PT Jyothi Datta Why are patients in India treated differently by companies, asks Vijay Vojhala, one of the patients seeking redressal — including compensation — for the faulty implants and health problems he has encountered following his surgery about 10 years ago.
His reference is to the $2.5-billion payout that Johnson & Johnson’s Depuy Orthopaedics had to fork out to about 8,000 patients in the US in 2013 after it voluntarily recalled its ASR Hip System in 2010. The payout was billed among the highest on a medical device recall.
In fact, with pressure building from patient representatives, the Union Health Ministry is looking at uploading online the report of an expert committee that went into the issue in India, an official source familiar with the development told
Calling for much-needed government intervention, a group of patients have meanwhile written to Health Minister JP Nadda, saying their pleas for redressal have been met with “apathy and dismissiveness” from the government. At the Central and State level, the administration should be looking to protect patients in the country, Vojhala told
The aggrieved patients and health advocacy representatives have flayed the government for keeping the expert committee’s report under wraps even six months after it had been submitted. The report raises, among other things, the issue of compensation, even though it suggests that each case be assessed again in terms of severity, etc before payment is finalised. About 4,700 patients in India have received the implant and the report is believed to have suggested compensation to the tune of about ₹20 lakh.
“Since February, some of us have made requests for the expert committee report to officials in the CDSCO (Central Drugs Standard Control Organisation) and in the Ministry of Health and Family Welfare, only to be told that the report cannot be shared without providing any reasons,” the letter said.
“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 said, adding that it has been about eight years since the product was recalled and some of those who still have the implant have since become disabled.
DePuy has maintained that it had kept regulatory agencies in the country abreast of developments involving the product. It has introduced outreach initiatives including advertisements, a portal and surgeon assistance programmes. About 1,080 patients had registered with the ASR helpline. Of them, 275 have undergone revision surgery and the rest are being monitored by their treating surgeons, a company spokesperson had said, adding that not all ASR patients needed a revision surgery.
Vojhala, however, pointed out that the company erred in selling the product in India even after it had been recalled in other markets. Waiting for the expert committee’s suggestions to see the light of day, he said, a beginning had been made, but the support and compensation need to take into account trauma, loss of wage and the overall quality of life that has since been eroded.