New Delhi: Patients and family members of those affected by Johnson and Johnson's faulty hip implants gathered in Delhi on Saturday demanding they be directly involved in the process of ascertaining the compensation.
They asserted the amount should not only be based on the physical, medical criteria but also take into account the mental, social and economic harm faced by them.
They expressed apprehension that the government could "toe the line" of the pharma giant as it was conducting an one-sided inquiry.
The affected patients said the government was jointly liable as it was neither responsive to the safety concerns associated with the device in other countries nor did it take immediate steps to order a mandatory recall and cancel the license of the firm.
Their demands came in the wake of news reports that the central committee being set up for compensation is likely to meet for the first time on September 18.
The AIDAN, a network working with the patients, called for criminal action against all involved, including people in government who failed to act against the use of such harmful implants.
They also responded to claims of Johnson and Johnson that it has been unable to trace the majority of ASR — anywhere between 2,400 to 3,700 — because it did not have access to patient details which were only available to surgeons because of confidentiality.
George Thomas, chief orthopaedic surgeon, St Isabel's Hospital in Chennai said, "All joints for human implantation have stickers which are used to trace the individual joint. As per normal protocols, one of these stickers has to be pasted in the surgical record of the patient. Therefore, it is difficult to believe that the patients cannot be found."
He said the company itself, as well as the surgeons should be in a position to track the patients. Joint replacements are routinely followed till the patient expires, so the address is always obtained, he said.
The victims and their relatives sought participation in any further meeting to decide on the compensation and action to be taken on a report submitted by a high powered expert committee set up by the health ministry.
"What are the checks or balances on the working of the committees? What is the guarantee that the committee will be fair, just, equitable and reasonable in determining compensation?" said Vijay Vojhala, who had his initial surgery in 2008 and the revision in 2012.
"The government is doing a one-sided inquiry and could easily toe the line of the company. We understand that the government has been closely consulting with J&J and yet, those who have suffered grievous injuries seem to have no seat at the table," he said, adding he was the only patient to have deposed before the Central Expert Committee.
The report of the committee was only made public after determined efforts of patients demanding that the report be put in the public domain.
The committee in its report stated 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 suggested that DePuy International Ltd, a subsidiary of Johnson and Johnson be made liable to pay at least Rs 20 lakh to each affected patient, and the reimbursement for revision surgeries should continue until August 2025.
They said despite assurances that the costs of their treatment would be covered when their implant failed, the company left most patients to fend for themselves.
"Compensation should be based on physical, mental, social and economic harm faced by patients. Not only the basis of physical medical criteria. It is important that patients, their representatives and a psychologist be part of the committee and their voices should be heard," said another victim Kabbir Chandhok.
Former commissioner of the Food and Drug Administration, Maharashtra, Mahesh Zagade, who had initiated probe into the faulty hip implants in 2011, accused the drug regulator of "inaction and sleeping over the issue despite enough proof".
"The regulator could have taken action, including criminal prosecution, immediately under the existing law and provided relief to the patients," he said.
He also questioned on the basis on which the company was given the import licence for the implants even though the company had officially recalled the product in 2010.
"The J&J issue once again reminds us of the grim reality that in the current scenario it is the responsibility of all the stakeholders to be vigilant and ensure that the commercial interests of the pharma and medical device corporations do not take precedence over everything else and in the process endanger human life," he said.
He also said as per the rules the importer has to maintain a registry of all the devices and products that are brought into the country and records are maintained.
He said an FIR can be filed by the DCGI, which is the licence granting authority, under section Section 320 of the IPC against the firm for causing grevious hurt.
The DCGI is completely accountable, he said demanding a CBI probe into the matter.
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