The Indian arm of Johnson &Johnson ‘suppressed’ key facts regarding the recall and compensation of the faulty hip replacement systems it sold in India, an expert committee set up by the Union Ministry of Health & Family Welfare said in a report.
The expert committee has recommended making the company liable to pay Rs 20 lakh per patient and also continue their reimbursement scheme for revision surgeries till August 2025, according to a report in The Indian Express report.
DePuy Orthopaedics Inc imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in India, which were globally recalled in 2010 for being faulty. The implant was leaking metals in the patient’s body. 93,000 patients had this implant worldwide out of which 4,300 were from India. Of the 4,300 only 1,032 have been registered with the ASR helpline till March 2017 and 254 have been provided with revision surgery.
“The firm has been found evasive in providing information desired by the committee regarding the design of the ASR, patient details including address, contact, compensation details, details of the usage of ASR, follow up Adverse Drug Reaction reports. The firm also appears to (have) delayed in passing information and awareness about the failure of the ASR,” the committee said.
The report points to the fallacy of the data provided to the Central Drugs Standard Control Organization (CDSCO) by the company regarding the adverse events due to the implants. J&J have only reported 121 adverse events whereas there have been 254 revision surgeries and 774 patients were kept on monitoring by surgeons. Even out of the 121 adverse cases J&J has made only 48 reports available with CDSCO.
The committee said that the information regarding the deaths of the four patients who had this implant provided by the company was ‘quite brief’.
The company reported the rate for revision surgery to be at 12 percent. “As per 2014 data, the cases of revision surgery were very high almost 35%. However, as per the latest data, the rate comes out to be 25 percent,” the expert committee said. However, even the 25 percent is based on the patients that have contacted the registry of the firm, it does not include all patients with faulty implants.
“In India, the revision surgeries took place around 7 years after the date of primary surgery… the product was recalled globally in the year 2010. Whereas the revision surgery in India started only in the year 2014,” the committee noted.
In 2013, J&J agreed to pay $2.47 billion to around 8,000 claimants in USA but in India the company hasn’t paid any compensation, according to the committee. The firm claims Rs 1.76 crore for diagnostic tests and Rs 14.2 crore for revision surgery has been reimbursed.
“In a strange way the company was equating reimbursement with compensation,” the committee said.