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.
Dr KK Aggarwal
Padma Shri
Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group
Editor-in-Chief IJCP Publications
President Heart
Care Foundation of India
Past National President
IMA
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