Regulatory Lessons of Faulty Hip Implants [ collected from ET for ref]


The faulty hip implant made by Johnson & Johnson that were put inside some 4,700 patients, four of whom died and 3,600 of whom cannot be traced, hold up a mirror to India’s healthcare regulation, and the picture is not pretty.

India needs comprehensive healthcare data storage and management, globally conversant regulation of implants and drugs and strict codes of conduct for medical companies that penalise unethical conduct.

The prosthetic, manufactured by a subsidiary of J&J, got clearance from America’s Food and Drug Administration in 2005. It secured approval for sale in India in 2006 for three years and renewed its application in April 2009, fortifying it with a declaration of no product complaints in September.

It obtained a renewed licence in December 2009, and began the process of importing them in the next month. But in December 2009, the product had already been recalled in Australia. And the recall became global in August 2010.

The company misbehaved by denying product complaints and going ahead with licensing and import after it had already recalled the product in Australia. The company agreed to a settlement of $2.47 billion to around 8,000 claimants in the US by end-2013.

Yet, India waited till 2017 to set up a committee to investigate, which submitted its report in February 2018, recommending at least Rs 20 lakh compensation for patients, and reimbursement by the company for revision surgeries till August 2025. The government must implement these recommendations.

The Companies Act allows those who suffer from these faulty implants to move a class-action suit against J&J. More to the point, the government must draw the right lessons and overhaul its regulatory process and apparatus. Healthcare data storage and management must become mandatory.

 

Advertisements

Author: Your useful Books.

An online seller of books. Lives in Mumbai and Kolkata.