New Delhi: A health ministry panel has recommended compensation with a base amount of Rs20 lakh each for patients who received hip implants from pharma giant Johnson and Johnson (J&J) seven years ago, which were faulty and had to be replaced with corrective surgery.
The hip replacement device called DePuy ASR was sold in India by DePuy International, a subsidiary of J&J. It was recalled in 2010, following global reports of metal poisoning and high failures.
“The committee recommends that the firm be made liable to pay adequate compensation commensurate with the loss of wages, severity of the pain, the resultant disability and sufferings (both mental and physical) of each of the patients who had received implant," the committee report said. Mint has seen a copy of the report.
Currently, India has no specific legal provisions to pay compensation in such cases. The government set up the committee in February 2016 to investigate the case. The compensation figure was first reported by Mint on 20 November.
The report also recommended forming another central panel of experts and regional expert committees to study claims of disability and suffering caused due to the device.
The final compensation will be determined by the central expert committee, based on the base amount and the loss of wages.
The committee also recommended free medical management to all the patients who had to undergo a revision, including follow-up for all affected patients for their health check-ups.
A detailed reconstruction of J&J’s handling of the case based on interviews and internal company documents revealed that the firm was “evasive" in providing the information, the report said.
Holding the company liable for failing in issuing warnings to the patients of the harm posed by the orthopedic implants, the committee also held it responsible 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 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," it said.
Due to a design flaw, toxic chromium and cobalt in the device leached into the body, endangering lives. In many cases, patients had to undergo strict bed rest. Experts on the panel have also found that the firm was negligent in not giving adequate training to the surgeons for performing the surgery too.
“Many patients reported general fatigue or local issues such as pseudotumor, pain in walking, metalossis (increase in cobalt and chromium levels, asthenozoospermia (reduced sperm motility), cyst in kidney, claudication pain," the report stated.
In the US, the company has already agreed to pay a total of $2.5 billion to around 8,000 citizens who sued it.
J&J declined to comment on the report, saying it has not received a copy. However, it said it did initiate a “one of its kind reimbursement programme" for the patients. “The company’s decisions leading up to the global voluntary recall of the ASR Hip System and subsequent actions, including a reimbursement programme for recall-related medical expenses, reflect our commitment to patients. We have supported ASR patients with a reimbursement programme for their medical costs, including revision surgery where necessary. DePuy established the reimbursement programme with the intention of removing financial barriers for patients so they could receive recall-related testing and treatment. The programme was the first of its kind worldwide, and it has, to date, resulted in thousands of payments globally on behalf of ASR Hip System patients," a company spokesperson said.
The health ministry formed the panel led by Arun Kumar Agarwal, former dean of Maulana Azad Medical College in February, seeking a thorough investigation into the ordeal of those fitted with the defective hip implant. “This report, we earnestly hope, addresses the concerns of affected patients who have been implanted with ASR, faced unfortunate medical conditions and went through the premature revision surgeries. We hope that the government will speedily accept these recommendations," added the report.