New Delhi: Embroiled in controversies, Johnson and Johnson Pvt. Ltd (JnJ) is likely to face another impending challenge as the Mumbai cops have reopened faulty hip implants case filed against its arm, DePuy Medical Pvt. Ltd. According to a recent media report, the city police has opened the investigation and is documenting statements of patients and doctors to collect evidence.
The investigation concerns an eight years old case filed by an inspector in the Food and Drug Administration (FDA), Maharashtra back in 2011. The case was filed in the Mahim police station.
The genesis of the case goes back to the year 2010 when a hip replacement device namely DePuy ASR was recalled over reports of metal poisoning and high failures due to the presence of toxic chromium, cobalt and a design flaw that filtered into the body, causing danger to lives. It was sold in India by DePuy International, a subsidiary of JnJ.
JnJ was further accused of taking a callous approach and double standard while compensating the victims in India and in the US. The company agreed to pay a hefty amount of $2.5 billion for around 8000 US citizens, who had sued the company over the faulty hip implants.
To look into the matter, the Government constituted a panel, led by Dr Arun Kumar Agarwal, former dean of Maulana Azad Medical College. The panel had held the company guilty of failing to issue warnings to the patients of the danger posed by the orthopaedic implants, and a delay in recalling the device. The firm was “evasive” in providing information, claimed the report by the committee.
Around 4,700 patients have undergone acetabular surface replacement (ASR) surgeries in India between 2004 and 2010. However, only 1,080 patients have been traced so far through the company’s ASR helpline.
In a wake of media reports and the findings of the expert committee, the police have now jumped into action. Ajinath Satpute, assistant commissioner of police, Mahim division, Mumbai, and the investigating officer in the case told Live Mint, “The case has been pending for long. However, it has now gathered speed due to the recent expert committee report. We will do a thorough investigation to take the case to its logical conclusion.”
“We have been contacting patients and the doctors to record their statements. We are also looking into the medical records of the patients and their present status with regard to the presence of chromium and cobalt levels in their body for the purpose of evidence,” Satpute added.
The victims of the faulty hip implants have been contacted by the Mahim police station and the concerned authority has written to patients seeking for their medical records.
“During the course of the investigation, it has come to our knowledge that a medical procedure was conducted and an allegedly faulty ASR hip implant marketed by the accused company was implanted in your body. As such, your assistance in this regard is necessary for further investigation. You are therefore requested to attend this office with all medical papers in respect of pre and post above said medical procedure,” reads the letter.
Prior to this, former Maharashtra FDA commissioner Mahesh Zagade had reportedly initiated an investigation in 2011 and lodged a criminal case against the company and even recommended that the case be taken up by the central investigation agencies.
“There was enough evidence against the company but nothing happened,” Zagade told Live Mint.