On Digging Deeper with Moneycontrol today, we will also ask whether international brands treat patients from certain countries or nationalities with less consideration
Rakesh Sharma | Reema Moudgil
On July 12, 2018, Reuters reported that a Missouri jury had ordered Johnson & Johnson to pay a record-setting $4.69 billion to 22 women who had claimed the company's talc-based products including its baby powder, contained asbestos and had caused them to develop ovarian cancer.
So, well, the company's skirmishes with consumers are old news, though its response to patients in India, according to observers, reeks of discrimination.
Johnson & Johnson’s eventual recall of Acetabular Surface Replacement (ASR), a faulty hip-implant in India brought into focus many niggling questions about standards of healthcare even for those who can afford to spend money on expensive procedures, the trust patients invest in companies they buy healthcare equipment from, and the legal ramifications post a breach. And the reasons why such breaches are made possible, in the first place.
The crisis also brought to the fore several other institutional issues. As Dr. Dhvani Mehta, writing for The Quint, pointed out, the crisis sparked outrage on many fronts – “the seeming brazenness of the company in applying for an import licence although it knew its devices were faulty, the inexcusable lethargy of the Central Drugs Standard Control Organisation (CDSCO) in cancelling the company’s import and marketing permissions, and the bewildering delay in setting up an expert committee to conduct a thorough enquiry.”
On Digging Deeper with Moneycontrol today, we will also ask whether international brands treat patients from certain countries or nationalities with less consideration. As Gauri Kamath wrote on Moneycontrol in August, in the US, UK and Australia, J&J has made cumulative payouts of billions of dollars to patients who were implanted with the products, not as compensation, but as settlements to shut down expensive lawsuits. So what was different about India?
In August this year, in a Hindu Business Line piece, a patient asked the very question.
Vijay Vojhala, one of the patients seeking redressal — including compensation – asked why patients in India were treated differently by companies like Johnson & Johnson as he recounted how the faulty implants had caused him immense hardship over a span of ten difficult years.
He cited the $2.5-billion payout that Johnson & Johnson had to fork out to about 8,000 patients in the US in 2013 after it voluntarily recalled its ASR Hip System in 2010. The payout was billed among the highest on a medical device recall, reported Business Line.
Vojhala, who testified before a government committee, told BloombergQuint, “I want to understand what exactly is the expert committee’s logic behind the baseline compensation in India.” He was, of course, asking why when each US victim got a compensation of Rs 7 crore, in the case of an Indian patient, it had whittled down to just Rs 20 lakh?
Things have since then been looking up on the compensation front and we will get to that eventually, but let us not forget that even the battle to win this initial amount of Rs 20 lakh was hard fought. And the role of the Union Health Ministry in this imbroglio, and its rather passive stance in the matter has come under scrutiny as well.
The expert committee’s report that advocated the Rs 20 lakh compensation was kept under wraps even six months after it had been submitted. This is significant because about 4,700 patients in India had received the implants and suffered through the consequences for years already in addition to waiting for the report to bring them some relief.
The lack of transparency on behalf of the CDSCO (Central Drugs Standard Control Organisation) and the Ministry of Health and Family Welfare, correctly came under scrutiny, too, considering eight years had passed since the product was recalled and some of those with the implant have since, unfortunately, become disabled.
DePuy Synthes, a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998, has maintained that it had kept regulatory agencies in the country abreast of developments involving the product.
The Hindu Business Line reported in August the company's claim that it had introduced outreach initiatives including advertisements, a portal for inquiries, and surgeon assistance programmes. A company spokesperson had said, "About 1,080 patients had registered with the ASR helpline. Of them, 275 have undergone revision surgery and the rest are being monitored by their treating surgeons,” adding that not all ASR patients needed a revision surgery.
Vojhala, however, had pointed out that the company erred in selling the product in India in the first place even after it had been recalled in other markets.
As many news sources stated, most notably The Indian Express, the Indian unit of Johnson & Johnson suppressed key facts on the ill effects of surgeries conducted on patients in India using their faulty hip implants.
According to The Quint, DePuy said in a statement that a voluntary recall doesn’t imply that the product is “faulty” nor does it imply that every patient who has received a hip implant will necessarily have to undergo revision surgery. The company, however, said it did not have access to data on patients who received an ASR hip implant due to confidentiality regulations, and has requested surgeons and hospitals to reach out to them.
