Three patients affected by “faulty” hip implants manufactured by a subsidiary of Johnson & Johnson, and the relatives of two deceased patients, have sought “participation in any further deliberations” regarding “action to be taken” on a report submitted by a committee set up by the Union Health Ministry on these medical devices.
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 key findings of the committee, reported by The Indian Express on August 24, constitute the first official indictment in India against J&J, which imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country — these devices were globally recalled in 2010. The panel found that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
It recommended that the company be made liable to pay at least Rs 20 lakh to each affected patient and that the reimbursement programme for revision surgeries continue until August 2025.
“The ASR hip implants were found to be faulty, which resulted in higher revision surgeries,” the report said. The “accelerated wear of metal on metal implant leads to higher levels of cobalt and chromium in the blood which lead to toxicity. These metal ions damage tissues and further damage body organs” and “may also cause localised and systematic health problems,” it said.
All this, the panel found, “results in increased pain and decreases mobility, affecting their family and social life” and has “a negative impact on their self esteem and mental health”.
J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics Inc, 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.
Replying to a question on the committee’s report, Nadda had told reporters Monday: “We are deliberating on the matter and will come back soon.”
The letter to Nadda, signed by three patients — Vijay Vojhala, Vinay Agarwal and Shailesh Bachate – and dated August 27, stated: “We believe that the investigation of Johnson & Johnson’s faulty hip implants and the resulting governmental action should be done in a transparent manner so as to ensure that vested interests do not unduly influence the process.”
The letter has also been signed by Jennifer Barucha and Praful Sardesai, the children of deceased patients who used these implants. “We also seek participation in any further deliberations by the government on the action to be taken on the report,” the letter stated.
“In the 8 years since the recall of this product, we have endured pain and become disabled. Some of us have lost family members who died awaiting redressal…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 and agony experienced by us, the response from the government for years was one of apathy and dismissiveness,” the letter stated.
“Recently, we have become aware of various media reports that the government is considering implementation of the expert committee’s recommendations, especially in respect of compensation of patients…The one matter astonishingly missing from these reports is whether there has been any consideration of criminal charges or investigations into the criminal acts of Johnson & Johnson in marketing this faulty product,” the letter stated.
On August 25, The Indian Express reported that the former Maharashtra Food and Drug Administration commissioner Mahesh Zagade wrote a letter on June 4, 2013, to the state’s Chief Secretary requesting a CBI enquiry against DePuy.
On January 5, 2015, Vojhala wrote an email to G N Singh, the then Drug Controller General of India, asking for a CBI enquiry. The Mumbai-based patient quoted the letter written by Zagade.
Praful Sardesai’s father Prataprao Atamaram Desai had the hip implant operation in February 2010. Speaking to The Indian Express, Praful said: “His (the father’s) hip started paining just two-three days after the operation. We took him to hospital and the doctor said that his hip has been dislocated. Pus formation began at the place where the operation was done. He was in immense pain…He died in May.”
On August 24, Johnson & Johnson told The Indian Express: “DePuy’s top priority is and always has been patient safety. We understand that the August 2010 ASR Hip System voluntary recall is concerning for patients, their family members and surgeons. Since the voluntary recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including a reimbursement programme to address recall-related costs that was the first-of-its-kind worldwide.”