Above: J&J office in Madrid/Photo: Luis Garcia/ Commons.wikipedia.org
J&J has been told to pay Rs 25 lakh to each patient who underwent surgery due to its faulty implants. Is this enough and how are compensations calculated?
By Dr KK Aggarwal
The Delhi High Court recently directed pharma major Johnson and Johnson (J&J) to make an interim payment of Rs 25 lakh each to four patients who had undergone revision surgeries after receiving faulty hip implants of the company. The direction was issued “without prejudice to the rights and contention of the parties” in the matter. Justice Vibhu Bakhru said the interim payment should be made before May 29, the next date of hearing. The interim order came after J&J volunteered to pay Rs 25 lakh as compensation to the affected patients.
How do we decide compensation in India in cases of clinical trials? Rule 122 DAB of the Drugs and Cosmetics Rules lays down the procedure. The licensing authority, the Drug Controller General of India (DCGI), is the primary body for the causal assessment of injury/death and compensation amount to be paid to a trial participant. In case of occurrence of a serious adverse event, the Expert Committee communicates its recommendation about causality and quantum of compensation to the licensing authority, which then passes the final order.
The sponsor needs to compensate the participant as per the order of the licensing authority. In case of failure to comply, the licensing authority can take necessary action as per the rule, including suspension or cancellation of the clinical trial and/or restricting the sponsor, including his representative(s), from conducting further clinical trials in India.
The compensation will depend on risk factors such as seriousness and severity of the disease, presence of co-morbidity and duration of disease at the time of enrolment in the clinical trial. It would not depend only on the age and annual income of the participant, as in the case of the Motor Vehicles Act and medical negligence cases.
In cases of hip implants, most people will have co-morbid osteoporosis, age-related heart disease or hypertension and in many cases, limited remaining life span.
In cases of medical negligence, the current formula decided in Dr Balram Prasad vs Dr Kunal Saha & Others is as follows: “70 – (age of patient at death/ injury) x annual income + 30% inflation – 1/3rd as personal expenses”. Example: Suppose there is a 60-year-old patient (average age for hip transplant) with Rs 1 lakh income per month, then the compensation payable would be calculated as: 70 – 60 x Rs 12 lakh + 30% – 1/3 = approximately Rs 75 lakh. The compensation will change based on the age and annual income of the patient.
The age and income-based compensation is discriminatory in nature and is being opposed by the Indian Medical Association. The formula of DCGI in clinical trials is the current formula as it is based on the seriousness of the disease and not the subject’s income or age.
ABOUT HIP FRACTURES
A hip fracture can cause life-threatening complications. People over the age of 65 are most at risk because the bones weaken and the risk of tripping and falling increases with age. A whopping 95 percent of hip fractures are caused by falls. These can also lead to earlier mortality. As per the Centre for Disease Control and Prevention, a large proportion of fall deaths are due to complications following a hip fracture. In-hospital mortality rates for hip fractures range from approximately 1 to 10 percent, depending on the location and patient characteristics. The rates are typically higher in men. A year’s mortality rates have ranged from 12 to 37 percent. Approximately half the patients are unable to regain their ability to live independently.
In hip fracture implants, metal-on-metal (MOM) wear is associated with numerous complications. These include early implant failure due to accelerated wear, adverse local tissue reactions and metal hypersensitivity reactions. Adverse local tissue reaction can lead to increased joint fluid in and around the joint and thickened synovium or local tissue necrosis which can be extensive and devastating. In asymptomatic patients (those without hip pain, swelling or dysfunction), only annual orthopaedic follow-up is needed. In patients who develop symptoms suggestive of hip dysfunction, such as pain, swelling or gait abnormality, intervention is needed. If surgical revision is not deemed necessary in such patients, evaluation has to be repeated every six months. So, not all of them will need revision surgeries.
The compensation formula should be transparent and based on the sickness of the patient and not on his or her age alone. As per the current formula for clinical trials calculated by the DCGI, the minimum compensation is Rs 2 lakh and the maximum Rs 45 lakh. There has to be capping of the compensation amount. Remember, if J&J had not come forward about the implant deficiency, all cases would have been decided against the hospitals or the doctors.
—The writer is President-elect, Confederation of Medical Associations in Asia and Oceania, and President, Heart Care Foundation of India