Medical Negligence by Pharma: Report on faulty hip implants ready, Centre informs Supreme Court

A bench comprising Chief Justice Ranajn Gogoi and Justices S K Kaul and K M Joseph has now asked the Centre to file its response within a week.

New Delhi: The Centre informed the Supreme Court recently that the report of its panel on alleged faulty hip implants, made by the US-based pharma major Johnson and Johnson, is ready and will be filed within a week.

The apex court on October 5 had asked the Centre to file its response to the PIL alleging that "faulty" and "deadly" hip implants have been fitted into the bodies of 4,525 Indian patients.

It had also asked the Union Ministry of Health and Family Welfare to apprise it within two months about the actions, if any, taken after an expert committee had allegedly found the pharma firms guilty of "medical negligence".

A bench comprising Chief Justice Ranajn Gogoi and Justices S K Kaul and K M Joseph has now asked the Centre to file its response within a week.

"Counsel appearing for the Union of India states that the report of the Committee headed by Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, is ready and will be filed within a week. List the matter after the report is received by the Registry. Let a copy of the said report be given to each of the contesting parties," the bench said in its order.

Earlier, senior lawyer Salman Khurshid and advocate Vivek Narayan Sharma had referred to the fact that the central government had in 2017 set up a committee headed by Agarwal to look into the aftermath of the disaster caused by the faulty hip implant produced and distributed by the US firm, its Indian subsidiary and DePuy Orthopaedics INC collectively.

"The Committee has found Johnson and Johnson guilty of medical negligence, however, till date nothing has been done to discover a vast number of patients who had undergone a hip transplant," said the plea filed by one Arun Kumar Goenka, whose mother had died following faulty hip implant surgeries.

The court, taking note of the PIL, had sought the assistance of one of the Additional Solicitor Generals and had listed the matter after two months.

The plea has sought a direction to the Centre and Central Drugs Standard Control Organisation for taking effective measures to save lives of those who have undergone "DePuy ASR hip implant surgeries and would be unknowingly living a life in hell, if alive or may be dead, due to the negligent acts of respondents."

DePuy Orthopaedics Inc (USA), a subsidiary of Johnson & Johnson, makes, sells and exports medical implants including articular surface replacements (ASR) hip implants, the plea said, adding that the hip implants have been withdrawn by the firms on their own in 2010 on the ground that they were defective.

The firms "illegally sold DePuy ASR Hip Implants in India from 2005 to 2006. In fact, Johnson and Johnson applied for Import license only on December 6, 2006, and was granted license by Drug Controller (India) on December 15, 2006; however, showing contempt and disregard to Indian Laws for safety of Indian Citizens, Respondents (the firms) imported and sold the implants even without Imports License," it said.

The plea, which has sought a SIT probe to oversee the effective measures for implementation of immediate actions to save the lives of patients of DePuy ASR Implants, referred to the fact that the company had to pay USD 4.40 Billion to over 9,000 victims of faulty implants in the USA and in India no such measures have been undertaken.

"As on date more than 1,500 lawsuits are pending in the Federal Courts in the USA for adjudication," it added.

The plea has sought a direction to the Centre to advertise about recall implants by the firms and devise a mechanism to ensure the safety of 14,525 Indian Patients who had undergone the hip replacement surgeries since 2005.