Issue

Context:

Central Drugs Standard Control Organization (CDSCO) recently directedJohnson & Johnson (J&J) to compensate a Maharashtra-based patient fitted with ASR(articular surface replacement) hip implant with over Rs 74.5 lakhin following a formula approved by Ministryof Health and Family Welfare.

Background of the case:

• J&J had marketed the ASR implants in India through its subsidiary DePuy (Deputy International Ltd.) between 2004 and 2010. ASR is a metal-based hip replacement device wherein both the socket and prosthetic ball are metal based, mainly Cobalt, Chromium, and Molybdenum.
• Metal-on-metal implant is considered to be more durable and provides more range of motion as compared to conventional ones. However, in case of metal-based implants, due to the friction, the metal debris would produce which may enter the bloodstream and cause metal poisoning (Cobalt and Chromium).
• The device was used in over 93,000 hip replacement surgeries worldwide which was soon followed by the complaints of complications like metal-poisoning and implant failure.
• Australia took legal action against J&J following the complaints of complications leading to replacement of faulty ASR hip implants in 2009.
• In 2010, J&J started a global recall of the device following a UK-based study which showed that these implants had a higher failure rate.
• In USA alone, J&J announced a compensation package of over $2.5 billion to around 8,000 patients in 2013.

Status in India:

• J&J got licence to import the ASR hip replacement device in India in 2006.
• In India, around 4,700 surgeries with faulty hip implants were performed, out of which J&J could trace only 2,300 and reimbursed only 275 till September, 2018.
• The maximum compensation amount paid India is around Rs. 3.5 lakh which includes revision surgery, doctor visit, tests, and loss of job during surgery.
• The amount paid in India is inadequate and miniscule when compared to compensation paid in countries like USA. Expert committee formed by the Indian government has also found grave inadequacy in steps taken by the company towards compensating the patients.

Steps taken by Government of India:

CDSCO cancelled the import of ASR implants and issued an alert following a case in Maharashtra of medical complication following the hip implants in 2013.

Expert committee formed by Ministry of Health and Family Welfare under Arun Kumar Aggarwal to examine issues arising out of ASR hip implants in India in 2017.

The expert committee provided a compensation formula would make patients eligible for amounts between Rs 30 lakh and Rs 1.23 crore, depending on their age and level of disability.

Committee also recommended for constituting regional expert committees to assess the disabilities among patients, creation of registry of usage of medical devices, creation of a centralised registry of patients’ health assessment records, and amendment to Medical Devices Rules, 2017 to insert provisions for compensation following complications due to medical device usage. 

Major ethical issues:

• Criminality on J&J’s part: Company suppressed facts about the issues associated with the implants and about compensation in USA, lack of professional standards, lack of concerted effort at tracing the patients, and making money out of human sufferings.
• Inadequate efforts: Company did not track the patients citing the doctor-patient confidentiality issue despite the method of tracing the trail of receipts from distributors to retailers being in place.
• Conflict of interest: Company sought out patients to pay them meagre compensation after making assessments on its own to prevent future legal suits.
• Negligence: CDSCO renewed J&J’s licence in 2009 despite the implants being recalled and replaced in Australia in 2009 following issues of metal-poisoning and other complications.
• Legal issues: Absence of compensation law in India and ambiguities in the compensation formula presented by the Expert Committee. CDSCO had initially relied on assurances by the firm that it would provide compensation.
• Doctor-corporate nexus: Professional ethics and principle of beneficence compromised for short-term monetary gains.
• Conduct of regulatory bodies: Ineffective regulations, absence of effective accountability mechanism, along with issues like corruption without consideration of adverse consequences in terms of patients’ health.
• Violation of patients’ rights: Like right to safe & quality healthcare, breach of trust, unfair treatment and compensation, etc.

Current status and issues:

J&J is currently challenging the compensation formula given by the expert committee of MoHFW in a court.

At present, there is no provision in the Indian laws to compensate victims of faulty devices. If CDSCO is able to enforce the compensation formula of expert committee, a precedent might be set for similar cases of patients seeking competition for faulty implants.

Some patients have raised concerns about the formula approved by the government of ambiguities and deficiencies as it lacks clarity on compensation for any deaths that have occurred as a result of the implants.

Way-forward:

1. Need of effective risk-monitoring system: India needs adequate post-market follow-up studies on usage of medical devices and other healthcare products to timely detect the defects, if any, and take corrective measures. The Materiovigilance Programme started in 2015 is an effective step in this direction. However, it needs to accelerated and strengthened further.
2. Compensation laws need to be mainstreamed to provide the patients effective, adequate and timely compensation. The recommendations of expert committee should be implemented in letter and spirit.
3. Regulatory environment needs overhaul for better monitoring and regulation of the market. Quality healthcare is the right of patients and it must be the centre of all healthcare-related policies.