In 2003, 15,829 articular surface replacement (ASR) XL and ASR Hip Resurfacing Systems were imported into India by the global pharmaceutical major Johnson & Johnson and its subsidiary DePuy. As many as 300 surgeons implanted these devices via 4,700 surgical procedures in Indian patients.
At the All India Institute of Medical Sciences, New Delhi, 5 out of 46 ASR surgeries required revisions (follow-up surgery to correct a malfunction in the device implanted), a 10 per cent revision rate. The company admitted to a 25 per cent revision rate in 2017 to the Indian government.
While the global recall of the ASR hip implant was announced in August 2010, the Central Drugs Standard Control Organisation, India’s national drug regulator under the Ministry of Health and Family Welfare, did not issue any notice to implant patients until December 2013.
Johnson & Johnson settled the ASR XL implant lawsuits for a staggering $2.5 billion in the US among 8,000 patients, averaging approximately $312 million a patient. In contrast, patients wronged in India were ordered compensation ranging from Rs.67 lakh to Rs.1.12 crore ($93,000 to $1,55,000). Consumer courts awarded significantly lower compensation compared with even this paltry sum. In the end, 67 patients who underwent revision surgeries received Rs.25 lakh each.
Also Read | A strong dose
DePuy earned Rs.35 billion in 2022-23 from India, which generated a profit after tax of Rs.11.31 billion. It spent Rs.515 million in “seminar conference expenses” and “advertising and promotional expenses” that year. Nine prominent surgeons were collectively paid $184 million to evangelise this device globally by the manufacturer.
These are facts; none of them is in dispute.
This is the unsettling truth about how pharmaceutical and medical device companies and the healthcare system defraud patients. In his book The Johnson & Johnson Files, the journalist Kaunain Sherrif unspools the stories of unsuspecting patients at the mercy of a corrupt and incompetent system in India that not only extracts their money but also inflicts unbearable pain and suffering. Sherrif has reported extensively on malpractices in the medical device industry for The Indian Express and was part of the Implant Files project with the International Consortium of Investigative Journalists. In this book, he documents how families and livelihoods have been destroyed at the hands of corporate marauders and a compromised regulatory system within the Indian administration.
Sherrif painstakingly follows the stories of a blue-collar worker in Pune, a young obstetrician in Hyderabad, and a medical device sales manager from Mumbai, among others. The stories highlight the deception and indifference of an elected administration whose job it is to protect its citizens, an incompetent regulator, and unscrupulous surgeons, all of whom subsequently washed their hands of the harm they caused to these patients. These devices, sold to patients as “miracles”, poisoned their bodies with metal shavings that leached out of the implants. The pain and suffering visited upon the patients thanks to the callousness of the pharma major and the healthcare system make for a very sobering read.
Works of this nature typically provoke soul-searching within a society and can galvanise efforts towards fundamental reforms. However, in today’s India, where partisanship rules all conversations, expecting society at large to read this excellent treatise rather than focus on Instagram reels and OTT series is a tall ask. Nonetheless, there are questions that must be asked—if nothing else, to place on record that there was evidence enough to demand accountability and change lest a future generation questions the current one.
Sherrif recounts the resistance and non-cooperation among the officials of the State Food and Drug Administration in Maharashtra in light of the crusade that former IAS officer Mahesh Zagade undertook to hold Johnson & Johnson to account in 2011. A few observations from the narrative are worth reproducing here: “The officials in the department had been trained for decades to remain silent.” Trained by whom? And to what end?
The Johnson and Johnson Files
The Indian Secrets of a Global Giant
By Kaunain Sherrif M.
Juggernaut Books
Pages: 400
Price: Rs.599
Likewise, while recounting the experience of Vijay Vojhala, a patient with a faulty implant who made an arduous trip to Delhi to meet the officials of the Ministry of Health and Family Welfare to make them understand his plight, Sherrif says: “He waited patiently, watching as officials moved about with an air of indifference.” Who does our elected government serve? The fact that Vojhala’s confidential communication with the ministry was disclosed to the manufacturer without sparing a thought about his privacy says all there is to say about why people shy away from taking a public stand against blatant wrongdoing.
The Broken Medical Device Regulatory System
At the heart of this unfortunate episode is the absence of any governing framework in the pre-Independence Drugs and Cosmetics Act, 1940 for medical devices, an apathetic administrative state, and an unqualified bureaucracy. This toxic combination manifests itself in a truly surreal manner in this book.
