HC seeks Centre's reply on Johnson & Johnson plea on compensation for faulty hip implants

The Delhi High Court Monday sought a response of the Centre on a plea by Johnson and Johnson challenging the orders by which it was directed to pay compensation to patients who received faulty hip implants made by the company.

Justice Vibhu Bakhru issued notice to the Centre on the petition and orally asked authorities not to take any steps against the firm till the next date of hearing.

The company also informed the court that it was willing to pay Rs 25 lakh as compensation to the patients who were affected by its hip implants.

Senior advocate Sandeep Sethi, appearing for the company, contended that the Centre has no jurisdiction under the Drugs and Cosmetics Act to fix and enforce the compensation.

The court asked the Centre, represented through central government standing counsel B S Shukla and Amit Mahajan, to seek instructions on the plea and the company's offer of Rs 25 lakh compensation and listed the matter for further hearing on May 2.

The company has challenged the March 8 and March 28 orders of the Centre by which it has arrived at a compensation formula and asked the firm to abide by it. It has sought a stay on the Centre's two orders.

"Many patients have exercised their remedies before the consumer courts. The actions of the respondents in unilaterally arriving at a compensation formula and further directing the petitioner to abide by the same in the absence of any legal basis thereto is arbitrary and devoid of any statutory power," the petition said.

It said the recent orders of the Centre fixing the compensation is based on a formula and a set of expert committees reports and recommendations which have already been challenged by the company and are pending in the high court.

It added that the Drugs and Cosmetics Act does not have any provisions that provide for a formula for payment of compensation in the matters pertaining to medical devices.

In the earlier petition filed in December last year, the company has sought quashing of a government's press release informing the general public about the formula worked out by an expert committee to compensate patients who received the faulty hip implants produced by the pharma major's subsidiary, DePuy Orthopaedics Inc (USA).

It has also challenged the report of the expert committee -- headed by R K Arya, Director, Sports Injury Centre -- which worked out the compensation formula.

Besides, it has also sought quashing of the report of another committee -- headed by Arun Agarwal, Professor of ENT, Maulana Azad Medical College -- which was appointed by the Health Ministry for looking into the allegations of faulty hip replacement implants.

According to the Arya committee report, compensation payable to patients would be determined in terms of the disability by the faulty hip implants in relation to their age.

Those between 20 to 35 years would get a compensation between Rs 58.08 lakh and Rs 49.66 lakh for 20 to 30 per cent disability; Rs 77.63 lakh to Rs 69.41 lakh for 30 to 40 pre cent disability; Rs 100.17 lakh to 89.32 lakh for 40 to 50 per cent disability and Rs 122.71 lakh to Rs 109.15 lakh over 60 pre cent disability, the press release had stated.

It has said those between 35 to 60 years will get a compensation between Rs 49.66 lakh and Rs 33.63 lakh for 30 per cent disability; Rs 69.49 lakh to Rs 44.45 lakh for 30 to 40 pre cent disability, Rs 89.32 lakh to Rs 57.26 lakh for 40 to 50 per cent disability and Rs 109.15 lakh to 69.08 lakh for over 60 pre cent disability.

Those above 65 years will get compensation of 30 lakh for 20 to 30 pre cent disability, Rs 40 lakh for 30 to 40 per cent ability, Rs 50 lakh for 40 to 50 per cent and 60 lakh for over 60 per cent disability, it had said.

The pharma major had earlier told the court that as a result of the press release, people are "landing at its doorstep" for compensation and contended that the government's public announcement was made without any legal basis.

A public interest litigation (PIL), which was earlier before the Supreme Court, has alleged that "faulty" and "deadly" hip implants have been fitted into the bodies of 4,525 Indian patients.

The plea has contended that DePuy makes, sells and exports medical implants, including articular surface replacements (ASR) hip implants which have been withdrawn by the firms on their own in 2010 on the ground that they were defective.

According to the PIL, the firms "illegally sold DePuy ASR Hip Implants in India from 2005 to 2006".