“The main task at hand is to identify the affected patients and then determine the degree of compensation. We plan to have regional committees (with help from the state food and drug commissioners), which will identify the affected patients in their region and then refer to the central committee,” a source said.
The regional committees would advertise in leading newspapers, alerting the patients about the process, the source added.
Eligible patients will be screened by conducting tests (cost of which would be borne by J&J) to determine the degree of disability. The report of individual patients will be submitted to the central expert committee, which will review it to determine the quantum of compensation.
“The compensation will be determined based on the degree of disability and the impact on one’s ability to lead a normal life and earn a livelihood. On a case-to-case basis, it can vary from Rs 2 million to tens of millions,” said the official.
The base amount (Rs 2 million) is such that if the affected patient keeps the amount of compensation in a bank by way of fixed deposit, at an interest of 7 per cent annually, he or she will get a monthly interest amount at least equivalent to the minimum wages. For example, the minimum monthly wage of an unskilled worker based in Delhi as of March 2017 was Rs 13,350. To earn this, a deposit of over Rs 2 million would be required to be kept in a bank account.
The central committee will also consider patients suffering on account of monetary loss due to loss of wages and other losses. In its report submitted to the health ministry, the expert committee formed by the ministry to address the issue of faulty ASR hip replacement has noted that in the absence of any other model available, the maximum amount that can be granted as compensation should be at par with the maximum amount that is granted in compensation in cases of clinical trial-related death and permanent disability.
On financial compensation, the central committee will send its recommendations for consideration to the Drug Controller General of India (DCGI), who shall, in turn, pass an appropriate order.
Sources in the government claimed that while the data related to hip implant surgeries was available with hospitals, in this case traceability became an issue as hospitals said they did not have data, as it was not mandatory to maintain the records beyond three years of conducting a surgery. In this case, the surgeries were conducted before 2010. Delay in initiating the process of identification of patients has made the matter complex.
J&J's subsidiary DePuy's ASR Hip System was registered in India in October 2006 with a validity of three years. J&J's Indian arm applied for a renewal of the license in May 2009 and obtained a fresh registration certificate in December 2009.
A J&J India spokesperson claimed that they had been fully transparent and furnished full information known to them at the time of making the renewal application in May 2009. The spokesperson added that the data showed that till mid-2010, their ASR Hip System was performing in line with other large diameter metal-on-metal monoblock and resurfacing hip devices. “Ultimately, after receiving the new 2010 UK National Joint Registry data, the company decided that it was in the best interests of patients to voluntarily recall the ASR Hip System worldwide. The ASR recall was voluntarily initiated by DePuy worldwide and in India simultaneously on August 24, 2010.”
Government sources claimed that not only the company did a voluntary recall of the device in 2010, after which it was not imported or sold in the country, but the government, too, on its part, had cancelled the import licence. “The company stopped manufacturing, importing and selling the device worldwide. The existing stock was recalled,” said an official.
J&J tried to clarify that a voluntary recall does not imply that the product was 'faulty'. “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 company spokesperson said.
Cracking the whip
Central and regional expert committees to be constituted by the health ministry
The regional committee will identify patients, conduct investigations, determine the degree of disability and submit its report to the central panel, which will review the report and determine the quantum of compensation
Govt will approach J&J with the patient data and ask for compensation
If J&J does not pay up, the government may sue the firm under the Code of Criminal Procedure
Under the Drugs and Cosmetics Act, for devices already approved by the regulator, there is no provision of compensation if something goes wrong
Parameters for deciding compensation
A base amount of Rs 2 million has been fixed by the committee formed by health ministry to look into the matter of ASR hip replacement systems
The rationale behind the base amount is that if the affected patient keeps it in a bank as FD (at 7% interest), he/she should get monthly interest equivalent to minimum wages
The reference taken here is the minimum wage of an unskilled worker in Delhi (Rs 13,350) as of March 2017
The maximum amount that can be granted as compensation should be at par with the maximum amount that is granted in compensation in cases of clinical trial-related death and permanent disability