While Johnson & Johnson has challenged the government’s order asking it to pay an estimated 4700 patients — from Rs 20 lakh to Rs 1.22 crore each — who got its ASR hip implant, when it comes to the identical Pinnacle implant, the company has claimed that there are “no adverse reports from any patients.” And that Pinnacle was not recalled like the ASR but only withdrawn — an attempt to limit its liability.
Over four months, The Indian Express tracked down eight patients — five men and three women — who had the Pinnacle implanted and are now facing its consequences. Investigating their medical records, their communication with doctors and, in some cases, with Johnson & Johnson as well, paints a story of suffering, neglect and indifference. Of patients hitting a wall when it comes to seeking justice even as they fight debilitating pain, organ damage, pseudo-tumours, the toxic effects of excess cobalt-chromium in the blood.
Here are four of them:
1. Nandakishore Joshi, 61 (Mumbai. Pinnacle implant: October 2007)
PATIENT: Joshi, a retired employee of a multinational civil engineering firm, is the sole earner of the family, including his wife and two college-going children. Movement restricted, difficulty in walking, fears the effects of metal poisoning in the blood.
IMPLANT SURGERY: Underwent first implant surgery in 1994 after he met with accident. In October 2007, due to wear and tear, the old implant was replaced with Pinnacle. In May this year, after being diagnosed with “dangerously high levels” of cobalt-chromium in the blood, and due to loosening of the implant, Joshi was advised “immediate” revision surgery.
CURRENT STATUS: The faulty implant is leaking metal ions in his body. A test on July 3 revealed that cobalt levels in blood has shot up to 24.16 microgram/litre, 60 times more than accepted levels of 0.08 to 0.4. And chromium levels stood at 9.95 microgram/litre, 11 times higher that the normal range of 0.3 to 0.9. Citing financial constraints, Joshi has sought reimbursement from J&J for the revision surgery.
WHAT J&J SAID: On May 7, 2019, Joshi called the company’s helpline in India to convey the adverse event reaction caused by Pinnacle. In an email on May 8, J&J asked him to provide “product details and discharge summary”. On May 10, Joshi emailed scanned copies of the documents.
On May 15, J&J replied that the Pinnacle implant “is not subject to voluntary ASR hip recall” — in other words, it referred to the recall of ASR implants and not Pinnacle which came before. “We recommend, that you contact your operating surgeon with additional questions or concerns you may have about the test and revision surgery,” the email stated.
On May 30, in another email, the company stated that Pinnacle, “was discontinued in 2013 and not withdrawn” and that the “decision to discontinue ULTAMET Metal on Metal was not related to any safety or efficacy issues”. ULTAMET Metal on Metal is the commercial name of the Pinnacle implant.
On June 3, Joshi emailed the company to say that in the US, J&J had agreed to pay $1 billion to resolve lawsuits filed by Pinnacle patients. On the same day, J&J responded by asking him to “confirm if J&J product was implanted during the primary surgery in 1994”.
On June 17, Joshi forwarded the cobalt-chromium tests, to which the company replied that “high ions” can released from the stem of the implant, and that he should provide details of the implant. After contacting his surgeon, Joshi wrote to J&J that the femoral stem was Muller, which is manufactured by JRI (UK), and that it contained Titanium, and not cobalt-chromium.
WHAT NEXT: “I am awaiting a reply from J&J to my last mail. I am planning to undergo the revision surgery soon, as advised by the doctor who has warned that toxic levels in the blood are dangerously high,” said Joshi.
DOCTOR/HOSPITAL: Dr Sanjay Pai, who conducted the surgery in 2007 at Wockhardt Hospitals in Bengaluru, said: “I am travelling outside the country. I will be able to answer to your detailed queries when I am back. Please contact me in August.”
2. Ansary A (Aluva, Ernakulam. Pinnacle implant: March 20, 2009)
PATIENT: Used to work in the Middle East but had to return home due to pain in the hip. Now runs a small business in Aluva to support his wife and a college-going son — his daughter is married. He says physical activity is restricted due to pain caused by the Pinnacle implant.
IMPLANT SURGERY: Within a year of surgery, the femoral component loosened. On September 13, 2010, a bone-graft surgery was conducted. In February 2019, after being diagnosed with high levels of toxic cobalt-chromium ions, he was advised to get the implant removed. Ansary is seeking reimbursement from J&J for the revision surgery, which is pending.
CURRENT STATUS: In 2017, the first evidence of cobalt-chromium poisoning was detected in his blood. Cobalt levels stood at 5.80 microgram/litre and chromium levels at 1.82 microgram/litre — well above normal range. This year, chromium levels shot up to 22.05.
