Feds searching for CEO in case of tainted syringes

For months, prosecutors say, technicians in the gloom of a run-down North Carolina plant prepared life-sustaining syringes and shipped them before ensuring they were sterile.

Investigators believe a rush to maximize profits led Dushyant Patel's AM2PAT Inc. to produce heparin and saline syringes that killed five people and sickened hundreds of others, some resulting in spinal meningitis and permanent brain damage. Authorities are now on an international search for Patel after he was indicted last week on 10 charges including fraud, false statements and selling adulterated medical devices.

U.S. Attorney George Holding said Tuesday that authorities believe Patel has fled to his native India and have turned to Interpol for cross-border aid in catching up to him.

"Our office is committed to pursuing him and bringing him here to account for his actions," Holding said.

Court documents portray a disturbing recklessness that allowed syringes to ship before they were checked for contamination. Reports detailing the testing were backdated to appear they passed procedure before shipping, and some test results were manipulated or fabricated to deceive inspectors from the U.S. Food and Drug Administration, prosecutors said.

Patel's company sold nearly $7 million worth of heparin, a blood thinner, and saline syringes in 2006-07. The plant in Angier, about 20 miles south of Raleigh, cut corners so it could maximize profit, including shipping products quickly without checking on safety, according to court documents.

The syringes were recalled in December 2007 after an outbreak of illnesses. Health inspectors identified bacterial infections in Colorado, Texas, Illinois and Florida and traced the contamination to AM2PAT.

It's a similar disregard for consumer health that congressional leaders portrayed in the salmonella outbreak traced to products from a Georgia peanut plant that sickened 600 people and may have contributed to nine deaths. Company e-mails released by a U.S. House committee showed Peanut Corp. of America owner Stewart Parnell ordered products tainted with the bacteria to be shipped because he was worried about lost sales. Parnell has not been charged, but federal officials are investigating.

Ned Feder, a staff scientist at the Washington-based nonprofit Project On Government Oversight, said the FDA must rely to some extent on the honesty of plants, but that the agency also needs to verify the paperwork companies produce. The FDA doesn't inspect often enough, largely because it is short on staff, he said.

"You hardly turn around and the FDA is breaking news," Feder said. "If it isn't peanuts in Georgia, it's syringes in North Carolina. They're completely different (cases), but they can both be traced back to the fact that the FDA doesn't have the manpower to do the policing it needs to do."

FDA spokeswoman Siobhan DeLancey declined to immediately discuss the syringe case. She acknowledged that it's impossible for inspectors to be in every plant at once but said the FDA performs regular checks.

Several people have sued since the fallout of the tainted syringe case, and prosecutors still aren't sure exactly how many were affected by it. Heparin and saline are used to flush intravenous lines during cancer treatments, kidney dialysis and other procedures.

"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," Holding said. "Sometimes it's hard to determine whether they were killed from the tainted heparin or whether it was the original illness. We're not able to say any more than five."

AM2PAT was incorporated in Chicago, where Patel lived, but had its only plant in North Carolina.

Patel said about a year ago when federal officials were investigating the sicknesses that his company voluntarily recalled the syringes in question and there was "nothing out there anymore." Prosecutors do not know if Patel still has an attorney. He faces up to 95 years in prison, if convicted.

Plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality control director Ravindra Kumar Sharma, 54, of Richmond, Va., each were sentenced Monday in U.S. District Court in Raleigh to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.

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