On January 11, 2010, the regulator granted a fresh import licence to J&J after receiving another undertaking that it would recall the product if found faulty by a regulator in any other country. The ASR implants were globally recalled on August 24, 2010.
In the US, the hip implant class action law suit against the pharma major began in 2011. Two years later, in 2013, the firm agreed to pay an estimated $2.5 billion to settle thousands of lawsuits from affected patients.
The delay in cancelling the licence assumes significance as the firm told the expert committee — appointed by the Union Health Ministry in February 2017 — that it cannot trace as many as 3,600 patients who underwent the surgeries involving the faulty implant.
Justice (retired) B S Chauhan said that the stringent sedition law should be invoked only in cases “where intention” behind the act is to “disrupt public order or to overthrow the Government with violence and illegal means”.
The Law Commission said it was doing this with the “intention to initiate a healthy and sustainable debate on the issue” since simultaneous polls are “not possible within the existing framework of the Constitution”.
The Health Ministry committee also found that J&J reported 121 “serious” adverse events to CDSCO from January 2014 to June 2017. But, the report says, “only 48 of such reports are available with CDSCO”.
The report by a government panel states that over 3,600 patients with the faulty implants remain untraceable and that at least four deaths have been reported from those who underwent surgeries using these devices.
Citing the proximity of some candidates to sitting judges and judicial officers, it has suggested the need for a wider pool of names, a stringent scrutiny mechanism, and the need for a dedicated secretariat.