While the Central government draws flak for its failure to take action against pharmaceutical major Johnson & Johnson over its allegedly faulty hip implants, a group of patients who suffered severe consequences post surgery has approached Union Health Minister JP Nadda for remedial measures and to gain access to an expert committee report.
As many as 4,700 patients in India had received articular surface replacement (ASR) hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents’ bodies and pose a risk to their health.
The panel constituted by the government observed in January that the company appeared to have suppressed certain facts about the implants from Indian regulators. It recommended that eligible patients should receive a “base amount” of Rs. 20 lakh as compensation, and proposed mechanisms to identify eligible patients. Nadda told the media on August 27 that the ministry was “deliberating” on the panel’s report.
However, the company has denied any wrongdoing.
In their letter dated August 27, three patients – Vijay Vojhala, Shailesh Bachate and Vinay Agarwal – said, “In spite of our attempts over several years to draw attention to the serious safety concerns with the ASR hip implant device and the pain agony experienced by us, the response from the government for years was one of apathy and dismissiveness.” Jennifer Bharucha, whose mother died of brain cancer after undergoing three surgeries since she was fitted with the implant in 2007, and Praful Sardesai, the son of a deceased patient, are also signatories to the letter.
In its report to the health ministry, the panel also noted that the company had not done enough to reach out to all patients in India who had received the implants. Shailesh Bachate, a victim of metal poisoning caused by the faulty implant, had to go for a painful revision surgery, which was paid by DePuy. “But even after the revision surgery, I can’t walk normally and my day-to-day life is riddled with barriers,” the South Mumbai-resident said.
The patients’ group has urged the government to make the expert committee report public. They also seek to “participate in any further deliberations by the government on the action to be taken on the report”.
However, many industry observers point out that the affected patients may find it tough to get compensation over faulty hip implants from the pharmaceutical major as the Drugs and Cosmetics Act, which regulates medical devices in India, does not have such provisions. As per the data available in the public domain, the company has tracked more than 1,000 Indian patients and reimbursed the cost of revision surgery to 275 of them and the costs for testing to all of them.
Even in the US where the norms are stricter, J&J secured a favourable appellate court ruling in April this year over its Pinnacle hip implant devices. The court overturned an earlier verdict that had awarded US$151 million to five people who blamed injuries they suffered on the company’s Pinnacle devices.