PRESS RELEASE

Patients affected by Johnson & Johnson faulty ASR hip implants demand seat at the table in deciding their fate; demand accountability and ask for participation in the process

New Delhi, September 15, 2018: Patients and families affected by Johnson & Johnson’s faulty ASR hip implants gathered in Delhi today to demand that the government directly involve them in the entire process of ascertaining responsibility and compensation for pain and suffering caused to them and their loved ones. Their urgent demands come as news reports emerged that the Central committee being set up for compensation is likely to meet for the first time on 18 September 2018.

Patients and family members affected by the ASR implant are concerned at the lack of any consultation with patients. “What are the checks or balances on the working of the committees? What is the guarantee that the committees will be fair, just, equitable and reasonable in determining compensation?” said Vijay Vojhala, who had his initial surgery in 2008 and the revision in 2012. “The Government is doing a one-sided inquiry and could easily toe the line of the company. We understand that the government has been closely consulting with J&J and yet, those who have suffered grievous injuries seem to have no seat at the table. I was the only patient to have deposed in front of the Central Expert Committee – how could they possibly understand the complexity and range of suffering across such a large number of victims across the country? We need patient representation on any committee that is set up.”

The establishment of the compensation committees comes as a result of the Expert Committee on ASR hip implants constituted under the Ministry of Health and Family Welfare. The report of the committee was only made public after determined efforts of patients demanding that the report be put in the public domain. The report recommended, among other things, compensation for patients of the ASR implants. The Government has hastily initiated a compensation mechanism involving state-level committees, for evaluations of medical disability, and a Central Expert Committee for deciding the quantum of compensation.

“Compensation should be based on physical, mental, social and economic harm faced by patients. Not only the basis of physical medical criteria. It is critically important that patients, their representatives and a psychologist are part of the committee and their voices should be heard” said Kabbir Chandhok, who had an ASR implant for seven years and continues to suffer severe from complications after multiple revision surgeries. “Irrespective of injury, compensation would have to be paid to all 4000 plus patients who got the ASR implant. One ought not to wait for harm to occur when a device has been shown to be harmful the world over and in India. For me there is an element of discrimination in how J&J is treating Indian patients and those in developed countries. If the company refuses, the Government should provide the compensation as it was neither responsive to the safety concerns associated the device in other countries nor took immediate steps to order a mandatory recall, cancel the license and delayed initiating any measures to the benefit of patients. For me The Government is jointly and severally liable too” he added.

Mr. Mahesh Zagade, former Commissioner of the Food and Drug Administration, Maharashtra said, “the J&J hip prosthesis issue once again reminds us of the grim reality that in the current scenario, it is the responsibility of all the stakeholders to be vigilant and ensure that the commercial interests of the pharma and medical device corporations do not take precedence over everything else and in the process endanger human life.”

“It is also the statutory responsibility of the regulator, the ‘Drugs Controller General of India and the Central Drugs Standards Control Organisation to conduct itself in such manner that episodes like those arising from the failure of ASR hip implants are prevented and to take timely action, if in rare cases these occur. The regulator could have taken action, including criminal prosecution, immediately under the existing law and provided relief to the patients” he continued.

“What the company has done in terms of knowingly provided harmful implants is a strict liability offence and criminal action should also be taken against all involved, including people in Government who failed to act against the use of such harmful implants” said Malini Aisola of the All India Drug Action Network (AIDAN). “The company had internal knowledge of the high failure rate of the device and harmful impact. The Australian regulatory had forced its removal from its market in 2009. Why then did they purposefully seek a license to sell it in India? Is it their position that the information leading to the so-called voluntary recall came to their knowledge overnight?”

Responding to claims by J&J that it has been unable to trace the majority of ASR (anywhere from 2400-3700 in number) because it does not have access to patient details that are only available to surgeons because of confidentiality, Dr. George Thomas, Chief Orthopaedic Surgeon, St. Isabel’s Hospital in Chennai said, “All joints for human implantation have stickers which are used to trace the individual joint. As per normal protocols, one of these stickers has to be pasted in the surgical record of the patient. Therefore it is difficult to believe that the patients cannot be found. The company itself, as well as the surgeons should be in a position to track the patients. Joint replacements are routinely followed till the patient expires, so address is always obtained.”

“Generally speaking, in arthroplasty, a few surgeons operate on the majority of the patients. The company will be fully aware in which hospital each patient was operated. Due to high cost of the implant, it is likely that many of the patients operated in India were not Indian nationals” he added.

“It is not possible that dealers do not know who has used the hip implants. The dealers are area specific and they know about every case, the place of the surgery and the surgeon as they bring the full inventory of implants and instruments for surgery. These implants are loan instruments and no surgeon buys them. Dealers are required to raise bills for the patients to the hospital or at times directly to patients” added Dr. Mathew Verghese, Head of Department of Orthopaedics, St. Stephen’s Hospital, Delhi.

Yogesh Mandhani, whose father has suffered from depression, memory loss, paralysis, heart attack and multiple medical conditions over the last many years, said “my father’s suffering and our agony could have all been avoided according to me. When in 2009 there was information about how faulty the implants were, why was it then recommended for my father in 2010? The voluntary recall date is being used as a technicality to avoid the issue of responsibility. And how is it that only in 2015, when we went back to the hospital were we told about the recall. Ironically, it was my father’s heart surgeon who asked us to go back to hospital to find out about this; he pointed out that there was a correlation between my father’s heart condition and implant. Even after the revision surgery my father has a clot due to the high percentage of cobalt and chromium still in his blood as a result of the faulty implant,” he said.

“J&J should have contacted us as soon as they knew about the fault. The Government should have taken independent measures and used its powers to obtain the names and contacts of patients years ago. To date the government is naively relying on the company to come out with information. Even the Expert Committee has observed numerous discrepancies in the firm’s reports and recorded the suppression of data by J&J. It is distressing that no hospital, no company official, no government representative has shown any interest in our case or in taking serious action on this issue,” he added.

“There is a public interest in preventing harm that overrides any claims of confidentiality that J&J is using to shield its refusal to get and make available patient data,” added Malini Aisola.

There is an apprehension among doctors that there are conflicts of interest of surgeons with respect to J&J. “Doctors serve on the payrolls of medical device companies. They promote implants, including the faulty hip replacement device in question. It would thus be naïve to expect criticism of faulty implants or reporting of a serious side effect by surgeons or physicians obliged to the companies that manufacture them” said Dr. Shah Alam, Department of Orthopaedics, All India Institute of Medical Sciences.

Lucky Pal (GPS Vij), whose mother was bedridden within two years of her first implant ‘(she had implants on both hips) said, “my mother has lost her mobility, her life and her dignity. Our demands as patients and families is not just for justice and participation in the compensation mechanism being set up by the government but for clear accountability and action against J&J so that neither they nor any other manufacturer of a medical device can get away with playing with our lives.”

For further information, contact:

Vijay Vojhala Patient 09987642207

Malini Aisola
All India Drug Action Network (AIDAN)
07838381185

Kabbir Chandhok
Patient
09820398215

Mahesh Zagade
former Commission, FDA Maharashtra
09921007558

Yogesh Mandhani
S/O Ramnivas Mandhani
09822060827

Lucky Pal
S/O Aninder Kaur Vij
09822220044