US Pharma company Johnson & Johnson was recently directed by the Delhi High Court to pay ₹25 lakh each to all the patients who received their faulty implants. The company confirmed that it had started the disbursement in a statement.
What is the case?
On May 2 this year, the Delhi High Court directed the company to make payments to patients who were affected due to their faulty Acetabular Surface Replacement (ASR) hip implants. The legal challenge is one of the landmark cases in the Indian context as the existing Drugs and Cosmetics (D&C) Act, 1940 does not cover patients who were affected because of such devices. Because of this, the government or patients could not force the company to make any payments.
On November 29, 2018, the health ministry approved a compensation formula for people who were fitted with ASR hip implants by the US Company. According to the formula, patients with get up to ₹1.2 crore each. They should be paid an additional ₹10 lakh for “non-pecuniary” losses. The government took the age, risk factor, and percentage of disability into account while deciding the formula. In 2017, it formed a panel headed by the former dean of Maulana Azad Medical College to decide the compensation for each patient.
The long struggle between the company and patients
The company went ahead and challenged the government’s formula. It said that the formula needs to be “within a fully transparent and legal framework” while suggesting that it is ready to provide adequate compensation per the law. Between 2004 and 2010, about 4,700 ASR surgeries were completed in India, but a helpline has only traced 1,080 patients. The implant in question was sold in India by a Johnson & Johnson unit called DePuy ASR.
The company is only willing to pay a sum of ₹25 lakh each. However, it was ordered by the Central Drugs Standard Control Organization (CDSCO) to pay ₹65 lakh and ₹74 lakh to two patients earlier this year. In two later judgments, it ordered the company to pay ₹1 crore and ₹90 lakhs to two other patients.
In its recent statement, J&J said,
“We are very pleased to make the voluntary payments to patients and the patient payments have been proceeding.”
It did not disclose the number of patients who have already received the compensation. The company didn’t define a timeline within which all patients will be compensated.