US-based Johnson & Johnson will have to pay compensation to patients in India for its faulty hip implant surgeries. The US giant is accused of selling faulty hip devices to over 4700 patients in the country – so far, four deaths have been reported and over 3600 patients with the hip surgeries are untraceable.
Ministry of Health and Family Welfare has asked the drug regulator – central drug standard control organisation (CDSCO)- to set up committees in states to receive complaints from patients who were affected by Johnson & Johnson’s faulty devices.
According to a report in the Times of India, the regulator is planning to place advertisements in different newspapers to identify such patients. “The CDSCO will also set up by the end of the week a central expert committee comprising orthopaedists, medical practitioners and legal experts to monitor functioning of expert committees at the state level and determine the compensation,” the TOI report said.
Last year in February, the Health Ministry had set up a committee under former dean of Maulana Azad Medical College Dr Arun K Agarwal to look into complaints about hip implants devices.
After considering all the facts and details as well as taking into account the relevant literature, the committee in its report said that “the ASR (articular surface replacement) hip implants manufactured by DePuy International Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India”. DePuy International Ltd is a subsidiary of Johnson & Johnson.
The report further said, “The committee is of the considered view that the revision surgeries were necessitated due to the faulty ASR, as well as negligence of the firm in approaching the patients, and therefore it is the responsibility of the firm to compensate all the affected patients.”
The committee suggested that Johnson & Johnson be made liable to pay at least Rs 20 lakh to each affected patient, and the reimbursement for revision surgeries should continue until August 2025.
According to the committee, the US giants suppressed the key facts while applying for a fresh licence. As per norms, the company had to file any adverse report of the products on its patients globally. However, the company did not have the records of all 4700 Indian patients who underwent the surgeries.
The company had records of only 1,032 patients; out of which 254 patients underwent revision surgery and 774 patients were monitored by surgeons.
The whole controversy began after Maharashtra Food and Drug Administration registered an FIR against Johnson & Johnson following an anonymous complaint in March 2011. The complaint was registered for importing and marketing the faulty hip devices in India despite recalling the product in several other countries.
Two years later, when reports emerged that J&J had agreed to pay compensation to around 8,000 American citizens who had sued the company for its faulty devices, the FDA received three more complaints from Mumbai, Chennai and Hyderabad seeking similar compensation for the faulty implants.
Later, the company received hundreds of complaints from its Indian patients.
In 2016, a US court had ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who had sued the company for faulty hip implants. The court had found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks.