Recalling a faulty hip implant, Johnson and Johnson has paid $2.5-billion in compensation in the US. Not so in India, where hundreds of patients are fighting for justice
New Delhi/Mumbai: “The truth is, we never know what life will bring us and we don’t have as much control as we think we have," said Vijay Anant Vojhala, pointing at the playground near his home in Dombivali, around 50 km from central Mumbai. That’s where, in a past life, he would spend hour after hour playing volleyball, the love of his life, tossing the ball to get that accurate serve.
Everyone’s eyes remain fixed on the ground as Vojhala limped towards his home. Pausing, he turned and said, “Of course, back then I couldn’t have imagined the significance of serving the ball without being able to jump." Vojhala’s wife Sujata took hold of his hand to help him walk. “He can’t walk more than 100 yards without a raging pain in his legs," she said.
The pharmaceutical multinational Johnson & Johnson (J&J) Inc. has a leading role in Vojhala’s misfortunes. His life has not been quite the same ever since he had a hip replacement surgery in 2008 and was fitted with a faulty Acetabular surface replacement (ASR) hip implant device known as DePuy ASR. This device was manufactured by DePuy Orthopaedics Inc., a fully-owned subsidiary of the $76.4 billion J&J, which is represented in India by the unlisted Johnson & Johnson Private Ltd.
Apart from Vojhala, many other patients in India have been adversely affected by the faulty hip replacement surgery they underwent almost a decade ago. At present, over 14,000 J&J ASR devices are in use in India. Some of these patients have approached the Indian government and are seeking its intervention to secure compensation from J&J.
A matter of compensation
The demand stems from massive compensation for the same defective hip part in the US, the home country of the multinational. There, patients have been given justice. In 2013, a unit of J&J agreed to pay an estimated $2.5 billion to settle thousands of lawsuits from individuals allegedly injured by the company’s artificial hip. Covering 8,000 US patients, the settlement, announced by DePuy Orthopaedics, is tipped to be the highest ever for any medical device.
In 2017, the Indian government, specifically the Union health ministry, had set up an expert committee to look into the issue. The committee, headed by former dean of Maulana Azad Medical College (MAMC) Dr Arun K. Agarwal, had top orthopaedic surgeons and legal experts in it. In its report submitted in February 2018, the committee recommended compensation with a base amount of ₹ 20 lakh each for patients who received faulty hip implants from DePuy Orthopaedics.
During their investigation, the expert committee had approached 101 patients, out of which 22 responded and stated that they had a revision surgery after the initial implant surgery. Some of them even had a third surgery. However, according to sources in the health ministry who did not wish to be named, the report has been gathering dust since February.
When contacted, R.K. Vats, additional secretary in the health ministry said there has been movement in the case. “The report has been accepted by the government in principle. There have been strong recommendations which will be implemented," he said.
The question is when will the patients get their due? Malini Aisola, co-convenor, All India Drugs Action Network (AIDAN), blames it on faulty products, lax compensation rules and believes that government’s action is long overdue. “There is a deeply flawed system in place that depends on companies to self-report adverse events with their devices. Not only is there a failure to hold companies accountability for unsafe, faulty products but the utterly lax oversight can even enable purposeful negligence amounting to criminal behaviour in following up with patients."
According to J&J India, 1,080 patients had registered with a helpline set up by the company, of whom 275 had a revision surgery in India. Though no further details are forthcoming from the company, it can be assumed that in these cases, J&J has borne the cost of the revision surgeries. (See the box to read the J&J India subsidiary DePuy Synthes India’s response to Mint’s questionnaire).
What makes the issue of compensation even more relevant is the recent news that J&J was ordered to pay $4.7 billion in damages to 22 women who alleged that they got cancer after using its talcum powder. A jury in the US state of Missouri initially awarded $550million in compensation and added $4.1 billion in punitive damages. The verdict, which came out in July 2018, comes as the pharmaceutical giant battles some 9,000 legal cases involving its signature baby powder.
The settlements by the company have once again put the spotlight on unresolved issue of patient safety and compensation in India.
