New Delhi: Representatives of American medical devices maker Johnson and Johnson (J&J) Pvt. Ltd will attend a meeting of the central expert committee that devised the compensation formula for patients affected by its faulty hip implants this week.
“We have confirmed our intention to attend the meeting of the central expert committee on 9 January," said J&J’s medical spokesperson. The government asked the central expert committee to hold further consultations with those who received the faulty J&J metal-on-metal acetabular surface replacement (ASR) hip implants and were unhappy with the current compensation formula. Subsequently, India’s drug regulator, Central Drugs Standard Control Organization, invited aggrieved stakeholders to the meeting through a notice on its website on 28 December.
According to two people aware of the matter, 14 patients have confirmed their participation. “The formula may be reworked, if the committee deems fit," said the first person cited above.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients have been traced through a helpline.
J&J blamed the government for alleged lack of transparency and failure to grant the company a hearing before the expert committee, in a plea to the Delhi high court in December. “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.
The government’s move to hold consultations is significant because a group of 70 patients fitted with the faulty implants had also rejected the compensation formula. These patients wrote to health minister J.P. Nadda on 6 December saying they could not accept a formula 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.
As per the formula approved by the health ministry on 29 November, compensation will range from ₹ 33 lakh to a maximum of ₹ 1.2 crore, based on disability, age and risk factor.
J&J has been criticized for failing to pay any compensation in India, although it has agreed to pay hefty damages of $2.5 billion to around 8,000 US citizens, who sued the company after receiving faulty hip implants.
The 9 January meeting will also see the participation of Vijay Vojhala, who has been at the forefront of the fight against the company and represents the patients’ group, and Malini Aisola co-convenor of All India Drugs Action Network (AIDAN).