Hunt for mastermind who shipped tainted syringes
Federal authorities are hunting the mastermind behind a “horrific case” in which bacteria-laden syringes shipped from an Angier, N.C., plant sickened hundreds of 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. The court heard of conditions at the plant more consistent with a Third World 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 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 and are seeking help from Interpol.
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 shuttered after an outbreak of Serratia, a bacterial infection, hit patients in Colorado, Texas, Illinois, Florida and other states.
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 production running faster. The drugs were not produced at the plant, but were loaded into syringes there, then shipped.
The plant was subject to U.S. Food and Drug Administration requirements for its production. The syringes were supposed to be loaded in a “clean room,” with employees in caps and gowns and air carefully ventilated to keep germs from spreading.
A photograph entered into evidence Monday shows a “clean room” refreshed with a common window fan 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.
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. If bacteria were cultured from the medicines, the whole batch should have been held back. That wasn’t happening, court documents show.
Batches of syringes went straight from the production line into the marketplace, with Sharma falsifying manufacturing dates to make it appear to regulators that requisite quality tests had been done. And when tests were done, results were ignored.
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.” The scheme led to bacterial infections in 200 to 300 patients, some of them resulting in spinal meningitis and permanent brain damages, prosecutors said.
Dusty Martin, a single father from Independence, Va., 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. Michael Martin recovered, but until his father got a letter last week from the U.S. attorney’s office in Raleigh telling him the infection was caused by a tainted syringe, Dusty Martin labored under the belief he had been careless and caused his son’s illness.