WHAT J&J SAID: After the blood tests, Ansary approached the government-appointed expert committee that is examining compensation to the ASR patients. However, his application was rejected since his implant was Pinnacle. His surgeon, Dr Jacob Varghese of Lakeshore Hospital in Kochi, has asked J&K to consider Ansary’s case for compensation.
WHAT NEXT: “I have written to the state-level committee in Kerala, which is examining claims for ASR patients. ASR and Pinnacle are identical models that release metal ions into the blood. If there is no response, I will take this matter up legally. The government is silent, despite knowing that the company is paying billions to compensate Pinnacle patients outside India,” says Ansary.
DOCTOR/HOSPITAL: Dr Jacob Varghese of Lakeshore Hospital says he is “available to talk on Friday morning”. In a communication to Johnson & Johnson, Varghese wrote: “Mr Ansary’s…cobalt and chromium levels are going up. MAMS MRI results are awaited. He has restricted movement, which compromises his daily activities. He has been advised revision surgery as early as possible. Please include him in your ASR reimbursement scheme as he has high cobalt chromium levels.”
3. Seema Mittal, 46 (New Delhi. Pinnacle implant: April 10, 2008)
PATIENT: Homemaker based in Mansarovar Garden in west Delhi. She is the mother of a four-year-old boy, who is specially abled, and the wife of a businessman. Her family fears the setting in of septicaemia, or blood poisoning, and says her pregnancy in 2014 may have been affected by metal poisoning caused by the Pinnacle implant. She has been advised not to walk.
IMPLANT SURGERY: In 2015, she underwent treatment for puss that had developed over the right thigh near the implant area. In January this year, she was diagnosed with an “infected” implant, with “blackish discolouration of right thigh”. On January 28, the hip joint was opened and puss removed.
CURRENT STATUS: Seema’s younger sister Dr Ritu Singla, a surgical pathologist practising in Australia, claims the doctors have failed to remove the implant. “He did not have the resources (tool) to remove the screw of the implant. We were told that J&J could not find one. A post-operation examination revealed that during the surgery, her pelvic bone was also fractured,” says Ritu.
“Seema gave birth to a baby boy in 2014. He is a specially challenged child. After his birth, we came to know that a metal on metal implant is not advised for women in the reproductive age. We were misled by the doctors. Now, we know the various long-term adverse effects of cobalt chromium poisoning. Was the birth of specially challenged child a result of the adverse reaction? We want answers,” says Dr Anupam Aggarwal, a relative and public health specialist based in Mumbai.
WHAT J&J SAID: There has been no direct communication with the company. Medical records show the patient was not informed about the implant model being used. “We traced the model (Pinnacle) only after an adverse reaction emerged,” says Sanjay Mittal, Seema’s husband.
WHAT NEXT: The family is consulting multiple surgeons on removing the Pinnacle implant.
DOCTOR/HOSPITAL: The implant surgery was conducted at Orthonova Hospital in Delhi, which is now shut.
4. Sabnis Uday Madhukar, 56 (Aurangabad, Maharashtra Pinnacle implant: April 10, 2008)
PATIENT: Former businessman, now lives with his wife and two children, one of whom is employed and the other a student. After undergoing five surgeries that cost about Rs 30 lakh, he was forced to shut his electronics shop. His movements are severely restricted.
IMPLANT SURGERY: After being diagnosed with ankylosing spondylitis, a form of arthritis that affects the spinal region, doctors fixed a J&J ASR implant on his right hip at an Aurangabad hospital in May 2005. In August 2008, the Pinnacle device was implanted on his left hip at a private hospital in Pune. In 2009, the stem of the Pinnacle implant was damaged and replaced in June that year in Pune. In 2017, the ASR device was found damaged too, and was replaced.
CURRENT STATUS: “Last year, doctors told me to get a limited CT scan done. The result showed the implant was loosening. However, doctors tell me I’m suffering from anaemia and that I should get my haemoglobin levels raised. They have not advised any cobalt-chromium tests. They say the culprit is spondylitis,” says Madhukar.
WHAT J&J SAID: Madhukar’s only communication with J&J was when he got the ASR implant removed. However, he is yet to be compensated in the ASR case. “The company said will not provide any compensation as I have crossed 12 years. The government said ASR patients are eligible. In the case of Pinnacle, despite the stem being damaged and replaced, the pain is getting worse,” says Madhukar.
WHAT NEXT: “I hope J&J will pay compensation for not one but two faulty implants in my body,” says Madhukar.
DOCTOR/HOSPITAL: Dr Sachin Tapasvi, The Orthopaedic Speciality Clinic, Pune. Has not responded to requests for comment.