A government panel has accused the Indian arm of Johnson & Johnson of suppressing facts on the adverse effects of faulty hip replacement systems it imported and sold for use in surgeries on hundreds of patients, The Indian Express reported on Friday.
The report was prepared by an expert committee set up by the Union Ministry of Health and Family Welfare to investigate complaints about the hip implant devices sold by the company in the country. The committee, which was set up on February 8, 2017, submitted its report on February 19, 2018. The government, however, has yet to implement the recommendations made in the report.
Additional Secretary in the Health Ministry, RK Vats, said the government has accepted the report in principle. “There have been strong recommendations which will be implemented,” Mint quoted him as saying.
“The Expert Committee Report has not been provided to the company for review so it would be inappropriate for us to comment on it,” a spokesperson for the company told The Indian Express.
Expert committee’s findings
The hip implant devices called articular surface replacement or DePuy ASR are manufactured by DePuy Orthopaedics Inc, a fully-owned subsidiary of Johnson & Johnson. In India, it is represented by Johnson & Johnson Private Ltd.
The report said the company did not inform the national regulator – Central Drugs Standard Control Organisation – about the number of patients who had used these devices, the adverse reports following such surgeries and the corrective operations subsequently conducted. It also “did not provide any compensation” to those affected.
The report said over 3,600 patients with the faulty implants were untraceable, and at least four people had died after undergoing surgery to implant the devices.
According to the report, around 4,700 people in India underwent surgery for hip replacement to implant the device. But, only 1,032 patients were registered with the ASR helpline, of which 254 patients underwent a revision surgery.
The committee also found that the revision surgery rate was not 12% as the company had reported. “...as per 2014 data, the cases of revision surgery were very high, almost 35%,” the report said. “However, as per the latest data, the rate comes out to be 25%. The committee noted that this data is only for the patients who had contacted the registry of the firm and it does not count those patients on whom the implant was inserted.”
The committee said “the firm has not provided any conclusive response” on compensation in India. “It is clear that the firm has not paid any compensation,” the report said, adding that the company equated reimbursements for diagnostic tests and revision surgeries as compensation.