The clock is ticking on an expert committee report submitted to the Health Ministry that recommends compensation to patients affected by faulty implants from Johnson and Johnson’s (J&J) Depuy Orthopaedics.

It has already been a long wait for some who have been living with the pain and disability caused by the faulty implants for over eight years. In 2010, Depuy had undertaken a voluntary global recall of its ASR Hip System and, in 2013, it made a payment of $2.5 billion to about 8,000 patients in the US.

Patient complaints on the faulty product were first red-flagged in India by then Maharashtra Food and Drug Administration (FDA) Commissioner Mahesh Zagade, who escalated the issue to the regulatory Drug Controller General of India’s (DGCI) office, even as he made a pitch for patient compensation in 2013. The people helming the office at the Maharashtra FDA and DCGI have since changed, but the patients’ woes remain unresolved.

In fact, even the expert committee set up by the Health Ministry in 2017 came well after the faulty implant issue first flared up. Also, the committee’s report submitted to the Health Ministry earlier this year was made public only last week, after much pressure from a patient group.

Be it patients who have directly suffered as a result of the cobalt and chromium “leakages” in the blood from the faulty implant or those who have lost a family member due to it, the grievance is that the Centre is yet to act on the report. While patients complain and struggle for redressal, no tough questions are being asked of the company.

Disturbing questions

And indeed the expert committee’s report has raised many, the main being: on why Depuy continued to sell the product in India despite the recall in Australia (2009); and over concerns on the whereabouts of the over 3,000 people with the faulty implants.

Industry watchers poke holes even in the numbers given to the expert committee.

Compensation precedent

While J&J says it kept the authorities informed about the recall developments, the expert committee insists the company was “evasive” in sharing information.

Its recommendation on patient compensation seeks to set a precedent of sorts for product recalls, though the math behind the base ₹20-lakh compensation has bewildered patients. While the recommendation reportedly relies on the compensation structure for clinical trials, the point to note is that even there the issue causes much heartburn in terms of how to map the trauma of a patient in financial terms.

A committee member explained that each patient’s details will be assessed in terms of the severity of the disability, loss of productive years and wages and physical and mental trauma. While the recommendation is a good start, the Health Ministry will have to get cracking on it for patients to get some, if any, relief.

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