An ICIJ-Express investigation: J&J advertised their surgeries ‘live’, then it all went wronghttps://indianexpress.com/article/india/an-icij-express-investigation-jj-advertised-their-surgeries-live-then-it-all-went-wrong-5474611/

An ICIJ-Express investigation: J&J advertised their surgeries ‘live’, then it all went wrong

In India, The Sunday Express found, the recall left behind a number of patients who went under the scalpel at these live surgeries — and now regret every moment under the spotlight.

An ICIJ-Express investigation: J&J advertised their surgeries ‘live’, then it all went wrong
(From left) Dinesh Pillay at his home in Pune, Ramandeep Singh at a private hospital in Amritsar, and Rameshbhai Dodhiya at his home in Rajkot. All three patients underwent ‘live’ surgeries in 2007.

The world over, global medical majors resort to a popular promotional strategy — “live surgeries” — to advertise their products and persuade doctors to push them. With top surgeons conducting these surgeries, that are telecast live to doctors, and the publicity that comes with it, it’s a win-win for all.

Except when things go wrong.

Horribly wrong, as in the case of patients who underwent live hip replacement surgeries to implant ASR metal devices manufactured by global major Johnson & Johnson.

In 2010, Johnson & Johnson issued a global recall of these ASR devices, many of which were found to be “faulty” with numerous complaints of toxic fluid seepage. In India, The Sunday Express found, the recall left behind a number of patients who went under the scalpel at these live surgeries — and now regret every moment under the spotlight.

During its Implant Files investigation on the unregulated medical bazaar, in collaboration with the International Consortium of Investigative Journalists (ICIJ), The Indian Express crisscrossed the country to trace the “victims” of this promotional campaign.

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And zoomed in on three telling cases: a retired civic body official in Rajkot, a former employee of an automobile giant in Pune, and a government school teacher in Faridkot.

All three said they were operated upon in 2007 by doctors brought from abroad, their implants led to severe complications and they continue to be in severe pain. And all of them accused the company of leaving them in the lurch, not informing them about the recall after using them to promote its product.

Read: Pharma majors gave freebies to doctors, claimed tax benefits

This is their story.

Rameshbhai Dodhiya, 61

# Retd employee, Rajkot Municipal Corporation
# Live surgery on July 13, 2007, at Madhuram Hospital, Rajkot

The victim of a road accident, Dodhiya says he was operated upon by an orthopaedic surgeon from New Zealand. “Dr Avinash Maru, the orthopaedic surgeon at Madhuram, said that a doctor from New Zealand has come to India with a new product. He said the product was specially designed and that he will conduct a live surgery to show it to other doctors,” says Dodhiya.

According to Dodhiya, the hospital also offered him a “deal”. “They told us they would not charge us for the surgery, and that we had to only pay Rs 1.3 lakh for the implant,” he says.

“It’s been over 10 years now but I am still suffering. Two years after the surgery, I started experiencing severe pain in the hip and back. By 2010, I couldn’t sit for long, or stand,” says Dodhiya.

His medical records show that doctors at Madhuram diagnosed it as a case of Ankylosing Spondylitis, a type of arthritis of the spine. “I continued to take medicines but nothing changed,” says Dodhiya.

A month ago, Dodhiya’s son Kalpesh read a newspaper report about the ASR recall in 2010. “I went to the doctor, who finally told us that it was a faulty implant,” says Kalpesh.

DOCTOR’S RESPONSE: “Dr Rocco Pitto from New Zealand conducted the live surgery. The company wanted to promote the device and they invited him to demonstrate the technique of implanting it. We took the permission of the patient and the state medical council,” says Dr Maru, while claiming that he had “informed all patients” about the recall.

HOSPITAL’S RESPONSE: Responding to queries from The Sunday Express, a representative said Dr Maru had the authority to speak on behalf of the hospital.

Read : In US, ortho major forced to admit it was corrupting doctors and hospitals in India

Dinesh Pillay, 49

# Former employee, Tata Motors, Pune
# Live surgery on April 10, 2007, at Aditya Birla Memorial Hospital, Pune

Pillay underwent a replacement surgery on his right hip in April 2007, after he was diagnosed with Avascular Necrosis, a condition that affects bone tissue due to lack of blood supply.

“The orthopaedic surgeon, Dr Mahesh Kulkarni, said the surgery would be conducted by Prof Ian Learmonth from the UK. They said they would implant the ASR metal ball and socket and use a Proxima stem manufactured by Johnson & Johnson. But in just four months, the experiment failed. They implanted another Johnson & Johnson product, a ceramic implant. But there was a fracture in the thigh bone during the implant procedure,” says Pillay.

His medical records show the implant had “sunk” from its position and had to be removed. “The doctor then used an Indian implant,” he says.

According to Pillay, he asked for a CD of the live surgery but “the hospital said they had misplaced it”. “After the first surgery went wrong, I never really recovered. Today, I feel my joint is paralysed, there is numbness, I can’t sit or stand for long,” he says.

DOCTOR’S RESPONSE: “This was not a live surgery. Prof Learmonth was only assisting us, you can call it supervision since he is a senior professor in England. They are designer surgeons who guide other surgeons in using the implants. In this case, it was an unfortunate failure,” says Dr Kulkarni.

HOSPITAL’S RESPONSE: “The hospital doesn’t allow (a) foreign doctor to perform the surgery till MCI (Board of Governors) gives permission. There was no tie up with Johnson & Johnson in this case,” a spokesperson said.

Also Read: Faulty hip implants: Health ministry approves formula for compensation

Ramandeep Singh, 41

# Govt school teacher, Faridkot
# Live surgery on February 12, 2007, at Indian Spinal Injuries Centre, Delhi

Records show that surgery on the two hips of Singh was conducted in two phases after he was found to be suffering from Ankylosing Spondylitis.

They show that the right hip replacement was conducted by Dr Bhushan Nariani on February 7, 2007. “Before the left hip surgery, it was conveyed to my parents that a German doctor has come to implant a new metal ball-and-socket implant of Johnson & Johnson. They said that in this new model, the stem would be shorter,” Singh says.

According to Singh, he visited the doctor in 2015, “when the pain persisted”. “He said the pain was due to my condition. In 2017, with the pain still there, he gave me the helpline number of Johnson & Johnson. It was then that I came to know that the device was faulty,” says Singh.

On December 26, 2017, records show, Singh underwent a revision surgery. “But the company did not pay for it, saying 10 years had lapsed since the first surgery,” he says.

Singh has now moved the apex consumer court, National Consumer Disputes Redressal Commission, seeking Rs 1 crore in damages from Johnson & Johnson for the “faulty” implant.

DOCTOR’S RESPONSE: “It is more than 10 years. I remember the patient but don’t recall if any German doctor was called to conduct the surgery,” says Dr Nariani.

HOSPITAL’S RESPONSE: When contacted by The Sunday Express, a spokesperson said the centre would respond “in a few days”.

‘Provide training on safe use’

Also Read: SC seeks Centre’s reply on PIL to trace patients

Responding to a questionnaire from The Sunday Express, a spokesperson of Johnson & Johnson stated:

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“Our professional education program is designed to enhance and expand upon what health care professionals learned in medical school, continuing medical education and clinical practice. We provide training on the safe and effective use of our products through a range of online and in person training. This includes opportunities for surgeons to join in training and educational events at one of the company’s global education facilities, which may include didactic lectures only or in combination with hands-on training with bone models. Other company sponsored events include the opportunity to attend live surgery with surgeon faculty in local hospitals to make education more accessible.”