The Johnson & Johnson ASR Implant Case

Context:

The government has constituted a 5-member expert committee to recommend on the amount of compensation for patients who has suffered from faulty Johnson &Johnson hip-implants.

Background of the Case:

• Deputy International Limited (DePuy), a subsidiary of Johnson and Johnson had engineered a metal-on-metal (both the prosthetic ball and socket are made of metals- cobalt &chromium) hip replacement device.
• The devices were used in more than 93,000 hip replacement surgeries internationally. However, soon there were complaints about complications arising out of the implants. Many patients experienced serious adverse reactions due to metallosis (metal poisoning) and some required revision surgery to replace the ASR implant with another kind.

Timeline of International Response:

• 2003- Johnson& Johnson marketed ASR overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies. However, J&J continued sale of a related model in USA, which did not require a similar safety review due to a regulatory loophole
• 2005– Doctors started issuing warnings on the defects and complications arising out of the implant
• 2009- Australia became the first country in the world to take regulatory action to ensure the removal of the DePuy ASR hip replacements from the market.
• 2010- J&J took initiative to recall the devices globally due increasing number of re-surgery.
• 2013- J&J announced $2.5-billion ASR settlement for around 8,000 patients in the US

Timeline of the Case in India:

• 2006- J&J got the license to import the device in India
• 2010- CDSCO issued imports licence to DePuy for implants on the basis of renewed registration
• 2011– Maharashtra FDA filed a First Information Report (FIR) against Johnson & Johnson after getting an anonymous complaint about a patient suffering a serious adverse reaction
• 2012- Maharashtra FDA asked the regulator Central Drug Standard Control Organization (CDSCO) to cancel the J&J’s import licence for not taking proper remedial measures or creating awareness about the “defective”.
• 2012- CDSCO cancelled the product’s import and marketing
• 2013– CDSCO and health ministry received grievances on ASR implants and discussed with DePuy. It also issued a medical device alert on ASR implants
• 2017- Health Ministry set up an expert committee headed by Arun Kumar Agarwal to examine issues arising out of faulty ASR implants in India

Committee Recommendations:

1. Compensation and Reimbursement:

• The company should be made liable to pay at least Rs 20 lakh to each patient with complications, the
• Reimbursement programme should be extended until August 2025.

2. Expert Committees:

• A regional expert committee should be constituted to monitor the extent and consequences of disability among patients.
• A central expert committee should be constituted to determine the quantum of compensation (base amount to be 20 lakh)

3. Health Assessment:

• Health assessment of patients should be reported once a year till 2025 and compliance report should be prepared periodically

4. Registry:

• An independent registry should be established for tracking usage of high-risk medical devices.

5. Medical Device Rules:

• Provisions for compensation should be included in Medical Device Rules if any serious adverse event or death is caused due to the sole use of a medical device.

Issues highlighted by the Case:

1. Negligence- According to the observations of the expert committee, the CDSCO renewed J&J’s registration of its ASR products in 2009 without the knowledge of these having been recalled in Australia. This clearly highlights regulatory authority’s negligence on global developments.
2. Post-market follow-up studies:

• India does not generate adequate local data on the safety of healthcare products once they are marketed and relies heavily on western regulators for signals. The post-market follow-up indicates early signs of a product being defective.
• India launched its Materiovigilance Programme only in 2015, five years after the ASR recall. It has also been alleged that the programme has been progressing at a snail’s pace

3. Definitional Ambiguity and Issue of Compensation:

• The manufacturing, import, sale, and distribution of medical devices are regulated under Drugs & Cosmetic Act and Rules (DCA)
• The Act presumes even a “device” to be a drug. It penalises all those who sell adulterated, spurious or sub-standard drugs. (15 devices are regulated as drugs in India)
• Critics are of the opinion that the definitional ambiguity makes it very difficult to prove that a faulty medical device amounts to a “spurious” or “adulterated” drug and thus hinders patients’ claims for compensation.

Ethical Issues Concerned:

1. Doctor – Doctors in connivance with the company for monetary gains have compromised the ‘principle of beneficence’, professional integrity, and also have eroded the trust of the people from sacrosanct profession.
2. Company (Johnson and Johnson) – Absence of professional standards, suppression of facts, varied conduct (like compensating in US but not in India), pursuance of profits at the cost of human sufferings.
3. Government – Ill-conceived policy formulations (leading to uncontrolled globalisation) without taking into account its adverse consequences, weak and inefficient accountability standards at place, ineffective regulatory mechanisms.
4. Regulatory Authorities – Basic provisions of code of conduct flouted owing to laxious attitude, red-tapism, corruption, negligence and non-compassionate attitude towards beneficiaries.
5. Patients – Right to healthy life, efficient medical care, right to justice and compensation, breach of trust.

Way Forward:

1. It is imperative that India use the learnings from the ASR case to take corrective steps.
2. There is an urgent need to strengthen and accelerate the Materiovigilance Programme and implementing rigorous risk monitoring and post-market follow-up of new devices wherever necessary.
3. The Committee recommendations on registries to facilitate tracking of high-risk medical devices should be discussed and speedily implemented.