Satisfied with the steps that have been taken by the government in compensating victims of faulty implants manufactured by US-based pharma major Johnson and Johnson (J&J), the Supreme Court on Friday accepted the principles of the formula that have been recommended to pay damages between Rs 30 lakh and Rs 1.22 crore to the patients fitted with the controversial hip implants between 2004 and 2010.
A Bench led by Chief Justice Ranjan Gogoi disposed of the PIL, filed by one Arun Kumar Goenka, that sought action against the multinational for manufacturing faulty hip implants after noting the steps being taken by the government to help victims.
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While accepting the government’s formula, according to which patients will get compensations between Rs 30 lakh and Rs 1.23 crore depending on their age and the level of disability, the judges asked the health ministry to give wide publicity to the scheme and also directed the health ministry expert committee headed by Dr Arun Agarwal to expeditiously compensate the victims.
The panel, which found the implants to be potentially toxic and unsafe for patients, had recommended that patients suffering as a result of the product be compensated.
The apex court also rejected Johnson and Johnson’s plea challenging the basis of the formula. It refused to say that the order in the PIL will not influence the case which the company has filed in the Delhi High Court.
In December, the HC had refused to grant any relief to J&J, which has challenged the Centre’s compensation formula, saying since the apex court is seized off matter it was not inclined to pass any orders. The US firm had asked the high court to quash the formula and direct the government not to take any coercive steps against it.
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The PIL in the SC had sought investigations into imports of alleged “faulty” and “deadly” hip implants without any proper clinical trial. Goenka had also sought a direction to the Centre to advertise about recall of J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics, and devise a mechanism to ensure safety of 14,525 Indian patients who had undergone the hip replacement surgeries since 2005.
The ASR hip implants were found to be faulty, resulting in higher revision surgeries. The firm had recalled the devices on August 24, 2010 from the US market. The implants had allegedly lead to higher levels of cobalt and chromium in the blood which lead to toxicity, thus causing increased pain and decreased mobility in patients.
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J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics, were first cleared by the United States Food and Drug Administration (USFDA) in 2005. Following red flags on the rising number of revision surgeries, the firm recalled the devices on August 24, 2010.
The firms “illegally sold DePuy ASR Hip Implants in India from 2005 to 2006. In fact, J&J applied for Import license only on December 6, 2006 and was granted license by Drug Controller (India) on December 15, 2006; however, showing contempt and disregard to Indian Laws for safety of Indian citizens, Respondents (the firms) imported and sold the implants even without imports license,” it said.
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Goenka said that the company had to pay $4.40 billion to over 9,000 victims of faulty implants in the USA, and in India no such measures have been undertaken. “As on date, more than 1,500 law suits are pending in the Federal Courts in USA,” it added.