pay Rs.25 lakh each to the affected patients identified in Uttar Pradesh and Maharashtra.

The CDSCO had in April last year asked the company to pay Rs.65 lakh, Rs.74 lakh, Rs.1 crore, and Rs.90 lakh, respectively to four patients.

Hearing a plea moved by J&J challenging CDSCO orders to pay the said compensation to these patients, a single-judge Bench of Justice Vibhu Bakhru said the company must pay these four patients the money before the next date of hearing on May 29, 2019.

During the last hearing on April 8, J&J said it was willing to pay Rs.25 lakh as compensation to those affected, but could not agree to the arbitrary amounts being imposed by the government.

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However, during the hearing on May 2, 2019, J&J said the Rs.25 lakh compensation it was willing to give would be applicable only to those patients who had undergone ‘revision surgery’, and not others.

In its plea before the HC, J&J has also challenged union health ministry statement in which it had asked the company to pay compensation to nearly 4,000 victims of the faulty ASR hip implants.

The statement issued by the health ministry was based on the recommendations of two committees formed under the chairmanship of Arun Kumar Agarwal and R K Arya.

While the Arya Committee had determined the quantum of compensation to be given to the victims, the Agarwal Committee had examined the various issues related to faulty hip implants.