Johnson & Johnson had got a clean chit from retired Justice BN Srikrishna in February 2014 and submitted it at Mumbai’s Mahim police station where a First Information Report was registered against it in connection with the company’s faulty hip implants, The Indian Express reported on Tuesday.
The police in 2013 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 Indian Penal Code. The police were acting on a complaint filed by the Maharashtra Food and Drug Administration.
The firm, however, sought the opinion of Justice Srikrishna regarding Section 328, which entails a maximum punishment of 10 years in prison. Justice Srikrishna’s 10-page opinion, which was verified by The Indian Express, claimed the police were on a “wrong footing”, revision surgeries are “routine”, no case under Section 328 of the IPC was made out, and that there was no evidence to show that cobalt and chromium – the two metals’ ions that leaked as a result of the faulty implants – were toxic.
Justice Srikrishna’s opinion was based on “discussions with advocates and representatives of the firm” and the Mumbai Police FIR. “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,” the judge wrote in the opinion.
The judge rejected the key allegation that the firm had “shown (a) lackadaisical approach” while investigating the faulty hip implants, arguing that not a single device was sold after August 24, 2010.
The company had submitted the opinion of the former Supreme Court judge to the police after it withdrew the criminal application from the Bombay High Court seeking to quash the FIR on October 14, 2013.
According to a report by an expert committee set up by the Ministry of Health and Family Welfare in February 2017, over 3,600 patients with faulty implants are now untraceable. At least four people died after undergoing surgery to implant the devices. The company itself has admitted that there were 121 “serious adverse events” related to the surgeries in India between January 2014 and June 2017.
The government said it was the company’s responsibility to compensate all patients who reported adverse reactions to faulty hip implants manufactured by a company subsidiary and underwent revision surgeries. The Centre in August asked the Central Drug Standard Control Organisation to set up committees in states to receive complaints from patients who were affected by the faulty devices. The central committee recommended compensation of at least Rs 20 lakh for patients.