J&J challenges compensation plan in HC
NEWDELHI: Us-based pharmaceutical giant Johnson and Johnson (J&J) Pvt. Ltd on Wednesday approached Delhi high court challenging the Union government’s orders to pay compensation to Indian patients hurt by its “faulty” hip implants, in a move that could heighten tensions between it and India.
The high court deferred the matter to February 26 as another public interest litigation (PIL) in the same matter is pending before the Supreme Court.
J&J’S move has caught the government unawares as it is in the process of plugging a gap in the law that reportedly invited the legal challenge in the first place, spelling a prolonged battle for trouble-stricken 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 up.
According to a senior official in the health ministry, the government will file an affidavit in the Supreme Court urging the court to direct J&J to compensate patients.
J&J 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 J&J’S “faulty” acetabular surface replacement (ASR) hip implant in India.
The health ministry had on November 29 approved a formula, based on the percentage of disability, age factor and risk factor, devised by a government panel of experts for determining the quantum of compensation. According to this formula, Indian patients suffering because of the hip implants sold by J&J 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.
The health ministry had said on November 29 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 J&J,” the health ministry had said. The government was awaiting correspondence or an acceptance from the company following a letter written to it on November 30.
The company challenged the government’s formula. “The company had used a lacunae in the law because of which the government cannot compel it to compensate, though in earlier meetings they said they were committed to paying compensation,” said another senior official in the health ministry. 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 J&J unit Depuy International.