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Tainted syringes killed five people

N.C. plant shipped dirty saline, heparin; two plead guilty, one is sought

Sarah Avery - Staff Writer

Published: Tue, Feb. 24, 2009 04:13AM

RALEIGH -- Federal authorities are hunting the mastermind behind a "horrific case" in which bacteria-laden syringes shipped from an Angier plant sickened at least a hundred people and killed five.

Two men pleaded guilty Monday in U.S. District Court in Raleigh for their roles in ignoring sterility standards at the former AM2PAT Inc. plant. Conditions there appeared more consistent with a textile factory than a pharmaceutical facility.

The men -- plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma -- were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.


Heparin scares

A blood thinner, heparin is widely used in medicine to flush catheters. People on dialysis, getting chemotherapy and receiving other intravenous drugs often use heparin.

In addition to the Angier case, there have been other heparin scares recently:

2008: Heparin manufactured in China was adulterated with a cheap knock-off ingredient, causing more than 60 deaths before the drug was recalled.

2007: An overdose of heparin nearly killed Dennis Quaid's newborn twins, prompting the actor to sue over the way different doses were packaged.

They were rewarded with a relatively light sentence in exchange for information about chief executive officer Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-07 that did not undergo proper sterility testing.

Dushyant Patel, indicted late last week on 10 charges that include fraud and selling adulterated medical devices, has not been arrested. Authorities think he may have fled to his homeland in India. They are seeking help from Interpol to find him.

Heparin is blood thinner, and saline is used for hydration. Both help flush intravenous lines during cancer treatments, kidney dialysis and other procedures.

Syringes from AM2PAT were pulled from the market early last year, and the Angier plant was shut down after an outbreak of Serratia, a bacterial infection, hit patients in Colorado, Texas, Illinois, Florida and other states. No cases were reported in North Carolina.

On Monday, prosecutors laid out a scheme before Judge Terrence Boyle in which the plant's operators routinely failed to follow sterility rules to keep the production line running faster. The drugs were not produced at the plant, but instead were loaded into syringes there, then shipped to hospitals, clinics and even patients' homes.

The plant was subject to U.S. Food and Drug Administration requirements for its production process. The syringes were supposed to be loaded in a "clean room," with employees in caps and gowns and the air carefully ventilated to keep germs from spreading.

A photograph entered into evidence Monday shows a "clean room" refreshed with a common window fan that was held together with duct tape. In another photo, women work on an assembly line under lamps, surrounded by what look like green plastic recycling bins. One bin is resting on its side on the floor between two workers. Floor paint has peeled.

Dates falsified

Once the syringes were loaded with drugs, each batch was required to be held for two weeks, while employees tested for bacteria and other contaminants in solution. If bacteria were cultured from the medicines, the whole batch should have been held back. That wasn't happening, court documents say.

Batches of syringes went straight from the production line into the marketplace, with Sharma falsifying the manufacturing dates to make it appear to regulators that the requisite quality tests had been done.

And when tests were done, the results were ignored. If a sample came up positive for bacteria, employees simply grabbed another until they found one that tested clean.

Even then, the drugs were shipped.

"This is a horrific case," said U.S. Attorney George Holding. "They were preying on the weakest of the weak."

Victims of the tainted drugs -- which prosecutors stated in court documents totaled more than 100, with at least five dead -- wrote letters and gave statements in court Monday. One man from Independence, Va., Dusty Martin, nearly lost his son a year ago after injecting him with the tainted heparin during a routine treatment for the 8-year-old's hemophilia, a condition in which the blood fails to clot.

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This sorta of blind hatred is pure evil. I would envite them to NY to go sight seeing. I would have someone club them over the head. I would place them in a large plastic box. On top of the box I would place a couple free toilets. Then I would have a chilli cook off. The rest is nature.

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When I lived in California in the 90s, a phlebotomist for a respected medical testing lab, decided--on her own and against company protocol--that instead of throwing away used butterfly clips, syringes, etc., she would soak them in a peroxide and water solution, then reuse them. Needless to say, many people wound up testing positive for HIV and Hep-C. At the time, I told my wife that she should either be put in stocks in the heart of San Francisco, where family and friends of those now afflicted could pummel her to death, or hanged. Sadly, I don't even think she received jail time. These idiots should receive similar treatment.

From that time on, if I don't see the needle, etc. coming out of the package, I tell the nurse to throw it out or give me another one.

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