Vijay Anant Vojhala
It all started in 2008.
There was nothing that Vojhala enjoyed more than the wind in his face and the thrill of adventure. A medical representative by profession, he spent considerable time pursuing his first love—volleyball. But all that changed one day, when Vojhala experienced an unexpected onset of intense pain in his right hip. Doctors told him to get the core decompression combined with bone graft substitutes done, a viable option for joint preservation. The procedure did nothing but left him with a pronounced limp, reducing his mobility dramatically.
While hip replacements are widely regarded as a great surgical success story, doctors recommended Vojhala to go for one. The same year hip replacement surgery was dubbed the “operation of the century" in a paper in The Lancet in 2007 for “revolutionising the treatment of crippling arthritis".
Thanks to being a medical practitioner, he got the best advice from orthopaedic surgeons. Finally, it was decided that the newly launched “metal on metal" hip implant made by the world’s largest medical device company J&J would be fitted.
In 2008, Vojhala had the hip implant surgery. “There was a lot of pain, discomfort and I continued limping," he said. Yet, he had no way of knowing what had gone wrong. But unknown to him, the surgery had changed the course of his life. Not the type of change that you welcome; it’s change that stays with you. “Things were not getting back to normal and it was a bit daunting," said Vojhala. His body had issues that should have come good few years down the line.
“I had a clouded mind, never-ending pain, felt completely exhausted all the time, and yet I was expected to answer questions like ‘How are you feeling?’ It sounded like a death sentence," lamented Vojhala.
The scandal first broke in 2010 after the company announced a worldwide recall of the metal-on-metal ASR hip implant device, otherwise known as DePuy ASR. In India, this was sold by DePuy International, a subsidiary of J&J. The recall happened after the National Joint Registry of England and Wales reported that 13% of patients implanted with DePuy ASR ended up needing revision surgery. There was a mandatory recall of 93,000 ASR implants worldwide. Moreover, the implant made of cobalt and chromium was found to be leaking metals in the body of patients, leading to fluid accumulation and metal poisoning in some cases.
The DePuy Synthes India spokesperson begs to differ. “It is well documented that all hip implants, no matter what materials are used, experience wear over time and generate wear debris since they require one component to slide against another component and the surfaces wear as they interact. With metal-on-metal hip replacements, the wear debris is made up of cobalt and chromium. Every person has some cobalt and chromium in their body and both are essential nutrients. The form of cobalt and chromium found in metal hip implants has been used safely in various medical devices for decades."
The fact is, some patients even required revision surgeries within five years of getting the first implant. Vojhala was one of them. Shockingly, he got to know about the recall not from the doctor or the company, but in one of the conferences that he was attending as a medical representative of Philips India. “A doctor saw me limping at a conference. When I shared my implant surgery story, he told me that the same implant had been recalled. That was news to me. I was aghast. He suggested that I must undergo tests to check the cobalt and chromium levels in my body," he said.
To Vojhala’s dismay, he had elevated blood levels of chromium and cobalt ions. He was told only a revision surgery could correct the damage to his body. Meanwhile, Vijay had started getting in touch with the company and its legal director. “I demanded that I must be taken care of. Though they agreed to pay for the revision surgery which was an estimated ₹ 7-8 lakh, they resisted paying for the pre and post surgery expenses. After a lot of hue and cry, they finally paid and I was operated on in 2012," said Vijay.
His ordeal was far from over. Soon after this, Vojhala started having dental problems. “Seven dentures were to be removed. The doctors could not fathom the reason for it even as they confirmed that there were no oral hygiene issues." Loss of hearing in one ear, sudden high palpation, obesity soon followed and added to his problems.
That year his main focus shifted away from work to recovering from the ailments. He was forced to quit his job. “My job demanded a lot of travel. Due to the several health issues, I lost my job and it paralyzed my confidence and self-esteem. Everybody from the company, doctor to the hospital, all just made money at the cost of our health. The design was defective, despite that the company took its own good time to recall the same from the Indian market," he said, explaining the sequence of events of his medical history.