Vojhala told The Quint that there was no proper tracking of patients even after the company recalled the implants bringing attention to just how riddled with loopholes the so-called attempt at redressal was.
And therein lies the rub. And a question that deserves to be asked again. Why did the company deem it fit in the first place to sell faulty implants in India? And how did it get away with taking as little responsibility as possible in the aftermath?
The System Is Lax And Allows Itself To Be Breached
The company in question withdrawing two products in 2010 as part of a global recall and then volunteering to pay for premature revision surgeries among Indian patients has a disconnect and as Gauri Kamath's Moneycontrol piece pointed out, India needs to be vigilant about the safety of healthcare products and should not rely heavily on western regulators for signals. Because if it remains lax, such issues will continue to crop up.
Add to that the usual lethargy with which we as a nation address pressing healthcare issues. The Pharmacovigilance Programme of India (PvPi), reported Gauri, was greenlighted in 2011 and took many years before it began from March 2016 onwards to generate India-specific drug safety alerts about unlisted adverse drug reactions (ADRs).
On the other hand, the effort to monitor medical devices, the Materiovigilance Programme, began only in 2015, five years after the ASR recall.
Gauri wrote, "In the ASR case, the regulator did not appear to have had vital information on the regulatory status of the products in other countries. According to the observations of the expert committee, it renewed J&J's registration of its ASR products in December 2009 without the knowledge of these having been recalled in Australia."
Dhvani Mehta, on The Quint, wrote: “At the time of application of its renewal certificate and import licence, Johnson and Johnson failed to inform the Drugs Controller-General India (DCGI) of the intervention by the Therapeutic Goods Administration, Australia. This omission amounted to a violation of the conditions of the Registration Certificate under Form 41 of the Drugs and Cosmetics Rules, 1945, which requires the manufacturer or authorized agent to inform the DCGI of restrictions imposed by regulatory authorities of other countries where the drug or device is marketed."
"It could be argued that the device was being marketed without a valid licence given that it was obtained by misrepresentation. This should attract a minimum term of imprisonment of three years under the Drugs and Cosmetics Act. Although the Act also allows fines imposed to be paid as compensation to victims, this applies only to adulterated and spurious drugs; these terms cannot be applied meaningfully to medical devices.”
And the price for this oversight was paid by the Indian patients, who in good faith, went through the procedures for the use of the implants.
The numbers are staggering. A total of 15,892 of these devices were imported to India between February and August 2010. And as the Quint reported, the expert committee’s report has indicted DePuy for not providing details of patients who were fitted with the faulty hip implants subsequently.
So how can we prevent such scenarios in the future? One way is by being proactive. The Materiovigilance Programme, says Gauri, can be more effective and more rigorous in the processes of risk monitoring, and the post-market follow-up of new devices can prevent similar failures in the future. The government needs to facilitate, as we said before, the tracking of high-risk medical devices as if the Indian patient's life depended on it, because well, it does.
As multiple news sources including Mint reported in October, the latest is that Indian victims of faulty hip implants sold by Johnson &Johnson may get as much as Rs 1.2 crore each in compensation, according to a formula devised by a government panel of experts. The formula though has to be approved by the health ministry
The compensation amount is expected to vary from Rs 33 lakh to Rs 1.2 crore, sources told Mint after the expert committee also recommended the use of the Indian Disability Evaluation and Assessment Scale (IDEAS) for the assessment and certification of disability in patients.We quote the sources, "In case the disability is on the higher scale (40%-45%) and the person underwent the hip surgery at a young age and is suffering, the quantum of compensation will go up.
The compensation will keep up with the cost of living in the future, disturbance of routine and mental agony. So, if a person underwent a surgery when he/she was 60 years or above and the disability is measured at the scale of 10%, he/she will be entitled to get a minimum of Rs 33 lakh.”
This, reports Mint, will be the first-ever instance of compensation being paid for substandard treatment in the country.
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, according to the piece.
Sushobhan Dasgupta, managing director, J&J Medical India and vice president (orthopaedics) for Asia Pacific, said in an interview, "The company would like to work with the expert committee and try and see what is the best way forward to be able to ensure that patients who require certain amounts of money as compensation... is fair, equitable and adequate... which is right for the patients. Because we will be taking care of the patients and that’s for sure and that’s the reason we would like to work with the government."
