BackJ&J directed to trace, compensate all faulty hip implant patients
A govt letter said J&J is liable to pay adequate compensation, commensurate with the severity of pain, the resultant disability, sufferings and the loss of wages of each patient who received ASR
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New Delhi: The government on Wednesday asked the Indian orthopaedics unit of Johnson and Johnson (J&J) to compensate all patients forced to undergo revision surgeries due to faulty hip implants, piling pressure on the drug maker.
Pointing out that a defective design led to high “wear and tear" and damage to the human body, a government letter said J&J is liable to pay adequate compensation, commensurate with the severity of pain, the resultant disability, sufferings and the loss of wages of each patient who received Acetabular Surface Replacement (ASR). The implant known as DePuy ASR was sold in India by DePuy International, a unit of J&J.
In the letter to the managing director of DePuy Medical Pvt. Ltd, the government asked the company to trace patients who received the metal-on-metal ASR but have not registered themselves through a company helpline. The firm has also been asked to extend its reimbursement programme till 2025.
While around 4,700 ASR surgeries were carried out in India between 2004 and 2010, only 1,080 patients could be traced through the ASR helpline. “The firm has to do due diligence to trace those remaining patients who have received ASR but have not registered with the helpline. Sincere efforts should be done by the firm to trace all the patients who have received ASR and collect data related to their health status with reference to hip joint," said the letter.
Mint has seen a copy of the letter. It suggested the firm advertise in leading newspapers to reach affected patients, and asked it to regularly update authorities about compliance with the direction. It blamed the defective product for the suffering of patients.
“The patients have suffered physical injury, bodily impairment, conscious pain and suffering, high level of toxic metal, high metal ion levels in the blood stream, loss of enjoyment of life, lack of mobility, metal sensitivity, loosening of the prosthesis, infection, dislocation, bone fracture and a medical need and necessity for a surgical revision consisting of removing the implanted device of the firm and replacing it with a non-defective implant," it further said.
Malini Aisola, co-convenor at non-profit All India Drug Action Network, said the government needs to take a tough approach. “In its order to J&J, the government categorically states that not only was ASR found to be defective, but also there was negligence of the firm in approaching the patients. Yet, no action has been initiated by the central government for wanton disregard of rules and callous treatment of patients."
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