Tainted Heparin Syringes Led to Deaths, Illness

Raleigh, NCThe tragedy is that patients using tainted heparin syringes from AM2PAT were sick already, only to have their health further compromised with spinal meningitis, or permanent brain damage. And even death. Five deaths have been linked to contaminated heparin, or saline syringes manufactured by AM2PAT.

On February 23rd of this year the former plant manager and quality control officer were each sentenced to 4 ½ years in prison for fraud--and their roles in allowing contaminated drugs onto the market.

According to a report from the Associated Press, the owner of AM2PAT, Dushyant Patel, has been on the run since his indictment last week on 10 charges including fraud, making false statements and vending adulterated medical devices. There is currently an international search for a man that allowed heparin and saline syringes to be shipped without proper testing.

According to court documents AM2PAT put nearly $7 million worth of heparin and saline syringes into the market in 2006 and 2007. However, it has become apparent that the company put profit before safety. Products were shipped before they were tested for contamination in a blatant attempt to cut corners and maximize profit.

When testing was done, documents were backdated to make it appear as if the syringes had passed procedure before shipping. Other test results, according to prosecutors, were manipulated and fabricated in such a way as to deceive inspectors from the US Food and Drug Administration (FDA).

Critics cite this case as yet another example of the ineffectiveness of the FDA to adequately protect the nation's drug supply. In this case, the tainted heparin syringes were not brought in from foreign shores, but rather originated on American soil, at the AM2PAT plant in Raleigh—a facility that has been described as gloomy, and run-down.

"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," U.S. Attorney George 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."

Heparin and saline are used to flush intravenous lines during cancer treatments, kidney dialysis and other procedures. The product is a common medical aid that is routinely used on hundreds of thousands of patients a day, ranging in age from infants to seniors. Heparin has been much in the news over the last 18 months, with the tainted heparin debacle stemming from China, and even vials of infant and adult-strength heparin becoming mixed up in hospitals.

However, the AM2PAT tainted heparin syringe case was one of the earliest cases of tainted heparin in recent memory, and various lawsuits against the firm have been well in the works for a while.

According to the Associated Press, 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, and AM2PAT owner Dushyant Patel is believed to have fled to his native India.

As authorities race to catch up to the disgraced Dushyant Patel, critics continue to lobby for a stronger, more effective and better-funded FDA which might serve to mitigate such disregard for safety on the part of entities which have been duly licensed to manufacture and supply products destined for the nation's drug supply.

Last night, in a live address to the nation while appearing before a combined gathering of the House and Senate on Capital Hill, President Obama pledged, among other priorities, to resolve the nation's health care crisis. One assumes a beefed-up and more effective FDA will be a part of that equation. As long as the status quo remains, however, the health of Americans will continue to be compromised.

And the courts will continue to be as busy as ever.