Significantly, in the first week of November, Johnson & Johnson also announced that it would initiate a new “India-specific” reimbursement programme for patients affected by its ASR implants.
Mint reported that the new programme to be introduced by the company proposes to support patients who have been implanted in India with its ASR 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 reimbursement programme will end on 24 August 2025. As per the earlier programme, patients could benefit only if the revision surgery had happened within the span of 10 years from the date of primary surgery.
Mint quoted the sources as saying, "Those who underwent revision surgeries after 10 years after the primary surgery were at loss and could not claim reimbursement as the earlier ASR reimbursement plan covered only those who have had revision surgeries within 10 years of primary surgery. However, with the new programme to be initiated by the company those patients who underwent revision surgery within 15 years of their primary surgery can also claim recall related expenses."
Patients will be eligible to claim recall related expenses like travel, hotel, and food from the time of admission until discharge from the hospital for the patient and one attendant. Expenses for follow up tests conducted in the year following revision surgery will also be reimbursed.
A Johnson & Johnson spokesperson said, “We are pleased to introduce the ASR India Patient Assistance Program (IPAP)—a unique program that is specifically designed to support and address the needs of patients in India. The programme provides for the reimbursement of eligible tests and revision surgery up to 15 years from the date of primary surgery. We are committed to our ASR patients in India and remain dedicated to the advancement of patient health in India as we have for the past 70 years.”
The company has also assured the government that it would reach out to patients and surgeons about the new ASR IPAP programme, and will provide for the expenses for testing and revision surgeries related to ASR hip implants recalled within 15 years from the date of primary surgery. Tests like Metal Ion (Cobalt and Chromium), X-Ray hip, MARS MRI, USG hip, CT scan, and cost of consultation with the surgeon, will all be covered under the reimbursement programme.
Will This Be A Case Of Too Little Too Late?
The company seems to be intent upon making some gesture to compensate consumers and released an ASR IPAP helpline number and email address for people affected to contact them.
Could this announcement, however, be a response to the Centre constituting an expert committee to determine the quantum of compensation as admissible under appropriate law and medical management for patients who received faulty ASR hip implants? Or could it be a result of the activism of All India Drug Action Network (AIDAN)?
Malini Asola, co-convenor of AIDAN thinks the latter when she told Mint, "For years J&J has denied legitimate claims of patients on the basis that an arbitrary timeframe set by the company, of ten years, had lapsed by the time patients approached the company for reimbursement. The newly framed India-specific program has been framed under pressure, to modify an unjust and callous exclusionary rule. Because patients were not informed of the faulty implants, they underwent numerous medical investigations, procedures and treatments at significant financial cost, prior to revision surgery. How will they be reimbursed for these costs?’’
She said that patients had to undergo medical procedures after the revision surgery as a consequence of health degeneration as an outcome of the initial defective device. The costs associated have been hefty but no one is even talking about providing reimbursement.
The company has, however, maintained that it is reaching out to patients registered on the helpline and separately to surgeons/hospitals, requesting them to inform their ASR patients about this program and direct them to the helpline.
Such A Long Journey
But to come to even this point has not been easy. Far from it. As Jyothi Datta wrote in September on Hindu Business Line, "It has already been a long wait for some who have been living with the pain and disability caused by the faulty implants for over eight years. Patient complaints on 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 in 2013. The people helming the office at the Maharashtra FDA and DCGI have since changed, but the patients’ woes remain unresolved."
As we have said before, even the expert committee set up by the Health Ministry came into being only in 2017 and the committee’s report submitted to the Health Ministry earlier this year was made public only when a great deal of pressure was exerted from a patient advocacy group.
"Be it patients who have directly suffered as a result of the cobalt and chromium “leakages” in the blood from the faulty implant or those who have lost a family member due to it, the grievance is that the Centre is yet to act on the report. While patients complain and struggle for redressal, no tough questions are being asked of the company."It remains to be seen if the “ASR India Patient Assistance Program” will, to some extent, make amends to those who have suffered for so long, not just because of acute physical discomfort caused by a faulty hip implant, but because an entire system of complicit silence exacerbated their agony.