Filed nearly two months ago, South Delhi-based businessman Arun Goenka’s (67) public interest litigation against multi-national pharmaceutical giant Johnson and Johnson came up for hearing in Supreme Court on Friday.

When Justice Ranjan Gogoi asked Goenka to clarify his stand as a petitioner, the latter told in the apex court, “The J&J hip implant case is like a mini-Bhopal Gas Tragedy. Patients were unaware of the poisoning that was spreading in their body due to the implant.”

Justice Gogoi has sought the Central government’s reply to the PIL, and has asked the expert committee to file its report within two months basis the court orders. The government along with Central Drugs Standard Control Organisation (CDSCO), Mumbai Police, the US-based J&J company, along with its Mumbai arm, and DePuy Orthopaedic Inc have been made respondents in the PIL.

Protecting citizens

In his PIL, Goenka has sought protection for Fundamental Rights of Indian citizens under Article 21 (Right to Life) for 14, 525 patients who had been fitted with J&J’s Acetabular Surface Replacement (ASR) hip implant surgeries in India since 2005. Senior lawyer and Congress politician Salman Khurshid was appearing on behalf of Goenka in the case.

The PIL alleges criminal negligence, grievous hurt by means of poison and distribution of adulterated drugs against the respondents. It pleads to the SC to take effective measures for saving lives of patients, ‘who have undergone DePuy ASR hip implant surgeries and would be unknowingly living a life in hell, if alive or may be dead, due to negligent acts of respondents.’

Goenka’s mother Poorna Devi, in her late eighties, died in March this year, after years of being wheel-chair ridden after the hip implant failed her way back in 2009. While Poorna Devi had undergone surgery for a hip replacement in 2007 at Batra Hospital in New Delhi, after two years, she experienced acute pain. Doctors discovered in CT scan reports that her hip implant had cracked into two parts, and that there was tremendous formation of pus in her body. She under went four surgeries since 2009 after she was diagnosed with septic arthritis.

“My mother was on wheel chair since 2009. She could not walk by her own self. Over the last two years, she developed alzheimer’s and later succumbed,” Goenka told BusinessLine.

Doctors unaware

In 2009, the doctors were not made aware of the design defect in ASR implants, which could lead to failures of as many as 44 per cent cases. J&J only voluntarily recalled the implants in 2011 from the Indian market. When the implant fails, it means that it leaches very high amounts of chromium and cobalt metal ions in patient’s blood. Leaching of metal can cause adverse reactions in a patient’s body including deterioration of multiple organs.

“Even in 2011, no doctor ever told us about the recall of implants or the helpline that existed for aid,” Goenka explained.

“We want to compel the government through the PIL to make the public aware of the harms caused by the implants,” said Goenka.

Only 1,500 patients have been identified through J&J’s ASR outreach programme, of which 1,080 have been claimed to be registered on their helpline, of which 275 have undergone revision surgery. The PIL questions why a large number of patients are untraceable.

As opposed to this, in the US, more than 10,000 US citizens’ claims have been settled by the company and as on date more than 1,600 lawsuits are pending in the US, the PIL contends.