Johnson & Johnson will have to pay patients with faulty hip implants who are found eligible for compensation by a committee that the government has set up, a senior health ministry official said.

“We will make them pay,” the official told on condition of anonymity. “It is no longer up to the company – the government has taken over responsibility of making sure patients are compensated.”

An expert committee set up last year to look into the issue of these implants had recommended the formation of a central compensation panel to accept claims from affected patients. J&J had told the ministry “in writing” that it will respect the recommendations of the expert committee, the official added.

The central compensation committee will study patient records and diagnostic tests to determine those who should get additional payments. The patients must directly approach the committee instead of contacting J&J if they want their grievances addressed, the official said.

Apart from cash compensation, the company is liable to pay for diagnostic tests and revision surgeries, the official said. Patients unhappy with the compensation could appeal to the government or approach court, the official added.

Several patients who received the faulty hip replacement devices have complained that they were not able to get a response from J&J’s helpline. Some alleged they were denied reimbursement for revision surgeries because it was more than 10 years after they received the implant.

The Drug Controller General of India announced a helpline for the compensation committee on September 11 and asked patients to reach out with their grievances and claims. Patients suffering from disability and “other losses” due to the faulty implants may approach the central compensation committee or state-level committees, the apex drug regulator said in the notice.

When ET called the government’s helpline on Tuesday, an official handling the call centre said details of thecompensation are still being worked out. “There is no clarity,” said the call centre official.

The compensation committee met for the first time on Tuesday to work out these modalities, said a person aware of the development.

A spokesperson for J&J Medical India said the company will be cooperative with the Indian government.

J&J officials told ET earlier that it continues to take queries from patients and the company is adding staff at its call centre to deal with increased volumes.

“Our helplines are open and we have already registered 1,080 patients,” the company spokesperson said. Efforts to support hip implant patients and their surgeons have been a top priority for J&J and it has requested all patients to register on our helpline, the J&J spokesperson added.

However, the ministry official reiterated that patients should approach the central compensation committee because it would decide on the payments to be made by J&J. A person aware of the development said J&J is also waiting for further directions and clarity from the government over this process.

In September, the health ministry decided to implement the expert committee’s recommendations to provide a minimum compensation of Rs 20 lakh to patients suffering from problems because of the implants.

J&J withdrew the implants from India in 2010 as part of a global recall after a study revealed a higher-than-normal failure rate of these devices.

The expert committee set up in 2017 said the design of the ASR implants led to high wear and tear and, in several cases, increase in chromium and cobalt levels in the body. The implants were potentially toxic due to this and could also damage organs in the body, according to the committee’s February 2018 report.

The regulator’s September 11 notification states that patients can reach out to the central compensation committee through the Central Drugs Standard Control Organisation’s legal cell at 011-23216367 (Ext. 315) or legalcell@cdsco.nic.in.

 

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