Delhi HC refuses to stay compensation formula for Johnson and Johnson faulty implants

Justice Bakhru’s response came after the counsel for J&J requested for passover of the matter as the counsel leading them in the matter was on his way.

J&J’s counsel said that it’s urgent, as patients are lining up after the government’s press release and the letter approving the formula for a compensation amount varying between Rs 30 lakh and Rs 1.22 crore, depending on a patient’s age and extent of disability.

It also argued that the Drugs and Cosmetics Act and Rules, which govern manufacture, import, sale and distribution of drugs and medical devices in Indian, do not contain any provision for compensation to patients in the manner that has been sought to be established and implemented by the government.

“Determination of compensation is the exclusive domain of the judiciary,” the counsel submitted.

To this, the court asked whether any coercive steps are being taken in pursuance to the government’s approval based on the recommendations of the expert committee chaired by Dr Arun Kumar Agarwal, former dean and professor of ENT at Maulana Azad Medical College, New Delhi.

The company’s counsel replied that the Ministry of Health and Family Welfare and the Drug Controller General of India (DCGI) should be asked not to take any coercive steps against them.

The government’s standing counsels Gaurang Kanth and Amit Mahajan, appearing for the ministry and DCGI, contended that a PIL seeking investigations into these faulty hip implants and compensation for victims is pending before Supreme Court, and the committee’s report has been placed before the apex court. “We should wait for the Supreme Court’s direction,” Kanth contended.

The company’s counsel submitted that they are not aware of the Supreme Court’s proceedings, and no notice has been issued to the company on that PIL.

The court replied, “Now you are aware of it. You should take steps to place your stand there (apex court). On the next date of hearing, this court does not want to hear that you were ignorant about the case before the Supreme Court…. In view of the fact that the Supreme Court is seized of the issue and the committee report is also subject matter before the court concern. It would not be appropriate to proceed in the matter as of now.”

J&J urged the court to issue a direction to the authorities to quash or set aside the government’s press release. It sought setting aside of the Agarwal committee report, and actions arising from it. It also sought quashing of the Dr R K Arya committee’s report.

J&J said in its petition that issues such as payment of compensation is cases of faulty products lie in the domain of consumer protection law.

Based on the Agarwal committee’s recommendations, the government had constituted a central expert committee under Dr Arya, director, Sports Injury Centre, to determine the quantum of compensation. All state governments and UT administrations were requested to form state-level committees to examine the affected patients in their jurisdiction and make the process less traumatic for them. These committees would send their recommendations to the central committee.

Thus, a person aged over 65 years who suffered a disability of 20-30 per cent is eligible for Rs 30 lakh compensation under the approved formula, while a 20-year-old person who suffered a disability of more than 50 per cent is eligible for compensation of Rs 1.22 crore.