An Indian government panel has recommended that Johnson & Johnson (J&J) pay compensation of at least US$28,500 to each Indian patient who suffered from artificial hip implants the US healthcare firm recalled eight years ago.
The Articular Surface Replacement (ASR) implants were recalled in 2010, after data suggested that they failed at a higher-than-expected rate.
In 2013, the firm agreed to pay nearly US$2.5 billion to settle thousands of lawsuits from those in the US who said they were injured by the implants.
In India, J&J paid US$2 million to patients for repeat surgeries and about US$250,000 in related diagnostic costs under its ASR reimbursement program, but the panel criticized the firm for offering no compensation.
“The fact remains that no compensation ever has been made by the firm in India to any patient,” the panel said in a 118-page report released late on Tuesday.
The panel was set up by the Indian Ministry of Health and Family Welfare, which has said it is reviewing the report.
J&J said its unit did not have access to data on patients who received implants because of patient confidentiality regulations, but it had given “top priority” to supporting ASR patients.
“The company has always put the health and safety of ASR patients first in everything we do,” it said in a statement.
About 93,000 people worldwide received ASR implants, the panel said, about 4,700 of them in India.
Metal hip implant systems such as ASR were designed to be more durable than a traditional metal-on-plastic ball-and-socket design, but many Indian patients experienced adverse reactions from the implant, the panel said.
It also criticized J&J for being “evasive” in sharing information on ASR’s design with it. Only in 2015, five years after the ASR recall, did the company run newspaper notices in India about the move.
This “shows the negligent behavior of the firm to reach out to the affected patients,” it said, calling for periodic ads to raise patient awareness about the implants.
J&J denied the panel’s assessment, saying its unit had not been evasive and had “fully cooperated with the expert committee in their investigation.”
The panel findings, first reported by Indian media last week, have sparked a public relations crisis for the US-based company, which has also faced criticism from patient rights activists.
J&J “has the responsibility to track patients, make them aware of the adverse effects and compensate them,” said Oommen Kurian, a health researcher at the New Delhi-based Observer Research Foundation.
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