HC asks J&J for interim payment of Rs 25 L to 4 patients for faulty hip implants

New Delhi: The Delhi High Court Thursday directed Johnson and Johnson to make an interim payment of Rs 25 lakh each to four patients after verifying that they have undergone revision surgeries on receiving faulty hip implants made by the company.

The court's direction came after the company said it was willing to pay Rs 25 lakh as compensation to the patients who were affected by the implants. Justice Vibhu Bakhru asked the company to give a list of all the claimants who are registered with it after verifying that they have undergone revision surgeries. The court listed the matter for further hearing on May 29 and asked the Central Drugs Standard Control Organisation (CDSCO) to give the details of all the claimants, which it has, to the company. CDSCO had asked the company to pay Rs 65 lakh, Rs 74 lakh, Rs 1 crore and Rs 90.26 lakh respectively to four patients.

As an interim, the court asked the company pay Rs 25 lakh to these four patients for whom CDSCO has already issued orders, after verification of their documents. The court was hearing the company's plea challenging a press release issued by the Ministry of Health and Family Welfare asking it to pay compensation to all the affected patients, as determined by the reports of the Committees formed to examine the issues relating to its faulty hip implants.

The company has also challenged the orders by which it was directed to pay compensation to patients. The court also granted one week more to the Centre, represented through Central government standing counsel Amit Mahajan, to file its response to the petition. Senior Advocate Sandeep Sethi, representing the company, informed the court that it has identified certain number of patients who were eligible for compensation after a verification process. "We have set down terms of eligibility...he/she is not entitled if he/she has not undergone the revision surgery," he said, adding that the number of eligible patients is around 250.

The company had earlier contended that the Centre has no jurisdiction under the Drugs and Cosmetics Act to fix and enforce the compensation. It said the recent orders of the Centre fixing the compensation is based on a formula and reports by a set of expert committees 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 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. 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".