As many news sources have stated, the Indian unit of Johnson & Johnson had suppressed key facts on the ill effects of surgeries conducted on patients in India using their faulty hip implants.
On Moneycontrol, we have been following the fall out of Johnson and Johnson Pvt Ltd's faulty hip implants in India. And now after prolonged suffering, the patients finally have a reason to celebrate at least a financial respite.
On this Moneycontrol podcast, we follow the latest development in the story.
A landmark decision
The latest in the J&J’s Acetabular Surface Replacement (ASR) hip implant story is that the affected patients will get as much as ₹1.2 crore each and an additional ₹10 lakh for ‘non pecuniary’ losses as compensation. This is truly a momentous decision as it is the first ever instance of compensation being paid for a sub- standard medical treatment in the country.
On 29 November, 2018, The Ministry of Health and Family Welfare approved the formula devised by a government panel of experts determining the quantum of compensation.
This has been a long road for patients who have directly suffered as a result of the cobalt and chromium “leakages” in the blood from the faulty implant and those who have lost a family member due to it.
As we have reported in an earlier podcast, patient complaints about the faulty product were first red-flagged in India by then Maharashtra Food and Drug Administration (FDA) Commissioner Mahesh Zagade, who escalated the issue to the regulatory Drug Controller General of India’s (DGCI) office, even as he made a pitch for patient compensation as far back as in 2013. But nothing really changed for those who had already received the implants and were suffering as a result.
If you have been following this story with us, you will recall a statement by Malini Asola, co-convenor of AIDAN in Live Mint where she had critiqued J&J for denying legitimate claims of patients on the basis of an arbitrary time frame of ten years set by the company, which had lapsed by the time patients approached the company for reimbursement.
Adding to the patients' woes were the numerous medical investigations, procedures and treatments at significant financial cost, that they went through prior to revision surgery.
As we have also reported before, in the first week of November, Johnson & Johnson announced that it would initiate a new “India-specific” reimbursement programme for patients affected by the faulty hip implants.
The new programme to be introduced by the company, proposed to support patients who have been implanted in India with its ASR hip implant from June 2004 to August 2010 and provide reimbursement, if the revision surgery and the tests have taken place within 15 years from the date of the primary hip replacement surgery.
The Ministry of Health and Family Welfare's decisive step to approve a substantial compensation formula has ensured finally that recommendations of the expert committee under the chairmanship of Dr Arun Kumar Agarwal, ex-dean and professor of ENT, Maulana Azad Medical College, New Delhi, do not just remain on paper. And that J & J pays up.
The committee has been busy trying to find a solution for a while and as reported by Mint earlier, its compensation formula was based on the percentage of disability, age factor and risk factor. The compensation amount was to vary from ₹30 lakh to ₹1.2 crore. In case the disability was on the higher scale (50%) and the person underwent the hip surgery at a young age of 20, the quantum of compensation was to be over ₹1.2 crore. The central expert committee examined the existing Acts such as the Motor Vehicles Act and the rules for injuries or deaths from clinical trials in India to arrive at the formula for determining the quantum of damages.
The compensation will also take into account the cost of living in the future, disturbance of routine and mental agony. If a person underwent a surgery when he/she was 60 years or above and the disability is measured at the scale of 20-30%, he/she will be entitled to get a minimum of ₹30 lakh, reported Mint.
Patients can now secure compensation from Johnson and Johnson in days to come. “Compensation will be paid in a time bound manner through bank accounts of affected persons by J&J Pvt Ltd,” the health ministry said in a statement.
Around 100 people fitted with J&J’s faulty hip implants have already approached the committee for compensation.
Better late than never
Still, the central question that deserves to be repeated is just why did the company deem it fit in the first place to sell faulty products for hip replacement in India? And how did it get away with taking as little responsibility as possible for the aftermath for so long ?
Especially after agreeing to pay damages to the tune of $2.5 billion to around 8,000 US citizens, who like their Indian counterparts had sued the company after receiving the faulty hip implants? As Indian Express reported, the hip implants were used on patients across the country for several years before the company in 2012 was asked to stop import. We quote, "In the faulty implants, accelerated wear of metal on metal resulted in higher levels of cobalt and chromium in the blood which lead to toxicity. Metal ions damage tissues and organs, experts found." Unquote.
Many patients could have also fallen through the gaps also during the prolonged wait for compensation. Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline.
Rajiv Nath, forum coordinator, AiMeD ( An Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including Consumables, Disposables, Equipments, Instruments, Electronics, Diagnostics and Implants) told Mint and we quote, "We are glad that Government has listened to patients angst and concerns - this formula will send a new benchmark internationally and though loss of life or disability can never be truly compensated to a troubled patient yet frankly this will be financially a tall order for any manufacturer to service and this will open up the insurance sector for product liability insurance in India.”
As many news sources stated, most notably the Indian Express, the Indian unit of Johnson & Johnson had suppressed key facts on the ill effects of surgeries conducted on patients in India using their faulty hip implants.The financial redressal may be a positive way forward but the fact remains that India needs more vigilance in monitoring the safety of healthcare products and to ensure that in the future, there are systems in place to prevent similar painful occurrences.