To build a strong case against pharmaceutical giant Johnson & Johnson’s subsidiary DePuy Medical Pvt Ltd (DMPL), which manufactured batches of faulty hip implants and later recalled them from India in 2010, the Mahim Police has identified and recorded statements of 146 patients from across the country who underwent the surgery and suffered from ‘leaching’ of cobalt and chromium ions in their blood.
Inspector Popat Yele said of the 146 patients, 115 residing outside Mumbai were contacted via phone and 31 were reached in person in Mumbai. Additional commissioner of Police (Central Region) Madhukar Pandey said, “The investigation is in final stages. Only statements of a few people are remaining, after which the chargesheet will be filed.”
In 2011, following cases of medical complications in patients who underwent faulty Articulate Surface Replacement (ASR) implants manufactured by DMPL, the Maharashtra FDA had lodged a first information report (FIR) with the police.
FDA joint commissioner Madhuri Pawar said, “We have received medical reports of three patients (two from Mumbai and one from Hyderabad) who underwent the hip implant. They complained of pain and underwent revision therapy. All the documents related to their surgery were provided to the police in February this year.”
Mumbai-based banker Raj Arvind Shroff (53) was the first person in the country to lodge a complaint against DePuy. “I have submitted my X-ray, CT scan, blood test, and other reports to the FDA. There is still presence of cobalt of chromium ions in my blood, and doctors detected high tissue formation in my left thigh,” said Shroff, who underwent the first implant in 2007. He later required a revision surgery in 2012.
J & J recalled the implants from India only in 2010 after it did so in Australia, Europe and USA. Till then DePuy had already imported 15,829 implants in the country, of which 4,700 implants had been carried out. Only 1,295 medical devices were sent back, said FDA authorities. A majority of 4,700 patients remain unaware of the implant’s effect, and the police are contacting them through hospital records.
Inspector Kishor Sawant, former investigating officer, said, “The local supplier of ASR implants, Malani Biomedical Pvt Ltd, maintained a list of all hospitals that were supplied with the faulty implants in Mumbai. We approached these hospitals to get the contacts of patients.”
“Till 2013, of the 4,700 people, only 280 have registered a complaint with the company and 68 patients reflected a need of revision surgery. Of these, 10 were suffering from severe pain,” Pawar said. While J & J has agreed to pay a compensation of $2.5 billion to 8,000 US citizens, the investigations in India are going on at a slow pace. Currently, DePuy appointed company — Puri & Crawford — is reaching out to patients to check whether they need a revision surgery.
“If the levels of cobalt or chromium ions in the blood are elevated above seven parts per billion, soft tissue reactions, fluid collection or soft tissue masses can occur for which revision surgery is required,” Pawar said.
A DePuy spokesperson said, “Almost 35 per cent of the total ASR patients in India have been contacted through a helpline. We continue to work with surgeons to support their efforts to notify ASR patients and have hired a firm to notify more patients.”
The spokesperson added that ASR continues to function well for some patients and not all patients would require revision surgery.