The details of the story of a metallic medical device gone awry are well reported — debilitating a number of patients, and leaving them with excruciating pain, disability and, in some alleged cases, even death.
The brief facts: DePuy, a subsidiary of Johnson & Johnson (J&J), engineered a hip replacement device that used metal in both the ball and the socket. Commonly called the “Articular Surface Replacement or ASR hip implant”, this device soon turned toxic, owing to the release of metal debris, resulting in inflammation, tissue damage and profound pain.
While one is not certain of the precise date on which DePuy first knew of the various problems with its device, there are indications that doctors began warning the company as early as 2005. Court testimonies suggest that doctors who brought it to the repeated attention of DePuy were ignored — or had their research funding cut off. In fact, the Australian registry took issue with the high failure rates of the allegedly superior metal implant as far back as 2007.
So DePuy clearly had knowledge of this problem by then. Yet it issued a global product recall only in 2010. Worse still, it renewed its Indian import licence in 2010 — just a few months prior to the global product recall.
More unfortunately though, it took a full three years for the Indian drug regulator (Central Drugs Standard Control Organisation, or CDSCO) to wake up and issue a product alert.
But what of the hapless patients such as Vijay Vojhala who have had to go though enormous pain and suffering in the interim? Losing their jobs, mobility and much more.
While DePuy reimbursed victims such as Mr. Vojhala for their revision surgeries (to replace the “metal” with other materials such as ceramic or polyethylene), they refused to compensate. Reimbursement is not the same as compensating a patient for the pain, suffering, disability and loss of work. Illustratively, consider the first law suit that went to trial in the U.S. against DePuy, where a jury awarded approximately $8.3 million as damages. Of this, only $338,000 was meant to reimburse the aggrieved patient for costs associated with surgery. The major chunk ($8 million) went towards compensating him for pain and suffering. It bears noting that most legal actions in the U.S. allege that despite knowledge of high failure rates, J&J failed to issue prompt warnings and take appropriate remedial steps.
The Indian government finally constituted an investigative committee in 2017. Its report (just made public) is a telling indictment of DePuy and its attempts to evade responsibility. It decries DePuy’s rather evasive responses: while 15,829 ASR hip implants were imported in India, only 4,700 surgeries were performed. Worse still, only 1,295 unused implants had been returned to the company. Where did the rest go? Is it not J&J’s responsibility to ensure that the recall is properly implemented and to account for all the missing pieces?
Unfortunately, the Drugs and Cosmetics Act (DCA) is woefully inadequate when it comes to victim compensation. The Act problematically presumes even a “device” to be a drug. And it penalises all those who sell adulterated, spurious or sub-standard drugs. It will take a stupendous stretch to argue that a faulty medical device amounts to a “spurious” or “adulterated” drug.
As such, invoking the DCA may not be a legally robust option. However, patients can invoke traditional tort law remedies and the Consumer Protection Act to claim damages. Some actions are pending before Indian courts and consumer fora which need to be consolidated and fast tracked.
Status quo since Bhopal
This is where memories of the Bhopal gas tragedy and a rather remorseless corporation (Union Carbide) spring to mind. The message at the end seemed clear: Poor hapless Indians are used to so much worse than their developed country counterparts. We can do with far less compensation, or even none at all.
Unfortunately, things haven’t changed much since then. A couple of years ago, when hit with a compulsory licence for its prohibitively priced anticancer drug Nexavar, Bayer went on record to state that it does not make its drugs for Indians. India needs to send out a clear message to multinationals that enough is enough: the lives of Indian patients matter as much, if not more.
Strangely, the government has been rather timid in taking on J&J. It even blocked a potential CBI inquiry, despite a former drug commissioner recommending this. This has forced patients to turn to the one institution that has fared a bit better when it comes to protecting public interest. But will our courts step up? If a recent court ruling in Mumbai is anything to go by, there is some hope. In Glenmark Pharmaceuticals v. Galpha Laboratories , the court imposed a whopping ₹1.5 crore as damages. Taking note of the fact that the defendant was a reckless violator of drug safety norms, the court issued a stern warning that could well apply on all fours to the controversy at hand: “Drugs are not sweets. Pharmaceutical companies which provide medicines for health of the consumers have a special duty of care towards them... However, nowadays, the corporate and financial goals of such companies cloud the decision of its executives whose decisions are incentivised by profits, more often than not, at the cost of public health. This case is a perfect example of just that.”
Shamnad Basheer is the founder of P-PIL, an initiative to promote public interest lawyering in India