J&J's faulty hip implant: Expert panel says gaps in follow-up care and compensation to patients

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The report of an expert committee constituted by the Health Ministry has highlighted lapses in reporting cases, providing follow-up care and compensating patients who were implanted with faulty ASR hip systems of DePuy, a division of US-based Johnson & Johnson.

The committee in its report alleged suppression of material facts and observed that DePuy sought import license from the Central Drugs Standard Control Organisation (CDSCO) in January 2010, even as it recalled its product in Australia in December 2009.

Moneycontrol reviewed a copy of the report.

The 11-member expert committee was constituted in February 2017 under Dr Arun Agarwal, former dean and professor of ENT at New Delhi-based Maulana Azad Medical College to examine complaints made by some patients.

The committee met seven times and said it had gone through documents taken from various sources including patients, orthopaedic surgeons, DePuy, hospitals, court orders and Indian drug regulator before finalising the report.

DePuy had voluntarily recalled its hip implants claiming that data from 2010 indicated that within five years of having an ASR resurfacing device implanted, approximately 12 percent of patients had revision surgery. It added that within five years of having an ASR total hip replacement, approximately 13 percent of patients had revision surgery, against the generally acceptable levels of 5 percent.

The report stated that the revision surgery rate in India was around 25 percent.

In a revision surgery, the existing implant is removed and replaced with a new one as per a doctor's recommendation.

DePuy had earlier informed CDSCO that around 93,000 people worldwide had ASR implanted, of which 4,700 were ASR surgeries performed in India and just 882 patients could be traced. The status of over 2,300 patients was untraceable.

DePuy so far reimbursed around Rs 16 crore towards diagnostic tests, revision surgery and associated costs including loss of wages. The committee recommended that a compensation of Rs 20 lakh be provided to affected patients and issued modalities on eligibility. The report recommended the formation of central and regional expert committees to ascertain the effect of disability to determine compensation.

According to the leaked report, the committee has sought extension of the ASR reimbursement programme until August 2025 since the average life span of an orthopaedic hip implant was 15 years. DePuy's reimbursement programme ended on August 24, 2017.

The committee wants DePuy to do due diligence to trace those remaining patients who have received ASR implants but have not registered with the helpline. The health assessment of ASR patients should be reported once a year until 2025.

The committee sought that free and complete medical management shall be provided by the firm to all patients on whom revision surgery was conducted.

In addition, the report mentioned about systemic gaps in India's regulatory system such as lack of independent registry for tracking usage of high risk medical devices and vigilance programme to report adverse reactions of implants.

The committee recommended that the government establish an independent registry for tracking usage of high risk medical devices and  advised it to strengthen materiovigilance programme of India to monitor adverse events associated with the usage of medical devices.

The committee also sought that the government come up with guidance over recall and inclusion of provision of compensation of Medical Devices Rules, 2017.