PT Jyothi Datta A global controversy involving Johnson & Johnson’s ASR hip implants seems to have come back to haunt the company in India, raising in the process the larger issue of patient compensation.

An expert committee under the Health Ministry has submitted a report that said the company had “suppressed” information on the faulty hip implants, according to media reports. While the report is not in public domain, Dr Arun Agarwal, who chaired the committee, told BusinessLine it had submitted the report in February to the Ministry. Agarwal is former Dean and Professor (ENT) with Maulana Azad Medical College.

“We are worried about patient safety and a system of compensation,” Agarwal said, adding the panel had recommended, among other things, a subject-specific expert committee that could examine individual cases and assess the severity of handicap if patients required compensation.

Internationally, DePuy Orthopaedics (part of J&J) had voluntarily recalled its ASR Hip System in 2010. In November 2013, it had agreed to pay $2.5 billion to settle consumer complaints in the US. Covering about 8,000 patients, it was billed among the highest payouts for a medical device.

Patient support

Investigating the issue a month later following a consumer complaint, the then Maharashtra Food and Drug Administration Commissioner Mahesh Zagade had also raised the issue of patient support and compensation.

Recalling the case, a now retired Zagade told BusinessLine the product has been implanted in about 4,700 Indian patients. The complaint against the product was of cobalt and chromium “leakages” into the blood that was harmful. In the US, the company financed revision surgeries and patients were compensated for their suffering, he said, adding that similar action should have been taken in India, too. The drug regulatory administrative system needs to follow up on such recalls and hold companies accountable for faulty products as it involves the lives of patients, Zagade said.

Maintaining that the company had responded responsibly, a DePuy spokesperson said: “We immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements.

“DePuy has fully cooperated with the expert committee in their investigation of the ASR matter. However, the Expert Committee Report has not been provided to the company for review to date, so it would be inappropriate for us to comment on it. We would like to reiterate that we have furnished full facts and the data available with us to the expert committee.”

DePuy has instituted a helpline, portal and surgeon assistance in India along with advertisements to reach out to patients. About 1,080 patients have registered with the ASR helpline. “Of those, 275 have undergone revision surgery and the rest are under testing/monitoring by their treating surgeons,” the spokesperson said, adding that not all ASR patients need a revision surgery.

After years of testing, ASR was imported and marketed in India and globally, with all regulatory approval and permissions, the spokesperson said. “After it was on the market, DePuy continued studying and closely watching how the device was performing and, in August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry,” the company said, outlining the recall process.

comment COMMENT NOW