Committee’s ‘Clean Chit’ On J&J Implants: The Unanswered Questions

With the expert committee giving Johnson & Johnson clean chit, what can patients do?

For the last few months, the media has been reporting on the plight of victims of hip implants imported and sold by Johnson & Johnson in India. Although the issue relates to implant surgeries done more than a decade ago, it has been in the news primarily because the government and the regulator have done little for the victims.

The committee seems to have found no one responsible for the plight of the victims and except for a rap on the knuckles for J&J, everyone else – government, regulator, doctors and hospitals, seems to have been given a “clean chit”.

This has been confirmed by the report of an expert committee set up by the government in February 2017. The report was published in August 2018 but raises more questions about the committee’s legitimacy, working and recommendations than it answers.

Where Are The Victims? How Do We Find Them All?

A feeble attempt was made by the committee to contact victims and the response was, as can be expected, poor. Letters were sent to orthopaedic surgeons and hospitals regarding the J&J hip implant but it is unclear from the report what the responses were. The recommendation of the committee, however, is that doctors be regularly advised by J&J about patient care but no mention is made of compelling doctors and hospitals to find the victims.

Patients are unlikely to know that they have been implanted with the recalled device and that may well be the reason for the lack of awareness among the patients about the recall and the poor response to the measures taken to identify them so far.

The expert committee has recommended advertisements be released to alert patients. But they are unlikely to be of much use.

If advertisements didn’t work in the past in encouraging patients to identify themselves, there is no reason that they will work to identify victims now.

Despite all the media reporting about this issue, no more than a handful of patients have come forward. Even if the victims were identified, what are the chances that they will have all their medical records from a decade ago?

The drug inspector has the power to inspect every licensee (importer, distributor and hospital) and seek documents regarding the import and sale of medical devices. Any failure of the licensee to provide these documents is an offence. The threat of prosecution by the drug inspector should be sufficient deterrent for licensees to comply with information requests.

The expert committee makes no mention of the failure of the regulator to obtain these documents – merely accusing J&J of being evasive is insufficient to ensure that these documents are available.

Over the last six years these documents could have been easily obtained and patients traced using this information.

Regulator, J&J, Doctors & Hospitals - Was No One Responsible?

J&J had a statutory duty to recall, and that was clearly stated in its registration certificate, which the expert committee has observed. The committee concluded that J&J was evasive in responding to information requests made by the committee and truant in its recall of the implants. It would be difficult to contend that its duty to recall was performed merely by informing surgeons, setting up a helpline and issuing public advertisements.

If this is “strict liability” and not just an obligation to make reasonable efforts to recall, should J&J not be obliged to ensure that all implants are recalled and fully accounted for?

Neither the regulator nor the expert committee could confirm the total number of patients who had the implants – they have relied on information from J&J, that it is 4,700, without asking for an account of the total implants imported which is more than 15,000.

The committee makes no comment on the conduct of the doctors and hospitals. Surely they had a significant role to play and have been complicit in the misery of the victims – at the very least, they did nothing to help the patients even when they knew of the recall.

One would have expected that if the committee was really keen to help the victims, it could have investigated the conduct of the doctors and hospitals and begun by insisting on them disclosing, confidentially of course, the list of patients who had the implants.

The committee published a list of patients (anonymised to protect their identity) who had undergone revision surgeries but seemed to make very little effort to identify the full list of victims. It isn’t difficult to get this information from the hospitals and doctors.

The Ministry of Health too has done nothing to help the victims, other than appoint the expert committee — not even a letter to J&J.

How Should Victims Be Compensated?

The committee observes that there is currently no provision for compensation in the law, but a procedure for assessing compensation to the victims has been recommended. This is a formula based on the clinical trial rules with a base of Rs 20 lakh, based on the assumption that the victim would be earning the minimum wage in New Delhi.

The committee seems to be ignorant of the provisions of the Indian Penal Code, the Criminal Procedure Code, Consumer Protection Act or principles of tort law which provide for compensation to the victims. In fact, nothing is said about prosecuting J&J under any of these provisions.

Surely the expert committee was aware of the pending criminal prosecution started in 2011 in Mahim, Mumbai. Nothing has been said about pursuing this case or the institution of new proceedings to put pressure on J&J. The committee seems to assume that J&J will cooperate by accepting all its recommendations and pay out the amount of money that the committee decides asex gratia compensation to the victims.

Compensation Less Than Clinical Trial Patients, But More Than Motor Accident Victims

The committee seems to have used the clinical trial guidelines to determine compensation for the implant victims. Risk of death or disability in a clinical trial is definitely a higher risk and known to the patients and doctors but the committee provides for lower compensation for an approved device where patients had no idea about the risk of these implants.

The clinical trial guidelines have a clear formula but the committee stopped short of actually recommending a specific formula in this case – that’s been left to a future case-by-case determination.

Meanwhile, in comparison, families of those killed in road accidents have in previous cases been awarded, on an average of Rs 3,00,000 to Rs 5,00,000 by the Motor Accident Claims Tribunal during the period 2010- 2016.

A constitutional bench of the Supreme Court recognised that there was a lack of consistency in how compensation was computed under the Motor Vehicles Act and tried to resolve this issue by framing guidelines in the case of National Insurance v. Pushpa (October 2017). Will the expert committee use these guidelines to determine the compensation? Will J&J and the patients accept this formula and the compensation determined by the expert committee?

Has enough thought and effort been applied in determining compensation guidelines in cases of faulty medical devices? Does the compensation formula consider loss of livelihood? What proof of income will suffice to support claims?

How Will Expert Committee Recommendations Be Enforced Against J&J?

The expert committee confesses that there is no real legal basis to implement any of its recommendations or hold J&J liable.

Since the legal basis for the expert committee is itself dubious, every action of the committee could be challenged, and if that happens, it is doubtful if the victims will ever get any compensation.

Worse still, victims may end up wasting money and time in pursuing the compensation.

There was a clear acknowledgment that the regulations were inadequate but there has been no criticism of the role of the regulator, doctors or hospitals.

It is only at the very end, a few years from now, when the victims have been completely exhausted by the “compensation process” that they will realise that it was all a jhumla, a charade.

Can This Happen Again?

The recent Medical Devices Rules, 2017 are just ad hoc regulations about general standards. Regulations around approvals, violations and remedies remain under the Drugs Act as if all regulations mentioning drugs applied to devices.

A former health secretary has confirmed that these regulations were delayed for many years due to industry lobbying.

These rules still don’t ensure that the hip implant victims will be treated better if they had similar issues arising from an implant today. 

The committee’s recommendations included a device registry so that patients and devices can be tracked, a standard operating procedure for recall, better procedure for reporting adverse events and a formula for compensation to the victims. However, no amendments to the main provisions of the Drugs Act have been recommended and as a result, the regulations will continue to be vulnerable to legal challenge.

With a public interest litigation filed in the Supreme Court last week, we may soon have more evidence that the expert committee is a huge disappointment, even by Indian government standards.

(This article was first published on BloombergQuint.)

(Murali Neelakantan is an expert in healthcare laws.)

(The views expressed here are those of the author’s and do not necessarily represent the views of FIT, Bloomberg Quint or its editorial team.)