Johnson and Johnson Hip Implants: Compensation Only an Eyewash

“The government is making a mockery of my pain, Why do they get to decide how much money should I be getting, patients have no say in the negotiations and there is deliberate shielding of the firm.” Says Vijay Vojhala the face representing the side of the patients in the tussle against Johnson and Johnson.

The pharma giant on Friday announced, that it would work with the Indian government to provide compensations to patients who are adversely affected by the faulty hip implants of J&J from a decade ago. Last month, a government panel recommended that J&J pay compensation of at least 2 million rupees ($27,812) to each patient who received an ASR hip implant in India, an estimated 4,700 people. The federal government has asked states to help the patients get relief soon. "We have always been and continue to be fully committed to supporting all ASR patients in India, and the rest of the world," a J&J spokeswoman said in a statement emailed to Reuters.

However, their compliance to pay the compensation needs to be looked at closely, According to Malini Aisola of AIDEN, “The company has cast aspersions over the findings of the report of the Health Ministry’s panel, the firm wants to possess enormous decision making powers as far as the compensation is concerned, the patients are not being involved in the process at all.” Adding to this, Vijay Vojhala says, “As far as the patients are concerned, our interests are being completely cornered and we are being kept in the dark.” The promise of a 20 Lakh rupee compensation at this stage looks bleak, as the firm wants to be a key stakeholder in identifying who deserves a compensation and what upper and lower limits must be set to the compensation.

The report of the government panel which was released in February this year had suggested this amount for the compensation. The panel which was set up in 2017, is headed by former dean of Maulana Azad Medical College (MAMC) Dr. Arun K. Agarwal, and had top orthopaedic surgeons and legal experts in it. Newsclick had previously reported on the findings of the committee which  have directly accused the Indian arm of Johnson & Johnson of suppressing facts on the adverse effects of the faulty hip replacement systems it imported and sold for use in surgeries of hundreds of patients. The report also mentions lapses on the company’s part in informing the national regulator of the exact number of patients who used these devices. Now, questions are being raised over the role of the regulator.  Johnson & Johnson recalled its faulty hip implant on August 24, 2010 but it took Indian regulators almost two years to ban its import and cancel its licence. This, despite the fact that the regulator, Central Drugs Standard Control Organisation, which comes under the Ministry of Health and Family Welfare, was informed of the global recall in 2010 itself. Reacting to this, Malini says, “There is ample evidence that the CDSCO delayed acting upon knowledge that it had and took only feeble steps for several years. It refused to enforce regulatory provisions against DePuy even when it was obvious that the company had lied, violated rules, and was undermining the process of identifying patients. Even the setting up of the expert committee was unnecessary, had the regulator done its job in the first place. All this points to deliberate attempts at protecting the company. The regulator seems to have been complicit in extending the agony of patients and delaying justice. Adding to this Mahesh Zagade from AIDEN says, “A regulators job is not to “blame” but to prevent such wrongdoings by the companies, to take timely action to safeguard interests of the people (patients) and to implement the law in such a manner that it becomes a deterrent exemplary action to prevent recurrences of this sort.

The irresponsibility of the government becomes explicit in its continuous denial to seek compensation from the firm. The government has time and again stated that it cannot compel J&J to provide compensation under the current law. “This is absolutely not true, under the Drugs and the Cosmetic Acts, the government can very well do so, it is a question of political will  and the hand in glove attitude it has.” The US pharma giant, got the licence to import the hip replacement devices in India in  2006, by the time it was recalled worldwide in 2010, an estimated 4,700 ASR implants had been done in the country. Amid concerns worldwide, the government has failed to trace more than 3,600 of the 4,700 patients who underwent the first round of surgery with many undergoing revisions as well, the number of which is yet to be established.  The reports of the committee which is finally made available to the patients after prolonged pressure brings to light the glaring extent of government inaction, despite the admission of the firm over product failure, J&J was given a leeway and it continued to function under the government’s nose. The company also blatantly manipulated data from coming under the scanner and also incorrectly sited revision rates. Despite this, the company may be let off without any criminal charges.

While the current state of affairs has left patients hanging in the middle, it is clear that despite being aware of the discrepancies the government deliberately shielded J&J. Now, under the garb of compensations both the firm and the government are trying to absolve the blame off of each other while the patients are not given slightest of the locus in the negotiations.

Previous report can be accessed here.