Johnson and Johnson offices. Photo: Wikimedia Commons
The government on Friday will file an affidavit in the Supreme Court urging the court to direct US-based pharmaceutical giant Johnson and Johnson Pvt. Ltd to compensate trouble-stricken patients as per the formula approved by the Union health ministry, two people aware of the matter revealed.
The company had in December last year approached the Delhi high court challenging the Union government’s orders to pay compensation to Indian patients hurt by its “faulty” hip implants.
“While the company had approached the delhi high court. Since the SC is hearing a Public Interest Litigation (PIL) in the same matter, government will also urge in its affidavit that the case be handled in SC only,” said one of the persons cited above.
A gap in the law reportedly invited the legal challenge in the first place, spelling a prolonged battle for patients. With no specific legal provisions in the existing Drugs and Cosmetics Act, 1940, or rules to provide compensation to patients in such cases, there is no way for the government to force the company to pay compensation.
“That’s why we are requesting the court to direct necessary directions to the company to pay compensation as per the formula approved by the government. Even though the company had told the regulatory authority in September that it was “agreeable” to working with the Drug Controller General of India (DCGI) to “compensate” people fitted with Johnson and Johnson’s “faulty” acetabular surface replacement (ASR) hip implant in India,” said another person, requesting anonymity.
The health ministry had said on 29 November that patients could “secure compensation from Johnson and Johnson in days to come”. “Compensation will be paid in a time-bound manner through bank accounts of affected persons by Johnson and Johnson Pvt. Ltd,” the health ministry had said. Apparently, the government was awaiting correspondence or an acceptance from the company following a letter written to it on 30 November. But company challenged the government’s formula, blaming the government for lack of transparency while devising the formula.
Meanwhile, the government also started a fresh round of discussions on the formula. Both- company and the group of patients shared their grievances with the expert committee on 9 January.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline. ASR was sold in India by DePuy International, a subsidiary of Johnson and Johnson.
According to the government approved formula, Indian patients suffering because of the hip implants sold by Johnson and Johnson would get as much as ₹1.2 crore each and an additional ₹10 lakh for “non pecuniary” losses. The minimum compensation according to the formula in case of a disability would be ₹33 lakh.