India issues recall, commences criminal investigation into defective ASR hip implant
Four Corners By Peter Cronau: exclusive
Updated 5 hours 13 minutes ago
Health authorities in India have initiated a criminal investigation into how an international medical devices company failed to adequately follow up a worldwide recall notice on a defective implant device.
The device, known as the DePuy ASR, was sold in India by DePuy International, a subsidiary of Johnson & Johnson, the world’s largest medical devices company.
Nearly 100,000 patients around the world were implanted with the device, 4,600 of whom were in India.
The commissioner of the Food and Drugs Administration in Maharashtra state, Mahesh Zagade, told Four Corners:
“We requested the Johnson & Johnson here in India that they should also initiate a recall, as they have done it in Europe and USA and other countries. They started saying that, yes, they’re in the process of recall.
“This could have been one week’s time to recall this, and they took more than one year and still there was no progress. We were not left with any other option but to take punitive measures under the Indian law, so we lodged a police complaint at the nearest police station.
“We have used the sections of the Indian Criminal Law wherein if the case is proven and if the condition happens, there would be minimum 10 years imprisonment to the concerned people.
“We have written to our state government and requested that they may consider transferring this case from local police to the CBI (Criminal Bureau of Investigation) for overall investigation.”
The worldwide recall of the ASR device occurred in 2010, after medical authorities in Australia and the UK noted a rate of failure of the device far higher than expected.
PHOTO: Joan Wager travelled to India to have her ASR implanted. (Four Corners)
Thousands of people worldwide have suffered adverse effects from the use of the faulty implant, including Joan Wager, who travelled to India to have her ASR implanted and who appears in tonight’s program.
Between 2004 and 2010, DePuy imported 15,829 ASR devices into India, with 4,600 subsequently implanted into patients.
Only 1,295 devices have been returned since the recall, according to the FDA, leaving a question mark over the fate of the remaining 9,900 devices.
“This is for the police mission to find out because the implants sold by the distributors go to retailers and from there go to hospitals,” FDA commissioner Mahesh Zagade told Four Corners.
“Now there could be a case that some of the implants may be lying in the hospital and they will still be being used, even after the recall was ordered by the company. But this fact could be verified by the police.”
India’s regulator issues recall of the device
In an extraordinary move CDSCO – India’s regulator of medical devices – issued its own recall of the device in December, three years after the worldwide recall was announced.
The Medical Devices Alert is recalling the ASR and instructing all medical professionals “Do not implant DePuy ASR hip replacements”.
The regulator requested the return of all unused devices and the medical follow-up of all patients who have the device implanted.
DePuy in a statement released to Four Corners stated:
“In India as with every other country where the ASR Hip System was sold, the recall was implemented according to the practices and regulations on the country.
“At the time of the recall in 2010, DePuy informed the Drugs Controller General of India (DCGI) of the recall, and we have continued to cooperate with them to help patients ever since.”
Initial police investigations have concentrated on finding people who have had the ASR implant.
Of 280 patients so far registering with the company’s help line, 68 have required revision surgery, or 24 per cent, according to the FDA.
Johnson & Johnson, DePuy’s parent company, had approached the High Court in Mumbai last year in an attempt to prevent an Indian police investigation of the failed recall.
They tried to prevent the handing over to police of names and address details of corporate directors and officers of the company in India.
In October 2013, Mumbai’s High Court dismissed the attempt.
“They approached the High Court in Mumbai. They wanted this police case to be withdrawn,” FDA commissioner Zagade said.
“We could convince the court that this is a life-threatening kind of an implant and the company is not taking effective steps to recall it. So the High Court refused the company’s plea to withdraw the police case.
“After our continuous insistence, also they refused to have any plan to recall these products or these implants in a given timeframe.
“They were just saying that ‘we will recall, we will recall’, and but they did not go beyond this. So therefore we were not convinced about their intention of recalling it and helping the patient.
“Some of the patients have, there are reports that they died. Maybe the cause of death could be anything, but the death because of this defective implant cannot also be ruled out.
“It is for the police mission to detect it. But one thing remains, that the patients suffered, and suffered a lot.”
The police are now compiling a charge sheet expected to include the names of senior DePuy and Johnson & Johnson staff based in India.
DePuy offers compensation to patients
Evidence of how early company executives became aware of the health problems caused by the implant is the subject of tonight’s Four Corners.
DePuy has told Four Corners: “From the moment of the recall, we supported ASR Hip System patients in India with a reimbursement program (now in its fourth year) for the medical costs, including revision surgery where necessary.”
Compensation available to Indian patients has reportedly been approximately $9,200. In Australia DePuy has offered medical costs plus $33,000 while in the US the amount of $US250,000 has been made to eligible patients.
“The companies which are large and which have a very large presence all across the globe, they have to really be very responsible in terms of patient safety,” commissioner Zagade said.
“If the patients are funding their dividends, funding their profit, they need to be very, very compassionate towards the humans.
“And if they suspect any suffering that is going to be caused because of the products, they should clearly immediately take corrective measures.”
Four Corners has discovered that in India the recall was not issued in the same way as in other countries.
The notice issued by DePuy in the US and Europe was called a Recall Notice – however in India it was called a Field Safety Notice.
India’s Food and Drug Administration did not believe that Johnson & Johnson and DePuy were taking the recall seriously.
“This particular case is a pointer, it highlights that sometimes these companies do not do this thing. And therefore they need to be more accountable and more responsible towards the patients,” commissioner Zagade said.
Johnson & Johnson’s share price increased 20 per cent in 2013.
The growth from all segments, including pharmaceuticals and medical devices, was driven mainly by higher margins and cost-cutting efforts.