December 26, 2018:
On Wednesday, in a move that may delay compensation to patients impacted by faulty hip implants from Johnson & Johnson, the Govt. has asked the central expert committee on compensation to consider representations from all stakeholders.
The move has been triggered by complaints from patients as well the company about lack of consultation while fixing the compensation, officials said. Now the committee is expected to hold separate consultations with all the parties before taking a final view on the compensation.
The official said, “The health ministry has asked the committee headed home Dr R K Arya to hold meetings with patients as well as J&J and hear their views. If required, the committee may revise the formula which was fixed earlier.”
The compensation formula which was earlier approved by the health ministry in November uses a combination of the patient’s age, level of disability due to the implant, and a base compensation of ₹20 lakh.
The range of compensation hence fixed varied from ₹30 lakh to ₹1.23 crore to each patient who has suffered adverse reactions because of faulty implant from the company.
While around 250 patients had come forward to different state expert committees and the central committee seeking compensation, many had opposed the formula raising issues like there is no compensation for those who have died, or for those who have not undergone revision surgery following the implant.
The patient group had written to health minister J P Nadda, saying they could not accept the formula that had been devised without consulting them.
“Any process relying on this formula will not be able to deliver just and fair compensation to patients and their families, defeating the purpose of the exercise,” patients said in the letter.
On the other hand, the company had approached the Delhi High Court earlier this month challenging the government’s orders, asking it to pay compensation.
While seeking clarity about provision of drug law used to fix compensation, it said the process followed by the government lacked transparency and that the company was not given a chance to present it’s views before the expert committee.
Meanwhile, the health ministry has also filed an affidavit in the SC, seeking its intervention in the matter.
J&J had initiated a global recall of its ASR hip implant in 2010. The company had initially stopped its reimbursement programme for affected patients in August 2017.
However, following an investigation in India, the regulator in Sep directed the multinational company to extend its medical management programme along with reimbursement of medical costs till 2025 as the average life of the orthopaedic implant is 15 years.
In the US, J&J had agreed to pay $2.5 billion to 8,000 patients in 2013 for faulty implants.
Following complaints from patients in India, the health ministry had constituted an expert committee under Dr Arun Kumar Agarwal, former dean of Maulana Azad Medical College to examine the issues relating to faulty ASR hip implants.