Mumbai: In two separate cases, the National Consumer Disputes Redressal Commission directed Johnson & Johnson Ltd, DePuy Orthopaedics Inc, and DePuy Medical Pvt Ltd to pay compensation of Rs 35 lakh each to two women, now senior citizens, who had to suffer several medical and financial hardships due to faulty hip implants . In one case, the osteoarthritis patient, Lalita Rajpurohit, managing director of a cooperative credit society, submitted that she was forced to give up her job due to the limited mobility caused by the implants. The other complainant, Usha Gupta, had undergone the surgery after experiencing pain in her right thigh for almost a decade and said that she was unable to walk, climb up, and come down the stairs without aid and assistance following the surgery.
In both orders, relying on several documents and the remedial measures and instructions of the US Food and Drug Administration, the commission said there appears to be no other conclusion except that the metal-on-metal implant was creating metal debris at the joint. This was the root cause for component loosening, infection, fracture of the bone, dislocation, metal sensitivity, and pain in at least 13% of patients, mostly women. "In view of the aforesaid evidence, we found that ASR (Acetabular System Resurfacing) hip implants, metal-on-metal manufactured.
.. suffer from inherent manufacturing defects and released a harmful amount of metal debris, which was poisonous," the commission said.
The allegedly faulty articular surface replacement (ASR) hip implant device known as DePuy ASR was manufactured by DePuy Orthopaedics. In both instances, the companies said the patients were reimbursed for the expenses of revision surgery. The lawyers for the companies contended that no compensation could be awarded by the commission and that the patients were voluntarily paid Rs 25 lakh as compensation.
Refuting the argument, the commission said, "This argument is not liable to be accepted. When defective goods caused bodily injury then the compensation has to be awarded..
." The commission, though, said the companies can adjust compensation against the Rs 25 lakh if it's already paid. The compensation will have to be paid along with six percent interest from the date the complaints were filed.
Rajpurohit, 46 years old when she underwent the surgery, filed the case in 2013 and claimed over Rs 100 crore. She sought relief for the "financial loss, trauma, suffering, and social humiliation" she underwent. Ahmedabad native, Rajpurohit underwent the surgery at a reputed hospital in Mumbai in 2007 and spent almost Rs four lakh.
Gupta had moved the commission in 2015 seeking compensation of over Rs 3.5 crore for "physical shock, agony, pain and suffering, internal bodily injury, which was neither identifiable nor curable, loss of expectation of life due to medical complications such as metal poisoning, damage to the central nervous system, risk of cancer, etc." She was 52 when she underwent the first surgery in South Delhi in 2009.
Both orders also mentioned a committee report which held that the ASR hip implants were found to be faulty, resulting in higher instances of revision surgeries globally, including in India. "Accelerated wear of the MoM implant leads to higher levels of cobalt and chromium in the blood, which may lead to toxicity. When the implant wears at an accelerated rate, the patient will experience local symptoms such as hip or thigh pain.
These metal ions can damage tissues and further damage body organs. The excessive release of metal ions may also cause both localised and systemic health problems. This results in increased pain and decreased mobility, affecting their family and social life, their ability to work, to undertake hobbies and leisure activities, and often have a negative impact on their self-esteem and mental health," the committee had said.
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