Health Ministry Reconstitutes Expert Panel for J&J ASR Hip Implant Compensation
New Delhi: The Ministry of Health and Family Welfare has reconstituted its Central Expert Committee to address compensation issues concerning faulty ASR hip implants manufactured by DePuy International Ltd., now a part of Johnson & Johnson Pvt. Ltd.
The newly constituted committee will be led by Dr. Ajay Kumar Shukla, , Professor of Orthopaedics, RML Hospital (New Delhi) to determine the quantum of compensation as admissible and medical management for the affected patients who were implanted with faulty ASR Hip implant.
In 2005, Johnson & Johnson received FDA approval for its metal-on-metal Articular Surface Replacement (ASR) hip implant devices, namely the XL Acetabular Hip System and Hip Resurfacing System. However, in 2010, the company issued a global recall of these devices due to widespread patient complaints of post-surgery pain, metal ion leaching, and infections.
Recognizing the potential impact on Indian patients, the Indian Health Ministry formed an 11-member expert committee in 2017 to investigate the matter. Nearly 4,700 patients in India had received these implants.
In February 2018, the committee concluded that J&J was responsible for the defects in the implants. Subsequently, on November 29, 2018, a central expert committee under the health ministry approved a compensation scheme. The compensation amount, ranging from Rs 30 lakh to Rs 1.23 crore, was determined based on factors such as age and disability level.
All states were directed to establish state-level committees to identify eligible patients, verify their claims, and determine the appropriate compensation based on the approved formula.
Also Read: JnJ Faulty Hip Implants: One more Expert panel formed to determine compensation to patients
Recently, the drugs regulator in its latest notification has asked the 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.
“In case the affected patients intend to approach State Level Committee, they may write to concerned State / UT Drugs Controllers, who will be the Member Secretary of State Level Committee,” the notice added.
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.
