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Published: Apr 10, 2008 12:30 AM
Modified: Apr 10, 2008 03:04 AM
 

Charges focus on contaminated needles

Former lab official in Angier accused

FAYETTEVILLE - A former lab director in Angier will have to stand trial on charges linking him to contaminated syringes that made patients severely ill, a federal judge said Wednesday.

Ravindra Kumar Sharma, a former quality control director at AM2PAT Inc, waived a hearing in a Fayetteville courtroom to review the charges against him. He will remain in federal custody while awaiting trial.

According to court documents, Sharma is accused of approving the shipment of the contaminated syringes, purposely failing to conduct the proper tests meant to ensure that they were safe.

"Sharma consistently falsified or directed others to falsify testing and production records of [syringes]," federal investigator Paul Pierce said in a criminal complaint.

Sharma was arrested Friday and charged with introducing adulterated and misbranded drug devices with the intent to defraud.

Rosemary Godwin, an assistant federal public defender representing Sharma, declined to comment. A spokeswoman at the defender's office was not available Wednesday afternoon.

In December 2007, the Food and Drug Administration issued a release saying that the syringes, which were distributed nationwide, were contaminated with bacteria and that AM2PAT had issued a recall. The FDA warned that the bacteria found in some syringes "could present a serious adverse health consequence that could lead to life-threatening injuries or death."

The FDA inspected the Angier site of AM2PAT and determined employees there "failed to have adequate controls to ensure necessary sterility of its pre-filled syringes," the release says.

Despite the recall, several patients claim they were hospitalized with illnesses caused by the syringes. Lawsuits against AM2PAT, which closed its Angier site, are pending in Illinois.

The Associated Press has reported that about 40 people got sick in Illinois and Texas -- including 20 outpatients from Rush University Medical Center in Chicago.

The syringes typically contained blood thinner to prevent clots in the intravenous lines, a federal agent said in a criminal complaint against Sharma. They were used in hospitals and by outpatients.

Studies performed by the Centers for Disease Control and Prevention linked the syringes to more than 100 illnesses and five deaths, Pierce said in the complaint.

An unidentified employee said that Sharma never tested any syringes, though he was responsible for it, according to the complaint. The syringes were labeled as sterile and shipped.

When a testing device broke in the lab, the employee said that Sharma told her to "just record a value," the complaint said. The testing device was broken between September 2006 and March 2007. Employees recorded false dates of the tests after authorization from an AM2PAT executive, the complaint said.

AM2PAT Inc. is based in Illinois and focuses on manufacturing medical devices. The company had been in good standing, according to records filed with the Office of the Secretary of State for Illinois.

The secretary's records list the company's president as Dushyant Patel. Telephone calls to a number listed for him in Illinois were not accepted.

Sharma's next court appearance has not been scheduled.

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