Implant anguish

Persistent efforts by affected patients and a new government report expose the huge trauma and loss caused to thousands in India by a faulty Johnson & Johnson hip replacement device.

Vijay Vojhala, who underwent hip replacement surgery in 2008, at his office in Dombivili, Mumbai.

VIJAY VOJHALA’S rage is palpable and understandable. At the age of 34 he was advised to undergo a hip replacement surgery. His doctor strongly recommended the device made by Johnson & Johnson (J&J), saying it would be life changing. But it did not turn out the way the doctor or Vojhala expected. After the surgery, Vojhala was bedridden for six months. Since July 2008, he has been in constant pain. “Immediately after the surgery, I could hear squeaking sounds from the hip. I was in constant pain. My movements were restricted.” He says he was particular about post-surgical care but it made no difference. Metallosis (build-up of toxic elements in the soft tissue of the body), giddiness, stomach ache, burning sensation while urinating, high palpitation, deafness, extreme light sensitivity to the eyes, constant irritation and a series of painful medical tests - this is what the future holds for him.

Vojhala used to be a product manager of a Fortune 500 company that specialised in medical equipment. He continued to work despite debilitating pain. In 2011, he met an orthopaedic surgeon at a medical conference who inquired about his pronounced limp. When the doctor heard Vojhala’s story he told him that J&J had a global recall of that very hip implant. He was told that if he did not go in for a revision surgery he might end up with multiple organ failure and brain haemmorhage because of the toxins from the implant that were leaking into his bloodstream.

Although he realised that there was no option, Vojhala was angry at the casual attitude of the company: “What is this recall... do they think it is a stepney or something? This thing is a part of my body.” He approached the helpline set up by J&J for implant patients but it was “not a smooth experience at all”. Vojhala went through a series of extremely painful tests before his second surgery in 2012. Given the nature of the damage already done, the second surgery did little to improve the quality of his life. The irony of it all does not escape him. “I was in the business of medical products but it took me two years to understand what was wrong. Imagine the plight of other patients,” he said. The constant leave of absence from work ultimately meant Vojhala had to resign from his job. He now runs a small business and tries to cope with what even a government report has described as “a compromised life”.

The implants in question are the ASR, or articular surface replacement XL acetabular system, and the ASR hip resurfacing system. Both were manufactured and sold by Deputy International Limited, or DePuy, United Kingdom, which is a subsidiary of J&J. The metal devices have components of cobalt, chromium and molybdenum. After being fitted into the patient, the ball and socket begin to function naturally. This involves one rubbing against the other. When both pieces of the implant are metal (as in this case), metal debris flakes off and enters the bloodstream. The increase in cobalt and chromium in the blood results in blood toxicity and metallosis.

Between 2006 and 2010, 4,700 patients in India had J&J hip implants. In 2010, the product was globally recalled. Although it was not used again in India, the plight of the patients was not addressed either by the company or by the government. It was only at the persistence of a few patients that the matter did not die away.

Interestingly, in 2009, while the Government of India renewed the company’s registration certificate for the product, the company itself had begun recalling the product in Australia. A 2007 analysis by Therapeutic Goods Administration, the Australian regulatory body under the Department of Health, indicated that the product had a higher-than-average replacement rate. In 2014, the National Institute of Health, an agency of the United States, also came up with a similar finding.

In the period of inactivity between 2012 and 17, Vojhala began writing to every forum to get justice. In 2015, he got a letter from the public grievances website of the government saying it was actively pursuing the matter. In 2016, another communication told him that it would try to address the grievance. In 2017, an expert committee was formed.

In August 2018, a group of patients and relatives of patients wrote to Jagat Prakash Nadda, Union Minister for Health and Family Welfare.

In their letter, they said: “In spite of our attempts over several years to draw attention to the serious safety concerns with the ASR hip implant device, and the pain and agony experienced by us, the response from the government for years was one of apathy and dismissiveness…. It is now six months since the report was submitted but it has not been made available to the public or to us….” They also say that the “actual compensatory amounts, which, if accurate in terms of the amounts mentioned, would only add insult to serious injury.”

But what they found especially disturbing was that there was no mention of the possibility of any criminal charges against J&J for “marketing this faulty product”.

Compensation mechanism

Once the report was made public and the recommendation of compensation was publicly established, the government quickly initiated a compensation mechanism involving State-level committees, for evaluation of medical disability, and a Central Expert Committee for deciding the quantum of compensation. Some of the key recommendations of the committee were payment of at least Rs.20 lakh to each patient who had complications; formation of a committee to determine whether there was permanent disability that affected the earning capacity of the patient; follow-up health assessments until 2025 of all those who received the implant; and creation of an independent entity to track the use of high-risk medical devices.

But the patients and the affected families felt the government was continuing to drag its feet and called a press conference on September 15 in Delhi. Vojhala has been spearheading the campaign ever since his own surgery went wrong in 2008. A press release quoted Vojhala as saying: “What are the checks or balances on the working of the committees? What is the guarantee that the committees will be fair, just, equitable and reasonable in determining compensation? 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. I was the only patient to have deposed in front of the Central Expert Committee—how could they possibly understand the complexity and range of suffering across such a large number of victims across the country? We need patient representation on any committee that is set up.”

Discrimination

Kabir Chandhok, a patient, said: “Compensation should be based on physical, mental, social and economic harm faced by the patients, not only the basis of physical medical criterion. It is critically important that patients, their representatives and a psychologist are part of the committee, and their voices should be heard…. Irrespective of injury, compensation should be paid to all patients who got the ASR implant. One ought not to wait for harm to occur when a device has been shown to be harmful the world over and in India. For me, there is an element of discrimination in how J&J is treating Indian patients and patients in developed countries. If the company refuses, the government should provide the compensation as it neither was responsive to the safety concerns associated with the device in other countries nor took immediate steps to order a mandatory recall and cancel the licence; it also delayed in initiating measures to the benefit of the patients. For me the government is jointly and severally liable, too.”

There is anger at the failure of the company to be more open about the implant device. Yogesh Mandhani, whose father had a hip implant in 2010, asks why it was used “when in 2009 there was information about how faulty the implants were”. In response to a query from Frontline, Johnson & Johnson Medical India said it had tried to reach out to patients. “As ASR patient data is maintained by surgeons and hospitals, DePuy has been actively requesting that surgeons and hospitals reach out to their ASR patients to ensure awareness. Efforts to support ASR patients and their surgeons have been a top priority for us, and we have sent several communications to surgeons who implanted ASR hips, informing them of the recall, available support, clinical and scientific support information and the reimbursement process.”

Questions are being raised about the role of the Drugs Controller General of India (DCGI). Vojhala says he “underplayed his role”, that is, adequate action was not taken under the existing law. “When the company recalled the product, did the DCGI inform the State FDAs, the Health Ministries? Apart from recall, what actions did the government and the company take to actively assist the patients?” he asked.

Vojhala minced no words when he said: “I’m living a compromised life. I have to use crutches to walk around and this puts painful pressure on my shoulders. From weighing 66 kg, I now weigh 92 kg. Obesity brings its own problems. Patients have lost their ability to work and earn. On what basis is Rs.20 lakh being offered to patients? We should be paid much more. The company is at fault but it has disowned responsibility. The regulators have not done their job either. Enough of hide and seek. The government says there is no law [under the Drugs and Cosmetics Act] to prosecute a company [that has recalled its products]. The matter should be brought under the Central Bureau of Investigation. There should be criminal prosecution and the government should offer the patients the strongest possible representation.”