The central government expects to make a legally convincing case on making Johnson & Johnson compensate people for its faultily made hip implants.
The multinational company has petitioned the high court at Delhi to argue it is not liable to pay. However, a public interest suit to compel it is pending before the Supreme Court (SC).
"Our Drugs and Cosmetics Act did not have a provision for compensation. J&J's main contention is that there is no provision under current law to compensate patients. We have already taken steps to plug the gap. Globally, J&J is paying affected patients, mostly through litigation or out-of-court settlements. There is no reason why they will not compensate the Indian patients," say senior health ministry sources.
The implants manufactured by J&J's wholly-owned subsidiary, DePuy International, were faulty, and several instances of revision surgeries were reported in India and across the globe.
The laws in several other countries, said one official source, also have no provision for compensation to patients if a product is found faulty. Said the official quoted earlier, "We are receiving claims from patients and evaluating these. Meanwhile, we have submitted the report to the court as required by them."
The government is also open to invoking other provisions in law to ensure the multinational company does pay. "If need be, the government can take legal recourse, including prosecuting under the consumer protection law, Code of Criminal Procedure, etc. However, we feel the matter would be settled soon in the SC," the official added.
The high court in Delhi took note on Wednesday of the government submission that the issue was before the SC and said it would wait for the apex court's decision. J&J has contested the formula the government had devised for compensation to patients affected by the faulty ASR hip implants. The government had set up a panel of experts to recommend a formula for compensation.
The government had written to DePuy Medical, asking them to provide compensation till 2025. The committee of experts was set up in 2017 by the health ministry to review the matter. Its report came in February this year.
The company says the panel did not consult it. A J&J Medical India spokesperson said, "Throughout this process, we have done our utmost to offer assistance to all authorities. However, we have not been given an opportunity to appear before the Central Experts Committee. Critical gaps and factual inaccuracies have been allowed to stand uncontested. The formula for compensation needs to be within a fully transparent and legal framework, arrived at through due process, and only after proper hearing of the facts and positions of all parties. The outcome also needs to be within a legal framework which is applicable across the industry."
The company says it is committed to providing assistance, including appropriate compensation under the law, to ASR hip implant patients in India who have undergone revision surgery.
The experts committee had proposed that age and risk factors from the disability caused be considered for compensation, over and above the base amount. Each patient should also be given Rs 1 million for non-pecuniary damage. According to the government's decision, the base will be multiplied by the score given for the risk and age factor, divided by 99.37, with Rs 1 million added to it. The disability caused has been put in four slabs and the compensation amount could vary from Rs 3 million to over Rs 12 million.
The company proposes to support patients who were implanted in India with the implant between June 2004 and August 2010 and to provide reimbursement if the revision surgery and tests took place within 15 years from the date of the primary hip replacement surgery. Close to 4,700 surgeries using these implants were done in the country. Subsequently, these implants were withdrawn from the market.