The 121-page report of the Union health ministry-constituted expert committee on the faulty hip implants of Johnson and Johnson (J&J) makes for an extremely sad read.
GETTY IMAGES/ISTOCKPHOTOn The average life of a hip implant is said to be around 15 years but the defective product forced many to undergo premature revision surgery to replace the defective implantNot only does it highlights sufferings of the consumers who got these defective implants put in their body in the hope of a cure, it also exposes the gaps in the law that failed to protect the victims and secure them justice.
Consumers in India often bear the brunt of poor regulatory oversight and this point once again comes across in this report.
The average life of a hip implant is said to be around 15 years but the defective product forced many to undergo premature revision surgery to replace the defective implant, with attendant risk, complications and misery.
The faulty Articular Surface Replacement (ASR) hip implants also left many with serious health complications on account of the release of elevated levels of metal ions (metal wear debris) such as cobalt and chromium.
J&J voluntarily recalled the product globally in august 2010, but given the serious nature of the defects, the company had a duty to immediately trace and inform each and every patient who had received the implant (and not just surgeons) of the risks and take all necessary action-medical as well as financial in a bid to mitigate their suffering. It failed in this duty.
And the regulator, the Central Drugs Standard Control Organization, as the protector of consumer interest, had the responsibility of holding the manufacturer accountable and keeping track of every patient who had received the implant. It should have set up or asked the health ministry to constitute a monitoring committee for this purpose in 2010 when the company recalled its product.
The fact that the health ministry constituted an expert group to look into the matter seven years after the recall and three years after the regulator received complaints from consumers, speaks volumes about the regulatory oversight in the country.
According to the data submitted by J&J, an estimated 4,700 ASR surgeries were carried out in India between 2004 and 2010. By 2017 March only , 1063 patients had registered with the firm’s helpline, of which 1032 were found to have ASR hip implant and 254 of them had undergone revision surgery, while four more were scheduled to have them. Another 774 were being monitored.
Which meant that the rate of revision surgery forced by the defective implant was as high as 25 per cent! Yet, the company did not pay any compensation to the patients or their families, but only reimbursement of medical expenses! And it is yet to trace the remaining patients!
The health ministry /government must now make an effort to trace each and every patient , including the families of the four who died , and ensure that the firm pays adequate damages to fully compensate them for their suffering.
The Consumer Protection Act provides for class action suits being filed by the government too on behalf of consumers and the health ministry should use this provision to immediately get the wheels of justice moving.
The apex consumer court in turn should raise to the occasion by fast tracking the process of justice and awarding exemplary damages.
The ministry should also make it mandatory for every surgeon/hospital to issue a separate bill for the implants/devices used , along with complete details of the product- its manufacturer, brand name, model number, product code, date of manufacture and expiry, so that it becomes easy to trace them in case of a defect. Today, most patients say that they never get those details.
It is also essential to closely monitor the performance and outcome of high risk medical devices. The committee has in fact suggested an independent registry for it, besides strengthening the existing materiovigilance programme, with active participation from all stakeholders.