J&J faulty hip implants: Govt panel to evaluate claims of 15 patients

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J&J faulty hip implants: Govt panel to evaluate claims of 15 patients

New Delhi: After eight years of struggle, patients with “faulty” hip implants sold by a subsidiary of pharma giant Johnson and Johnson (J&J) can finally expect to receive damages. A central expert committee formed by the government will meet on Tuesday to evaluate cases of the first 15 patients who had approached the drug regulatory authority for financial compensation. This will be the first-ever initiative of compensation being paid for sub-standard treatment in the country.

The government had on 11 September constituted the committee under the chairmanship of Dr. R.K. Arya, director at sports injury centre, Safdarjung Hospital, to decide on the quantum of compensation and medical management for patients with the “faulty” hip implants.

“In their first meeting, the experts will design a protocol that will be adopted to decide on compensation for the affected patients,” said a senior health ministry official, on condition of anonymity.

J&J faulty hip implants: Govt panel to evaluate claims of 15 patients

“About 15 patients have come forward and approached the legal cell of CDSCO (Central Drugs Standard Control Organization). Based on the documents submitted by them, they will be called and referred to government hospitals to examine the extent of the damage,” the official added.

A company spokesperson said they are cooperating with the government to develop a clear process for providing further support and compensation for ASR (acetabular surface replacement) patients. “We are also ramping up our helpline and adding additional responses to support patients”.

The government has also asked principal and health secretaries to form state-level committees to examine details of the affected patients and determine the quantum of compensation for patients who had to undergo corrective surgery after being fitted with “faulty” hip implants sold by the J&J subsidiary.

The state-level committees, the panel said, will evaluate the claim made by patients from disability and suffering caused from using the device. The total compensation will be decided by the central committee on the basis of the base amount and loss of wages.

In 2017, the ministry formed an expert committee under the chairmanship of Dr. Arun Agarwal, former dean of Maulana Azad Medical College, which suggested at least ₹ 20 lakh be paid to each patient. The state-level panels will comprise two orthopaedic surgeons, one radiologist from the government medical college and a representative from the zonal office of drug regulator. States have also been asked to issue advertisements in newspapers so that affected patients can approach the committees.

“The panels should be formed to enable hassle-free access to patients so that they can easily approach state-level committees in respective states,” the health ministry said in its earlier letter. Mint has reviewed a copy of the letter.

At present, there are no specific legal provisions to provide compensation to patients in such cases. The government swung into action after Mint on 23 August exposed the case and highlighted concerns over the metal-on-metal ASR hip implant.

J&J has been in the dock for adopting double standards as it hasn’t paid any compensation in India contrary to a hefty compensation of $2.5 billion that it agreed to pay to around 8,000 US citizens who have sued the company after faulty hip implants.

On their part, the affected patients feel that compensation should be based on physical, mental, social and economic harm faced by patients. “Not only the basis of physical medical criteria. It is critically important that patients, their representatives and a psychologist are part of the committee and their voices should be heard,” said Kabbir Chandhok, who had an ASR implant years ago and continues to suffer from complications after multiple revision surgeries.

source: livemint