Patients and their families affected by Johnson & Johnson's (J&J) faulty hip implants have said that despite of assurances that all costs for their treatment will be covered after the implant failed, the company has shirked responsibility and has left most patients fending for themselves.

Also, patients are concerned about the central government's one-sided nature of inquiry and that it 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. We need patient representation on any committee that is set up,” said Mumbai-based Vijay Vojhala, one of the victims.

In 2014, 63-year-old Ramnivas Mandhani, resident of Jalna in Maharashtra suffered from a heart attack and three years later, a paralytic attack. He had been operated upon with ASR hip implant in April 2010. His family never thought these could be related incidents, unless doctors told them so. “My father's health went downslide in 2014 after his heart attack. A year later, we were told that the implant has been recalled and that I should contact the company's ASR helpline. In 2017, he underwent a revision surgery, and cobalt as well as chromium levels in his body were high. There were multiple blood clots in his body. This is when he suffered another paralytic attack, and doctors told us this could be a result of metals from implants leaching into his blood stream,” said Ramnivas's son Yogesh.

While Ramnivas's doctor informed the family of the product recall that had been initiated by J&J, seven years after safety alerts were issued, Delhi -based Manish Kumar (43) was not aware of the cause of pain he was reeling under until he saw the news of the faulty hip implants splashed across the media. “I under went the ASR hip implant in 2008. Three years, later I had to get it removed, but I was never told it was the company's fault. For three years, I was on crutches with limited leg movement. In 2014, I underwent a resurgery and doled out lakhs of rupees for my treatment, unaware that I was entitled for reimbursement,” Manish told BusinessLine.

Over 4,000 patients had been fitted with the ASR implant in India, of the 90,000 across the world. Only 844 of these have been traced by the company. Former Food and Drugs Administration (FDA) commissioner Mahesh Zagade, who first flagged the issue to Drugs Controller General of India (DCGI) said that laws have not been enshrined in the Constitution to obtain a decorative seat in our drawing rooms, but need to be implemented. “There are enough laws in place to hold DCGI accountable for its lapse as a regulator. “If it was withdrawn in Australia in 2009, DCGI could have checked this. Also it is not on own sweet will of the company to 'voluntarily recall,' their product in India. Under the Drugs and Cosmetics Act, DCGI should have enforced a 'mandatory recall.'” Zagade said.

Under rules of DCA licensing conditions, the importer has to maintain a registry of all items that are brought into the country and a chain of records is maintained through channels where it gets distributed – hospitals, retail chains, uptil the point where it is implanted into the patient. “DCGI has clearly failed in tracing the implants, and its rules have been violated. Further under Section 320 of Indian Penal Code an FIR can be filed by the licensee, which is DCGI, against the company for causing grievous hurt. There are enough provisions under the law which DCGI has failed to invoke. Hence a CBI probe is demanded,” Zagade explained.

Despite J&J repeatedly emphasizing that they have covered revision surgery costs, patients are refuting their claims. Nagpur-based patient Aninder Kaur who weighed close to seventy kilos before the implant, was reduced to a stick within two years of the implant. It failed and she suffered multiple complications which rendered her bed-ridden. “She is barely forty kilos now, and we spend Rs 750 per day behind her physiotherapy and rehabilitation. J&J has refused to cover rehab costs,” said Lucky Pal, Aninder's son.

Also, responding to claims by J&J that it has been unable to trace the majority of ASR implanted and affected patients (anywhere from 2400-3700 in number) because it does not have access to patient details that are only available to surgeons because of confidentiality, 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."

“It is impossible 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 Mathew Verghese, Head of Department of Orthopedics, St. Stephen’s Hospital, Delhi.

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