Implant victims lack legal backing

The regulator’s ruling on compensation has to be backed by statutory provisions in law

The regulator’s ruling on compensation has to be backed by statutory provisions in law. AASHISH ARYAN writes

In a first of its kind ruling, the Central Drugs Standard Control Organization (CDSCO) recently asked Johnson and Johnson (J&J), a US-based company, to pay a hefty penalty of nearly ~75 lakh to an unidentified Mumbai-based victim of a faulty hip implant.

In November, the government had come up with a compensation formula based on factors such as age, risk and percentage of disability. The quantum of compensation recommended in such cases varied from ~30 lakh to nearly ~1.2 crore.

Experts, however, doubt the ability of the government, and the regulator, to actually realise the penalty amount from the company in the absence of statutory legal provisions to back this decision.

“The government order asking J&J to pay compensation is complete hogwash. There is no provision (in law) under which the government can do so,” says Prashant Reddy, senior resident fellow at Vidhi Centre for Legal Policy.

There is no law that empowers the government to order one private party to pay a certain amount to another private party, he adds. Most legal experts expect J&J to challenge the ruling by the regulator.

A senior advocate notes that in US companies such as J&J pay hefty fines to settle legal cases because of the high cost of litigation. “India will see many rounds of legal battle,” he says.

Experts say it is unlikely that the compensation suggested by the regulator will become a precedent and help other victims to claim compensation easily.

“The process of claiming relief by claimants is painstaking because it is not easy to establish negligence, especially under criminal laws,” says Atul Pandey, partner at law firm Khaitan & Co. Experts say the only legal compulsion for paying compensation can come through a court case invoking tort law or product liability law or consumer protection law.

Most experts, however, believe that the formula suggested by the

government is a start. Since the Supreme Court accepted the formula suggested by the government, it could become a precedent, notes Rajdutt Shekhar Singh, partner at law firm Singh and Associates.

“In case, any similar matter arises in the future, the procedure

adopted by the government in the J&J case would be considered as a precedent in determining the quantum of compensation,” Singh adds.

The Drug Technical Advisory Board (DTAB), set up by the government last year, suggested including compensation for victims suffering from faulty implants in the law. Though the Medical Devices Rules of 2017 could be amended for this purpose, dedicated legislation that deals with compensation laws for aggrieved patients and users of medical devices will help ease the burden of proof that currently lies squarely on the patient, says Pandey.

Though the new medical devices rules talk about compensation in cases of clinical investigation-related death, the rules for victims of faulty medical devices and implants are absent.

The lack of a proper legal framework notwithstanding, the Indian medical consumer is also largely unaware of his or her right, say experts. “The consumers in the West are more aware of their rights associated with health care, along with the seriousness accorded by the courts to such cases. Therefore, we see a larger number of medical malpractice compensation claims in countries like the US and the UK,” says Pandey.

In the J&J hip implant case, instead of each victim approaching the courts in their individual capacity, the government could file a collective case on behalf of the patients, suggests Reddy.

“For individuals to prove that a medical device causes a problem requires an expert certifying the same. Now, that cannot obviously be done for free. The government should get such experts and it will help bring down the costs for victims,” he says.

According to experts, this can be done under Section 12(1)(d) of the Consumer Protection Act of 1986 that empowers the central or the state government to take up the case, either in its individual capacity or as a representative of interests of the consumers in general.