New Delhi: In a significant move the government on Monday decided to hold consultations with various stakeholders unsatisfied with the government-approved formula devised to compensate patients with the metal-on-metal Acetabular Surface Replacement (ASR) hip implants. Even as the health ministry is in process to file an additional affidavit in the Supreme Court, asking the court to direct J&J to compensate trouble-stricken patients.
The health ministry on Monday asked the central expert committee to hold meetings where all stakeholders including patients and even J&J can make representations, participate, and share their opinion, a senior ministry official confirmed.
The company had approached the Delhi high court earlier this month challenging the government’s orders, asking it to pay compensation. The company blamed the government for lack of transparency and that they were not given a chance before the expert committee. “We have not been given an opportunity to appear before the Central Expert Committee and critical gaps and factual inaccuracies have been allowed to stand uncontested. The formula for compensation needs to be within a fully transparent and legal framework arrived at through due process, and only after proper hearing of the facts and positions of all parties. The outcome also needs to be within a legal framework which is applicable across the industry," the company had said in a statement.
Nevertheless, a group of patients fitted with faulty hip implants also rejected the compensation formula. 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," said the letter dated 6 December.
The health ministry therefore decided to hold consultations with those unsatisfied with the formula. “It’s not an open and shut case. Those unsatisfied including the company can give representations and let the expert committee decide what it deems fit," added another senior official.
The committee has been asked to meet forthrightly where stakeholders can give suggestions regarding the formula.
Meanwhile, the health ministry has also sent the additional affidavit to be filed in the court for vetting. “We shall be filing an affidavit in the Supreme Court and that has been sent for vetting to the solicitor general," added the second official cited above.
On November 29, the health ministry approved a formula by which Indian patients suffering from ASR hip implants sold by J&J will get up to ₹ 1.2 crore each, and an additional ₹ 10 lakh, for “non pecuniary" losses.
According to the formula, the experts have recommended a minimum compensation in case of a disability at ₹ 33 lakh to a maximum of ₹ 1.2 crore. The formula is based on the percentage of disability, age factor and risk factor. For example, in case the disability is on the higher scale (50%) and the person underwent the hip surgery at a young age of 20, the quantum of compensation will be over ₹ 1.2 crore. However, if a person underwent a surgery when he/she was 60 years or older, and the disability was measured at 20-30%, they will be entitled to get a minimum of ₹ 33 lakh.
The experts recommended the use of the Indian Disability Evaluation and Assessment Scale for the assessment and certification of disability.
J&J has been criticized for failing to pay any compensation in India, although it had agreed to pay hefty damages of $2.5 billion to around 8,000 US citizens, who sued the company after receiving faulty hip implants.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline.