Faulty hip implants: No tinkering with compensation formula despite fresh appeal

Expert committee chairman asks Johnson and Johnson’s faulty hip implant victims to approach court

By Banjot Kaur
Published: Monday 18 February 2019
Patients talking to the media. Credit: Banjot Kaur Patients talking to the media. Credit: Banjot Kaur

The expert committee, formed by the central government to decide the compensation formula for those affected by Johnson and Johnson’s (J&J’s) faulty hip implants, may not be able to tinker with it even as the patients approached them following the Supreme Court (SC) judgment on January 11, 2019.

Hip Implant Patients Support Group wrote a letter to the expert committee on February 13, 2019, pointing out several concerns with the compensation formula, and also stated that the SC order did not go into the merits of the calculation of compensation reached at by the government.

“As much as my legal understanding goes, the Supreme Court asked to widely disseminate the formula and start giving compensations. If it had reservations with the compensation, it would not have asked us do so. Now, the matter is between the patients and the court. If the patients are not satisfied with the formula, they should go to the court again and file a curative petition,” R K Arya, chairman of the central expert committee that was tasked with deciding the formula, said.  

Asked if they would move the court again, Vijay Vojhala, who wrote to the government on the behalf of the patients, said: “We are yet to receive any response from the government. All options are open before us.”

"We are left with no choice but to move the court again,” said another member of the group on the condition of anonymity. Hence, court proceedings over the case seem far from over.

The point of contention here is the interpretation of the judgment. “In view of the above developments taken place (the compensation announced), we do not find any justification in keeping this matter pending any longer,” the apex court observed in the order.

It disposed of the petition asking the government to give publicity to the compensation to enable all the affected persons to approach the committee. The patients, however, contend that the petition — filed by one Arun Kumar Goenka — which the court disposed of, did not have any prayer on the merits of the compensation formula.

They, therefore, wrote in the letter to the expert committee that “the court’s judgment may not be used as an excuse to deny patients the due modifications and changes to the formula that would be necessary to ensure a more just compensation to their sufferings.”

The patients, incidentally, had met the committee members for the first time on January 9, 2019, to raise their concerns following which they were asked to make a written submission — which came as this letter.

According to them, more than 4,000 patients had got the implants. The compensation formula arrived at by the government would have given the victims anything between Rs 30 lakh and Rs 1.23 crore, depending upon a number of factors.

Raising concerns about the base amount, that is Rs 20 lakh, the patients wrote that it seems to have been derived to compensate the patients for clinical drug trial. “In a clinical trial, there is a certain presumption of the risk because the drug is under study for safety and efficacy. However, in the case of hip implants, the device was commercially approved for sale by the regulatory authority,” states the letter.

Talking about the exclusion of patients who did not apply for compensation within 15 years from the date of surgery (which were done in 2004-05), the letter states that it was unjust because another committee of the government — Aggrawal Committee — had itself pointed out that the outreach of Johnson and Johnson to the affected Indian patients was extremely poor and majority of them could not be traced.

The patients have also accused the government of ‘over-simplifying’ the risk factor and linking it with current disability only. “The disability caused due to faulty implants is incremental and hence could assume a greater degree in the course of a patient’s life. We ask that all the patients are assigned a minimum risk value of 2.5, which could vary upwards,” states the letter.   

Calling the quantum of Rs 10 lakh for non-pecuniary damages as ‘highly insufficient’, the patients wrote that the harmful effects of the toxicity that were caused by presence of metals in these implants could unfold completely only in years to come; while some patients had already reported vision impairment, hearing loss, adverse impact on reproductive system, inability to stand for longer period of time etc.

The patients also said that the requirement of a disability certificate to establish the risk factor and not just the criteria, differs from state to state; but the current disability that patients have might not be a complete reflection of what they are going to expernce.

They further pleaded with the committee to take into consideration factors like multiple implants, the interest factor due to delay in compensation and smoothening the entire process of awarding the compensation.        

A meeting of the expert committee is slated to take place later this month. “While I am clear about the legal implications about the Supreme Court order, legal experts of the committee would also have a look in the light of this letter. This matter would be further taken up there,” said Arya.

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