November 30, 2018
Johnson & Johnson has been indicted by a Government committee for “suppressing” key facts on the aftermath of its ASR knee implant surgeries. Over 3,600 patients with the implants remain untraceable and, at least four deaths were reported from those who got these implants — that case, filed by the family of a patient who died, is now in the Supreme Court.
What slipped under the radar is a story of how Johnson & Johnson used a loophole in US laws to push into the Indian market, just like it did with ASR, another hip implant product, Pinnacle, without any clinical trials in the country, an investigation by The Indian Express has found.
Both Pinnacle and ASR were found to be “faulty” but while the company officially recalled the ASR implant in 2010, it “commercially withdrew” the Pinnacle device only three years later. This qualified withdrawal means that patients suffering “multiple complications” from ASR implants were liable to be compensated. But for those who used the Pinnacle device, justice remains a distant dream.
On Monday, the Implant Files, an investigation by the International Consortium of Investigative Journalists (ICIJ) and 59 media houses including The Indian Express, exposed how medical devices are advertised, sold, and surgically implanted across the world under regulatory systems riddled with holes.
Records show Johnson & Johnson subsidiary DePuy waved the US clearance for Pinnacle and ASR to push both the products through. Records show that Indian regulators approved both the products based on the US clearance — without conducting any clinical trials of their own.
The result, for many Indian patients, was disastrous: toxic fluid seepage of cobalt and chromium was reported from both the metal-on-metal implants, comprising essentially a metal ball in a metal socket at the hip.
“We didn’t know we were jumping into a well,” says Rajeev Thukral at his two-storey home in Delhi’s Rajouri Gardens. Rajeev’s wife Mamta, 50, has a Pinnacle device in one hip and an ASR implant in the other, and both had gone wrong.
“Today, her situation is so bad that she is not able to even step inside an MRI machine. We have also been visiting a family counsellor for the mental trauma,” he says. Back in the US, meanwhile, 8,000 patients joined hands to sue Johnson & Johnson in a class action suit over “faults” in the Pinnacle implant.
In November 2017, a Dallas federal jury ordered the company to pay $247 million to six patients who said they were injured by the “defective” implants. The six complainants claimed that after implantation, the device led to tissue death, bone erosion and other negative side effects.
Nine months later, the Texas Northern District Court awarded $245 million to six other complainants. Court records show that the jury found “J&J liable for defects and fraud”. The official website of US-based law firm McGartland states that the August 29 judgment covers “past and future medical expense and punitive damages, as well as pain and suffering”.
In India, while Pinnacle went under the radar, ASR was at the centre of a series of investigative reports by The Indian Express in August, including the key findings of a committee set up by the Union Health Ministry to probe complaints from hospitals and patients.
The committee indicted J&J and recommended that J&J be made liable to pay at least Rs 20 lakh to each affected patient and that the reimbursement programme for revision surgeries continue until August 2025.
That, however, has come as little consolation for Pinnacle users who say that they are still suffering the “unbearable” aftermath of those implants.
“ASR came after Pinnacle. So why is the government ignoring us? We spent Rs 15 lakh to get the implant removed. But what about the permanent damage? The company should be held accountable,” says Bhavesh Ganger, who works as an agent in a garment factory in Mumbai.
Bhavesh’s father Shantilal Hansraj Ganger, 74, continues to suffer “intense pain” from a “severe infection” caused by the Pinnacle implant on his right hip in 2006 to replace an earlier device that had successfully run its lifecycle of “more than 12 years”.
“My father injured the hip in a road accident after which he underwent a replacement surgery in 1992. Fourteen years later, we went to a private hospital for the new implant. The doctor told us that the Pinnacle device would last 15-20 years, and that the metal-on-metal technology was a proven one that is best,” says Bhavesh.
“But this time, my father started developing unbearable pain within weeks. Soon, there were sores near the hip, and on the feet,” says the son.
Ganger’s medical records show that he even conducted a skin-grafting procedure on the advice of another doctor. “But again, the sores reappeared. The grafting was redone, and failed,” says Bhavesh.
In 2013, Ganger’s records show, the family finally came to know what was wrong. “A hip examination revealed that there was infection around the ball of the joint, there was liquid-like material on the ball. The doctor immediately removed the metal ball of the joint,” he says.
