The Indian government has recently taken action to address the issue of defective hip implants produced by Johnson & Johnson (J&J) Pvt Ltd. This includes the establishment of a central expert committee, coupled with requests for individual states to form independent committees. The primary objectives of these committees are to determine appropriate compensation amounts and to identify affected patients.
Identifying and Compensating Patients
In order to reach out to affected individuals, the states have been urged to publicise through newspaper ads and other media outlets. These state-level committees are assigned with the task of evaluating claims arising from disability and suffering caused by the use of these defective devices. The total compensation will hinge on the base amount and wage loss, as decided by the central committee.
In 2017, the health ministry put together an investigative committee spearheaded by Dr Arun Agarwal, former dean of Maulana Azad Medical College. The committee recommended compensation of at least ₹20 lakh for each affected patient. However, legal provisions for providing compensation in such cases are currently not specified.
The Intricacies of Hip Replacement
Total hip replacement involves replacing all components of the hip joint with prosthetic ones, usually made from robust plastic, metal, or ceramics. The most common hip implants utilise metal on polythene, and ceramic on polythene.
Failings in Hip Replacement Devices
DePuy, a subsidiary of J&J, created a hip replacement device employing metal in its prosthetic components, known as the “Articular Surface Replacement or ASR hip implant”. This device became problematic due to the release of metal debris, leading to inflammation, tissue damage, and severe pain.
Although this issue was first flagged in 2005, DePuy did not respond. It wasn’t until 2009 that Australia, where the product had received approval in 2004, took action against ASR, leading to the removal of the device from the market. Notably, though aware of the problem by then, DePuy only issued a global product recall in 2010, while remarkably renewing its import license in India just months before.
The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, issued an alert on the issue only three years later. According to the CDSCO report, over 3,600 patients with the faulty implants are still untraceable.
Looking Ahead
Pharmaceutical companies play a crucial role in consumer health care and should uphold their duty of care. The recent government action against DePuy is a step in the right direction that will set a precedent for unethical companies. It is essential that victims receive fair compensation for their pain, suffering, disability, and loss of work.
In addition to compensation, there must be measures in place to prevent similar incidents. This includes strengthening regulatory mechanisms and potentially conducting a Central Bureau of Investigation (CBI) enquiry, as advised by the former drug commissioner. Pending actions before Indian courts and consumer forums should be consolidated and expedited for an effective resolution to this public health crisis.
