A North Carolina company has been accused of bypassing sterilization tests for medical syringes in a cost-cutting move. Prosecutors say this has sickened hundreds of patients and led to five deaths. According to U.S. Attorney George Holding, federal authorities have launched an international search for the executive charged with rushing shipments of bacteria contaminated syringes from an AM2PAT Inc. plant. Two former plant workers who provided prosecutors details about the plant’s operations have pleaded guilty for their roles in shipping tainted syringes. The syringes contained Heparin, a blood thinner, and saline, and were recalled in December 2007 after an outbreak of illnesses. Health inspectors identified bacterial infections in Colorado, Texas, Illinois and Florida. Heparin and saline are used to flush intravenous lines during cancer treatments, kidney dialysis and other procedures.
The company sold nearly $7 million worth of heparin and saline syringes in 2006-07. Prosecutors said the facility in Angier, about 20 miles south of Raleigh, N.C. cut corners and failed to follow rules for checking sterility. They also said manufacturing dates were falsified to make it appear that safeguards were followed. The scheme led to bacterial infections in 200 to 300 patients around the country, some of them resulting in spinal meningitis and permanent brain damages, according to the prosecutors. The U.S. Attorney had this to say:
One of the worst things about this case is that the people who were taking saline and heparin, they’re usually sick already or have some debilitative illness and need these medicines to try to get well. Sometimes it’s hard to determine whether they were killed from the tainted heparin or whether it was the original illness. In any event, we’re not able to say any more than five.
The plant manager, Aniruddha Patel, and the quality control director, Ravindra Kumar Sharma, have been sentenced to 4½ years in prison for fraud and allowing tainted drugs into the marketplace. The CEO of the company has left the country.
Source: Associated Press
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