Johnson and Johnson (J&J) has revised its terms of offering assistance to the affected, nearly two months after the Union Health Ministry observed that the US pharma major has shoddily treated patients fitted with ‘faulty,’ hip implants.

Earlier, it was offering the revision surgery only to patients who had developed complications within ten years of the original surgery. J&J has extended this period and now said patients can seek revision surgery up to 15 years from the original operation.

A statement released by J&J on Friday said: “The programme provides for the reimbursement of eligible tests and revision surgery up to 15 years from the date of primary surgery. The assistance programme will benefit patients who received an ASR hip system between June 2004 and August 2010 (when the system was available in India) for up to 15 years from the date of primary surgery when they register on the helpline and complete the documentation process.”

Legal stand

Businessline had first reported on September 7, the plight of Punjab-based Ramandeep Chawla (40), who was debilitated after his Articular Surface Replacement (ASR) hip implant failed. Puri and Crawford, appointed by J&J to handle the complaints, had rejected Chawla’s application for undergoing a revision surgery, stating that it had been over ten years since Chawla was fitted with the original implant and that the company’s guidelines did not allow for a revision surgery. Chawla had to cough up ₹5 lakh for a revision surgery.

"Even those patients who had to spend extra money for revision surgery in the past will be reimbursed,” a J&J spokesperson confirmed.

ASR implants were globally recalled in 2010 owing to the high failure rate of up to 44 per cent.

Health Ministry directive

J&J’s legal stand in consumer courts, which it has maintained till now, is that patients who have to undergo revision surgery after 10 years of implant will not be eligible for reimbursement. But this is in direct violation of the Health Ministry’s latest circular that any person with a faulty ASR implant can apply to Central or State committees for a base compensation of ₹20 lakh. It can be enhanced after analysing the degree of disability, and the suffering on account of monetary loss.

Further, the Ministry had said in its report that patients implanted with ASR within 10-15 years of the first surgery and who are symptomatic, are eligible to apply for compensation. The compensation will be over and above any revision surgery, which J&J has to facilitate separately. Vijay Vojhala, a Mumbai-based, patient, said: “For summoning of patients in terms of government compensation, I received an email from the Drug Controller General of India’s legal cell to come to Delhi to present myself before the expert committee. However, there was no clarity on who will reimburse my travel and stay. Thirty patients, including me, have boycotted the compensation proceedings.”

Of the 90,000 across the world fitted with the ASR implant, over 4,000 were in India. Only 844 of these have been traced by the company and 275, who developed complications within ten years of the original surgery, have been offered a revision surgery by the company.

 

J&J opens registry

The company has asked patients who received an ASR Hip system to register at +91 44 421 44842 or 0008000501443 (9:30 am to 6:30 pm from Monday to Friday) or on asri@puricrawford.com.