No relief for Implant firm

Mumbai: The Bombay HC has declined relief to DePuy Medical Private Ltd, a group company of Johnson & Johnson in a criminal case filed by the FDA for importing faulty orthopaedic implants and neglecting the patients on whom the surgeries were performed.

 

"The probe shall continue. However, chargesheet shall not be filed without prior court permission...in the event, the investigating officer desires to arrest any of the directors or officers of the petitioner, we direct that the IO shall serve 72 hours advance notice, excluding court holidays and Sundays, in writing to enable to avail of appropriate remedy," Justices A S Oka and A P Bhangale observed in their brief order.

 

In the FIR lodged with the Mahim police station on November 19, 2011, FDA inspector R N Tirpude submitted that since the firm has imported defective devices and implanted them on patients, it has 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.

 

"We found that the company imported defective medical devices and implanted them on the patients. No steps were taken for removal of the defective implants. The firm did recall defective products from across the world, but did not take any steps to inform the patients accordinglyIn our opinion, it's an eye-wash," Tirpude said.

 

In his affidavit before the court, Mahim police inspector Kishor Sawant submitted that following a specific complaint, when investigations were carried out, it was found that a several patients had to undergo revisionary surgery. owing to defective implants.

 

"An FSL report showed very high percentage of chromium, cobalt and molybdenum in t in theimplantt...most of the patients have experienced pain, hurt, discomfort and trouble in walking and other painful conditions ," he said. He said that from early 2010 and on their own admission, the firm knew the devices are dangerous, but did not take corrective measures in India.

 

Describing the FDA's criminal complaint as frivolous, vexatious and absurd, the firm told the HC that the FIR was an abuse of process of law and has resulted in a serious miscarriage of justice.

 

It urged the HC to quash the FIR on the grounds that it has not demonstrated any motive in committing any crime. "In the present case, by no stretch of imagination could the company be alleged to have committed any act for the purpose of causing any bodily pain, disease or infirmity. On the contrary, the implants were meant for the elevation of bodily pain or infirmity...the device involved in the FIR was allowed to be imported under a licence granted by the DCGI," it stated.

 

Further, it submitted that all the facts in the complaint were gathered from the internet and various presumptions were drawn, information on the internet was based on hearsay evidence no stringent law can be set into motion on the basis of such a shaky evidence.

 

When the company found that there was higher than expected revision of surgeries with regard to hip resurfacing system, the company decided to recall the productt from across the world. "A global notice was issued to all surgeons directing them to stop implanting the implant device and actions to be taken with regard to their patients...no product was sold after the notice... a remedial and reimbursement process was put in place," it submitted. Of the 4,700 implants, 64 patients have registered, while 28 patients have undergone revision surgery.