New Delhi: J&J faces criminal charges in faulty hip implants case as the Mumbai Police are likely to file a formal case against it.
Mumbai Police are likely to file a formal case against J&J (Johnson & Johnson) over a complaint that a unit of the US company had supplied faulty hip implants to patients in India, a senior official said.
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The complaint was filed nearly nine years ago, but the police had ignored it until last April, when it launched a probe following a series of reports about allegedly faulty J&J implants and based on the findings of a central government-constituted expert committee.
The company had recalled the faulty hip implants devices in India after global reports of metal poisoning and high failure rate, and the government had last year told it to pay compensation to the affected patients.
The police have taken the statements of more than 65 patients, 15 doctors and distributors, Ajinath Satpute, an assistant commissioner of police and the investigating officer in the case, told.
“We have collected maximum evidence and will come to the conclusion very soon,” he said over phone from Mumbai.
J&J didn’t respond to an email seeking comment. A Food and Drug Administration (FDA) inspector in Maharashtra had filed the complaint against DePuy Medical Pvt Ltd, a J&J subsidiary, in 2011.
An estimated 4,700 patients had undergone acetabular surface replacement (ASR) surgeries in India during 2004-10 to fix hip problems with J&J implants.
The company traced 1,080 patients through its ASR helpline. The police too are trying to find more patients, but have “enough concrete evidence” against the company, Satpute said.
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“We have been trying to get in touch with patients in other states too. We have investigated the medical papers in respect of pre- and post-medical procedure.”
Satpute said the police had taken statements of insurance surveyors and loss assessors through which DePuy had established the reimbursement process and ASR helpline.
A high-level expert committee was set up in 2017 by the government to look into the matter of J&J’s hip implants that allegedly left many people permanently disabled.
The committee held the company guilty of failing to issue warnings to the patients of the harms posed by the orthopaedic implants, and a delay in recalling the devices.
The firm was “evasive” in providing information, claimed the report by the committee.