New Delhi: The Mumbai Police has opened investigation into an eight-year-old case against DePuy Medical Pvt. Ltd, a subsidiary of Johnson and Johnson Pvt. Ltd (J&J), for its faulty hip replacement implants, a top police official said on Thursday. The city police is in the process of recording statements of patients and doctors to collect evidence.
The investigation concerns a complaint filed against DePuy at the Mahim police station in 2011 by an inspector in Food and Drug Administration (FDA), Maharashtra.
The police, having ignored the matter, has now sprung into action after a spate of recent media reports on the subject and the findings of an expert committee.
The central government too became serious about the issue after a Mint investigation brought to light the plight of Indian patients, who had suffered because of faulty implants. A high-level panel set up by the government to look into the matter recommended that every affected patient be compensated.
The suggested amounts range from ₹33 lakh to ₹1.25 crore.
“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 presence of chromium and cobalt levels in their body for the purpose of evidence," Ajinath Satpute, assistant commissioner of police, Mahim division, Mumbai, and the investigating officer in the case, said on the phone.
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.
The Mahim police station has written to the patients asking for their medical records.
“During the course of 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.
Mint has reviewed a copy of the letter.
“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," said Satpute.
Controversy hit J&J when ASR, the hip replacement device, was recalled in India in the wake of global reports of metal poisoning and high failure rate. J&J was also accused of double standards in the payment of compensation in India, having agreed to a hefty compensation of $2.5 billion for around 8,000 US citizens, who had sued the company over the hip implants.
Patients have accused the company of taking a callous approach.
In fact, former Maharashtra FDA commissioner Mahesh Zagade had initiated an investigation in 2011, and filed a criminal case against the company. Considering the seriousness of the issue, he had even recommended that the case be taken up by central investigative agencies.
“There was enough evidence against the company but nothing happened," Zagade said on the phone.
In 2017, the government formed a committee under the chairmanship of Arun Agarwal, former dean of Maulana Azad Medical College, to look into the matter. The panel held the company guilty of failing to issue warnings to the patients of the harms 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.