Food & Drug Administration wants CBI to probe Johnson & Johnson faulty implant case

MUMBAI: Over two-and-a-half years after it filed a criminal case against DePuy Medical Pvt Ltd, a group company of Johnson & Johnson, for importing faulty orthopaedic implants and neglecting patients on whom surgeries were performed, the Food & Drug Administration (FDA) has urged the state government to entrust the probe to the Central Bureau of Investigation (CBI).

FDA commissioner Mahesh Zagde confirmed to TOI on Wednesday that he had written to the government to entrust the probe to the CBI "in view of the case's magnitude".

In an FIR lodged with the Mahim police on November 19, 2011, FDA inspector R N Tirpude had submitted that since the firm had imported defective devices and implanted them on patients, it had committed a crime under Sections 320 (causing grievous hurt, fracture or dislocation of a bone), 321 (voluntarily causing hurt), 328 (unwholesome drug) and 17-A (using adulterated drug) of the Drugs and Cosmetics Act, 1940.

It was pointed out that the company imported defective medical devices and implanted them, and no steps were taken for their removal. "The firm recalled defective products across the world, but did not take steps to inform patients. It was an eyewash,'' the FDA had said in the FIR.

In his affidavit before court, police inspector Kishor Sawant submitted that after a specific complaint, when investigations were carried out, it was found that many patients had to undergo revisionary surgery owing to the defective implants. "A forensic science laboratory showed a very high percentage of chromium, cobalt and molybdenum in the implant... most patients experienced pain, hurt, discomfort and trouble in walking and other painful conditions,'' Sawant said.

When DePuy moved the Bombay HC in January 2013, it declined relief. It said that while the probe would continue, the charge-sheet should not be filed without prior court permission, and if the investigating officer wanted to arrest any director or officer of the petitioner, he would have to serve 72 hours notice, excluding court holidays and Sundays, in writing to enable them to avail of an appropriate remedy.

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