India’s Central Drugs Standard Control Organization is calling on Johnson & Johnson to compensate patients who suffered serious adverse events linked to the company’s ASR hip implants.
CDSCO is recommending compensation of 2 million rupees (roughly US$28,000) per patient who underwent revision surgery with the ASR XL acetabular hip system and ASR hip resurfacing system. The ASR implants were globally recalled in 2010 due to defects. About 4,700 patients in India received the hip implants.
The Aug. 30 order is based on the degree of disability and monetary losses patients suffered. The recommendation followed an investigation by the Ministry of Health & Family Welfare. The ministry’s expert committee released a report in January reviewing actions taken by J&J to replace the faulty ASR implants and to judge the adequacy of the firm’s response.
“Many patients in India and across various countries have suffered due to the ASR and have been forced to live a compromised life to the [the] faulty implant,” the expert committee concluded. It said an “opportunity should be given to make the claim for ‘just and adequate’ compensation to each and every patient who had undergone revision surgery to mitigate some of their pain and sufferings.”
The report says that J&J “has been found to be evasive in providing the information desired by the committee regarding the design of the ASR [and] patient details” and that it failed to provide the exact number of patients who had undergone surgeries/re-surgeries with ASR.
The expert committee also recommended that J&J provide medical management to all affected patients both with and without symptoms.
It also urged the government to strengthen its device oversight program and to establish an independent registry for tracking high-risk medical devices.
Numerous lawsuits over metal-on-metal Pinnacle Acetabular Cup System hip implant devices are working their way through U.S. courts. J&J stopped selling the devices in 2013. The most recent verdict came from a Dallas federal court in November 2017 that ordered J&J to pay $247 million to six patients (IDDM, Nov. 27, 2017).
J&J’s DePuy did not respond to a request for comment by deadline.