Criminal charges for faulty hip implants case by DePuy Synthesis subsidiary of Johnson &Johnson.
Depuy Synthesis was acquired by Johnson and Johnson in 1998. An expert committee set up by the Ministry of Health indicated that Johnson and Johnson had supressed facts regarding the hip replacement systems thus causing health issues in many individuals who had to undergo several surgeries again and some even getting permanently disabled.
The actual process of the hip replacement:
The hip joint consists of a ball and a socket, which are covered with cartilage and surrounded by a lubricating membrane to protect against wear. In a total hip replacement the entire hip is replaced with prosthetic components. A metal stem is placed into the hollow centre of the thighbone (femur), the prosthetic ball, socket and cartilage can be made of strong plastic, metal or ceramics. The commonest hip implants are metal on polythene, and ceramic on polythene. These implants are metal on metal, with cobalt, chromium and molybdenum as major constituents. Called ASR (Articular Surface Replacement) XL Acetabular System and ASR Hip Resurfacing System. DePuy, the subsidiary of Johnson and Johnson used to manufacture and sell these.
The cause for the legal proceeding:
Wheh the prosthetic ball and the socket rub against each other it causes wear. If both the components are metal then the rubbing action of the prosthetic ball on the socket would lead to metal debris being released into the bloodstream leading to complications and re-surgery in many cases. Out of 93,000 patients implanted with ASR many patients faced complications thus having to undergo a re-surgery to have the metal component replaced with an implant of other kind. The company later recalled the product in august 24, 2010.
The company had obtained license to import the device in India in 2006 and by the time the device was recalled already 4700 ASR implants had been done in the country.
Amid all the concerns been faced by patients worldwide due to their faulty ASR devices the company set up a committee in 2017 to keep track and examine the issues being faced by the patients.
The committee concluded that not only did the patients had to undergo a revision surgery but many had to undergo surgeries more than once. Many patients reported to have pain while walking, fatigue and many similar local problems. The faulty ASR devices also caused many patients to be permanently confined to their beds.
The committee recommended that the company be liable to pay a compensation of Rs 20L to every patient with complications caused due to the faulty ASR devices by the company by August 2025.