Prosecutors: NC company shipped tainted syringes

[samanthajane13]

By MIKE BAKER, Associated Press Writer Mike Baker, Associated Press Writer – 48 mins ago

RALEIGH, N.C. – A North Carolina company is accused of bypassing sterilization tests for medical syringes in a cost-cutting move prosecutors say sickened hundreds of patients and led to five deaths.

U.S. Attorney George Holding said Tuesday that 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 U.S. attorney said investigators believe AM2PAT CEO Dushyant Patel has fled to his native India. Patel was indicted last week on 10 charges including fraud, false statements and selling adulterated medical devices.

"Our office is committed to pursuing him and bringing him here to account for his actions," Holding said. "We're putting all resources available to bringing him back here."

Holding did not know who Patel's attorney was.

AM2PAT is based in Chicago and had a subsidiary in North Carolina.

Patel's 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, 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, prosecutors said. Even more people may have become infected.

"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 its 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."

Patel said about a year ago when federal officials were investigating the outbreak that company voluntarily recalled the implicated syringes and there was "nothing out there anymore."

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.

___

Associated Press Writer Estes Thompson contributed to this report.


http://news.yahoo.com/s/ap/20090224/...inted_syringes

[samanthajane13]

Feds searching for CEO in case of tainted syringes
By MIKE BAKER, Associated Press Writer Mike Baker, Associated Press Writer – Tue Feb 24, 6:25 pm ET



RALEIGH, N.C. – 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.

___

Associated Press Writer Estes Thompson contributed to this report.


http://news.yahoo.com/s/ap/20090224/...inted_syringes

[samanthajane13]

02/25/09 06:16 PM
FDA didn't inspect syringe plant despite reports
By MIKE BAKER
Associated Press Writer

A North Carolina syringe factory linked to hundreds of sicknesses and five deaths operated for almost two years without an inspection despite a series of complaints that its needles were dirty or filled with colored particles.

Court documents in the North Carolina case show the U.S. Food and Drug Administration only inspected the AM2PAT Inc. plant in December 2007 after an outbreak of illness was reported by the Centers for Disease Control and Prevention.

Federal investigators contend that the company was so consumed with maximizing profits that it shipped syringes filled with saline and the blood-thinner heparin from a dingy facility without ensuring they were sterile. Authorities are now searching for the Chicago-based company's CEO Dushyant Patel, who was indicted last week. They believe he fled to his native India.

In 2007, before the outbreak of illness was traced back to the company's syringes, the FDA received more than a dozen reports of problems with AM2PAT's products. Some reported "orange specks" floating inside the unopened syringes, while others reported "yellow sediment" or "muddy brown" syringes filled with floating white specks.

FDA records show the agency first received complaints of particles in AM2PAT syringes in November 2005. FDA spokeswoman Siobhan DeLancey said the company was inspected in January 2006 but then wasn't checked again until the December 2007 inspection: a gap of 22 months.

DeLancey did not have an immediate explanation for why the facility wasn't inspected for so long. But inspections at AM2PAT were frequent by FDA standards. A Government Accountability Office report issued last year found the agency was more likely to inspect manufacturers like AM2PAT every five years.

"Typically a firm is inspected within two years," DeLancey said. "They'd prefer to do them faster, but there's always that resources issue that we have."

The FDA declined this week to release its inspection reports detailing its January 2006 and December 2007 visits to the plant in Angier, about 20 miles south of Raleigh. DeLancey said those reports could be released through a Freedom of Information Act request, which is pending.

But Diana Zuckerman, who tracks health and safety issues as president of the nonprofit National Research Center for Women and Families, said there's no excuse for inaction when people are reporting visible contamination of a product.

"Any time you get to a point where there's a contamination of a syringe you can see with the naked eye, you close down the business if you care about the public health," Zuckerman said. "You have to assume that this is the tip of the iceberg. If 15 people reported it, it happened a lot more than that."

AM2PAT, which also sold products under the name Sierra Pre-Filled, produced syringes of heparin and saline, which are often used on already vulnerable patients during cancer treatments, kidney dialysis and other procedures. Along with five deaths, prosecutors say the tainted product sickened up to 300 people, with some of the illnesses resulting in spinal meningitis and permanent brain damage.

"FDA can complain about resources, but if you're going to triage your resources, I think contaminated syringes would be pretty high on the list (to investigate)," Zuckerman said.

Assistant U.S. Attorney Jason Cowley said a person who had the title of "microbiologist" at the company was a teenager who had dropped out of high school. Photographs that prosecutors introduced as evidence also show a "clean room" with a window fan patched with duct tape. Other photos show a rundown facility with paint chipping from the floor and syringes piled high on a table.

"The pictures speak for themselves in regard to the type of environment that these syringes were being manufactured," Cowley said.

In court documents, investigators contend: the company bypassed internal checks designed to ensure the safety of syringes; testing reports were backdated to make it appear as if the syringes had passed internal inspection before shipping; and some of the test results, which the company was required by federal rules to keep on file, were also manipulated or fabricated.

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.

Prosecutors do not know if Patel still has an attorney. He faces up to 95 years in prison if convicted.


http://www.buffalonews.com/260/story/590254.html

[samanthajane13]

02/25/09 06:21 PM
Timeline: Reports, inspections of syringe factory
The Associated Press

Court documents and federal officials say a North Carolina syringe factory linked to hundreds of sicknesses and five deaths went for almost two years without an inspection despite a series of complaints about dirty needles. Here's a timeline of when the complaints and inspections took place:

2005

- June: U.S. Food and Drug Administration inspects Chicago-based AM2PAT Inc.'s facility in Angier, N.C.

- Nov. 15: FDA receives complaint that someone found particles inside a heparin solution manufactured by AM2PAT.

2006

- January: FDA inspects AM2PAT.

2007

- March 20: FDA receives a complaint that a patient's husband saw "both brown and black particulate matter found throughout unopened flush syringe." The patient was hospitalized with a blood infection. The company later said the sample was not available for evaluation but that it tested samples from the same lot. FDA records do not show those results.

- May 1: FDA receives a complaint that "white particulate matter of various sizes" was found in multiple syringes produced by Sierra Pre-Filled, another name for AM2PAT.

- June 6: FDA receives a complaint that "white precipitate or powder" was found in syringe produced by Sierra Pre-Filled.

- Aug. 24: FDA begins receiving a series of almost a dozen complaints of "muddy brown," yellow, orange and "dingy" syringes, some with debris.

- Dec. 11: The Centers for Disease Control and Prevention advises the FDA of two clusters of infections linked to flushes produced at AM2PAT. Prosecutors say the tainted lot sickened hundreds and killed five.

- Dec. 13: FDA initiates inspection of AM2PAT.

- Dec. 20: AM2PAT issues nationwide recall of product found to be contaminated with bacteria.

2008

- Jan. 18: AM2PAT expands nationwide recall of syringes.

- April: Prosecutors file criminal complaints against two AM2PAT workers.

2009

- Feb. 19: Prosecutors indict AM2PAT CEO Patel Dushyant on a range of charges and begin international search for him. Authorities believe he fled to his native India.

- Feb. 23: Former AM2PAT plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality control director Ravindra Kumar Sharma, 54, of Richmond, Va., are sentenced to 4 1/2 years in prison each for fraud and allowing tainted drugs into the marketplace.

Sources: U.S. Food and Drug Administration; court documents.


http://www.buffalonews.com/260/story/590258.html