JOHNSON & Johnson, indicted by the Government’s expert panel for allegedly “suppressing” key facts on the faulty hip implants it manufactured and imported in India, had obtained an opinion as early as February 2014 from retired Justice B N Srikrishna giving itself a clean chit.
The company was then under investigation by the Mumbai Police. Acting on a complaint by the Maharashtra Food and Drug Administration, the police had filed an FIR against Johnson & Johnson under Sections 320 (grievous hurt), 321 (voluntarily causing hurt) and 328 (causing hurt by means of poison, etc., with intent to commit an offence) of the IPC.
However, the firm sought the opinion of Justice Srikrishna regarding Section 328 IPC which entails a maximum punishment of 10 years in prison.
Justice Srikrishna’s 10-page opinion, accessed by The Indian Express, says the police are on a “wrong footing,” revision surgeries are “routine,” no case under Section 328 IPC was made out; there was no evidence to show that cobalt and chromium — the two metals ions that leaked as a result of the faulty device — were toxic.
Three months later, in May 2014, once again based on complaints by patients who were suffering after J&J hip implant surgeries, Maharashtra FDA asked the state government to recommend a CBI investigation into the criminal case filed by Mumbai police against Johnson & Johnson. In July 2015, the Centre decided against a CBI probe.
Significantly, the clean chit to the firm by Justice Srikrishna came just months after Johnson & Johnson, in November 2013, had agreed to pay $2.5 billion to settle thousands of consumer lawsuits in US. Also, the company submitted the opinion of the former SC judge to the police, after it withdrew the criminal application from the Bombay HC seeking quashing of FIR on October 14, 2013.
In fact, by the time Justice Srikrishna gave his opinion, the following facts were in the public domain: J&J had withdrawn the device in India, its licence was cancelled in 2013, its director and employees were questioned by the Mumbai Police and as ,many as 126 patients had undergone revision surgeries in India.
Justice Srikrishna’s opinion, which he says is based on “discussions with advocates and representatives of the firm” and the Mumbai Police FIR, is silent on key facts. It makes no reference to the over 3,600 patients with Johnson & Johnson’s faulty implants who remain untraceable and the deaths that were reported from those who underwent surgeries using these devices. It doesn’t mention that the Australian regulator had withdrawn the product in 2009 itself and this information wasn’t shared with the Indian regulator when it renewed its licence in 2010. It also does not deal with serious adverse reaction reports submitted by the firm itself to the Indian regulator.
The Indian Express sent a detailed questionnaire to Justice Srikrishna but no reply was received. Asked about the judge’s opinion, Johnson & Johnson spokesperson said the company didn’t wish to comment on this issue.
In his opinion, Justice Srikrishna wrote: “Looked from any angle, an offence under Section 328 of the IPC cannot be made out at all because all allegations contained in the FIR are with regard to the distribution of product and failure to recall the products.”
He added: “(Section 328 IPC) cannot be applied to the case of implanted medical devices…even if such devices are alleged to be defective…Section 328, like any other criminal liability section requires the essential ingredient of mens rea. In other words, it would have to be shown that the accused has done what is alleged ‘with intention’. This can hardly arise in the case of distribution of an implanted medical product.”
This opinion was submitted by DePuy Medical Private Limited, the Indian subsidiary of Johnson & Johnson, to Senior Inspector of Police of the Mahim Police station where the FIR was registered.
The judge rejected the key allegation that the firm had “shown (a) lackadaisical approach” while investigating the faulty implants arguing that not a single device was sold after August 24, 2010.
On the allegation that the amount of cobalt and chromium would increase in the patient’s body upon implantation of the faulty device and that the patient suffered from injuries and disorders because of ‘the said toxic metals,” Justice Srikrishna wrote: “There does not appear to be a single case referred to in the FIR of any patient who has thus suffered.” He then goes on to say that, “there is also no medical literature suggesting that there is any standard level of cobalt and chromium in the human body beyond which they become injurious to health.”
“The assumption that cobalt and chromium levels increased in the patients as a result of the implantation of the concerned medical device is purely speculative and appears to be based on no verifiable medical literature,” Justice Srikrishna said. He added that the FIR does not refer to “any medical literature” which would suggest that there is “any standard level of cobalt and chromium in the human body beyond which they would be injurious to health and cause disorders.”
The Government’s expert committee, headed by Arun Agarwal, former Dean, Maulana Azad Medical College, said just the opposite: “accelerated wear of metal on metal implant leads to higher levels of cobalt and chromium in the blood which lead to toxicity…these metal ions damage tissues and further damage body organs” and “may also cause localised and systematic health problems.”