J&J to work with govt to provide "further" compensation to ASR hip implant patients

NEW DELHI: US medical device giant Johnson & Johnson, which has been under fire lately over its response to patients and the government during a year-long investigation into 'faulty' hip implants that it had sold in the country before 2010, said on Thursday that it would work with the government to provide patients "further" compensation.

The development follows a letter sent by the country's apex drug regulator on Tuesday directing it to comply with "all" recommendations of an expert committee that looked into the matter.

"In light of the recent committee report, we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation for patients in need," a Johnson & Johnson Medical India spokesperson told ET. "We have always been and continue to be fully committed to supporting all ASR patients in India, and the rest of the world. That’s why J&J instituted an unprecedented patient reimbursement program in August 2010."

ET is awaiting responses to queries sent to J&J about this and will update the article.

"The committee is of the considered view that the revision surgeries were necessitated due to faulty ASR as well as negligence of the firm in approaching patients," stated Drug Controller General of India Eswara Reddy in his letter to J&J on September 4. The DCGI told J&J that it has to trace the remaining patients who have received the implants but have not registered on the company's ASR helpline.

"Sincere efforts should be done by the firm to trace all the patients who have received the ASR and collect data related to their health status with reference to hip joint," stated Reddy in his letter.

Other issues linked to the implants include increased levels of chromium and cobalt in the body, which could lead to poisoning, according to the expert committee's report.

The company told the expert committee that it had provided patients in its reimbursement programme with free hospitalisation, medical management like diagnostic tests and the cost of the implant, according to the committee's report. J&J provided a total of Rs 1.76 crore for these diagnostic tests and Rs 14.20 crore for revision surgery and associated costs, including out-of-pocket and loss of wages.

"It is clear that the firm has not paid any compensation," the committee observed, stating the costs provided were reimbursements.

Over 250 patients in India who had received these implants had received revision surgeries following complaints of pain, according to the committee. So far, around 1,032 patients have been traced, but it is not clear how many patients with the implants are yet to be contacted, it suggested.

Around 4,700 surgeries had been conducted with these implants, it stated.