Central expert panel to look into J&J implant compensations

The Drugs Controller General of India (DCGI), Rajiv Singh Raghuvanshi, on Monday issued a formal notice conveying the reconstitution of the committee.

The Union ministry of health and family welfare has reconstituted the central committee of experts to look into applications from Indians eligible for compensation from Johnson & Johnson for faulty hip implants, according to people familiar with the matter.

All states were asked to form a state-level committee, to track and verify eligible patients. (File photo.)

The Drugs Controller General of India (DCGI), Rajiv Singh Raghuvanshi, on Monday issued a formal notice conveying the reconstitution of the committee.

“The ministry of health and family welfare, government of India,… has reconstituted a Central Expert Committee to examine issues related to the faulty ASR hip Implants manufactured by M/S DePuy International Ltd., UK, (now M/S Johnson & Johnson Private Limited) and imported by M/S DePuy Medical Private Limited…,” read the DCGI’s notice.

Dr Ajay Kumar Shukla, medical superintendent, Ram Manohar Lohia Hospital, and a professor in orthopaedics, will head the committee that will “determine the quantum of compensation as admissible and medical management for the affected patients...,” added the drugs regulator’s notice.

In 2005, the US Food and Drug Administration (FDA) cleared for use Johnson & Johnson’s metal-on-metal Articular Surface Replacement (ASR) hip implant devices- XL Acetabular Hip System and Hip Resurfacing System. In 2010, the company globally recalled this hip implant device after patients complained of pain post surgery associated with metal leaching, infections etc. In 2017, India’s health ministry formed a 11-member expert committee to look into the matter as nearly 4,700 patients received these implants in India.

In February 2018, the final committee report that was submitted to the government held J&J guilty. On November 29, 2018, a central expert committee under the health ministry approved compensation of between ₹30 lakh and 1.23 crore, based on a specific formula based on age and the level of disability of the person, with younger people with higher disability getting the maximum compensation.

All states were asked to form a state-level committee, to track and verify eligible patients, and decide the compensation based on the formula.

In the latest order, the drugs regulator asks patients who were implanted faulty ASR and have suffered disability and other losses to approach either the central expert committee or state level expert committees.

“In case the affected patients want to intend to approach the central expert committee, they may write an email or send the hard copy by post/by hand to legal cell, CDSCO (HQ), FDA Bhavwan, Kotla Road, New Delhi- 110002, email id: legalcell@cdsco.nic.in …,” read the notice.

Those affected patients who have already filed an application for claim under the supervision of the previous central expert committee need not submit a fresh application.

“We have to reconstitute this committee after a particular period because there still may be affected patients left who are eligible for compensation but not applied because they aren’t aware. The process has to continue till each one of them is identified. The earlier committee became defunct because some of the members retired...,” said a senior health ministry official requesting anonymity.