A son who has seen his mother go through five surgeries in two years. A young man who spent a good part of his 20s in and out of the hospital. The list of patients affected by the Johnson and Johnson hip implant crisis is growing steadily.
In less than a month since the “faulty” hip implant controversy broke–after an expert committee report submitted to the Union ministry of health and family welfare was made public in August–three more cases of patients affected by the implant (recalled in 2010) have come to light, all of whom have been in severe pain, and denied any compensation by pharmaceutical giant.
“It was like grease, like a thick oil,” Nagpur-based Lucky Pal said, while recalling his mother's revision surgery. Pal's mother, Aninder Kaur, got both her hips replaced in a surgery in 2007. Within the next two-three years, Pal says Aninder was bed-ridden, and in 2014, was advised a revision surgery for her right hip. When doctors sliced into her hip, they found that there “was no hip, only a thick, oily, grease-like substance” due to the faulty metal-on-metal implant that was leaking toxic metals into her blood. “The surgery, that usually takes a couple of hours, took ten hours. She also had to undergo two grafting surgeries. In 2016, she had to undergo another revision surgery, this time for her left hip. ” said Pal.
Today, Aninder, who was once an active woman, is confined to her home, can only walk with support, and has to undergo physiotherapy everyday. “The company only paid for revision surgeries. None of the costs related to the graft surgeries, diagnostic tests, physiotherapy were ever reimbursed,” he said.
Mumbai-based Kabir Chandhok, 34, who had to get a hip replacement surgery in 2007 because of an existing auto-immune disorder, recalled how the implant had caused a “clicking noise” and a visible limp. “It was only when I went for my right hip replacement in 2013 that I was told by my doctors that the product had been recalled,” he said. In his case too the revision surgery took an usually long time— nine hours. The doctors had to “rip apart the bone” to take out the faulty implant and put another one.
Patients such as Chandhok said now that the government had constituted a committee to fix the quantum of compensation, they ought to make patients a part of the process.
Globally, 93,000 patients received the implant, of which, around 4,700 are in India. In the ministry’s report, the company claimed that until March 2017, a total of 1,063 cases were registered with the company’s helpline, out of which 1,032 were found to have the implant. Of those, 254 patients have undergone revision surgeries and the rest were being monitored, a step that the committee found inadequate. Besides, no compensation was handed to Indian patients, in stark contrast to the money that the company had shelled out to settle the lawsuits in the US and Australia, the report concluded.
On the subject of tracing the affected patients, the company has claimed that it did not have access to patient details because of confidentiality issues. George Thomas, chief orthopaedic surgeon, St. Isabel's Hospital, 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 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 can always obtained, said Thomas. "In arthroplasty, a few surgeons operate on the majority of the patients. The company will be fully aware of the details of hospitals where 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.
Mathew Verghese, head of department of orthopedics, St. Stephen’s Hospital, Delhi, said, “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.” According to Verghese, such 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,” he said.
Mahesh Zagade, former commissioner of the Food and Drug Administration, Maharashtra said, “It is the statutory responsibility of the regulator, the Drugs Controller General of India and the Central Drugs Standards Control Organisation to ensure such events are prevented. The regulator could have taken action, including criminal prosecution, immediately under the existing law and provided relief to the patients.”
“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 the 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 authority 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?” Aisola said.