Broken completely: Vijay Vajhala, who had revision surgery. (Express Photo/Kaunain Sheriff M)
On December 23, 2009, the Indian arm of Johnson & Johnson obtained a fresh registration certificate for its ASR hip replacement implants from the national regulator for medical devices. On January 11, 2010, the firm applied for an import licence on the basis of that certificate.
However, the company did not inform authorities at the time that the product had been recalled in Australia in December 2009, a committee set up by the Union Health Ministry has found.
In its report that details the timeline (see box below), the committee also states that in documents submitted during its probe on the “faulty” implants, the global pharma major “themselves have admitted about the product failure”. The product was globally recalled on August 24, 2010.
On Friday, The Indian Express reported on the key findings of the committee leading to its conclusion that the company “suppressed” key facts on the harmful aftermath of hip replacement surgeries conducted on hundreds of patients using the implants it imported and sold.
Its report states that over 3,600 patients with the implants remain untraceable, and that at least four deaths have been reported from those who underwent surgeries using these devices. J&J imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country until they were globally recalled in 2010.
Also read | Top official sought CBI probe: ‘Failure of govt’
When contacted by The Indian Express, a company spokesperson said: “We would like to clarify that DePuy Australia made the decision to discontinue sale of the ASR Hip System in Australia because of declining demand. There was no recall in Australia in 2009. In fact, the ASR Hip System was voluntarily recalled by DePuy across the globe in August 2010.”
The Government committee stated in its report it was informed of the recall by Australian authorities. It said that the company may have violated Indian laws by applying for a fresh licence later to sell the devices in the country.
“The firm had applied for import licence on the basis of the registration certificate on 11 January, 2010. However, the fact the ASR was already recalled in Australia in December 2009, was not informed to the CDSCO even at the time of application for import licence. That the committee observes that there appears to be suppression of material facts by the firm to the CDSCO. This is construed as serious breach of a condition of approval,” the committee’s report states.
The Central Drugs Standard Control Organisation (CDSCO) is the national regulator for pharmaceuticals and medical devices. According to CDSCO rules, when a registration certificate is granted to a medical device, it is mandatory for the manufacturer to inform the regulator about any adverse reports on the product globally.
J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics Inc, were first cleared by the United States Food and Drug Administration in 2005. Australia was among the first countries to take regulatory action to remove the ASR hip replacement system from the market.
Referring to Australia, the committee said: “The ASR hip prosthesis was removed from the Australian market in December 2009 after intervention from Therapeutic Goods Administration (TGA). The TGA had acted upon the data from the Australian National Joint Replacement Registry (NJRR) that showed an unacceptably (high number of) revision surgery in patients who had received an ASR.”
The report states that it was only on March 8, 2010, that the firm informed CDSCO about the Australian findings. Five months later — on August 10, 2010 — the firm conveyed its decision to voluntary recall the ASR, the report states.
The committee also makes detailed observations in its report on the product’s failure.
“…the committee observed that in an urgent Field Safety Notice (FSN) issued by the firm on 24 August, 2010, they have themselves admitted about the product failure on the patients…the firm has also stated that the product causes metal wear debris and elevated release of cobalt and chromium beyond 7 parts per billion,” the report says.
“The committee observed that almost all the revision surgeries were performed within 7 years on an average from the date of primary surgery whereas the average life span of orthopaedic hip implants is 15 years. This indicates premature revision surgeries solely because of ASR,” it says.
To back its conclusions, the report says, the committee sent letters to 101 patients on a “random basis” out of which 22 responded. Based on the responses, the committee found that not only did the patients undergo revision after first surgery, but “in some cases, more than one revision surgeries have been performed”.
“The patients have suffered a physical injury, bodily impairment, conscious pain and suffering, high level of toxic metal, high metal ion levels in the blood stream, loss of enjoyment of life, lack of mobility, metal sensitivity, loosening of prosthesis, infection, dislocation, bone fracture and a medical need and necessity for a surgical revision consisting of removing the implanted device of the firm and replacing it with a non-defective implant,” the report says.
The committee, chaired by Dr Arun Agarwal, ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi, has 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 should continue until August 2025.
The committee, which was set up on February 8, 2017, submitted its report on February 19, 2018. The Government is yet to implement the recommendations.
Johnson & Johnson responds:
‘Actions concerning product were appropriate, responsible’
DePuy’s top priority is and always has been patient safety. We understand that the August 2010 ASR™ Hip System voluntary recall is concerning for patients, their family members and surgeons. Since the voluntary recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including a reimbursement programme to address recall-related costs that was the first-of-its-kind worldwide.
After years of testing, ASR was imported and marketed in India and in various countries around the world, with all regulatory approval and permissions as were then applicable. After it was on the market, DePuy continued studying and closely watching how the device was performing and in August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry.
DePuy’s actions concerning the product were appropriate and responsible. We immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements.
DePuy has fully cooperated with the expert committee in their investigation of the ASR matter. However, the Expert Committee Report has not been provided to the company for review to date, so it would be inappropriate for us to comment on it. We would like to reiterate that we have furnished full facts and data available with us to the expert committee.
In addition to the above statement, we would also like to provide you with a background on some important actions undertaken by the company in India to maximize patient outreach:
ASR Help Line: DePuy established an unprecedented reimbursement process and ASR Help Line for ASR patients in India through Puri Crawford in September 2010. ASR website specific to India: DePuy provided detailed information regarding the recall for both patients and surgeons, including online access for surgeons to the ASR resource guide available via http://asrrecall.depuy.com/india Newspaper Advertisement: DePuy also issued advertisements in leading newspapers about the ASR helpline and reimbursement program to reach out to the general public. Surgeon resources: DePuy provided an ASR resource guide containing information about the recall and reimbursement programme that was sent to all surgeons in India who implanted the ASR Hip System. The guide outlined the comprehensive patient reimbursement process and how patients should register at the ASR Help Line. Hired independent third-party firms to assist surgeons in outreach: DePuy hired two third-party firms to help surgeons and hospitals across India to reach out to ASR patients and encourage them to register through the ASR Help Line. Reinforcement communications: DePuy sent out multiple reminder letters to surgeons and hospitals about the recall and reimbursement programme, to encourage them to continue to reach out to their respective patients. With reference to your query on Australia, we would like to clarify that DePuy Australia made the decision to discontinue sale of the ASR Hip System in Australia because of declining demand. There was no recall in Australia in 2009. In fact, the ASR Hip System was voluntarily recalled by DePuy across the globe in August 2010.
Please note that ASR continues to function well for many patients in India and around the world.