Illustration: Jayachandran/Mint
Illustration: Jayachandran/Mint

Opinion | J&J case is a step in the right direction, finally

India has definitely set a precedent by enhancing the compensation for victims of faulty hip implants

Decades ago, on the intervening night of 2-3 December 1984, a highly toxic chemical made its way into and around the small towns located near the Union Carbide India Ltd (UCIL) pesticide plant in Bhopal exposing more than 500,000 people to the deadly methyl isocyanate (MIC). In 1989, the Supreme Court ordered UCIL to cough up 750 crore for the tragedy touted as the “world’s worst industrial disaster". That sum was to be distributed among the 105,000 people affected by the leakage of MIC gas, including 3,000 dead and 102,000 injured.

While the survivors and relatives of those killed are still engaged in a legal fight for an enhanced payout, there is no disputing that in India, compensation for death or disability arising from the fault of others is paltry. Consider the fact that road accident victims in the case of death or permanent disability get a maximum of 5 lakh. This is after the government increased the minimum payout 10-fold after 24 years.

“So human life does not seem to have great value," a Supreme Court bench of justices Madan B. Lokur and Deepak Gupta said in January while hearing a case were 17 people had died in a fire that broke out at an illegal firecracker packaging unit. That sentiment has been expressed several times over earlier. Indians have always felt powerless, doubting if progress will ever be made. Life in India is obviously much cheaper than in developed nations.

On Thursday, though, things changed. India made a big stride on compensation, a critical appraisal in terms of various aspects of human life. The government announced that the patients fitted with faulty hip implants supplied by pharmaceutical giant Johnson & Johnson Pvt. Ltd (J&J) be compensated between 30 lakh and 1.23 crore, along with an additional 10 lakh paid towards non-pecuniary damages. This is by far the highest ever compensation announced for a living human being in India.

It has not been an easy journey for the patients, though. It took eight long years for the patients to get what they wished for. The Acetabular Surface Replacement (ASR) hip implants were recalled globally in August 2010. The government swung into action in 2017 and formed a committee to look into the matter in 2017 under the chairmanship of former dean of Maulana Azad Medical College, Arun Agarwal. However, it was only in August 2018 after the media took over the case that the government took a stern stance, providing a big relief to the patients.

The compensation amount would set a precedent for future cases of medical negligence to be paid to patients in case of injury caused by “faulty" medical devices. The ministry approved the formula for determining quantum of compensation for patients who had received, prior to August 2010, ASR hip implants manufactured by DePuy International Ltd, a subsidiary of J&J. While a base compensation of 20 lakh was recommended by the expert committee formed in 2017, the compensation has been enhanced keeping in mind the percentage of disability and age of the patient. The lower the age and more the percentage of disability in the patient, the higher the compensation.

This is significant since under the existing law companies pay monetary benefits only in case something goes wrong during a clinical trial. The sum of 1.23 crore as compensation amount is, therefore, something that has never been heard of in India.

But a more heartening development is that the government is now contemplating changes in the Drugs and Cosmetics Act, 1940, to make pharmaceutical companies liable to pay compensation for injuries and damage caused to consumers by their products, including drugs and medical devices. The Central Drugs Standard Control Organization, the national regulatory body for Indian pharmaceutical and medical device makers, has proposed changes in the existing law to introduce a compensation provision for approved drugs and medical devices that have an adverse impact on a patient.

Once this becomes law, it would have large implications, not the least of which is that affected parties will not be given the runaround for the compensation as it would become mandatory for the company or entity concerned to make the payment.

Coming back to the instance of clinical trials: According to a non-profit organization called Swasthya Adhikar Manch (SAM), thousands of Indians have died in unethical clinical trials over the past decade. To be precise, between January 2005 and November 2017, 4,967 people died during the course of drug trials and research and 20,000-odd people have suffered adverse reactions in such trials. SAM says companies involved have shied away from paying the aggrieved and relatives of the dead. And this was even where there was a law in place to pay victims of clinical trials.

The right of victim for compensation has suffered in India but with the J&J case, India has definitely set a new precedent.

Does the J&J case offer a silver lining for victims in the form of a higher compensation? Tell us at views@livemint.com

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