Feds Searching for CEO in Case of Tainted Syringes

By: By MIKE BAKER
By: By MIKE BAKER

RALEIGH, N.C. (AP) - 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 4½ years in prison for fraud and allowing tainted drugs into the
marketplace.
---
Associated Press Writer Estes Thompson contributed to this
report.


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