New Delhi: There seems to be no end to the problems faced by patients fitted with faulty hip implants from multinational pharma giant Johnson and Johnson Pvt. Ltd (J&J). Although the committee looking into the seven-year-old case has concluded that J&J’s “faulty" product led to revision surgeries, it has also suggested a complex mechanism—including a battery of tests—to determine the severity of damage to the patient. The experts recommended a separate set of tests for patients with symptoms and those without symptoms to ascertain the extent of disability and assess compensation.
“It has to be first decided whether there is any permanent disability and, if so, the extent of such permanent disability," said the report of the expert committee formed by the health ministry last year. The committee headed by former dean of Maulana Azad Medical College Dr Arun K. Agarwal had submitted the report to the health ministry in February this year. Mint has reviewed a copy of the report.
According to the report, in case the claimant suffers permanent disability as a result of injuries, the compensation would be decided on the basis of the effect and impact of such permanent disability on his earning capacity.
Days after Mint exposed the ordeal of patients, who were fitted with the faulty hip implant, the government has swung into action and asked state governments to form committees at the state level. A central expert committee will also be constituted by the ministry of health for evaluation of claims made by patients in respect of disability and suffering caused by the use of faulty acetabular surface replacement (ASR) hip implant device known as DePuy ASR. This device was manufactured by DePuy Orthopaedics, a fully-owned subsidiary of the $76.4 billion J&J, which is represented in India by the unlisted Johnson and Johnson Pvt. Ltd.
The central expert committee will comprise orthopaedic surgeons, one clinical pharmacologists, one legal expert and a representative of the drug regulatory authority.
The 11-member committee has taken into account the non-pecuniary damages, which include damages for mental and physical shock, pain, suffering and trauma as a consequence of injuries, inconvenience, hardship and loss of expectation of life, and has further suggested that the experts looking into compensation assess whether the disablement is permanent or temporary. If the disablement is permanent, the experts should find out whether it is “permanent total disablement" or “permanent partial disablement".
“If the disablement percentage is expressed with reference to any specific limb, then the effect of such disablement of the limb on the functioning of entire body" should be taken into consideration, said the report.
The committee will ascertain the effect of the permanent disability on the patient’s actual earning capacity—which activities the claimant could carry out in spite of the permanent disability and which he could not. The committee will also ascertain the claimants’ avocation, profession and nature of work before the operation, as well as their age.
Going into minute details, the expert committee wants the central committee to examine if the claimant is totally disabled from earning any kind of livelihood; whether in spite of permanent disability, the claimant can still effectively carry on the activities and functions which they were carrying on earlier; or whether they are prevented from discharging the previous activities and functions but can carry out some other or lesser scale of activities and functions so that they can continue to earn.
“The proposed committee should be an active explorer and seeker of the truth for determining the just compensation," said the report.
“The process of compensation as suggested by the expert committee appears to be too unwieldy and is likely to put the patients through many more years of agony and procedural entanglements before they see even a rupee of compensation. This is without even commenting on the amount, which appears too inadequate to account both for the actions of J&J in marketing its faulty product and the pain suffering and even loss of life that patients have endured," said Malini Aisola of All India Drug Action Network.
In the report, the existing committee recommended that a base amount of ₹ 20 lakh be paid as compensation to patients.
Vijay Vojhala, one of those who underwent multiple revision surgeries, said: “Patients have already suffered for long. Government should take proactive steps to make sure that the company is held liable and sufferers are paid their due without any hassle."