J&J made Indian patients haggle for compensation after faulty hip recall
By December 2011, more than a year after the recall, the Johnson & Johnson’s helpline had traced 73 patients, of whom 31 were paid Rs 1,09,59,780 — approximately Rs 3.5 lakh each — in all, which included revision surgery, doctor visit, tests, and loss of job during surgery.india Updated: Sep 02, 2018 14:23 IST
Compensation payouts to patients in India who used Johnson & Johnson’s (J&J ) faulty metal-on-metal Articular Surface Replacement (ASR) hip are not only a fraction of what was paid to patients in the US, but were given out for revision surgery and loss of livelihood after years of haggling.
South Mumbai-based driving instructor Sailesh Bachate, 47, got the ASR hip in 2007 and within months, developed pain, frequent fever, headache and bodyache. “No one told me the symptoms were related to the implant. In 2011, I went back to my surgeon, who gave the J&J helpline number set up after the hip recall,” he said.
The helpline was unhelpful. “I told them I had pain, fever and have begun limping, but they asked me to call back only if I had a major problem. They didn’t ask for a metal toxicology test,” said Bachate.
He heard about chromium-cobalt toxicity from Vijay Vojhala, another patient who had been fighting for patients with the faulty hips. On testing, Bachate found he had high levels of chromium and cobalt, which had leeched into the blood stream from friction between the ball and socket of the implant. Confronted with the toxicity reports, J&J finally paid for a revision surgery to replace the faulty joints in October 2016.
But the nine years with the faulty hips took a toll on Bachate’s income, as his condition forced him to take breaks after every driving session.
J&J’s DePuy Orthopaedics unit recalled its ASR systems from the worldwide market in August 2010 after reports of high failure rates. In India around 4,700 surgeries were done using the faulty hip implants, but the company said it managed to trace only 2,300 patients and paid for only 275 revision surgeries.
By December 2011, more than a year after the recall, the J&J helpline had traced 73 patients, of whom 31 were paid Rs 1,09,59,780 — approximately Rs 3.5 lakh each — in all, which included revision surgery, doctor visit, tests, and loss of job during surgery.
”Not all ASR patients will require revision surgery and a number of patients continue to do well with ASR implants... We have reimbursed the cost of revision surgery and related medical costs pertaining to it to each of the 275 eligible patients ,” said J&J in a statement.
In the US, J&J agreed to pay $2.5 billion to 8,000 patients in 2013 for the faulty implants.
HT contacted five patients with acute side effects. Four of them had been paid for revision surgeries and two had been given Rs 2 lakh as compensation for loss to livelihood, which is a tenth of the Rs 20 lakh compensation recommended by the Union health ministry’s expert committee set up to review the issue.
“There is a clear conflict of interest here. Why would the company want to trace the patients when they would have to end up paying for their treatment? Either the government has to set up an independent tracking system or they have to be tough on the company,” said Malini Aisola, co-convenor, All India Drug Action Network.
“I had a lot of pain while walking and sitting down, I used to limp, and I could hear the implant creaking,” said Vinay Agarwal, 54, another patient who got the faulty implant in 2005.
Agarwal’s story panned out in a similar manner as Bachate’s. His manufacturing business suffered and he shut shop . “I called the helpline and had to haggle even to get a revision surgery. I finally got both implants replaced in 2013 and 2015, and was given a compensation of Rs 2 lakh for the “loss of livelihood” after I sent a legal notice,” said Agarwal, who now works as a senior manager with a private company.
Jennifer Barucha also received a Rs 2 lakh compensation after her 67-year-old mother Daisy died of brain tumour in 2014. Daisy had undergone total hip replacement in 2007, following which she developed a lump with “greyish, metallic liquid in her inner thigh, ” said Jennifer. Her surgeon was supportive and called J&J and Daisy underwent a revision surgery in 2011. But by then, her “metallic” lump was back and her teeth had started loosening.
J&J said it sent notices to surgeons, set up a helpline and a website with resource material, put out newspaper advertisements and hired a third-party firm to assist surgeons in tracing cases, but none of these measures reached the patients contacted.
“The committee is of the considered view that the steps taken by the firm are inadequate,” the government’s expert committee said in its report.
J&J says it cannot access data on patients because of doctor-patient confidentiality.
Drug regulators disagree. “In cases of recall, the company gets in touch with the distributors, who reach out to wholesalers and the retailer. There is a trail of receipts so they would know exactly who they sold the product to,” said an official with the drug department, on condition of anonymity.
(Ms Bharucha has since clarified that while she told Hindustan Times that she was given Rs 2 lakh as compensation by Johnson & Johnson, what she meant was that she had been offered this sum. She has also clarified that she did not accept the compensation.)
First Published: Sep 01, 2018 07:29 IST