J&J Faulty Hip Implants

• 05 Sep 2018

The government has constituted a central expert committee and also asked states to form separate committees to determine the quantum of compensation and also to identify patients who have received the faulty implant by Johnson and Johnson (J&J) Pvt. 

• States have been asked to take out advertisements in newspapers so that affected patients can approach the committees.
• The state level committees will evaluate the claim made by patients from disability and suffering caused from using the device.
• The total compensation will be decided by the central committee on the basis of the base amount and loss of wages.
• In 2017, the health ministry formed an investigative committee under the chairmanship of Dr Arun Agarwal, former dean of Maulana Azad Medical College, which suggested at least ₹20 lakh be paid each patient.
• At present there are no specific legal provisions to provide compensation to patients in such cases.

Hip Replacement

• In total hip replacement, all components of hip joints are replaced with prosthetic components.
• Prosthetic components are made of strong plastic, metal or ceramics.
• The commonest hip implants are metal on polythene, and ceramic on polythene.

Concern over Hip Replacement 

• DePuy, a subsidiary of Johnson & Johnson (J&J), engineered a hip replacement device that used metal in prosthetic components, commonly called “Articular Surface Replacement or ASR hip implant”.
• This device soon turned toxic, owing to the release of metal debris, resulting in inflammation, tissue damage and profound pain.
• This issue  was brought to notice in 2005 but it was ignored by DePuy.
• Australia, which had approved the product in 2004, was the first to take regulatory action against ASR and it was removed from the Australian market in 2009.
• So DePuy clearly had knowledge of this problem by then. Yet it issued a global product recall only in 2010. However, it renewed its Indian import licence in 2010 — just a few months prior to the global product recall.
• More unfortunately though, it took a full three years for the Indian drug regulator (Central Drugs Standard Control Organisation, or CDSCO) to issue a product alert.
• Currently as per CDSCO report notes over 3,600 patients with the faulty implants remain untraceable.

Way Forward

• Pharmaceutical companies which provide medicines for health of the consumers have a special duty of care towards them which should be adequately performed.
• Swift action should be taken by the Goverment to penalise DePuy so that it will set right precedent for the unethical companies who play with the life of people.
• Fair compensation for the pain, suffering, disability and loss of work should be provided to victims rather than only providing reimbursement  for replacement as done by DePuy in revision surgeries.
• Further the regulatory mechanism should be strengthened so that such incidents don't occur again.
• CBI enquiry should be taken up as recommended by former drug commissioner.
• Some actions are pending before Indian courts and consumer fora need to be consolidated and fast tracked.