New Delhi: A day after Mint exposed the seven-year-old case of patients undergoing corrective surgeries after being fitted with faulty hip implants by multinational pharma giant Johnson and Johnson (J&J), the Union health ministry on Friday swung into action.
The firm will be asked to pay compensation to the affected patients, said R.K. Vats, additional secretary in the health ministry, in what could be the first such official move in India to ensure that compensation is paid for sub-standard treatment.
“The company is at fault and there is no doubt about it. They will have to pay compensation to those who suffered due to their faulty implant," said Vats on Friday. The ministry will also soon ask the states to form state-level committees that will evaluate claims made by patients with regard to disability and suffering caused by the implant.
Earlier in 2017, the health ministry had formed an expert committee that in its report submitted in February this year suggested that a base amount of at least ₹ 20 lakh be paid to patients. At present there are no specific legal provisions in the existing Act and Rules to provide compensation to the patients in such cases.
“Considering all the facts and details as well as taking into account the relevant literature…the committee holds the ASR (Acetabular surface replacement) hip implants manufactured by DePuy International Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India," the report said. DePuy Orthopaedics Inc. is a fully-owned subsidiary of J&J, which is represented in India by Johnson & Johnson India Pvt. Ltd.
“The committee is of the considered view that the revision surgeries were necessitated due to the faulty ASR, as well as negligence of the firm in approaching the patients, and therefore it is the responsibility of the firm to compensate all the affected patients," the report said. Mint has reviewed the report and had reported the findings in January this year.
The committee had also recommended the setting up of a central expert committee and regional expert committees for evaluation of claims made by patients about disability and suffering caused by the device. The compensation would be determined by the central expert committee based on the base amount and the loss of wages.
“In addition to that we have suggested that state level committees be formed. The affected patients can approach the state drug controllers who can be the member secretaries of the state level committee. Through your report we hope that people will contact us," said Vats.
The committee has also recommended that free medical management be provided to all the patients on whom revision surgery has been conducted, including the follow up for all the affected patients for their health check ups.
Controversy hit J&J when ASR, the hip replacement device, was recalled in India in the wake of global reports of metal poisoning and high failure rate. J&J had been in the dock for double standards in the payment of compensation in India—unlike the hefty compensation of $2.5 billion that it agreed to pay to around 8,000 US citizens who had sued the company following faulty hip implants. A detailed reconstruction of J&J’s handling of hips implants, based on interviews and internal company documents revealed that the firm was “evasive" in providing the information, suggested the report.
“The committee is of the view that the firm has neither provided the exact number of patients who had undergone surgeries, re-surgeries with ASR nor they had stated categorically that they have approached each patient and informed them about the risks associated with the faulty ASR," said the report.
“The committee is of the considered view that the firm has to give due diligence to trace those remaining patients who have received ASR but have not registered with the helpline. Sincere efforts should be done by the firm to trace all the patients who have received the ASR," it further said.
The panel held the company liable for failing to issue warnings to the patients of the harms posed by the orthopedic implants, and also for the delay in recalling the device. “In 2012, the firm had clearly admitted that a 5% revision rate is expected. However, they had recalled the product when the revision rate was 12-13% which is almost two and half times the normal rate," said the report with the recommendation that the firm put out a suitable advisory from time to time up to the year 2022. “The patient will continue to require medical care and attention for a longer time because of the implant and it needs to be guaranteed by the firm as long as the problem persists."
The case histories of the affected people revealed that the due to the flaw in the design of the implant there was an increase in the chromium and cobalt levels into the human body, which had a toxic effect on the other parts of the body, endangering the lives of patients. In many such cases the patients had to undergo strict bed rest and were unable to move, living life like a retired person even at a young age. Experts have also found that the firm was negligent in giving adequate training to the surgeons for performing the surgery. “Many patients reported general fatigue or local issues such as pain while walking, metalossis (increase in cobalt and chromium levels), asthenozoospermia (reduced sperm motility), cyst in kidney, claudication pain," the report stated.