UPA allowed import of faulty Johnson & Johnson implants: Centre in SC

NEW DELHI: The Centre has told the Supreme Court that when patients in different countries were complaining about Johnson & Johnson’s (J&J) faulty hip replacement implants, the UPA government had permitted its import to India in February 2010 even though the company had withdrawn these from Australia months ago.
In an affidavit, the Central Drugs Standards Control Organisation (CDSO) said even though the hip replacement implant product was withdrawn from Australia in December 2009 after several complaints, J&J applied for an import licence in India on January 11, 2010, and was granted the same on February 18, 2010.
After informing CDSO on September 23, 2009, that its hip implant product had not got any complaint about its quality in the last three years, J&J on March 8, 2010, submitted a field safety notice to CDSO informing about higher rate of revision surgeries on patients who had received hip replacement implant products. J&J withdrew the metallic hip implant product from US, UK, Canada and Brazil in August 2010 and then informed the CDSO on August 24, 2010, about voluntary recall of the product from India.
The Dr Arun Agrawal committee, which went into the issue, said in its report that J&J was not providing adequate corrective measures to patients who had received their faulty hip implant. “The firm has failed to provide medical management to all the patients. In addition, the firm has not paid compensation to any patient so far as per available records,” the committee’s report said in February 2018 and suggested a base compensation of Rs 20 lakh to each patient who received the faulty hip implant.
In its affidavit, the Centre said it had not accepted J&J’s stand that it would not make any reimbursement to patients after August 24, 2017, and added that the company has to extend its reimbursements to patients till 2025.
The Centre said the Central Expert Committee headed by Dr R K Arya had devised a formula for recalculation of compensation to patients who received faulty hip implants and pegged the outer limit at Rs 1.22 crore. “The relevant formula has been approved by the ministry of health and family welfare on November 29 for determination of compensation for those patients who received (prior to August 2010) faulty Articular Surface Replacement (ASR) hip implants manufactured by DePuy International Ltd, UK (Johnson and Johnson Pvt Ltd),” it said.
A PIL filed by Arun Kumar Goenka had sought a direction from the SC to the government to protect the rights of 14,525 patients who received these faulty hip implants since 2005 and set up a special investigation team to ensure implementation of the SC ordered relief to patients.