A meeting between senior officials of the Union Health Ministry and executives of Johnson and Johnson, embroiled in a controversy over its "faulty" hip implants, to discuss the modalities of paying compensation to affected patients in India is likely to take place this week.

While sources in the Union Health Ministry said that the pharma giant has sought an appointment, the company when contacted indicated that it has "reached out to the ministry". The move came after the company in a statement recently said it was seeking to work with the Indian government to develop an appropriate process for providing further support and compensation for patients in need.

An expert panel, constituted earlier by the ministry to probe complaints about "faulty" ASR hip implant devices, in its report, has said the pharma giant "suppressed" facts on the harm of surgeries which was conducted on patients in India using "faulty" hip replacement systems. It had also suggested that the firm pay compensation of around Rs 20 lakh to the affected patients. Some of the patients who had suffered due to faulty implants had questioned the panel's recommendation of the paltry amount, saying it was like "rubbing salt on the wounds".

A source in the ministry told PTI, "They (firm) have sought an appointment with us. Although the date is not fixed, we will call a meeting this week. We will discuss the process of compensation. We will also hear suggestions given by them (firm)." The ministry has already directed Johnson and Johnson to comply with all the recommendations of the expert panel while asserting that it is the responsibility of the firm to compensate all the patients.

In a recent order communicated to the pharma giant, the ministry has said the company be made "liable" to pay adequate compensation commensurate with severity of pain, the resultant disability sufferings (both mental and physical) and with the loss of wages of each of the patients who had received articular surface replacement (ASR). The ministry has also asked Johnson and Johnson to trace the remaining patients who received ASR but have not registered with the helpline, while also directing it to extend the ASR reimbursement programme which was being run by the firm till 2025.

Meanwhile, the company maintained that a voluntary recall doesn't imply that the product is "faulty" nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. "ASR continues to function well for many patients in India and around the world," it said in a e-mail statement .

The company in a statement to PTI also said since the voluntary recall decision was made, DePuy (the subsidiary of the firm) has worked to provide patients and surgeons with the information and support they need, including an "unprecedented reimbursement programme" to address recall-related costs that was the first-of-its kind worldwide. "Our goal has always been to make sure as many ASR patients in India as possible were aware of the voluntary recall and understood the support available to them. 

"DePuy does not, however, have access to data on patients who have received an ASR hip implant due to patient confidentiality regulations," it said in the statement. It said DePuy has been "actively" requesting that surgeons and hospitals reach out to their ASR patients to ensure awareness. "Efforts to support ASR patients and their surgeons have been a top priority for us, and we have sent several communications to surgeons who implanted ASR hips, informing them of the recall, available support, clinical and scientific support information and the reimbursement process," it said.

It said the efforts include an urgent filed safety notice dated August 24, 2010 was to surgeons informing them about the higher than expected revision rates involving ASR and directions to them to stop implanting the ASR devices and giving them full details about the reimbursement process and ASR Helpline. Other efforts also include establishment of an ASR Helpline, ASR website specific for India which provided detailed information regarding the recall for both patients and surgeons, newspapers advertisements among others.

The statement said as a result of the outreach efforts, to date the company has through surgeons, hospitals and independent service providers, demonstrated outreach to more than 2,300 patients who underwent ASR surgery in India. "It is important to note that not all ASR patients will require revision surgery and a number of patients continue to do well with ASR implants. In India, 1,080 patients have registered with the ASR Helpline.

"We have reimbursed the cost of revision surgery and related medical costs pertaining to it to each of the 275 eligible patients who were known to us through the registry who underwent revision surgery. We also have reimbursed cost for testing and monitoring to all 1080 ASR patients registered on the helpline," it said in a statement. The ASR recall was voluntarily initiated by DePuy worldwide on August 24, 2010.