Johnson and Johnson faulty hip Implant Case: Health Ministry deliberating report says Nadda

The Indian Express, recently stated that the Indian arm of Johnson and Johnson obtained a fresh registration certificate for its ASR hip replacement implants in the same month from the Indian Regulator, when the Australian regulator had ordered a recall on the same product.

It also added that the company obtained the said fresh registration certificate from the national regulator for medical devices on December 23, 2009, without informing the authorities that the product had been recalled in Australia in December 2009. On January 11, 2010, the firm applied for an import licence on the basis of that certificate.

The daily has reported that as per the committee report, the documents submitted during its probe on the “faulty” implants, the global pharma major “themselves have admitted about the product failure”. The product was globally recalled on August 24, 2010.

The Government committee stated in its report it was informed of the recall by Australian authorities. It said that the company may have violated Indian laws by applying for a fresh licence later to sell the devices in the country.

“The firm had applied for import license on the basis of the registration certificate on 11 January, 2010. However, the fact the ASR was already recalled in Australia in December 2009, was not informed to the CDSCO even at the time of application for import licence. That the committee observes that there appears to be suppression of material facts by the firm to the CDSCO. This is construed as serious breach of a condition of approval,” the committee’s report states, the daily quoted.

Further, Reports quoting the expert committee findings say that over 3,600 patients with faulty implants remain untraceable and that at least four deaths have been reported among these patients.

According to reports, the expert committee, set up to investigate complaints about hip implant devices, has suggested that the company pay compensation of around Rs 20 lakh to the affected patients.