Johnson and Johnson faulty hip implant victims on Monday questioned the credibility of a panel formed by the Centre to determine the compensation amount for them, and alleged the entire process lacked transparency and followed no proper guidelines.
In a letter written to Union Health Minister J P Nadda, a group over 30 victims also opposed the involvement of the multi-national company in the process and threatened to boycott the entire exercise if their concerns are not addressed.
The government had constituted the five-member Central Expert Committee to determine the quantum of compensation to be given to patients who received "faulty" hip implants, manufactured by DePuy International, a subsidiary of Johnson and Johnson.
They patients questioned the credibility of the panel.
They said they are distressed to see the government continuing its consultation with the J&J while the patients who suffered grievous injuries "have not been consulted even a single time".
"Given the lack of transparency and any guidelines, there are grave concerns about whether the committee will be fair, just, equitable and reasonable in determining compensation.
"A committee operating without guidelines, framed through a consultative process...lacks credibility and effectiveness," they said in the letter.
The patients said their apprehensions are compounded by issues such as the lack of clarity on which cases will be considered appropriate for compensation and the documents required by patients to make their claims.
They also expressed concerns over the manner in which compensation will be calculated, the "lack of expertise" in the committee to compensate for broader harm caused (for example, mental and physical pain, suffering, trauma), and the absence of any patient representative.
Earlier, a committee headed by Dr Arun Agarwal was formed by the government to look into complaints of alleged faulty implants.
The committee stated in its report that "the ASR (articular surface replacement) hip implants manufactured by DePuy International Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India".
The report recommended that DePuy International Ltd be made liable to pay at least Rs 2 million to each affected patient, and the reimbursement for revision surgeries should continue until August 2025.
The Union Health Ministry, after that, had asked principal/health secretaries of all the states and the UTs to constitute separate state committees so that they can receive such complaints from the affected patients.
The patients said they are shocked by Johnson and Johnson's media statement seeming to indicate that it has questioned the "factual basis of conclusions" of the Agarwal expert committee and made an unjustifiable demand to be involved in the process to determine compensation for patients.
"We are unaware of the outcomes of any discussions between the government and J&J. We remain perplexed over the apparent inaction of the government to hold J&J accountable for the harm they have caused to patients, including through criminal proceedings," they said in the letter.
The patients said that they will not participate in the compensation process in its present form and unless their concerns are addressed.
"Until these and other critical issues with the Central and state committees are resolved, we feel compelled to not participate in the compensation process for ASR hip implant victims in its present form where there is no transparency, lack of concern and lack of dialogue with the patients.
"We respectfully request the Ministry of Health to protect and uphold our rights instead of the interests of J&J," they said.