New Delhi: Patients and families in India affected by faulty hip implants recalled by a Johnson&Johnson subsidiary demanded on Saturday that their representatives be included in the process to determine compensation, signalling their lack of trust in a government-appointed panel.
Sections of patients who underwent revision surgery after receiving the hip implants between 2004 and 2010 said the government should "directly involve" them in the process to determine compensation, citing regulatory delays and the government's inaction against the company as reasons for their distrust.
The Union health ministry has asked a central expert committee of four doctors and a lawyer to determine the compensation amounts Johnson&Johnson would need to pay eligible patients in India.
A company spokesperson told The Telegraph that it was keen to cooperate with the government in determining "individualised compensation" amounts.
About 4,700 patients across India had received the implants manufactured by DePuy. A health ministry panel had last year examined DePuy's actions in the country and submitted a report in February this year recommending a "base amount" compensation of Rs 20 lakh.
But patients appear worried about how the central expert committee would approach the compensation issue.
"The government is doing a one-sided inquiry and could toe the line of the company," said Vijay Vojhala, a Mumbai-based patient who had a revision surgery in 2012.
The Central Drugs Standards Control Organisation, the central regulatory authority, had issued a "medical device alert" in December 2013, more than three years after the company had withdrawn the device worldwide.
The government panel probing DePuy's actions in India has found that the company had not informed Indian regulators in 2010 about recall of the implants from Australia in December 2009. About 93,000 patients worldwide had received the recalled implants, but not all patients need revision surgery.
DePuy and Johnson&Johnson had between 2013 and 2015 settled more than 9,000 lawsuits over the implants for $4.4 billion, according to a report last month from Drugwatch, a US-based website that provides information on medicines and devices.
"I think there is an element of discrimination in how J&J is treating Indian patients and those in the developed countries," said Kabbir Chandhok, another patient in India who had to undergo revision surgery after receiving an implant that was recalled.
The J&J spokesperson said the company was following all laws of the land and had responded to claims from patients in different countries in different ways, depending on the legal systems in each country.
Since the implants were recalled in August 2010, the company has tracked 1,080 patients and reimbursed the cost of revision surgery to 275 eligible patients, the spokesperson had said earlier this month.
The company said it was entirely dependent on hospitals and doctors and advertisements to find patients who had received the recalled implants.
But a former government official and two doctors said on Saturday that tracing patients who have received medical devices was easy and could have been done within a week if the company really wanted and if regulators had pushed the company.
"Finding patients can be done within three to five days," said Mahesh Zagade, former commissioner with the Food and Drug Administration in Mumbai, the state regulatory agency. "A medical device is a licensed commodity - out laws require companies to maintain registers and lists of sales."
Existing rules also require distributors and hospitals to maintain records of sale and use of devices, he said. "It is impossible that dealers do not know who used the implants," said Mathew Verghese, head of orthopaedics at the St Stephen's Hospital, New Delhi. "Dealers are area-specific, they know every case, the surgery, the surgeon as they bring the full inventory of implants and instruments for surgery," he said.