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Company Knowingly Shipped Tainted Syringes That Killed Five

Feb 25, 2009 | Parker Waichman Alonso LLP

A manhunt is underway for the  owner of a North Carolina company that knowingly shipped tainted pre-filled syringes.   The syringes, shipped by  AM2PAT Inc. resulted in a massive recall, hundreds of illnesses and at least five deaths.

As we reported previously, in 2007  numerous infections from Serratia marcascens bacteria were traced to heparin-filled syringes made by AM2PAT. In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues.

The AM2PAT facility  in North Carolina was shut down after the contamination problems were discovered.  At the time, the Food & Drug Administration (FDA) said that inspections of the facility revealed that the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

According to the Associated Press, the tainted syringes  were eventually linked to hundreds of infections, some of which resulted in spinal meningitis and permanent brain damage.. Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems.

According to a report in Newsday, AM2PAT  plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.  Patel, who may have fled to his home in India, was indicated last week on 10 charges that include fraud and selling adulterated medical devices, Newsday said.

According to the Associated Press, prosecutors charge that AM2PAT allowed syringes to ship before they were checked for signs of contamination. Reports detailing the testing were backdated to appear they passed procedure before shipping, and some test results were manipulated or fabricated in an attempt to deceive inspectors from the FDA.

According to prosecutors, the company sold nearly $7 million worth of heparin and saline syringes in 2006-07.  If found and convicted of all charges, Patel could face as much as 85 years in prison, the Associated Press said.