The Delhi High Court on 2 May had directed US pharma major Johnson and Johnson Pvt Ltd to pay ₹25 lakh each to patients affected by its faulty Acetabular Surface Replacement (ASR) hip implants.
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. The company went to the court, challenging government’s formula.
As per the compensation formula approved by the health ministry on 29 November, Indian patients fitted with ASR hip implants sold by J&J will get up to ₹1.2 crore each, and an additional ₹10 lakh, for “non-pecuniary" losses. The formula is based on the percentage of disability, age factor and risk factor.
“We continue to believe the formula for compensation needs to be within a fully transparent and legal framework, arrived at through due process. As we have always maintained, Johnson & Johnson Private Limited remains committed to providing assistance, including appropriate compensation under the law, to ASR patients in India who have undergone revision surgery," said a company spokesperson in the statement.
The next date of hearing is on 8 August.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients have been traced through a helpline.
India’s drug regulatory authority had ordered the company to pay compensation to the patients, following the recommendation of the central expert committee. The Central Drugs Standard Control Organization (CDSCO) had asked Johnson & Johnson to pay ₹65 lakh and ₹74 lakh as compensation to two unidentified patients of Maharashtra in March and on 30 April. It once again ordered the company to pay over Rs1 crore and Rs90 lakh, respectively, to two more patients from Uttar Pradesh. However, the pharma major had moved the Delhi High Court against government orders to compensate patients. J&J said they will pay compensation based on law.
The implant, DePuy ASR, was sold in India by DePuy International, a J&J unit.
In 2017, the government formed a panel headed by Dr Arun Agarwal, former dean of Maulana Azad Medical College, which suggested compensation for each patient.
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