New Delhi: The Union government on Thursday started exploring legal options to ensure patients receive compensation in the faulty hip implant case, a day after US pharma giant Johnson & Johnson (J&J) challenged the government’s orders asking it to pay compensation to Indian patients affected by its acetabular surface replacement (ASR) hip implants.

While Delhi high court denied interim relief to the company, as another public interest litigation (PIL) in the same matter is pending before the Supreme Court, the government is exploring all legal options to make the company pay up, two people aware of the matter said.

A gap in the law reportedly invited the legal challenge, spelling a prolonged battle for trouble-stricken patients. With no specific legal provisions in the existing Drugs and Cosmetics (D&C) Act, 1940, or rules to provide compensation to patients in such cases, there is thought to be no way for the government to force the company to pay up.

“But there are other legal options that are available and we are exploring those options now to ensure that the company pays up. An additional affidavit may be filed in the court asking the court to give directions to the company to compensate patients. The matter is under discussion," said the first of the two people quoted above.

Ironically, J&J has settled, or is in the process of settling, about 3,300 of 10,000 lawsuits targeting its Pinnacle line of hip-replacement devices, a judge said in a 9 December court filing, Bloomberg reported on Thursday.

A proposal to amend the medical devices rules 2017 to include provisions for compensation in case of injury or death due to a device found malfunctioning or unsafe is already in the works, said the second person. India’s top advisory board in its meeting on 29 November constituted a sub-committee of experts to deliberate on the issue.

The ten-member committee will examine the issue of having a regulatory provision for payment of compensation by the manufacturer and importer in case of injury and submit the report to Drug Technical Advisory Board.

While J&J’s action caught the government unawares, public health experts had warned against relying on the firm to voluntarily pay up. “Relying on J&J to pay a compensatory amount beyond the corrective surgery and replacement was foolish to say the least... Either the government was naive in assuming this or there is something else going on," said Shamnad Basheer, founder of the website SpicyIP and former chair professor of intellectual property law at the West Bengal National University of Juridical Sciences, Kolkata.

“The expert committee report was a scathing indictment of J&J’s subsidiary DePuy which sold the defective hip replacement units. It showed that J&J didn’t disclose accurate information (despite being asked to by the committee etc), and merely reimbursed some of those affected. But reimbursement alone is not sufficient to compensate for pain and any ensuing loss of wages and disability etc as the committee rightly noted. The committee however got it wrong on the legal front," he said.

Basheer said the only legal compulsion for compensation can come through a court case invoking tort law, product liability law and consumer protection law. “There is provision for compensation under the law, under age-old tort law and more recently under consumer protection laws," he said.

Other experts said they saw J&J’s move coming. “Why would they admit their liability," Basheer added. “It is all progressing as I and a few others had predicted. J&J will go to court and even quote the expert committee itself as admitting that the D&C Act doesn’t allow J&J to be held liable," said Murali Neelkantan, an expert in healthcare law.

J&J said it remained committed to providing assistance, including appropriate compensation under the law, to ASR patients in India who have undergone revision surgery. However, it blamed the government for lack of transparency. “We have not been given an opportunity to appear before the Central Expert Committee and 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 said in a statement.

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