A landmark victory for patient rights in India

The J&J compensation could also open up the insurance sector for product liability in the country

In the biggest ever payout for disability not leading to death, the government has directed the multinational major Johnson & Johnson (J&J ) to pay up to ₹1.2 crore each along with an additional ₹10 lakh for “non pecuniary” losses as compensation to patients who were sold faulty hip implants between 2006 and 2010. The compensation each patient gets will depend on the degree of disability and healthy years and income lost that will be calculated using the Indian Disability Evaluation and Assessment Scale (IDEAS) for the certification of disability. The money is to be paid in a “time-bound manner” through bank accounts of affected persons, around 100 of whom have already approached the government for compensation.

It’s a big win for patient rights in India, where compensation payouts are paltry and few and far between and where most patients continue to accept poor medical outcomes as fate. The few who file complaints spend years, sometimes decades, proving medical negligence against a seemingly insurmountable nexus of doctors, hospitals and big pharmaceutical companies.

In the highest ever compensation paid in a medical negligence case in India, it took US-based Dr Kunal Saha 15 years of legal battle before the Supreme Court awarded him ₹5.96 crore in 2013 as compensation for the death of his wife in 1998 from complications after being treated for fever and respiratory infection at Kolkata’s Advanced Medical Research Institute Hospital.

Patients also have to deal with high tradechannel margins sought by profiteering hospitals and industry. Last year, massive margins led the National Pharmaceutical Pricing Authority to cap the prices of coronary stents used to prop open blocked arteries and orthopaedic implants for joint replacement surgeries. The price regula- tor’s investigations into the death of a sevenyear-old girl from dengue haemorrhagic fever at Gurugram’s Fortis Memorial Research Institute found the hospital had on occasion marked up consumables by up to 1,737%. J&J has drawn criticism for agreeing to pay $4.4 billion as damages to patients in the US who were given faulty metal-onmetal Articular Surface Replacement (ASR) hip implants, while it did not inform most patients in India that the implant had been recalled from the worldwide market in August 2010 after reports of high failure rates and pain and inflammation because of metal toxicity, which led to bone damage and tissue death.

Close to 4,700 people received the faulty implant in India before the recall, but only 1,080 have been tracked. Of them, only 275 underwent revision surgeries, while the others are being monitored for side effects. With the manufacturer, orthopaedic surgeons and hospitals making little effort to reach out, more than 3,600 patients have slipped between the cracks and continue to be live in pain. Mumbai-based ASR hip recipient Vijay Vojhala had to haggle with J&J for two years before the company agreed to foot the bill for a compensatory revision surgery in 2012 to replace its faulty hip that had led to the then 40-year-old losing his teeth, hearing in one ear, his ability to walk without pain and his job.

Improved regulation will force the health care sector to acknowledge that the patient is a client and hospitals and pharmaceutical companies are service and product providers. For those who charge hundreds of thousands for preventing illness and saving lives, health care is a business and not a favour they are doing the patient or the community. If their work falls short of expectation, they will and must be held accountable like other professionals and businesses.

Patients not happy with the service have every right to complain, just as they have a right to full disclosure about the treatment being given. The hospital, too, has every right to explain why a certain modality was used to treat a particular disease or condition, and if the treatment fails, why it did. If documentation is needed to prove that the right treatment was given, it must be maintained and shared with all patients and their families. The J&J compensation could open up the insurance sector for product liability in India, which makes it imperative to hold doctors, hospitals and companies accountable to strengthen the sharing of information on adverse drug reactions and drug and device recalls. Medicine is a science that follows validated protocols and full disclosure about the treatment being provided to them is every patient’s right.

PATIENTS NOT HAPPY WITH THE SERVICE HAVE EVERY RIGHT TO COMPLAIN, JUST AS THEY HAVE A RIGHT TO FULL DISCLOSURE. THE HOSPITAL, TOO, HAS EVERY RIGHT TO EXPLAIN WHY A CERTAIN MODALITY WAS USED