It was a query that was raised in India about six years ago, when Johnson & Johnson had forked out $2.5 billion in a settlement covering over 8,000 patients in the US. The case involved its faulty ASR hip implants that were globally recalled in 2010. The query came up again this week, as patient compensation and the larger canvas of regulating medical devices was brought up by Congress representative Anand Sharma in the Rajya Sabha.
In fact, the last few weeks have seen the wheels move a little on medical device regulations. For instance, steps were initiated end-July to set up the Medical Device Technical Advisory Group to advise the drug regulatory authority on implementing regulations governing the segment, among other things. And in a rare occurrence, industry and Government representatives familiar with these developments concur that India was setting a global benchmark of sorts by addressing patient compensation for product liability under the ambit of laws governing health.
Taking the J&J development as a case in point, a regulatory expert who did not want to be named said that patient compensation in the US had materialised through the legal avenue and not directed by the health regulator. In contrast, India had taken a big step by setting up the Agarwal and Arya committees respectively to investigate the impact of the faulty product and need for compensation and fix the patient compensation formula, all under the umbrella of the Health Ministry. This issue has been taken to the Delhi High Court by J&J. But the compensation of ₹25 lakh that they have agreed upon, even as the merits of the case are borne out, is a path-breaking development, the representative said, as other compensations in the country range from ₹50,000 to between ₹2 lakh and ₹5 lakh. One of the committees’ compensation recommendation crosses ₹1 crore, the official said, countering the flak the Indian regulatory system was getting for not taking tough action in the interest of patients after the faulty ASR hip implants were globally recalled.
While patient compensation has not been on the radar in the past, Rajiv Nath, who is with the Association for Indian Medical Device Industry, points to the new Consumer Protection Bill 2019 that will cover product liabilities and manufacturing defects, including medical devices. The Bill even talks of a central authority, he says, of avenues opening up for consumer redress.
But the other development that could be “path breaking” in the medical devices segment is the recommendation by the sub-committee appointed by the DTAB (Drugs Technical Advisory Board), still to be made public. The compensation guidelines from this committee will bring in greater clarity for patients and industry, he says. “Consumers will know whom to contact and what to expect in terms of an adverse impact of a faulty product and the industry too will have clarity on what their liabilities are,” he said, adding that both sides could be saved the time, money and efforts of entering into lengthy litigation. Mistakes happen in a product and they have to addressed, he said.
Other developments involving the medical devices segment in the recent past include discussions to cap trade margins of products, as opposed to direct price control, and talk of a new Medical Device Regulation being spearheaded by the NITI Aayog.
Too long a wait for some
But for Vijay Vojhala, one of the patients suffering from J&J’s faulty implants for over 10 years, the discussions and wait have been for way too long. “If companies get pre-implant insurance money, why do they wait so long to compensate patients when a product is faulty? And if a company has, in the past, not offered to compensate, then why this change of heart now to pay ₹25 lakh,” he asks.
Clearly there is a faulty product and questions are being asked of the company and the speed of the regulatory action that followed, he says, “but no one has been held culpable and not one has been prosecuted.”
With the issue being raised in Parliament and scheduled to come up shortly in the Delhi High Court, hopefully medical devices, as a segment, get the momentum they deserve and patients remain a core part of it.