Consumer protection: Manufacturer held liable for defective hip implant

The National Consumer Commission exonerated the doctor and the hospital but found DePuy and Johnson & Johnson liable for the defective implant

Lalita Rajpurohit, diagnosed with osteoarthritis of the hip, underwent a drilling procedure in Ahmedabad in April 2005, but experienced no relief. She then consulted an orthopaedic surgeon at a leading Mumbai hospital, who advised a total hip replacement using the DePuy Acetabular System Resurfacing (ASR) metal-on-metal, large head, implant, supposedly a superior product with no side effects. The surgery on the right hip was performed in June 2007 and on the left in August 2007.

 

By January 2008, Rajpurohit began experiencing discomfort, which worsened into severe pain and impaired mobility. On reporting the issue to the surgeon, she was advised to use a higher vehicle, prompting her to purchase a Tata Innova.

 

As her condition deteriorated, she found it difficult to follow up with her operating surgeon. She consulted another doctor who informed her that the implant had been declared medically unfit by the United States Food and Drug Administration (USFDA) and withdrawn from the American market. Further online research revealed that safety concerns around the implant had been flagged on social media as early as 2005. Experts had opined that cobalt and chromium implants can cause fatal complications. Yet, the devices continued to be distributed in India.

 

Rajpurohit filed a complaint before the National Consumer Disputes Redressal Commission (NCDRC) against DePuy, Johnson & Johnson, the surgeon, and the hospital. She sought over ₹107 crore in compensation, stating that she was only 46 at the time of surgery and had to quit as managing director of a credit cooperative society, where she earned ₹64 lakh per month. She added that as a widow she was solely responsible for her 19-year-old daughter’s education and care.

 

DePuy Medical defended itself, stating it was a subsidiary of DePuy Orthopaedics Inc, USA, founded in 1895 and known as the world’s oldest manufacturer of orthopaedic products. It claimed that the implant was made in the UK by DePuy International, a division of Johnson & Johnson. Upon learning of the high revision rate of surgeries, it voluntarily stopped selling the ASR implant in 2010 and issued a product recall, even though there was no defect. It argued that wear in artificial hip components was inevitable, and that friction could cause metal particles to enter surrounding tissues. DePuy also raised the objection that the complaint filed in 2013 was time-barred.

 

The National Commission held that the defect only became known in 2012, when DePuy and Johnson & Johnson recalled the product and offered a remedial scheme for affected patients. Considering that the limitation period would run from the date of knowledge that the product was defective, the complaint filed in 2013 was held to be within time.

 

On merits, the Commission relied on a Certificate of Analysis from a Malaysian laboratory, which confirmed that Rajpurohit’s cobalt and chromium levels were dangerously high, necessitating revision surgery, which was carried out in 2014.

 

The Commission exonerated the doctor and the hospital due to absence of any evidence establishing negligence. However, it found DePuy and Johnson & Johnson liable for the defective implant. As Rajpurohit had not provided documentary proof of her income, the Commission awarded her only ₹35 lakh as compensation, with 6 per cent interest from the date of the complaint. It also granted ₹1 lakh towards costs. The liability was imposed solely on DePuy and Johnson & Johnson.

 

The writer is a consumer activist