Mumbai, India – One of the world’s largest pharmaceutical companies is under investigation in India for failing to adequately follow up on a worldwide recall of a flawed hip implant.
The device, known as the Articular Surface Replacement or ASR hip system, was sold in India by DePuy Orthopaedics Inc., a subsidiary of Johnson and Johnson.
Around 93,000 patients around the world were implanted with the ASR between 2004 and 2010 with 4,700 surgeries taking place in India alone.
A global recall was issued in 2010 after the device failed at a higher-than-expected rate. Patients experienced pain, swelling, joint dislocation and metallosis, a condition where metal deposits build up in the soft tissues of the body.
Vijay Vojhala’s decision to have hip replacement surgery was not an easy one. But by 2008, his back pain was unbearable and he was diagnosed with Avascular Necrosis, a disease where bone tissue dies due to a lack of blood supply.
|Vijay Vojhala says he was shocked to find his chromium levels were around 170 times higher than the recommended levels [Suranjana Tewari/ Al Jazeera]|
As he was just 34 years old, Vojhala’s surgeon recommended he have a so-called metal-on-metal implant fitted because it was marketed to provide greater range of motion and more flexibility.
Vojhala who works as a general manager in the medical supplies industry himself, was advised that the DePuy ASR was the best in the market and he was encouraged by Johnson and Johnson’s reputation.
But immediately after his surgery, Vojhala started experiencing problems with his implant.
“I had squeaking sounds when walking and sitting, pain and limping,” Vojhala told Al Jazeera. “I had some other health problems but I didn’t realise what was going wrong or why. I had a lot of problems like breathlessness, giddiness, nausea, constant tiredness and severe dental problems. In fact, my pereodontist was amazed at the speed of decay given my normal dental hygiene.”
In September 2011, while attending a medical conference for work, he was told that the DePuy hip system had been recalled and was advised to get his chromium and cobalt levels tested.
He was shocked to find his chromium levels were around 170 times higher than the recommended levels. The levels of cobalt in his blood were also unusually high.
It was then that Vojhala began researching the global recall and failed to understand why he not been contacted to undergo the necessary tests.
“Until 2011, no-one called me. Not my operating surgeon, the hospital I was operated in, the Maharashtra Food and Drug Administration, Johnson and Johnson or DePuy. Nobody. It was all initiated from my end,” Vojhala said.
Failure to follow up
Health authorities in India have accused Johnson and Johnson of not going far enough to initiate the recall and contact patients.
The Food and Drug Administration in the state of Maharashtra filed a criminal case against Johnson and Johnson in 2011, which is still under investigation. It has also asked the Central Bureau of Investigation – India’s federal police unit – to step in.
Documents seen by Al Jazeera show that DePuy issued Field Safety Notices related to the recall to clinicians and the Drug Controller General of India on August 24, 2010, the same day as the international recall was announced.
In an email statement to Al Jazeera, Johnson and Johnson said, “DePuy India provided the necessary recall information to surgeons and hospitals and had sought their support so patients could be notified.”
“Due to patient confidentiality requirements governed by the ethics code of the medical profession in India. DePuy India does not have access to data on patients who have received an ASR hip implant,” the statement said.
While DePuy says it has recovered all the implants that were imported into the country, it admits that it has only managed to contact 35 percent of ASR patients in India.
Some doctors say DePuy did everything within its power to reach patients.
|Orthopaedic surgeon Dr Harish Bhende says Johnson and Johnson contacted him as soon as the global recall was issued [Suranjana Tewari/ Al Jazeera]|
“All the revision surgeries were paid for by Depuy,” said Dr Harish Bhende, an Orthopeadic Surgeon at Laud Clinic in Mumbai. “They have taken extensive efforts to contact our patients. We gave them the data and they contacted some of the patients themselves. They even paid for travel.”
Dr Bhende fitted more than 40 patients with the ASR hip system.
He says DePuy notified him as soon as the international recall was issued and his practice stopped using the device immediately.
It is not always easy to contact patients in India, according to Dr Bhende, because many people change their addresses and phone numbers regularly. He says that if patients are not experiencing any health problems, many refuse to return for tests.
Some patients are angry that the hip implant was brought into the Indian market in the first place. But Dr Bhende disagrees.
“I genuinely believe that it is the technique that matters in the outcome of the surgery,” Bhende said of the recall. “There are enough medical devices in the past that have been launched, failed and withdrawn from the market well after being released.”
‘Several parties responsible’
Vojhala eventually had revision surgery in 2012. Johnson and Johnson paid for all tests and expenses related to the surgery, but Vojhala was left to do most of the paperwork and co-ordination with the hospital.
And his health problems had already had a huge impact on his life.
“Of course my company supported me during that time but any company will only support you to an extent. And if you are bedridden or have lost your confidence in walking, how can you argue with the company. I had to quit my job after a lot of struggle,” Vojhala told Al Jazeera.
He said that the government also delayed its response to the recall.
It took until December 2013, more than three years after the international recall, for the CDCSO – India’s regulator of medical devices – to issue its own recall notice.
Vojhala says that the government and Johnson and Johnson are therefore equally responsible.
Vojhala has now served a legal notice to all parties involved in his surgery, including government agencies and Johnson and Johnson. A complaint will then be filed in a national consumer court.
Johnson and Johnson agreed to a $2.5bn settlement for 8,000 ASR patients in the US last year.
“Americans, Japanese, Russians, Ukrainians – if they are allowed to get compensation why not Indians?” Vojhala told Al Jazeera. “We are not guinea pigs.”
Follow Suranjana Tewari on Twitter: @suranjanasays