The multiple surgeries not only affected Vojhala’s lifestyle but also that of the dependent family members. To manage finances at home, Vojhala’s wife Sujata Vojhala, 35, had to take up the job of a commerce professor in a nearby college. With this ended the couple’s normal life. “He used to travel so often but due to the never ending road to recovery, he had to limit everything and with him changed our lives too. Today, we cannot go anywhere. He cannot walk much and sit for long. His movements are restricted. The family life has been affected tremendously," she said, hesitantly, that life as a pared down human being with compromised health, is not that easy.
His children—a son and a daughter— were heartbroken seeing their father in a vulnerable state, struggling to move. Although dealing with this crippling disease was difficult, his wife said his personal struggles were far more challenging.
“I could not go out for a meal or play with my children. It was not my proudest moment but it reduced my stress level every time I saw them laughing. My daughter was just three then and I could not hold her in my arms, leave aside playing with her. I just saw them growing."
Vojhala still cannot squat, run, walk long distances, cannot do exercises, cannot sit on the floor or for that matter cannot sit for longer periods.
57 years old banker, Raj Shroff can walk, but slowly and finds himself stopping every 20 feet or so to rest, catch his breath. When he’s ready to cross a bustling traffic signal at the heart of Mumbai central, he pays close attention to the traffic signal and takes off as soon as he sees the green signal. Every second counts. He doesn’t want to get caught in the street with traffic barrelling in his direction.
“Welcome to my little house," Shroff said as he parked himself on the sofa-cum-bed with a little discomfort. In the one bedroom house in central Mumbai there is a small table, with only two chairs. A tiled floor signifies the separation between the kitchen and the rest of the house. “This is in close proximity to my office and it suits me the best. Long traveling is not possible for me," said Shroff, looking around.
Shroff had to undergo major hip surgery in 2007 when he was just 47 years old. There was a discrepancy in the leg length and the doctor advised a hip implant. “Several health problems were diagnosed soon after. I have been feeling sick and in pain, developed cataract, a tumour formed near the implant and the doctors had to cut it open and remove it," he said in a sad voice.
Shroff’s wife, Sushma Raj Shroff, who has been running from pillar to post, claims that the issue of faulty implants has been brushed under the carpet in India. “We have been treated like guinea pigs. When the company could compensate people in the US for their wrong doing why have we been treated differently? Is there no value for our life," she asked.
“He underwent this surgery when our daughter was very young. I had to take up his role. I taught her how to ride a bicycle. The children expect certain things from their father. But I had to do all those things for her. Till date we are so scared that if he has a fall that’s the end of it," she said clearing her throat. “We don’t go anywhere. He used to walk briskly. He is 6-feet tall so the steps were so long that he would leave everyone behind. But today he is left with no choice but to make soft careful steps—patient steps," added Sushma Shroff.
Dr Harish Bhende, a senior orthopaedist, who operated in Hinduja hospital and Breach Candy in Mumbai on several such patients, said that the product was good but it had its problems. “The product was US Food and Drug Administration approved and was meant for young and highly active patients. So we used it in India as it was already under use in the US. The early function was very good but in some cases it caused loosening. The technique of insertion was not easy and the margin for error was lesser than the standard metal on Poly hip joint," he said.
While none of his patients—a total of 45 to be precise—had any complications, he conducted several revision surgeries. “I have revised some patients with such failures, from other surgeons. These revisions are less difficult if patient comes for revision early after signs of failure are recognized. Longer the patient waits, more tissue damage occurs," he added.
Daisy Bharucha passed away in 2014, aged 73. She had to undergo several additional surgeries because of the health complications that followed her hip implant surgery. “The poison that was put into her body has wreaked havoc. She was in pain and severely sick, yet no one could identify what was wrong with her," said Jennifer Bharucha, Daisy’s daughter. She said that the metal that ruptured from the implants leaked into her mother’s brain, causing a brain tumour. “It left her with a tumour and permanent damage—severely impacting her ability to work," added Jennifer.
