NEW DELHI: For Daisy Bharucha, 67, who had worked hard all her life and continued to do so even after retirement, a fall at Mumbai’s Bandra station in 2007 was the beginning of a nightmare that would eventually end with her painful death seven years later.
Bharucha, like thousands worldwide, was recipient of a hip implant by DePuy—a subsidiary of Johnson & Johnson—which a committee formed by the Union Ministry of Health and Family Welfare has now said was of faulty design and has found the company guilty of not doing enough for about 4,700 patients who got its ASR hip implants in India.
The 11-member committee has also asked the company to pay a minimum of `20 lakh each to every patient in India. The committee also said that the company’s claim that repeat surgery was needed in only about 10-12 per cent cases was “not true” as there is evidence of about 30 per cent patients going for the repeat procedure.
But for Jennifer Bharucha, Daisy’s daughter who has undergone a lot of physical and emotional trauma over last 11 years, the committee’s, released publicly now—seven months after it was submitted to the government—is akin to handling a “mass-shooter with a kid glove”.
“My mother was a spirited person, full of life and her independence meant everything to her. But the first hip replacement surgery which saw an ASR joint inserted in her heralded a downward spiral,” says Jennifer.
Following the surgery, Daisy was not pain-free for a moment and never really walked without massive struggle, says Jennifer. “She started hearing a squeaking sound right after the surgery and pain was so excruciating that she was given high doses of pain-killer throughout.”
A year later, she had to go for repeat surgery but that did not make things any better.
In 2010, following a hue and cry from patients worldwide, DePuy finally recalled its two controversial implants that were causing toxic leakage of two of its constituents, Cobalt and Chromium. It was then that the Bharucha family realised what the root cause of Daisy’s suffering was.
In other area of Mumbai, Dombivili, Vijay Vojahala, a product manager with an MNC, had waged a lonely battle following a similar experience. After two surgeries and multiple complications later, Vojhala had pin-pointed an “unwanted” presence in his body that was crippling him and was knocking at every door possible.
Both Vojhala and Bharucha got Johnson & Johnson to reimburse for their second and third corrective surgeries, respectively, but they both believed that the company was not doing as much as it ought to do.
“They were not reaching out to patients in India who had got their implants and not compensating the way they were made to compensate in countries like the US, following lawsuits,” says Vojhala, who is suffering from vision, hearing and severe movement problems due to the toxic build-up in the body caused by the leakages in the implant.
Johnson & Johnson settled more than 9,000 lawsuits over the defective hip models for around $4.4 billion between 2013 and 2015 alone.
In India, though a compassionate Mumbai Food and Drug Administration commissioner heard Vojhala and recommended a CBI inquiry, noting that hardly 25 of the total 4,700 patients who had got the “defective” implants were even reimbursed for their surgeries.
A senior member of the Central committee concedes it was Vojhala’s persistent noise that led to setting up of the review panel last year. The panel has said that states should publicise its recommendations and ask the affected patients to come forward to claim compensation.
But for Jennifer, who lost her mother to brain cancer in 2014, which she says was result of the toxicity in her body, the suggestions by the committee is “not more than a joke”. “Even after testimonials from over 20 patients, the company has not been penalised by the Indian regulators in anyway. Are Indian lives cheaper than those in US, Australia and Europe?” she asks.
The pharma giant, in response to queries by The Sunday Standard, said, “Allegations that DePuy chose not to contact ASR patients are completely false. As a result of our various efforts, to date we have, through surgeons, hospitals and independent service providers, demonstrated outreach to more than 2,300 patients who underwent ASR surgery in India.”
Committee set up to review complaints
An 11-member committee was set up under Arun Kumar Agarwal, ex-dean and ENT professor at Maulana Azad Medical College, Delhi. It could not trace about 3,644 of total 4,700 patients. The panel found that not only did the patients undergo revision after the first surgery, but in some cases, more than one revision surgery was performed.