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Patient interest must override criminal action threat in Johnson & Johnson implant case

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If the government has to ensure speedy and just settlement for all 4700 patients, it must consider an unpalatable option.

Is the threat of criminal prosecution against Johnson & Johnson causing more harm than good to the patients who have suffered due to the faulty hip implants?

As Johnson & Johnson’s faulty hip implant controversy snowballs into a bigger crisis with every passing day, there is mounting pressure for criminal prosecution of the management-level officers at the company as well as muted calls for action against the doctors who carried out the surgeries.


Also read: Johnson & Johnson, Modi govt at odds over compensation for faulty hip implants


DePuy Medical, which is now a part of Johnson & Johnson, had sold thousands of its new ASR-metal implants in the Indian market from 2006 to 2010 when it began a global recall because of a higher rate of revision surgeries reported in multiple jurisdictions like the US, UK and Australia. It was sued in the US and settled a class action lawsuit for $2.5 billion dollars. In India, the recall process progressed at a much slower rate.

According to the report of an expert committee of the Drug Controller General of India (DCGI), 4,700 patients received the implants. Of these, only 1,032 patients appear to have been informed about the recall either by their doctors or through advertisement published by a claim settlement agency appointed by Johnson & Johnson.

That the advertisements were published only in two English language newspapers (TOI & HT) demonstrates that it was a half-hearted attempt. The company cited doctor-patient confidentiality as the reason for not being able to contact the remaining 3,600-odd patients who presumably continue to be poisoned by the cobalt and chromium leaching from the hip implants into their blood. Simply put, the hospitals are not ready to reveal the names to J&J because they may be sued by patients. The fact that 3,600 patients are yet to be notified is stunning.

The reason for this delay in contacting patients, and this is a calculated guess, is a criminal prosecution launched in Mumbai. In 2011, the Maharashtra FDA commissioner filed an FIR under sections of the Indian Penal Code (IPC) seeking prosecution of the company for causing grievous hurt, voluntarily causing hurt and causing hurt by means of poison. It is unlikely that the Mumbai Police will be able to establish Johnson & Johnson’s guilt under any of these provisions because proving mens rea or mal-intent beyond reasonable doubt in these cases is incredibly difficult.

So far, the criminal investigation against the company has not been quashed. It did file a motion before the Bombay High Court under Section 482 of the Code of Criminal Procedure in 2011 to quash the FIR but ultimately withdrew its petition in October 2013 to take it up at an “appropriate stage”.


Also read: Modi’s Ayushman Bharat and price control will bring down quality of healthcare in India


The only other criminal option available under the law is a prosecution under Section 27 of the Drugs & Cosmetics Act, 1940, which allows drug inspectors and not the police to prosecute the company because devices are classified as drugs in Section 3 of the Drugs & Cosmetics Act. Unlike the IPC, most offences under the Drugs & Cosmetics Act are strict liability offences that don’t require the prosecution to prove mens rea. The mere fact that the implant resulted in poisoning of the human body will suffice to prove guilt.

However a certain amount of prosecutorial discretion vests with the government. But will patient interests be served by pressing on with a criminal prosecution?

Threats of a prosecution and incarceration tend to cause corporations to clamp down on sharing information in the fear that the information voluntarily shared with the government can be used against them in a criminal prosecution. Both J&J and the hospitals will try every trick in the book to delay and frustrate cooperation with the government in the hope that the issue falls off the media’s radar.

If the government is to trace the remaining 3,600 patients and effect a speedy and just settlement for all 4,700 patients, it must consider an unpalatable option. It must offer the company and the doctors legal immunity in exchange for information about patients.

Carceral regulatory tools are rarely the preferred option in such complex cases dealing with new products. A few years ago when a South Korean airliner crash landed in California, the Americans had called on South Korean authorities to not threaten criminal action against the pilots because it would thwart the investigation and sharing of information.

But criminal prosecution is not always off the table. When pharmaceutical companies demonstrate criminal negligence such as failure to conduct legally mandated tests or willfully sell drugs that they know to be sub-standard or untested, criminal prosecution is certainly warranted.


Also read: Overuse of the word ‘epidemic’ in healthcare warnings has become a common scare tactic


But the fault with the Johnson & Johnson’s hip implant appears to be a design flaw rather than a failure to adhere to prescribed standards. The record suggests that the company did begin a recall process in India, which included payments for revision surgeries for approximately 254 patients while another 774 patients are being monitored by surgeons.

Patient interest in this case is better served by swift and transparent information sharing, followed by just compensation for the suffering. If the company and the doctors cooperate on both counts, the government should consider offering them conditional immunity from criminal prosecution.

The author is Assistant professor at NALSAR University and is co-author of Create, Copy, Disrupt: India’s Intellectual Property Dilemmas published by OUP in 2017.

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