This is a disturbing case, having been a victim of greed myself  at the hands of  unscrupulous criminals who wanted to cash in on a billion dollar industry. I hope to see justice for the victims in this case, I know I will not. 

Here is some Background on Dushyant Patel, CEO of AM2PAT, Inc.

AM2PAT, Inc’s headquarters was originally located in Chicago, IL, the company started in 2001 with an est. annual sales of  $4,200,000. The company opened the Angier location last year.

According to documents on the FDA’s website; AM2PAT,Inc. (aka Sierra Pre-Filled, Inc) products were contaminated with Serratia marcescens ,  the first recall was issued on December 20, 2007  for Heparin Lock Flush Solution USP, 100 units/ml, 5ml  in pre-filled syringes. On January 18th, 2008 another recall was issued by the FDA this recall involved multiple products. Patel applied for AM2PAT’s Section 510(k) (Intent to market a medical device) on December 17th, 2003. Patel also made campaign contributions saying he was a homemaker.

Tainted syringes killed five people

Source: Sarah Avery – The News and Observer

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.

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.

Image: The N&O

Image: The N&O

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. You can read the rest of the article here.

In a press release  issued on Monday, United States Attorney George E.B. Holding had this to say about the defendents:

“The crimes committed by Mr. Sharma and Mr. Anu Patel, and the related crimes alleged in the Indictment against AM2PAT and Dushyant Patel constitute the most fundamental breach of the public’s trust. Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product. As we’ve seen in this case, such lies can literally mean the difference between life and death. I hope this case sends a message to medical device makers everywhere: If you cut corners, and violate the public’s trust, we’ll bring you to justice.”

Now let’s hope they are able to track down Patel.