New Delhi: The government has constituted a central expert committee and also asked states to form separate committees to determine the quantum of compensation in an 8-year-old case of patients undergoing corrective surgery after being fitted with “faulty” hip implants sold by a subsidiary of pharma giant Johnson and Johnson (J&J) Pvt. Ltd, in the first-ever initiative of compensation being paid for sub-standard treatment in the country.
In 2017, the health ministry formed an expert committee under the chairmanship of Dr Arun Agarwal, former dean of Maulana Azad Medical College, which suggested at least ₹20 lakh be paid each patient.
The state level committees, the panel said, will evaluate the claim made by patients from disability and suffering caused from using the device. The total compensation will be decided by the central committee on the basis of the base amount and loss of wages.
The ministry of health and family welfare, in a letter to health secretaries of all states dated 30 August, called for the constitution of state-level committees comprising two orthopaedic surgeons, one radiologist from the government medical college and a representative from the zonal office of drug regulator. States have been asked to take out advertisements in newspapers so that affected patients can approach the committees.
“The committees should be formed to enable hassle-free access to patients so that they can easily approach state-level committees in their respective states,” the health ministry said in the letter. Mint has reviewed a copy of the letter.
At present there are no specific legal provisions to provide compensation to patients in such cases. The government swung into action after Mint on 23 August exposed the case and highlighted concerns over the metal-on-metal acetabular surface replacement (ASR) hip implant.
Additional secretary in the health ministry, R.K. Vats, had earlier told Mintthat the “firm will be asked to pay compensation to the affected patients.”
All patients implanted with ASR will be eligible to apply to the state-level and central expert committees for compensation. According to the health ministry, for the patients to be eligible for compensation, the first surgery of ASR must have been performed in India on or after 2006 and the patients must have been fitted with ASR within 10 years from the date of first surgery. Patients who have been implanted with ASR between 10-15 years from the date of first surgery, but are symptomatic, can also apply.
Patients can approach either the central expert committee or state-level committees as per their convenience.
“The central expert committee with the assistance of the state-level committee will arrive at the exact amount of the compensation as admissible under appropriate law, which will be communicated to central Drugs Standard Control Organisation (CDSCO), which will pass an order for grant for compensation,” the letter said.
Earlier, the committee had held the ASR hip implants manufactured by DePuy International Ltd to be faulty. “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 affected patients,” the committee report said.
Mint has reviewed the report and had reported the findings of the report in January this year.
J&J has been in the dock for adopting double standards in paying compensation in India contrary to a 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 reconstruction of J&J’s handling of hips implants, based on interviews and internal company documents revealed that it was “evasive” in providing the information, suggested the report.
The DePuy spokesperson reiterated that the company’s actions concerning the product were “appropriate” and “responsible”. “It is also important to note that a voluntary recall doesn’t imply that the product is faulty. Nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the spokesperson said.