Health and wellness

Indian victims of faulty hip implants wait on compensation, years after US patients’ US$2.5b payout

Eight years after US multinational Johnson & Johnson recalled a defective implant, less than a quarter of Indian patients who received them have been awarded compensation; some have died

PUBLISHED : Monday, 17 September, 2018, 8:18am
UPDATED : Monday, 17 September, 2018, 8:03pm

Jyoti Rani was sure there was something wrong with the hip implant she had received soon after leaving hospital in 2016. She kept complaining of pain, and an inability to walk or sit down.

Rani’s doctor asked her to get a cobalt and chromium test, and warned her against trying to conceive. The doctor was aware that the implant, produced by American health care multinational Johnson & Johnson (J&J) and made of cobalt and chromium, had been found to be leaking metals into the body of patients, in some cases leading to fluid accumulation and metal poisoning.

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The test results showed levels that were abnormally high, and Rani had to have revision surgery last year.

The former jewellery designer from the city of Visakhapatnam in eastern India, who had married in her late 30s, says the first years of her marriage were ruined.

“I got married four years ago and I feel so guilty because all it’s been is hospitals, doctors and tests. My husband has been supportive but it has disrupted my life. I had to give up my work and I haven’t been able to have a baby,” says Rani, who is still in pain even after the revision surgery.

She is one of 4,700 patients in India, and one of 93,000 globally, to have received defective articular surface replacement (ASR) hip implants. J&J began recalling the faulty implants in 2010, six years before Rani received hers, and in the United States was ordered to pay US$2.5 billion in compensation to about 8,000 claimants there in 2013.

I have led a life of isolation, sadness, misery and pain
Vijay Vojhala

Yet only this year has J&J finally been taken to task in India over the implants. Following a health committee report, an Indian government panel recommended last week that J&J should pay at least 2 million rupees (US$27,900) to each patient for the faulty ASR hip implant. But so far only 1,032 of the Indians given the ASR implant have been traced. Four are known to have died.

The others are probably bedridden and in pain, with no idea that the company has been officially indicted by the Indian government for its conduct.

Vijay Vojhala became the unwitting face of an Indian campaign for J&J to be held to account.

A Mumbai-based former product manager at a medical devices company, Vojhala, 45, had his first implant was in 2004, but it caused him so much pain he had to have revision surgery four years later. Even after that, he had to quit his job because he was so unwell. He approached J&J but the company refused to compensate him.

He describes J&J as “butchers” who caused him “untold suffering for the sake of a few dollars”.

“I have led a life of isolation, sadness, misery and pain. My family life has been shattered. When my kids were toddlers I couldn’t pick them up. I missed out on a lot,” Vojhala says.

It was a great relief to him when the Ministry of Health and Family Welfare set up a committee of doctors to look into claims of faulty implants last year. The ministry submitted its report in February, but the government only published it in August after Vojahala asked for it to be made public.

The report states that the hip implant was manufactured by DePuy Orthopaedics, a wholly owned subsidiary of J&J. Indians who received the implant “had to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life, which will also have a bearing on their dependents apart from loss of work”, it says.

The committee accused the company of suppressing key facts about the harmful effects of its device.

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“Some of the patients had reported that they had to [endure excruciating] pain … after the implant. Many patients reported general fatigue or local issues such as pseudo tumour, pain walking, metallosis (increase in cobalt and chromium levels), Asthenozoospermia (reduced sperm motility), cysts in kidneys … Some of them are still having difficulty in carrying out their routine activities and are confined to bed, which has led them to mental turmoil and agony,” the committee reported.

Vojhala was one of over 250 Indian patients who had to undergo repeat surgeries due to the pain. He only learned about the recall when he attended a conference in India as the medical representative of Philips India. A doctor saw him limping and asked him why.

“When I told him about the implant, he said it had been globally recalled. I was aghast. I had no idea,” he says.

Between a government that’s painfully slow to act and a multinational that has no shame, we have been badly hurt
Jyoti Rani

With the release of the government report damning J&J, those who suffered are feeling vindicated. However, questions remain, among them why less than a quarter of the Indian patients who received the implants have been found. The company has told Indian regulator the Central Drugs Standard Control Organisation that it has been unable to trace the others.

“That’s hardly surprising,” says Malini Aisola, co-convenor of the All India Drugs Action Network. “There is a conflict of interest here. Why would the company be sincere in trying to trace the others when it knows it will have to pay compensation?” The amount of two million rupees that the Indian government panel ordered J&J to pay as interim compensation to all those affected, is also much less that the amount paid out in compensation to patients abroad.

Vojhala says: “The company is rubbing salt into our wounds by not doing the right thing. They should pay us exactly what they paid people in America and Europe without having to be told. That would be the ethical thing to do. Are Indians inferior to others?”

In July, an American court ordered J&J to pay nearly US$4.7 billion in damages to 22 women who claimed the company’s talcum powder caused them to develop ovarian cancer. The women’s lawyer said J&J had covered up evidence of asbestos in its products for more than 40 years.

In the case of the faulty hip implants, the Indian government has been slow to act. Alarm about the ASR was first raised in 2010 when the Food and Drug Administration in the western Indian statre of Maharashtra received an anonymous complaint about a patient suffering a serious adverse reaction. After an investigation, a complaint was lodged with the police, but it wasn’t followed up.

Two years later, the medical regulator banned imports of the product, and issued a medical device alert on ASR implants in 2013 – three years after the global recall. The government’s health ministry committee was only set up last year, leading to accusations of apathy.

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“Between a government that’s painfully slow to act and a multinational that has no shame, we have been badly hurt,” Rani says.

J&J told the Post in an email that it had always intended to make sure as many ASR patients in India as possible were aware of the voluntary recall and understood the support available to them.

“DePuy [Orthopaedics] does not, however, have access to data on patients who have received an ASR hip implant due to patient confidentiality regulations,” it said.

The company agreed to pay the 2 million rupees compensation. Regarding the panel’s recommendation that compensation beyond that should be determined after assessing a patient’s level of disability, J&J said: “In light of the recent committee report, we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation for patients in need.”

But patients are against J&J being involved in determining the criteria because they have no faith in the company. Jennifer Bharucha, who says her mother Daisy died in 2014 in Mumbai owing to complications caused by the initial surgery and then by the revision surgery, has a simple solution.

“It’s already been almost a decade. Why waste more time with committees discussing the criteria for more compensation? Why not simply give us compensation based on the same criteria used in other countries?” she suggests.

For Vojhala, the struggle goes on and it will not end until all sufferers receive more compensation. He wants justice and he believes that can only happen after criminal charges are filed against company officials.

“Those responsible for ruining my life, my family life, my livelihood, my confidence and my self-respect must pay. They must be punished in the courts,” he says.