In Delhi, Rajeev’s wife Mamta says she underwent her first replacement surgery in Mumbai in April 2006. “I have been suffering from rheumatoid arthritis and underwent a hip replacement on the left side with the ASR implant. For the first six months, I had to use crutches. For the right hip, which also required replacement, the doctor recommended Pinnacle and the surgery happened in December 2007,” she says.
What followed, Mamta says, was intense pain on the left hip. “We thought it was due to the difference in leg length. But various tests and an ultrasound examination showed that the hip implants were at fault. There was fluid collection around the implants. Our surgeon advised a left hip revision in 2009,” she says.
But two other doctors gave contradictory views. Steroid injections were administered by one, while another said a revision surgery was not required.
Two years later, in 2011-12 after the official recall of ASR, Mamta’s tests again revealed fluid collections around both implants. “We got the fluid tested at a laboratory in the UK in 2012. This revealed that debris of the cobalt and chromium were deposited around the hip. While this was at an alarming level around the ASR implant, the Pinnacle device was also releasing these ions,” says Rajeev.
“I have been suffering other adverse reactions ever since… Cataract in both eyes, which required surgeries, ovarian cysts that grew and ruptured… a total hysterectomy surgery, all these within 3 months of each other… then neurological problems, skin pigmentation, development of chest infection, even my voice has gone hoarse,” says Mamta.
The family is now pinning its hopes on a revision surgery. “But our fight against the company is not over. We are going to court. In 2005, Mamta was earning Rs 85,000 per month with an American home furnishing firm. Later, she started her own business and almost immediately generated revenue of upto Rs 85 lakh in a year but we finally had shut it down… This is the kind of damage that these implants have caused,” says Rajeev.
When contacted by The Indian Express, a Johnson & Johnson spokesperson stated that “no adverse events” related to the implant have been reported in India. The spokesperson, however, did not respond to a specific query on the number of patients who opted for the metal-on-metal implants in India.
On Tuesday, the US Food and Drug Administration (USFDA) admitted that “it is time to fundamentally modernize” the loophole in its law that allowed devices such as a Pinnacle and ASR to hit the market. The ASR-Pinnacle debacle involves two devices.
The first model, DePuy ASR Hip Resurfacing, entered the Indian market with a January 2003 CE certification allowing it to be sold in Europe. But it was not marketed in the US with the FDA rejecting a licence in August 2009.
The second model, DePuy ASR XL Acetabular System, entered the Indian market based on approval from the USFDA. An “FDA 510 (k) clearance” was given to this product, which meant that it was allowed to enter the market based on the conclusion that it was “substantially equivalent” in safety and effectiveness to Pinnacle, the earlier product that was recognised by FDA. Both the ASR metal-on-metal models were globally recalled in August 2010 by Johnson & Johnson.
‘No adverse events in India’
Responding to a questionnaire from The Indian Express, a spokesperson for Johnson & Johnson stated:
“At DePuy Synthes, we have no greater responsibility than to the patients who use our products. The ULTAMET Metal-on-Metal Articulation was the metal-on-metal bearing option previously available within the PINNACLE Acetabular Cup System.
“In designing ULTAMET Metal-on-Metal Articulation, in the late 1990s, DePuy Synthes was responding to the medical need at the time for a hip replacement option that might better meet the demands placed by younger, more active patients and that would help reduce the complications with the implants previously available. ULTAMET Metal-on-Metal was the result of more than six years of research and development and extensive testing and is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain.
“On the basis of US FDA approval, the ULTAMET Metal-on-Metal Articulation was introduced in India in February 2006. DCGI guidelines for medical device approval began in the year 2006, before which there were no guidelines from DCGI for approval of medical devices. We applied for the local approval in June 2006 and it was approved by the DCGI for marketing in India in February 2007.
“In 2013, DePuy discontinued sales of its ULTAMET Metal-on-Metal Articulation worldwide including in India based on low demand from clinicians and the availability of alternative options that meet the clinical needs of patients. To date, no adverse events related to ULTAMET Metal-on-Metal Articulation have been reported to the Company in India.”
Source : The Indian Express
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