US pharma major Johnson and Johnson's (J&J) decision to reimburse revision surgeries of patients who were affected by faulty hip implants in retrospective effect comes a little too late, echo patients who have suffered since over a decade now.

Upon much of pressure from patients, the media and the government instructions, the company on Friday has now extended the reimbursement program to cover revision surgery related costs up to 15 years. Earlier only those patients seeking revision surgery up to ten years from the time of their original surgery in case the first surgery failed, were reimbursed.

“It is our position that because the device was known to be defective and a high risk for causing harm, restrictions on reimbursement - 5,7, or 10 years - were never warranted in the first place. The reimbursement program was and remains very narrow in scope and is not designed to cover the full extent of medical costs related to the fault hip implants,” alleged a Mumbai-based victim Vijay Vojhala.

“It is important to bring to light the fact that patients were absolutely in the dark as regards the faulty hip implants and were left to deal on their own, facing numerous mysterious medical problems for which they paid a huge cost in terms of mental, physical suffering and financial costs. For many patients, the issues with the implant came to their knowledge after many, many years and were disqualified when they required reimbursement after 10 years. The poor awareness of patients is obvious from the fact that many patients came to know of the problems with the Articular Surface Replacement (ASR) only recently through news reports after August 2018, eight years after the recall in 2010,” said Vojhala.

Businessline had first reported Ramandeep Chawla's case, who had been denied reimbursement for a revision surgery because he had needed one in the eleventh year after his first implant failed. While J&J has promised that it will look into all reimbursements in retrospective effect too, it remains to be seen when patients will be reimbursed. For example, Chawla spent up to Rs five lakh from his own pocket for a revision surgery and needs to be reimbursed by J&J now as the company has tweaked it's policies and extended the time frame for reimbursement of revision surgery costs.

Over 4,000 patients had been fitted with the ASR implant in India, of the 90,000 across the world. Only 844 of these have been traced by the company and 275 patients who developed complications under ten years from original surgery have been offered a revision surgery by the company. Patients who developed complications from leaching of cobalt and chromium from the metal-on-metal device, for example, after ten years time frame had lapsed, were asked to fend for themselves by the company.

“For years J&J has denied legitimate claims of patients on the basis that an arbitrary time frame set by the company, of ten years, had lapsed by the time patients approached the company for reimbursement. The newly framed India-specific program has been framed under pressure, to modify an unjust and callous exclusionary rule,” said Malini Aisola, co-convenor of All India Drug Action Network (AIDAN).

Aisola also pointed out that it also remains to be seen how J&J will now initiate processes for hapless patients who underwent numerous medical investigations, procedures and treatments at significant financial cost, prior to revision surgery. In other cases, patients have had to undergo medical procedures after the revision surgery as a consequence of health degeneration as an outcome of the initial defective device. The costs associated have been hefty.

Apart from J&J's efforts to reimburse revision surgery costs, an expert committee set up by the Union Health Ministry has ordered a base compensation of Rs 20 lakh for all Indian patients who were fitted with ASR implants, irrespective of the fact that the implant failed in the patient's body or not. The committee has also said in it's report that those patients in which degree of disability and suffering is more the compensation will be significantly enhanced. However, as far as the compensation process for all patients that were fitted by the 'faulty,' device goes, RK Arya, director of Safdarjung Sports Injury Centre and head of the national committee for patient redressal chose not to comment on the issue.

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