Daisy Bharucha had to undergo the hip implant surgery in 2007 when she was 67 years old. She was never told by the hospital that she had been given the toxic implants; she had to find out herself. “She felt dislocation of the implant within six months. She was in pain and complained about some shrieking noise from hip as she moved around. It was in 2008 that she also started complaining about a huge lump that was developing below the hip," added Bharucha’s daughter Jennifer.
Daisy was admitted for a revision surgery and as doctors cut her open, they found blackish-greyish fluid inside her body. “The doctors admitted that there was corrosion and removed it (the implant)."
Daisy knew that something had gone utterly wrong. What she did not know was that the next few years would be worse. “While the pain persisted, towards the end of 2008 she started getting shooting headaches too," said Jennifer.
In 2010, the family got to know that there was a clot in the brain. It was during a visit to the hospital that Daisy got to know that the hip implant that she was fitted with had been recalled.
“We contacted the company and got to know that the news was true. It was a global recall. The company never bothered to get in touch," Jennifer said. Daisy had to undergo another brutal surgery. But this time the recovery took time. She was in the hospital for more than a month. By now she was 71 years old.
Meanwhile, Bharucha filed a case with the Mahim police station for the physical and mental stress that the company had caused. “The company had paid up for the revision surgery. But that was not enough. They experimented their faulty implant on people. If they had thought through and done their research work well, this would not have happened," said Jennifer.
Her tragic story was not over yet. In 2013, Jennifer got to know that Daisy had brain tumour. In 2013, Daisy underwent another surgery—this time to remove the tumour. Daisy eventually died after several years of declining health. They filed a case against J&J in National Consumer Disputes Redressal Commission in 2012, which is still unresolved. “She told the lawyer that it was not about money but the amount of pain that the family underwent due to the company should be compensated. Now I want to win the case not for money but to get justice for my mother," says Jennifer.
“The cobalt and chromium ions are found in human body in all cases where metal implants are inserted (like nails, plates, standard hip replacement prosthesis. So far, they have not been proved to cause cancer in any of the studies , but the effect on the surrounding tissues create a mass (called pseudo tumour ) almost like what one gets in tuberculosis," said Dr Bhende.
Kabbir Chandhok still gets upset when he recalls the years he suffered with the faulty device. At 32, he has had three hip replacement surgeries. The problems started during his childhood. As a child, he broke his hand six times. At the age of 13 he was wrongfully diagnosed for bone tuberculosis and given 120 injections, kept on bed rest for 18 months, underwent an unnecessary hernia surgery and finally diagnosed with an autoimmune disease that has no cure because of which he had to replace his hip joints three times.
Kabbir is also a victim of metal poisoning caused due to the faulty implants. “In 2014, the doctors replaced my metal-on-metal with a pink ceramic hip joint," he said.
What pains him more is that he got to know about the recall three years too late. He underwent the first surgery in 2007 and in 2013 during his visit to the doctor he got to know that the product had been recalled. “I was earlier operated upon my left hip and I went to the doctor to get my right one examined as I was experiencing shooting pains. To my disbelief the doctor told me that I would have to undergo a re-replacement surgery on the left one. So I had the surgery on the left hip in 2013 and then another surgery on my right hip in 2014," he said.
What hurts Chandhok is that the company only paid for only two months of physiotherapy sessions. “I require continued physiotherapy sessions otherwise my movements are restricted but the company stopped paying after two months." Chandhok is approaching lawyers in the US to file a case against the erring company. “I am approaching lawyers in the US so that some prompt action is taken like it happened for the US citizens who were compensated properly. The lawyers in India say that it qualifies for a consumer case and it may take decades for the verdict to come, so it’s better not to file any case here".
Indeed, the delay in the Indian government committee report is puzzling. “The government action is long overdue, eight years have passed since the ASR hip implants were withdrawn," said Aisola. This thought is echoed by the patients. “In fact, what’s going on in India is more dysfunctional than the patients had imagined in their worst moments," said Vojhala.
While everyone has a story on how their life has changed post the implant, age-related anxieties often accentuate the lack of hope for the future.
Shroff’s wife says it is upsetting to lose the sense of normality of everyday life. It makes them feel broken, bewildered, trapped between reality and a distant possibility.