The Central Drugs Standard Control Organization (CDSCO), which controls the manufacture and sale of drugs and medical devices in India, sent a letter to J&J on Tuesday asking it to pay interim compensation to each of the 4700 people that received the implant. The drug regulator made the decision on the recommendation of a panel chaired by Dr. Arun Kumar Agarwal. The implants were made by DePuy International, a unit of J&J.
The Times of India said that all patients who got the implants will be evaluated individually to gauge the extent of the medical problem and the compensation amount will be enhanced accordingly.
The report in the Times of India also said that apart from the base compensation, the regulator has asked J&J to extend all necessary medical assistance to the patients till 2025 as well as refund medical bills.
The company had earlier informed that as many as 4,700 patients in India had received the faulty implants, but about 3600 patients are yet to be traced, the Times of India reported.
The expert committee held an investigation for 12 months and the 118-page report revealed that several Indian patients who received the Acetabular Surface Replacement (ASR) hip implant device, known as DePuy ASR, almost a decade ago, had to undergo years of suffering due to adverse reactions from the faulty product. Of the 101 patients approached by the company, 22 patients said that they underwent a revision surgery after the initial implant surgery, while some of them even had to undergo a third surgery, according to Indian business newspaper Mint.
The letter notes five category of patients who are considered eligible for the base compensation: patients who underwent ASR surgery but no revision, patients who underwent ASR surgery with no disability or suffering from disability, patients who underwent more than one revision surgery yet suffering from disability or patients implanted with ASR, suffering from any other systemic disorder or casualties will come under the compensation scheme.
The ASR hip implants were recalled in 2010 after it emerged that they failed at a higher-than-expected rate, Reuters reported. In 2013, J&J agreed to pay about $2.5 billion to settle lawsuits from 8,000 patients in the United States who said they suffered due to the implants.
In India, the United States-based firm paid $2 million to patients for repeat surgeries and about $250,000 in related diagnostic costs under its ASR reimbursement program, the report added. It has, however, been criticized for offering no compensation to the victims.