At least 34 patients affected by faulty hip implants manufactured by Johnson and Johnson (J&J) have refused to apply to the Central committee for evaluation of compensation until their queries are resolved by the Union Health Ministry.

The patients, in a letter to Health Minister JP Nadda, have said they are concerned about the Centre’s compensation mechanism, which is based on the recommendations of an expert committee headed by Dr Arun Agarwal. They said the process is non-transparent and there is zero dialogue with the patients. Dr Agrawal is Professor of ENT at the Maulana Azad Medical College.

Nearly 4,700 Indian patients have been fitted with the company’s ASR implants, and close to 3,600 of them remain untraceable, the government and J&J have claimed.

All the patients who have written to Nadda have suffered due to the failure of the hip implant, which led them to a revision surgery, and leak of toxic chromium and cobalt in their blood stream due to the leaching of the metal implant.

Seeking redress

“Immediately after the Agarwal committee report was put in the public domain, the government initiated a compensation mechanism, involving State-level committees, for evaluation of medical disability, and a Central expert committee for deciding the quantum of compensation.

“We respectfully consider this action to have been too hasty and are distressed to see the government continuing to closely consult with J&J, while patients like us who have suffered grievous injuries have not been consulted even a single time,” the letter said.

The expert panel was constituted on August 30, has convened a few times and started accepting applications for compensation, but no State-level committees appears to have been instituted, the letter observed.

Govt clarification

However, Preeti Sudan, Secretary, Union Health Ministry, said: “As per information collected from our zonal offices, Delhi, Rajasthan, Punjab and Jammu & Kashmir have constituted State-level committees for the J&J matter.”

“Our apprehensions about the compensation process are compounded by several issues — the lack of clarity about which cases will be considered appropriate for compensation and the documents required of patients to make their claims, 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 obvious exclusion of any patient representative,” said 31-year-old Manoj Kumar, a resident of Visakhapatnam who was implanted with ASR in August 2008 and later had to undergo a revision surgery in April 2018.

Patients also include those like Ramandeep Chawla from Faridkot in Punjab, whose revision surgery was not reimbursed by J&J as there was a lapse of over 10 years from the original surgery, and this went against the company’s reimbursement guidelines.

Factual basis

“We are also concerned and shocked by Johnson & Johnson’s statements to the media 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 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,” the letter said.

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