The first outbreak of diethylene glycol (DEG) poisoning in the US occurred in 1937. The pharmaceutical company S.E. Massengill of Bristol, Tennessee, which sold a broad spectrum antibiotic called Sulfanilamide in syrup form primarily for the pediatric market, had used DEG as a solvent. This resulted in the deaths of 105 patients, including 34 children. The deaths prompted a bottom-up overhaul of the Federal Food, Drugs and Cosmetics Act in 1938. There has been no instance of DEG poisoning since.
Compare this with the recent news of deaths of children in Madhya Pradesh and Rajasthan due to DEG poisoning. This is the ninth such mass casualty event in India, beginning with the one in Chennai in 1972. The first and immediate response of any regulator in such a mass casualty event is to effect a complete recall of the suspect drug from the market.
Yet, despite knowing that the Drugs and Cosmetics Act does not have a provision to empower the drug regulator to effect such a recall, successive administrations held inconsequential and mostly ineffective meetings of the Drugs Consultative Committee (whose membership is composed of representatives from the respective drug controllers from the States and the Drug Controller General of India) and the Drugs Technical Advisory Board for 46 years from 1976 until 2019, all at the expense of the taxpayer, to “discuss” how to effectively recall “Not of Standard Quality” drugs and devices from the market. For over half a century now, the bureaucracy and the administrative state have not devised an effective method to remove defective drugs from the market to prevent harm to patients. What we see in Sheriff’s narrative is a manifestation of this dysfunction and its impact on the hapless citizens of this country.
The absence of a governing regulation is one aspect of this sordid story. Equally reprehensible is the manner in which the bureaucracy and the administrative state function. Here is a glaring example. By the company’s own admission in June 2011, they located 23,366 implant recipients in the US (about 60 per cent of the patient pool), 2,970 patients in Australia (about 50 per cent of the patient pool), 2,098 patients in South Africa (about 55 per cent of the patient pool), and 1,968 patients in the UK (about 55 per cent of the patient pool). In India, however, the same company located a mere 45 patients, approximately 1 per cent of the patient pool.
In July 2014, The Times of India reported that despite the 2010 global recall, 82 per cent of the ASR patients in India remained untraced. No law would have enabled the bureaucracy within the Ministry of Health to hold the manufacturer to account if there is no accountability within the bureaucracy to be responsive toward its own citizens. Transparency and a sense of urgency even in such dire circumstances seem alien to them. DePuy marketed the ASR implant with no preclinical studies in India. In fact, it received market authorisation at the same time that it withdrew this device from global markets. Such is the competence and accountability of India’s regulatory apparatus.
Disputes regarding medical malpractice are adjudicated under two laws in India: the Consumer Protection Act and the Indian Penal Code (or IPC, now replaced by the Bharatiya Nyaya Sanhita, or BNS). The two laws offer different remedies and mechanisms of accountability. While consumer courts can award damages for deficiency in service or unfair trade practices with medical negligence being a subset, Section 304A of the IPC (now replaced by Section 106 of BNS) applies only to cases of a death by medical negligence.
Each of these paths is littered with hurdles and challenges unique to its own. In fact, Sheriff’s juxtaposition of a case litigated in California and another in a consumer court in India shows how the consumer courts rob the litigant of the adversarial process, where a skilled advocate strips away the veneer of respectability that the erring manufacturer creates to defend its indefensible actions. The absence of a jury system consisting of ordinary people from all walks of society impoverishes our system of justice where implicit biases and influential forces often throttle the lone voice of the litigant seeking justice from the system.
In February 2020, the Union government notified some changes to the Rules of the Drugs and Cosmetics Act. This amendment brought medical devices under the remit of the Act by treating “devices” as “drugs”. Think about what this means. A device is a contraption, often mechanical and engineered. A drug is a chemical, sometimes biological. Rather than amending the Act, the government made rules to regulate an engineering product as a chemical.
Also Read | Behind the Indian cough syrup that killed many in Gambia and Uzbekistan
As I wrote in The Indian Express in 2019, creating a regulatory framework out of notifications and rules using delegated powers led to a toothless regulatory framework. The amended rules have no penal provisions, which only the Parliament can enact by amending the second schedule of the Act and defining standards for medical devices. The Union government can clearly push through legislation in Parliament when it wants to. In August 2023, we saw Parliament pass the Jan Vishwas Act that decriminalised making and marketing a substandard drug to patients in India. It is therefore a question of intent.
Sherrif’s book is a must-read for anyone who is interested in public health, drug regulation, regulatory capture, and how medical malpractice is held to account in the country. Access to safe and effective healthcare has never been a priority of our polity when it comes to electing our representatives. Perhaps reading these stories, and the fact that this could well happen to any of us at any time, may give us a reason to demand accountability from our government. One can only hope.
Dinesh S. Thakur is a public health activist.
