“It is like rigorous imprisonment”, says Vijay Vojhala, explaining his constant discomfort after a hip surgery 10 years ago went awry. The faulty implant affected his mobility, vision and hearing, he says, and “even pain killers don’t have any effect.”

The ASR Hip System had been voluntarily recalled by Johnson &Johnson’s Depuy Orthopaedics in 2010. And in November 2013, the company made a $2.5-billion payout in the US to 8,000-odd patients, billed then among the highest payments on a medical device recall.

Vojhala and other similarly affected patients are calling for the Indian Government to hold J&J accountable for the incident and the trauma they live with resulting from cobalt and chromium “leakages” into their blood due to the faulty implant. A recent report by an expert committee (under the Health Ministry) has recommended, among other things, compensation with a base of ₹20 lakh. But aggrieved patients are outraged, saying that they are being asked to establish their trauma, while the company is not being questioned on selling a product after it had been recalled in markets like Australia.

The incident puts on centre stage the crucial issue of patient compensation following a product recall, for drugs and medical devices. It also highlights the need for traceability of faulty or substandard products, so the drug regulator can contain the damage and take steps to protect the patient. Presently, the Drugs and Cosmetics Act has penalties, even punishment, for substandard products. Medical devices, though entirely different from drugs, are viewed through a similar lens. So, while there is a process for adverse event (or side-effect) reporting, the law does not address recall and the penalty for physical and mental trauma caused by the device. High-profile medicines like Merck’s painkiller Vioxx (Rofecoxib) and GlaxoSmithKline’s diabetes drug Avandia (Rosiglitazone) have been yanked off the Indian market following global regulatory action.

Faced with class action patient suits and investigations, these companies have had to pay top dollars to settle cases internationally — an action not mirrored in India.

Traceability concerns

With devices, be it with Abbott’s dissolvable stent Absorb or J&J’s faulty implant, a common refrain is that companies sell through hospitals and are not allowed to contact patients directly, as that could be seen as influencing them.

J&J maintains it had kept the drug regulatory authority abreast of developments involving the recall and had undertaken revision surgeries for patients, advertised in newspapers, set up surgeon support, etc.

Maharashtra’s former Food and Drug Administration Commissioner Mahesh Zagade is not convinced that patients cannot be traced. “It is a licensed product. It is not difficult to establish a trail of patients who used the product”, he says. Zagade first raised patient compensation in India while investigating a consumer complaint on the implant. He escalated the issue to the Central Drug Controller General of India and even called for a CBI enquiry.

Speaking for Indian medical device makers, Rajiv Nath agrees that products are traceable and adds that traceability should be made mandatory.

“Unlike drugs, devices are an engineering product and any manufacturer can make a mistake,” says Nath. There should be a line of control (especially with implants) to trace products, he says, adding that it is a collective responsibility across the chain, from producer to the regulator. The expert committee’s report has also suggested a registry of patients on whom products are used.

Nath adds that good manufacturers should adhere to an ethical standard that is even above the law. Praful Sardesai’s father died within months of the hip implant. “We are sportsmen. My father at 81 was a healthy personality,” he says, adding that his mother blamed him for his father’s death. “She felt if he hadn’t gone for the surgery he would have been alive,” he says. With both parents now deceased, Sardesai says that compensation aside, the company needs to be held accountable for using patients like his father as “guinea pigs”, despite recalling the product elsewhere.

The Government and J&J need to be way more vocal and visible in addressing this issue, because clearly the trauma continues to haunt both patients and their families.

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