The Maharashtra Food and Drug Administration (FDA) has recommended that 35 patients should receive compensation in the Johnson and Johnson hip implant case after careful scrutiny of the 68 applications received from across Maharashtra over the past six months.
In 2010, the pharmaceutical giant had globally recalled articular surface replacement (ASR) implants after noticing an adverse reaction in patients who underwent hip implant surgery. Among the most common adverse reaction was cobalt and chromium leaching from the metal implant into the bloodstream.
The Central government began the process of calculating compensation for patients after finding the faulty implant had adversely affected thousands in 2018. The move came after much delay – in 2013 Johnson & Johnson was directed to pay compensation of $2.5 billion (Rs 2,500,000,000) to around 8,000 US citizens who had sued the company for faulty implants.
A report by Maharashtra FDA, which registered an FIR against the company in March 2013, shows J&J called for a recall late in India in 2010. Till then, DePuy Medical Private Limited, its subsidiary, had imported 15,829 implants in the country.
In India, 4,700 patients underwent the hip implant surgery between 2006 and 2010. By 2010, when a recall was announced, only 1,295 medical devices were sent back.
In 2013, a Maharashtra FDA report stated that 68 patients had high ESR (erythrocyte sedimentation rate) value, which indicated poisoning due to the faulty implant. The report also stated that the ASR implants led to cobalt and chromium ions leaching in the body, leading to muscular toxicity and pain in addition to affecting mobility.
Even as Maharashtra has begun the painstaking effort of reaching out to all the affected persons, patients claim the process is tedious.
Dr Nilesh Shah (58), who underwent the first hip implant surgery in 2005, second implant in 2007 and revision surgery in 2016, said the side effects worsened since his revision surgery. “My body is tilted towards one side. I played table tennis regularly. Now, I require special shoes to play the sport,” Shah said. He added that while J&J offered to pay for those who required revision surgery, the pharma giant has refused compensation to those who have still not required revision surgery.
“Even for revision surgery, they are paying only Rs 25 lakh,” he said.
In 2017, Shah had sent a legal notice to J&J. “In India, the process is tedious. Tests showed cobalt and chromium levels are 10-15 times higher than the normal level in my body,” he said.
Another doctor, Suresh Shah, had undergone ASR hip implant in 2006 but has not required revision surgery so far. J&J has not paid any compensation to him. “The cobalt and chromium leaching in the bloodstream can affect the brain and kidney. In my body it is 5-9 times higher than the normal level,” he said.
Maharashtra officials said the 68 applications it received were scrutinised by a five-member committee, including three doctors from JJ hospital. “Those (applications that have been) rejected have not undergone ASR implants,” FDA drug inspector Mahesh Deshpande said. Several, Deshpande added, have died while waiting for compensation.
FDA Commissioner Pallavi Darade said the FDA will continue the process of inviting applications and forward them to the Central government. “We have given newspaper advertisement asking ASR hip implant patients to submit their medical reports,” she said.
Officials said the compensation will be based on the level of deformity caused by the implant. It may range between Rs 30 lakh to Rs 1.22 crore. Several have alleged locomotive disability and hearing problem.