NEW DELHI: US multinational Johnson & Johnson will have to compensate patients in India adversely affected by "faulty" hip replacement surgery using the company's implant with the health ministry asking the drug regulator to set up committees in states to receive complaints.

The central drug standard control organisation ( CDSCO ) will also set up by the end of the week a central expert committee comprising orthopedists, medical practitioners and legal experts, to monitor functioning of expert committees at the state level and determine the compensation.

The drugs controller general of India Dr S Eswara Reddy said usually life of an implant is 15 years and reimbursement and compensations will continue for any disability reported by at least 2015-17. The base amount recommended by a government committee is Rs 20 lakh but individually cases will be evaluated.

The committees proposed at state level will examine specific cases and make recommendations for the amount of compensation to be paid by J&J. The central panel will approve the compensation and also give a timeline by which the medical devices and consumer giant should pay the compensation.

According to the regulator, the company informed that the faulty implant was placed in around 4,700 patients in India but over 3,600 patients are yet to be traced. The regulator now plans to place advertisements in different dailies to identify such patients.

The health ministry’s move comes in the wake of recommendations of a report prepared by an expert committee it set up to investigate complaints about hip implant devices. The committee under former dean of Maulana Azad Medical College Dr Arun K Agarwal, suggested J&J be made liable to pay at least Rs 20 lakh to each affected patient, and the reimbursement should continue until August 2025.

The report, reviewed by TOI, says, "Considering all the facts and details…the Committee holds that the ASR hip implants manufactured by M/s. DePuy International Limited, UK were found to be faulty which resulted in higher instances of revision surgeries globally including India."

"This results in increased pain and decreases mobility affecting their family and social life, their ability to work, to undertake hobbies and leisure activities and often have a negative impact on their self-esteem and mental health," the report said.

It also noted that though the firm has taken some corrective measures by initiating reimbursement programs, the efforts were "not been found to be adequate". It also "has not paid compensation to any patients so far as per the available records."

"The Dr Agarwal committee has recommended a base amount of Rs 20 lakh for compensation but the actual amount of compensation will depend on the disability caused to the patient. The expert committees will determine that based on their examination of individual cases," Dr Reddy said.

In 2013, J&J agreed to pay an estimated $2.5 billion in compensation to around 8,000 US citizens who sued the company after implants that were recalled globally in August 2010. In November 2017, the federal jury in Dallas ordered Johnson and Johnson and its subsidiary DePuy Orthopaedics unit to pay $247 million to six patients. The jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks.

The allegedly faulty articular surface replacement (ASR) hip implant device known as DePuy ASR were manufactured by DePuy Orthopaedics.

