What slipped under the radar is a story of how Johnson & Johnson used a loophole in US laws to push into the Indian market without any clinical trials in the country, an investigation by The Indian Express has found.
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.
On Tuesday evening, the Central Drugs Standard Control Organisation (CDSCO), the national pharmaceutical and medical devices regulator, uploaded the report on its website. The report was submitted in February.
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.
A US court has ordered Johnson & Johnson to pay $ 72 million in damages for an ovarian cancer death linked to the use of its baby powder. It’s a product widely used in India too — does it cause cancer?