• Posted by CERC India
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Rs. 33 L to Rs. 1.2 cr compensation mooted in J&J case

New legal provision to hold medical device makers liable for defects soon


Victims of faulty hip implants, sold in India by DePuy International, a subsidiary of Johnson and Johnson (J&J), may get compensation in the range of Rs. 33 lakh to Rs. 1.2 crore, according to a formula devised by a government panel of experts.

Due to a design defect, the hip replacement device (called the DePuy ASR) leached toxic chromium and cobalt into the body. Patients who received the hip implants suffered severe pain, resultant disability, and loss of wages. Many had to undergo corrective surgeries.

The device was recalled in 2010 following global reports of metal poisoning and high failures. Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. In the US, J&J agreed to pay $2.5 billion in 2013 to around 8,000 citizens who sued the company. Currently, India has no specific legal provisions to pay compensation in such cases. 

New legal provision soon 

In response to the J&J case, the Indian government is set to introduce a legal provision under which a company manufacturing medical devices will have to offer compensation to patients in case of an adverse event. The provision is to be notified soon as part of the Medical Device Rules, 2017.

Under the existing law, companies pay compensation only in case something goes wrong during a clinical trial. The Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceutical and medical device makers, has proposed changes in the existing law.

According to consumer activist Bejon Misra, founder of Patient Safety and Access Initiative of India, India needs a law that offers automatic compensation to patients for harm done by any defect in a product, or because a manufacturer compromised on quality and safety. 

Delayed action 

Though the Indian regulators knew of thesptl2 recall in 2010, they banned the import of the devices and cancelled the licence of the company only two years later. Moreover, it took the Indian health ministry seven years (after the recall) to constitute an expert group to look into the matter.

The Indian government has told J&J that it is liable to pay adequate compensation, or take care of the patient’s medical needs or both, depending on the severity of the case. In addition, it should issue a suitable advisory from time to time till 2025 for medical professionals. The advisory should provide recommendations to orthopaedic surgeons for patient management, including regular follow-up. The firm was also told to trace the patients who have not registered for compensation with the ASR helpline so far.

Failure of company 

According to consumer safety and rights columnist Pushpa Girimaji, “J&J voluntarily recalled the product globally in August 2010, but given the serious nature of the defects, the company had a duty to immediately trace and inform each and every patient who had received the implant (and not just surgeons) of the risks and take all necessary action-medical as well as financial – in a bid to mitigate their suffering. It failed in this duty.”

She also writes that the Consumer Protection Act provides for class action suits being filed by the government on behalf of consumers and the health ministry should use this provision immediately. The apex consumer court in turn should fast track the process of justice and award exemplary damages.

Patients claiming compensation are required to fill in a form published on the drug regulator’s website. Other than some personal details, the patients have to mention the date of the first surgery, type of surgery, identification number of the ASR implant, details of revision surgery, if any compensation other than the reimbursement has been paid by the company, and the medical symptoms arising out of the use of the implant.

Disclaimer: The information is updated till the time of going to print.

Source: Newspaper reports

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