Implanting correct measures
The details coming out of the Johnson & Johnson (J&J)’s Acetabular surface replacement (ASR) hip implant controversy raise more questions than answers. This metalon-metal type hip joint replacement device is manufactured by J&J’s fully-owned subsidiary DePuy Orthopedics Inc. It was withdrawn globally by the company in August 2010 following complications developed among some patients fitted with the implant requiring many patients to undergo revision surgery. As against the permissible limit of 5% almost double the number of patients developed the complications requiring the product recall.
Like in case of many other faulty drugs and medical devices ASR hip implant too has become a big legal issue in the US with the company facing lot many court cases and ending in paying millions of dollars as compensation . The company agreed to pay approximately $2.5 billion in 2013 covering 8,000 patients to settle thousands of law suits emerging out of the faulty hip joint. But in India the patients with post-operation complications have not been paid any compensation. The reason reported being that there is no provision for compensation in case of approved products as per the Act.
The hip joint was implanted in about 4700 patients in India before it was globally recalled in 2010. No ASR hip joint was implanted thereafter in India. But it took two years to cancel the import license of the company. Later a medical device alert was issued to hospitals, surgeons and patients. Then in 2014 the regulator started seeking information on patients fitted with the implant. Two MPs, Sanjay Jaiswal of BJP and Brinda Karat of CPM, have severely criticised the regulator for failing in its duty of safeguarding the patients.
A suffering patient informed media that he was not aware of the alert. Only when a doctor saw him limping in a conference which he attended as he was working as medical representative and asked him about his condition he came to know from that doctor that such an alert was issued. If that is the case with educated people and that too from medical field one can imagine the situation of uneducated patients and those from remote areas.
The government formed an 11-member committee in February 2017 to go into the issue which gave its report in February 2018. The committee has indicted the company for “suppressing” key facts on the harmful effects of the implant. The committee could track only 1080 of the 4700 patients fitted with the implant. Revision surgery was conducted only on 275 of them. Over 3,600 patients remaining untraceable even after 8 years is a serious issue exposing the shortcoming of the national joint registry, a common database of all joint replacement surgeries.
The committee has recommended among other things appointment of central and regional committees for evaluating patients’ claims, the company should be made liable to pay at least Rs 20 lakh to each patient, an independent registry should be set up to track usage of medical devices and provision for compensation should be included in medical devices rules. Compared to US, minimum compensation of Rs 20 lakh is too low.
It is a good development that the government is using this opportunity to send a strong signal to medical devices producing companies that they cannot escape from paying damages to the Indian patients. It has already initiated the process to make a legal provision making companies pay the compensation to patients. This incidence can also be used to correct the shortcomings within its regulatory system to initiate quick actions in future.
The government has launched Ayushman Bharat for providing medicines, healthcare facilities, health insurance at reasonable rates to the masses. But at the same time, tackling such issues effectively with quick actions to safeguard the interests of patients should also be considered as an integral part of Ayushman Bharat.