J&J faulty implant case aftermath: Government mulling provision for compensation
The government is planning to bring a provision under which a medical device manufacturing company will have to offer monetary relief to patients in case of an adverse event.
A high-powered expert committee has been formed to evaluate and determine the quantum of compensation to be given to the victims.
This comes after numerous complaints filed against Johnson & Johnson for faulty hip implants.
Compensation value to be decided on the severity of cases
Under the provision, to be introduced as part of Medical Device Rules, 2017, companies will have to provide compensation to patients if the device causes injury, turns out to be unsafe, malfunctions, or there is non-compliance with the license rules, a Health Ministry official said.
The value of the compensation to be given to patients will be decided on the severity of the case.
Five-member expert panel to determine quantum of compensation
The five-member expert committee, which has been formed by the Center on the recommendations of an earlier panel probing the J&J case, is being chaired by Director, Sports Injury Center, Safdarjung Hospital, RK Arya.
The previous panel was constituted by the Ministry to investigate complaints about faulty articular surface replacement (ASR) hip implant devices manufactured by DePuy International, a subsidiary of Johnson & Johnson.
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J&J made liable to pay Rs. 20L to each patient
That panel had said that J&J "suppressed" facts on the harm of surgeries afterwards and that "the ASR implants were found to be faulty which resulted in higher instances of revision surgeries globally including India".
The report recommended that DePuy International be made liable to pay at least Rs. 20L to each affected patient and reimbursement for revision surgeries should continue till August 2025.
Johnson and Johnson
Johnson & Johnson
Medical Device Rules