The Union Health Ministry on Wednesday directed Johnson and Johnson to comply with all the recommendations of an expert panel, constituted earlier to probe complaints about "faulty" ASR hip implant devices, saying it is the responsibility of the firm to compensate all the patients.
In an order communicated to the pharma giant, the ministry has said the company be made "liable" to pay adequate compensation commensurate with severity of pain, the resultant disability sufferings (both mental and physical) and with the loss of wages of each of the patients who had received articular surface replacement (ASR).
The ministry has also asked Johnson and Johnson to trace the remaining patients who received ASR but have not registered with the helpline, while also directing it to extend the ASR reimbursement program which was being run by the firm till 2025.
The panel, in its report, has said the pharma giant "suppressed" facts on the harm of surgeries which was conducted on patients in India using "faulty" hip replacement systems. It had also suggested that the firm pay compensation of around Rs 20 lakh to the affected patients.
Some of the patients who had suffered due to faulty implants had questioned the panel's recommendation of the paltry amount, saying it was like "rubbing salt on the wounds".
"You are hereby directed to comply with all the recommendations of the committee specifically the following... to extend the ASR reimbursement program as mentioned in the report which was being run by the firm till the year 2025.
"The firm has to give due diligence to trace those remaining patients who have received ASR but have not registered with helpline. Sincere efforts should be done by the firm to trace all the patients who have received the ASR and collect data related to their health status with reference to hip joint," the order said.
It said the panel has also recommended performing health assessment of patients for the laboratory tests specified in this report, at least once in a year based on the advice of the clinician till 2025.
It also directed the firm to spread patient awareness by way of advertisements in leading newspapers periodically to reach to all patients implanted with ASR Medical management by the firm.
The ministry, in its order, also directed the firm to provide medical management to all affected patients with symptoms in the manner as specified in the report. Apart from this, it said the firm should from time to time also issue a suitable advisory for medical professionals up to the year 2025.
"The advisory shall provide recommendations to orthopedic surgeons for patient's management including regular follow-up.
"It is the responsibility of the firm to compensate all patients. The firm be made liable to pay adequate compensation commensurate with severity of the pain, the resultant disability sufferings (both mental & physical) and with the loss of wages of each of the patients who had received ASR," the order added.
The quantum of compensation would be determined according to the procedure approved by the Union Health Ministry, it said, adding updates of compliance on the recommendations of the panel should be submitted to the office on a regular basis for further necessary action.
The order said the ministry had constituted a high-powered expert committee to examine issues related to the faulty ASR hip implants manufactured by DePuy International Limited, UK (now M/s Johnson & Johnson Pvt Ltd) and the committee has submitted its report.
The ministry, in the order, said the committee has observed that on account of its poor performance, essentiality to the defect in the design, has led to its high wear and tear while causing damage to the human body, necessitating requirement of revision of surgery on a rate higher than similar equivalent implants.
"The patients had suffered similar and in some case identical injuries as a result of the hip implants caused by the same injury causing process.
"The patients have suffered a physical injury, bodily impairment, conscious pain and suffering, high level of toxic metal, high metal ion levels in the blood stream, loss of enjoyment of life, lack of mobility, metal sensitivity, loosening of the prosthesis, infection, dislocation, bone fracture and a medical need and necessity for a surgical revision consisting of removing the implanted device of the firm and replacing it with a non-defective implant," the ministry said in the order.
The ministry had constituted a five-member expert committee to determine the quantum of compensation to be given to patients who have "faulty" hip implants. It has also asked states and union territories to constitute separate panels so that they can receive such complaints from affected patients.
In a letter sent earlier, the ministry has also asked the states and Union Territories to bring out advertisements in newspapers so that the affected patients can approach the state-level committee or the state drug controller concerned.